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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One)
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(For the fiscal year ended December 31, 2024)
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 001-40627
SOPHiA GENETICS SA
(Exact name of Registrant as specified in its charter)
Switzerland
(Jurisdiction of incorporation or organization)
La Pièce 12
CH-1180 Rolle
Switzerland
+41 21 694 10 60
(Address of principal executive offices)
George Cardoza
SOPHiA GENETICS, Inc.
401 Park Drive Suite 505
Boston, MA 02215
(617) 982-1210
(Name, telephone, e-mail and/or facsimile number and address of company contact person)
Securities registered or to be registered, pursuant to Section 12(b) of the Act.
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Title of each class |
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Trading symbol(s) |
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Name of each exchange on which registered |
| Ordinary shares, par value CHF 0.05 per share |
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SOPH |
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The Nasdaq Stock Market LLC |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number of outstanding shares of each of the issuer’s classes of capital stock or common stock as of the close of business covered by the annual report. Ordinary shares, nominal value CHF 0.05 per share: 66,687,085
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. o Yes x No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. o Yes x No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes o No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). x Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. o
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. o
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o
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If “Other” has been checked in response to the previous question indicate by check mark which financial statement item the registrant has elected to follow. Item 17 o Item 18 o
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
TABLE OF CONTENTS
ABOUT THIS ANNUAL REPORT
Unless otherwise indicated or the context otherwise requires, all references in this Annual Report to “SOPHiA GENETICS,” “SOPH,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to SOPHiA GENETICS SA and its consolidated subsidiaries.
Trademarks
We own various trademark registrations and applications, and unregistered trademarks, including for “SOPHiA GENETICS,” “SOPHiA DDMTM,” “Alamut,” “SOPHiA Trial Match,” “SOPHiA Insights,” “SOPHiA CDx,” “SOPHiA Awareness” and our corporate logo. All other trade names, trademarks and service marks of other companies appearing in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Presentation of Financial Information
Our consolidated financial statements are presented in U.S. dollars and have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board (“IASB”). None of the consolidated financial statements were prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The terms “dollar,” “USD” and “$” refer to U.S. dollars and the terms “Swiss franc” and “CHF” refer to the legal currency of Switzerland, unless otherwise indicated. We have made rounding adjustments to some of the figures included in this Annual Report. Accordingly, any numerical discrepancies in any table between totals and sums of the amounts listed are due to rounding.
Our fiscal year ends on December 31. References in this Annual Report to a fiscal year relate to our fiscal year ended on December 31 of that calendar year.
Market and Industry Data
This Annual Report contains industry, market and competitive position data that are based on general and industry publications, surveys and studies conducted by third parties, some of which may not be publicly available, and our own internal estimates and research. Third-party publications, surveys and studies generally state that they have obtained information from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information. While we are not aware of any misstatements regarding the industry, market and competitive position data presented herein, these data involve a number of assumptions and limitations and contain projections and estimates of the future performance of the industries in which we operate that are subject to a high degree of uncertainty.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, market opportunity, business strategy, technology, collaborations and partnerships, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this Annual Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others.
Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified in the section titled “Item 3. Key Information—D. Risk Factors” in this Annual Report. These forward-looking statements include, among others:
•our expectations regarding our revenue, gross margin, expenses, other operating results, and cash usage;
•our plans regarding further development of our SOPHiA DDM Platform and its expansion into additional features, applications and data modalities;
•future investments in our business, our anticipated capital expenditures and our estimates regarding our capital requirements, future revenues, expenses, reimbursement rates and needs for additional financing;
•our expectations regarding the market size for our platform, applications, products, and services and the market acceptance they will be able to achieve;
•our expectations regarding changes in the healthcare systems in different jurisdictions, in particular with respect to the manner in which electronic health records are collected, distributed and accessed by various stakeholders;
•the timing or outcome of any domestic and international regulatory submissions;
•impact from future regulatory, judicial, and legislative changes or developments in the United States and foreign countries;
•our ability to acquire new customers and successfully engage and retain customers;
•the costs and success of our marketing efforts, and our ability to promote our brand;
•our ability to increase demand for our applications, products, and services, obtain favorable coverage and reimbursement determinations from third-party payors and expand geographically;
•our expectations of the reliability, accuracy and performance of our applications, products, and services, as well as expectations of the benefits to patients, medical personnel and providers of our applications, products, and services;
•our expectations regarding our ability, and that of our manufacturers, to manufacture our products;
•our efforts to successfully develop and commercialize our applications, products, and services;
•our competitive position and the development of and projections relating to our competitors or our industry;
•our ability to identify and successfully enter into strategic collaborations in the future, and our assumptions regarding any potential revenue that we may generate thereunder;
•our ability to obtain, maintain, protect and enforce intellectual property protection for our technology, applications, products, and services, and the scope of such protection;
•our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property or proprietary rights of third parties;
•our ability to attract and retain qualified key management and technical personnel; and
•our expectations regarding the time during which we will be an emerging growth company under the Jumpstart our Business Startups Act of 2012 (“JOBS Act”) and a foreign private issuer.
These forward-looking statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described in the sections in this Annual Report titled “Item 3. Key Information—D. Risk Factors” and “Item 5. Operating and Financial Review and Prospects” and elsewhere in this Annual Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
PART I
Item 3. Key Information
D. Risk Factors
Our business faces significant risks and uncertainties. You should carefully consider all of the information set forth in this Annual Report and in other documents we file with or furnish to the SEC, including the following risk factors, before deciding to invest in or to maintain an investment in our securities. If any of the events or developments described below were to occur, our business, results of operations, financial condition and prospects could suffer materially and the trading price of our ordinary shares could decline. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.
•We may not be successful in expanding features, applications and data modalities of our SOPHiA DDM Platform and related solutions, applications, products, and services.
•We may experience challenges with the acquisition, development, enhancement and deployment of technology necessary for our data analytics platform technologies.
•If we are unable to expand our sales and marketing capabilities, including through additional strategic relationships, in a cost-effective manner, we may not be able to grow our revenue.
•The coverage and reimbursement status of newly developed applications and products, such as data analytics platforms and related solutions, applications, products, and services, particularly in a new category of diagnostics and therapeutics, is uncertain. An inability to obtain or maintain adequate coverage and reimbursement could limit the commercial potential of our SOPHiA DDM Platform and related solutions, applications, products, and services.
•If we cannot maintain our current relationships and enter into new relationships with hospitals, reference and specialty laboratories and biopharmaceutical companies, our revenue prospects could be reduced.
•We are highly dependent on our senior management team and other qualified personnel, and our business could be harmed if we are unable to retain and attract such personnel.
•Our industry is subject to rapid change, which could make our SOPHiA DDM Platform and related solutions, applications, products, and services obsolete. If we are unable to continue to innovate and improve our SOPHiA DDM Platform and related solutions, applications, products, and services, we could fail to attract new customers and expand our market share and we could lose existing customers and market share.
•We face competition from many sources, some of whom have much greater financial resources, and we may be unable to compete successfully.
•Cybersecurity or data privacy breaches, other unauthorized or improper access, or (distributed) denial service lack of access (e.g., ransomware, persistent DoS/DDoS) could result in additional costs, loss of revenue, significant liabilities, harm to our brand and decreased use of our SOPHiA DDM Platform and related solutions, applications, products, or services.
•If we are not able to obtain, maintain, defend and enforce patent and other intellectual property protection or if the scope of such patent and other intellectual property protection is not sufficiently broad, our competitors could develop and commercialize applications, products, services and technology similar or identical to ours.
•We license patent rights from third-party owners. If such owners do not properly or successfully obtain, maintain, defend and enforce the patents underlying such licenses, or if they retain or license to others any competing rights, our competitive position and business prospects may be adversely affected. If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our relationships with any of our licensors, we could lose license rights that are important to our business.
•We have incurred net losses since our inception and expect to continue to incur losses for the foreseeable future. We may never achieve or sustain profitability.
Risks Related to the Development of Our SOPHiA DDM Platform and Related Solutions, Applications, Products, and Services
We may not be successful in expanding features, applications and data modalities of our SOPHiA DDM Platform and related solutions, applications, products, and services.
Our SOPHiA DDM Platform offers a broad range of genomics applications across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism and other disease areas. A major part of our long-term strategy is bringing new high-impact content to our customers through updates to our platform, which may include expanding our platform with additional features, applications and data modalities and related solutions, applications, products, and services. However, enhancing our platform and developing new related solutions, applications, products, and services poses various risks and challenges, including the inability to develop features, applications, data modalities and services that achieve the desired results, analytical accuracy and utility; the need to alter our platform, solutions, applications, products, or services; the time and resources required for platform, solution, application, service, and product development; uncertainty regarding and potential limitation in the scope of new features, solutions, applications, data modalities, products, or services; and the potential need to obtain U.S. Food and Drug Administration (the “FDA”), European Medicines Agency (the “EMA”), United Kingdom (the “U.K.”) Medicines and Healthcare products Regulatory Agency (the “MHRA”) and other regulatory clearances, authorizations or approvals. Even if we successfully develop a feature, application, data modality, solution, service or product and receive any necessary regulatory clearance, authorization or approval, such feature, application, data modality, solution, service or product may never achieve significant market acceptance among various stakeholders and be commercially successful. The expenses or losses associated with unsuccessful platform innovation or expansion could adversely affect our business revenue growth and results of operations.
This risk may be heightened as we generally sell our platform, solutions, applications, products, and services in industries that are characterized by rapid technological changes, frequent new application and product introductions and changing industry standards. Operating in and servicing such industries require us to develop platform enhancements based on technological innovation on a timely basis. In addition, whereas we purposefully built our SOPHiA DDM Platform in a decentralized manner and strategically positioned it as a “universal operating-system” for multimodal data analytics in order to provide for a broad range of application, product, and service expansion opportunities, certain jurisdictions, such as the Netherlands and the U.K., have implemented or is expected to implement centralized services architectures for electronic healthcare records (“EHR”) where all patient data passes through a single, often government-run, entity rather than being shared directly between the healthcare providers. The widespread implementation of such centralized systems may limit the adoption and development of our platform.
Strong platform, application, product, and service performance, security and reliability are necessary to maintain and grow our business.
We need to maintain and continuously improve the performance, security and reliability of our SOPHiA DDM Platform and related solutions, applications, products, and services. Our platform, solutions, applications, and other products may contain errors or defects, and while we have made efforts to test them and are not aware of any widespread material errors, defects or other performance-related issues, there can be no assurance that our platform, solutions, applications, products, and services do not or will not have performance problems. As we continue to launch more platform features, applications, data modalities, solutions, products, and services, these risks may increase. Poor performance, security and reliability could adversely impact our customers and lead to customer dissatisfaction, adversely affect our reputation and revenues and increase our application, service, and product care, and distribution costs and working capital requirements.
In particular, our SOPHiA DDM Platform and related solutions, applications, products, and services use artificial intelligence, machine learning, data analytics and similar tools that collect, aggregate and analyze data (collectively, “Data Tools”).
The use of such Data Tools poses risks such as incomplete or inaccurate data, human error, or lack of appropriate controls and processes, the technologies underlying how we store and leverage data and their use cases are subject to a variety of laws. Uncertainty around new and emerging Data Tools may require additional investment in the development of proprietary datasets, machine learning, large language models and systems to test for accuracy, bias and other variables and computing capabilities.
We may experience challenges with the acquisition, development, enhancement and deployment of technology necessary for our data analytics platform technologies.
Our business requires sophisticated computer systems and software in order to accurately and efficiently capture, service and process increasing volumes of health data, in particular a growing number of genomic profiles generated by our customers through various NGS test kits, sequencers and sample materials from different manufacturers. Some of the technologies are changing rapidly and we must continue to adapt to these changes in a timely and effective manner at an acceptable cost. There can be no assurance that we will be able to develop, acquire, enhance, deploy or integrate new technologies, including technologies needed to integrate new genomics test kits into our data analytics platform, that these new technologies will be effective and efficient, will meet our needs or achieve our expected goals or that we will be able to do so as quickly or cost-effectively as our competitors. Significant technological change could render our data analytics platform and technologies obsolete and incompatible with new or improved genomics test kits. In addition, we may face challenges in expanding into markets without suitable cloud infrastructure compatible with our SOPHiA DDM Platform. Our continued success will depend on our ability to adapt to changing technologies, manage and process ever-increasing amounts of data and information and improve the performance features of our data analytics platform technologies in response to an ever-changing patient population. We may experience difficulties that could delay or prevent the successful design, development, testing and introduction of new versions of our data analytics platform technologies, limiting our ability to identify new solutions, applications, products, and services. Any of these challenges could have a material adverse effect on our operating results and financial condition.
Any failure to offer high-quality support for our applications, products, and services may adversely affect our relationships with customers and collaborators and negatively impact our reputation and our business, financial condition and results of operations.
In implementing and using our SOPHiA DDM Platform and related solutions, applications, products, and services, our customers and collaborators depend on our support to resolve issues in a timely manner. We may be unable to respond quickly enough to accommodate short-term increases in demand for customer support. Increased customer demand for support could increase costs and adversely affect our financial condition and results of operations. In addition, we need highly trained technical support personnel. Hiring technical support personnel is very competitive in our industry due to the limited number of people available with the necessary scientific and technical backgrounds and ability to understand our technology at a technical level. Our sales are highly dependent on our reputation and on positive recommendations from our customers, users, care collaborators, providers, laboratories, hospitals and clinics. If we do not maintain high-quality customer support, or if the market perceives that we do not maintain high-quality customer support, our reputation and our business, financial condition and results of operations could be adversely affected.
Delays in the commencement and successful completion of multimodal clinical studies, and negative or ambiguous data generated from such studies, could increase costs and delay or prevent regulatory approval of our SOPHiA DDM Platform and related solutions, applications, and products.
To further improve our SOPHiA DDM Platform and its capabilities, for example by developing new predictive algorithmic models that we can deploy on our platform, we are sponsoring and intend to continue to sponsor observational multimodal clinical studies in various disease areas. These clinical studies are subject to numerous risks. Events that may prevent successful or timely commencement and completion of multimodal clinical studies include:
•delays in receiving the required regulatory clearance from the appropriate regulatory authorities to commence the studies, delays in reaching an agreement on acceptable terms with prospective contract research organizations (“CROs”) and participating sites and difficulties in obtaining required Institutional Review Board (“IRB”) or ethics committee approval at each participating site;
•challenges in recruiting and enrolling suitable patients that meet the study criteria to participate in the studies, which challenges may be heightened for any clinical study that seeks to enroll patients with characteristics that are found in a small population;
•our CROs or participating sites failing to comply with regulatory requirements or meet their contractual obligations to us, which risk may be heightened by our reliance on third parties;
•lower than anticipated patient retention rates and difficulties in maintaining contact with patients, resulting in incomplete data;
•changes in regulatory requirements and guidance;
•lack of adequate funding to continue the study; or
•delays and disruptions as a result of unforeseen external events.
Furthermore, there can be no assurance that any multimodal clinical study will produce the data necessary to support further development of our platform in a particular disease area or to support any potential regulatory submission. Even if a study is completed, the data generated may be negative, ambiguous or otherwise insufficient. To obtain sufficient data, we may be required to conduct additional studies beyond those that we currently plan for, which would increase our costs and delay potential regulatory submissions and commercialization activities.
If we do not have the support of key opinion leaders or clinical data using our applications and products is not published in peer-reviewed journals, it may be difficult to drive adoption of our applications and products.
We have established relationships with leading thought leaders. If these key opinion leaders determine that our SOPHiA DDM Platform and related solutions, applications, products, and services are not accurate or that alternative technologies, applications, products, and services are more accurate or more cost-effective, or if we fail to establish new relationships with key opinion leaders in different markets, geographies and among various stakeholders, we may see lower demand for our SOPHiA DDM Platform and related solutions, applications, products, and services, which would limit our revenue growth and our ability to achieve profitability.
The publication of clinical data using our applications and products in peer-reviewed journals is also crucial to our success. We are unable to control when, if ever, results of current or future trials and projects are published, which may delay or limit adoption of our SOPHiA DDM Platform and related solutions, applications, products, and services. Such peer-reviewed publications may be limited by many factors, including delays in the completion of, poor design of, or lack of compelling data from, clinical studies, as well as delays in the review, acceptance and publication process. If our SOPHiA DDM Platform and related solutions, applications, products, and services do not receive sufficient favorable exposure in peer-reviewed publications, the rate of adoption of our SOPHiA DDM Platform and related solutions, applications, products, and services among medical personnel and positive reimbursement coverage determinations for them could be adversely affected.
Risks Related to Commercialization
If we are unable to expand our sales and marketing capabilities, including through additional strategic relationships, in a cost-effective manner, we may not be able to grow our revenue.
Our future sales will depend in large part on our ability to develop, train and retain our sales force, to increase the scope of our marketing efforts, including into markets and geographies where our presence is currently limited, and to maintain our current strategic relationships and enter into new strategic relationships.
We are continuously expanding our sales and marketing infrastructure. Retaining and training qualified sales and marketing personnel requires significant time, expense and attention. Competition for such personnel is intense. It often takes several months or more before a sales representative is fully trained and productive, depending on the target market or geography. Our sales force may subject us to higher fixed costs than those incurred by our competitors that utilize independent third parties, which could place us at a competitive disadvantage.
In addition, we currently have multiple strategic relationships with third-party providers of solutions, applications, products, and services that can be bundled with our SOPHiA DDM Platform and offer our SOPHiA DDM Platform and related solutions, applications, products, and services through various global and local distributors. There is no guarantee that we will be successful in maintaining our existing arrangements or entering into new arrangements on favorable terms. Most of our distribution relationships are non-exclusive and permit such distributors to distribute competing applications and products. As such, our distributors may not commit the necessary resources to market our applications and products to the level of our expectations or may choose to favor marketing the applications and products of our competitors. If current or future distributors do not perform adequately or we are unable to enter into effective arrangements with distributors in particular geographies, we may not achieve revenue growth and realize our expansion strategy.
Sales and marketing activities in the healthcare space are subject to various rules and regulations. In addition, our marketing messaging can be complex and nuanced, and there may be errors or misunderstandings in our sales force’s communication of such messaging. As we continue to grow our sales and marketing efforts, we face an increased need to continuously monitor and improve our policies, processes and procedures to maintain compliance with a growing number and variety of laws and regulations. To the extent that there is any violation, whether actual, perceived or alleged, of our policies or applicable laws and regulations, we could incur additional training and compliance costs, receive inquiries from third parties or be held liable or otherwise responsible for such acts of noncompliance. Any of the foregoing could adversely affect our business, reputation and results of operations.
The commercial success of our SOPHiA DDM Platform and current and future applications, products, and services depend on attaining significant market acceptance.
Our commercial success depends, in part, on market acceptance of our SOPHiA DDM Platform and our applications, products, and services. We cannot predict how quickly, if at all, our SOPHiA DDM Platform and related solutions, applications, products, and services will attain significant market acceptance or, if accepted, how frequently they will be used. These constituents must believe that our SOPHiA DDM Platform and related solutions, applications, products, and services offer benefits over other available alternatives. The degree of market acceptance of our SOPHiA DDM Platform and related solutions, applications, products, and services depends on a number of factors, including:
•whether there is adequate utilization of our SOPHiA DDM Platform and related solutions, applications, products, and services based on their potential and perceived advantages over those of our competitors;
•the safety, accuracy and ease of use of our SOPHiA DDM Platform and related solutions, applications, products, and services relative to those currently on the market;
•our ability to develop, commercialize and obtain regulatory clearance or approval for in vitro diagnostic (“IVD”) applications and products for diagnostic use and our compliance with the FDA’s “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”) and other laws and regulations governing Research Use Only (“RUO”) and IVD applications and products in the United States (“U.S.”), and other geographies;
•our ability to be compliant with the phased introduction of the European Union (EU) IVD Regulation 2017/746 including new product submissions;
•the clinical flexibility, operational versatility and technology agnostic nature of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•the prices at which we and our distributors offer our SOPHiA DDM Platform and related solutions, applications, products, and services;
•the effectiveness of our sales and marketing efforts;
•our ability to provide incremental data that show the clinical benefits and cost-effectiveness, and operational benefits, of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•our ability to build and maintain robust data sets with respect to patient populations, both in geographic regions that we have historically served and in geographic regions that we may seek to enter or further penetrate in the future;
•the coverage and reimbursement acceptance of our applications, products, and services;
•pricing pressure, including from group purchasing organizations (“GPOs”), seeking to obtain discounts on our SOPHiA DDM Platform and related solutions, applications, products, and services based on the collective bargaining power of the GPO members;
•negative publicity regarding our or our competitors’ platforms, applications, products, and services; and
•the accuracy of our SOPHiA DDM Platform and related solutions, applications, products, and services relative to those of our competitors.
Additionally, even if our SOPHiA DDM Platform and related solutions, applications, products, and services achieve widespread market acceptance, they may not maintain that market acceptance over time if more cost-effective or more favorably received platforms, applications, products, services or technologies are introduced. Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue.
There can be no assurance that we will be able to further penetrate our existing markets, that our existing markets will be able to sustain our current and future solutions, applications, products, and services offerings and that we will be able to expand into new markets. Any failure to increase penetration in our existing markets or expand into new ones would adversely affect our revenues and results of operations.
The market opportunities for our SOPHiA DDM Platform and related solutions, applications, products, and services may be smaller than we estimate.
Our estimates of the addressable market for our SOPHiA DDM Platform and related solutions, applications, products, and services are derived from a variety of sources, including scientific literature, surveys of clinicians, medical personnel and healthcare professionals and other forms of market research. These estimates may be inaccurate or based on imprecise data. Further, these estimates are based on various assumptions, including the outcomes of clinical studies, and whether the clinical studies will achieve objectives needed to meet clinical and payor expectations, the number of people who have a particular disease or condition, our expansion into other features, applications and data modality opportunities and disease areas, maintenance and expansion of our clinical and multimodal data sets for patient populations in specific geographic regions, the prices at which we and our distributors provide or sell our SOPHiA DDM Platform and related solutions, applications, products, and services in the market, the regulatory framework governing the development, sale and use of our SOPHiA DDM Platform and related solutions, applications, products, and services, including the laws and regulations governing RUO and IVD applications and products, the degree of coverage and reimbursement, the cost-containment efforts by payors, customers and collaborators as well as obtaining necessary clearance or regulatory approvals. While we believe our assumptions and estimates are reasonable, these assumptions and estimates may prove to be incorrect and the conditions supporting our assumptions or estimates may change at any time. If the addressable market for our SOPHiA DDM Platform and related solutions, applications, products, and services is smaller than our estimates, or if the prices at which we can sell our SOPHiA DDM Platform and related solutions, applications, products, and services are lower than our estimates, our business, financial condition, and results of operations could be negatively impacted.
The coverage and reimbursement status of newly developed applications and products, such as data analytics platforms and related solutions, applications, products, and services, particularly in a new category of diagnostics and therapeutics, is uncertain. An inability to obtain or maintain adequate coverage and reimbursement could limit the commercial potential of our SOPHiA DDM Platform and related solutions, applications, products, and services.
The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford our current and future platforms, solutions, applications, products, and services, if approved for IVD use. In addition, because our SOPHiA DDM Platform and related solutions, applications, products, and services represent new approaches to the research, diagnosis, detection and treatment of diseases, we cannot accurately estimate how they would be priced, whether reimbursement could be obtained or any potential revenue generated.
Sales of our SOPHiA DDM Platform and related solutions, applications, products, and services, if approved for IVD use, may depend substantially on the extent to which they are covered by health maintenance, managed care and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our SOPHiA DDM Platform and related solutions, applications, products, and services. Even if coverage is provided, the available reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our research and development and sales and marketing costs.
Coverage and reimbursement are ever changing, and we are not in control of how our competitors’ coverage and pricing strategies are established. Some of our competitors have widespread brand recognition and substantially greater financial and technical resources and development, production and marketing capabilities than we do. Others may develop lower-priced, less complex tests that payors and healthcare professionals could view as functionally equivalent to our applications and products, which could force us to lower the list price of our tests and impact our operating margins and our ability to achieve and maintain profitability. Payors may compare our applications and products to our competitors and utilize them as precedents, which may impact our coverage and reimbursement. In addition, technological innovations that result in the creation of enhanced diagnostic tools that are more effective than ours may enable other clinical laboratories, hospitals, medical personnel or medical providers to provide specialized diagnostic tests similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible.
Cost-containment efforts of our customers and third-party payors could have a material adverse effect on our sales and profitability.
Increasing efforts by governmental and third-party payors to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for newly cleared, authorized or approved devices and medicines and, as a result, they may not cover or provide adequate payment for our platform and related solutions, applications, products, and services. Such efforts include legislation and regulations designed to control pharmaceutical and biological pricing and hospitals’ participation in group purchasing organizations (“GPOs”) and Integrated Delivery Networks (the “IDNs”) that negotiate pricing arrangements with medical device companies and distributors.
We expect that a significant portion of our revenue will be derived from sales to customers for research and development applications. The demand for our SOPHiA DDM Platform and related solutions, applications, products, and services will depend in part upon the research and development budgets of these customers, which are impacted by factors beyond our control. In addition, academic, governmental and other research institutions that fund research and development activities may be subject to stringent budgetary constraints that could results in spending reductions, reduced allocations or budget cutbacks, which could jeopardize the ability of these customers to purchase our applications and products.
Risks Related to Our Business Strategy
Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our SOPHiA DDM Platform and related solutions, applications, products, and services and manage our inventory.
To ensure adequate inventory supply, we must forecast inventory needs and assemble products related to our SOPHiA DDM Platform and services based on our estimates of future demand. Our ability to accurately forecast demand could be negatively affected by various factors, including our failure to accurately manage our expansion strategy, application and product introductions by competitors, change in customer demand, changes in customer acceptance, changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions. Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which would adversely affect our gross margin and impair the strength of our brand. Conversely, if we underestimate customer demand for our SOPHiA DDM Platform and related solutions, applications, products, and services, our supply chain, manufacturing collaborators and/or internal manufacturing team may not be able to deliver components to meet our requirements, which could damage our reputation, sales growth, and customer relationships. In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, if at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, which could adversely affect our business, reputation, and results of operations.
We have in the past and may in the future acquire other businesses, which could require significant management attention, disrupt our business, dilute shareholder value and adversely affect our results of operations.
As part of our business strategy, we have in the past and may in the future acquire complementary companies, platforms, applications, products, or technologies that we believe fit within our business model and can address the needs of our current and potential customers. There can be no assurance that we can acquire or successfully integrate such companies, platforms, applications, products, or technologies into our business, in particular that we can successfully integrate any acquired technology into our SOPHiA DDM Platform. We may not be able to find suitable acquisition candidates, and we may not be able to complete such acquisitions on acceptable terms, if at all. In addition, the pursuit of potential acquisitions may divert the attention of management and cause us to incur additional expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. If we do complete acquisitions, we may not ultimately strengthen our competitive position or achieve our strategic goals and any acquisitions we complete could be viewed negatively by our customers, investors and industry analysts. We may not be aware of all of the risks associated with the acquired business. In addition, an acquisition may result in unforeseen operating difficulties and expenditures, such as:
•difficulties integrating businesses, services, personnel, operations and financial and other controls and systems and retaining key employees;
•assumption of unknown liabilities, known contingent liabilities, that become realized or known liabilities that prove greater than anticipated;
•difficulties retaining the customers or employees of any acquired business;
•incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill;
•entry into a new market or business line in which we have no prior experience and in which we may not successfully compete;
•integration of an acquired company, which may disrupt ongoing operations and require management resources that would otherwise be used in developing our existing business; and
•divergent interests from those of our collaborators.
Acquisitions involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures and languages, currency risks, and the particular economic, political and regulatory risks associated with specific countries.
Any such acquisitions may reduce cash available for operations and other uses and could result in amortization expense related to identifiable assets acquired. We may have to pay cash, incur debt or issue equity securities to pay for any such acquisition, each of which could adversely affect our financial condition and the value of our ordinary shares. The sale or issuance of equity securities to finance any such acquisitions would result in dilution to our current shareholders. The incurrence of indebtedness to finance any such acquisition would result in fixed obligations and could also include restrictive covenants that impede our ability to manage our operations. In addition, our results of operations may be adversely affected by the dilutive effect of an acquisition, performance earn-outs or contingent bonuses, and restructuring costs associated with an acquisition.
Risks Related to Our Relationships with Third Parties
If we cannot maintain our current relationships and enter into new relationships with hospitals, reference and specialty laboratories and biopharmaceutical companies, our revenue prospects could be reduced.
We collaborate with various constituents in the healthcare ecosystem, such as hospitals, reference and specialty laboratories, and biopharmaceutical companies to analyze patient samples for multiple applications; strategic partners with whom we combine our SOPHiA DDM Platform with their offerings and with whom we jointly develop application, product, and service offerings; and manufacturers, suppliers and distributors of our products and offerings. See “Item 10. Additional Information—Material Contracts.” There can be no assurance that these collaborations will be successful or provide benefits to us as we expect. The revenue attributable to such relationships may fluctuate from period to period, which could adversely affect our financial condition and results of operations. In addition, the termination of these relationships could result in a temporary or permanent loss of revenue and could negatively impact our reputation.
Our future success depends in part on our ability to maintain these relationships and to establish new relationships, including with additional partners and collaborators and with governmental and third-party payors and patients. Many factors have the potential to impact such relationships, including our customers’ and collaborators’ satisfaction with our SOPHiA DDM Platform and related solutions, applications, products, and services, their perceptions of our SOPHiA DDM Platform, which may be impacted by decisions of our other collaborators, and our ability to respond to the evolving needs of our customers. Furthermore, our customers may decide to decrease or discontinue their use of our SOPHiA DDM Platform and related solutions, applications, products, and services due to changes in clinical routine, research and development plans, financial constraints or utilization of internal testing resources or tests. In addition, our collaborators may decide to discontinue providing services or manufacturing products, for instance testing kits, complementary to or compatible with our SOPHiA DDM Platform and related solutions, applications, products, and services, in particular, applications and products offered as part of “bundle” solutions together with our SOPHiA DDM Platform. Furthermore, our collaborators with whom we entered into both manufacturing and distribution agreements may be dis-incentivized from adequately performing their obligations under the applicable distribution agreement if we substantially decrease the quantities of products purchased from them under the manufacturing agreement or terminate the manufacturing agreement. In addition to reducing our revenue, the loss of one or more of these relationships may reduce our exposure to clinical routine and research that facilitate the collection and incorporation of new data, including new genomic profiles, into our SOPHiA DDM Platform.
We engage in conversations with potential collaborators regarding commercial opportunities on an ongoing basis. There can be no assurance that any of these conversations will result in a commercial agreement, or if an agreement is reached, that the resulting relationship will be successful or that clinical or research studies conducted as part of the engagement will produce successful outcomes.
Our operating results depend on the performance of third-party distributors.
A portion of our sales is made through independent global and regional distributors that are not fully under our control. We rely on distributors to grow and develop our customer base and anticipate customer needs, and any lack of such actions by our distributors may adversely affect our results of operations. If the business relationship with such distributor is terminated, whether through industry consolidation or otherwise, and we are unable to find a suitable replacement, our operations and operating results could be materially adversely affected. While in such instances we would revert to using internal resources to service the market in the impacted geography, the hiring process and building a support infrastructure for a given market, can be time consuming and there could be customer attrition in the interim period.
These independent distributors also generally represent applications and products offered by several companies and are not subject to any minimum sales requirements or obligation to market our applications and products to their customers. In turn, distributors could reduce their sales efforts for our applications and products or choose to terminate their representation of us. They may also fail to perform their obligations under the agreements with us, including their obligations to ensure that end users of our SOPHiA DDM Platform are aware that informed consent is required from patients prior to obtaining access to our SOPHiA DDM Platform.
We rely on third-party service providers to host and deliver our SOPHiA DDM Platform and related services, and any interruptions or delays in these services could harm our business.
We currently serve our customers from third-party data center hosting facilities located in the United States, Canada, Brazil, Switzerland, France, Netherlands, Turkey, United Arab Emirates and Australia. Our operations depend, in part, on our third-party facility providers’ ability to protect these facilities against damage or interruption from natural disasters, power or telecommunications failures, criminal acts, and similar events. In the event that our data center arrangements are terminated, or if there are any lapses of service or damage to a center, we could experience lengthy interruptions in providing our SOPHiA DDM Platform and related solutions, applications, products, and services as well as delays and additional expenses in making new arrangements.
In addition, we currently use Microsoft Corporation (“Microsoft”) and Microsoft Azure Services for a substantial portion of our computing, storage, data processing, networking and other services. Our platform can also be deployed onto other platforms, including Amazon Web Services (“AWS”) or Google Cloud Platform (“Google Cloud”). Any significant disruption of, or interference with, our use of Microsoft Azure Services, AWS, Google Cloud or other similar cloud platforms, could affect the use of, and our customers’ satisfaction with, our applications, products, and services and could harm our business, results of operations and reputation.
Cloud providers have broad discretion to change and interpret the terms of service and other policies with respect to us, and those actions may be unfavorable to our business operations. Cloud providers may also take actions beyond our control that could seriously harm our business, including discontinuing or limiting our access to one or more services, increasing pricing terms, terminating or seeking to terminate our contractual relationship altogether or altering how we are able to process data in a way that is unfavorable or costly to us. If our arrangements with cloud providers were terminated, we could experience interruptions on our platform and in our ability to make our content available to users, as well as delays and additional expenses in arranging for alternative cloud infrastructure services. Any transition to new cloud providers would be difficult to implement and would cause us to incur significant delays and expense.
We rely on third-party manufacturers for the supply, manufacture and production of our products. Our reliance on these third parties may impair the advancement and commercialization of our products.
We rely, and expect that we will continue to rely, on third parties for the manufacturing and supply of our products offered with our SOPHiA DDM Platform, and such reliance on third-party manufacturers may expose us to different risks than if we were to manufacture products ourselves. If our agreements with these third parties expire or are terminated, there can be no assurance that we would be able to negotiate new agreements with them or other third parties on equally favorable terms as the current agreements, or at all.
Reliance on third-party providers exposes us to different risks than if we were to manufacture and supply products ourselves. For example, third-party manufacturers may fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable prices, and we may be unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality on a timely basis. Further, as we do not have control over a manufacturer’s compliance with applicable manufacturing standards and other laws and regulations, we may receive required materials for, or components of, our products that are defective, contaminated or otherwise not conforming to applicable quality control specifications, warranties and statutory and regulatory requirements. Any failure to achieve and maintain compliance with laws, regulations and standards could lead to suspension of the manufacturing and sales of our products, revocation of obtained regulatory clearance, product recalls, marketing or promotional restrictions, litigation, customer loss and reputational harm. Further, our manufacturing collaborators may be unable to successfully increase the manufacturing capacity for our products in a timely or cost-effective manner, or at all, as needed for our development efforts or, if our additional products are developed and approved, our commercialization efforts.
Establishing additional or replacement manufacturers could take a substantial amount of time and be expensive, which may result in interruptions in our operations and product delivery, negatively affect the quality and performance of our products or require that modifications be made to our products’ designs. Even if we are able to find replacement manufacturers, we will be required to verify that the new manufacturer maintains facilities, procedures and operations that comply with our quality expectations and applicable regulatory requirements. If we are unable to find an adequate replacement or another acceptable solution in time, our research and development and commercial activities could be harmed.
We rely on third parties to conduct multimodal clinical studies. If they do not properly and successfully perform their obligations to us, we may not be able to gather data necessary to support further development of our SOPHiA DDM Platform in a particular disease area or to support potential regulatory submissions and commercial activities.
We rely, and we expect that we will continue to rely, on third parties to assist in managing, monitoring and otherwise carrying out multimodal clinical studies of the performance of our SOPHiA DDM Platform and related solutions, applications, and products. As a result of our reliance on these third parties, we have less direct control over the conduct, timing and completion of these studies than we would otherwise have if we relied entirely upon our own staff. If these third parties do not successfully carry out their duties under their agreements, or if the quality or accuracy of the data they obtain is compromised, or if they fail to comply with study protocols or meet expected deadlines, the multimodal clinical studies of our SOPHiA DDM Platform and related solutions, applications, and products, may fail to generate data necessary to support further development of our platform in a particular disease area or to support potential regulatory submissions and commercial activities and could subject us to liability claims. If third parties fail to comply with applicable regulatory requirements, the data generated in the multimodal clinical studies may be unreliable and these studies may be extended, delayed, suspended or terminated and we could be subject to liability claims.
We compete with many other companies for the resources of these third parties. These third parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources away from our studies. If any of our relationships with these third parties terminate, we may not be able to enter into alternative arrangements or to do so on commercially reasonable terms. As a result, delays may occur in our studies, which can materially impact our ability to meet our desired development, regulatory and commercialization timelines. There can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, results of operations, financial condition and prospects.
Performance issues, service interruptions or price increases by our shipping carriers and warehousing providers could adversely affect our business, reputation and ability to provide our products on a timely basis.
Expedited, reliable shipping and delivery services and secure warehousing are essential to our operations. We rely on providers of transport services for reliable and secure point-to-point transport of our research and diagnostic products and for tracking of these shipments, and from time to time require warehousing for our products. Should a carrier encounter delivery performance issues such as loss, damage or destruction of any systems, it would be costly to replace such systems in a timely manner and such occurrences may damage our reputation, reduce demand for our SOPHiA DDM Platform and related solutions, applications, products, and services and increase costs and expenses to our business. In addition, any significant increase in shipping or warehousing rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters, civil unrest and disturbances or other service interruptions affecting delivery or warehousing services we use would adversely affect our ability to process orders for our products on a timely basis and adversely affect specimen integrity and our ability to process samples in a timely manner. We carry marine cargo insurance, covering certain potential losses related to the shipment of our products, in an amount that we believe is reasonable for our business, but there can be no assurance that such potential losses will be covered or will not exceed our policy limits.
Risks Related to Our Business and Industry
We are highly dependent on our senior management team and other qualified personnel, and our business could be harmed if we are unable to retain and attract such personnel.
We are highly dependent on our senior management, including our Chief Executive Officer and co-founder Dr. Jurgi Camblong. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists and other highly skilled personnel. The inability to attract and retain members of our senior management, sales and marketing professionals, scientists, IT and data experts or clinical and regulatory specialists could result in delays in application and product development and commercialization and harm our business.
To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have granted and intend to continue to grant share-based compensation awards that vest over time.
The value to employees of such awards is significantly affected by movements in our share price due to market volatility, and such awards may be insufficient to retain key employees and senior management, as well as to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice. We do not maintain “key person” insurance policies.
Our industry is subject to rapid change, which could make our SOPHiA DDM Platform and related solutions, applications, products, and services obsolete. If we are unable to continue to innovate and improve our SOPHiA DDM Platform and related solutions, applications, products, and services, we could fail to attract new customers and expand our market share and we could lose existing customers and market share.
Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new application, product, or service introductions and enhancements and evolving industry standards, all of which could make our SOPHiA DDM Platform and related solutions, applications, products, and services and others we are developing obsolete. Our future success will depend on our ability to keep pace with the evolving needs of our customers on a timely and cost-effective basis and to pursue new market opportunities that develop as a result of scientific and technological advances.
In recent years, there have been numerous advancements in genomics and our understanding of cancer, rare diseases, cardiology, neurology, metabolism and infectious diseases. There have also been advancements in methods used to analyze very large amounts of molecular information. New technologies, including new artificial intelligence/machine learning-powered technologies, and evolving business models in the field of precision medicine continue to develop rapidly. We must continuously enhance our offerings and develop new and improved features, applications and data modalities of our SOPHiA DDM Platform and related solutions, applications, products, and services to keep pace with scientific and industry developments. If we do not leverage or scale our database of genomic profiles or update our data analytics platform and improve our services and research and diagnostic applications and products to reflect new scientific knowledge, including in the fields of oncology and hereditary disorders, our SOPHiA DDM Platform and related solutions, applications, products, and services could become obsolete and sales of our SOPHiA DDM Platform and related solutions, applications, products, and services could decline or fail to grow as expected. A failure to make continuous improvements to our SOPHiA DDM Platform and related solutions, applications, products, and services to keep ahead of those of our competitors could result in the loss of customers or market share.
We face competition from many sources and we may be unable to compete successfully.
There are a number of healthcare technology companies providing bioinformatics analysis solutions, applications, services, and products in North and South America, Europe and Asia. See “Item 4. Information on the Company—Business Overview—Competition.” These competitors provide AI-driven precision medicine platforms, applications, services, and research and diagnostic products to hospitals, researchers, medical personnel, laboratories and other medical facilities. Many of these organizations, particularly in the United States, are more established, possess regulatory clearances and approval, have broader or deeper relations with healthcare professionals, customers and third-party payors, have greater ability to price their platforms, solutions, applications, products, and services competitively and have significantly greater financial and personnel resources and market share than we do. As a consequence, they may be able to spend more on application and product development, marketing, sales and other application and product initiatives than we can. Our continued success depends on our ability to:
•further penetrate the disease diagnostic solutions market and increase utilization of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•maintain and widen our technology lead over competitors by continuing to innovate and deliver new application and product enhancements on a continuous basis;
•cost-effectively develop and improve our SOPHiA DDM Platform and related solutions, applications, products, and services;
•add new clinically relevant features, applications and data modalities to our SOPHiA DDM Platform and related solutions, applications, products, and services, such as anatomical pathology and proteomics, and generate suitable evidence supporting the research and clinical utility of our multimodal analytical approach ahead of our competitors; and
•maintain existing and establish additional research and development, manufacturing, distribution and commercialization collaborations and partnerships.
Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, development of our SOPHiA DDM Platform and related solutions, applications, products, and services. Because of the complex and technical nature of data-driven healthcare analysis and the dynamic market in which we compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our ability to develop and commercialize our SOPHiA DDM Platform and related solutions, applications, products, and services, which would have a material adverse effect on our business, financial condition and results of operations.
As we attain greater commercial success, our competitors are likely to develop technology, platforms, applications, products, and services that offer features and functionality similar to ours. Improvements in existing competitive technology, platforms, applications, products, and services or the introduction of new competitive technology, platforms, applications, products, and services may make it more difficult for us to compete for sales, particularly if competitors demonstrate better accuracy, reliability, convenience or effectiveness or price their platforms, applications, products, and services less expensively.
Our competitors may develop data analytics platforms, applications, and products or adopt and implement standards or technologies not compatible with our SOPHiA DDM Platform and our other applications, services, and products. This may inhibit our efforts to develop our platform, applications, services, and products in a technology-agnostic manner, which could narrow the addressable market for our SOPHiA DDM Platform and our other applications, services, and products, adversely impact their sales and market acceptance, and limit our revenue growth and potential profitability.
In addition, we operate in an ecosystem where we and our customers have multiple offerings and our own customers may become our competitors or may view us as potential competitors. This could dis-incentivize our customers or potential customers from adopting our offerings and sharing data with us, which would adversely impact sales and market acceptance and limit our revenue growth and potential profitability.
Cybersecurity or data privacy breaches, other unauthorized or improper access, or (distributed) denial service lack of access (e.g., ransomware, persistent DoS/DDoS) could result in additional costs, service outages, loss of revenue, significant liabilities, harm to our brand and decreased/denied use of our SOPHiA DDM Platform and related solutions, applications, products, or services.
Any failure to prevent or mitigate cybersecurity incidents or improper access to, use, disclosure or other misappropriation of our data or customers’ personal data or the inability to rightfully access/control any such data (e.g., ransomware, persistent DoS/DDoS, system compromise, IP leak) could result in significant liability under state (e.g., state breach notification and privacy laws such as the California Consumer Privacy Act (“CCPA”)), federal (e.g., the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), collectively “HIPAA”) and international laws (e.g., the General Data Protection Regulation (“GDPR”) and the U.K. General Data Protection Regulation (“UK GDPR”)). Such an incident may also cause a material loss of revenue from the potential adverse impact to our reputation and brand, affect our ability to retain or attract new users and customers of our applications, products, and services and potentially disrupt our business.
As we become more dependent on information technologies, to conduct our operations, cybersecurity incidents, including deliberate cybersecurity attacks and attempts to gain unauthorized access to computer systems and cloud/hybrid networks, may increase in frequency and sophistication. Next generation sequencing (NGS) is becoming a new standard in public health sector. Its growing visibility inevitably attracts malicious activity threats, as it combines mission-critical infrastructure and high-value data. In addition to the nature of the data we hold and process, geopolitical factors could make cybersecurity attacks more common and targeted.
These cybersecurity threats pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data, and these risks apply both to us (including via our corporate systems and any employees that may be working remotely) and to third parties on whose systems we rely for the conduct of our business.
The techniques used to obtain unauthorized access, disable or degrade service or sabotage systems develop and change frequently and often are not recognized until launched against a target. Increasingly, attackers leverage AI-powered cyberattacks to automate and enhance the sophistication of such techniques, making detection and mitigation more challenging. As a result, we and our collaborators may be unable to anticipate these techniques or to implement adequate preventative measures. We may in the future experience security incidents. In particular, we may be subject to cybersecurity incidents as we continue to adapt and upgrade our platform architecture. If we do not allocate and effectively manage the resources necessary to build and sustain the proper technology and cybersecurity infrastructure, we could suffer significant business disruption, data loss or damage to intellectual property or other proprietary information. While no security incidents in the past have had a material adverse effect on our business, financial condition and results of operations, we cannot predict the impact of any such future events. Further, although we are obligated under certain laws and regulations to ensure that our platform, systems and servers and those of our service providers remain compliant with the relevant legal requirements with respect to data privacy and cybersecurity, we do not have any control over the operations of the facilities or technology of such providers, including any third-party vendors that collect, process and store personal data on our behalf. Our platform, systems and servers and those of our service providers may be vulnerable to malware or physical or electronic break-ins that our or their security measures may not detect, including via supply chain attacks. Individuals able to circumvent such security measures may misappropriate our confidential or proprietary information, disrupt our operations, damage our computers or otherwise impair our reputation and business. We may need to expend significant resources and make significant capital investments to protect against cybersecurity breaches or to mitigate (compensating controls) the impact of any such breaches. In addition, to the extent that our platform, systems and servers and those of our service providers experience security breaches that result in the unauthorized or improper use of confidential data, employee data or personal data, we may not be indemnified for any losses resulting from such breaches. Currently, we carry cybersecurity insurance in amounts that we believe is reasonable for our business, but there can be no assurance that such potential losses will be covered or will not exceed our policy limits.
There can be no assurance that we or our third-party providers will be successful in preventing cyberattacks or successfully mitigating their effects. If we are unable to prevent or mitigate the impact of such security breaches, our ability to attract and retain new customers, patients and other collaborators could be harmed as they may be reluctant to entrust their data to us, and we could be exposed to litigation and governmental investigations, proceedings and regulatory actions by federal, state and local regulatory entities in the United States and by other national regulatory entities, and we could breach our contractual obligations, all of which could result in significant legal and financial exposure and reputational damages and lead to a potential disruption to our business or other adverse consequences.
If we experience significant disruptions in our information technology systems, our business may be adversely affected.
We depend on our information technology systems for the efficient functioning of our business, including the performance, distribution and maintenance of our SOPHiA DDM Platform and related solutions, applications, products, and services, as well as for accounting, data storage, compliance, purchasing and inventory management, and our continued growth is dependent on our ability to adapt and upgrade our platform architecture without suffering significant business disruption, data loss or the loss of or damage to intellectual property or other proprietary information. Our information technology systems may fail and are vulnerable to breakdown, cybersecurity breach, interruption or damage from computer viruses, ransomware, DoS/DDoS attacks or other malware, attacks by computer hackers, including sophisticated nation-state and nation-state-supported actors, employee error or malfeasance, theft or misuse, failures during the process of upgrading or replacing software, databases or components thereof, power outages, damage or interruption from fires or other natural disasters, hardware failures, telecommunication failures and user errors, among other malfunctions. We could be subject to an unintentional event that involves a third party gaining unauthorized access to our systems, which could disrupt our operations, corrupt our data or result in release of our confidential information. Technological interruptions would disrupt our operations, including our ability to timely ship and track diagnostic test orders and results, project inventory requirements, manage our supply chain and otherwise adequately service our customers or disrupt our customers’ ability to use our applications, products, and services. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our business, financial condition and results of operations. Due to the confidential nature of the information that we deal in, any loss in customer trust could have a significant adverse impact on our business.
Currently, we carry business interruption insurance in amounts that we believe is reasonable for our business, but there can be no assurance that such potential losses will be covered or will not exceed our policy limits. We are increasingly dependent on complex information technology to manage our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance our existing systems. Failure to maintain or protect our information systems and data integrity effectively could have a material adverse effect on our business, financial condition and results of operations.
Our business could be adversely affected by health epidemics, pandemics and unplanned events.
Our business could be adversely affected by health epidemics, pandemics and natural disasters. To the extent any pandemic, epidemic or outbreak of an infectious disease adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.
In addition, any unplanned event, such as a flood, fire, explosion, earthquake, extreme weather condition, power shortage, telecommunication failure or other natural or man-made accidents or incidents that result in us being unable to fully use our facilities, which may render it difficult or impossible for us to operate our platform for some period of time or result in damages to our inventory that require sensitive storage conditions. Certain of these natural events and disasters may become more frequent and severe as a result of the effects of climate change. We do not presently have an emergency back-up generator in place at our Rolle, Switzerland laboratory facility which would otherwise mitigate, to some extent, the effects of a prolonged power outage. Furthermore, our facility and the equipment we use to perform our research and development work could be unavailable or costly and time-consuming to repair or replace, which may increase backlog. It would be difficult, time-consuming and expensive to rebuild our facility, to locate new facilities or license or transfer our proprietary technologies to a third party.
Currently, we carry business continuity insurance in amounts that we believe is reasonable for our business, but there can be no assurance that such potential losses will be covered or will not exceed our policy limits.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our SOPHiA DDM Platform and related solutions, applications, products, and services.
We face an inherent risk of product liability as a result of the marketing and sale of our SOPHiA DDM Platform and related solutions, applications, products, and services and the testing of our SOPHiA DDM Platform in clinical studies. Such claims may be made against us even if the apparent injury is due to the actions of others or the preexisting health of the patient. This risk may be heightened by our reliance on third parties for the manufacturing, marketing and research and development of our SOPHiA DDM Platform and related solutions, applications, products, and services. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt the marketing and sale of our products. Even successful defense would require significant financial and management resources, harm our reputation in our industry and reduce sales.
We believe that we have adequate product liability insurance, but it may not prove to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the marketing and sale of our applications, products, and services. In addition, any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage.
If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial condition and results of operations in a timely manner or prevent fraud.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent and/or detect errors and/or fraud in a timely manner . Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. As required by Section 404 of the Sarbanes-Oxley Act, our management has conducted an assessment on the effectiveness of our internal controls over financial reporting.
However, as an emerging growth company, our independent registered public accounting firm has not provided an attestation report on our internal controls over financial reporting. There can be no assurance that any future testing conducted by us or, if required, by our independent registered public accounting firm will not reveal deficiencies in our internal controls over financial reporting. If we do not maintain an effective system of internal controls over financial reporting, we may be unable to accurately report our financial condition and results of operations in a timely manner, may incur additional financial and management resources to remediate any deficiencies, or may be unable to detect and prevent fraud, all of which would adversely affect our business and investor confidence.
Litigation and other legal proceedings may adversely affect our business.
From time to time, we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, regulatory investigations, securities class action and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. Litigation is inherently unpredictable and can result in excessive or unanticipated judgments and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for our solutions, applications, products, and services, even if the regulatory or legal action is unfounded or not material to our operations.
Our business is subject to economic, political, regulatory and other risks associated with international operations.
Our results could be adversely affected by a variety of risks associated with our international operations, including economic weakness, such as inflation and rising interest rates, or political instability in economies and markets; global trends towards pharmaceutical pricing; differing regulatory requirements for bioinformatics analysis services and research and diagnostic products approvals; differing reimbursement, pricing and insurance regimes; potentially reduced protection for, and complexities and difficulties in obtaining, maintaining, protecting and enforcing, intellectual property rights; difficulties in compliance with U.S. and non-U.S. laws and regulations, including data security and data protection laws, which may result in increased compliance costs to us, and anti-corruption and anti-bribery laws; changes in regulations and customs, tariffs and trade barriers; changes in currency exchange rates and currency controls; changes in a specific country’s or region’s political or economic environment; trade protection measures, economic sanctions and embargoes on certain countries and persons, import or export licensing requirements or other restrictive actions by governments, including with respect to our applications, products, and services, in particular IT solutions, services and technologies on which our operations rely; changes in tax laws; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; workforce uncertainty in countries where labor unrest is more common than in Switzerland and the United States; difficulties associated with staffing and managing international operations, including differing labor relations; production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; business interruptions resulting from geopolitical actions, including war and terrorism (including the ongoing conflict between Russia and Ukraine and in the Middle East), or natural disasters including earthquakes, typhoons, floods and fires; and the impact of public health epidemics on employees and the global economy. As a result, we may experience supply chain disruptions and interruptions in our operations. Any of these factors could require us to modify our business plans and strategy and significantly harm our future international expansion and operations and, consequently, our revenue and results of operations.
Risks Related to Governmental Regulation
Currently our applications and products in the United States are labeled as RUO. We intend to seek regulatory clearance or approval to offer our applications and products as IVD applications and
products for diagnostic use. We cannot guarantee when, if at all, we will apply for regulatory clearance or approval or that we will be successful in obtaining such clearances or approvals.
While we have several CE-IVD marked applications and products in the European Union (“EU”), our currently available applications and products in the United States are labeled as RUO applications and products and are not intended for diagnostic use. Although we have focused initially on the RUO applications and products only, our strategy is to expand our application and product line to encompass applications and products that are intended to be used as IVDs. Such IVD products will be subject to regulation by the FDA as medical devices, including requirements for regulatory clearance or approval of such applications and products before they can be marketed. Accordingly, we will be required to obtain FDA 510(k) clearance or premarket approval (“PMA”) in order to sell our applications and products in a manner consistent with FDA current laws and regulations. Such regulatory approval processes or clearances are expensive, time-consuming and uncertain; our efforts may never result in any premarket approval or 510(k) approval or clearance for our applications and products; and failure by us to obtain or comply with such approvals and clearances could have an adverse effect on our business, financial condition or operating results.
Regulatory authorities have substantial discretion in the clearance and approval process. They may refuse to accept any application or may decide that our data are insufficient for clearance or approval and require additional studies. Therefore, even if we believe the data collected from studies of our platform are promising, such data may not be sufficient to support clearance or approval by any regulatory authority. If we are required to conduct additional studies or other testing of any of our platform beyond those we contemplate, we may incur significant additional costs and regulatory approval may be delayed or prevented. Furthermore, approval by one regulatory authority does not ensure approval by regulatory authorities in other jurisdictions, and we may be required to undertake additional studies to access particular markets.
If we successfully obtain such clearance or approvals, we will be subject to a substantial number of additional requirements for medical devices, including establishment registration, device listing, and compliance with the Quality Systems Regulation (“QSR”), and future Quality Management System Regulation (“QSMR”), which cover the design, testing, production, control, quality assurance, labeling, packaging, servicing, sterilization (if required), and storage and shipping of medical devices (among other activities), advertising, record keeping, post-market surveillance, post-approval studies, adverse event reporting, and correction and removal (recall) regulations. We may be required to expend significant resources to ensure ongoing compliance with the FDA regulations and/or take satisfactory corrective action in response to enforcement action, which may have a material adverse effect on the ability to design, develop and commercialize applications and products using our technology as planned. Failure to comply with these requirements may subject us to a range of enforcement actions, such as warning letters, injunctions, civil monetary penalties, criminal prosecution, recall and/or seizure of products, and revocation of marketing authorization, as well as significant adverse publicity. If we fail to obtain, or experience significant delays in obtaining, regulatory approvals for IVD or other applications and products, such applications and products may not be able to be launched or successfully commercialized in a timely manner, or at all.
Laboratory developed tests (“LDTs”) are a subset of IVD tests that are designed, manufactured and used within a single laboratory. The FDA maintains that LDTs are medical devices and has historically exercised enforcement discretion for most LDTs. The FDA published a final rule on May 6, 2024 bringing LDTs under the current definition of an IVD and under a new and phased-in regulatory framework. The rule changes the way that the FDA regulates any LDTs that our customers develop using our RUO applications and products and may affect our business. The rule change phases in over four years, and will be fully effective by May 6, 2028. As the FDA now requires LDTs to undergo premarket review, and comply with other applicable FDA requirements, the cost and time required to commercialize an LDT will increase substantially, and may reduce the financial incentive for laboratories to develop LDTs, which could reduce demand for our RUO applications and products.
We develop applications and products for clinical laboratories, which may be qualified as LDTs, as well as market RUO applications and products. Our customers may decide to validate our applications and products to use as an LDT, which will be covered under FDA’s final rule on LDTs published in May 2024.
The laws and regulations governing the marketing of diagnostic applications and products are evolving, extremely complex and in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), the FDA has jurisdiction over medical devices, including in vitro diagnostics and, therefore, potentially our applications and products.
Pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, record keeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses.
We currently do not offer any diagnostic applications and products in the United States. We believe that our research applications and products, as utilized in clinical laboratories by our customers, are and would be considered LDTs and that as a result, the FDA does not require that they obtain regulatory clearances or approvals for the LDTs or their components pursuant to the FDA’s current policies and guidance. Although we believe that our products and test components delivered to our customers, when validated as LDTs, are either exempt from FDA medical device regulations or are subject to an enforcement discretion policy, it is possible that the FDA would not agree with these determinations or that the FDA will change its regulations and policies such that our applications and products become regulated as medical devices.
On May 6th, 2024, the FDA issued a final rule to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. In conjunction with the proposed amendment, the FDA has proposed a policy under which it intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. Some of our customers in the United States may decide to discontinue the use of RUO products and test components in their LDTs.
In addition, changes in the current regulatory framework for diagnostic applications, products, and services can impose additional regulatory burdens on us. For example, the FDA’s Center for Devices and Radiological Health is currently considering a total product lifecycle-based regulatory framework for artificial intelligence/machine learning (“AI/ML”) technologies. On January 12, 2021, the FDA released its Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan. As the regulatory framework evolves, we may incur substantial costs to ensure compliance with new or amended laws and regulations. Failure to comply with any of these laws and regulations could result in enforcement actions against us, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business. In addition, legislation could require us to seek FDA-premarket review of other applications, products, and services, including reports that we do not currently believe require premarket authorization but could be subject to additional regulation including premarket review. For any such review, we may be required to conduct extensive analytical validation and user comprehension studies to demonstrate the accuracy of our test results and that they are appropriate for sale directly to consumers. This process will likely be costly, time-consuming and uncertain.
Further, on September 28, 2022, the FDA has issued the guidance on Clinical Decision Support software. It is unclear how any such guidance will impact our SOPHiA DDM Platform.
Our operations, therefore, are or may become subject to extensive regulation by the FDA in the United States, the IVDR in the EU, the MHRA in the U.K., and various health authorities, in particular SwissMedic in Switzerland, and the ANSM in France, and in other jurisdictions in which we conduct business. Government regulations specific to medical devices are wide-ranging and govern, among other things:
•test design, development, manufacture, and release;
•laboratory and clinical testing, labeling, packaging, storage and distribution;
•product safety and efficacy;
•premarketing clearance, approval or certification;
•service operations;
•record keeping;
•application and product marketing, promotion and advertising, sales and distribution;
•post-marketing surveillance, including reporting of deaths or serious injuries, recalls, correction and removals;
•post-market approval studies; and
•product import and export.
As discussed above, although we believe that our current line of products and their components, as utilized in clinical laboratories by our customers, are LDTs, subject to state licensing requirements and federal regulation by CMS under CLIA, it is possible that the FDA or comparable regulatory authorities would not agree with our determinations. If our products become subject to 510(k) or other similar FDA regulations, we would need to comply with the applicable regulations or face significant civil and criminal penalties. Exposure to these additional regulatory requirements would also affect our business, financial condition and results of operations.
We may fail to obtain required clearances or approvals in additional jurisdictions for any of our applications, products, or services and, even if we do, we may never be able to commercialize them in additional jurisdictions, which would limit our ability to realize their full market potential.
In order to eventually market any of our current or future applications, products, and services in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a jurisdiction-by-jurisdiction basis regarding quality, safety, performance and efficacy. In addition, regulatory clearance, authorization or approval in one country does not guarantee regulatory clearance, authorization or approval in any other country. For example, the performance characteristics of our applications, products, and services may need to be validated separately in specific ethnic and genetic populations. Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods.
Seeking regulatory clearance, authorization or approval could result in difficulties and costs. Regulatory requirements and ethical approval obligations can vary widely from country to country and could delay or prevent the introduction of our applications, products, and services in those countries. We have no experience in obtaining regulatory clearance, authorization or approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required regulatory clearances, authorizations or approvals in international markets, or if those approvals are delayed, our target market will be reduced and our ability to realize the full market potential of our applications, products, and services will be unrealized.
Our products or services may be subject to product or service recalls in the future. A recall of products or services, either voluntarily or at the direction of a regulatory authority, or the discovery of serious safety issues with our products or services, could have a significant adverse impact on us.
Regulatory authorities can require the recall of commercialized products or services that are subject to its regulation. Manufacturers may, under their own initiative, recall a product or service if any deficiency is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable health risk, component failures, failures in laboratory processes, malfunctions, manufacturing errors, design or labeling defects, or other deficiencies and issues. Recalls of any of our commercialized products or services would divert managerial and financial resources, subject us to liability claims and require us to bear other costs and adversely affect our business, results of operations, financial condition and reputation. If we initiate a recall, including a correction or removal, for one of our commercialized products or services, issue a safety alert, or undertake a field action or recall to reduce a health risk, this could lead to increased scrutiny by the FDA, other governmental and regulatory enforcement bodies, and our customers regarding the quality and safety of our products and services, and to negative publicity, including FDA alerts, press releases, or administrative or judicial actions. Furthermore, the submission of these reports could be used against us by competitors and cause customers to delay purchase decisions or cancel orders, which would harm our reputation.
We are subject to stringent privacy and, information security laws and regulations and changes in such laws and regulations could adversely affect our business and increase our costs.
We are subject to numerous state, federal and foreign laws and regulations that govern the collection, transmission, storage, dissemination, use, privacy, confidentiality, security, availability, integrity and processing of individually identifiable information. For additional details, please see “Item 4. Information on the Company—B. Business Overview—Government Regulation—Data Privacy and Security.” These laws and regulations are complex and change frequently, at times due to changes in political climate, and existing laws and regulations are subject to different and conflicting interpretations, which adds to the complexity of processing personal data from these jurisdictions. Failure to comply with any of these laws and regulations could result in enforcement actions against us, including fines, imprisonment of company officials, public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business.
This risk is heightened as there is uncertainty regarding the applicability of data privacy regulations to certain types of data that we process, such as health-related and genetic data. While we deploy specific measures and processes designed to de-identify data, we may fail in the comprehensive application of the process resulting in a breach of requirements and our contractual obligation. Some of our product and services rely on anonymized data and while the legal definition is clear, the effective application of the anonymization techniques are subject to multiple interpretation and can prove to be highly difficult and costly.
The transfer of data has been subject to increasing scrutiny. Although there are legal mechanisms to allow for the transfer of personal data from the European Economic Area (the “EEA”), Switzerland and the U.K. to the United States, uncertainty remains about such mechanisms. There have been and there may in the future be legal challenges surrounding the mechanisms that allow companies to transfer personal data from the EU and EEA to the United States, which could limit our ability to transfer personal data across borders, particularly if governments are unable or unwilling to reach new or maintain existing agreements that support cross-border data transfers. Inability to transfer personal data from the EU, EEA, Switzerland or the U.K. to the United States may restrict our research and development activities in these territories and limit our ability to offer applications, products, and services we may develop.
Because the interpretation and application of health-related and data protection laws, regulations, standards and other obligations are uncertain, and often contradictory and in flux, it is possible that the scope and requirements of these laws may be interpreted and applied in a manner that is inconsistent with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful. If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. In addition, these privacy regulations may differ from country to country, and may vary based on whether testing is performed in the United States or in the local country, and our operations or business practices may not comply with these regulations in each country.
In addition to the possibility of fines, sanctions, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business. Complying with these various laws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Any inability to adequately address data privacy or security-related concerns, even if unfounded, or to comply with applicable laws, regulations, standards and other obligations relating to data privacy and security, could result in additional cost and liability to us, harm our reputation and brand, damage our relationships with customers and have a material and adverse impact on our business.
Any failure to comply with our privacy policies or contractual or statutory notification obligations could result in significant liability or reputational harm.
We make public statements about our use and disclosure of personal information through our privacy policy, information provided on our internet platform and press statements. Although we endeavor to comply with our public statements and documentation, we may be alleged to have failed to do so. The publication of our privacy policy and other statements that provide promises and assurances about data privacy and security can subject us to potential government or legal action if they are found to be deceptive, unlawful, unfair or misrepresentative of our actual practices. Any failure, real or perceived, by us to comply with our posted privacy policies or with any legal or regulatory requirements, standards, certifications or orders or other privacy or consumer protection-related laws and regulations applicable to us could cause our customers to reduce their use of our applications, products, and services and could materially and adversely affect our business, financial condition and results of operations. In many jurisdictions, enforcement actions and consequences for noncompliance can be significant and are rising. In addition, from time to time, concerns may be expressed about whether our applications, products, services, or processes compromise the privacy of customers and others. Concerns about our practices with regard to the collection, use and reuse, retention, security, disclosure, transfer and other processing of personal information or other privacy-related or security-related matters, even if unfounded, could damage our reputation and materially and adversely affect our business, financial condition and results of operations.
Many statutory requirements, both in the United States and abroad, include obligations for companies to notify individuals of security breaches involving certain personal information, which could result from breaches experienced by us or our third-party service providers. For example, the GDPR requires from companies experiencing a personal data breach to report the breach within 72 hours to the supervisory authority and where necessary to the individuals affected by the breach. Also, laws in all 50 U.S. states and the District of Columbia require businesses to provide notice to consumers whose personal information has been disclosed as a result of a data breach. These laws are not consistent, and compliance in the event of a widespread data breach is difficult and may be costly. Moreover, jurisdictions have been frequently amending existing laws, requiring attention to changing regulatory requirements. We also may be contractually required to notify customers or other counterparties of a security breach. Although we may have contractual protections with our third-party service providers, contractors and consultants, any actual or perceived security breach could harm our reputation and brand, expose us to potential liability or require us to expend significant resources on data security and in responding to any such actual or perceived breach. Any contractual protections we may have from our third-party service providers, contractors or consultants may not be sufficient to adequately protect us from any such liabilities and losses, and we may be unable to enforce any such contractual protections.
Our operations may subject us to various healthcare laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.
Our operations may subject us to healthcare regulation and enforcement by both U.S. (federal government and state governments) and foreign jurisdictions in which we conduct our business, which influence, among other things, how we structure our sales offerings, including discount practices, customer support, education and training programs, and physician consulting and other service arrangements. Applicable U.S. federal and state healthcare laws and regulations include the following:
•the federal Anti-Kickback Statute (the “AKS”), which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for, or to induce, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or services for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs;
•the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients to providers of “designated health services” with whom the physician or a member of the physician’s immediate family has an ownership interest or compensation arrangements, unless a statutory or regulatory exception applies;
•the federal Eliminating Kickbacks in Recovery Act of 2018 (the “EKRA”) prohibits payments for referrals to recovery homes, clinical treatment facilities, and laboratories. EKRA’s reach extends beyond federal health care programs to include private insurance (i.e., it is an “all payor” statute);
•HIPAA, which established additional federal civil and criminal liability for, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program or making false statements in connection with the delivery of or payment for healthcare benefits, items or services;
•HIPAA, as amended by HITECH and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
•federal false claims and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to the federal government;
•the federal Physician Payments Sunshine Act requirements, which require certain manufacturers of drugs, devices, biologics and medical supplies to report to CMS information related to payments and other transfers of value made to or at the request of physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and certain ownership and investment interests held by physicians and their immediate family members; and
•state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Ensuring that our business and operations comply with applicable healthcare laws and regulations is costly. Any action brought against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the violation, including, among others, significant administrative, civil and criminal penalties, damages, fines, disgorgement, imprisonment, integrity oversight and reporting obligations, and exclusion from participation in government-funded healthcare programs such as Medicare and Medicaid. Additionally, we could be required to refund payments received by us, and we could be required to curtail or cease our operations. Any of the foregoing consequences could seriously harm our business, financial condition and results of operations.
Our employees, collaborators, distributors, agents, contractors and collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We cannot ensure that our compliance controls, policies and procedures will in every instance protect us from acts committed by our employees, collaborators, distributors, agents, contractors or collaborators that would violate the laws or regulations of the jurisdictions in which we operate, including, without limitation, healthcare, employment, anti-corruption, environmental, competition, and patient privacy and other privacy laws and regulations. Misconduct by these parties could include intentional failures to comply with FDA, EMA, MHRA or other applicable regulations, including, without limitation, regulations governing the marketing, sale, labeling and use of RUO and IVD applications and products, provide accurate information to the FDA, the EMA, the MHRA and comparable regulatory authorities, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. In addition, because business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments, government purchasers and healthcare providers who are employed by governments, we face heightened risk with respect to compliance with the Foreign Corrupt Practices Act (the “FCPA”) and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K. Bribery Act 2010 and the French Law n° 2016-1691 (Sapin II). These laws prohibit offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a government official in order to influence official action, or otherwise obtain or retain business.
There is no certainty that all of our employees, collaborators, distributors, agents, contractors and collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. We have provisions in our Code of Business Conduct and Ethics (the “Code of Ethics”), an anti-corruption policy, certain provisions in some of our agreements with third parties, including our collaborators and distributors, and certain controls and procedures in place that are designed to mitigate the risk of noncompliance with anti-corruption and anti-bribery laws. However, it is not always possible to identify and deter misconduct by employees and agents, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions stemming from a failure to comply with these laws or regulations. Violations of these laws and regulations could result in, among other things, significant administrative, civil and criminal fines and sanctions against us, our officers, or our employees, the closing down of our facilities, exclusion from participation in federal healthcare programs, implementation of compliance programs, integrity oversight and reporting obligations and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our SOPHiA DDM Platform and related solutions, applications, products, and services in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results and financial condition.
We face risks related to handling of hazardous materials and other regulations governing environmental safety.
Our activities currently require and may in the future continue to require the use of hazardous chemicals and biohazardous waste, including chemical, biological agents and compounds, blood and bone marrow samples, and other human tissue. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we are subject on an ongoing basis to laws and regulations governing the use, storage, handling and disposal of these materials and specified waste services that both public officials and private individuals may seek to enforce. We could discover that we, an acquired business or our suppliers are not in material compliance with these regulations. The cost of compliance with these laws and regulations may become significant and could negatively affect our business, financial condition and results of operations. We do not carry specific biological waste or hazardous waste insurance coverage, workers’ compensation or property and casualty and general liability insurance policies that include coverage for damages and fines arising from biological or hazardous waste exposure or contamination.
If a clinical trial subject’s or a clinical research study participant’s informed consent is challenged or proven invalid, unlawful, or otherwise inadequate for our purposes, our application and product development efforts may be hindered and we could become involved in legal challenges.
We seek to ensure that all data and biological samples that we receive from our collaborators and customers have been collected from subjects or participants who have provided appropriate informed consent for purposes that extend to our development activities. We also strive to make sure such data and samples are provided to us in a subject de-identified manner. Our collaborators currently conduct clinical trials and clinical research studies in a number of different countries. The collection of data and samples in many different countries results in complex legal questions regarding the adequacy of informed consent and the status of genomic material under a large number of different legal systems. Therefore, we rely on our collaborators and customers to comply with the informed consent requirements and with applicable local law and international regulation. The subject’s or participant’s informed consent obtained in any particular country could be challenged in the future, and those could prove invalid, unlawful or otherwise inadequate for our purposes. Any findings against us, or our collaborators and customers, could deny us access to or force us to stop using some of our data and clinical samples, which would hinder our application and product development efforts, potentially involve us in costly and prolonged litigation, result in reputational harm and adversely affect our business, financial condition and results of operations.
If we or our suppliers fail to comply with ongoing FDA or comparable regulatory authority requirements, or if we experience unanticipated problems with our research and diagnostic, they could be subject to restrictions or withdrawal from the market.
Any medical device that we manufacture, including those for which we obtain regulatory clearance, approval, or certification and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such diagnostic test, will be subject to continued regulatory review, oversight and periodic inspections by the FDA and comparable regulatory authorities. In particular, we and our suppliers may be required to comply with the FDA’s QSR for medical devices, the International Standards Organization (“ISO”) 13485 standards for the manufacture of our diagnostic products and other regulations that cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any diagnostic test for which we obtain clearance or approval. Regulatory authorities such as the FDA enforce the QSR and other regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and comparable regulatory authorities, or the failure to timely and adequately respond to any adverse inspection observations or product safety issues, could result in, among other things, one or more of the following enforcement actions:
•untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
•unanticipated expenditures to address or defend such actions;
•customer notifications for repair, replacement or refunds;
•recall, detention or seizure of our diagnostics products;
•operating restrictions or partial suspension or total shutdown of production;
•refusing or delaying our requests for 510(k) clearance or PMA of new diagnostics products or modified versions of such products currently manufactured, as well as CE marking certification (in the EU);
•operating restrictions;
•withdrawing 510(k) clearances on PMA approvals that have already been granted;
•suspending or withdrawing our CE mark certifications; and
•criminal prosecution.
In addition, we are required to conduct surveillance to monitor the safety or effectiveness of our research and diagnostic products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our research and diagnostic products. Later discovery of previously unknown problems with our diagnostic products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling restrictions on such products or manufacturing processes, withdrawal of the research and diagnostic products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties, which would adversely affect our business, operating results and prospects.
Risks Related to Intellectual Property
If we are not able to obtain, maintain, defend and enforce patent and other intellectual property protection or if the scope of such patent and other intellectual property protection is not sufficiently broad, our competitors could develop and commercialize applications, products, services, and technology similar or identical to ours.
Our success depends in part on our ability to obtain, maintain, defend, and enforce patents and other forms of intellectual property rights, including in-licenses of intellectual property rights of others, as well as our ability to preserve our trade secrets and to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property and proprietary rights. Our ability to protect our applications, products, or services from unauthorized use by third parties depends on the extent to which valid and enforceable patents cover them or they are effectively protected as trade secrets. Although we have filed a number of patents, our patent portfolio is in an earlier stage of prosecution, and we own a limited number of issued patents related to our applications, products, and technology. For information regarding our patent portfolio, see “Item 4. Information on the Company—B. Business Overview—Intellectual Property.”
The patent position of biotechnology and information technology companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. There can be no assurance that our patent rights will not be invalidated or held to be unenforceable, will adequately protect our technology, applications, products, or services or provide any competitive advantage, or that any of our pending or future patent applications will issue as valid and enforceable patents. Our ability to obtain and maintain patent protection for our methods and related solutions, applications, products, or services is uncertain due to a number of factors, including that:
•we or our licensors may not have been the first to invent the technology covered by our pending patent applications or issued patents;
•we or our licensors may not be the first to file all patent applications, as patent applications in the United States and most other countries are confidential for a period of time after filing;
•our methods and related solutions, applications, and products may not be patentable;
•our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability;
•any or all of our pending patent applications may not result in issued patents;
•others may independently develop identical, similar or alternative technologies;
•others may design around our patent claims to produce competitive technologies, methods, applications, or products that fall outside of the scope of our patents;
•we may fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection;
•we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity;
•any patents issued to us may not provide a basis for commercially viable methods, applications, or products, may not provide any competitive advantages or may be successfully challenged by third parties;
•a third party may challenge our patents in court and, upon such a challenge, a court may not hold that our patents are valid, enforceable and non-infringing;
•a third party may challenge our patents in various patent offices and, if challenged, we may be compelled to limit the scope of our pending, allowed or granted claims or lose some or all of the pending, allowed or granted claims altogether;
•the patents of others could harm our business; and
•our competitors could conduct research and development activities in countries where we will not have enforceable patent rights and then use the information learned from such activities to develop competitive methods, applications, or products for sale in our major commercial markets.
While we will endeavor to protect our technology with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming, expensive and sometimes unpredictable, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. Although we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations (“CROs”) or manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Furthermore, we cannot guarantee that any patents will be issued from any of our pending or future patent applications. The standards applied by the U.S. Patent and Trademark Office (“the USPTO”) and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology or information technology patents. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. As such, we do not know the degree of future protection that we will have on our proprietary applications, products, services, and technology. Thus, even if our patent applications issue as patents, they may not issue in a form that will provide us with meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.
Even if we have or obtain patents, we may still be barred from making, using, and selling such methods, applications, products, or services because of the patent rights of others. Others may have filed, and in the future may file, patent applications covering compositions, software applications, products, or methods that are similar or identical to ours, which could materially affect our ability to successfully develop our technology or to successfully commercialize any approved assays alone or with collaborators. Patent applications in the United States and elsewhere are generally published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications could have been filed by others without our knowledge.
Additionally, pending claims in patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our platform technologies or related solutions, applications, products, and services. These patent applications may have priority over patent applications filed by us.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to third party pre-issuance submissions of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our applications, products, services and technology and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize applications, products, or provide services without infringing third-party patent rights. Moreover, we, or our licensors, may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge priority of invention or other features of patentability. Such challenges may result in loss of patent rights, loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical applications, products, services, and technology, or limit the duration of the patent protection of our applications, products, services, and technology. Such proceedings also may result in substantial cost and require significant time from our employees and management, even if the eventual outcome is favorable to us. In addition, if the breadth or strength of protection provided by the patents and patent applications we own or in-license is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future technology.
In addition, third parties may be able to develop technology that is similar to, or better than, ours in a way that is not covered by the claims of our patents or may have blocking patents that could prevent us from marketing our applications and products or practicing our own patented technology. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed and the life of a patent, and the protection it affords, is limited. Without patent protection for current or future methods and related solutions, applications, products, and services, we may face competing technology. Given the amount of time required for the development and testing, and regulatory review where necessary, patents protecting such technology might expire before or shortly after such technology is commercialized. At the same time, given the rapid pace of technological advancement and innovation in the information technology field, the time needed to obtain patents for novel information technology solutions often renders the protection, once obtained, ineffective if the protected solution has become obsolete or widely-adopted while the patent protection was pending. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing technology similar or identical to that we or our collaborators may develop.
Moreover, certain of our patents and patent applications may in the future be, co-owned with third parties. If we are unable to obtain an exclusive license to any such third party co-owners’ interest in such patents or patent applications, such co-owners may be able to use or license their rights to other third parties, including our competitors, and our competitors could market competing applications, products, and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our business, financial conditions, results of operations, and prospects.
We may in the future be involved in lawsuits to defend or enforce our patents and proprietary rights. Such disputes could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of our technology, applications, products, and services, prohibit our use of proprietary technology or put our patents and other proprietary rights at risk.
Competitors and other third parties may infringe, misappropriate or otherwise violate our patents and intellectual property rights or the patents and intellectual property rights of our licensors. The enforcement of such claims can be expensive and time-consuming. In an infringement proceeding, a court may decide that a patent owned or in-licensed by us is invalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our owned and in-licensed patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our owned or in-licensed patents at risk of being invalidated or interpreted narrowly. In addition, our ability to enforce our patents or other intellectual property rights depends on our ability to detect infringement.
It may be difficult to detect those who infringe on our intellectual property rights who do not advertise the components or methods that are used in connection with their applications, products, and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s application, product, or service.
If we were to initiate legal proceedings against any other third party to enforce a patent covering our technology, the defendant could assert that our patent is invalid or unenforceable. In patent litigation in the United States and Europe, defendants alleging invalidity or unenforceability are common responses to a claim of infringement. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, obviousness, overbreadth or lack of utility. Third parties might allege unenforceability of our patents because during prosecution of the patent, an individual connected with such prosecution withheld relevant information or made a misleading statement. Third parties may also raise challenges to the validity of our patent claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to, our patents in such a way that they no longer cover our technology, applications, or products. The outcome of proceedings involving assertions of invalidity and unenforceability, including during patent litigation, is unpredictable. With respect to the validity of patents, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution, but that an adverse third party may identify and submit in support of such assertions of invalidity. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our technology. Such a loss of patent protection could have a material adverse effect on our business. Our patents and other intellectual property rights also will not protect our technology if competitors design around our protected technology without infringing our patents or other intellectual property rights.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. There can be no assurance that we will have sufficient financial or other resources to file and pursue infringement claims, which typically last for years before they are concluded. We may or may not choose to pursue litigation or other actions against those who have infringed on our patents, or have used them without authorization, due to the associated expense and time commitment of monitoring these activities. In addition, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our ordinary shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or commercialization activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Uncertainties resulting from patent and other intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace, our ability to raise additional funds, and could otherwise have a material adverse effect on our business, financial condition, results of operations, and prospects.
We may in the future be subject to claims against us alleging that we are infringing, misappropriating or otherwise violating the intellectual property rights of third parties, the outcome of which would be uncertain and could have a material adverse effect on our business.
Our commercial success depends in part upon our ability to develop, manufacture, market, and sell our applications, products, and services and use our proprietary technology without infringing, misappropriating or otherwise violating the patents or other intellectual property or proprietary rights of third parties. Litigation relating to infringement, misappropriation or other violations of patents and other intellectual property rights in the biotechnology industry is common, including patent infringement lawsuits, trade secret lawsuits, interferences, oppositions, and inter partes review, post-grant review and re-examination proceedings before the USPTO, and corresponding international patent offices.
In the future, we may be subject to third-party claims and similar adversarial proceedings or litigation regarding our infringement, misappropriation, or any other violation of a third party’s patent or other intellectual property rights. If any such claim or proceeding is brought against us, our collaborators or our third-party service providers, our development, manufacturing, marketing, sales, and other commercialization activities could be similarly adversely affected.
Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable, and infringed, which could materially and adversely affect our ability to develop, manufacture, market, sell and commercialize any of our applications, products, or services. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If we are found to infringe any third party’s patents or other intellectual property rights, and we are unsuccessful in demonstrating that such patents or other intellectual property are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing, marketing, selling, and commercializing our applications, products, and services. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, which would give our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing, royalty, and other payments. We also could be forced, including by court order, to cease developing, manufacturing, marketing, selling, and commercializing the infringing application, product, or technology. In addition, we could be found liable for significant monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations, and prospects.
The various markets in which we plan to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights. It is possible that one or more organizations will hold patent rights to which we will need a license. If those organizations refuse to grant us a license to such patent rights on reasonable terms, we may be unable to develop, manufacture, market, sell, and commercialize applications, products, or services or perform research and development or other activities covered by these patents. Some claimants may have substantially greater resources than we do and may be able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time than we could. In addition, many companies in intellectual property-dependent industries, including the biotechnology industry, have employed intellectual property litigation as a means to gain an advantage over their competitors. Furthermore, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. As the biotechnology industry expands and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our applications, products, services, and technology may be subject to intellectual property-related claims by third parties.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays or prohibit us from manufacturing, marketing, selling or otherwise commercializing our applications, products, services, and technology. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our ordinary shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or commercialization activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Uncertainties resulting from patent and other intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace, our ability to raise additional funds, and could otherwise have a material adverse effect on our business, financial condition, results of operations, and prospects.
We license patent rights from third-party owners. If such owners do not properly or successfully obtain, maintain, defend and enforce the patents underlying such licenses, or if they retain or license to others any competing rights, our competitive position and business prospects may be adversely affected. If we fail to comply with our obligations in the agreements under which we license intellectual property rights
from third parties or otherwise experience disruptions to our relationships with any of our licensors, we could lose license rights that are important to our business.
Even though we actively file patent applications, we also rely on intellectual property rights licensed from third parties to protect our technology, including licenses that give us rights to third-party intellectual property that is necessary or useful for our business. For example, we are dependent on licenses from Normandie Valorisation for certain products we commercialize. If one or both of our license agreements with Normandie Valorisation were to terminate for any reason, we may be required to cease the manufacturing, marketing, selling, and commercialization of certain products. For more information regarding these license agreements, please see “Item 10. Additional Information—C. Material Contracts.”
We also may license additional third-party intellectual property in the future. Our success will depend in part on the ability of our licensors to obtain, maintain, protect, and enforce patent protection for our licensed intellectual property, in particular, those patents to which we have secured exclusive rights. These licenses, and other licenses we may enter into in the future, may not provide adequate rights to use such intellectual property and proprietary technologies in all relevant fields of use or in all territories in which we may wish to develop or commercialize technology, applications, products, and services in the future. In some cases, patent prosecution of our licensed technology is controlled by the licensor. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, and maintained in a manner consistent with the best interests of our business. For example, under our license agreements with Normandie Valorisation, Normandie Valorisation controls the prosecution, maintenance and defense of the patents licensed to us pursuant to the agreements. Our licensors may not successfully prosecute the patent applications licensed to us, by failing to draft or prosecute the patents and patent applications licensed to us in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such applications. Even if patents issue or are granted, our licensors may fail to maintain these patents, may determine not to pursue litigation against other companies that are infringing these patents, or may pursue litigation less aggressively than we would. Further, we may not obtain exclusive rights, which would allow for third parties to develop competing applications and products. In addition, our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If our licensors fail to obtain and maintain a patent or other protection for the proprietary intellectual property we license from such licensor, we could lose our rights to such intellectual property or the exclusivity of such rights, and our competitors could market competing technology using such intellectual property. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we or our collaborators may be unable to develop or commercialize the affected technology, which could adversely affect our competitive business position and harm our business prospects.
Our existing license agreements impose, and we expect that future license agreements will impose, various development, commercialization, royalty, diligence, patent prosecution and enforcement, and other obligations on us. If we breach any of these obligations, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in our being unable to commercialize related solutions, applications, products, or services that are covered by these agreements, which could materially adversely affect the value of any such technology and our business. In spite of our efforts, our licensors might conclude that we have breached our obligations under such license agreements, and might therefore terminate the license agreements. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future applications and products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in the applications, products, and services that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize applications, products, and services, we may be unable to achieve or maintain profitability.
In addition, disputes may arise under our license agreements, including regarding the payment of the royalties or other payments due to licensors in connection with our exploitation of the rights we license from them. For example, licensors may contest the basis of royalties we retained and claim that we are obligated to make payments under a broader basis. In addition to the costs of any litigation we may face as a result, any legal action against us could increase our payment obligations under the respective agreement and require us to pay interest and potentially damages to such licensors.
Disputes may arise regarding intellectual property subject to a license agreement, including those relating to:
•the scope of rights, if any, granted under the license agreement and other interpretation-related issues;
•the amounts of royalties due under the license agreement;
•whether, and the extent to which, our technology and processes infringe, misappropriate or otherwise violate intellectual property of the licensor that is not subject to the license agreement;
•our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
•the sublicensing of patent and other rights under the license agreements;
•the inventorship and ownership of inventions and know-how resulting from the creation or use of intellectual property by our licensors and by us and our collaborators; and
•the priority of invention of patented technology.
The agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement. Such disputes may be costly to resolve and may divert management’s attention away from day-to-day activities. If disputes over intellectual property that we have licensed from third parties prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we or our collaborators may be unable to successfully develop and commercialize the affected technology, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
We may not be successful in obtaining necessary rights to any applications, products, or services we may develop through acquisitions and in-licenses.
We currently have rights to intellectual property, through licenses from third parties, to identify and develop certain applications, products, services and technology. Many pharmaceutical companies, biotechnology companies and academic institutions are competing with us and filing patent applications potentially relevant to our business. In order to avoid infringing these third-party patents, we may find it necessary or prudent to obtain licenses from such third-party intellectual property holders.
However, we may be unable to secure such licenses or otherwise acquire or in-license any compositions, methods of use, processes or other intellectual property rights from third parties that we identify as necessary for our business. The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, it could have a material adverse effect on our business, financial condition, results of operations, and prospects.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
Filing, prosecuting, and defending patents in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States, assuming that rights are obtained in the United States. In-licensing patents covering our technology in all countries throughout the world may similarly be prohibitively expensive, if such opportunities are available at all. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection, or from selling or importing our technology in and into the United States or other jurisdictions.
We generally apply for patents in those countries where we intend to make, have made, use or offer for sale our applications, products, or services, and where we assess the risk of infringement to justify the cost of seeking patent protection. However, we may not seek protection in all countries where we will commercialize our applications, products, and services and we may not accurately predict all the countries where patent protection would ultimately be desirable. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may use our technology in jurisdictions where we do not pursue and obtain patent protection to develop their own assays and products and may export otherwise infringing assays and products to territories where we have patent protection, but where our ability to enforce our patent rights is not as strong as in the United States. These applications, products, and services may compete with technologies that we or our collaborators may develop, and our patents or other intellectual property rights may not be effective or sufficient to prevent such competition.
The laws of some other countries do not protect intellectual property rights to the same extent as the laws of the United States. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. In addition, the legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals or biotechnologies. As a result, many companies have encountered significant difficulties in protecting and defending intellectual property rights in certain jurisdictions outside the United States. Such issues may make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation or other violation of our other intellectual property rights. For example, many other countries, including countries in the EU, have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents and could limit our potential revenue opportunities. Accordingly, our and our licensors’ efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license.
Furthermore, proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, subject our patents to the risk of being invalidated or interpreted narrowly, subject our patent applications to the risk of not issuing or provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded to us, if any, may not be commercially meaningful, while the damages and other remedies we may be ordered to pay such third parties may be significant.
If we are unable to execute invention assignment agreements with our employees and consultants or protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patent protection for certain aspects of our technology, we also consider trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position. We protect trade secrets and confidential and unpatented know-how, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, corporate collaborators, outside scientific collaborators, CROs, or manufacturers, consultants, advisors and other third parties.
We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to us.
We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes or that the assignment agreements that have been entered into are self-executing. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, or claim ownership in intellectual property that we believe is owned by us. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets.
Moreover, our competitors or other third parties may independently develop knowledge, methods and know-how equivalent to our trade secrets or seek to reverse-engineer our technology for which we do not have patent protection. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third parties, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
We are also subject both in the United States and outside the United States to various regulatory schemes regarding requests for the information we provide to regulatory authorities, which may include, in whole or in part, trade secrets or confidential commercial information. While we are likely to be notified in advance of any disclosure of such information and would likely object to such disclosure, there can be no assurance that our challenge to the request would be successful. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.
We have in the past and may in the future be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed trade secrets or other confidential information of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
Many of our employees, consultants and advisors are currently or were previously employed at universities, research institutes or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we have in the past and may in the future be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.
In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached or invalid, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic, cancelled or determined to be infringing on other marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings.
This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a trademark of ours is not valid or is unenforceable, or may refuse to stop the other party from using the trademark at issue. We may not be able to protect our rights to these and other trademarks and trade names or may be forced to stop using these names, which we may need to build name recognition with potential collaborators or customers in our markets of interest.
We have certain trademark applications pending in the United States and abroad, but there can be no assurance that these applications will be allowed and not opposed. Any denial of our trademark applications or adverse ruling in any opposition proceedings could prevent us from differentiating our applications, products and/or services and maintaining consistency across our brand. Even if these applications proceed to registration, third parties may challenge our use or registration of these trademarks in the future. In the event that our trademarks are successfully challenged, we could be forced to rebrand our applications and products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Other biotechnology companies may be using trademarks that are similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, they may infringe our trademarks and we may not have adequate resources to enforce our trademarks. If we attempt to enforce our trademarks and assert trademark infringement claims, a court may determine that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks. Furthermore, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Failure to maintain our trademark registrations, or to obtain new trademark registrations in the future, could limit our ability to protect our trademarks and impede our marketing efforts in the countries in which we operate. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
Our use of “open-source” software could subject our proprietary software to general release, adversely affect our ability to sell our applications and products or provide our services, and subject us to possible litigation.
A portion of the applications, products, or technologies licensed, developed or distributed by us incorporate so-called “open-source” software, and we may incorporate open-source software into other applications, products, or technologies in the future. Such open-source software is generally licensed by its authors or other third parties under open-source licenses. Some open-source licenses may contain requirements that we disclose source code for modifications we make to the open-source software and that we license such modifications to third parties at no cost. In some circumstances, distribution of our software in connection with open-source software could require that we disclose and license some or all of our proprietary code in that software as well as distribute our applications and products that use particular open-source software at no cost to the user.
We monitor our use of open-source software in an effort to avoid uses in a manner that would require us to disclose or grant licenses under our proprietary source code; however, there can be no assurance that such efforts will be successful. Open-source license terms are often ambiguous and such use could inadvertently occur. There is little legal precedent governing the interpretation of many of the terms of certain of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations regarding our applications, products, and technologies.
Companies that incorporate open-source software into their applications and products have, in the past, faced claims seeking enforcement of open-source license provisions and claims asserting ownership of open-source software incorporated into their applications and products. If an author or other third party that distributes such open-source software were to allege that we had not complied with the conditions of an open-source license, we could incur significant legal costs from defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of our applications and products. In addition, if we combine our proprietary software with open-source software in certain ways, under some open-source licenses we could be required to release the source code of our proprietary software, which could substantially help our competitors develop applications, products, and services that are similar to or better than ours and otherwise have a material adverse effect on our business, financial condition, results of operations, and prospects.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our applications and products.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Changes in either the patent laws or the interpretation of the patent laws in the United States or other jurisdictions could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.
Risks Related to Our Financial Position and Capital Requirements
We have incurred net losses since our inception and expect to continue to incur losses for the foreseeable future. We may never achieve or sustain profitability.
We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. For the years ended December 31, 2024 and 2023, we reported net losses of $62.5 million and $79.0 million, respectively. As of December 31, 2024, we had an accumulated deficit of $440.3 million.
We expect to continue to incur net losses for the foreseeable future as we continue to devote substantial resources to (i) research and development, in particular to further expand and enhance the features, applications and data modalities of our SOPHiA DDM Platform in order to accommodate multimodal data analytics capabilities across a wide range of disease areas; (ii) expanding selling and marketing efforts for our SOPHiA DDM Platform, in particular to drive new customer adoption with clinical customers and biopharmaceutical companies; (iii) establishing and maintaining relationships with our collaborators and customers across the healthcare system; and (iv) obtaining regulatory clearance or approval to offer our applications and products as IVD applications and products for diagnostic use. We may encounter unforeseen expenses, difficulties, complications, delays and unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of growth of our expenses and of our revenue. In addition, we have incurred and expect to continue to incur increased general and administrative expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter to quarter and from year to year.
Because of the numerous risks and uncertainties associated with our research and development and commercialization efforts, although we have stated our desire to become cash flow positive in the next few years, we may not be able to achieve this goal. We may never become profitable or cash flow positive. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to achieve or sustain profitability could depress our market value and could impair our ability to raise capital, and execute our business plan, develop additional applications, products, and services and continue our operations. A decline in the value of our company could cause our shareholders to lose all or part of their investment.
We may need to raise additional capital to fund our existing operations; further develop our SOPHiA DDM Platform, applications, and products; commercialize our applications, products, and services; and expand our operations.
Since our inception, we have used substantial amounts of cash. The research and development process as well as selling and marketing efforts are capital intensive and we expect that we will continue to expend substantial resources for the foreseeable future to develop, commercialize and market additional features, applications and data modalities of our SOPHiA DDM Platform and related solutions, applications, products, and services. In addition, we may also raise capital to expand our business and pursue strategic investments, to take advantage of financing opportunities or for other reasons. Additional funds may not be available when we need them or on terms that are acceptable to us. Our ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. Further, as a Swiss company, we have less flexibility to raise capital, particularly in a quick and efficient manner, as compared to U.S. companies. See “—Risks Related to Our Securities—Our shareholders enjoy certain rights that may limit our flexibility to raise capital, issue dividends and otherwise manage ongoing capital needs.” The restrictions contained in our contractual agreements may also limit our ability to raise capital.
For example, subject to certain exceptions, the Perceptive Credit Agreement restricts our ability to incur additional indebtedness. If adequate funds are not available to us on a timely basis or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our research and development, commercialization and growth efforts.
We may seek additional capital through a variety of means, including through public and private equity offerings and debt financings, credit and loan facilities and collaborations. If we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such equity or convertible debt securities may include liquidation or other preferences that are senior to or otherwise adversely affect your rights as a shareholder. If we raise additional capital through the sale of debt securities or through entering into credit or loan facilities, we may be restricted in our ability to take certain actions, such as incurring additional debt, making capital expenditures, acquiring or licensing intellectual property rights, declaring dividends or encumbering our assets to secure future indebtedness. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. If we raise additional capital through collaborations with third parties, we may be required to relinquish valuable rights to our intellectual property, technology, applications, and products or we may be required to grant licenses for our intellectual property, technology, applications, and products on unfavorable terms.
Our indebtedness under the Perceptive Credit Agreement and the associated restrictive covenants thereunder could adversely affect our financial condition.
Indebtedness under the Perceptive Credit Agreement requires us to dedicate a substantial portion of our cash and cash equivalents to the payment of interest on, and principal of, the indebtedness, thereby reducing the amounts available to fund working capital, capital expenditures, research and development efforts, commercialization efforts and other general corporate purposes. Indebtedness under the Perceptive Credit Agreement bears variable rates of interest based on the prevailing SOFR, thereby making us more vulnerable to rising interest rates.
The Perceptive Credit Agreement contains certain restrictions on our activities and customary covenants, including an affirmative covenant to maintain qualified cash of at least $3.0 million, an affirmative last twelve months revenue covenant of $51.8 million as of December 31, 2024. The last twelve months revenue covenant is tested on a quarterly basis beginning June 30, 2024, and negative covenants including limitations on indebtedness, liens, fundamental changes, asset sales, investments, dividends and other restricted payments and other matters customarily restricted in such agreements. The obligations under the Perceptive Credit Agreement are secured by substantially all of our and certain of our subsidiaries’ assets. Such covenants could limit our flexibility in planning for, or reacting to, changes in our business and our industry; place us at a competitive disadvantage compared to our competitors who have less debt or competitors with comparable debt on more favorable terms; and limit our ability to borrow additional amounts.
Our ability to maintain compliance with the covenants imposed by our indebtedness and to repay the principal of, pay interest on and refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors, many of which are beyond our control. If we are unable to comply with the covenants imposed by our indebtedness or to generate sufficient cash flow to service or repay our indebtedness, we may be in default of the Perceptive Credit Agreement and be required to adopt one or more alternatives, such as restructuring debt or obtaining additional financing on terms that may be unfavorable to us or highly dilutive.
Our operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause the price of our ordinary shares to fluctuate or decline.
Our quarterly and annual operating results may fluctuate significantly. This fluctuation may be as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the underlying performance of our business. The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual financial results. Because a substantial portion of our expenses are relatively fixed in the short-term and require time to adjust, our results of operations and liquidity would suffer if revenue falls below our expectations in a particular period. If our operating results fall below the expectations of investors or securities analysts, the price of our ordinary shares could decline substantially. Furthermore, any fluctuations in our operating results may, in turn, cause the price of our ordinary shares to fluctuate substantially.
We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
We may not be able to sufficiently reduce our costs to achieve sustainable gross margins.
Operating our business is costly, and we expect our expenses to continue to increase in the future as we broaden our customer base and expand our platform, applications, services, and product offerings. In particular, a significant portion of our business, including our SOPHiA DDM Platform, is provided through a cloud-native software platform and computational and storage-related costs and fees constitute a significant portion of our cost of revenue. While we seek to negotiate favorable economic arrangements with respect to computational and storage-related costs and fees, in the near term, we expect that our gross profit margin will be adversely impacted by such fees and costs as we have purchased, and may be required to continue to purchase, increased capacity at less favorable rates in order to address increased demand for our SOPHiA DDM Platform and related solutions, applications, products, and services. In addition, we collaborate with manufacturers in the assembly and development of our research and diagnostic products, in particular DNA enrichment kits. While we are undertaking a number of initiatives designed to reduce our costs, including provisions in our manufacturing and supply agreements that limit our counterparty’s ability to increase prices for the manufactured products if certain conditions are met by us, and expect that our gross margin will increase as we broaden our customer base and increase customer engagement, there can be no assurance that we will be able to achieve planned cost reductions. There may also be unforeseen occurrences that increase our costs, such as increased prices of the components of our products, increased costs of hosting and consumer support services, changes to labor costs or less favorable terms with third-party suppliers, service providers or manufacturing collaborators. In addition, if our platform, applications, services and product mix becomes more customer-specific and diversified, our costs may increase. If we are unable to reduce our costs, or if cost reductions are less significant or less timely than those we project, we will not be able to achieve sustainable gross margins, which would adversely affect our ability to invest in and grow our business.
We customize a substantial portion of our research and diagnostic products to address the needs of individual customers and collaborators. If we cannot sell our customized products in the event an order is cancelled, we may be unable to cover our costs and may be left with substantial unsaleable inventory, which could have a material adverse effect on our financial condition and results of operations.
We assemble a substantial portion of our products to address the needs of individual customers. Some of the agreements with our customers require us to cover the initial manufacturing and assembly costs of such products. We will be paid only upon delivery of such products to our customers once the products have been ordered. If our customers fail to purchase these customized products from us in sufficient quantities, do not purchase such products from us at all or otherwise fail to perform their obligations under the agreements with us, we may bear the full cost of manufacturing and assembling of such products, fail to cover our costs and have substantial unsaleable inventory, each of which could have a material adverse effect on our financial condition and results of operations.
Our ability to use tax loss carryforwards in Switzerland, the United States and other jurisdictions may be limited.
We are entitled to carry forward losses incurred in Switzerland, the United States and other jurisdictions in which we conduct business, which could be used to offset future taxable income. Due to our limited income and ongoing losses, there is a significant risk that our tax loss carryforwards will expire in part or in their entirety and cannot be used to offset future taxable income for corporate income tax purposes. Furthermore, any tax loss carryforwards that we report on our tax returns are subject to review and confirmation by the competent tax authorities in their tax assessment of the tax year for which the tax loss carryforwards are used to offset taxable income. Consequently, we are exposed to the risk that the competent tax authorities may not accept the reported tax loss carryforwards in part or in their entirety.
We are subject to risks related to taxation in multiple jurisdictions.
We are subject to income taxes in Switzerland and foreign jurisdictions. Significant judgments based on interpretations of existing tax laws or regulations may be required in determining our provision for income taxes.
Our effective income tax rate could be adversely affected by various factors, including, but not limited to, changes in the combination of earnings in tax jurisdictions with different statutory tax rates, changes in the valuation of deferred tax assets and liabilities, changes in existing tax policies, laws, regulations or rates, changes in the level of non-deductible expenses (including share-based compensation), changes in the location of our operations, changes in our future levels of research and development spending, mergers and acquisitions or the result of examinations by various tax authorities. Although we believe our tax estimates are reasonable, if taxing authorities disagree with the positions taken on our tax returns, we could have additional tax liability, including interest and penalties.
Exchange rate fluctuations have in the past materially affected and may in the future materially affect our results of operations and financial condition.
We operate internationally and a meaningful portion of our revenue, expenses, assets and liabilities are denominated in currencies other than the U.S. dollar, our presentation currency, and the Swiss franc, SOPHiA GENETICS SA’s functional currency. In preparing our consolidated financial statements, those revenues, expenses, assets and liabilities are translated into U.S. dollars at applicable exchange rates. Increases or decreases in exchange rates between the U.S. dollar and other currencies affect the U.S. dollar value of those items, as reflected in the consolidated financial statements. We expect that a significant part of our revenues and expenses will continue to be denominated in currencies other than the U.S. dollar, including the euro and Swiss franc, and to a lesser extent, British pound, Australian dollar, Brazilian real, Turkish lira and Canadian dollar. Therefore, unfavorable developments in the value of the U.S. dollar relative to other relevant currencies could adversely affect our results of operations, financial condition and liquidity. For example, fluctuations in the exchange rate between the U.S. dollar and the Swiss franc has impacted our revenues and results of operations for the year ended December 31, 2024 and 2023.
The exchange rates of the U.S. dollar and other currencies are affected by many factors, including forces of supply and demand in the foreign exchange markets and global economic events. These rates are also affected by the international balance of payments and other economic and financial conditions, government intervention, speculation and other factors. We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the U.S. dollar and even if we engage in hedging operations in the future, there can be no assurance as to the success of any hedging operations that we may implement. Foreign currency fluctuations may adversely affect our results of operations, financial condition and liquidity.
We are subject to risks related to the accounting treatment of our pension and other post-employment benefit plans.
We provide retirement benefits to our employees as required by Swiss law by means of a pension fund that is maintained by a life insurance company. The life insurance company operates a pension plan for all of our employees as a defined benefit plan under International Accounting Standards (“IAS”) 19, Employee Benefits (“IAS 19”). As of December 31, 2024, we reported an employee benefit obligation related to our Swiss plan, before deduction of plan assets, of $23.1 million in accordance with IAS 19. The obligation represents our projected obligations towards current and future pensioners discounted at an annual rate of 0.95%. Under Swiss statutory rules and pursuant to our contract with the group life assurance provider, all risks including investment risk are fully covered. That said, no underfunding exists under Swiss law. The variance between Swiss statutory rules and IFRS Accounting Standards is apparent in many Swiss companies, and the IFRS Accounting Standards obligation of our pension plan does not necessarily reflect a true payment obligation under Swiss law because Swiss law allows us to maintain flexibility to adjust benefit levels under the plans and we could use this flexibility to mitigate any liability. For more information, see Note 21—“Post-employment benefits” to the audited consolidated financial statements included elsewhere in this Annual Report. However, should the Swiss statutory rules at any time require a determination that our pension plan is significantly underfunded, we could be obliged to make additional contributions to the pension plan in addition to our obligation to make regular contributions as defined in the pension plan regulation. If such risk materializes, this could have a material adverse effect on our financial position or results of operations.
Risks Related to Our Securities
The market price of our ordinary shares has historically been, and in the future may continue to be, volatile and may fluctuate due to factors beyond our control.
In the past, we have experienced significant fluctuations in the price of our ordinary shares. The market price of our ordinary shares could be subject to wide fluctuations in response to many risk factors listed in this “Risk Factors” section, some of which are beyond our control, including:
•actual or anticipated fluctuations in our financial condition and operating results;
•effectiveness, accuracy and efficiency of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•public concern relating to the commercial value or safety of any of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•the timing and results of multimodal clinical studies of our SOPHiA DDM Platform;
•our inability to adequately protect our proprietary and intellectual property rights, including patents, trademarks and trade secrets;
•our inability to raise additional capital and the terms on which we raise it;
•our ability to enter into strategic collaboration or licensing agreements and the commencement, termination and terms of such agreements;
•regulatory developments, including actions with respect to our and our competitors’ platforms, applications, products, and services;
•publication of research reports by securities analysts about us or our competitors or our industry;
•our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
•additions and departures of key personnel;
•the passage of legislation or other regulatory developments affecting us or our industry;
•fluctuations in the valuation of companies perceived by investors to be comparable to us;
•sales of our ordinary shares by us, our insiders or our other shareholders;
•changes in market conditions for our industry, including changes in the structure of healthcare payment systems; and
•changes in general market and economic conditions.
In addition, the stock market has historically experienced significant volatility, particularly with respect to healthcare technology company stocks. As we operate in a single industry, we are particularly vulnerable to these factors to the extent that they affect our industry. In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price. This risk is particularly relevant for healthcare technology companies, which have experienced significant stock price volatility in recent years. Securities litigation could result in substantial costs and divert our management’s attention and resources and could also require us to make substantial payments to satisfy judgments or to settle litigation.
Future sales, or the possibility of future sales, of a substantial number of our ordinary shares could adversely affect the price of our ordinary shares.
Future sales of a substantial number of our ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of our ordinary shares. Ordinary shares that were issued prior to our initial public offering can be sold pursuant to Rule 144 under the Securities Act, subject to current public information and volume and manner of sale limitations applicable to affiliates. In addition, we have registered under the Securities Act all ordinary shares that we may issue under our share-based compensation plans, such that they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates. We have adopted a sell-to-cover approach for withholding and other taxes upon restricted stock units (“RSU”) settlement for executive officers and certain directors, which may result in substantial sales of ordinary shares into the market in relatively short periods of time, particularly around the date of our annual general meeting. If our shareholders sell substantial numbers of ordinary shares in the public market or if the market perceives that such sales may occur, the market price of our ordinary shares and our ability to raise capital through the issuance and sale of equity or equity-linked securities in the future could be adversely affected.
Under Swiss law, shareholders benefit from pre-emptive rights to subscribe on a pro rata basis for issuances of equity or other securities that are convertible into equity, unless such pre-emptive rights are excluded in accordance with Swiss law and our articles of association. However, due to the laws and regulations in certain jurisdictions, shareholders in certain jurisdictions may not be able to exercise such rights, unless we register or otherwise qualify the rights offering, including by complying with Annual Report requirements under the laws of that jurisdiction. There can be no assurance that we will take any action to register or otherwise qualify an offering of subscription rights or shares under the laws of any jurisdiction where the offering of such rights is restricted, other than the United States. If shareholders in such jurisdictions are unable to exercise their subscription rights, their ownership interest will be diluted.
We have never paid dividends and do not expect to pay any dividends in the foreseeable future.
Since inception, we have not paid any dividends. Even if future operations lead to significant levels of distributable profits, we currently intend to reinvest any earnings in our business and do not anticipate declaring or paying any dividends until we have an established revenue stream to support dividend payments. In addition, any proposal for the payment of future dividends will be at the discretion of our board of directors after taking into account various factors including our business prospects, liquidity requirements, financial performance and new application and product development. Furthermore, payment of future dividends is subject to certain limitations pursuant to our current and future debt instruments, Swiss law and our articles of association. See “Item 10. Additional Information—Memorandum and Articles of Association.” The Perceptive Credit Agreement also limits our ability to pay dividends. Accordingly, investors cannot rely on dividend income from our ordinary shares, and any returns on an investment in our ordinary shares will likely depend entirely upon any future appreciation in the price of our ordinary shares.
If securities or industry analysts publish inaccurate or unfavorable research about our business or case to publish research about our business, the price of our ordinary shares and our trading volume could decline.
The trading market for our ordinary shares depends, in part, on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our ordinary shares or publish inaccurate or unfavorable research about us or our business, the price of our ordinary shares will likely decline. In addition, if our operating results fail to meet the forecast of analysts, the price of our ordinary shares will likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our ordinary shares could decrease, which might cause the price of our ordinary shares and trading volume to decline.
The rights of our shareholders may be different from the rights of shareholders in companies governed by the laws of U.S. jurisdictions.
We are a Swiss corporation. Our corporate affairs are governed by our articles of association and by the laws governing companies, including listed companies, incorporated in Switzerland. The rights of our shareholders and the responsibilities of members of our board of directors may be different from the rights and obligations of shareholders and directors of companies governed by the laws of U.S. jurisdictions.
In the performance of its duties, our board of directors is required by Swiss law to consider the interests of our company, our shareholders, our employees and other stakeholders, in all cases with due observation of the principles of reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, shareholders’ interests. Swiss law limits the ability of our shareholders to challenge resolutions made or other actions taken by our board of directors in court. Our shareholders generally are not permitted to file a suit to reverse a decision or an action taken by our board of directors, but are instead only permitted to seek damages for breaches of fiduciary duty. As a matter of Swiss law, shareholder claims against a member of our board of directors for breach of fiduciary duty would have to be brought to the competent courts in Switzerland, or where the relevant member of our board of directors is domiciled. In addition, under Swiss law, any claims by our shareholders against us must be brought exclusively to the competent courts in Switzerland. For a further summary of applicable Swiss company law contained in this Annual Report, see “Item 10. Additional Information—Memorandum and Articles of Association.” However, there can be no assurance that Swiss law will not change in the future, which could adversely affect the rights of our shareholders, or that Swiss law will protect our shareholders in a similar fashion as under U.S. corporate law principles.
Our shareholders enjoy certain rights that may limit our flexibility to raise capital, issue dividends and otherwise manage ongoing capital needs.
Swiss law reserves for approval by shareholders certain corporate actions over which a board of directors would have authority in some other jurisdictions. For example, the payment of dividends and cancellation of treasury shares must be approved by shareholders. Swiss law also requires that our shareholders themselves resolve to, or authorize our board of directors to, increase our share capital. While our shareholders may authorize share capital that can be issued by our board of directors without additional shareholder approval, Swiss law limits this authorization to 50% of the issued share capital at the time of the authorization. The authorization, furthermore, has a limited duration of up to five years and must be renewed by the shareholders from time to time thereafter in order to be available for raising capital. Additionally, subject to specified exceptions, including exceptions explicitly described in our articles of association, Swiss law grants pre-emptive subscription rights to existing shareholders to subscribe for new issuances of shares. Swiss law also does not provide as much flexibility in the various rights and regulations that can attach to different categories of shares as do the laws of some other jurisdictions. These Swiss law requirements relating to our capital management may limit our flexibility, and situations may arise where greater flexibility would have provided benefits to our shareholders. See “Item 10. Additional Information—Memorandum and Articles of Association.”
Our ordinary shares are not listed in Switzerland, our home jurisdiction. As a result, our shareholders will not benefit from certain provisions of Swiss law that are designed to protect shareholders in a public takeover offer or a change-of-control transaction.
Because our ordinary shares will be listed exclusively on Nasdaq and not in Switzerland, our shareholders will not benefit from the protection afforded by certain provisions of Swiss law that are designed to protect shareholders in the event of a public takeover offer or a change-of-control transaction. For example, Article 120 of the Swiss Financial Market Infrastructure Act and its implementing provisions require investors to disclose their interest in our company if they reach, exceed or fall below certain ownership thresholds. Similarly, the Swiss takeover regime imposes a duty on any person or group of persons who acquires more than one-third of a company’s voting rights to make a mandatory offer for all of the company’s outstanding listed equity securities. In addition, the Swiss takeover regime imposes certain restrictions and obligations on bidders in a voluntary public takeover offer that are designed to protect shareholders. However, these protections are applicable only to issuers that list their equity securities in Switzerland, and because our ordinary shares will be listed exclusively on Nasdaq, they will not be applicable to us. Furthermore, since Swiss law restricts our ability to implement rights plans or U.S.-style “poison pills,” our ability to resist an unsolicited takeover attempt or to protect minority shareholders in the event of a change-of-control transaction may be limited. Therefore, our shareholders may not be protected in the same degree in a public takeover offer or a change-of-control transaction as are shareholders in a Swiss company listed in Switzerland.
U.S. shareholders may not be able to obtain judgments or enforce civil liabilities against us or our executive officers or members of our board of directors.
We are organized under the laws of Switzerland and our registered office and domicile is located in Rolle, Canton of Vaud, Switzerland. Moreover, a number of our directors and executive officers are not residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States.
As a result, it may not be possible for investors to effect service of process within the United States upon us or upon such persons or to enforce against them judgments obtained in U.S. courts, including judgments in actions predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our Swiss counsel that there is doubt as to the enforceability in Switzerland of original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent solely predicated upon the U.S. federal and state securities laws. Original actions against persons in Switzerland based solely upon the federal or state securities laws are governed, among other things, by the principles set forth in the Swiss Federal Act on Private International Law (the “PILA”). This statute provides that the application of provisions of non-Swiss law by the courts in Switzerland shall be precluded if the result is incompatible with Swiss public policy (ordre public). Also, certain mandatory provisions of Swiss law may be applicable regardless of any other law that would otherwise apply.
Switzerland and the United States do not have a treaty providing for reciprocal recognition and enforcement of judgments in civil and commercial matters. The recognition and enforcement of a judgment of the courts of the United States in Switzerland is governed by the principles set forth in the PILA. This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if:
•the non-Swiss court had jurisdiction pursuant to the PILA;
•the judgment of such non-Swiss court has become final and non-appealable;
•the judgment does not contravene Swiss public policy;
•the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
•no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state, and this decision is recognizable in Switzerland.
Anti-takeover provisions in our articles of association could make an acquisition of us, which may be beneficial to our shareholders, more difficult.
Our articles of association contain provisions that may have the effect of discouraging, delaying or preventing a change in control of us that shareholders may consider favorable, including transactions in which our shareholders may receive a premium for their shares. Our articles of association include provisions that:
•in certain cases, allow our board of directors to place up to 33,199,082 ordinary shares and rights to acquire an additional 33,199,082 ordinary shares (in aggregate, 50% of our share capital) with affiliates or third parties, without existing shareholders having statutory pre-emptive rights in relation to this share placement;
•allow our board of directors not to record any acquirer of ordinary shares, or several acquirers acting in concert, in our share register as a shareholder with voting rights with respect to more than 15% of our share capital as set forth in the commercial register;
•limit the exercise of voting rights by shareholders, acting alone or in concert with others, to a maximum of 15% of the share capital recorded in the commercial register;
•limit the size of our board of directors to eight members; and
•require two-thirds of the votes represented at a general meeting of the shareholders for amending or repealing most of the above-mentioned authorizations to place shares as well as the above-mentioned voting and recording restrictions, for amending the provision setting a maximum board size or providing for indemnification of our directors and members of our executive committee and for removing the chairman or any member of the board of directors before the end of his or her term of office.
These and other provisions, alone or together, could delay or prevent takeovers and changes in control. See “Item 10. Additional Information—Memorandum and Articles of Association.” These provisions could also limit the price that investors might be willing to pay in the future for our ordinary shares, thereby depressing the market price of our ordinary shares.
There can be no assurance that we were not a passive foreign investment company for any taxable year, which could subject U.S investors in our ordinary shares to significant adverse U.S. federal income tax consequences.
Under the Internal Revenue Code of 1986, as amended (the “Code”), we will be a passive foreign investment company (“PFIC”), for any taxable year in which, after the application of certain look-through rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income” or (ii) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production of, “passive income” (including cash). Passive income generally includes dividends, interest, certain non-active rents and royalties, and capital gains.
Cash is generally characterized as a passive asset for these purposes. Goodwill is generally characterized as a non-passive or passive asset based on the nature of the income produced in the activity to which the goodwill is attributable. The extent to which our goodwill should be characterized as a non-passive asset is not entirely clear. We hold a substantial amount of cash, and while this continues to be the case our PFIC status for any taxable year will depend largely on the value of our goodwill and the characterization of our goodwill as passive or non-passive. The value of our goodwill for any taxable year may be determined in large part by reference to the average of our market capitalization for that year. Although we believe that we were a PFIC for our 2022 taxable year, based on the nature of our operations and assets, as well as certain estimates as to our income and the relative values of our assets during our 2023 and 2024 taxable years, we believe that we were not a PFIC for our 2023 and 2024 taxable years (subject to the discussion in the next paragraph with respect to U.S. Holders who held our ordinary shares during our 2022 taxable year). There can be no assurance that the IRS will agree with our conclusion, however.
If we are a PFIC for any taxable year during which a U.S. investor holds ordinary shares, we generally will continue to be treated as a PFIC with respect to that U.S. investor for all succeeding years during which the U.S. investor holds ordinary shares, even if we cease to meet the threshold requirements for PFIC status. Accordingly, since we believe that we were a PFIC for our 2022 taxable year, we believe that we will remain a PFIC with respect to a U.S. Holder that held our ordinary shares during our 2022 taxable year unless certain mitigating steps were taken. For further discussion, see “Item 10. Additional Information—. Taxation—Material U.S. Federal Income Tax Consequences for U.S. Holders.”
If we are deemed to be a PFIC with respect to a particular U.S. investor, such U.S. investor may be subject to adverse U.S. federal income tax consequences, including (i) the treatment of all or a portion of any gain on disposition as ordinary income; (ii) the application of a deferred interest charge on such gain and the receipt of certain dividends; and (iii) compliance with certain reporting requirements. A “mark-to-market” or “qualified electing fund” (“QEF”) election may be available that will alter the consequences of PFIC status if our ordinary shares are regularly traded on a qualified exchange. For further discussion, see “Item 10. Additional Information—E. Taxation—Material U.S. Federal Income Tax Consequences for U.S. Holders.”
Risks Related to Our Status Under U.S. Securities Laws
We are a foreign private issuer, and, as a result, we are not subject to certain rules and obligations that are applicable to a U.S. domestic public company and are not subject to certain Nasdaq corporate governance listing standards that are applicable to a Nasdaq-listed U.S. domestic public company.
We report under the Exchange Act as a non-U.S. company with foreign private issuer status. Because we qualify as a foreign private issuer under the Exchange Act and although we intend to furnish quarterly financial information to the SEC, we are exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities, and liability for insiders who profit from trades made in a short period of time; and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K upon the occurrence of specified significant events.
In addition, foreign private issuers are not required to file their annual report on Form 20-F until four months after the end of each financial year, while U.S. domestic issuers are required to file their annual report on Form 10-K in less time. Foreign private issuers are also exempt from the Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information.
Furthermore, because we are a foreign private issuer, we comply with our home country governance requirements and certain exemptions thereunder, rather than complying with certain of the Nasdaq corporate governance listing standards that are applicable to U.S. companies listed on Nasdaq. For example, we are exempt from Nasdaq listing standards that require a listed U.S. company to have (i) a majority of the board of directors consist of independent directors, (ii) regularly scheduled executive sessions with only independent directors and (iii) a compensation committee and a nomination and corporate governance committee consisting entirely of independent directors. Furthermore, Nasdaq listing standards generally require Nasdaq-listed U.S. companies to, among other things, seek shareholder approval for the implementation of certain equity compensation plans and issuances of securities, which we are not required to follow as a foreign private issuer. Accordingly, our shareholders may not have the same protections afforded to shareholders of companies that are not foreign private issuers. For an overview of the material differences between our governance principles and Nasdaq corporate governance listing standards, see “Item 16G—Corporate Governance.”
We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting and other expenses.
We qualify as a foreign private issuer, and therefore we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. We may no longer be a foreign private issuer as of June 30, 2025, which would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers, as of January 1, 2026. In that case, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers. We would also be required to make changes in our corporate governance practices in accordance with various SEC and stock exchange rules. The regulatory and compliance costs to us under U.S. securities laws, if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer, may be significantly higher than the cost we would incur as a foreign private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time-consuming and costly. We also expect that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would be more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to retain and attract qualified members of our board of directors.
We are an emerging growth company, and the reduced reporting requirements applicable to emerging growth companies may make our ordinary shares less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, but not limited to, (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (ii) reduced disclosure obligations regarding executive compensation in this Annual Report and our periodic reports and proxy statements and (iii) exemptions from the requirements of holding a non-binding advisory vote on executive compensation.
We could be an emerging growth company for up to five years from our initial public offering, although circumstances could cause us to lose that status earlier, including if the market value of our ordinary shares held by non-affiliates equals or exceeds $700.0 million as of any June 30 (the end of our second fiscal quarter) before that time or if we have total annual gross revenues of $1.235 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company as of the following December 31 (our fiscal year end); or, if we issue more than $1.0 billion in non-convertible debt during any three-year period before that time, we would cease to be an emerging growth company immediately.
Even after we no longer qualify as an emerging growth company, if we no longer qualify as a foreign private issuer, we may still qualify as a “smaller reporting company,” which, under certain circumstances, would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our ordinary shares less attractive because we may rely on these exemptions. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares and the price of our ordinary shares may be more volatile. When these exemptions cease to apply, we expect to incur additional expenses and devote increased management effort towards ensuring compliance with them, and we cannot predict or estimate the amount or timing of such additional costs.
Item 4. Information on the Company
A. History and Development of the Company
SOPHiA GENETICS SA was incorporated as a Swiss stock corporation (société anonyme) under the laws of Switzerland on March 18, 2011. Our principal executive office is located at La Pièce 12, CH-1180 Rolle, Switzerland and our telephone number is +41 21 694 10 60. Our agent for service of process in the United States is SOPHiA GENETICS, Inc., 401 Park Drive, Suite 505, Boston, MA 02215, and its telephone number is (617) 982-1210.
Our website is www.sophiagenetics.com. The reference to our website is an inactive textual reference only and information contained therein or connected thereto are not incorporated into this Annual Report. We file reports and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains an internet site at www.sec.gov that contains reports, proxy and information statements and other information we have filed electronically with the SEC.
In July 2021, we completed our initial public offering on the Nasdaq Global Select Market (“Nasdaq”) and our ordinary shares are listed under the ticker symbol “SOPH”.
B. Business Overview
Our Mission
SOPHiA GENETICS was founded to generate clinically actionable insights from data to improve patient outcomes. Our mission is to provide equal access to knowledge and capabilities by democratizing data-driven medicine.
We observed that across the healthcare ecosystem, a vast amount of digital healthcare data was being generated, fueled by technologies such as NGS, and which held promise to accelerate the understanding of biology and disease. However, this data has been generated primarily using non-standardized methods and by clinicians and researchers across many healthcare institutions. As a result, the data remained siloed and complex and was not fully leveraged for the benefit of patients.
We founded SOPHiA GENETICS to address this issue. We are unlocking data silos, leveraging AI to generate actionable insights from data and helping healthcare professionals work together as a community and deploy their collective expertise for the benefit of patients around the world.
We refer to data-driven medicine as the practice of drawing insights from complex data sets to improve diagnosis, treatment and drug development. Using data-driven medicine, healthcare professionals supplement their own experience and intuition with data insights and shared knowledge from their peers to inform the best course of action for their patients or research. Our goal is to empower clinicians and researchers around the world to practice data-driven medicine and improve clinical and scientific outcomes.
Overview
We are a cloud-native software technology company in the healthcare space dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. We purposefully built a cloud-native software platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. Our platform standardizes, computes and analyzes digital health data and is used across decentralized locations to break down data silos. This enables healthcare institutions to share knowledge and experiences and to build a collective intelligence. We envision a future in which all clinical diagnostic test data is channeled through a decentralized analytics platform that will provide insights powered by large real-world data sets and AI. We believe that a decentralized platform is the most powerful and effective solution to create the largest network, leverage data and bring the benefits of data-driven medicine to customers and patients globally. In doing so, we can both support and benefit from growth across the healthcare ecosystem.
In 2014, we launched the first application of our platform to analyze NGS data for cancer diagnosis. We offer a broad range of applications used by healthcare providers, clinical and life sciences research laboratories and biopharmaceutical companies for precision medicine across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism and other disease areas.
In 2019, we launched our solution for radiomics data that enables longitudinal monitoring of cancer patients and tumor progression throughout their disease journey. In 2022, we unveiled SOPHiA CarePath, a new multimodal module on our SOPHiA DDM Platform powered by our artificial intelligence and machine learning algorithms, which also incorporates our original radiomics offering. The module will allow healthcare practitioners to visualize data across multiple modalities (including genomic, radiomic, clinical, and biological) for individual patients in a longitudinal manner and derive additional insights through cohort design and comparison. SOPHiA CarePath has already been deployed as part of our Deep-Lung IV multimodal clinical study on non-small cell lung cancer and is now live at 30 sites across the world.
Today, we believe that our SOPHiA DDM Platform, commercialized under the name “SOPHiA DDM,” is one of the most widely used decentralized analytics platforms globally for clinical genomics. As of December 31, 2024, we served more than 810 hospital, laboratory and biopharma customers globally through our SOPHiA DDM Platform and related solutions, applications, products, and services, and our SOPHiA DDM Platform has supported the analysis of approximately 1,900,000 genomic profiles and has been utilized in clinical trials and research projects discussed in more than 767 peer-reviewed publications. As of December 31, 2024, we had approximately 472 core genomics SOPHiA DDM Platform customers (defined as the number of customers who generated revenue through usage of our bundle access, dry lab, and integrated access models during the specified time period, which, in this case, is the twelve months ended December 31, 2024). In addition to our core genomics customers we have many customers utilizing the Alamut product on a stand alone basis. We commercialize our SOPHiA DDM Platform and related solutions, applications, products, and services as RUO and CE-IVD products.
In the United States, our products are labeled and sold for research use only. Because such applications and products are not intended for use in clinical practice and diagnostics and cannot make clinical or diagnostic claims, the FDA regulations require that RUO applications and products be labeled “For Research Use Only. Not for use in diagnostic procedures.” In the EU, we have self-certified our applications and products without the intervention of a notified body in order to affix the CE marking.
Data-driven medicine has become possible through technological breakthroughs, like NGS, that have driven creation of digital healthcare data and an accelerated understanding of biology and disease. While genomics has played a large role in these advances, emerging technologies such as radiomics, digital pathology and proteomics are creating new data sets that add phenotypic context to genomic information. Additionally, the adoption of EHRs has enabled the matching of clinical outcome data to these data sets. The digital format of these data sets makes them ideal candidates for data exploration, analysis and interpretation by advanced algorithmic computing solutions. We believe that analytics approaches have traditionally primarily focused on analyzing data from a single modality and not on combining structured data from multiple modalities. Although some institutions and laboratories have created service-based business models designed to capture multimodal data, these approaches are typically centralized at a single institution, which we believe limits their ability to scale globally.
With our SOPHiA DDM Platform, we have the potential to serve and collaborate with all types of institutions in the global life sciences ecosystem, including healthcare providers, clinical and life sciences research laboratories and biopharmaceutical companies. Our platform is built on a decentralized model in which we push data analytics solutions to our customers’ sites, rather than a centralized model that requires samples to be sent to a central location. Our customers therefore generally perform testing on their own samples, retain custody of both their sample and data, and use our SOPHiA DDM Platform to analyze the pseudonymized and de-identified data and share insights with other sites in our network. Through this process, we create and grow a global collective intelligence. Our platform is designed to improve as we analyze more data over time, leveraging AI and then sharing the benefits of this growing collective intelligence with our customers.
We believe that our global platform empowers better patient care through data-driven medicine by offering the following benefits for customers:
•high accuracy genomic analysis to support clinical diagnosis and life sciences research;
•rapid turnaround time for data analysis and insights;
•ability to lower cost of data analysis through higher efficiency;
•capacity to develop their own in-house precision medicine expertise and operations, retain custody of their samples and data and use their preferred instrument setup; and
•option to rapidly launch new precision medicine applications on our SOPHiA DDM Platform.
We believe that our strategic positioning as a universal healthcare analytics platform for multimodal data analytics offers us a broad range of application, product, and service expansion opportunities and significant long-term growth in our total addressable market opportunity. We estimate the total addressable global market opportunities in 2024 for our current commercial clinical applications and for our current biopharma applications were approximately $25 billion and $15 billion, respectively.
We offer a range of platform access models to meet our customers’ needs. Our primary pricing strategy for our clinical customers is a pay-per-use model, in which customers can access our platform free of charge but pay for each analysis performed using our platform. To commercialize our applications and products, we employ our direct sales force, use local distributors and form collaborations with other global product and service providers in the healthcare ecosystem to assemble solutions to address customer needs. For example, we combine our solutions and applications with other products used in the genomic testing process to provide customers integrated products in the testing workflow. We offer our SOPHiA DDM Platform and related solutions, applications, products, and services across 73 countries through our direct sales force and our distributor partners. As of December 31, 2024, our direct sales team consisted of more than 96 field-based commercial representatives with a direct presence in 58 countries. To supplement our direct sales force, we also offer our SOPHiA DDM Platform and related solutions, applications, products, and services in 46 countries through our distributor partners.
The Importance of Data-Driven Medicine
Over the last decade, there has been an explosion in the amount of healthcare data. This growth has been fueled by technologies that enable high throughput analysis and data generation at large scale, as well as the collection and digitization of real-world health data in EHRs. The ability to draw insights from this data has led to an acceleration in the understanding of biology and disease and paved the way for data-driven medicine.
Data-driven medicine aims to produce better clinical and scientific outcomes by drawing insights from complex data sets to improve diagnosis, treatment and drug development. Using data-driven medicine, healthcare professionals are able to supplement their own experience and intuition with shared knowledge and data insights from their peers and have the potential to select the best course of action for their patients or research.
Genomics is propelling data-driven medicine. The development of large-scale genomics data is advancing data-driven medicine. With broad access to NGS technologies, the life sciences field is beginning to successfully document the relationship between the genome and various diseases and is deploying this information to improve clinical and scientific outcomes. This has given rise to the field of precision medicine, which is having an increasing impact on a range of life sciences areas. In oncology, for example, advancements in genomics and the understanding of cancer have fueled the growth of a large precision oncology ecosystem, in which genomic information is critical to informing diagnostic, treatment and drug development decisions. In other areas such as rare diseases, cardiology, neurology, metabolism and infectious diseases, the adoption of data-driven medicine is just beginning and represents a significant opportunity for growth. For instance, in cardiology, clinical genomics is becoming more common for screening, diagnostic and therapy selection for certain inherited conditions, while in neurology, clinical genomics is helping direct treatment decisions for therapeutic intervention.
Multimodal data provides novel and deep insights to assess health and disease states. While the growing understanding of genomics has dramatically advanced the life sciences field and data-driven medicine, it is only one piece of the biological equation. Phenotypic information is also needed to put genomic information into context and provide a more complete picture of biology and disease. Driven by this need, innovation is accelerating across new health technologies, such as radiomics, digital pathology and proteomics, providing this phenotypic context. We believe that combining data from different instrument modalities, or a multimodal approach, will transform clinical and scientific outcomes by generating clinically actionable insights from combined relevant healthcare data sets. If leveraged properly, these data sets have the potential to provide a stronger “signal,” or window into biology and disease, than any single modality alone. In oncology, for example, oncologists can characterize the genetic determinants of a tumor at the time of diagnosis and complement this with phenotypic information through radiomics analysis of CT, MRI, SPECT and PET imaging, digital pathology analysis of histology slides and proteomics analysis of the tumor stroma and blood samples.
Then, throughout a patient’s disease journey, the oncologist can collect longitudinal insights through imaging, liquid biopsies and proteomics assessment of repeat blood sampling. This information can be aggregated and linked to clinical outcome data to find associations between disease evolution and response to therapy. In addition, deep-learning algorithms applied to multimodal data sets now make it possible to predict the evolution of a disease or the response to a specific treatment with high accuracy, in order to inform the best treatment decisions for the patient. These unique insights are driving the opportunity and demand for analytics platforms that can draw clinically actionable insights from this information.
AI/ML produce novel insights from large and complex data sets. The output of these new health technologies is generated in a digital format, making data highly amenable to advanced algorithmic computing solutions for exploration, analysis and interpretation. AI approaches have enabled the ability to standardize, classify, analyze and interpret massive volumes of data, and separate the signal from the noise. Large volumes of digital information across modalities can then be mined using AI approaches to generate novel insights, enabling truly data-driven medicine.
Challenges to the Adoption of Data-Driven Medicine Today
While we believe that data-driven medicine has the potential to transform healthcare, currently, there are significant challenges that limit its democratization and adoption at scale. These challenges include:
•Lack of data harmonization and standardization across the healthcare ecosystem. Data is often produced with different approaches and methodologies, which can result in dramatic variability in data quality. In the clinical genomics field, for example, every experimental step, from using different technologies for nucleic acid extraction and DNA or RNA amplification to using different models of NGS instruments, could lead to inconsistent data across sites and experiments, or “noise” in the data. As a result, obtaining a comparable set of clinical genomics data can be challenging, particularly in decentralized settings in which inter-laboratory variability can be considerable.
•Data silos and lack of knowledge sharing. Most healthcare data is produced by different healthcare institutions and by centralized laboratories that use different instrument modalities. As a result, data is created and remains in silos. In hospitals, for example, clinicians may struggle to collect and piece together data sets from clinical genomics to pathology to medical imaging for patients that have been produced in different, non-standardized ways. Pharmaceutical companies face similar challenges when reconciling their clinical trial data with disparate real-world data sources, resulting in highly variable quality of insights.
•Barriers to collaboration. Healthcare professionals and researchers may be limited in their ability to share their patients’ healthcare data for various reasons, such as privacy or concerns over losing control of their data. In addition, they have difficulties collaborating with peers from different sites or different fields. As a result, collaborations among healthcare professionals and researchers across different sites and fields is suboptimal.
•Healthcare infrastructure is designed to facilitate healthcare delivery at a local or regional level, rather than on a global scale. Healthcare infrastructure is generally designed around centralized institutions, such as hospitals and laboratories, that generate data within their own facilities. This centralized design is not built to scale or to provide equal access to data-driven medicine globally.
•Existing software analytics approaches are limited in their ability to generate insights from multimodal data. Traditional approaches to software analytics solutions have primarily focused on analyzing data from a single modality and not on combining structured data from multiple modalities. Existing analytical software solutions thus have limited utility to generate insights from multimodal information.
Our SOPHiA DDM Platform
We believe that a decentralized platform is necessary to create the largest network that will bring the benefits of big data to customers and to both support, and benefit from, growth across the healthcare ecosystem. We purposefully built a cloud-native software platform capable of being used in decentralized locations and of analyzing data from multiple modalities and that can be scaled globally. With our SOPHiA DDM Platform, we have the potential to serve and collaborate with a variety of types of institutions in the healthcare ecosystem, including healthcare providers, centralized laboratories and biopharmaceutical companies.
Our SOPHiA DDM Platform is a global, cloud-native software platform that we began building in 2011. It is powered by our SOPHiA AI that standardizes, computes and analyzes digital health data, generating insights from complex multimodal data sets that have the potential to improve diagnosis, therapy selection and drug development. Our customers generally perform testing on their own samples, retain custody of both their sample and data, and use our SOPHiA DDM Platform to analyze the pseudonymized data and share insights with each other. Through this process, we create and grow a collective intelligence. We offer multiple platform access models that enable customers to choose how they want to use our platform and customer network. These range from models in which customers produce their own data independently through their own testing operations to those in which customers produce the data through testing operations provided by our network of customer institutions. In all cases, customers access their data and our analytics through our SOPHiA DDM Platform. Our platform is designed to continually improve as we analyze more data over time, leveraging AI and then sharing the benefits of this growing collective intelligence with our customers.
We believe that our SOPHiA DDM Platform addresses key challenges to the adoption and democratization of data-driven medicine by:
•Enabling data harmonization and standardization across the healthcare ecosystem. The accuracy of our pattern-recognition AI/ML-based algorithms enables our platform to separate the signal from the noise and standardize data at high-quality levels.
•Breaking down data silos. We empower our customers to practice data-driven medicine through a decentralized model and support clinicians, laboratories and researchers across the healthcare ecosystem to improve clinical and scientific outcomes.
•Empowering clinicians and researchers to collaborate with peers from different sites or different fields. Our customers use our platform to share insights with each other across sites in our network. Our platform is designed to improve as we analyze more data over time, leveraging AI and then sharing the benefits of this growing collective intelligence with our customers.
•Offering a highly scalable platform. We designed our cloud-native software platform to be capable of scaling globally and to use AI to leverage the data that this scale provides.
•Generating insights from complex multimodal data sets. We believe our platform is uniquely positioned to combine high-quality data at the patient level to generate multimodal insights, leveraging the power of advanced AI/ML models.
The following figure shows how our SOPHiA DDM Platform functions within the healthcare ecosystem.
Our SOPHiA DDM Platform within the Healthcare Ecosystem
We launched the first commercial application of our platform in 2014 to analyze NGS data for cancer diagnosis. We now offer a broad range of applications focused on precision medicine across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism and other disease areas. In 2019, we launched our solution for radiomics data that enables longitudinal monitoring of cancer patients and tumor progression throughout their disease journey. In 2022, we unveiled SOPHiA CarePath, a new module that will further enhance our solution for longitudinal monitoring of cancer patients and tumor progression by integrating data across multiple modalities including genomic, radiomic, clinical, and biological). CarePath serves as the successor to our radiomic solution, which we plan to integrate into the module.
Our Network and Data
Today, we believe that our SOPHiA DDM Platform, commercialized under the name “SOPHiA DDM,” is one of the most widely used decentralized analytics platforms globally for clinical genomics. As of December 31, 2024, we served more than 810 hospitals and laboratory customers globally through our SOPHiA DDM Platform who are part of our clinical genomics network. The establishment and creation of this network of customers has enabled us to capture and compute approximately 1.9 million raw clinical genomics profiles in oncology and other genetic-related disorders as of December 31, 2024, which is now growing by approximately 30,000 new profiles on a monthly basis.
Our SOPHiA DDM Platform Architecture
We believe that our platform architecture allows our platform to be highly flexible and scalable in terms of analyzing larger volumes of data, supporting additional data modalities, expanding to new geographies and deploying new applications and functionalities. This flexibility and scalability comes from our platform’s underlying architecture that is developed based on a deep understanding of our users’ needs and a thorough domain model, allowing us to build re-useable User Interface (“UI”) components and services to interact with the data. Our SOPHiA DDM Platform includes multiple tailored analytics engines, each tuned to specific domains and use cases. Each domain is responsible for its own data with a common shared data model that allows powerful Extract-Transform-Load (“ETL”) pipelines to process specific data sets, integrating data into a series of regional data warehouses that enable comprehensive and performant multimodal queries to be run across the entire global data set. We have nine regional data centers in Switzerland, France, the Netherlands, the United States, Canada, Brazil, Australia, Turkey, and the UAE.
As of December 31, 2024, this platform architecture was deployed in 73 countries through our cloud-based solution. We have developed significant operational experience by running such a large-scale cloud-based platform, which we believe enables us to deploy rapidly in new geographies. We have demonstrated that we can deploy in a new geography in approximately four weeks if appropriate cloud infrastructure exists such as Microsoft Azure, Amazon Web Services or Google Cloud Platform, or in approximately twelve weeks if such cloud infrastructure does not exist.
We regularly release platform updates. Through these updates, we offer our customers either new content, in the form of new applications, or improvements to existing applications, such as new functionalities. We believe the frequency of our updates is a competitive advantage in a rapidly evolving precision medicine ecosystem and allows our customers to benefit from new biological discoveries, such as genomic associations, that are reflected on the platform.
Cybersecurity
As part of our business, we collect, transmit, receive, process, use and store pseudonymized data provided by our customers. Our customers are required to obtain their patients’ consent to our use of the data. We use security techniques designed to safeguard data received from our customers using a combination of data architecture, pseudonymization, anonymization, minimization and segregation, and process and store this data only in accordance with our agreements with customers and applicable data protection laws and regulations. This data is aggregated and analyzed by our proprietary algorithms and models in our SOPHiA DDM Platform to generate insights. These insights, which show aggregated and general trends without identifying specific patients and without providing personally identifiable information, form the growing collective intelligence that we provide to our customers.
Cybersecurity and data protection are core tenets of our company. We have processed over 1.9 million genomic profiles and continue to process more than 50 terabytes of data each month for our customers around the world, subject to applicable data protection laws and regulations, including HIPAA and the GDPR. We accomplish this through our global compliance framework that integrates specialized and dedicated personnel, procedures and controls and ISO/IEC 27001:2022, ISO/IEC 27017:2015 and ISO/IEC 27018:2019 security infrastructure and cloud service processing, to protect data against damage, loss and unauthorized access, use, modification, disclosure or other misuse.
Applications of Our Platform
We currently have commercial applications targeting both clinical and biopharma markets. We serve our clinical market customers through two offerings of our SOPHiA DDM Platform. Our first offering is our SOPHiA DDM Platform for clinical genomics, spanning a broad range of applications that we market for analyzing genomic data across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism and other disease areas. Our SOPHiA DDM Platform empowers customers to build their own precision medicine operations, including testing, and then use our platform to generate insights from their data. Our second offering is our Alamut suite of genomics mutation interpretation software, which is connected to our SOPHiA DDM Platform and gives our customers advanced analytics capabilities for a deeper and more informed genomic data interpretation.
For revenues generated from applications for which the disease end market is known, approximately 70% of our revenue from clinical customers in the year ended December 31, 2024 was attributable to oncology applications, including hereditary cancer, while approximately 30% was attributable to other disease areas such as rare diseases, cardiology, neurology and metabolism, with applications ranging from targeted gene panels to whole-exome solutions. In the future, we intend to pursue additional IVD status and FDA approval for specific solutions. We also intend to support external collaborators in deploying their own IVD or FDA-approved solutions on our SOPHiA DDM Platform.
We serve our biopharma customers by leveraging the capabilities and Data of our SOPHiA DDM Platform to help customers solve bottlenecks across the biopharma value chain, including throughout the Discovery, Development and Deployment stages.
We currently have four branded applications for biopharma customers: SOPHiA Insights for generating insights pre- and post-approval of a drug based on our own proprietary SOPHiA DDM Platform data sets or on the biopharma customers’ own data sets; SOPHiA Trial Match for clinical trial recruitment of biomarker-defined patient populations; SOPHiA CDx for companion diagnostics development and deployment in our decentralized network of customer institutions; and SOPHiA Awareness for providing real-world insights into NGS testing to inform market-shaping and commercialization strategies. We launched our initial applications for the biopharma market in 2019.
The following figure shows our applications that we currently commercialize across both clinical and biopharma markets.
Our SOPHiA DDM Platform’s Applications Currently in Market
Clinical Applications
In the clinical market, we currently serve three main customer segments: academic and non-academic hospitals (including comprehensive cancer centers and children’s hospitals), reference laboratories and specialty laboratories. We currently serve our clinical market customers through two offerings of our SOPHiA DDM Platform: our SOPHiA DDM Platform for clinical genomics and our Alamut suite of genomics mutation interpretation software. We have also unveiled SOPHiA CarePath, a multimodal module on our SOPHiA DDM Platform, encompassing the capabilities of our radiomic solution, which we plan to commercialize across our clinical customer base in the future.
Oncology Applications
Our oncology applications support both germline and somatic oncology testing across both solid and liquid tumors. Our commercial oncology applications support diagnosis, therapy selection and disease monitoring. Our SOPHiA DDM Platform also supports the deployment of novel oncology testing applications. In genomics, this includes liquid biopsy-based early cancer screening as well as treatment response monitoring and minimal residual disease monitoring. In multimodal, we are able to complement and enhance our genomics capabilities with other data modalities, such as radiomic and clinical data, to include diagnosis, prediction of disease evolution and response to specific therapies, as well as longitudinal follow-up of the tumor for treatment response monitoring. The following figure shows our current applications in oncology.
Our SOPHiA DDM Platforms’ Oncology Applications
Non-Oncology Applications
Our non-oncology applications currently focus on disease areas such as rare diseases, cardiology, neurology and metabolism, with applications ranging from targeted gene panels to whole-exome solutions. While clinical genomics applications are still emerging in these disease areas, we expect significant opportunity as the life sciences field continues to establish the genetic determinants of high-profile diseases such as hereditary cardiovascular conditions, multiple sclerosis, Alzheimer’s disease, autism and metabolic syndrome. We also see significant promise of multimodality in these other disease areas, for example, in cardiology by generating novel multimodal insights stemming from the joint analysis of genomics data, radiomic analysis of ultrasound images and analysis of electrocardiograms.
Our SOPHiA DDM Platform in Genomics
We believe that our technical capabilities are cutting-edge in the genomics space. Our platform can process data from any type of biological sample, including fresh frozen tissue, formalin-fixed paraffin-embedded samples as well as liquid circulating tumor DNA samples. It can also process data from any nucleic acid source across DNA and RNA. We can identify with confidence any type of genomic alteration, including single nucleotide variants (“SNVs”), insertions-deletions (“indels”), copy-number variations (“CNVs”) and gene fusions, as well as more complex mutational signatures such as microsatellite instability (“MSI”), tumor mutational burden (“TMB”), homologous recombination deficiency or minimal residual disease. Our smart algorithms allow us to reach high accuracy on the detection and identification of challenging genomic alterations, such as mutations in CEBPA or FLT3-ITD, MET exon14 skipping mutations, or rare gene fusions. The following figure shows our SOPHiA DDM Platform’s capabilities in genomics.
Our SOPHiA DDM Platform’s Capabilities in Genomics
Our SOPHiA DDM Platform clinical genomics workflow involves CLIA-CAP and equivalent laboratories in academic hospitals, comprehensive cancer centers, children’s hospitals and reference and specialty laboratories collecting patient samples and conducting the genetic sequencing on their premises. In doing so, they can use different NGS solutions on different NGS sequencing instruments.
For somatic oncology applications, for example, the laboratory technician logs into our SOPHiA DDM Platform and loads the raw, pseudonymized, NGS data of multiple patients from the sequencing run, indicating the oncology indication to be investigated. The genomics data is securely transferred to our platform that operates globally in eight different regional data centers, keeping the data closest to the customer and complying with all local data handling requirements. The data is automatically recognized by our AI-based smart algorithms that check data quality. All types of genomic variants and signatures are then detected and identified with high accuracy, including SNVs, indels, CNVs, fusions, MSI and TMB. This molecular information is then annotated and pre-classified using AI/ML techniques.
The principal investigator, usually a pathologist or geneticist (for germline applications), accesses the results and completes the interpretation. The principal investigator may flag or store the genomic variants that he or she has recognized as being associated with a certain disease on our platform. Because of the decentralized nature of our network, other users in different sites can see the aggregated flagging of a specific variant from the community to further assist their own interpretation. The more interpretations being conducted in our platform, the more novel knowledge is generated and made available to our community. Our platform is particularly easy to use as it does not require an additional technician and provides a user-friendly interface to upload data and navigate data analytics. We believe that this ease-of-use, coupled with the scale of our decentralized platform, will empower our users to continue to rapidly uncover new variants.
This workflow is technology-agnostic in terms of sequencer type and sample preparation technology and supports a broad range of different commercial NGS solutions. The following figure shows our SOPHiA DDM Platform’s genomics workflow.
Our SOPHiA DDM Platform’s End-to-End Genomics Workflow
Our SOPHiA DDM Platform in Multimodal Data Analytics
Through our SOPHiA CarePath module on our SOPHiA DDM Platform, we can support the multimodal analysis of any source of digital health data, developing machine learning predictive models of aggregated multimodal data stacks for the same patient. We can support the analysis of clinical, biological, genomics, radiomics data today and intend to support additional data modalities such as digital pathology, proteomics, spatial genomics and metabolomics in the future.
We offer a range of predictive modeling applications ranging from disease screening, disease early detection, disease diagnosis and subtype discrimination, prediction of disease evolution, prediction of response to therapy, therapy selection and monitoring. We develop these multimodal predictive models in close collaboration with leading academic institutions together with cross-functional teams consisting of treating physicians (such as oncologists), radiologists and pathologists. Illustrative examples of advanced clinical research projects in which we have proof-of-concept data include prediction of response to anti-PD-1 immunotherapy for patients with metastatic non-small cell lung cancer, and prediction of pathological complete response after neoadjuvant therapy for patients with triple-negative breast cancer. For example, we sponsored a retrospective 57-patient analysis of the use of nivolumab for the treatment of relapsed or refractory non-small cell lung cancer to identify predictive markers of immune-oncology response based on multiple sources of data through machine learning analysis. We found that machine learning could help predict a patient’s response using baseline data and can help identify markers that are predictive of the patient’s response. We are sponsoring multimodal clinical studies to refine and assess the clinical significance of some of these multimodal signatures, which we believe will enable us to further improve our SOPHiA DDM Platform and develop new predictive algorithmic models that we can then deploy on our platform to serve a wide range of stakeholders, including oncologists and other treating physicians. The following figure shows our SOPHiA DDM Platform’s capabilities in multimodal data analytics.
Our SOPHiA DDM Platform’s Capabilities in Multimodal Data Analytics
Among our multimodal capabilities, besides our initial core competency in genomics, we have built out technical capabilities that we believe are cutting-edge in the radiomics space. These capabilities are integrated into and offered through our SOPHiA CarePath module. We can process and analyze data from any type of three-dimensional medical imaging technology, including CT, PET, MRI and SPECT scanners. We have developed AI/ML-powered segmentation algorithms that detect tumors in the scans and that segment and reconstruct tumors in three dimensions on our SOPHiA DDM Platform. Our current segmentation applications cover a wide range of major tumor types, including lung, breast, liver, kidney and brain cancer, supporting the analysis of primary and secondary (i.e., metastatic disease of another organ origin) tumors. In addition, we are developing new applications in areas such as colorectal, prostate, ovarian or neuroendocrine cancers. Radiomics features extraction is conducted on segmented tumors, generating hundreds of data points across volumetric, morphological, first order (i.e., heterogeneity), second order (i.e., texture), and deep-learning generated features. Our features extraction process is compliant with the Image Biomarker Standardization Initiative (“IBSI”) recommendations, such that results from our radiomics analyses are standardized and can be readily compared with similar analyses globally. Through our segmentation and radiomics features extraction steps, we turn existing medical images into hundreds of novel data points. We offer radiomics applications ranging from disease detection, discrimination of disease histological subtypes, prediction of tumor evolution and prediction of disease progression. In the future, we intend to develop additional radiomics applications for existing and new tumor types, as well as for disease areas outside of oncology, such as cardiology, neurology and metabolism.
Additionally, we may expand applications to other imaging modalities such as two-dimensional modalities (e.g., ultrasound, traditional x-rays) as well as testing modalities that can be processed through imaging-based approaches (e.g., electrocardiograms). The following figure shows our SOPHiA DDM Platform’s capabilities in radiomics.
Our SOPHiA DDM Platform’s Capabilities in Radiomics
While the data modality is different for radiomics compared to genomics, the same overall workflow and principles apply. The user, typically a radiologist, identifies the relevant medical images for a specific patient in the local picture archiving and communication system. The user then uploads the images into our SOPHiA DDM Platform. For a metastatic lung cancer case, for example, deep learning and other machine learning proprietary algorithms automatically detect the imaging modality, recognize the organ, segment the tumor and extract more than 200 radiomics features from the tumor image. These radiomics features can then be aggregated with genomics, clinical and biological data from the same patient. The following figure shows our SOPHiA DDM Platform workflow for radiomics.
Our SOPHiA DDM Platform’s End-to-End Radiomics Workflow
Biopharma Applications
In the biopharma market, we currently serve three types of customers: pharmaceutical companies, biotechnology companies, and CROs. Leveraging both our SOPHiA DDM Platform genomic applications and our customers’ own proprietary data through our AI/ML-powered multimodal analytics capabilities, we help customers solve development complexities and bottlenecks across the biopharma value chain. We categorize our applications based on a framework to address specific needs across the Discovery, Development, and Deployment stages of the drug and therapeutic life cycle both pre- and post-commercialization supported by the underlying data generated on our Platform. Across our application portfolio, we offer four branded applications: SOPHiA Insights, SOPHiA Trial Match, SOPHiA Awareness and SOPHiA CDx, to address the needs of our biopharmaceutical and biotechnology customers, including diagnostic assay development, clinical trial matching and application, drug and therapeutic design optimization, and diagnostic assay deployment. The following figure shows our capabilities across the biopharma value chain.
SOPHiA GENETICS’ Offerings across Biopharma Value Chain
We began commercializing biopharma applications in 2019. Our biopharma applications are competitively positioned as insights programs, which utilize data already uploaded to the SOPHiA DDM Platform or proprietary data provided directly by a biopharma customer. We believe that our customers value our biopharma applications for their ability to identify unique patient populations in clinical research and asset commercialization efforts. We signed our first biopharma customer in 2019. We served three biopharma customers accross multiple programs during the fiscal year ended December 31, 2024.
Discovery Applications.
While Moore’s law has generally played out accordingly in the computation and software space with significantly greater efficiency for lower cost being achieved over time, Eroom’s law has been used to explain an observed trend in the drug discovery space as the inflation-adjusted costs to bring a drug to market continue to rise over time. Despite the improvements in technology over time, drug discovery has remained very complex with many critical decisions that need to be made along the way at which point could ultimately lead to an unviable path forward.
To address the growing costs of drug discovery, biopharma and biotechnology companies are increasingly turning to technology solutions, particularly artificial intelligence and machine learning, to apply the benefits of Moore’s law to reverse the observed costs according to Eroom’s law. With our SOPHiA DDM Platform, we can help our biopharma and biotechnology customers make more informed decisions in the drug discovery process by leveraging the data we generate on our SOPHiA DDM Platform across our global network and applying our proprietary artificial intelligence and machine learning algorithms to the data across our network and the proprietary data of our customers. Within the Discovery segment, our current primary focus is on the later sub-stages post target identification and prior to Development, such as assay development and lead optimization.
Development Applications
The drug and therapeutic development process can be very long and capital intensive. There are both significant financial and opportunity costs that are incurred but never recouped should a drug or therapeutic fail in development stage. To increase the likelihood of success, biopharmaceutical and biotechnology companies are increasingly turning to algorithm based approaches powered by machine learning and artificial intelligence to better predict drug properties and aid in drug and therapeutic design and clinical trial testing and applications.
We are supporting our biopharma and biotechnology customers in the drug and therapeutic development process through our decentralized, technology agnostic SOPHiA DDM Platform powered by our machine learning and artificial intelligence algorithms. Our SOPHiA DDM Platform’s unique ability to harmonize data derived from diverse genomic instruments and deploy as a robust, standardized solution enables a new model for clinical trial testing through a decentralized approach, allowing our biopharma and biotechnology customers to optimize patient selection and clinical trial design. Leveraging our SOPHiA DDM’s capabilities and multimodal data, we can also support our customers in developing companion diagnostics (“CDx”) to improve testing across the target patient populations and help them in optimizing their drug and therapeutic designs. Through our SOPHiA CarePath module, we will also enable our customers to track patients longitudinally across multiple data modalities to support their clinical trials.
Deployment Applications
As biopharmaceutical companies begin deploying their drugs and therapies, they can face challenges associated with the identification and enrollment of eligible patients. To increase adoption, biopharma companies have partnered with clinical institutions to expand access to diagnostic testing that could help identify new patients eligible for and who can benefit from the new drugs and therapies.
We can help our biopharma customers with their deployment-related challenges in multiple ways. In the absence of an applicable diagnostic assay, the versatility of our SOPHiA DDM Platform allows us to support our customers by helping them develop new targeted assays, including companion diagnostics, to diagnose and identify eligible patients. We can then help our customers expand access to diagnostic testing by deploying a SOPHiA GENETICS developed diagnostic assay or a third-party developed diagnostic assay across our broad global network of hospital and laboratory customers.
SOPHiA Insights
Faced with a complex and fragmented precision medicine environment, we believe biopharmaceutical companies need access to high quality real-world data sets and advanced data analytics capabilities to generate insights from these data sets to inform their decision-making. However, currently, these data sets are often fragmented, siloed and of variable quality, while data analytics capabilities are typically more focused on single-modality applications.
We offer solutions to support biopharma customers by generating insights pre- and post-approval of a drug throughout the entire pharma value chain, including the research, development and commercialization stages. We can generate these insights both based on our SOPHiA DDM Platform real-world data sets and by leveraging our AI/ML-powered multimodal analytics capabilities on the biopharma customer’s own data sets, including data from their clinical trials. For example, a biopharmaceutical company may ask us to generate insights from our platform regarding the real-life molecular epidemiology of rare genomic variants in a specific cancer type, including NGS sequencing install base and testing practices across geographies. A biopharmaceutical company may also ask us to support it in the AI/ML-powered multimodal analysis of its own data sets, which could include genomics, clinical, biological and medical imaging data from its clinical trials, for example to identify new biomarkers associated with patient subgroups that may have a higher likelihood of response to an investigational therapy. As we generate increasingly more multimodal patient-level data stacks in our SOPHiA DDM Platform, in the future, we may support biopharmaceutical companies on novel use cases, including real-world virtual control arms for clinical trials.
SOPHiA Trial Match
Challenges of clinical trial patient enrollment is a major bottleneck for clinical trial sponsors, which leads to delays, increased costs and clinical trial failures. This challenge is magnified in the case of biomarker-targeted investigational therapies associated with rare genomic variants due to the difficulty of finding and recruiting patients with the desired genomic traits.
With SOPHiA Trial Match, sponsors can place “molecular alerts” in our SOPHiA DDM Platform for specific genomic variants or signature that may indicate eligibility for a clinical trial. When a genomic profile matching the recruitment criteria is detected in our platform, the participating local healthcare Institutions or research centers are notified in real-time and given the opportunity to connect with the clinical trial sponsor. We provide the real-time trial matching services for our participating customers.
SOPHiA CDx
We are witnessing a steady growth in the number of regulatory approvals for therapies linked to companion diagnostic assays in oncology and other disease areas. Today, these CDx assays are typically used in a centralized model in which healthcare institutions lose access to their samples and data and which can suffer from poor turnaround times due to logistical issues. We believe that in the future CDx assays will become increasingly decentralized which will drive further testing uptake at scale and enable faster turnaround times.
We offer strategic and operational support for biopharma CDx programs. Biopharma customers can leverage our capabilities to develop genomic variant detection and identification solutions with high accuracy and precision, as well as our ability to decentralize such CDx solutions at scale through our global footprint. We believe that, in the future, CDx programs may become multimodal in nature, which we would be in a position to support through our multimodal analytics capabilities.
SOPHiA Awareness
As biopharmaceutical companies commercially launch new biomarker-targeted therapies (e.g., linked to a specific companion diagnostic assay), they face significant challenges in driving broad adoption and testing rates of specific biomarkers of interest. For example, the genomics testing landscape is currently fragmented with important regional and local variations. In that context, we believe it is imperative for biopharmaceutical companies to adequately manage parallel and interdependent adoption curves across the biomarker testing and therapy prescription dimensions. While biopharmaceutical companies tend to have insights into prescription patterns by health practitioners, they typically lack insights into real-life genomics testing practices across geographies.
We support biopharma customers with real-world insights on NGS testing trends to support their market-shaping and commercial strategies. For example, when novel therapies enter the market, a biopharmaceutical company may ask us to provide regular aggregated statistical reports on NGS testing results in specific geographies to optimize resource allocation for its go-to-market strategy. A biopharmaceutical company may also collaborate with us to increase the NGS testing rate of specific biomarkers in our network, thus supporting the identification of relevant genomic variants for targeted therapies, for example by sponsoring increased testing volumes and NGS panel upgrades. As more data modalities are computed in our SOPHiA DDM Platform, we envision additional market opportunities for SOPHiA Awareness.
Alamut Suite of Genomics Analysis Software
Our offering in the clinical genomics space also includes the Alamut suite of genomics mutations interpretation software. This add-on software is connected to our SOPHiA DDM Platform through an API and provides our customers with advanced analytics capabilities for a deeper and more informed genomic data interpretation. It simplifies and accelerates variant interpretation workflows by providing an exploration and visualization application powered by an extensive collection of top-ranked external databases and proprietary prediction tools, which has the potential to be particularly impactful in deepening genomic investigations in rare diseases.
In the future, we plan to offer other add-on software solutions that are integrated with our SOPHiA DDM Platform, including software solutions from external collaborators, and that provide additional analytics capabilities. Such offerings have the potential to further increase the value of our SOPHiA DDM Platform through indirect network effects, attracting new types of customers and solutions to our network.
Clinical Publications
Our technology and its broad applications have been utilized in clinical trials and research projects discussed in more than 767 peer-reviewed publications as of December 31, 2024. These publications support scientists in new discoveries and applications across oncology, immunology, cardiology, neurology, rare diseases and other disease categories.
Access Models
We currently have three models through which customers access our SOPHiA DDM Platform. In the dry lab access model and the bundle access model, we empower customers to produce their own data. In the integrated access model, we help customers produce data through our existing network of institutions. In all cases, clinical customers access their data through our SOPHiA DDM Platform. Our biopharma customers can access our SOPHiA DDM Platform through the same three models, but they may also have access to data generated through our SOPHiA DDM Platform in the form of custom reports and analytics.
The dry lab access model involves customers using the testing instruments and consumables of their choice and our SOPHiA DDM Platform and algorithms for variant detection and identification. In this model, we provide clinical genomics analytics capabilities without influencing the tools that customers use to generate the data.
For example, in genomics, a laboratory might order an NGS kit directly from the manufacturer, conduct the sequencing using its installed sequencer and then use our smart algorithms in our SOPHiA DDM Platform for data analytics.
The bundle access model enables us to support our customers end-to-end across the data generation, analytics and reporting steps. In this model, we bundle third-party instruments and consumable products with our analytics solution to provide customers the ability to perform end-to-end workflows. By bundling our algorithmic capabilities with specific high-performance instruments and consumables from third parties, we can further increase the accuracy of our genomics solutions.
The integrated access model provides customers with the ability to access high-quality data on our platform even when they cannot generate data themselves. Customers that are not able or do not wish to locally conduct the sequencing steps, for example, due to a lack of appropriate resources, can have their samples processed and sequenced within our SOPHiA clinical network. We route their samples to selected SOPHiA DDM Platform collaborators who conduct the sequencing process for the customer and upload the resulting data into our SOPHiA DDM Platform. The customer is then able to access the data through our SOPHiA DDM Platform. Through this model, the selected SOPHiA DDM Platform collaborators can increase their sequencing volumes, while our SOPHiA DDM Platform is further enriched by the data produced.
The same conceptual access models apply to our multimodal solution SOPHiA CarePath. For multimodal, including our integrated radiomics solution, we are currently offering a dry lab access model, in which we provide the algorithmic analytics solutions while leaving the data generation at the discretion of our customers. We have developed, and intend to continue to develop, smart algorithms for specific radiomics applications, such as deep learning-enabled algorithms that can automatically recognize a lung CT scan image, detect an advanced lung cancer tumor, segment the tumor and extract radiomics features for further analysis. In the future, we may also offer a bundle access model, in which we offer solutions linked to specific imaging contrasting agents or imaging procedure modalities to optimize the performance of the final signal analysis.
We intend to apply the same conceptual access models to additional data modalities that we may support in our SOPHiA DDM Platform in the future, such as digital pathology, proteomics, spatial genomics and metabolomics.
Benefits to Customers
Our platform has the potential to offer the following benefits for customers, empowering them to adopt data-driven medicine to improve clinical and scientific outcomes:
•Accuracy. Our platform design and data analytics capabilities provide high accuracy analytics for our customers, who have access to high quality, standardized data through our SOPHiA DDM Platform.
•Turnaround time. We empower our customers to generate data themselves locally, which avoids delays associated with shipment, logistics and processing of samples through an external collaborator. We therefore significantly reduce the turnaround time, which is a critical factor in driving toward timely diagnosis and treatment of disease.
•Cost-control through increased efficiency. Customers can compute, detect and annotate any type of genomic alterations through our SOPHiA DDM Platform without the need for specific orthogonal assays, thus reducing additional testing costs.
•Maintenance and development of in-house expertise. By empowering our customers to retain ownership and access to their biological samples and data, we enable them to build in-house expertise while benefiting from world-class analytics accuracy through our SOPHiA DDM Platform’s network effects.
•Accelerated launch of new precision medicine applications. The universal nature of our SOPHiA DDM Platform facilitates adding new applications to the same workflow once an institution adopts our platform. Our customers can avoid having to set up parallel and sometimes redundant workflows for different assays and technologies.
Markets
We estimate that our clinical and biopharma applications targeted a $40 billion global total addressable market opportunity in 2024, approximately $9 billion of which was in the United States based on our addressable clinical market. These estimates are primarily based on epidemiological data, including incidence and prevalence estimates of addressable populations for each application, as well as a range of price assumptions for our applications and products taking into account differences in panel sizes. Further, these estimates do not depend on obtaining regulatory clearances or approvals to market our applications and products as in vitro diagnostics (“IVD”) and / or software as a medical device (“SaMD”) in the United States. Over time, we believe that our platform and insights enable market opportunity expansion through new application and product development. The following figure shows our estimated total addressable market in 2024.
Our Total Addressable Market
Clinical Market Opportunity
We estimate our total addressable global clinical market opportunity for our current offerings was $25 billion in 2024, with the largest market opportunity being in oncology.
Oncology. While the majority of commercial business today in the clinical market comprises diagnosis and advanced therapy selection, our capabilities enable us to serve the oncology testing market across the full patient journey. We can also support healthcare practitioners across tumor and sample types at any stage of the patient journey as long as genomic information or 3D medical imaging is applicable. Our clinical oncology market opportunity consists of five market segments: screening, early detection, diagnosis, therapy selection and monitoring.
Rare diseases. In rare diseases, we believe the adoption of data-driven medicine is just beginning and represents a significant opportunity for growth. In the rare disease market, there has been growing preference among clinical institutions for larger genetic testing panels, including whole-exome and whole genome panels, to test for a more comprehensive array of rare diseases in contrast to the smaller, more targeted panels that are common in the market today. We believe we are well adapted to address this market opportunity with the exome solutions offered through our SOPHiA DDM Platform. In addition to our SOPHiA DDM Platform, our Alamut suite of genomics mutation interpretation software could be particularly impactful in deepening genomic investigations in rare diseases.
Other disease areas and conditions. We believe that the aggregate market opportunity linked to other disease areas beyond oncology and rare diseases could ultimately be larger than our current opportunity in oncology and rare diseases given their higher prevalence compared to cancer.
Our SOPHiA DDM Platform has applications in areas such as cardiology, neurology and metabolism, through applications ranging from targeted gene panels to whole-exome solutions. While genomics applications are still emerging in these disease areas, we expect significant opportunity in the coming years as novel findings establish the genetic determinants of high-profile diseases such as inherited cardiovascular conditions, multiple sclerosis, Alzheimer’s disease, autism and metabolic syndrome. We provide applications in each of these disease areas today, and plan to further penetrate the testing landscape in these disease areas through genomics and other data modalities in the future.
Other data modalities beyond genomics. We designed our platform architecture to be able to scale with new digital healthcare data modalities beyond genomics. We have already taken the next step in that direction by developing and deploying our proprietary radiomics analytics capabilities onto our SOPHiA DDM Platform. In radiomics, we offer analytics solutions for three-dimensional medical imaging technologies, including CT, MRI, SPECT and PET scanners, regardless of manufacturers. Additionally, we may expand applications to other imaging modalities such as two-dimensional modalities (e.g., ultrasound, traditional x-rays) as well as testing modalities that can be processed through imaging-based approaches (e.g., electrocardiograms). Beyond radiomics, we intend to support additional data modalities in the future, for example digital pathology, proteomics, spatial genomics and metabolomics. We believe that supporting additional data modalities in our SOPHiA DDM Platform, both as stand-alone modalities and in a multimodal approach, has the potential to open significant new market opportunities and increase our total addressable market in the future.
Biopharma Opportunity
Oncology and rare diseases. We estimate our total addressable biopharma opportunity for our current offerings was $15 billion in 2024 based on three market segments: Discovery, Development, and Deployment. We believe also that our strategic positioning as a healthcare data analytics platform will enable other business opportunities to become available in the future, in, for example, global public health solutions.
Other Market Opportunities Accessible with our Business Model
We believe that our strategic positioning as a healthcare data analytics platform has the potential to enable other business opportunities to become available in the future.
Universal analytics platform for digital health data. Leveraging our global network and customer base, we may enter into collaboration agreements with third-party providers of solutions and services that can be deployed through our SOPHiA DDM Platform and to our customer network, thereby generating new indirect network effects. We believe that we could provide a single, unified analytical workflow through our SOPHiA DDM Platform for instruments generating many kinds of digital health data, such as digital pathology, proteomics, single-cell sequencing and other similar applications.
Global public health solutions. Our SOPHiA DDM Platform could provide a fast and reliable ecosystem to gather data on a global scale and inform public health agencies on significant health-related events, such as pandemics. The COVID-19 pandemic has demonstrated the need for solutions able to harmonize and analyze vast data sets on a global scale, for example, to track the evolution of new variants of the SARS-CoV-2 virus over time and across geographies. This may apply to other infectious diseases, and to human host factors such as detecting specific susceptibility characteristics through genomics and other phenotypic information across populations.
Value-based medicine. As data-driven medicine and multimodality diagnostic approaches are further adopted in the future, we may collaborate with healthcare stakeholders such as payors, providers and integrated healthcare systems to increase the overall affordability of healthcare. We may develop outcomes-based business models in which we enter into risk-sharing agreements with these stakeholders to support the optimal care management of specific patient populations with the goal of achieving better health and economic outcomes.
Our Platform’s Advantages
We believe our SOPHiA DDM Platform has several advantages over alternative genomics analytics platforms as well as other business models aimed at providing data-driven medicine.
Unique Value Proposition as a Genomics Analytics Platform
Our SOPHiA DDM Platform enables highly sensitive and specific testing and rapid turnaround time, enabling customers to compute, detect and annotate genomic alterations with high confidence. Our platform and its many applications also allow customers to rapidly build and scale precision medicine operations with different applications. We believe that a crucial characteristic for customers and a key differentiator of our platform is accuracy, leading to quality of insight. The accuracy of our pattern-recognition, AI/ML-based algorithms enable our platform to separate the signal from the noise and standardize data at high-quality levels. Our smart algorithms have high accuracy across applications, from oncology to rare diseases and cardiology, and reduce testing costs by obviating the need for orthogonal assays. The accuracy of our algorithms is a result of the scale and diversity of data within our database.
The following table shows how our SOPHiA DDM Platform performs on genomic variant detection from NGS data across a range of selected genomics applications versus the analytical performance of widely used orthogonal assays such as Sanger Sequencing, MLPA, array CGH and digital PCR.
Our SOPHiA DDM Platform’s Analytical Performance in Selected Current Genomics Applications
1.Results of the CE-IVD study based on our Solid Tumor Solution (STS) that included data from 6 different sequencing centers and a total of 155 clinical and commercial FFPE samples in which 192 confirmed variants were used as the standard.
2.Results of the CE-IVD study based on our Hereditary Cancer Solution (HCS) that included data from 7 different sequencing centers and a total of 159 clinical and commercial samples in which 1,252 confirmed variants were used as the standard.
3.Results based on the clinical exome analysis of the Ashkenazim trio (mother, father and son’s DNA) from the Genome In a Bottle consortium that included data from 2 different sequencing centers and a total of 9 samples (including replicates) in which an average of 6,241.2 confirmed variants per sample were used as the standard.
4.Results based on two similar studies that included data from 2 different sequencing centers and a total of 113 clinical and commercial samples in which 833 confirmed variants were used as the standard.
Sensitivity measures how often a test correctly generates a positive result for samples in which a certain genomic variant is present (“true positive” rate). Specificity measures how often a test correctly generates a negative result for samples in which a certain genomic variant is not present (“true negative” rate). Accuracy measures the proportion of tested samples that are correctly classified (“true positives” plus “true negatives”). Precision measures the ability for repeated analyses on the same samples to give similar results.
Broad and Growing Multimodal Application Offering
The breadth of our applications and multimodal capabilities enables our customers to deploy and scale their data-driven medicine operations rapidly and to incorporate additional clinically relevant data sets over time. We believe our platform is uniquely positioned to combine high-quality data at the patient level to generate multimodal insights, leveraging the power of advanced AI/ML models. We have developed proprietary capabilities in AI/ML-enabled exploration of multimodal signatures. Through these, we can unlock the synergistic power of next-generation healthcare data to advance predictive capabilities. We believe that over time, multimodal data will provide a superior means to diagnose and treat disease relative to the current approach focusing on just a single modality.
Software-based Platform Facilitates Rapid Global Scaling and Data Collection
We designed our cloud-native software platform to be capable of scaling globally and to use AI to leverage the data that this scale provides. As of December 31, 2024, we served more than 810 hospital, laboratory and biopharma customers globally through our SOPHiA DDM Platform and related solutions, applications, products, and services. We believe that this global footprint is unique and enables us to capture a wide variety of real-world clinical data around the world. The following figure shows our customer base by region as of December 31, 2024.
Our Customer Base by Region
We have been expanding our customer base as well as the volume of data that we analyze. From December 31, 2016 to December 31, 2024, our number of active customers grew from 182 to more than 810. During the same period, the aggregate number of genomic profiles analyzed using our SOPHiA DDM Platform grew from approximately 80,000 profiles to approximately 1,900,000 profiles, recently growing by approximately 30,000 new profiles on a monthly basis.
We regularly release platform updates, currently at a pace of once every three weeks. Through these updates, we offer our customers either new content, in the form of new applications or improvements to existing applications, such as new functionalities. We believe this update frequency is a competitive advantage in a rapidly evolving precision medicine ecosystem and allows our customers to benefit from new biological discoveries, such as genomic associations, that are reflected on the platform.
Ability to Work with All Stakeholders in the Healthcare Ecosystem
We are empowering our customers through a decentralized model and are able to support clinicians, laboratories and researchers across the healthcare ecosystem. This enables us to benefit from growth across the industry and provide the benefits of our network to different stakeholders. We are also able to collaborate with other product providers in the ecosystem to bundle our solutions to provide differentiated end-to-end solutions. For example, we collaborate with testing kit companies, testing hardware providers, software analytics companies, and diagnostic companies operating with a centralized model. We collaborate with companies including Twist, IDT and Agilent to create an integrated solution using our analytics platform and their library preparation products, including DNA enrichment kits, and with hardware and lab automation providers such as Hamilton and PerkinElmer. We believe that we can support and collaborate with any industry player for their data analytics needs and are therefore not dependent on any specific business model or industry segment.
We believe that this unique ecosystem positioning strategy, coupled with our industry-leading analytics capabilities and our global footprint, position us as a global leading healthcare data analytics company. The following figure shows our unique position in the healthcare ecosystem.
SOPHiA GENETICS’ Unique Position as an “Operating System”
Real-time Visibility into the Healthcare Ecosystem Provides Product and Application Expansion Opportunities
Our strategic positioning as a universal healthcare data analytics platform gives us real-time visibility into data and events in the healthcare ecosystem, including diagnosis, clinical data, customer behavior, performance of third-party technology solutions and other data important to stakeholders. We believe that we are well positioned to provide value to stakeholders across the healthcare ecosystem and to benefit from product and application expansion opportunities.
High Visibility and Predictability into Our Business
Once onboarded onto our SOPHiA DDM Platform, our customers tend to steadily increase their use of our SOPHiA DDM Platform, which offers a level of predictability that helps us project and manage our growth. In addition, customers rarely leave our SOPHiA DDM Platform given that we are generally integrated into their processes. These observed trends hold particularly well for our dry lab and bundle access model customers. We have a revenue churn rate, which we define as the annualized revenues we estimate to have lost from customers who access our platform through our dry lab access and bundle access models and have not generated revenue over the past 12 months in that period based on their average quarterly revenue contributions from point of onboarding as a percentage of total recurring platform revenue, of 4% across our customer base over the year ending December 31, 2024. Furthermore, our customers generally increase their use and adopt new applications of our SOPHiA DDM Platform as our relationship with them grows.
Our Growth Strategy
Our mission is to empower clinicians and researchers around the world to practice data-driven medicine and improve clinical and scientific outcomes. Our growth strategy is to:
•Drive innovation and advancement of our SOPHiA DDM Platform to increase its capabilities and broaden its applications. We plan to continue to invest in scientific innovation to bring new, high-impact content to our customers through regular updates to our platform. This may include new features, new applications, new data modalities and new services. Furthermore, we intend to augment our offering across a multimodality framework, generating novel insights enabled by our expanding data assets, including genomics data, radiomics analysis of medical imaging, clinical data and future additional data modalities such as digital pathology, proteomics, spatial genomics and metabolomics.
•Drive new customer adoption with clinical customers worldwide. We intend to continue to raise awareness of the benefits of data-driven medicine and drive adoption of our platform around the world through our direct sales force, our distributors and our collaborator network. We plan to further penetrate the U.S. market, which we see as our largest opportunity, by significantly investing in our direct sales force to further scale the size of our network, both in terms of the number and types of customers. In addition, we also plan to focus on commercializing our solutions by forming additional collaborations with reference and specialty laboratories. Outside the United States, we believe there is significant growth opportunity across EMEA and Latin America markets, as well as untapped potential in APAC, including in China, India, Korea and Japan. In selected geographies outside the United States, we intend to utilize a hybrid commercial model including direct sales force or direct collaborations and distributors.
•Increase utilization within our clinical customer base. We employ a “land and expand” commercial model that is focused on winning new customers and then driving utilization of our solution by those customers. Once we secure a customer, we use our direct sales force to build further engagement and help that customer profitably increase its testing operations. For example, we may initially support a customer in setting up its NGS testing operations for hereditary cancer screening, including operational support through our set-up programs. Once the customer is fully onboarded onto our SOPHiA DDM Platform, it is then comparatively easier to deploy additional germline testing solutions as well as somatic oncology testing solutions, creating synergies across the offerings and a unified workflow. We also target incremental users within each institution, for example, additional clinicians within a provider across expanded departments such as radiology or pathology.
•Leverage our platform and database to drive adoption by biopharmaceutical companies. We have a distinct sales force focused on biopharma opportunities across the discovery, clinical development and commercialization value chain. We continue to promote our current applications, products, and services, which we believe will strengthen existing collaborations with biopharmaceutical companies as well as lead to new relationships. For example, we may collaborate with a biopharmaceutical company to generate insights on the real-world molecular epidemiology of specific genomic variants relevant for an investigational targeted therapy, including insights on testing trends across our network of customers. This may lead to additional collaborations on a multimodal program to investigate new biomarkers of response to the investigational therapy, a tailored companion diagnostic program, clinical trial recruitment efforts, and market-shaping activities on biomarker testing to support the asset go-to-market strategy. Additionally, we plan to develop new offerings for biopharma as we expand the number and type of new applications and data modalities on our platform. Our biopharma strategy is also highly synergistic to our virtuous cycle.
•Establish and grow industry collaborations across the healthcare ecosystem. We intend to establish new industry collaborations with other companies providing applications, products, and services to our customers. We intend to collaborate with a diverse array of industry participants, including instruments, reagent and software companies in genomics and in other fields such as digital pathology and proteomics. We intend to collaborate with service providers such as centralized laboratory players and interpretation services providers to expand the breadth of our capabilities. We believe that each new collaboration we develop helps facilitate further adoption of our platform, the evolution of the solution we provide to customers and the growth of our network and application and product capabilities. A larger network enables us to continue to collaborate with customers to develop new solutions and to commercialize these solutions, benefiting all users across the healthcare ecosystem.
Commercial
We sell our SOPHiA DDM Platform and related solutions, applications, products, and services to healthcare providers, centralized laboratories and biopharmaceutical companies through our own sales force as well as through distributors and industry collaborators. As of December 31, 2024, our direct sales team consisted of approximately 96 field-based commercial representatives, including sales and business development managers, key account managers and biopharma alliance managers who are engaged in sales efforts and promotional activities towards our customers. We also employ subject matter experts, clinical genomic experts and biopharma operations specialists who provide customer-facing technical and scientific support. As of December 31, 2024, we had a sales presence in 73 countries, including a direct sales presence in 58 countries and 46 countries in which we offer our SOPHiA DDM Platform and related solutions, applications, products, and services through distributors. The following figure shows our global commercial footprint as of December 31, 2024.
SOPHiA GENETICS’ Global Footprint – Countries and Sales Force
Our initial focus has been on winning clinical customers in order to drive data capture and building our reputation for accuracy and quality in the clinical community. We estimate that there are more than 10,000 laboratories globally that are using NGS instrumentation. We believe that there is significant opportunity to expand our customer base as well as grow utilization of our SOPHiA DDM Platform by our existing customers. Our sales strategy is focused on both attracting new customers to our platform and driving their utilization and adoption of our applications. Once we win a new customer, our direct sales team provides set-up programs to accelerate the adoption of our SOPHiA DDM Platform and facilitates our customers to adopt our platform into their routines. In 2024, we refocused resources from our more established and penetrated markets in EMEA to higher-growth and under-penetrated regions in NORAM and APAC, as well as specific markets in EMEA, such as the U.K., Germany, and the Middle East, and implemented a more strategic approach towards winning and managing key, high-volume accounts in the clinical market.
We started commercializing our biopharma services in 2019. In 2024, we refocused our sales efforts to target smaller, more repeatable business that we can execute in high volume to expedite our sales cycle.
Suppliers and Manufacturers
Our platform is a cloud-native software platform. To deploy our platform, we rely on cloud-based service providers. We also collaborate with consumables and hardware suppliers for the bundle access model and with platform customers for the integrated access model.
Platform Suppliers. Our platform production environment currently runs on Microsoft Azure. As our platform architecture is vendor-agnostic, we could readily deploy our solutions onto any cloud infrastructure, as well as on-premise if necessary. We have ongoing research and development projects on all major cloud solution providers, including Microsoft Azure, Amazon Web Services and Google Cloud Platform. This allows us a strong degree of flexibility and helps manage vendor risks.
Consumables and Hardware Suppliers. In the bundle access model, we work with Integrated DNA Technologies (“IDT”), Twist Biosciences (“Twist”), Qiagen, Beckman Coulter, Thermo Fisher Scientific (“Thermo Fisher”) and others for consumables and with Hamilton, PerkinElmer and others for hardware equipment.
Platform Customers. In the integrated access model, we route a customer’s samples to selected SOPHiA DDM Platform collaborators who conduct the sequencing process for the customer and upload the resulting data into our SOPHiA DDM Platform. As of December 31, 2024, we collaborated with eleven laboratories across nine countries to provide this service.
We continually assess our dependence on our suppliers and manufacturers and evaluate alternative solutions. We have built our business such that we do not rely on any single supplier or manufacturer, such that we are able to switch suppliers and manufacturers as necessary. We believe that this mitigates risks to our business and provides us the opportunity to drive down costs.
Competition
We operate in a market characterized by rapidly advancing technologies and a strong emphasis on intellectual property. Our main competitors are institutions that collect multimodal data that have developed in-house analytics solutions, such as Tempus Labs, F. Hoffmann-La Roche and Caris Life Sciences, but we believe these competitors also represent our potential customers. In addition, other companies such as Siemens, Koninklijke Philips and Konika Minolta are also positioning themselves in the market with data analytics platform capabilities to build a multimodal world. We also face competition from companies that have developed software analytics platforms for genomics data, such as Agilent, Fabric Genomics, Illumina, Qiagen Digital Insights, Velsera Inc., Congenica Ltd and Thermo Fisher. We believe that our proprietary technology and the agility and the scalability of our platform distinguishes us from other players. We believe that our position as a “universal operating system” enables us to empower and sell to many different players in the ecosystem, including competitors. See “Item 3. Key Information—D. Risk Factors—Risks Related to Our Business and Industry—We face competition from many sources and we may be unable to compete successfully.”
Intellectual Property
Intellectual property is of vital importance in the biotechnology field. Our success depends in part on our ability to obtain and maintain intellectual property and proprietary protection for our technology, defend and enforce our intellectual property rights, preserve the confidentiality of our trade secrets, and operate without infringing, misappropriating or otherwise violating valid and enforceable intellectual property and proprietary rights of others.
We are actively involved in research and development and therefore seek to protect the investments made into the development of our technology by relying on a combination of patents, trademarks, copyrights, trade secrets, including know-how, and license agreements. We also seek to protect our proprietary technology, in part, by requiring our employees, consultants, contractors and other third parties to execute confidentiality agreements and invention assignment agreements and by implementing technological measures and other methods.
Our ability to stop third parties from making, using, selling, offering to sell or importing our platform, applications, services, and products depends on the extent to which we have rights under valid and enforceable patents, trade secrets or other intellectual property and proprietary rights that cover these activities. We pursue intellectual property protection to the extent we believe it would advance our business objectives. Notwithstanding these efforts, there can be no assurance that we will adequately protect our intellectual property or provide any competitive advantage. For more information regarding risks relating to intellectual property, see “Item 3. Key Information—D. Risk Factors—Risks Related to Intellectual Property.”
Patents
Our intellectual property strategy is focused on protecting our ongoing research and development through patents and other intellectual property rights.
As of December 31, 2024, we solely owned 8 issued U.S. patents, 32 pending U.S. patent applications, 41 issued patents and approximately 34 pending patent applications in foreign jurisdictions, including Europe, Canada, Australia, Brazil, China, and India, wherein 5 are pending Patent Cooperation Treaty applications relating to laboratory methods and/or software to provide molecular diagnosis in germline diseases. These include filings for 29 families of utility patents and 2 families of design patents relating to graphical user interfaces. Such issued utility patents and any patents derived from such applications or applications that claim priority from such applications, if granted, would be expected to expire between (2036 and 2044), excluding any additional term for patent term adjustments.
As of December 31, 2024, our most material patents and patent applications consisted of (i) one issued patent in Israel, one issued patent in Australia, one issued patent in Brazil, one issued patent in Europe, one issued patent in India, three pending U.S. patent applications and two pending foreign patent applications in Canada and China relating to our algorithm for next generation sequencing data which is used in our SOPHiA DDM Platform, (ii) one issued European Patent, one issued U.S. patent, and one pending U.S. patent application relating to a method for processing certain genomic data which is used in our SOPHiA DDM Platform, (iii) one issued European Patent, one issued U.S. patent, and one pending U.S. patent application for a method to improve the accuracy of the estimated length of homopolymer and heteropolymer regions, which is used in our SOPHiA DDM Platform, (iv) one pending U.S. patent application, one pending European patent application, and five pending foreign patent applications in Australia, Brazil, Canada, Japan, and South Korea relating to a unique molecular identifier and related analytics workflow which is incorporated in our software applications and products and into our SOPHiA DDM Platform, (v) one issued European patent, one issued U.S. patent, and one U.S. pending patent application for a method to detect microsatellite instability that is used in our SOPHiA DDM Platform, (vi) one pending European patent application, three U.S. pending patent application, and seven pending foreign patent applications in Hong Kong, Australia, Brazil, Canada, China, Japan, and South Korea relating to a method to detect homologous recombination deficiency (“HRD”), which is used in our SOPHiA DDM Platform and SOPHiA DDM HRD solution, (vii) one pending European patent application and one pending U.S. patent application relating to a Limit of Detection aware variant calling method which is not currently used in our software applications and products, (viii) one issued European patent, one pending but allowed U.S. patent application, and five pending foreign patent applications in Australia, Brazil, Canada, Japan, and South Korea relating to a unique molecular identifier and related analytics workflow which is incorporated in our probes for detecting gene fusion events in our SOPHiA DDM Platform RNAtarget Technology. Any patents derived from such applications or applications that claim priority from such applications, if granted, would be expected to expire between 2036 and 2042, excluding any additional term for patent term adjustments.
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file or intend to file, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent. We cannot be sure that patents will be granted with respect to any current pending patent application or with respect to any patent applications filed by us in the future, and we cannot be sure that any current or future patents will be commercially useful in protecting our platform, applications, products, services, technologies and processes. In addition, any patents that we may hold, whether owned or licensed, may be challenged, circumvented or invalidated by third parties.
Trademarks
The success of our business strategy depends on our continued ability to use our existing intellectual property in order to increase brand awareness and develop our branded services.
As of December 31, 2024, we owned 11 registered U.S. trademarks, 3 pending U.S. trademarks, approximately 134 registered foreign trademarks and 3 pending foreign trademark applications. Our trademark portfolio is designed to protect the brands of our current and future applications and products and includes U.S. trademark registrations for our company name, “SOPHIA GENETICS”, and application and product names, such as “SOPHIA DDM” and “ALAMUT”. We have granted licenses to certain of our trademarks to our domestic and international collaborators.
Trade Secrets
We also rely on trade secrets, including know-how, unpatented technology and other proprietary information, to strengthen our competitive position. We have determined that certain technologies that are not amenable to, or that we do not presently consider appropriate for, patent protection, such as our analysis techniques and analysis generated using our proprietary algorithms in the context of our SOPHiA DDM Platform, are better kept as trade secrets in order to protect and maintain our competitive position and aspects of our business and prevent competitors from reverse-engineering or copying our technologies.
We seek to protect trade secrets and confidential and unpatented know-how, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, corporate collaborators, outside scientific collaborators, CROs, or manufacturers, consultants, advisors and other third parties. We also seek to enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to us. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes or that the assignment agreements that have been entered into are self-executing.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, or claim ownership in intellectual property that we believe is owned by us. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary information by third parties.
Government Regulation
Laboratory Developed Tests
CLIA and State Laboratory Licensing
CLIA is a U.S. federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, or treatment of disease, or impairment of, or the assessment of the health of, human beings. CLIA regulations require, among other things, clinical laboratories to obtain a certificate and mandate specific standards in the areas of personnel qualifications, administration, participation in proficiency testing, test management, and quality assurance. CLIA certification is also required for us to be eligible to bill state and federal healthcare programs, if such reimbursement is otherwise available, as well as many private third-party payors, for our applications and products.
In addition to federal certification requirements of laboratories under CLIA, CLIA provides that states may adopt laboratory regulations and licensure requirements that are more stringent than those under federal law. A number of states have implemented their own more stringent laboratory regulatory requirements. Such laws, among other things, establish standards for the day-to-day operation of a clinical laboratory, including the training and skills required of personnel and quality control. For example, New York laws and regulations establish standards for day-to-day operation of a clinical laboratory, including training and skill levels.
We do not currently operate a CLIA-certified laboratory. Our customers are responsible for their own CLIA certification.
Federal Oversight of Laboratory Developed Tests
The laws and regulations governing the marketing of clinical laboratory testing and diagnostic products are evolving and extremely complex and, in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. Clinical laboratory tests are regulated under CLIA, as administered by CMS, as well as by applicable state laws. In addition, the FDCA defines a medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, pre-market clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the export of medical devices manufactured in the United States to international markets.
Although the FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, prior to 2024 the FDA has generally exercised its enforcement discretion and not enforced applicable regulations with respect to in vitro diagnostics that are designed, manufactured and used within a single laboratory for use only in that laboratory. These tests are referred to as LDTs.
On May 6, 2024, the FDA issued a final rule which amends the FDA’s regulations to make it explicit that LDTs are included in the definition of in vitro diagnostic products (“IVDs”) and outlines the adjustment of enforcement discretion of LDTs over 5 phases ending in May 2028 (four years after the rule’s publication date). Exemptions to the rule exist; LDTs first market before the rule publication date can remain on the market subject to certain conditions (e.g. no significant change), LDTs within the DoD or VHA, LDTs approved by NYS CLEP, are all examples.
AI/ML-Based Medical Software
The FDA recognizes that the traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies. The FDA has cleared or approved several AI/ML-based software as medical devices (“SaMD”). Typically, these have only included algorithms that are “locked” prior to marketing, where algorithm changes likely require FDA premarket review for changes beyond the original market authorization. However, not all AI/ML-based SaMD are locked; some algorithms can adapt over time. Following distribution, these types of continuously learning and adaptive AI/ML algorithms may provide a different output in comparison to the output initially cleared for a given set of inputs.
The FDA’s Center for Devices and Radiological Health is building a total product lifecycle-based regulatory framework for AI/ML technologies. On January 12, 2021, the FDA released its Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan, which outlines five actions that the FDA intends to take, including:
•further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
•supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
•fostering a patient-centered approach, including device transparency to users;
•developing methods to evaluate and improve machine learning algorithms; and
•advancing real-world performance monitoring pilots.
In April 2023, the FDA further advanced its regulatory efforts by publishing detailed recommendations for Marketing Submissions that incorporate Predetermined Change Control Plans (“PCCPs”), emphasizing a structured approach to managing post-market modifications for AI/ML-based medical devices. It requires manufacturers to outline anticipated AI/ML modifications in their initial marketing submission, detailing a structured approach for implementing and validating these updates. The impact of the modifications should be assessed in advance to ensure they maintain safety and performance. It also highlights the need for transparency and traceability, requiring clear documentation of AI/ML updates. Risk mitigation strategies must be in place to address potential issues like model drift or performance degradation.
The recommendations have been drafted to ensure continuous compliance of AI-driven medical devices.
U.S. Medical Device Regulatory Framework
Pursuant to its authority under the FDCA, the FDA has jurisdiction over medical devices, which are defined to include, among other things, IVDs and SaMD. The FDA regulates the research, design, development, preclinical and clinical testing, manufacturing, safety, effectiveness, packaging, labeling, storage, recordkeeping, pre-market clearance or approval, adverse event reporting, marketing, promotion, sales, distribution and import and export of medical devices. Specifically, if the FDA begins to actively regulate LDTs, then, unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States could require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA (“510(k) clearance”) or approval from the FDA of a PMA application. Both the 510(k) clearance and PMA processes can be resource-intensive, expensive, and lengthy, and require payment of significant user fees.
Device Classification
Under the FDCA, medical devices are classified into one of three classes (Class I, Class II or Class III) depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.
Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to General Controls for Medical Devices, which require compliance with the applicable portions of the FDA’s Quality System Regulation, facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.
While some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described below, most Class I products are exempt from the premarket notification requirements.
Class II devices are those that are subject to the General Controls, as well as Special Controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These Special Controls can include performance standards, patient registries, FDA guidance documents and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process.
Class III devices include devices deemed by the FDA to pose the greatest risk, such as life-supporting, life-sustaining devices or implantable devices, in addition to those deemed novel and not substantially equivalent following the 510(k) process. The safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and Special Controls described above. Therefore, these devices are subject to the PMA process, which is generally more costly and time-consuming than the 510(k) process. Through the PMA process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction. Accordingly, a PMA typically includes, but is not limited to, extensive technical information regarding device design and development, preclinical and clinical trial data, manufacturing information and labeling and financial disclosure information for the clinical investigators in device studies. The PMA application must provide valid scientific evidence that demonstrates to the FDA’s satisfaction a reasonable assurance of the safety and effectiveness of the device for its intended use.
The 510(k) Clearance Process
Under the 510(k) clearance process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to a PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence.
After a 510(k) premarket notification is submitted, the FDA determines whether to accept it for substantive review. If it lacks necessary information for substantive review, the FDA will refuse to accept the 510(k) premarket notification. If it is accepted for filing, the FDA begins a substantive review. By statute, the FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification. As a practical matter, clearance often takes longer, and clearance is never assured. Although many 510(k) premarket notifications are cleared without clinical data, the FDA may require further information, including data from samples collected in a clinical setting, to make a determination regarding substantial equivalence which may significantly prolong the review process. If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market the device.
If the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA approval process or seek reclassification of the device through the De Novo classification process.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, under current regulations, will require a new 510(k) clearance or, depending on the modification, could require a PMA application. The FDA requires each manufacturer to determine whether the proposed change requires a new submission in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many minor modifications are accomplished by an internal letter-to-file in which the manufacture documents its reasoning for why a change does not require premarket submission to the FDA. The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for such change. The FDA can always review these letters-to-file in an inspection.
If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or approval of a PMA application is obtained. In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite application(s).
The De Novo Process
The De Novo classification process is an alternate pathway to classify medical devices that are automatically classified into Class III but which are low to moderate risk. A manufacturer can submit a petition for direct De Novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk. De Novo classification may also be available after receipt of a “not substantially equivalent” letter following submission of a 510(k) to the FDA.
The PMA Approval Process
Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it is not, the agency will refuse to file the PMA. If it is, the FDA will accept the application for filing and begin the review. The FDA has 180 days to review a filed PMA application, although the review of an application more often occurs over a significantly longer period of time. During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.
Before approving or denying a PMA, an FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as inspections of the manufacturing facility and processes. Overall, the FDA review of a PMA application generally takes between one and three years, but may take significantly longer. The FDA can delay, limit or deny approval of a PMA application for many reasons, including:
•The device may not be shown safe or effective to the FDA’s satisfaction;
•The data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval;
•The manufacturing process or facilities may not meet applicable requirements; and
•Changes in FDA clearance or approval policies or adoption of new regulations may require additional data.
If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter or an approvable letter, the latter of which usually contains a number of conditions that must be met in order to secure final approval of the PMA. When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter. If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not-approvable letter. The FDA also may determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are available. The PMA process can be expensive, uncertain and lengthy, and a number of devices for which FDA approval has been sought by other companies have never been approved by the FDA for marketing.
New PMA applications or PMA supplements are required for modification to the manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, ingredients, materials or design of a device that has been approved through the PMA process. PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
In approving a PMA application, as a condition of approval, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and effectiveness data for the device. The FDA may also approve a PMA application with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale, distribution and use. New PMA applications or PMA supplements may also be required for modifications to any approved diagnostic tests, including modifications to manufacturing processes, device labeling and device design, based on the findings of post-approval studies.
Clinical Trials
In the United States, absent certain limited exceptions, human clinical trials intended to support medical device clearance or approval require an investigational device exemption (“IDE”) application. Some types of studies deemed to present “non-significant risk” are deemed to have an approved IDE–without affirmative submission of an IDE application to the FDA–once certain requirements are addressed and IRB approval is obtained. If the device presents a “significant risk” to human health, as defined by the FDA, the sponsor must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate IRBs at the clinical trial sites. Submission of an IDE will not necessarily result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.
Such clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. Clinical trials must further comply with good clinical practice regulations for IRB approval and for informed consent and other human subject protections. Required records and reports are subject to inspection by the FDA for any clinical trials subject to FDA oversight. The results of clinical testing may be unfavorable, or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant marketing approval or clearance of a product. The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application or clearance of a 510(k) premarket notification, for numerous reasons.
The Breakthrough Devices Program is a voluntary program intended to expedite the development, assessment and review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. All submissions for devices designated as Breakthrough Devices will receive priority review, meaning that the review of the submission is placed at the top of the appropriate review queue and receives additional review resources, as needed. Although Breakthrough Device designation or access to any other expedited program may expedite the development or approval process, it does not change the standards for approval. Access to an expedited program may also be withdrawn by the FDA if it believes that the designation is no longer supported by data from our clinical development program. Additionally, qualification for any expedited review procedure does not ensure that we will ultimately obtain regulatory clearance or approval for such product.
Research Use Only
In the United States, SOPHiA applications and products labeled and sold for research use only, and not for the diagnosis or treatment of disease, are sold to a variety of parties, including biopharmaceutical companies, academic institutions and molecular laboratories. Because such applications and products are not intended for use in clinical practice in diagnostics, and the applications and products cannot include clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical devices.
In particular, while the FDA regulations require that RUO applications and products be labeled “For Research Use Only. Not for use in diagnostic procedures,” the regulations do not otherwise subject such applications and products to the FDA’s pre- and post-market controls for medical devices.
A significant change in the laws governing RUO products or how they are enforced may require a change to our business model in order to maintain compliance. For instance, in November 2013 the FDA issued the RUO Guidance, which highlights the FDA’s interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory, developed test is in conflict with RUO status. The RUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation or verification, or similar specialized technical support, to clinical laboratories conflicts with RUO status. If we engage in any activities that the FDA deems to be in conflict with the RUO status held by the applications and products that we sell, we may be subject to immediate, severe and broad FDA enforcement action that would adversely affect our ability to continue operations. Accordingly, if the FDA finds that we are distributing our RUO applications and products in a manner that is inconsistent with its regulations or guidance, we may be forced to stop distribution of our RUO tests until we are in compliance, which would reduce our revenues, increase our costs and adversely affect our business, prospects, results of operations and financial condition. In addition, the FDA’s proposed implementation for a new framework for the regulation of LDTs may negatively impact the LDT market and thereby reduce demand for RUO applications and products.
If the FDA requires marketing authorization of our RUO applications and products in the future, there can be no assurance that the FDA will ultimately grant any clearance or approval requested by us in a timely manner, or at all.
Post-Market Regulation
After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:
•establishment registration and device listing with the FDA;
•QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;
•labeling regulations and FDA prohibitions against the promotion of investigational products or the promotion of “off-label” uses of cleared or approved products;
•requirements related to promotional activities;
•clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices;
•medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
•correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;
•the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and
•post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
Device manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file and complaint files. In January 2024, the FDA published a final rule to amend the QSR to align the regulations more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other countries. Manufacturers have until February 2, 2026, to modify their quality systems to meet QMS Regulations (QMSR).
Manufacturers are subject to periodic scheduled or unscheduled inspections by the FDA. A failure to maintain compliance with the regulatory requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of products. The discovery of previously unknown problems with products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, including the following:
•issuance of warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties;
•requesting or requiring recalls, withdrawals or administrative detention, or seizure of our products;
•imposing operating restrictions or partial suspension or total shutdown of production;
•refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;
•withdrawing 510(k) clearances or PMA approvals that have already been granted;
•refusal to grant export approvals for our products; or
•criminal prosecution.
Authorization to Market In Vitro Medical Devices in the European Economic Area
In the EEA, in vitro medical devices that are in transition to the new regulations are required to conform with the essential requirements of the EU In Vitro Diagnostic Directive (IVDD Directive No 98/79/EC, as amended, the “IVDD”). The scope of 98/79/EC applies to IVD medical devices and accessories, which can include not just reagents and kits but also instruments and software. To demonstrate compliance, ISO 13485 is recognized as the harmonized standard for regulatory quality system compliance. Companies are required to meet the essential requirements of the IVDD.
EU IVD Regulatory Classification
Under the IVDD, the risk presented by a device determines the classification and therefore the level of control and regulatory review required. Annex II of the IVDD identifies specific device types that are categorized as either high risk (List A) or moderate risk (List B). General IVDs may self-certify without the intervention of a Notified Body in order to affix the CE Marking. Self-test IVDs, because of the greater risk associated with being used by untrained lay users, have special requirements, while all other devices not classified as either List A, List B or self-test are regarded as general IVDs.
SOPHiA currently has self-certified applications and products in the EU market through SwissMedic.
On April 5, 2017, the EU adopted the new In Vitro Device Regulation (EU) 2017/746 (the “IVDR”), which repeals and replaces Directive No 98/79/EC effective May 2022. Unlike directives, which must be implemented into the national laws of the EU member states, a regulation is directly applicable, i.e., without the need for adoption of EU member state laws implementing them, in all EEA member states. The IVDR, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EU for in vitro diagnostic medical devices and ensure a high level of safety and health while supporting innovation. The IVDR will not become fully applicable until five years following its entry into force. Once applicable, the IVDR will, among other things:
•strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
•establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
•improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; and
•set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.
On July 9, 2024, the the Regulation (EU) 2024/1860 was published in the Official Journal of the European Union, which includes new transitional periods for IVDs. When following certain conditions i.e. QMS requirements and Notified Body agreements the transition deadlines are extended as follows; December 2027 for class D devices that are transitioning from IVDD self declared, December 2028 for class C devices that are transitioning from IVDD self declared, and December 2029 for class B that are transitioning from IVDD self declared and A sterile devices. Moreover, the application of certain requirements of Article 5(5) of the IVDR for devices manufactured and used in the same health institution (so-called ‘in-house devices') came into force in May 2024 with full compliance to Article 5(5) required in May 2030. Any products currently on the market with a CE-IVD label before May 2022 may remain on the market until the new deadline or until the product undergoes a significant change, at which point, it must comply with all the requirements of the IVDR.
Brexit and the Regulatory Framework in the U.K.
On June 23, 2016, the electorate in the U.K. voted in favor of leaving the EU, commonly referred to as Brexit. On December 24, 2020, the U.K. and the EU entered into a Trade and Cooperation Agreement. The agreement sets out certain procedures for approval and recognition of medical products in each jurisdiction. Since the regulatory framework for medical products in the U.K. covering quality, safety and efficacy of medical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical medical is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime which applies to medical products in the U.K., as the U.K. legislation now has the potential to diverge from EU legislation. It remains to be seen how Brexit will impact regulatory requirements for medical products in the U.K. in the long-term. The Medicines and Healthcare products Regulatory Agency published detailed guidance for industry and organizations to follow from January 1, 2021, which will be updated as the U.K.’s regulatory position on medicinal products evolves over time.
A new UKCA mark will replace the CE mark in Great Britain (CE marks or UKNI marks will be required in Northern Ireland). However, all medical devices and IVD's must be registered with the Medicine and Healthcare products Regulatory Agency to be placed on the Great Britain market, CE marked devices can be placed on the Great Britain market until, at least, 30 June 2030, depending on the device type and classification.
EU-Swiss Institutional Framework Agreement
In May 2022, Switzerland adopted the new Ordinance on In vitro Diagnostic Medical Devices (“IvDO”), which replaced the former agreement. Under the new regulation, in order to market products in Switzerland, companies that manufacture diagnostic and medical devices are required to register the products with the Swiss Agency for Therapeutic Products (“Swissmedic”) and label the products accordingly.
Additionally, products manufactured in the Swiss facilities of companies are subject to additional registration and representation requirements in order to be marketed within the European Economic Area (“EEA”), including but not limited to the appointment of an Authorized Representative.
Other Jurisdictions
Outside the United States, the EU, the U.K. and Switzerland, regulatory pathways for the marketing of medical devices vary greatly from country to country. In many countries, local regulatory agencies conduct an independent review of medical devices prior to granting marketing approval and may require specific disclosure or localization to access the local market.
For instance, in Brazil all medical devices imported into or distributed within Brazil must first be registered with the Agência Nacional de Vigilância Sanitária (“ANVISA”) or the National Health Surveillance Agency. ANVISA is an autonomous regulatory agency responsible for the regulation and oversight of medical devices and other medical products in Brazil, including the registration of medical devices and the maintenance of a registered products database. The medical device company must be located in Brazil or arrange for a licensed third-party company to be the Brazilian registration certificate title holder. Resolution RDC 36/2015 is the central regulation applicable to registration of in vitro diagnostic devices and Resolution RDC 751/2022, which became effective on March 1, 2023, covers software as medical devices in Brazil, describing the protocol and documents required, including localization into Brazilian Portuguese. Chapter II set forth of RDC 36/2015 the classification scheme, assigning devices to one of four risk classes, based upon various rules enumerated therein. This classification structure is aligned with the EU’s one. If a device fits into more than one risk classification, its final risk class is the one associated with the highest risk level. Class I and Class II registrations do not expire. Class III and IV registrations are valid for ten years. Registration renewals must be initiated no earlier than one year and no later than six months prior to expiration. Manufacturers are also subject to audits to ensure compliance with the Brazilian Good Manufacturing Practices (“BGMP”) prior to receiving authorization to sell from ANVISA. BGMP audits may be fulfilled through other audits by recognized entities through the Medical Device Single Audit Program. RUO products are labeled accordingly and are not subject to these registration requirements. While we are currently able to market our SOPHiA DDM Platform and related solutions, products and services in Brazil, including through our Brazilian subsidiary, any changes to the regulatory framework for RUO products could result in additional costs to us, including expenses related to additional audits, translations and registration fees, or delays in accessing the Brazilian market, including due to the time required to obtain necessary ANVISA approvals.
In Turkey, medical devices are regulated by the Medicines and Medical Devices Agency within Ministry of Health and pursuant to the Medical Device Regulation, the Regulation on Active Implantable Medical Devices and the Regulation on In Vitro Diagnostic Medical Devices. These regulations generally resemble analogous EU directives and regulations. To be sold in Turkey, medical devices must bear a CE mark and must subsequently be registered in the Turkish Ministry’s online database (Turkish Drug and Medical Device National Databank, or TITUBB) in order to be marketed in Turkey. Manufacturers without local presence in Turkey must appoint a Local Authorized Representative. A product will generally be considered a medical device if it is marketed as a medical device in the EU. In recent years, software and mobile application medical devices have been increasing and the Medicines and Medical Devices Agency has considered certain software and mobile applications as medical devices, taking into consideration their intended use. In March 2021, the Product Safety and Technical Regulations Law No. 7223 (the “Product Safety Law”) became effective. The Product Safety Law reconciled some outstanding differences between Turkish and EU product safety standards, providing in part for manufacturer and importer liability in the event that a noncompliant or unsafe product causes harm or damage and mandating recall of such products. Because the current regulatory framework in Turkey closely parallels the EU’s framework, we do not currently experience material difficulties in marketing our SOPHiA DDM Platform and related solutions, applications, products, and services in Turkey that are unique to that jurisdiction.
In Japan the Ministry of Health, Labour and Welfare (“MHLW”) uses a classification system based on risk for IVDs, there are three types of registration procedures; Pre-market notification for Class I (lowest) risk devices, Pre-market certification (“PMC”) for Class II devices, and Pre-Market Approval (“PMA”) for Class III (highest) risk devices. Companies must comply with the Pharmaceuticals Medical Device Act (“PMDA”), manufacturers must also comply with MHLW Ordinance No. 169 relating to quality management systems in addition to appointing an in country representative and registration of design and manufacturing facilities. The Japanese regulatory space requires interactions with authorities in Japanese and therefore partnership or local expertise is required for engagement in the country.
The Therapeutic Goods Administration (“TGA”) regulates IVDs in Australia which classifies IVDs into four categories based on risk; Class 1 No public health risk or low personal risk, Class II Low public health risk or moderate personal risk, Class III Moderate public health risk or high personal risk, Class 4 High public health risk. Similar to the EU, the TGA allows In-House manufacture of IVDs, this includes assembly of commercially available components which may not be regarded as IVDs because they are marked for RUO. The TGA separates IVDs into two categories the first being in house IVDs in Classes 1-3, the second being in house IVDs in Class 4. Both categories require the involvement of Australia’s National Association of Testing Authorities in conjunction with the Royal College of Pathologists in that in house manufacturers must be accredited to ISO 15189 for medical testing labs.
Federal and State Health Care Laws in the United States
Federal Physician Self-Referral Prohibition
In the United States, we are subject to the federal physician self-referral prohibition, commonly known as the Stark Law. Under this law, physicians who have an ownership interest or a compensation relationship with a clinical laboratory may not, unless an exception applies, refer Medicare or Medicaid patients for testing to the laboratory, regardless of the intent of the parties. Similarly, laboratories may not bill Medicare or Medicaid for services furnished pursuant to a prohibited self-referral. Several Stark Law exceptions are relevant to many common financial relationships involving clinical laboratories and referring physicians, including: (1) fair market value compensation for the provision of items or services; (2) payments by physicians to a laboratory for clinical laboratory services; (3) space and equipment rental arrangements that satisfy certain requirements and (4) personal services arrangements that satisfy certain requirements. Penalties for violating the Stark Law include significant denial of payment, the return of funds received for all prohibited referrals, fines, civil monetary penalties, and exclusion from the federal health care programs. In addition, knowing violations of the Stark Law may also serve as the basis for liability under the federal False Claims Act (the “FCA”), which can result in additional civil and criminal penalties. Many states have their own self-referral laws as well, which in some cases apply to all patient referrals, not just government reimbursement programs.
Federal Anti-Kickback Law
The federal Anti-Kickback Statute (AKS) prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (i.e., anything of value), directly or indirectly, overtly or covertly, in cash or in kind, in order to induce or in return either for the referral of an individual, or for purchasing, leasing, ordering, or arranging for the purchase, lease, or order of any healthcare item or service that is reimbursable under any federal health care program, including Medicare or Medicaid. Liability under the AKS may be established without proving actual knowledge of the statute or specific intent to violate it. Federal and state law enforcement authorities scrutinize arrangements between health care providers and potential referral sources to ensure that the arrangements are not designed as a mechanism to induce patient care referrals or induce the purchase or prescribing of particular applications, products, or services. Generally, courts have taken a broad interpretation of the scope of the AKS, holding that the statute may be violated if merely one purpose of a payment arrangement is to induce referrals or purchases. Although there is a number of statutory exceptions and regulatory safe harbors protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. In addition, the government may assert that a claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim under the federal civil False Claims Act (FCA), which is discussed in greater detail below. Although the AKS applies only to items and services reimbursable under any federal health care program, a number of states have passed statutes substantially similar to the AKS that apply to all payors. Violations of the AKS are punishable by imprisonment, criminal fines, damages, civil monetary penalties, and exclusion from participation in federal healthcare programs.
False Claims Act
The FCA prohibits, among other things, a person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval and from making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in order to secure payment or retain an overpayment by the federal government.
In addition to actions initiated by the government itself, the statute authorizes actions to be brought on behalf of the federal government by a private party having knowledge of the alleged fraud. Because the complaint is initially filed under seal, the action may be pending for some time before the defendant is even aware of the action. If the government intervenes and is ultimately successful in obtaining redress in the matter or if the plaintiff succeeds in obtaining redress without the government’s involvement, then the plaintiff will receive a percentage of the recovery. Finally, the Social Security Act includes its own provisions that prohibit the filing of false claims or submitting false statements in order to obtain payment. Several states have enacted comparable false claims laws which may be broader in scope and apply regardless of payor.
Other Health Care Laws
In addition to the requirements discussed above, several other health care fraud and abuse laws could have an effect on our business
The Social Security Act includes civil monetary penalty provisions that impose penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. In addition, a person who offers or provides to a Medicare or Medicaid beneficiary any remuneration, including waivers of copayments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable under the civil monetary penalties statute. Moreover, in certain cases, providers who routinely waive copayments and deductibles for Medicare and Medicaid beneficiaries, for example, in connection with patient assistance programs, can also be held liable under the AKS and FCA. One of the statutory exceptions to the prohibition is non-routine, unadvertised waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts. The Office of Inspector General of the U.S. Department of Health and Human Services (HHS) emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular patient.
The Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, “HIPAA”) imposes criminal and civil liability for, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. Like the AKS, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
The Eliminating Kickbacks in Recovery Act (EKRA) is an all-payor anti-kickback law that makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of recovery homes, substance use clinical treatment facilities, or laboratories. Although the enactment of EKRA focused on patient brokering and similar arrangements to induce the patronage of substance use recovery and treatment, EKRA’s statutory prohibition is broadly written. The full scope and application of EKRA is uncertain.
The Physician Payments Sunshine Act, enacted as part of the Affordable Care Act (ACA), also imposed annual requirements on manufacturers of certain devices, drugs, and biologics to report annually to CMS information related to payments and other transfers of value made to physicians, other health care professionals, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Also, many states have laws similar to those listed above that may be broader in scope and may apply regardless of payor.
If our operations are found to be in violation of any of the fraud and abuse laws described above or any other laws that apply to us, we may be subject to penalties, including potentially significant criminal, civil and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, contractual damages, reputational harm, integrity oversight and reporting obligations, limitations to the sale of certain applications, products, or services, diminished profits and future earnings, and the curtailment or restructuring of our operations. Efforts to ensure that our internal operations and business arrangements with third parties comply with applicable laws and regulations involve substantial costs.
Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
Coverage and Reimbursement
Sales of our SOPHiA DDM Platform and related solutions, applications, products, and services, if approved for IVD use in the United States, may depend substantially on the extent to which health maintenance organizations, managed care organizations, pharmacy benefit managers, federal and state government health administration authorities, private health coverage insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for such solutions, applications, products, and services.
In the United States, many significant decisions about coverage and reimbursement for new diagnostics and medicines are made by CMS, which decides whether and to what extent a new diagnostic or medicine will be covered and reimbursed under Medicare, although it frequently delegates this authority to local Medicare Administrative Contractors (MACs), and by states under their Medicaid programs. Medicare is a federally funded program managed by CMS through MACs and carriers that administer coverage and reimbursement for certain healthcare items and services furnished to the elderly, disabled individuals, and individuals with certain medical conditions. Medicaid is an insurance program for certain categories of patients, including pregnant women, whose income and assets fall below state defined levels, that is both federally and state funded and managed by each state. In the United States, private health insurers and other third-party payors often provide reimbursement for products and services based on the level at which the government provides reimbursement through the Medicare or Medicaid programs for such products and services. It is difficult to predict what CMS, state Medicaid programs, and other third-party payors will decide with respect to coverage and reimbursement for novel platforms, applications, products, and services such as ours.
Outside the United States, the reimbursement process and timelines vary significantly. Certain countries, including a number of member states of the EU, set prices and make reimbursement decisions for diagnostics and pharmaceutical products, or medicinal products, as they are commonly referred to in the EU, with limited participation from the marketing authorization holders or medical device manufacturers, or may take decisions that are unfavorable to the marketing authorization holders or medical device manufacturers where they have participated in the process.
Health Reform
In the United States and many foreign jurisdictions, there has been significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls and restrictions on reimbursement. Because private payers often follow Medicare and Medicaid coverage policy and payment limitations in setting their own reimbursement rates, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments from private payers. We expect to experience pricing pressures in connection with the sale of any products that we develop due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative and regulatory measures.
Such legislative changes in the United States include the ACA, which intended to broaden access to health insurance, reduced or constrained the growth of healthcare spending, enhanced remedies against healthcare fraud and abuse, added new transparency requirements for healthcare and health insurance industries, and imposed additional health policy reforms. We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal, state, and foreign governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.
Data Privacy and Security
Health Insurance Portability And Accountability Act and Other U.S. Laws and Regulations
Under HIPAA, as amended by HITECH, HHS has issued security, privacy, and breach notification regulations pertaining to protected health information (PHI) used or disclosed by certain entities, including certain health care providers such as us.
Three standards have been promulgated under HIPAA’s and HITECH’s regulations: the Standards for Privacy of Individually Identifiable Health Information, which restrict the use and disclosure of certain individually identifiable health information, the Standards for Electronic Transactions, which establish standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures, and the Security Standards for the Protection of Electronic Protected Health Information, which require covered entities and business associates to implement and maintain certain security measures to safeguard certain electronic health information, including the adoption of administrative, physical and technical safeguards to protect such information.
The HIPAA privacy regulations cover the use and disclosure of PHI by covered entities as well as business associates, which are defined to include subcontractors that create, receive, maintain, or transmit PHI on behalf of a covered entity or business associate, as well as their covered subcontractors. They also set forth certain rights that an individual has with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or disclosure of PHI. The HIPAA security regulations establish requirements for safeguarding the confidentiality, integrity and availability of PHI that is electronically transmitted or electronically stored. HITECH, among other things, established certain health information security breach notification requirements. A covered entity must notify any individual whose PHI is breached according to the specifications set forth in the breach notification rule. The HIPAA privacy and security regulations establish a uniform federal “floor” for PHI and do not preempt state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their records containing PHI or insofar as such state laws apply to personal information that is broader in scope than PHI. In addition, individuals (or their personal representatives, as applicable) generally have the right to access test reports directly from laboratories and to direct that copies of those reports be transmitted to persons or entities designated by the individual.
HIPAA authorizes U.S. state attorneys general to file suit on behalf of their residents for violations. Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the basis for duty-of-care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In addition, violations of HIPAA could result in significant penalties imposed by the HHS’s Office for Civil Rights. HIPAA also mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA-covered entities, such as us, and their business associates for compliance with the HIPAA privacy and security standards. It also tasks HHS with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the civil monetary penalty paid by the violator. Our company may receive, as part of the normal course of its business, PHI that is covered by HIPAA. Considering this, we have certain obligations under HIPAA regarding the use and disclosure of any PHI that may be provided to us. Therefore, noncompliance with privacy and security requirements imposed by HIPAA and HITECH could subject us to significant administrative, civil, and criminal penalties.
In addition, many states in which we operate have laws that protect the privacy and security of sensitive and personal information. Certain state laws, such as those of California and other states that have adopted versions of the Consumer Data Privacy Act, are more stringent or broader in scope, or offer greater rights to individuals, with respect to sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which may complicate compliance efforts. In addition, new legislation or constitutional amendments proposed or enacted in various states impose, or have the potential to impose, additional obligations on companies that collect, store, use, retain, disclose, transfer, and otherwise process confidential, sensitive, and personal information, and will continue to shape the data privacy environment nationally. State laws are changing rapidly and there is discussion in the U.S. Congress of a new federal data protection and privacy law to which we would become subject if it is enacted. All of these evolving compliance and operational requirements impose significant costs that are likely to increase over time, and may require us to modify our data processing practices and policies, divert resources from other initiatives and projects, and could restrict the way applications, products, and services involving data are offered, all of which may have a material and adverse impact on our business, financial condition and results of operations.
Numerous other federal and state laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of patient health information. We intend to continue to comprehensively protect all personal information and to comply with all applicable laws regarding the protection of such information through our policies and procedures as well as through administrative, physical and technical safeguards.
General Data Protection Regulation and Other Foreign Laws and Regulations
As we are operating worldwide, including in the EU and the EEA member states, the U.K., and Switzerland, we have to ensure the compliance of our processing activities with different data protection laws and regulations. Non-compliance with these data protection laws and regulations may not only result in high penalties, it can also cause a loss of reputation and trust.
In the EU and the EEA, processing operations of personal data, including health and genetic personal data, are governed by the GDPR. The GDPR strengthens the powers of the relevant authorities and adds a broad array of requirements for handling personal data, including, for example, requirements to establish a legal basis for processing, higher standards for obtaining consent from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, requirements to implement safeguards to protect the security and confidentiality of personal data that requires the adoption of administrative, physical and technical safeguards, shortened timelines for data breach notifications to appropriate data protection authorities or data subjects, limitations on retention and secondary use of information, increased requirements pertaining to health data and additional obligations when we contract third-party processors in connection with the processing of the personal data. EU and EEA member states are tasked under the GDPR to enact, and have enacted, certain implementing legislation that adds to and/or further interprets the GDPR requirements and potentially extends our obligations and potential liability for failing to meet such obligations. The GDPR, together with national legislation, regulations and guidelines of the EU and the EEA member states governing the processing of personal data, impose strict obligations and restrictions on the ability to collect, use, retain, protect, disclose, transfer, and otherwise process personal data. In particular, the GDPR includes obligations and restrictions concerning the consent and rights of individuals to whom the personal data relates, the transfer of personal data out of the EEA, security breach notifications and the security and confidentiality of personal data, including the following:
•Lawfulness, fairness and transparency: Personal data must be processed lawfully, fairly, and in a transparent manner.
•Purpose limitation: Personal data must be obtained for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes.
•Data minimization: Personal data processed must be adequate, relevant, and limited to what is necessary.
•Accuracy: Personal data must be accurate and, where necessary, kept up to date.
•Storage limitation: Personal data must not be kept longer than is necessary.
•Integrity and confidentiality: Appropriate technical and organizational measures must be put in place to guard against unauthorized or unlawful processing, loss, damage, or destruction.
The GDPR authorizes fines for certain violations of up to 4% of global annual revenue or €20 million, whichever is greater, and other administrative penalties. The U.K. has transposed the GDPR into domestic law, with its version of the GDPR that took effect on January 1, 2021, which could expose us to two parallel regimes, each of which potentially authorizes similar fines for certain violations.
In addition, processing of personal data may be governed by the New Federal Act on Data Protection (FADP). The FADP entered into force in September 2023 and provides for data protection principles that are substantially similar to those applied under the GDPR. The purpose of the FADP is to protect the personality rights, including privacy rights, and the fundamental rights of data subjects. The FADP is broad in its material scope and applies to personal data processing activities carried out by federal authorities, private organizations and individual private persons (excluding processing activities for exclusively personal use). The territorial scope of the FADP goes beyond those processing operations carried out in Switzerland, also covering operations that have an effect in Switzerland, even if they originate in another country. Sensitive personal data, including health data, genetic data and biometric data, which unequivocally identify a natural person, are subject to stricter protective measures in various respects.
For example: (i) if consent is required, it must be given expressly in the case of processing of sensitive personal data; (ii) controllers must keep record of their data processing activities; (iii) sensitive data must not be disclosed to third parties without justification; (iv) the controller of a data file is obliged to inform the data subject of the collection personal data; and (v) disclosing personal data in breach of a confidentiality obligation may be criminally prosecuted. Processing activities by companies must not harm the privacy or personality of the data subject. If the FADP is violated, the Federal Data Protection and Information Commissioner may request that the processing is fully or partially adjusted, suspended, or terminated. Additionally, the new FADP authorize criminal fines for certain violations of up to CHF 250,000. Such fines are mainly imposed upon the individual responsible for the violation and most likely levied against C-level executives and those responsible for the organization’s data protection program. The FADP also authorizes fines of up to CHF 50,000 on the responsible data controller or processor. Fines under the FADP may be imposed in addition to fines under other data protection regimes. As part of our processing activities, we implemented a global compliance plan with applicable laws and regulations, which includes in particular:
•the appointment of a Data Protection Officer;
•the creation of the Information Security and Privacy Committee, of which the Information Security Governance Director and Data Protection Officer is the manager;
•the implementation of contractual documentation with our collaborators, aligned with the GDPR requirements;
•the preparation of procedures and guidelines, such as a global data protection policy, a data breach responses plan and standard operating procedures for data subject requests; and
•the realization of global data mapping and record by the Data Protection Officer.
In particular, the purpose of the Information Security and Privacy Committee is to ensure the data and information we process are protected against data protection risks (in compliance with various data privacy regulations and principles of good governance) as well as to assess the effectiveness of our systems, controls and procedures.
The Data Protection Officer is in charge, in particular, of establishing and maintaining processes for receiving, documenting, tracking, investigating, and taking actions on all complaints concerning data protection and considering the risks associated with processing operations, taking into account the nature, scope, context, and purposes of processing.
For more information regarding risks relating to data privacy and security laws and regulations, see “Item 3. Key Information—D. Risk Factors—Risks Related to Governmental Regulation—We are subject to stringent privacy and, information security laws and regulations and changes in such laws and regulations could adversely affect our business and increase our costs.”
Information Security
We have implemented protections consistent with the ISO/IEC 27001:2022 standard with respect to technical and physical security in an effort to ensure a level of security appropriate to the risk of our processing activities, in particular with respect to protecting the personal data and customer data we process against damage, loss and unauthorized access, use, modification, disclosure, destruction, or other misuse. For this purpose, we have what we believe are adequate data breach response plans, disaster recovery plans, and security arrangements in place. However, there can be no assurance that our efforts will be successful in protecting against adverse events or successfully mitigating their effects. For more information regarding risks relating to information security, see “Item 3. Key Information—D. Risk Factors—Risks Related to Our Business and Industry—Cybersecurity or data privacy breaches, other unauthorized or improper access, or (distributed) denial service lack of access (e.g., ransomware, persistent DoS/DDoS) could result in additional costs, service outages, loss of revenue, significant liabilities, harm to our brand and decreased/denied use of our SOPHiA DDM Platform and related solutions, applications, products, or services.”
Data Use Rights
As part of our activities, we process thousands of genetic profiles for our customers around the world. As a result, and in accordance with applicable data protection laws and regulations, we may produce aggregate anonymized statistical data from the results of all analyses performed using our proprietary algorithms (“Insights”), which are our sole and exclusive property.
Hence, a distinction is made between customer data (i.e., the data uploaded by our customers on our SOPHiA DDM Platform) on the one hand and other data generated and developed by us (i.e., the results of the performance of our proprietary algorithms, such as Insights) on the other hand. In this respect, Insights are generated using our proprietary algorithms in the context of our SOPHiA DDM Platform and constitute our know-how and trade secrets.
As part of the performance of our services related to our commercial and research and development activities and in accordance with our contractual documentations accepted by our customers and collaborators, we may use our customers’ and collaborators’ data in particular: (i) for the performance of our contractual obligations; (ii) to pseudonymize and anonymize data (and consequently reuse anonymized data); (iii) for statistical, scientific, or research purposes; (iv) for providing biomarker identification; (v) for researching, developing, maintaining, or promoting our technology, products or services; and (vi) as permitted by applicable laws and regulations.
In addition, in accordance with the FADP and the GDPR, we can reuse customer data (including personal data) for further processing activities for statistical purposes. European data protection authorities have previously noted that processing for statistical purposes and for research purposes (including marketing research) are contexts where legitimate purpose can arise. In addition, the processing of personal data for purposes other than those for which the personal data was initially collected should be allowed where the processing is compatible with the purposes for which the personal data was initially collected.
Specific derogations apply for processing operations for statistical purposes, in accordance with the GDPR, as follows:
•personal data can be stored for longer periods insofar as the personal data will be processed solely for statistical purposes subject to implementation of the appropriate technical and organizational measures; information obligations in processing for statistical purposes do not apply if they would involve a disproportionate effort; consideration of this takes into account the number of data subjects and the age of the data, and appropriate safeguards must be adopted; and
•restrictions of the right of a data subject to exercise its “right to erasure” apply if it is likely to significantly impair processing for statistical purposes.
Meanwhile, processing for statistical purposes is subject to certain requirements to:
•set up appropriate safeguards to protect the rights and freedoms of the data subject; and
•implement adequate technical and security measures entrenching the principle of data minimization and using pseudonymized data as the default.
Insights consist of aggregated data providing general trends without identifying individual data subjects and do not contain personally identifiable information. The GDPR does not apply to data that does not relate to or identify an individual, such as aggregated data sets. Consequently, such data sets do not constitute personal data or identifiable information under the GDPR. We believe we have taken reasonable measures to ensure appropriate safeguards and adequate technical and security measures for the processing activities required to generate Insights.
Environmental, Health, and Safety Regulations
We are subject to various federal, state, local, and foreign environmental, health, and safety laws and regulations and permitting and licensing requirements. Such laws include those governing laboratory practices, the generation, storage, use, manufacture, handling, transportation, treatment, remediation, release and disposal of, and exposure to, hazardous materials and wastes, and worker health and safety. Our operations involve the generation, use, storage and disposal of hazardous materials, and the risk of injury, contamination or non-compliance with environmental, health, and safety laws and regulations or permitting or licensing requirements cannot be eliminated.
Compliance with environmental laws and regulations has not had a material effect on our capital expenditures, financial position, or competitive position.
International Regulations
Many countries in which we may offer any of our diagnostic tests in the future have anti-kickback regulations prohibiting providers from offering, paying, soliciting, or receiving remuneration, directly or indirectly, in order to induce business that is reimbursable under any national health care program. In situations involving physicians employed by state-funded institutions or national health care agencies, violation of the local anti-kickback law may also constitute a violation of the FCPA.
The FCPA prohibits individuals and companies, and their employees, agents, and intermediaries from offering, providing, giving, or authorizing the provision of, directly or indirectly through a third party, including any potential distributors we may rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws. We can also be held liable for the corrupt or illegal activities of our agents and intermediaries, even if we do not explicitly authorize or have actual knowledge of such activities. In addition, the FCPA requires public companies to maintain accurate books or records and to maintain a system of internal accounting controls.
Violations of the FCPA’s anti-bribery provisions for corporations and other business entities are subject to a fine of up to $2 million, and officers, directors, stockholders, employees, and agents are subject to a fine of up to $100,000 and imprisonment for up to five years. Other countries, including the U.K. and other member states of the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, have similar anti-corruption regulations, such as the United Kingdom Bribery Act 2010.
When marketing our diagnostic tests outside of the United States, we may be subject to foreign regulatory requirements governing human clinical testing, prohibitions on the import of tissue necessary for us to perform our diagnostic tests or restrictions on the export of tissue imposed by countries outside of the United States or the import of tissue into the United States, and marketing approval. These requirements vary by jurisdiction, differ from those in the United States and may in some cases require us to perform additional pre-clinical or clinical testing. In many countries outside of the United States, coverage, pricing and reimbursement approvals are also required.
C. Organizational Structure
We have the following wholly owned subsidiaries:
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| Name |
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Jurisdiction of Incorporation |
| SOPHiA GENETICS S.A.S. |
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France |
| SOPHiA GENETICS LTD |
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U.K. |
| SOPHiA GENETICS, Inc. |
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Delaware, U.S. |
| SOPHiA GENETICS Intermediação de Negócios LTDA |
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Brazil |
| SOPHiA GENETICS PTY LTD |
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Australia |
| SOPHiA GENETICS S.R.L. |
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Italy |
D. Property, Plants and Equipment
We do not own any real property. We believe that our facilities meet our present needs and we are continuously reviewing our space requirements. The table below sets forth the sizes and uses of our facilities as of December 31, 2024:
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| Location |
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Primary Function |
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Approximate Size |
| A-ONE Park Building B2 Z.A La Pièce 12, 1180 Rolle Switzerland |
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Office, Laboratory & Warehouse |
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65,860 sq ft |
| Technopole Izarbel 158 Allée Fauste d'Elhuyar 64210 Bidart France |
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Office |
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13,509 sq ft |
| 401 Park Drive Suite 505 Boston, Massachusetts 02215 USA |
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Office |
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12,807 sq ft |
| Bâtiment GIENAH 11 avenue de Canteranne 33600 Pessac France |
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Office |
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3,450 sq ft |
We continuously review our anticipated requirements for facilities and, on the basis of that review, may from time to time acquire or lease additional facilities and/or dispose of existing facilities. We are not aware of any environmental issues or other constraints that would materially impact the intended use of our facilities.
Item 4A. Unresolved Staff Comments
None.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
For a comparison of our results of operations and KPIs for the years ended December 31, 2023 and 2022, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Results of Operations” in our Annual Report on Form 20-F filed with the SEC on March 4, 2024.
Overview
We are a cloud-native software company in the healthcare space dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. We purposefully built a cloud-native software platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. Our platform standardizes, computes and analyzes digital health data and is used across decentralized locations to break down data silos. This enables healthcare institutions to share knowledge and experiences and to build a collective intelligence. We envision a future in which all clinical diagnostic test data is channeled through a decentralized analytics platform that will provide insights powered by large real-world data sets and AI. We believe that a decentralized platform is the most powerful and effective solution to create the largest network, leverage data, and bring the benefits of data-driven medicine to customers and patients globally. In doing so, we can both support and benefit from growth across the healthcare ecosystem.
In 2014, we launched the first application of our platform to analyze NGS data for cancer diagnosis. We have a broad range of applications used by healthcare providers, clinical and life sciences research laboratories, and biopharmaceutical companies for precision medicine across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism, and other disease areas. In 2019, we launched our solution for radiomics data that enables longitudinal monitoring of cancer patients and tumor progression throughout their disease journey. In 2022, we unveiled SOPHiA CarePath, our multimodal solution that integrates the capabilities of our genomics and radiomics solutions with additional modalities to further enable clinical decision-making. Today, we believe that our SOPHiA DDM Platform, commercialized under the name “SOPHiA DDM,” is one of the most widely used decentralized analytics platforms globally for clinical genomics. As of December 31, 2024, we served more than 810 hospital, laboratory, and biopharma customers globally through our SOPHiA DDM Platform and related solutions, applications, products, and services, and our SOPHiA DDM Platform has supported the analysis of approximately 1.9 million genomic profiles and has been utilized in clinical trials and research projects discussed in more than 767 peer-reviewed publications. As of December 31, 2024, we had 472 core genomics SOPHiA DDM Platform customers (defined as the number of customers who generated revenue through usage of our bundle access, dry lab, and integrated access models during the specified time period, which, in this case, is the twelve months ended December 31, 2024).
We commercialize our SOPHiA DDM Platform and related solutions, applications, products, and services as RUO and CE-IVD applications and products. In the United States, our applications and products are labeled and sold for research use only. Because such products are not intended for use in clinical practice in diagnostics and the applications and products cannot include clinical or diagnostic claims, the FDA regulations require that RUO applications and products be labeled “For Research Use Only. Not for use in diagnostic procedures.” In the EU, we have self-certified our applications and products without the intervention of a notified body in order to affix the CE marking.
Our clinical customers primarily include academic and non-academic hospitals and reference and specialty laboratories. Our biopharma customers primarily include pharmaceutical companies, biotechnology companies, and CROs. Our customers are able to access our SOPHiA DDM Platforms through three primary access models: dry lab access, bundle access, and integrated access. As of December 31, 2024, we operated a global direct sales team of more than 96 field-based commercial representatives across 58 countries in all four of our major regions of operations (Europe, the Middle East, and Africa (“EMEA”); North America (“NORAM”); Latin America (“LATAM”); and Asia-Pacific (“APAC”)) and further supplemented our direct sales team with distributors in 46 countries. For the years ended December 31, 2024 and 2023, we generated $65.2 million and $62.4 million in revenue, respectively, representing 4% year-over-year growth.
We have funded our operations primarily through equity financings that have generated $498.3 million in gross proceeds as of December 31, 2024, through revenue generated from the sale of access to our SOPHiA DDM Platform and related licenses, solutions, applications, products, and services, and through debt financings. As of December 31, 2024, we had cash and cash equivalents of $80.2 million. Since our inception, we have incurred net losses, which have been significant in recent periods. For the years ended December 31, 2024 and 2023, our net losses were $62.5 million and $79.0 million, respectively. As of December 31, 2024, we had an accumulated deficit of $440.3 million. We expect to continue to incur net losses for the foreseeable future as we continue to devote substantial resources to (i) research and development, in particular to further expand the features, applications and data modalities of our SOPHiA DDM Platform in order to accommodate multimodal data analytics capabilities across a wide range of disease areas, (ii) expanding our selling and marketing efforts for our SOPHiA DDM Platform and related solutions, applications, products, and services, in particular to drive new customer adoption with clinical customers and biopharmaceutical companies, (iii) establishing and maintaining relationships with our collaborators and customers across the healthcare system, and (iv) obtaining regulatory clearance or approval to offer our applications and products as IVD applications and products for diagnostic use. Our ability to achieve profitability depends on the successful commercialization and further development of our SOPHiA DDM Platform and related solutions, applications, products, and services.
Factors Affecting Our Performance
We believe that our financial performance has primarily been driven by, and in the foreseeable future will continue to be primarily driven by, the factors discussed below. While these factors present significant opportunities for our business, they also pose challenges that we must successfully address in order to sustain our growth and improve the results of our operations. Our ability to successfully address these challenges is subject to various risks and uncertainties described elsewhere in this prospectus, particularly in the section titled “Item 3. Key Information—D. Risk Factors.”
Customer Acquisition and Analysis Volume
We principally derive revenue from the use of our SOPHiA DDM Platform by our customers as well as the sales of related licenses, solutions, applications, products, and services. Our analysis volume is dependent on both the acquisition of new customers as well as usage volume from our existing customers. We employ a “land and expand” commercial model focused on winning new customers and then driving subsequent recurring utilization of our solutions by those acquired customers. Once we secure a customer, we use our direct sales force to build further engagement and help that customer increase its testing operations. For example, we may initially support a customer in setting up its NGS testing operations for hereditary cancer screening, including operational support through our set-up programs, also referred to as MaxCare. Once the customer is fully onboarded on our SOPHiA DDM Platform, it is then comparatively easier to deploy additional germline testing solutions as well as somatic oncology testing solutions, creating synergies across the offerings and a unified workflow.
We also target incremental users within each customer, for example, additional clinicians within a provider across expanded departments such as radiology or pathology.
We expect our analysis volume to increase and new customer acquisitions to accelerate as we further expand the features, applications, and data modalities of our SOPHiA DDM Platform; expand our presence into new geographies; and further penetrate existing geographies, particularly geographies that represent largely under-penetrated opportunities, such as North America and East Asia. We intend to significantly invest in the development of our SOPHiA DDM Platform to accommodate multimodal data analytics capabilities across a wide range of disease areas, including under-penetrated disease areas such as cardiology and neurology, which we believe will allow us to attract new customers and increase usage of our SOPHiA DDM Platform within our existing customer base. While we believe that our existing sales force can support our near-term growth plans, to continue expanding our presence into new geographies and further penetrate existing geographies, we will continue to opportunistically invest in our direct sales force to further scale the size of our network in under-penetrated geographies such as North America, form additional collaborations with reference and specialty laboratories, and collaborate with collaborators and distributors in selected geographies outside of North America.
Revenue Mix
We derive revenue from the use of our SOPHiA DDM Platform by our customers as well as the sales of related licenses, solutions, applications, products, and services. Our clinical customers can access our platform using three different models: dry lab access, bundle access, and integrated access. In the dry lab access model, our customers use the testing instruments and consumables of their choice and our SOPHiA DDM Platform and algorithms for variant detection and identification. In the bundle access model, we bundle DNA enrichment kits with our analytics solution to provide customers the ability to perform end-to-end workflows. In the integrated access model, our customers have their samples processed and sequenced through select SOPHiA DDM Platform collaborators within our clinical network and access their data through our SOPHiA DDM Platform. Our biopharma customers can access our SOPHiA DDM Platform through the same three models, but they may also have access to data generated through our SOPHiA DDM Platform in the form of custom reports and analytics.
We have experienced fluctuations in how our clinical customers access our SOPHiA DDM Platform across the three access models. Specifically, certain customers may transition from one access model to another over time. For example, we have observed a trend with certain customers being onboarded onto our platform through the dry lab access model, but, over time, as our relationships with them grow, these customers transition to the bundle access model as customers trust us to curate a set of instruments and consumable products to help increase the accuracy of the analysis they generate. This trend is one illustration of our “land and expand” commercial model, as bundle access is typically a higher revenue-generating model compared to dry lab access based on the incremental value from the sale of consumables and instruments as well as higher platform usage on average for bundle access customers. Certain types of customers are also more likely to access our SOPHiA DDM Platform using one access model compared to other customers. For example, customers who are unable or do not wish to conduct sequencing locally are inclined to use the integrated access model. These customers have historically represented a small percentage of our customer base relative to customers that use the bundle access and dry lab access models. We expect that the revenue contribution from each of the three access models will vary depending on our customer base and the rate of new customer acquisition.
We also derive revenue from the sale of licenses for our Alamut suite of genomics mutations interpretation software. While we view Alamut as a complementary add-on to our SOPHiA DDM Platform, there are a number of Alamut users who currently are not customers of our SOPHiA DDM Platform. We expect that revenue contribution from Alamut will continue to vary based on the number of stand-alone Alamut users as well as our ability to cross-sell our SOPHiA DDM Platform to Alamut users and vice versa.
Seasonality
We typically experience lower usage of our SOPHiA DDM Platform in the first and third quarters compared to the second and fourth quarters, which tend to be seasonally stronger. We typically see relatively lower usage in the first quarter as customers across our global network return from their holidays and new customers are still being onboarded onto our platform. Meanwhile, we believe the relatively lower usage in the third quarter is due to the seasonal slowdown at our customers’ European facilities attributable to vacations and European holiday schedules.
As we expand in the North American market, we expect that we will be subject to somewhat lower seasonal variations in our usage per customer. We typically experience the highest usage of our SOPHiA DDM Platform in the fourth quarter as we bring new customers and new applications and products with existing customers into routine usage over the course of the year.
Biopharma Expansion
To date, the majority of our revenue is generated through our clinical customers, including academic and non-academic hospitals, and reference and specialty laboratories. However, we see potential for our biopharma business to comprise a more significant portion of our revenues. We began commercializing our biopharma application, product, and service offerings in 2019. While we have the ability to offer a robust package of pre- and post-market solutions to our biopharma customers across the Discovery, Development, and Deployment stages through a broad set of solutions, including SOPHiA Trial Match, SOPHiA Insights, SOPHiA CDx, and SOPHiA Awareness, our biopharma business is still nascent with the initial focus on establishing pilot programs with large pharmaceutical and biotech companies to build customer trust and raise awareness about our offerings in a manner similar to the “land and expand” strategy we employ for our clinical business. We intend to leverage our platform and database to drive adoption by biopharmaceutical companies through our sales force focused on biopharma opportunities across the value chain. In addition, we plan to develop new offerings for biopharma as we expand the number and type of new applications and data modalities on our platform.
SOPHiA CarePath
In 2022, we unveiled SOPHiA CarePath, a new multimodal module on our SOPHiA DDM Platform powered by our artificial intelligence and machine learning algorithms. The module will allow healthcare practitioners to visualize data across multiple modalities (including genomic, radiomic, clinical, and biological) for individual patients in a longitudinal manner and derive additional insights through cohort design and comparison. SOPHiA CarePath has already been deployed as part of our Deep-Lung IV multimodal clinical study on non-small cell lung cancer and is now live at 30 sites across the world. We believe that the module will be adopted by our existing customers and help drive additional adoption of our SOPHiA DDM Platform by clinical institutions and biopharmaceutical companies.
Strategic Acquisitions and Collaborations
We vigilantly monitor the market for potential investments to expand or add key technologies to our offerings that we believe will improve our platform’s ability to address our customers’ needs and catalyze the commercialization of new applications, products, and services. Our investment strategy could take the form of a business acquisition, asset acquisition, or strategic licensing of patented technology, all of which may affect our future financial results. For example, our acquisition of Interactive Biosoftware (“IBS”) in 2018 expanded the functionality of our SOPHiA DDM Platform. The Alamut suite of genomics mutation interpretation software is connected to our SOPHiA DDM Platform and gives our customers advanced analytics capabilities for a deeper and more informed genomic data interpretation. We view Alamut as a complement to our SOPHiA DDM Platform and expect to be able to accelerate our growth by cross-selling our SOPHiA DDM Platform to Alamut users and vice versa.
To complement our investment strategy, we have also collaborated, and intend to form additional collaborations, with other product providers in the ecosystem to bundle our solutions to provide differentiated end-to-end solutions. We currently collaborate with testing kit companies, testing hardware providers, software analytics companies, and diagnostic companies operating with a centralized model. For example, we formed collaborations with companies including Twist, IDT, and Agilent to create an integrated solution using our analytics platform and their library preparation products, including DNA enrichment kits. We continue to regularly evaluate our role in the genomics and radiomics value chain in order to provide both our existing and new customers with a comprehensive product offering, enhance our overall market and competitive position and expand into adjacent untapped markets and new geographies.
Research and Development
A significant aspect of our business is our continued investment in research and development, including new features, new applications, new data modalities, and new services. We plan to continue investing in scientific innovation to bring innovative, high-impact content to our customers through regular updates of our platform.
Exchange Rates
We operate internationally and a majority of our revenues, expenses, assets, liabilities and cash flows are denominated in currencies other than our presentation currency, the U.S. dollar, and the functional currency of SOPHiA GENETICS SA, the Swiss franc. Our revenues are generated primarily in the U.S. dollar, the euro and Swiss franc and, to a lesser extent, British pound, Australian dollar, Brazilian real, Turkish lira, and Canadian dollar depending on our customers’ geographic location. Our expenses are incurred primarily in the U.S. dollar, the euro and Swiss franc and, to a lesser extent, British pound, Australian dollar, and Brazilian real. We expect that a part of our revenues and expenses will continue to be denominated in currencies other than the U.S. dollar. Therefore, part of the fluctuations in our operating results in any period may result from changes in exchange rates. We currently do not use any financial instruments to manage our exchange rate risks, which we have been partially mitigating by matching costs in the same foreign currency.
Key Operating Performance Indicators
We regularly monitor a number of key operating performance indicators and metrics to evaluate our business, measure our performance, identify key operating trends, and formulate financial projections and strategic plans. We believe that the following metrics are representative of our current business, but the metrics we use to measure our performance could change as our business continues to evolve. Our key operating performance indicators primarily focus on metrics related to our SOPHiA DDM Platform metrics, as platform revenue comprises the majority of our revenues.
As used in this section, the term “customer” refers to any customer who accesses our SOPHiA DDM Platform through the dry lab and bundle access models. We exclude from this definition any customers accessing our SOPHiA DDM Platform using the integrated business model because they tend to use our platform in an ad hoc manner compared to our dry lab and bundle access customers who typically do so in a recurring fashion, generate an immaterial portion of our revenue and analysis volume, and constitute a small part of our customer base. We also exclude from this definition customers who only use Alamut through our SOPHiA DDM Platform.
Platform Analysis Volume
Quarterly Platform Analysis Volume from Q1 2018 to Q4 2024*
The following table shows platform analysis volume for the year ended December 31, 2024 and 2023:
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Year ended December 31, |
|
|
|
|
|
|
2024 |
|
2023 |
| SOPHiA DDM Platform analysis volume* |
|
|
|
|
|
352,628 |
|
317,062 |
*The figures in the bar chart and table above have been adjusted to exclude analyses conducted during the period but for which chargebacks were issued or other adjustments were made to customers after the period. We do not believe that such adjustments are material to the periods presented.
Platform analysis volume represents a key business metric that reflects our overall business performance, as we generate revenue on a pay-per-analysis basis. Platform analysis volume measures the number of analyses that generated revenue to us and were conducted by our customers. Analysis volume is a direct function of the number of active customers and usage rates across our customer base during a specified time period. While our platform analysis volume is a major driver of our revenue growth, other factors, including application and product pricing, access model used, and customer size mix, also affect our revenue. Because of that, our revenue may increase in periods in which our analysis volume decreases and vice versa.
Analysis volume increased to 352,628 in the year ended December 31, 2024 from 317,062 in the year ended December 31, 2023. We observed an increase in chargeable analysis volume of 11% for the year ended December 31, 2024, as compared to the year ended December 31, 2023. This increase is primarily attributable to increased usage from our existing customers as well as new customers onboarded onto our platform, with outsized growth across our Solid Tumors, Hematological Oncology (“HemOnc”), and Rare Disorders applications and primarily related to strong volume growth in NORAM and APAC. The increase in analyses was partially offset by a decline in analyses in LATAM and the continued reduction of COVID-19 related analyses. We increase prices annually or as necessary throughout the year. While platform analysis volume is a primary driver of our overall revenue, there are other important factors that also contribute to our revenue performance, including access model mix, Alamut license sales, biopharma service revenue and workflow equipment and services revenue.
These factors also contributed to year-over-year growth in our overall revenue in 2024.
Core Genomics Customers
The following table shows the number of Core Genomics Customers as of December 31, 2024 and 2023:
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As of December 31, |
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2024 |
|
2023 |
|
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|
|
|
| Core Genomics Customers |
|
472 |
|
|
450 |
|
We track the number of our Core Genomics Customers, defined as the number of customers who generated revenue through usage of our bundle access, dry lab, and integrated access models during the specified time period, as a key measure of our ability to generate recurring revenue from our install base. We exclude from this number any customers who do not utilize our SOPHiA DDM Platform through one of the three access modes, such as customers who only use Alamut and our biopharma customers.
This number also excludes customers without any usage of our SOPHiA DDM Platform over the past twelve months and customers who have executed agreements with us but have not yet generated any revenue, including customers that are in the process of being onboarded onto our SOPHiA DDM Platform.
Core Genomics Customers increased to 472 as of December 31, 2024 from 450 as of December 31, 2023. The increase is primarily attributable to our continued customer acquisition momentum over the course of the intervening period net of churn.
Net Dollar Retention (NDR)
The following table shows the net dollar retention as of December 31, 2024 and 2023:
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As of December 31, |
|
|
2024 |
|
2023 |
| Net dollar retention (NDR) |
|
104 |
% |
|
130 |
% |
We track net dollar retention for our dry lab, bundle access, and integrated access customers as a measure of our ability to grow the revenue generated from our Core Genomics Customers through our “land and expand” strategy net of revenue churn, which we define as the annualized revenues we estimate to have lost from customers who access our platform through our dry lab access, bundle access and integrated access models and have not generated revenue over the past twelve months in that period based on their average quarterly revenue contributions from point of onboarding as a percentage of total recurring platform revenue. To calculate net dollar retention, we first specify a measurement period consisting of the trailing two-year period from our fiscal period end. Next, we define a measurement cohort consisting of Core Genomics Customers who use our dry lab access, bundle access, and integrated access models from whom we have generated revenues during the first month of the measurement period, which we believe is generally representative of our overall dry lab access, bundle access, and integrated customer base. We then calculate our net dollar retention as the ratio between the U.S. dollar amount of revenue generated from this cohort in the second year of the measurement period and the U.S. dollar amount of revenue generated in the first year. Any customer in the cohort that did not use our platform in the second year are included in the calculation as having contributed zero revenue in the second year.
Net dollar retention decreased to 104% as of December 31, 2024 from 130% as of December 31, 2023. The year-over-year decrease in revenue growth momentum is attributable to the slower growth across our existing customer base. Additionally, we had a slight headwind from unfavorable foreign exchange movements for revenue generated in key transactional currencies other than the U.S. dollar, particularly the euro and the Swiss franc, which depreciated against the U.S. dollar. The annualized churn rate was 4%, which is in line with expectations.
Components of Results of Operations
Revenue
We generate revenue from goods and services rendered to our clinical and biopharma customers. Our clinical customers include academic and non-academic hospitals (including comprehensive cancer centers and children’s hospitals), and reference and specialty laboratories. Our biopharma customers include companies along the full biopharma value chain. We group our solutions that we offer our customers into two primary reporting segments: our SOPHiA DDM Platform and workflow equipment and services.
SOPHiA DDM Platform revenue comprises the bulk of our revenue and includes goods and services related to the use of our SOPHiA DDM Platform, including our clinical genomics solutions, which span across a broad range of unique applications for analyzing genomic data; our Alamut suite of genomics mutation interpretation software, which gives our clinical customers advanced analytics capabilities for a deeper and more informed genomic data interpretation; and biopharma applications designed to help customers solve bottlenecks across the biopharma value chain, including discovery, clinical development and commercialization; and the sale of third-party instruments and consumables to our bundle access customers.
For clinical customers, our primary pricing strategy for our SOPHiA DDM Platform is a pay-per-use model, in which customers access our platform free of charge but pay for each use of our platform. Pricing varies based on our customer mix, as customers require differing levels of customization. For Alamut, our primary pricing strategy is a licensing model, in which customers access our platform for a contracted price. For biopharma customers, we are continuing to refine our pricing strategy since we launched our initial applications for the biopharma market in 2019. We recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration that we expect to receive in exchange for those goods or services. For revenue generated from our SOPHiA DDM Platform customers, we recognize revenue from analyses as the analyses are conducted and revenue from bundled instruments and consumables at the point of delivery. For revenue generated from Alamut licenses, we recognize revenue over the course of the license period. Payments from our customers are typically between 30 and 60 days with payment terms extended up to 180 days from the invoice date. Although we have a diverse range of customers, for the year ended December 31, 2024, we generated $8.2 million revenue from one of our largest distributors. For the year ended December 31, 2023, no single customer accounted for more than 10% of our revenue.
Workflow equipment and services revenue includes all revenue from the sale of materials and services that do not form part of a contract for the provision of platform services rendered primarily to clinical customers. These include the provision of set-up programs and training and the sale of equipment that are not linked to the use of the platform, such as automation equipment. Set-up programs and training are typically combined with a customer’s first order prior to the customer being onboarded onto our SOPHiA DDM Platform. Revenue from services is generally recognized when the services are performed. Revenue from materials are recognized when control of the goods is transferred to the customer, generally at the time of delivery.
We have demonstrated continued revenue growth during 2024 and 2023 as a result of the continued development of our platform and technology and further penetration of the market. Revenue performance is reflective of the strong foundation that has been built, focused around clinical and biopharma customers. This category of revenue also includes the revenue from the sale of DNA sequencing automation equipment accounted for under IFRS 16, Leases (“IFRS 16”), leasing, and the fees charged for the maintenance of this equipment.
Cost of Revenue
Cost of revenue comprises costs directly incurred in earning revenue, including computational and storage-related costs and fees paid to hosting providers, manufacturing costs, materials and consumables, the cost of equipment leased out under finance leases, personnel-related expenses, and amortization of capitalized development costs. Capitalized software development costs are amortized using the straight-line method over an estimated life of five years.
While we currently expect increased investments to accelerate growth, we also expect to realize increased efficiencies and economies of scale and undertake cost containment measures to reduce the cost of using cloud infrastructure. Over time, we expect our gross profit margin to increase as we broaden our customer base, increase customer engagement, expand our cloud infrastructure, and negotiate additional arrangements with service providers, including computational and storage-related costs and fees paid to hosting providers.
However, in the near term, we expect that our gross profit margin will be adversely impacted by increased computational and storage-related costs and fees as we have purchased, and may be required to continue to purchase, increased capacity at less favorable rates in order to address increased demand for our SOPHiA DDM Platform and related solutions, applications, products, and services. Our cost of revenue as a percentage of revenue may fluctuate from period to period depending on the interplay of the various components of cost of revenue.
Operating Expenses
Operating expenses consist of research and development, selling and marketing, general and administrative, and other operating income (expense), net.
Research and Development Costs
Research and development costs consist of personnel and related expenses for technology, application, and product development, depreciation and amortization, laboratory supplies, consulting services, computational and data storage fees paid to hosting providers related to research and development, and allocated overhead costs. These costs are stated net of government grants for research and development and innovation received as tax credits and net of capitalized costs.
In the long term, we expect our research and development costs to increase in absolute dollars, but not necessarily as a percentage of revenue, while we continue to develop, refine, and optimize our platform, technology, applications, products, and services as we seek to expand the features, applications, and data modalities of our SOPHiA DDM Platform, broaden our customer base, and increase customer engagement to drive revenue growth. We expect research and development costs, inclusive of capitalized research and development, to continue to comprise one of the largest components of our overall operating expenses. Our research and development costs as a percentage of revenue may fluctuate from period to period due to the timing and extent of such expenses.
Selling and Marketing Costs
Selling and marketing costs consist of personnel and related expenses for the employees of our sales and marketing organization, costs of communications materials that are produced to generate greater awareness and utilization of our platform among our customers, costs of third-party market research, costs related to transportation and distribution of our products and allocated overhead costs, and commissions to sales employees.
In the short term, we expect our selling and marketing costs to increase in absolute dollars and as a percentage of revenue as we seek to broaden our customer base and increase customer engagement to drive revenue growth and as we hire additional sales personnel and related account management and sales support personnel to properly service our growing customer base. However, in the long term, we expect our selling and marketing costs to gradually and modestly decrease as a percentage of revenue. Our selling and marketing costs as a percentage of revenue may fluctuate from period to period due to the timing and extent of such expenses.
General and Administrative Costs
General and administrative costs consist of personnel and related expenses for our executive, accounting and finance, legal, quality, support and human resources functions, depreciation and amortization, professional services fees incurred by these functions, general corporate costs and allocated overhead costs, which include occupancy costs and information technology costs.
In the short term, we expect that our general and administrative costs may vary in absolute dollars and as a percentage of revenue in line with our business needs. However, in the long term, we expect our general and administrative costs to gradually and modestly decrease as a percentage of revenue.
Other Operating Income (Expense), Net
Other operating income (expense), net consists of gains and losses related to the disposal of tangible assets, write-offs of intangible assets and other operating income and expenses. We cannot predict the amount of other operating income (expense), net for future periods.
Interest Income
Interest income consists of interest income earned on cash and cash equivalents, term deposits and short-term investments, and lease receivables.
Interest Expense
Interest expense consists of interest expense incurred on lease liabilities and loans, which includes, interest on commercial borrowings.
We currently do not use any financial instruments to manage our interest risk exposure.
Fair Value Adjustments on Warrant Obligations
Fair value adjustments on warrant obligations consists of any gains or losses from changes in fair value to our warrant obligations.
Foreign Exchange (Losses) Gains, net
Foreign exchange losses (gains), net consists of foreign exchange realized and unrealized gains and losses arising principally from intercompany receivable balances in the parent company denominated in U.S. Dollar, whose functional currency is the Swiss franc.
Taxation
We are subject to corporate taxation in Switzerland and other jurisdictions in which we operate, in particular, the United States, France, the U.K., Italy, Brazil, and Australia, where our wholly owned subsidiaries are incorporated.
Pursuant to a written agreement with the Swiss government, we were exempted from corporate taxes (including capital tax) in Switzerland until December 31, 2022. Effective as of January 1, 2023, we are subject to ordinary cantonal and Swiss federal corporate taxes, including capital tax.
We are entitled under Swiss laws to carryforward any losses incurred for a period of seven years, which could be used to offset future taxable income. As of December 31, 2024, we had total tax loss carryforwards totaling $352.2 million with $347.5 million of which no deferred tax asset has been recorded as they are expected to expire prior to being utilized to offset future incomes. We currently have tax loss carryforwards in Switzerland, the U.S., the U.K., and Brazil. Of our loss carryforwards, $344.6 million are in Switzerland and can be carried forward through future periods that will expire at various dates between January 1, 2025 and December 31, 2031. There is no certainty that we will make sufficient profits to be able to utilize these tax loss carryforwards in full during the allotted time periods.
Results of Operations
The following table summarizes our results of operations for the years ended December 31, 2024 and 2023:
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|
Year ended December 31, |
|
Change |
|
|
2024 |
|
2023 |
|
$ |
|
% |
| Revenue |
|
$ |
65,173 |
|
|
$ |
62,371 |
|
|
$ |
2,802 |
|
|
4 |
% |
| Cost of revenue |
|
(21,236) |
|
|
(19,458) |
|
|
(1,778) |
|
|
9 |
% |
| Gross profit |
|
43,937 |
|
|
42,913 |
|
|
1,024 |
|
|
2 |
% |
| Research and development costs |
|
(34,366) |
|
|
(36,969) |
|
|
2,603 |
|
|
(7) |
% |
| Selling and marketing costs |
|
(29,369) |
|
|
(28,423) |
|
|
(946) |
|
|
3 |
% |
| General and administrative costs |
|
(46,953) |
|
|
(53,301) |
|
|
6,348 |
|
|
(12) |
% |
| Other operating income, net |
|
183 |
|
|
954 |
|
|
(771) |
|
|
(81) |
% |
| Operating loss |
|
(66,568) |
|
|
(74,826) |
|
|
8,258 |
|
|
(11) |
% |
| Interest income |
|
3,362 |
|
|
4,547 |
|
|
(1,185) |
|
|
(26) |
% |
| Interest expense |
|
(1,913) |
|
|
(588) |
|
|
(1,325) |
|
|
(225) |
% |
| Fair value adjustments on warrant obligations |
|
370 |
|
|
— |
|
|
370 |
|
|
100 |
% |
| Foreign exchange gains (losses), net |
|
3,479 |
|
|
(7,628) |
|
|
11,107 |
|
|
146 |
% |
| Loss before income taxes |
|
(61,270) |
|
|
(78,495) |
|
|
17,225 |
|
|
(22) |
% |
| Income tax expense |
|
(1,223) |
|
|
(486) |
|
|
(737) |
|
|
152 |
% |
| Loss for the year |
|
$ |
(62,493) |
|
|
$ |
(78,981) |
|
|
$ |
16,488 |
|
|
(21) |
% |
Revenue
The following table presents revenue by stream for the years ended December 31, 2024 and 2023:
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|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| SOPHiA DDM Platform |
|
$ |
63,546 |
|
|
$ |
60,904 |
|
|
$ |
2,642 |
|
|
4 |
% |
| Workflow equipment and services |
|
1,627 |
|
|
1,467 |
|
|
160 |
|
|
11 |
% |
| Total revenue |
|
$ |
65,173 |
|
|
$ |
62,371 |
|
|
$ |
2,802 |
|
|
4 |
% |
Revenue was $65.2 million for the year ended December 31, 2024, compared to $62.4 million for the year ended December 31, 2023. This increase was primarily attributable to an increase in SOPHiA DDM Platform revenue, partially offset by a $0.1 million headwind in foreign exchange impact over the course of the year related to the depreciation in the exchange rates between key transactional currencies, particularly the euro and the Swiss franc, and our reporting currency, the U.S. dollar. SOPHiA DDM Platform revenue was $63.5 million for the year ended December 31, 2024 compared to $60.9 million for the year ended December 31, 2023. This increase was primarily attributable to an increase in analysis volume, particularly across our Oncology application portfolio driven by growth in our HemOnc application, partially offset by a decrease in biopharma revenue of $1.9 million. Workflow equipment and services revenue was $1.6 million for the year ended December 31, 2024, compared to $1.5 million for the year ended December 31, 2023.
Cost of Revenue
The following table presents cost of revenue, gross profit, and gross margin for the years ended December 31, 2024 and 2023:
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|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Cost of revenue |
|
$ |
(21,236) |
|
|
$ |
(19,458) |
|
|
$ |
(1,778) |
|
|
9 |
% |
| Gross profit |
|
$ |
43,937 |
|
|
$ |
42,913 |
|
|
$ |
1,024 |
|
|
2 |
% |
| Gross margin |
|
67 |
% |
|
69 |
% |
|
|
|
|
Cost of revenue was $21.2 million for the year ended December 31, 2024, compared to $19.5 million for the year ended December 31, 2023. This increase was primarily attributable to an increase of $1.4 million in amortization of capitalized software development expense as expenses were $3.5 million and $2.1 million for the years ended December 31, 2024 and 2023, respectively. We also saw a $1.3 million increase in materials and services-related costs driven by our increased volumes, partially offset by a $1.1 million decrease in computational and storage-related costs. The increase in gross profit to $43.9 million for the year ended December 31, 2024 as compared to $42.9 million for the year ended December 31, 2023 was due to benefits from economies of scale achieved with regards to our computational and storage-related costs partially offset by higher amortization of capitalized software development expense.
Operating Expenses
The following table presents research and development costs, selling and marketing costs, general and administrative costs, and other operating income, net for the years ended December 31, 2024 and 2023:
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| (Amounts in USD thousands, except %) |
|
Year ended December 31, |
|
Change |
|
2024 |
|
2023 |
|
$ |
|
% |
| Research and development costs |
|
$ |
(34,366) |
|
|
$ |
(36,969) |
|
|
$ |
2,603 |
|
|
(7) |
% |
| Selling and marketing costs |
|
(29,369) |
|
|
(28,423) |
|
|
(946) |
|
|
3 |
% |
| General and administrative costs |
|
(46,953) |
|
|
(53,301) |
|
|
6,348 |
|
|
(12) |
% |
| Other operating income, net |
|
183 |
|
|
954 |
|
|
(771) |
|
|
(81) |
% |
| Total operating expenses |
|
$ |
(110,505) |
|
|
$ |
(117,739) |
|
|
$ |
7,234 |
|
|
(6) |
% |
Research and Development Costs
Research and development costs were $34.4 million for the year ended December 31, 2024, compared to $37.0 million for the year ended December 31, 2023. This decrease was primarily attributable to a $2.5 million decrease in professional fees expenses driven by a $0.8 million increase in outsourced capitalized software development cost and cost saving efforts of $1.7 million to minimize external resourcing development utilization, offset by an increase in employee-related expenses, including bonuses and share-based compensation, of $0.5 million for R&D initiatives related to the development of new applications and products, as we retain and hire key positions.
Selling and Marketing Costs
Selling and marketing costs were $29.4 million for the year ended December 31, 2024, compared to $28.4 million for the year ended December 31, 2023. The increase was primarily attributed to an increase in marketing and conference-related expenses of $1.1 million as we launched more focused campaigns and a $0.4 million increase in professional fees as we improve our sales-cycle timeline, partially offset by a decrease of $0.7 million in our allowance for doubtful accounts as we continue to improve our ability to collect on outstanding cash in a timely manner.
General and Administrative Costs
General and administrative costs were $47.0 million for the year ended December 31, 2024, compared to $53.3 million for the year ended December 31, 2023. This decrease was primarily attributable to a $3.3 million decrease in employee-related expenses, including bonus and share-based compensation from the headcount reduction taken in 2023 and the reduction of executive and employee performance related bonuses; a $1.0 million decrease in public company-related expenses as we negotiated more favorable public company insurance terms; and a $0.6 million decrease in professional fees as we continue to reduce spending.
Other Operating Income, net
Other operating income, net was $0.2 million for the year ended December 31, 2024, compared to $1.0 million for the year ended December 31, 2023.
Interest Income
The following table presents interest income for the years ended December 31, 2024 and 2023:
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Interest income |
|
$ |
3,362 |
|
|
$ |
4,547 |
|
|
$ |
(1,185) |
|
|
(26) |
% |
Interest income was $3.4 million for the year ended December 31, 2024, compared to $4.5 million for the year ended December 31, 2023. The decrease was primarily driven by a $1.2 million decrease in the interest earned on cash held in short term deposits and money market funds due to lower cash balances than in the prior year and decreasing interest rates.
Interest Expense
The following table presents interest expense for the years ended December 31, 2024 and 2023:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Interest expense |
|
$ |
(1,913) |
|
|
$ |
(588) |
|
|
$ |
(1,325) |
|
|
225 |
% |
Interest expense was $1.9 million for the year ended December 31, 2024, compared to $0.6 million for the year ended December 31, 2023. The increase was primarily driven by a $1.3 million increase in interest expense from borrowings under the Perceptive Loan Agreement.
Fair Value Adjustments on Warrant Obligations
The following table presents the fair value adjustments on warrant obligations for the years ended December 31, 2024 and 2023:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Fair value adjustments on warrant obligations |
|
$ |
370 |
|
|
$ |
— |
|
|
$ |
370 |
|
|
100 |
% |
Fair value adjustments on warrant obligations had a gain of $0.4 million for the year ended December 31, 2024. We did not have any fair value adjustments on warrant obligations for the year ended December 31, 2023 as the warrant certificate was issued on May 2, 2024 as part of the Perceptive Credit Agreement.
Foreign Exchange Gains (Losses), net
The following table presents the foreign exchange gains (losses), net for the years ended December 31, 2024 and 2023:
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|
|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Foreign exchange gains (losses), net |
|
$ |
3,479 |
|
|
$ |
(7,628) |
|
|
$ |
11,107 |
|
|
(146) |
% |
Foreign exchange gains were $3.5 million for the year ended December 31, 2024, compared to foreign exchange losses of $7.6 million for the year ended December 31, 2023. This increase in foreign exchange gains was primarily driven by a change in unrealized net foreign exchange gains (losses), net of $11.2 million, primarily arising from the revaluation of intercompany foreign currency receivable balances into SOPHiA GENETICS SA’s functional currency of the Swiss franc, partially offset by $0.1 million in realized net foreign exchange losses. Unrealized gains and losses do not constitute a cash impact until the related transactions are settled.
Income Tax Expense
The following table presents income tax expense for the years ended December 31, 2024 and 2023:
|
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|
|
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|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
Year ended December 31, |
|
Change |
| (Amounts in USD thousands, except %) |
|
2024 |
|
2023 |
|
$ |
|
% |
| Income tax expense |
|
$ |
(1,223) |
|
|
$ |
(486) |
|
|
$ |
(737) |
|
|
152 |
% |
Income tax expense was $1.2 million for the year ended December 31, 2024, compared to $0.5 million for the year ended December 31, 2023. This tax expense is primarily attributed to current and deferred tax expenses recorded in France, the U.S., and Italy, and, to a lesser extent, to the provision for uncertain tax positions.
Off-Balance Sheet Arrangements and Commitments
We have a minimum purchase agreement with a vendor related to computational and hosting-related costs. As part of the agreement, we have a total minimum commitment of approximately $70.7 million from the period beginning November 1, 2022 through October 31, 2027 and an additional one-year grace period to meet the minimum commitment by October 31, 2028. As of December 31, 2024 and 2023, our remaining commitments are $58.8 million and $70.3 million, respectively.
Other than the above agreement with Microsoft, we did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements or commitments that may have a material current or future effect on financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenues or expenses.
B. Liquidity and Capital Resources
For a discussion of our liquidity and capital sources and cash flows for the year ended December 31, 2023 and comparison to the year ended December 31, 2022, see “Item 5. Operating and Financial Review and Prospects—B. Liquidity and Capital Resources” in our Annual Report on Form 20-F filed with the SEC on March 4, 2024.
Sources of Capital Resources
Our principal sources of liquidity were cash and cash equivalents totaling $80.2 million as of December 31, 2024 which were held for a variety of growth initiatives and investments in our SOPHiA DDM Platform and related solutions, applications, products, and services as well as working capital purposes. Our cash and cash equivalents are comprised of cash on hand, deposits held at call with external financial institutions, money market funds, and bank and other short-term highly liquid investments with original maturities of three months or less.
On May 2, 2024 (the “closing date”), SOPHiA GENETICS SA and our subsidiary SOPHiA GENETICS, Inc. entered into a credit agreement and guaranty (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings IV, LP, as lender and administrative agent, pursuant to which we may borrow up to $50.0 million principal amount of term loans, including (i) an initial tranche of $15.0 million principal amount of term loans on the closing date and (ii) up to $35.0 million principal amount of term loans that we may draw upon on or prior to March 31, 2026, subject to satisfaction of certain customary conditions. The term loans are scheduled to mature on the fifth anniversary of the closing date and accrue interest at Term Secured Overnight Financing Rate (“SOFR”) plus 6.25% per annum; provided that upon the occurrence and during the continuation of any event of default, the term loans will accrue interest at Term SOFR plus 9.25% per annum. Term SOFR means the SOFR reference rate that is two business days prior to the first day of the preceding calendar month. We have the right to prepay the term loans at any time subject to applicable prepayment premiums. The Perceptive Credit Agreement also contains certain mandatory prepayment provisions, including prepayments from the proceeds from certain asset sales and casualty events (subject to a right to reinvest such proceeds in assets used in our business within 180 days) and from issuances or incurrences of non-permitted debt, which will also be subject to prepayment premiums. The obligations under the Perceptive Credit Agreement are secured by substantially all of our and certain of our subsidiaries’ assets and are guaranteed initially on the closing date by SOPHiA GENETICS SA and SOPHiA GENETICS, Inc. The Perceptive Credit Agreement contains customary covenants, including an affirmative covenant to maintain qualified cash of at least $3.0 million, an affirmative last twelve months revenue covenant tested on a quarterly basis, and negative covenants including limitations on indebtedness, liens, fundamental changes, asset sales, investments, dividends and other restricted payments and other matters customarily restricted in such agreements. The Perceptive Credit Agreement also contains customary events of default, including payment defaults, material inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against us and our subsidiaries and change in control, the occurrence of which gives the lenders the right to declare the term loans and all obligations under the Perceptive Credit Agreement immediately due and payable. We remain in full compliance with all covenants contained in the Perceptive Credit Agreement as of December 31, 2024.
In addition, we issued to Perceptive Credit Holdings IV, LP a warrant certificate (the “Warrant Certificate”) representing the right to purchase up to 400,000 ordinary shares at $4.9992 per share, with the right to purchase 200,000 ordinary shares available immediately and the right to purchase an additional 200,000 ordinary shares to be available upon the drawdown of the second tranche of the term loans. The purchase rights represented by the Warrant Certificate are exercisable after becoming available, on a cash basis, at the option of the holder at any time prior to 5:00 p.m., Eastern time on the tenth anniversary of the applicable date of availability. The Warrant Certificate contains customary anti-dilution adjustments.
On April 23, 2024 we entered into a credit agreement with Credit Suisse SA for up to CHF 0.1 million ($0.1 million) to be used for cash credits, contingent liabilities, or as margin for OTC derivative transactions. Borrowings under the new credit agreement will bear interest at a rate to be established between us and Credit Suisse SA at the time of each draw down. As of December 31, 2024, we had no borrowings outstanding under the Credit Facility.
In August 2023, we established an at-the-market (“ATM”) offering program pursuant to which we may sell, from time to time, ordinary shares having an aggregate offering price of $50.0 million. For the year ended December 31, 2024, we did not sell any ordinary shares under this program.
We have funded our operations primarily through equity financing and through revenue generated from the sale of access to our SOPHiA DDM Platform and related licenses and services. Invoices for our products and services are a substantial source of revenue for our business, which are included on our consolidated balance sheet as trade receivables prior to collection. Accordingly, collections from our customers have a material impact on our cash flows from operating activities. As we expect our revenue to grow, we also expect our accounts receivable and inventory balances to increase, which could result in greater working capital requirements.
Uses of Capital Resources
Since our inception, we have incurred net losses, which have been significant in recent periods. For the years ended December 31, 2024 and 2023, our net losses were $62.5 million and $79.0 million, and our cash burn was $58.0 million, exclusive of the $15.0 million in cash received from the Perceptive Credit Agreement, and $55.4 million, exclusive of $17.5 million from the maturity of term deposits, respectively. As of December 31, 2024, we had an accumulated deficit of $440.3 million. Our primary use of capital sources has been to fund our operations and grow our business, which has included developing new solutions, expanding our market opportunities for our SOPHiA DDM Platform.
Operating Capital Requirements
We expect to continue to incur net losses for the foreseeable future as we continue to devote substantial resources to research and development, in particular, to further expand the applications and modalities of our SOPHiA DDM Platform in order to accommodate multimodal data analytics capabilities across a wide range of disease areas; selling and marketing efforts for our SOPHiA DDM Platform to establish and maintain relationships with our collaborators and customers; and obtaining regulatory clearances or approvals for our SOPHiA DDM Platform and our applications, products, and services. We believe that our existing cash and cash equivalents will be sufficient to meet our working capital and capital expenditure needs for at least the next 12 months. Our future funding requirements will depend on many factors, including:
•our ability to achieve revenue growth;
•our ability to secure any required regulatory clearance or approval for additional features, applications and data modalities of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•the ability of our customers and collaborators to secure any required regulatory clearance or approval for their product candidates, other products, and services the development of which they rely on our SOPHiA DDM Platform and related solutions, applications, products, and services;
•our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our SOPHiA DDM Platform and related solutions, applications, products, and services;
•the rate of progress in establishing payor coverage and reimbursement arrangements with domestic and international commercial third-party payors and government payors by us with respect to our application and products, if approved for IVD use, and by our customers and collaborators, with respect to their product candidates, other products, and services;
•the cost of expanding our research and development; manufacturing and laboratory operations; and applications, products, and services offerings;
•the cost of building out our facilities, including our corporate headquarters in Switzerland and our locations around the world;
•our ability to maintain and expand our collaborations with biopharmaceutical companies, both advanced and early stage, and reference and specialist laboratories;
•our rate of progress in, and cost of research and development activities associated with, early research and development efforts;
•the effect of competing technological and market developments;
•market acceptance of our platform, solutions, applications, products, and services;
•costs related to international expansion; and
•the potential cost of, and delays in, application and product development as a result of regulatory oversight.
Unless and until we can generate sufficient revenue to finance our cash requirements, which may never happen, we may seek additional capital through a variety of means, including through public and private equity offerings and debt financings, credit and loan facilities and collaborations. Additional funds may not be available when we need them or on terms that are acceptable to us. See “Item 3. Key Information—D. Risk Factors—Risks Related to Our Financial Position and Capital Requirements.”
Cash Flows
The following table summarizes our cash flows for the years ended December 31, 2024 and 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
| (in USD thousands) |
|
2024 |
|
2023 |
| Net cash from (used in): |
|
|
|
|
| Operating activities |
|
$ |
(42,822) |
|
|
$ |
(48,575) |
|
| Investing activities |
|
(8,176) |
|
|
8,320 |
|
| Financing activities |
|
11,585 |
|
|
(2,817) |
|
| Net (decrease) increase in cash and cash equivalents |
|
$ |
(39,413) |
|
|
$ |
(43,072) |
|
| Effect of exchange rate differences on cash and cash equivalents |
|
$ |
(3,612) |
|
|
$ |
5,018 |
|
Operating Activities
Net cash used in operating activities was $42.8 million for the year ended December 31, 2024 as compared to $48.6 million for the year ended December 31, 2023. This decrease of $5.8 million was primarily attributable to a decrease in our net loss before tax, and was aided by a decrease in working capital of $3.5 million as we are more cost conscious and focused on collections of account receivables and a decrease of $8.1 million in finance (income) expense, net primarily driven by unrealized foreign exchange gains on intercompany loans, which is a non-cash impact, and interest income; offset by a $1.2 million increase in share-based compensation from the 2024 grants and $1.3 million increase in movements in provisions and pensions from the increase of pension costs associated with the change in pension plans. The pension charge was related to the increase in the actuarial value of the Company’s pension liability and was not a cash expense in 2024.
Investing Activities
Net cash used in investing activities was $8.2 million for the year ended December 31, 2024 as compared to $8.3 million provided from investing activities for the year ended December 31, 2023. The decrease of $16.5 million was primarily attributable to the proceeds associated with the maturity of investments in term deposits of $17.5 million in 2023 and no investments in term deposits in 2024, partially offset by a decrease of $1.3 million in our purchase of property and equipment as no additional capital purchases were required to support research and development and revenue-generation activities.
Financing Activities
Net cash provided from financing activities was $11.6 million for the year ended December 31, 2024 as compared to $2.8 million used in financing activities for the year ended December 31, 2023. This increase of $14.4 million was primarily attributable to the $15.0 million in cash received from the Perceptive Credit Agreement.
C. Research and Development, Patents and Licenses
See “Item 4. Information on the Company—B. Business Overview” and “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Results of Operations.”
D. Trend Information
See “Item 5. Operating and Financial Review and Prospects—A. Operating Results.”
E. Critical Accounting Estimates
The preparation of financial statements in conformity with IFRS Accounting Standards requires the use of accounting estimates. It also requires management to exercise judgment in applying our accounting policies. Disclosed below are the areas which require a high degree of judgment, significant assumptions and/or estimates.
Revenue
We recognize revenue when control of promised goods or services is transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services. Significant judgment is required to determine the stand-alone selling price (“SSP”) for each performance obligation in our SOPHiA DDM Platform, the amount allocated to each performance obligation and whether it depicts the amount that we expect to receive in exchange for the related application use, product, and/or service. As the selling prices of our analyses are highly variable, we estimate SSP of our analyses using the residual approach when the analyses are sold with other products and services and observable SSPs exist for the other products and services.
We enter into arrangements with multiple performance obligations where it could be difficult to determine whether there is more than one performance obligation under a sales agreement; in such cases, how and when revenue should be recognized is subject to certain estimates or assumptions. Should these judgments and estimates not be correct, revenue recognized for any reporting period could be adversely affected.
SOPHiA DDM Platform
The majority of SOPHiA DDM Platform revenue is derived from each use of our SOPHiA DDM Platform by customers to generate analyses on their patient data. Analysis revenue is recognized as analysis results are made available to the customer on our SOPHiA DDM Platform. Contract assets are recognized on the balance sheet as accrued contract revenue for any analyses performed by customers that have not been invoiced at the reporting period date. Any payments received in advance of customers generating analyses are recorded as deferred contract revenue until the analyses are performed.
Customers use our SOPHiA DDM Platform to perform analyses under three different models: dry lab access; bundle access; and integrated access.
For dry lab arrangements, customers use the testing instruments and consumables of their choice and our SOPHiA DDM Platform and algorithms for variant detection and identification. In these arrangements, we have identified one performance obligation, which is the delivery of the analysis result to the customer.
For bundle arrangements, customers purchase a DNA enrichment kit along with each analysis. Customers use the DNA enrichment kit in the process of performing their own sequencing of each sample. Customers then upload their patient data to our SOPHiA DDM Platform for analysis. In these arrangements, we have identified two performance obligations: the delivery of the DNA enrichment kits and the performance of the analyses. Revenue is recognized for the DNA enrichment kits when control of products has transferred to the customer, which is generally at the time of delivery, as this is when title and risk of loss have been transferred. Revenue for the performance of the analyses is recognized on delivery of the analysis results to the customer. Refer to “—Arrangements with multiple performance obligations” below for how revenue is allocated between the performance obligations.
Deferred contract revenue balances relating to analyses not performed within 12 months from the date of the delivery date are recognized as revenue. This policy is not based on contractual conditions but on our experience of customer behavior and expiration of the supply kits associated with the analyses.
For integrated arrangements, customers have their samples processed and sequenced through selected SOPHiA DDM Platform partners within the clinical network and access their data through our SOPHiA DDM Platform. We have identified one performance obligation, which is delivery of the analysis results to the customer.
Through our SOPHiA DDM Platform, we also sell access to our Alamut software application. Some arrangements with customers allow customers to use Alamut as a hosted software service over the contract period without the customer taking possession of the software.
Other customers take possession of the software, but the utility of that software is limited by access to our proprietary SOPHiA database, which is provided to the customer on a fixed term basis. Under both models, revenue is recognized on a straight-line basis over the duration of the agreement.
We also derive revenue from our SOPHiA DDM Platform by providing services to biopharma customers who engage us to (i) develop and perform customized genomic analyses and/or (ii) access the database for use in clinical trials and other research projects.
We enter into biopharma contracts that contain multiple products or services or non-standard terms and conditions. The biopharma contracts are generally unique in nature and each contract is assessed upon execution. Contracts may contain multiple performance obligations or performance obligations that are recognized over time, at a point in time upon achievement of milestones, or through a combination of both methods depending on our ability to satisfy the requirements to recognize revenue over time and reasonably estimate the amount of revenue to recognize. See “Arrangements with multiple performance obligations” below for further discussion on treatment of biopharma contracts.
Generally, the primary performance obligation in these arrangements is the delivery of analysis results in the form of a final report, resulting in revenue being recognized, in most cases, upon the issuance of the final report or successful recruitment of clinical trial participants.
Workflow Materials and Services
Revenue from workflow materials and services includes all revenue from the sale of materials and services that do not form part of a contract for the provision of platform services. These include the provision of set-up programs and training and the sale of kits and tests that are not linked to use of the platform. Set-up programs and training, also referred to as MaxCare, are typically combined with a customer’s first order prior to the customer beginning to use our SOPHiA DDM Platform, or customer’s first order of a new product prior to the customer being able to access the new pipeline.
Revenue from services is generally recognized when the services are performed. Revenue from materials is recognized when control of the goods is transferred to the customer, generally at the time of delivery. This category of revenue also includes the revenue from the sale of DNA sequencing automation equipment accounted for under IFRS 16, Leases (“IFRS 16”) and the fees charged for the maintenance of this equipment.
Arrangements with Multiple Performance Obligations
For multi-element arrangements the following steps are performed to determine the amount of revenue to be recognized and when it should be recognized: (1) identify the contract or contracts; (2) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (3) measure the transaction price, including the constraint on variable consideration; (4) allocate the transaction price to the performance obligations based on estimated selling prices; and (5) recognize revenue when (or as) each performance obligation is satisfied.
We have determined that the stand-alone selling prices for services and DNA enrichment kits are directly observable. For set-up programs and training services sold along with dry lab arrangements or bundle arrangements, the stand-alone selling price of these services is determined on a time and materials basis. For DNA enrichment kits sold as part of a bundle, the stand-alone selling price is based on an expected cost-plus-margin approach.
We have determined that the stand-alone selling price for the analyses, in both a dry lab arrangement and bundle arrangement, is highly variable and therefore a representative stand-alone selling price is not discernible from past transactions. As a result, the residual approach is used to determine the stand-alone selling price of the analyses in dry lab arrangements that include services and in bundle arrangements that include DNA enrichment kits and, in some cases, services.
We also have a small number of bundle contracts with a fixed term, generally four years, that also include providing the customer with DNA sequencing automation equipment, which we have determined is an IFRS 16 leasing component. In these arrangements, we provide DNA sequencing automation equipment to the customer over the fixed term and at completion of the contract term the customer takes possession of the equipment. We have determined that we are a dealer lessor and provision of this equipment to the customer is classified as a finance lease.
As a result, upon delivery of leased equipment at the inception of the agreement, a selling profit is recognized based on the fair value of the underlying equipment less the cost of the equipment. Over the term of the agreement, the minimum lease payment is deducted from the proceeds of the bundle sales in order to reduce the net investment in the corresponding lease receivable over the contract term and interest income is recognized as the discount on the lease receivable unwinds. The remaining proceeds from the contract are accounted for under IFRS 15, Revenue from Contracts with Customers (“IFRS 15”), using the policies described above.
We assess biopharma contracts upon execution of each contract given their project based nature. We establish each performance obligation within the contract and determines the appropriate value to be ascribed to be each performance obligation. When relevant to the biopharma contract, we utilize previously established SSPs for our dry lab and bundle solutions or other services. When the performance obligation(s) is only specific to the biopharma contract, we utilize all available information to reasonably estimate the correct value allocated to each performance obligation
Capitalized Internal Software Development Costs
All work performed by our research and development personnel is tracked and allocated to codes based on the nature of the work done. The hours spent are costed on the basis of the related salaries, benefits and share-based compensation. The cost of work attributable to the development of new data analytics solutions and services or to the improvement or enhancement of existing solutions and services is capitalized, once it is evident that the project is technically and financially feasible and that it will bring economic benefits to us. Capitalized software development costs are amortized using the straight-line method over an estimated life of five years.
Costs incurred for research, for development projects that do not meet the capitalization criteria, for maintenance and for minor modifications are expensed when incurred and presented as research and development costs. Other, administrative costs are expensed and presented as general and administrative costs.
Share-Based Compensation
For the years ended December 31, 2024 and 2023, we granted share options under one plan - the SOPHiA GENETICS 2021 Equity Incentive Plan (the “2021 Equity Incentive Plan” or the “2021 EIP”). Under this plan, our Board of Directors may offer options to directors, employees and advisors. The exercise price of the share options is set at the time they are granted. Options, once vested, can be exchanged for an equal number of ordinary shares.
Measuring the Cost of Share Options
The fair value of the options outstanding under all plans are measured at each reporting date using an adjusted form of the Black-Scholes option pricing model, taking into account the terms and conditions upon which the options were granted.
For options granted after the IPO in July 2021, the fair value at grant date is determined using a Black-Scholes option pricing model and the strike price is determined as the most recent public market close price of our stock on the date of grant.
The key inputs used in the valuation model for the stock options are outlined below.
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EIP 2021 |
|
|
Year Ended December 31, |
|
|
2024 |
|
2023 |
| Weighted average strike price (in USD) |
|
$4.78 |
|
$4.44 |
| Share price at grant date (in USD) |
|
$3.40 |
- |
$4.96 |
|
$2.53 |
- |
$4.72 |
| Expected life of share options (years) |
|
5.50 |
- |
7.00 |
|
5.50 |
- |
7.00 |
| Expected volatility (%) |
|
72.86 |
% |
- |
74.95% |
|
69.50 |
% |
- |
74.96% |
| Risk free interest rate (%) |
|
3.50 |
% |
- |
4.40% |
|
3.45 |
% |
- |
4.67% |
| Dividend yield (%) |
|
—% |
|
—% |
Recognizing the Cost of Share Options
At each reporting date, we record expense for the vested options granted and for partially earned but non-vested portions of options granted. This results in a front-loaded expense to the statement of loss. In addition, at each reporting date we reappraise our estimate of the likelihood and date of a future transaction that would cause all outstanding options to vest and, if necessary, accelerates the recognition of the unrecognized cost in the statement of loss. We account for these plans as equity-settled. The expense to the statement of loss therefore results in a corresponding credit being booked to “Other reserves” within equity.
Goodwill Impairment Testing
We operate as one segment or as a single cash-generating unit (“CGU”). As a single CGU, goodwill is tested by considering its recoverability in terms of the entire business. We assess the recoverable value of goodwill by comparing our equity value, either from observable market prices or based on discounted cash flow forecasts, to the net assets as reported in our consolidated financial statements. Impairment testing is performed on an annual basis as of October 1. The value as of October 1, 2024 and 2023 were in part based on our market capitalization, which is a factor of our outstanding shares multiplied by the price of our stock on October 1, 2024 and 2023, respectively.
Capitalized internally developed software costs
Capitalized costs are based on the employment costs of individuals working on software development and based on timesheets. Special attention is paid to distinguishing between costs incurred on developing new software or software upgrades, which may be eligible for capitalization, and costs incurred in maintenance and in the correction of problems, which is not eligible.
Judgment is required in identifying whether individual projects meet all of the criteria required to permit capitalization, in particular, whether the software will generate probable future economic benefits.
Defined Benefit Pension Liabilities
The liability or asset recognized on the balance sheet in respect of defined benefit pension plans is the present value of the defined benefit obligation at the end of the reporting period less the fair value of plan assets. The defined benefit obligation is calculated annually by independent actuaries using the projected unit credit method.
The present value of the defined benefit obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms approximating to the terms of the related obligation. In countries where there is no deep market in such bonds, the market rates on government bonds are used.
The net interest cost is calculated by applying the discount rate to the net balance of the defined benefit obligation and the fair value of plan assets. This cost is included in employee benefit expense in the statement of loss.
Remeasurement gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized in the period in which they occur, directly in other comprehensive income. They are included in retained earnings in the statement of changes in equity and on the balance sheet.
Changes in the present value of the defined benefit obligation resulting from plan amendments or curtailments are recognized immediately in income as past service costs.
For defined contribution plans, we pay contributions to publicly or privately administered pension insurance plans. Employee contributions to these plans is voluntary and these contributions are matched by the employer. We have no further payment obligations once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available. Contributions are charged to the statement of loss as incurred.
Expected Credit Losses
We have adopted the simplified method indicated in IFRS 9, Financial Instruments (“IFRS 9”), to build our allowance for expected credit losses (“ECL”). We use a matrix based on a calculation of collectability rates according to historical accounts receivable. Allowance is made for lifetime expected credit losses as invoices are issued. The amount of allowance initially recognized is based on historical experience, tempered by expected changes in future cash collections, due to, for example, expected improved customer liquidity or more active credit management.
Accounts receivable-trade balances are non-interest bearing and payment terms are generally under agreements with payment terms typically of 30 to 60 days, payment terms can be extended up to 180 days. Our customers primarily consist of government-owned or government-funded hospitals, laboratories with very low credit risks, and biopharmaceutical companies. We had minimal instances of actual credit losses in 2023 and 2024 and believe that this will continue to be the case.
Income Taxes
Uncertain Tax Positions
We file tax returns as prescribed by the tax laws of the jurisdictions in which we operate and is therefore subject to tax examination by various taxing authorities. In the normal course of business, we are subject to examination by local tax authorities in Switzerland, France, Italy, Brazil, Australia, the U.K. and the U.S. In 2022 a tax assessment examination was rendered by the French tax authority during an audit of our 2018 and 2019 tax returns. In 2023, a tax assessment was rendered by the French tax authority during the review of the 2022 tax return as discussed below. In 2024, a tax assessment was rendered by the Swiss tax authority regarding our 2019 through 2023 tax returns. We are not aware of any additional issues that could result in any other significant payments, accruals or material deviation from its tax positions. There are no other tax examinations in progress as of December 31, 2024.
We record tax liabilities or benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available at the reporting date. There is inherent uncertainty in quantifying income tax positions, especially considering the complex tax laws and regulations in each of the jurisdictions in which we operate.
Item 6. Directors, Senior Management, and Employees
A. Directors and Senior Management
The following table presents information about our executive officers and directors. Ages are as of February 15, 2025.
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| Name |
|
Position(s) |
|
Age |
| Executive Officers and Directors |
|
|
|
|
| Jurgi Camblong |
|
Chief Executive Officer and Director |
|
46 |
| Ross Muken |
|
President |
|
45 |
| George Cardoza |
|
Chief Financial Officer |
|
63 |
| Daan van Well |
|
Chief Legal and Compliance Officer |
|
50 |
| Manuela da Silva Valente |
|
Chief People Officer |
|
55 |
| Zhenyu Xu |
|
Chief Scientific Officer |
|
42 |
| Philippe Menu |
|
Chief Medical Officer and Chief Product Officer |
|
43 |
|
|
|
|
|
| Non-Executive Directors |
|
|
|
|
| Troy Cox |
|
Chairman of the Board of Directors |
|
60 |
| Tomer Berkovitz |
|
Director |
|
45 |
| Kathy Hibbs |
|
Director |
|
61 |
| Didier Hirsch |
|
Director |
|
73 |
| Vincent Ossipow |
|
Director |
|
56 |
| Jean-Michel Cosséry |
|
Director |
|
65 |
Executive Officers
Jurgi Camblong, Ph.D., M.B.A., has served as our Chief Executive Officer and a member of our board of directors since March 2011 when he co-founded our company with Dr. Pierre Hutter and Professor Lars Steinmetz. From 2010 to 2011, Dr. Camblong served as the Chief Executive Officer of Gene Predictis SA. Prior to that, Dr. Camblong was a post-doctoral associate researcher at Oxford University and at the University of Geneva. Dr. Camblong was a member of the Advisory Council on Digital Transformation to the Swiss Government and is a Board member of the Swiss Biotech Association. Dr. Camblong holds a Ph.D. in life sciences from the University of Geneva and an Executive M.B.A. in management of technology from EPFL/HEC Lausanne.
Ross Muken, B.Sc., has served as our President since November 2024 and was previously our Chief Financial Officer from February 2021 to November 2024 and our Chief Operating Officer from March 2023 to November 2024. From 2019 to 2020, Mr. Muken served as the Chief Financial Officer of Click Therapeutics, Inc. From 2012 to 2019, Mr. Muken served as the Senior Managing Director and Partner of Equity Research at Evercore/ISI Group. Prior to that, Mr. Muken served in various roles at Deutsche Bank, including as Managing Director of Equity Research, and at Thomas Weisel Partners. Mr. Muken holds a B.Sc. in business administration from Boston University.
George Cardoza, M.B.A., has served as our Chief Financial Officer since November 2024. From August 2023 to November 2024, he was the Chief Financial Officer and Head of Service Delivery at Biocartis, a molecular diagnostics company. From July 2022 to August 2023, he was the Chief Executive Officer of AccuraGen. Prior to that, he spent over twelve years with NeoGenomics Laboratories in several executive roles (CFO from November 2009 to March 2018, President Pharma Services Division from March 2018 to July 2021), and President and Chief Operating Officer Laboratory Operations from July 2021 to April 2022), and previously spent more than fourteen years with Quest Diagnostics in various roles including Controller of the Central Region. Mr. Cardoza holds a B.S. in Finance and Accounting from Syracuse University and an M.B.A. from Michigan State University.
Daan van Well, LL.M., M.B.A., has joined as our General Counsel in June 2019. In March 2023 was appointed Chief Legal & Compliance Officer, and since November 2024 he has served as Chief Legal & Regulatory Officer. Mr. Van Well has more than 20 years of legal, governance and compliance experience. From 2018 to 2019, Mr. Van Well served as the founder and managing partner of consulting firm SpringWorks Sàrl. From 2010 to 2017, Mr. Van Well served in various legal positions with PwC Switzerland, including as the Head of Legal from 2011 to 2017. Prior to that, Mr. Van Well served as corporate secretary and senior legal counsel of Royal Ahold N.V. (currently Koninklijke Ahold Delhaize N.V.) and practiced law at Loyens & Loeff N.V. in Rotterdam, The Netherlands. Mr. Van Well holds a LL.M. in Dutch civil law from Utrecht University and an Executive M.B.A. in management and corporate finance from HEC Lausanne.
Manuela da Silva Valente, B.A., has served as our Chief People Officer since January 2019. Ms. Da Silva Valente has more than 20 years of human resources experience. From 2011 to 2018, Ms. Da Silva Valente served in various human resources leadership roles at IQVIA (formerly Quintiles and IMS Health Inc.), including as Global Senior Director of Human Resources from 2016 to 2018. Prior to that, Ms. Da Silva Valente held various human resources roles at Outcome Sciences, Inc. prior to its acquisition by IQVIA. Ms. Da Silva Valente holds a B.A. in business administration from the Business Management School of Zurich and a Management & Human Resources Diploma from CEFCO Lausanne.
Zhenyu Xu, Ph.D., has served as our Chief Scientific Officer since January 2021 and was previously our Chief Technology Officer since May 2014. Dr. Xu was the leader of the technology team that developed our SOPHiA DDM Platform. Prior to that, Dr. Xu was a post-doctoral fellow at the European Molecular Biology Laboratory. Dr. Xu holds a Ph.D. in molecular and computational biology from the European Molecular Biology Laboratory.
Philippe Menu, M.D., Ph.D., M.B.A., has served as our Chief Medical Officer since February 2020 and our Chief Product Officer since March 2023. From 2011 to 2020, Dr. Menu was a management consultant with McKinsey & Company, focusing on the biopharmaceutical sector and in particular innovative therapies and diagnostics in oncology and rare diseases. Prior to that, Dr. Menu was a post-doctoral fellow at the University of Lausanne. Dr. Menu holds an M.D./Ph.D. in life sciences from the University of Lausanne and an M.B.A. from the Open University Business School.
Non-Executive Directors
Troy Cox, M.B.A., has served as the Chairman of our board of directors since June 2019. From 2017 to 2019, Mr. Cox served as the chief executive officer of Foundation Medicine Inc. From 2010 to 2017, Mr. Cox served as the senior vice president of U.S. commercial of Genentech, Inc. Prior to that, Mr. Cox held various executive and senior positions at UCB S.A., Sanofi-Aventis U.S. LLC and Schering-Plough Corporation. In addition to our board of directors, Mr. Cox serves on the board of directors of Zymeworks Inc., LetsGetChecked, Standard BioTools (formerly SomaLogic, Inc.), BioSplice Therapeutics, Inc. and previously served on the board of directors of Foundation Medicine Inc. Mr. Cox holds an M.B.A. from the University of Missouri.
Tomer Berkovitz, Ph.D., has served as a member of our board of directors since March 2021. Since 2018, Dr. Berkovitz has served as General Partner of aMoon Fund, where he co-leads its Growth fund. From 2014 to 2018, Dr. Berkovitz served as the Chief Operating Officer and Chief Financial Officer of Alcobra Ltd. Prior to that, Mr. Berkovitz served as an Executive Director in J.P. Morgan’s investment banking division in New York. In addition to our board of directors, Dr. Berkovitz serves on the board of directors of several other healthcare companies in the aMoon portfolio. Dr. Berkovitz holds a Ph.D. in finance from Columbia Business School.
Kathy Hibbs, J.D., has served as a member of our board of directors since March 2021. She served as Chief Administrative Officer at 23andMe, Inc. from 2022 to May 2024, and prior to that, as Chief Legal and Regulatory Officer from 2014 to 2022. Earlier in her career, Ms. Hibbs held key leadership roles in legal, business development and compliance functions at Genomic Health, Inc., Monogram Biosciences Inc. and Varian Medical Systems, Inc. In addition to our board of directors, Ms. Hibbs serves on the board of directors of Standard BioTools. Ms. Hibbs holds a J.D. from the University of California, Hastings College of Law.
Didier Hirsch, M.Sc., M.S., has served as a member of our board of directors since June 2020. From 2010 to 2018, Mr. Hirsch served as the senior vice president and chief financial officer of Agilent Technologies, Inc. Prior to that, Mr. Hirsch held various leadership roles in finance at Agilent Technologies, Inc. and Hewlett-Packard Company. In addition to our board of directors, Mr. Hirsch serves on the board of directors of Knowles Corporation and previously served on the board of directors of International Rectifier Corporation, Logitech International S.A. and Azenta Inc. Mr. Hirsch holds an M.Sc. in computer science from Toulouse University and an M.S. in industrial administration from Purdue University.
Vincent Ossipow, Ph.D., has served as a member of our board of directors since June 2014. Dr. Ossipow has been a partner at Omega Funds. Dr. Ossipow has also served as the Chief Scientific Officer of Omega Alpha SPAC. Prior to that, Dr. Ossipow held various investment management positions at Sectoral Asset Management and Pictet Bank. In addition to our board of directors, Dr. Ossipow serves on the board of directors of BioInvent International AB and FoRx SA, and previously served on the board of directors of Aerium Inc., Immunic, Inc., eTheRNA NV, Andrew Alliance S.A., Lifespan, Inc., Raindance Technologies, CNx SA and Kuros Biosciences AG. Dr. Ossipow holds a Ph.D. in molecular biology from the University of Geneva.
Jean-Michel Cosséry, Ph.D., Pharm.D., M.B.A., has served as a member of our board of directors since June 2022. From 2012 to 2018, Dr. Cosséry served in various senior leadership positions at Eli Lilly and Company, including as Vice President, North America Oncology, as well as Vice President and Managing Director of Lilly U.K. and Northern Europe. Prior to that, he served as Vice President and Chief Marketing Officer of GE Healthcare as well as in senior positions at Novartis International AG and Serono (now Merck (Schweiz) AG). Dr. Cosséry serves on the board of directors of Malin Corporation plc and is the chairman of Scancell Holdings PLC. He previously served on the boards of Exact Therapeutics AS, Diurnal plc, Eracal Therapeutics Ltd., Immunocore Holdings Limited and Kymab Ltd. When based in the UK he served on the board of directors of ABPI (UK) LIMITED and as chairman of the board of directors of the American Pharmaceutical Group in the UK. Dr. Cosséry holds an M.B.A. from the Rotterdam School of Management, a Ph.D. with honors in nuclear chemistry and neurobiology from Paris Sud University, and a Pharm.D. with honors in pharmacology from Paris Sud University.
Relationships
There are no family relationships among any of our directors or executive officers.
B. Compensation
Compensation of Directors and Executive Officers
For the year ended December 31, 2024, the aggregate compensation paid or accrued to the members of our board of directors and our executive officers for services in all capacities, including retirement and similar benefits, was $4.5 million, the total fair value of stock options and non-vested share awards granted to the members of our board of directors and our executive officers was $13.2 million, and the amount set aside or accrued by us to provide pension, retirement or similar benefits to our executive officers was $0.3 million.
Equity Incentive Plans
On June 29, 2021, our shareholders approved the 2021 Equity Incentive Plan that our board of directors had previously adopted. The purpose of the 2021 Equity Incentive Plan is to motivate and reward performance of our employees, directors, consultants and advisors and further the best interests of the Company and our shareholders.
Plan Administration. The 2021 Equity Incentive Plan is administered by the compensation committee of our board of directors, subject to the board of directors’ discretion to administer or appoint another committee to administer it.
Awards. Equity incentive awards under the 2021 Equity Incentive Plan may be granted in the form of options (including incentive stock options and non-qualified stock options), share appreciation rights, restricted shares, restricted share units, performance awards or other share-based awards. Options and share appreciation rights will have an exercise price determined by the compensation committee and, in the case of options granted to a participant subject to U.S. taxation, will not be less than fair market value of the underlying ordinary shares on the date of grant (or, if such options consist of incentive stock options and the participant owns (or is deemed to own) at least 10% of the total combined voting power of all classes of our capital stock (a “ten percent shareholder”), an exercise price not less than 110% of the fair market value of the underlying ordinary shares on the date of grant). In addition, under the 2021 Equity Incentive Plan, options and share appreciation rights may not have a term that exceeds ten years (or, in the case of an incentive stock option granted to a ten percent shareholder, a term that exceeds five years).
Eligible Participants. The compensation committee is able to offer equity awards at its discretion under the 2021 Equity Incentive Plan to (1) any of our employees or any of our subsidiaries, (2) any non-employee directors serving on our board of directors and (3) any consultants or other advisors to us or any of our subsidiaries; provided that only employees of our company or certain of our subsidiaries may be granted incentive stock options. To the extent required by applicable law and our articles of association in effect from time to time, all awards and rights, payments and benefits granted or made under the 2021 Equity Incentive Plan to our directors and executive officers are subject to the approval of the relevant total amount of compensation by our shareholders.
Share Reserve. The maximum number of ordinary shares initially reserved for issuance pursuant to awards under the 2021 Equity Incentive Plan is 7,800,740 ordinary shares, which will be increased on the first day of each fiscal year of the Company, beginning with the 2022 fiscal year, in an amount equal to the least of (i) a number of ordinary shares equal to five percent (5%) of the total number of shares of all classes of shares of the Company outstanding on the last day of the immediately preceding fiscal year, (ii) such number of shares determined by our board of directors, and (iii) the aggregate number of shares available to our board of directors under our articles of association or otherwise that may be granted as, or be subject to, equity incentive awards on such date. To ensure that our board of directors can reserve a sufficient number of ordinary shares for purposes of the 2021 Equity Incentive Plan, we plan to request shareholders approve annual increases to the Company’s conditional share capital for employee participation. In addition, ordinary shares reserved for issuance under the 2021 Equity Incentive Plan are subject to adjustment in the event of certain corporate transactions or events if necessary to prevent dilution or enlargement of the benefits made available under the 2021 Equity Incentive Plan.
Vesting. The vesting conditions for grants under the equity incentive awards under the 2021 Equity Incentive Plan are set forth in the applicable award documentation.
Termination of Service and Change in Control. In the event of a participant’s termination of employment or service, the compensation committee may determine in the applicable award agreement the extent to which an equity incentive award may be exercised, settled, vested, paid or forfeited. Unless otherwise provided in the applicable award agreement, in the event of a change in control by way of a merger, a sale of the Company’s securities, a sale of all or substantially all of the Company’s assets or similar transaction, each award that is outstanding as of immediately prior to such change in control will, (i) to the extent not then vested, accelerate and become fully vested (with any performance award assumed to have achieved the applicable performance criteria at the greater of target and maximum level of performance), and (ii) be cancelled and converted into the right to receive a payment in cash with a value equal to the value of such award based on the per share value of consideration received or to be received by other shareholders of the Company in such change in control, with the value of the any such award that is an option or a share appreciation right reduced by the applicable exercise price. In the event of a change in control, the compensation committee may also, in lieu of the acceleration and cash out of outstanding awards described above, take any one or more of the following actions with respect to outstanding awards that the compensation committee determines to be appropriate: (i) cancel any such award in exchange for a payment in securities or other property other than cash or any combination thereof with a value equal to the value of such award based on the per share value of consideration received or to be received by other shareholders in the event (or without payment of consideration if the compensation committee determines that no amount would have been realized upon the exercise of the award or other realization of the participant’s rights); (ii) require the exercise of any outstanding option; (iii) provide for the assumption, substitution, replacement or continuation of any award by the successor or surviving corporation, along with appropriate adjustments with respect to the number and type of securities (or other consideration) of the successor or surviving corporation, subject to any replacement awards, the terms and conditions of the replacement awards (including performance targets) and the grant, exercise or purchase price per share for the replacement awards; (iv) make any other adjustments in the number and type of securities (or other consideration) subject to awards that may be granted in the future; (v) provide that any such award shall be accelerated and become exercisable, payable and/or fully vested with respect to all ordinary shares covered thereby or (vi) provide that any award shall not vest, be exercised or become payable as a result of such event.
Termination and Amendment. Unless terminated earlier, the 2021 Equity Incentive Plan will continue for a term of ten years. Our board of directors has the authority to amend or terminate the 2021 Equity Incentive Plan subject to shareholder approval with respect to certain amendments. However, no such action may materially adversely affect the rights of any participant under any outstanding award without the consent of the affected participant.
During the year ended December 31, 2024, we have granted to the members of our board of directors and to our executive officers, in the aggregate, the right to acquire 2,810,010 ordinary shares under the 2021 Equity Incentive Plan. Options granted to executive officers during 2024 vest 25% on the first anniversary of the grant date and the remaining 75% vesting ratably on a monthly basis over the remaining three years. The weighted-average exercise price for the options granted during 2024 was $3.29. During the year ended December 31, 2024, we granted to the members of our board of directors and to our executive officers, in the aggregate, 840,681 RSUs under the 2021 Equity Incentive Plan. The RSUs granted to an executive officer are subject to a four-year vesting schedule with 25% vesting on the first anniversary of the grant date and the remaining 75% ratably on a quarterly basis over the remaining three years, subject to the executive officer’s continued employment with us; any unvested RSUs will be forfeited should the executive officer terminate his or her employment with us. The restricted share units granted to a non-executive member of the board of directors are subject to a vesting period set to be completed upon the the Company’s 2025 Annual General Meeting, subject to continued service on our board of directors.
Employment Agreements
We have entered into employment agreements with certain of our executive officers. Each of these agreements provides for an initial salary and annual bonus opportunity, as well as participation in certain pension and welfare benefit plans. These agreements may require advance notice of termination and in some cases provide for paid garden leave. Some of our executive officers have agreed to covenants not to compete against us or solicit our employees or customers during employment and for a period of up to one year following termination. We may be required to pay some of our executive officers compensation for their covenant not to compete with us following termination. If we experience a “change in control”, then our executive officers’ then-unvested awards will become fully vested at such time.
Additional Information
We are required under Swiss law to provide additional disclosure regarding the compensation of our executive officers and directors. We incorporate by reference the information contained in
Exhibit 99.2 of the Report on Form 6-K filed with the SEC on March 4, 2025 (other than the Report of the Statutory Auditor and Section 4 Equity and Equity-Linked Instruments Held by Members of the Board of Directors and the Executive Committee).
C. Board Practices
Board Composition and Election of Directors
Our board of directors is composed of seven members. Under the laws of Switzerland, each director is elected for a one-year term. The current members of our board of directors will serve until our annual general meeting of shareholders in 2025.
Board Practices
We are a foreign private issuer under the rules of the SEC. As a result, in accordance with Nasdaq listing standards, we rely on home country governance requirements and certain exemptions thereunder rather than on Nasdaq corporate governance requirements. For an overview of our corporate governance principles, see “Item 10. Additional Information—B. Memorandum and Articles of Association” and “Item 16G—Corporate Governance.”
Director Independence
Our board of directors has affirmatively determined that each of Troy Cox, Tomer Berkovitz, Kathy Hibbs, Didier Hirsch, Vincent Ossipow, and Jean-Michel Cosséry is an independent director within the meaning of applicable Nasdaq standards.
Diversity
Our board of directors values diversity among its members. Our nomination and corporate governance committee, within the purview of its mandate, has the responsibility to take diversity into consideration as part of the overall director selection and nomination processes and to make the identification of diverse candidates a search criterion.
The matrix below sets forth a summary of the diversity of our board of directors as of February 1, 2025:
Country of Principal Executive Offices: Switzerland
Foreign Private Issuer: Yes
Disclosure Prohibited under Home Country Law: No
Total Number of Directors: 7
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Female |
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Board Meetings
In 2024, our board of directors held 9 meetings.
Committees of the Board of Directors
Our board of directors has three committees: an audit committee, a compensation committee, and a nomination and corporate governance committee.
Audit Committee
The audit committee, which consists of Didier Hirsch (chair), Tomer Berkovitz, and Kathy Hibbs, assists our board of directors in overseeing our accounting and financial reporting processes and the audits of our consolidated financial statements. In addition, the audit committee is directly responsible for the compensation, retention, and oversight of the work of our independent registered public accounting firm that our shareholders elect as our external auditors. The audit committee consists exclusively of members of our board of directors who are financially literate, and each of Didier Hirsch and Tomer Berkovitz are considered an “audit committee financial expert” as defined by the SEC. Our audit committee complies with Rule 10A-3(b)(1) of the Exchange Act. Our board of directors has determined that each of Didier Hirsch, Tomer Berkovitz, and Kathy Hibbs satisfy the “independence” requirements under Nasdaq listing standards and Rule 10A-3 under the Exchange Act.
The audit committee is governed by a charter that complies with the Nasdaq listing standards that apply to us. The audit committee has the responsibility to, among other things:
•select, appoint, compensate, retain, terminate and oversee the work of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services;
•pre-approve the audit services and non-audit services (including the fees and terms thereof) to be provided by the independent auditor pursuant to pre-approval policies and procedures;
•review and approve the planned scope and timing of our independent registered public accounting firm’s annual audit plan(s);
•discuss significant findings from the audit and any problems or difficulties encountered, including any restrictions on the scope of our independent registered public accounting firm’s activities or on access to requested information, and any significant disagreements with management;
•evaluate the independent auditor’s qualifications, performance and independence, and present its conclusions with respect to the independent auditor to the board of directors on at least an annual basis;
•supervise the ethics committee as provided in the Code of Ethics, consider related party transactions and supervise compliance with any other policies over which the audit committee has oversight authority;
•review and discuss with management and the independent auditor the annual audited consolidated and stand-alone financial statements and make its recommendation to the board of directors for their presentation to the general meeting of shareholders for approval;
•review and discuss with management and the independent auditor the unaudited condensed consolidated quarterly financial statements
•review with management and the independent auditor (i) any analyses or other written communications prepared by management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the financial statements, (ii) our material accounting policies and practices, (iii) the effect of regulatory and accounting initiatives, as well as off-balance-sheet transactions and structures, on our financial statements and (iv) any major issues regarding accounting principles and financial statement presentations;
•in conjunction with the chief executive officer and chief financial officer, review disclosure controls and procedures and internal control over financial reporting;
•review and discuss with the independent auditor any audit problems or difficulties and management’s response thereto;
•discuss with the chief financial officer and the chief executive officer the results of its review of the management or internal control letter issued by the independent auditor;
•resolve disagreements between management and the auditor regarding our financial reporting;
•review our risk assessment and risk management policies and practices;
•establish procedures for the receipt, retention and treatment of complaints received regarding accounting, internal accounting controls or auditing matters, as well as the receipt of summary whistleblower reports and the confidential, anonymous submission by employees of concerns regarding questionable accounting or auditing matters;
•review our compliance with laws and regulations; and
•review any major litigation or investigations against us that may have a material impact on our financial statements.
The audit committee meets as often as it determines is appropriate to carry out its responsibilities, but in any event meets at least quarterly.
Compensation Committee
The compensation committee, which consists of Kathy Hibbs (chair), Jean-Michel Cosséry, and Vincent Ossipow, supports our board of directors in establishing and reviewing the compensation and benefits strategy and guidelines as well as in preparing the proposals to the annual general meeting of shareholders regarding the compensation of the members of the board of directors and the executive officers. The compensation committee may submit proposals to the board of directors on other compensation-related matters. Swiss law requires that we have a compensation committee, so in accordance with Nasdaq listing standards, we follow home country requirements with respect to the compensation committee. As a result, our practice varies from Nasdaq listing standards, which set forth certain requirements as to the responsibilities, composition and independence of compensation committees for domestic issuers. Swiss law requires that our board of directors submit the aggregate amount of compensation of all members of our board of directors and of all executive officers to a binding shareholder vote every year. The members of the compensation committee will be elected by our annual general meeting of shareholders. The board of directors appoints the chair of the compensation committee and fills any vacancies until the following annual general meeting of shareholders.
The compensation committee has the responsibility to, among other things:
•regularly review and make recommendations to the board of directors regarding our compensation and benefits strategy and guidelines;
•review and make recommendations to the board of directors regarding the compensation of the members of the board of directors, of the executive committee and of our extended management team;
•prepare the proposals to the shareholders’ meeting regarding the compensation of the members of the board of directors and of the executive committee;
•review and approve the recommendation of our chief executive officer regarding the fixed and variable compensation, including incentive plan participation and benefits, of the members of the management team other than members of the executive committee;
•review and make recommendations to the board of directors regarding our compensation and benefits plans (cash and/or equity-based plans) and, where appropriate or required, make recommendations to adopt, amend, and terminate such plans;
•to the extent not delegated by the compensation committee to a different body or a third party, administer our compensation and benefits plans; and
•review and assess risks arising from our employee compensation policies and practices and whether any such risks are reasonably likely to have a material adverse effect on us.
Nomination and Corporate Governance Committee
The nomination and corporate governance committee, which consists of Troy Cox (chair), Kathy Hibbs, and Didier Hirsch, is responsible for director and board committee nominations, succession planning, performance evaluation, and reviewing and amending, if required, our corporate governance framework and guidelines. The members of the nomination and corporate governance committee and its chair are appointed by our board of directors.
The nomination and corporate governance committee has the responsibility to, among other things:
•determine selection criteria for the succession of the members of the board of directors and board committees, our chief executive officer and our chief financial officer, and establish such succession planning (including for the event of the incapacitation, retirement or removal of such individuals) by making recommendations to the board of directors;
•oversee searches, identify qualified individuals and recommend individuals for membership on the board of directors and for the position of chief executive officer;
•recommend individuals for appointment to the audit committee annually and as vacancies or newly created positions occur;
•at least annually, prepare the board of directors’ assessment of the performance of the board of directors and board committees and of our chief executive officer;
•review the recommendations of the other board committees based on their self-evaluations and discuss its own evaluation with the board of directors;
•monitor and assess developments and trends in corporate governance to the extent that these do not have an impact on the activities and tasks of the audit committee or the compensation committee;
•review proposals to be made to the board of directors for the amendment of our articles of association, our organizational regulations, and any other charter, rules or regulations;
•approve in advance any acceptance by a member of our management of a position as member of the board of directors in companies not belonging to our group;
•periodically review and assess the adequacy of the charter of the nomination and corporate governance committee and recommend any proposed changes to the board of directors for approval;
•if it deems necessary, develop and recommend to the board of directors corporate governance guidelines for us;
•periodically review and reassess the adequacy of the Code of Ethics and recommend any proposed changes to the board of directors;
•oversee compliance with the Code of Ethics and report on such compliance to the board of directors;
•supervise the ethics committee as provided in the Code of Ethics; and
•review and consider any requests for waivers of the Code of Ethics for members of our board of the directors, our management and other senior financial officers, and make a recommendation to our board of directors with respect to such request for a waiver.
D. Employees
We employ great minds in biotechnology and machine learning who continuously advance our algorithms, applications, products, and services to benefit clinical researchers around the world. Approximately 30% of our employees hold doctoral degrees in diverse fields that range from cell biology to computer science. Our employees bring widely varied expertise and competencies to our company. Our multidisciplinary team includes bioinformaticians, medical and genetic experts, scientists, software engineers, web developers, graphic designers, commercial experts and lab specialists, as well as staff in our administrative and corporate teams.
We pride ourselves on the excellence and integrity of our employees. We work towards the best quality and target the highest performance. Our corporate DNA, rooted in quality, precision and robustness, is the key to our success. We strive to foster an entrepreneurial, innovative and unique culture that ignites employees’ passion and inspires them to challenge the status quo. We create work environments that preserve and value individuality and diversity of viewpoints and approaches such that our employees trust each other and collaborate to achieve our collective goals.
The following strategies help ensure that we attract and retain high quality employees:
•Attracting Talent. Our dedicated and experienced global talent acquisition team identifies and attracts the most qualified candidates. Our locations were strategically selected to attract highly educated talent from renowned universities and engineering schools, and we regularly attend events and use social media to increase awareness of our brand to prospective candidates. As part of our hiring process, we conduct scientific and technical assessments to ensure that candidates have the appropriate skills and expertise.
•Retaining and Developing Talent. As part of our effort to continuously motivate and engage our employees and provide professional development for our employees, we provide corporate talent reviews and follow-up individual development plans for our employees, and have created career ladders with grading systems for all departments with detailed job descriptions on what is required at each level. We also perform employee engagement surveys that inform our dedicated task forces as they continuously strive to increase employee satisfaction and morale.
•Training. To help our employees integrate into our company, advance their knowledge and skills and remain at the forefront of innovation, we created Learning@SOPHiA, which consists of (i) an onboarding program with a new hire learning path, a manager’s guide to onboarding and a buddy system for new hires, (ii) ongoing learning paths with department specific training modules, technical and non-technical training, cross-functional information sessions, mentoring and soft skill training, and (iii) leadership and development programs for managers. In addition,
for our salespersons, our sales success department provides commercial training, including consultative sales, negotiations skills and cold call training.
As of December 31, 2024, we had 423 full-time equivalents (“FTE”) across 27 countries, of whom 323 were located in EMEA, 75 were located in North America, 15 were located in Latin America and 10 were located in Asia Pacific. Over the course of the year ended December 31, 2024, we employed, on average, 431 FTEs. Approximately 43% of our employees are engaged in research and development.
In certain countries in which we operate, we are subject to, and comply with, local labor law requirements, which may automatically make our employees subject to industry-wide collective bargaining agreements. As of December 31, 2024, we have bargaining agreements in place for France, Spain, Italy, Belgium, and Austria, with 96 employees subject to collective bargaining agreements. We believe that our relationship with our employees is good.
E. Share Ownership
See “Item 7. Major Shareholders and Related Party Transactions—A. Major shareholders.”
F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation
None.
Item 7. Major Shareholders and Related Party Transactions
A. Major Shareholders
The following table presents information relating to the beneficial ownership of our ordinary shares as of February 15, 2025 by:
•each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding ordinary shares;
•each of our executive officers and directors and persons nominated to serve in such positions; and
•all executive officers and directors and persons nominated to serve in such positions as a group.
The number of ordinary shares beneficially owned by each entity, person, executive officer or director is determined in accordance with the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership includes any ordinary shares over which the individual has sole or shared voting power or investment power as well as any ordinary shares that the individual has the right to acquire within 60 days from February 15, 2025 through the exercise of any option or other right. Except as otherwise indicated, and subject to applicable community property laws, we believe that the persons named in the table have sole voting and investment power with respect to all ordinary shares held by that person based on information provided to us by such person.
The percentage of outstanding ordinary shares beneficially owned is computed on the basis of 66,831,071 ordinary shares outstanding as of February 15, 2025. Ordinary shares that a person has the right to acquire within 60 days are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all executive officers and directors as a group. Unless otherwise indicated below, the business address for each beneficial owner is SOPHiA GENETICS SA, La Pièce 12, CH-1180 Rolle, Switzerland.
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Beneficially Owned |
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Beneficially Owned |
|
|
|
|
|
| 5% or Greater Shareholders |
|
|
|
|
Alychlo NV(1) |
|
6,993,800 |
|
10.46% |
Generation IM Sustainable Solutions Fund III, L.P.(2) |
|
6,789,560 |
|
10.16% |
aMoon(3) |
|
5,510,564 |
|
8.25% |
Balderton Capital VI, S.L.P.(4) |
|
3,361,880 |
|
5.03% |
|
|
|
|
|
| Executive Officers and Directors |
|
|
|
|
|
|
|
|
|
Jurgi Camblong(5) |
|
2,654,245 |
|
3.97% |
| Vincent Ossipow |
|
443,811 |
|
* |
Zhenyu Xu(5) |
|
396,605 |
|
* |
| Troy Cox |
|
234,251 |
|
* |
| Daan van Well |
|
126,710 |
|
* |
| Didier Hirsch |
|
133,931 |
|
* |
| Jean-Michel Cosséry |
|
111,720 |
|
* |
| Ross Muken |
|
128,133 |
|
* |
| George Cardoza |
|
— |
|
* |
| Philippe Menu |
|
39,605 |
|
* |
| Manuela da Silva Valente |
|
60,375 |
|
* |
| Kathy Hibbs |
|
35,508 |
|
* |
| Tomer Berkovitz |
|
— |
|
* |
|
|
|
|
|
| All executive officers and directors as a group (13 persons) |
|
4,364,894 |
|
6.53% |
*Less than 1% of our total outstanding ordinary shares.
(1)This information is based solely on a Schedule 13G filed by Alychlo NV and Marc Coucke with the SEC on February 14, 2022. Marc Coucke is the principal shareholder, chairman and managing director of Alychlo NV. The principal business address of each of the foregoing persons or entities is Lembergsesteenweg 19, 9820 Merelbeke, Belgium.
(2)This information is based solely on a Schedule 13G filed by Generation Investment Management LLP, Generation IM Sustainable Solutions GP III Limited, and Generation IM Sustainable Solutions Fund III, L.P. with the SEC on November 13, 2024. The principal business address of each of the foregoing entities is 20 Air Street, 7th floor, London, United Kingdom W1B 5AN.
(3)Based on information available to us, aMoon Growth Fund Limited Partnership holds voting and dispositive power over 5,139,917 shares and aMoon Edge Limited Partnership holds voting and dispositive power over 192,541 shares. The principal business address of each of the foregoing entities is 34 Yerushalaim Rd, Beit Gamla, 6th Floor Ra’anana, 4350110, Israel.
(4)This information is based solely on a Schedule 13G filed by Balderton Capital VI, S.L.P. with the SEC on February 20, 2024. Balderton Capital General Partner VI, S.a.r.l. is the managing general partner of Balderton Capital VI, S.L.P. and may be deemed to have voting, investment and dispositive power with respect to these securities. Adrian Rainey, Donatien-Xavier Martin and Marie Calinet are the managers of Balderton Capital General Partner VI, S.a.r.l. and may each be deemed to share voting, investment, and dispositive power with respect to these securities.
(5)The shares owned by the parties have been pledged pursuant to lending arrangements.
As of February 15, 2025, we had approximately 155 shareholders of record of our ordinary shares. We estimate that as of February 15, 2025, approximately 61.87% of our outstanding ordinary shares are held by 10 U.S. record holders. The actual number of shareholders is greater than this number of record holders and includes shareholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include shareholders whose shares may be held in trust or by other entities such as Cede & Co. as nominee for the Depository Trust Company.
B. Related Party Transactions
The following is a description of certain related party transactions we have entered into since January 1, 2024 with any of our executive officers and directors or their affiliates and holders of more than 10% of any class of our voting securities in the aggregate, which we refer to as related parties, other than compensation arrangements, which are described under “Item 6. Directors, Senior Management, and Employees—B. Compensation.”
Indemnification Agreements
We have entered into indemnification agreements with our executive officers and directors. The indemnification agreements and our articles of association require us to indemnify our executive officers and directors to the fullest extent permitted by law.
Related Person Transaction Policy
We have adopted a related person transaction policy. Our related person transaction policy states that any related person transaction must be approved or ratified by our audit committee or board of directors. In determining whether to approve or ratify a transaction with a related person, our audit committee or board of directors will consider all relevant facts and circumstances, including, without limitation, the commercial reasonableness of the terms of the transaction, the benefit and perceived benefit, or lack thereof, to us, the opportunity costs of an alternative transaction, the materiality and character of the related person’s direct or indirect interest and the actual or apparent conflict of interest of the related person. Our audit committee or board of directors will not approve or ratify a related person transaction unless it has determined that, upon consideration of all relevant information, such transaction is in, or not inconsistent with, our best interests and the best interests of our shareholders.
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information
Financial Statements
See “Item 18. Financial Statements,” which contains our financial statements prepared in accordance with IFRS Accounting Standards.
Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The results of litigation and claims cannot be predicted with certainty. As of the date of this Annual Report, we do not believe that we are party to any claim or litigation the outcome of which would, individually or in the aggregate, be reasonably expected to have a material adverse effect on our business.
Dividends and Dividend Policy
We have never declared or paid cash dividends on our share capital. We intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination related to dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions and business prospects and other factors our board of directors may deem relevant.The Perceptive Credit Agreement also limits our ability to pay dividends.
Under Swiss law, any dividend must be approved by our shareholders. In addition, our auditors must confirm that the dividend proposal of our board of directors to the shareholders conforms to Swiss statutory law and our articles of association. A Swiss corporation may pay dividends only if it has sufficient distributable profits from the previous business year (bénéfice de l’exercice) or brought forward from previous business years (report des bénéfices) or if it has distributable reserves (réserves à libre disposition), each as evidenced by its audited stand-alone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and its articles of association have been deducted.
Distributable reserves are generally booked either as free reserves (réserves libres) or as reserves from capital contributions (apports en capital). Distributions out of share capital, which is the aggregate par value of a corporation’s issued shares, may be made only by way of a share capital reduction. See “Item 10. Additional Information—B. Memorandum and Articles of Association.”
B. Significant Changes
There have been no significant changes in our business since the date of the annual financial statements, other than those described under “Item 4. Information on the Company—B. Business Overview.”
Item 9. The Offer and Listing
A. Offer and Listing Details
Our ordinary shares are listed on Nasdaq under the symbol “SOPH.” For a description of our ordinary shares, see “Item 10. Additional Information—B. Memorandum and Articles of Association.”
C. Markets
See “—A. Offer and Listing Details.”
Item 10. Additional Information
B. Memorandum and Articles of Association
See Exhibit 2.1 to this Annual Report for a description of our ordinary shares and Exhibit 1.1 to this Annual Report for a description of our articles of association.
C. Material Contracts
The following descriptions of our material agreements are not complete and are qualified in their entirety by reference to the full text of such agreements, which are filed as exhibits to this Annual Report and incorporated herein by reference.
License Agreements
Normandie Valorisation—Exclusive License Agreements
In March of 2018, we entered into an Exclusive License of Patents and Results (the “2018 Normandie Agreement”) with the University of Rouen Normandy, the Henri Becquerel Centre, INSERM Transfert SA (collectively, the “Co-Owners”) and Normandy University, acting through Normandie Valorisation, pursuant to which we obtained an exclusive, royalty-bearing, non-sublicensable license under certain patents related to methods for diagnosing hematological malignancies and an associated diagnostic kit to develop, manufacture and sell products for the diagnosis of acute myeloblastic leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia in the countries covered by the licensed patents.
In May 2019, we entered into an additional Exclusive License of Patents and Results (the “2019 Normandie Agreement”) with the same parties, pursuant to which we obtained an identical license under the same patents for products for the diagnosis of carcinomas other than acute myeloblastic leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia.
Under each agreement, we are obligated to act with a standard of care to develop, manufacture and sell the licensed products. Our failure to meet the standard of care requirement could subject us to a reduction of applicable territory or respective field of use by way of an amendment to the applicable agreement if (i) we have not marketed nor implemented necessary steps for the marketing of the applicable licensed products within a reasonable time following the end of the agreed-upon development plan for the commercialization of such products or (ii) our delay in executing the development plan exceeds a certain specified time. Pursuant to both agreements, Normandie Valorisation is responsible for the prosecution, maintenance and defense of the licensed patents.
Pursuant to the 2018 Normandie Agreement, we paid Normandie Valorisation a low five-digit Euro upfront fee and are obligated to pay to Normandie Valorisation a low-tens Euro fee per each analysis utilizing Myeloid Plus Solution (MYS+). Pursuant to the 2019 Normandie Agreement, we paid Normandie Valorisation a low five-digit Euro upfront fee and are obligated to pay Normandie Valorisation a mid-single-digit Euro fee per each analysis utilizing Solid Tumor Plus Solution (STS+).
The term of each agreement continues until the expiration of the last-to-expire licensed patent in September 2033, unless automatically terminated upon our cessation of business, bankruptcy or insolvency or upon the invalidation of the applicable licensed patents in France. In addition, Normandie Valorisation may terminate either agreement if we challenge the validity or enforceability of the licensed patents. Either party may terminate either agreement in the event of non-performance by the other party of one or more of its obligations under such agreement which is not cured within three months of receipt of written notice of such non-performance. Either party may also terminate the 2019 Normandie Agreement at any time, with one year’s prior written notice.
Collaboration Agreements
We have built an agnostic platform that enables others to get the most out of their data. As such, our model is valuable to all types of players within the health care ecosystem. For hardware and consumable players our platform and smart algorithms bring large benefits to their customer base as it allows for a more rapid set-up of their technology, better results in terms of clinical outcomes on the same hardware, bringing value to a larger number of samples and as such higher volumes.
We collaborate not only to provide valuable technologies to hospitals and laboratories around the world directly or through collaborators, but also to increase our channels and to offer a variety of application and product choices to our large customer base.
IDT—Manufacturing and Supply Agreement
In December 2015, we entered into a manufacturing and supply agreement with IDT for the manufacture and supply of various commercial and research products, in particular DNA enrichment kits. The agreement was amended and restated in October 2018 and amended in March 2019.
Under the agreement, IDT committed to manufacture and supply to us or directly to our customers, as applicable, various products, in particular DNA enrichment kits. IDT shall manufacture the products covered by this agreement in accordance with product specifications provided by us, (such products, “commercial products”). IDT is required to certify that the delivered products were manufactured in accordance with said specifications. In addition, we can purchase products already manufactured by IDT pursuant to its own specifications, (such products, “research products”) and resell such products to our customers and collaborators.
Purchase prices for both commercial and research products are set upon completion of the corresponding master specification document. We are obligated to provide IDT on a quarterly basis with written good faith non-binding purchasing forecasts of the aggregate quantities of commercial products to be purchased by us in the following twelve months and IDT is obligated to ensure sufficient inventory and manufacturing capacity to deliver the forecasted quantities. We are not required to purchase the commercial products from IDT in the previously forecasted quantities. However, if we fail to purchase a specified percentage of the forecasted quantities of commercial products, IDT will have the right to increase the prices of such products by amounts in excess of the additional manufacturing costs associated with our reduced purchase. At the same time, we have the right to place purchase orders for products beyond the previously forecasted quantities and IDT is obligated to use its commercially reasonable efforts to fill such orders at regular prices. We are not required to provide IDT with forecasts for research products that we intend to purchase in any given period. The purchase prices for such products are not adjustable based on the quantities actually ordered by us.
All inventions made directly as a result of the manufacture of commercial and research products that are improvements to such products will be owned by us. IDT will obtain a fully-paid up, royalty-free, worldwide license under such improvements to make, have made, use and sell the commercial and research products exclusively for and to us.
The agreement had an initial term of five years. It automatically renews for additional one-year periods unless a party notifies the other of its decision not to renew the agreement. We also have the right to terminate the agreement if we do not agree with changes made by IDT in accordance with the provisions of the agreement, including in connection with changes to master specification documents for any research or commercial product.
In addition, each party has the right to terminate the agreement effective immediately if the other party fails to meet essential terms of the agreement and such failure is not cured.
Qiagen—OEM Supply Agreement
In January 2018, we entered into an OEM supply agreement with Qiagen for the supply of certain amplification technologies required to complement our NGS technologies. The agreement was amended in June 2019.
Under the agreement, we receive the exclusive right to offer and resell the products manufactured by Qiagen as part of “bundle” solutions. We cannot offer such products as stand-alone or single items, unless it is required for product replacement or quality control reasons or in other special circumstances discussed by the parties in good faith. Qiagen is obligated to use its commercially reasonable efforts to manufacture and deliver products in quantities ordered by us. We are required to provide Qiagen in writing with a monthly rolling forecast covering the next six months. In addition, both parties shall meet at least once every quarter to discuss any adjustments to the forecast. Furthermore, we are obligated to purchase minimum quantities of products every year. If we fail to do so in any given calendar year, we will be obligated to make a one-time payment at the end of the year in an amount equal to the difference between the value of the products forecasted to be purchased in that year and the products actually purchased.
The agreement had an initial term of three years. It automatically extended for one two-year period followed by an additional one-year period, thereafter it automatically extends for one-year periods unless a party notifies the other of its decision not to renew the agreement. The parties may terminate the agreement effective immediately for cause or upon notice in certain situations.
New England Biolabs (“NEB”)—Supply Agreement
In January 2019, we entered into a supply agreement with NEB for the supply of various reagents. These products may only be used in the research field and in compliance with applicable intended use statements, limited use statements or limited label licenses.
We are required to provide NEB with twelve-months' rolling written forecasts of our estimated product supply requirements. The forecasts for the certain months of each twelve-month rolling period are binding, and the forecasts for the remaining months are non-binding and serve only as a good faith estimate to facilitate NEB’s production scheduling.
NEB shall not unreasonably reject any purchase order and shall use commercially reasonable efforts to fill purchase orders for any quantity of product that, alone or cumulatively with other purchase orders submitted to it for product delivery during the relevant calendar quarter, exceeds the amount specified in the binding portion of the then-current rolling forecast.
Prior to each shipment of products, NEB shall perform quality control procedures reasonably necessary to ensure that the products to be shipped conform fully to the specifications as agreed upon by us with NEB from time to time.
The agreement had an initial term of three years. It has been automatically extended for two additional two-year periods and thereafter it will automatically extend for successive two-year periods, unless either party notifies the other party in writing at least six months prior to the expiration of the then-current term that such party does not wish to continue the agreement.
Watchmaker Genomics, Inc. (“Watchmaker”)— OEM Supply Agreement
In December 2021, we entered into an OEM supply agreement with Watchmaker for the supply of certain components embedded into our library preparation kits. Under the agreement, we receive the non-exclusive right to offer and resell the products manufactured by Watchmaker as part of “bundle” solutions worldwide. We cannot offer such products as stand-alone items or as components of products other than our library preparation kits. Watchmaker is obligated to use its commercially reasonable efforts to manufacture and deliver products in quantities ordered by us.
We are required to provide Watchmaker in writing with a rolling four-quarter forecast on a quarterly basis, which serve as a good faith estimate to facilitate Watchmaker’s production scheduling and solely impact delivery dates.
The agreement has an initial term of five years. It will renew automatically for one-year periods unless a party notifies the other of its decision not to renew. The parties may terminate the agreement for cause on 30-day prior notice. We may terminate the agreement on 60-day prior notice in the event the company might be prevented from manufacturing or selling “bundle” solutions.
Microsoft—Strategic Framework Agreement
We entered into a multi-year integrated strategic partnership agreement with Microsoft to improve healthcare workflows globally by enabling multimodal data curation, development, and deployment. Pursuant to the amendment to our original agreement, effective as of November 1, 2022, we committed to buy products and services from the Microsoft Azure suite of offerings for an aggregate amount of approximately $70.7 million over a five-year period in exchange for (i) discounted pricing, (ii) a twelve-month Azure credit for a value of approximately $1.8 million and (iii) the provision by Microsoft of additional consulting and product support services at no cost for SOPHiA GENETICS as part of Microsoft’s “End-Customer Investment Funding” program, for a value of approximately $1.3 million.
Microsoft may terminate the agreement for cause on 30-day prior notice. None of the parties may terminate the agreement for convenience prior to the coverage period.
Debt Agreements
Perceptive—Credit Agreement
On May 2, 2024 (the “Closing Date”), SOPHiA GENETICS SA and our subsidiary SOPHiA GENETICS, Inc. entered into a credit agreement (the “Perceptive Credit Agreement”) and related guaranty with Perceptive Credit Holdings IV, LP, as lender and administrative agent, pursuant to which we may borrow up to $50.0 million principal amount of term loans, including (i) an initial tranche of $15.0 million principal amount of term loans on the closing date and (ii) up to $35.0 million principal amount of term loans that we may draw upon on or prior to March 31, 2026, subject to satisfaction of certain customary conditions. The term loans are scheduled to mature on the fifth anniversary of the Closing Date and accrue interest at Term SOFR (Secured Overnight Financing Rate) plus 6.25% per annum; provided that upon the occurrence and during the continuation of any event of default, the term loans will accrue interest at Term SOFR plus 9.25% per annum. We have the right to prepay the term loans at any time subject to applicable prepayment premiums.
The Perceptive Credit Agreement also contains certain mandatory prepayment provisions, including prepayments from the proceeds from certain asset sales and casualty events (subject to a right to reinvest such proceeds in assets used in our business within 180 days) and from issuances or incurrences of non-permitted debt, which will also be subject to prepayment premiums. The obligations under the Perceptive Credit Agreement are secured by substantially all of SOPHiA GENETICS SA’s and certain of its subsidiaries’ assets and are guaranteed initially on the closing date by SOPHiA GENETICS SA and SOPHiA GENETICS, Inc. The Perceptive Credit Agreement contains customary covenants, including an affirmative covenant to maintain qualified cash of at least $3.0 million, an affirmative last twelve months revenue covenant tested on a quarterly basis, and negative covenants including limitations on indebtedness, liens, fundamental changes, asset sales, investments, dividends and other restricted payments and other matters customarily restricted in such agreements. The Perceptive Credit Agreement also contains customary events of default, including payment defaults, material inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against us and our subsidiaries and change in control, the occurrence of which gives the lenders the right to declare the term loans and all obligations under the Perceptive Credit Agreement immediately due and payable.
In addition, we issued to Perceptive Credit Holdings IV, LP a warrant certificate (the “Warrant Certificate”) representing the right to purchase up to 400,000 ordinary shares at $4.9992 per share, with the right to purchase 200,000 ordinary shares available immediately and the right to purchase an additional 200,000 ordinary shares to be available upon the drawdown of the second tranche of the term loans.
The purchase rights represented by the Warrant Certificate are exercisable after becoming available, on a cash basis, at the option of the holder at any time prior to 5:00 p.m., Eastern time on the tenth anniversary of the applicable date of availability. The Warrant Certificate contains customary anti-dilution adjustments.
Lease Agreements
Swisscanto Anlagestiftung—Lease Agreement
We entered into a lease agreement with Swisscanto Anlagestiftung, Zürich for our new offices in Rolle, effective as of July 1st, 2021, for a ten-year term ending on June 30th, 2031. The lease in total is for approximately 65,860 square feet, and comprises our headquarters of office space and laboratory facilities. We may terminate the lease agreement after eight years, subject to a 12-month prior notice and liquidated damages. Conversely, we have a right to request the extension of the term under similar terms no later than fourteen months prior to the initial term. The base rent amounts to approximately $1.14 million per year from 2024 onward and is indexed on Swiss Consumer Price Index as published by Swiss Federal Statistical Office. Payment obligations under the lease agreement are secured by bank guarantees. We are prohibited from subleasing all or part of the leased surface or to transfer the lease to a third-party without the lessor’s prior consent. The parties may terminate the agreement for cause on 30-day prior notice. Upon expiry of the lease, we may leave the facilities “as is”, except for the laboratory which must be dismantled, unless otherwise agreed with the lessor.
D. Exchange Controls
There are no Swiss governmental laws, decrees or regulations that restrict, in a manner material to us, the export or import of capital, including any foreign exchange controls, or that generally affect the remittance of dividends or other payments to non-residents or non-citizens of Switzerland who hold our ordinary shares.
E. Taxation
The following discussion is based on the tax laws, regulations, and regulatory practices of Switzerland and the United States as in effect on the date hereof, which are subject to change (or subject to changes in interpretation), possibly with retroactive effect.
Current and prospective shareholders are advised to consult their own tax advisors in light of their particular circumstances as to the Swiss or U.S. tax laws, regulations and regulatory practices that could be relevant for them, the acquiring, owning and selling or otherwise disposing of our ordinary shares and receiving dividends and similar cash or in-kind distributions on our ordinary shares (including dividends on liquidation proceeds and share dividends) or distributions on our ordinary shares based upon a capital reduction or reserves paid out of capital contributions and the consequences thereof under the tax laws, regulations, and regulatory practices of Switzerland or the United States.
Swiss Tax Considerations
Swiss Federal Withholding Tax
Dividends and other cash or in-kind distributions (including scrip or stock dividends), if any, on ordinary shares made or paid by us out of reserves from capital contributions (réserves d’apports de capital) and distributions, if any, on ordinary shares made or paid by us based upon a reduction of nominal value of ordinary shares (réduction de la valeur nominale) and the purchase price for ordinary shares bought back, if any, by us for a capital reduction booked against reserves from capital contributions and nominal value of ordinary shares, are exempt from Swiss federal withholding tax. The proceeds from the offering of the ordinary shares (net of certain deductions) will qualify as reserves from capital contributions and as nominal value of the ordinary shares.
Dividends and other cash or in-kind distributions (including scrip or stock dividends), if any, on ordinary shares made or paid by us out of profit or reserves other than reserves from capital contributions and the purchase price for ordinary shares bought back, if any, by us for a capital reduction booked against reserves other than reserves from capital contributions, are subject to Swiss federal withholding tax at a rate of 35%. Any Swiss federal withholding tax must be withheld by us on the gross amount of the dividend or distribution or purchase price, as applicable, and be remitted to the Swiss Federal Tax Administration.
Capital gains realized on the sale of ordinary shares in the secondary market are not subject to Swiss federal withholding tax.
Refund of Withholding Tax on Taxable Distributions
The Swiss Federal Tax Administration or the relevant cantonal tax authority, as applicable, will refund or credit Swiss federal withholding tax on dividends or other cash or in-kind distributions (including scrip or stock dividends), if any, on ordinary shares made or paid by us, or the purchase price paid by us for ordinary shares bought back, if any, for a capital reduction, out of or against profit or reserves other than tax-exempt reserves from capital contributions in full to holders who are individuals resident in Switzerland and to holders, who hold the ordinary shares on which the dividends or other distributions have been paid, as part of a trade or business in Switzerland, and, who, in each case, inter alia, are the beneficial owners of the ordinary shares and duly report the dividend or distributions or the purchase price paid by us for ordinary shares bought back for a capital reduction in the income tax return or the financial statements, respectively, for the relevant tax period.
A holder who is a resident of the U.S. for purposes of the double taxation agreement between the U.S. and Switzerland (the “Treaty”) without taxable presence in Switzerland to which the ordinary shares are attributable or who is a qualified U.S. pension fund and who, in each case, is the beneficial owner of the ordinary shares and the dividend or distribution and who meets the conditions of the Treaty may apply for a full refund of the Swiss federal withholding tax in the case of qualified U.S. pension funds or in excess of the amount of the 15% treaty rate in all other cases. The claim for refund must be filed on Swiss Tax Form 82 (82C for corporations, 82I for individuals, 82E for other entities and 82R for regulated investment companies), which forms together with an instruction form may be obtained from any Swiss consulate general in the U.S., the Swiss Federal Tax Administration at the address below or be downloaded from the Swiss Federal Tax Administration’s website. Four copies of the form must be duly completed and signed before a notary public of the U.S., and three of them must be sent to the Swiss Federal Tax Administration (currently at Eigerstrasse 65, CH-3003, Bern, Switzerland). The form must be accompanied by suitable evidence of deduction of the Swiss federal withholding tax, such as certificates of deduction, bank vouchers or credit slips. The form must be filed no later than December 31 of the third year following the calendar year in which the dividend subject to the tax became payable.
Any other holder who is not resident in Switzerland and who does not hold the ordinary shares as part of a trade or business in Switzerland, may be entitled to a full or partial refund of the Swiss federal withholding tax deducted if the country in which the recipient resides for tax purposes has entered into a bilateral treaty for the avoidance of double taxation with Switzerland, the recipient is the beneficial owner of the ordinary shares and the dividend or distribution or the purchase price and the other conditions of the treaty are met. Refund forms are available on the Swiss Federal Tax Administration’s website.
Swiss Federal Issue Stamp Tax
We will be liable to Swiss federal issue stamp tax on the issuance (droit d’émission sur capital propre) of the ordinary shares of 1% of the proceeds from the offering, net of certain deductions.
Swiss Federal Securities Turnover Tax
The delivery of ordinary shares to the initial purchasers of the ordinary shares against payment of the offer price will not be subject to Swiss securities turnover tax (droit de négociation).
Any subsequent transactions in ordinary shares in the secondary markets are subject to Swiss federal securities turnover tax at a rate of 0.15% of the purchase price of the ordinary shares if a Swiss or Liechtenstein domestic bank or securities dealer (as defined in the Swiss Federal Stamp Tax Act) is a party or an intermediary to the transaction, and none of the exemptions provided for in the Swiss Federal Stamp Tax Act applies. Generally, half of the tax is charged to the one party to the transaction and the other half to the other party, subject to applicable statutory exemptions in respect of the one or the other party to the transaction and their respective halves of the tax. Secondary market dealings in ordinary shares where no domestic bank or securities dealer is a party or an intermediary to the transaction are not subject to Swiss federal securities turnover tax.
Swiss Federal, Cantonal, and Communal Income Taxes
Ordinary Shares Held By Holders Resident Outside of Switzerland and With No Trade or Business in Switzerland
Holders of ordinary shares who are not residents of Switzerland for tax purposes, and who during the taxable year have not held ordinary shares through a permanent establishment within Switzerland for tax purposes, are not subject to any Swiss federal, cantonal or communal income tax in respect of the receipt of dividends, or other distributions, if any, on ordinary shares, or gain realized on the sale or other disposition of ordinary shares.
For a discussion of the Swiss federal withholding tax treatment of dividends and distributions or capital gains on ordinary shares, see above “—Swiss Federal Withholding Tax.” For a discussion of the automatic exchange of information in tax matters, see below “—International Automatic Exchange of Information in Tax Matters” and for a discussion of the Swiss facilitation of the implementation of the Foreign Account Tax Compliance Act (FATCA), see below “—Swiss Facilitation of the Implementation of FATCA.”
Ordinary Shares Held By Swiss Resident Individuals as Private Investments
Dividends and other cash or in-kind distributions (including scrip or stock dividends), if any, on ordinary shares, to the extent made or paid by us out of reserves from capital contributions and distributions, if any, to the extent made or paid by us on ordinary shares based upon a capital reduction, and the purchase price of ordinary shares bought back for a capital reduction charged to reserves from capital contributions are exempt from Swiss federal, cantonal, and communal income tax for holders of ordinary shares who are individuals resident in Switzerland for tax purposes and who hold the ordinary shares as private investments.
Conversely, any dividends and other cash or in-kind distributions (including scrip or stock dividends), if any, on ordinary shares to the extent made or paid by us out of profit and reserves other than reserves from capital contributions, and the purchase price for ordinary shares bought back, if any, by us for a capital reduction to the extent booked against reserves other than reserves from capital contributions, will be subject to Swiss federal, cantonal, and communal taxable income for such holders.
A capital gain realized by a holder on the sale of ordinary shares (other than a sale to us in a share buy-back for capital reduction) held as private investments classifies as tax-exempt private capital gain and, vice versa, a capital loss as non-tax deductible private capital loss for purposes of Swiss federal, cantonal, and communal income tax.
See below “—Ordinary shares held as assets of a Swiss business” for a summary of the taxation treatment of Swiss resident individuals who, for income tax purposes, are classified as “professional securities dealers.”
Ordinary Shares Held as Assets of a Swiss Business
For a corporation or an individual who holds the ordinary shares as part of a trade or business carried on in Switzerland, any dividends and any other distributions, if any, made or paid by us on ordinary shares, and any capital gain or loss realized on the sale of ordinary shares, are includable in, or deductible from, respectively, the taxable income in the relevant taxation period for purposes of Swiss federal, cantonal, and communal individual or corporate income tax. This taxation treatment also applies to Swiss resident private individuals who, for income tax purposes, are classified as “professional securities dealers.”
Corporate taxpayers will be eligible for dividend relief (réduction pour participations) in respect of dividends and distributions, if any, on ordinary shares if either the market value of the ordinary shares held by them equals or exceeds CHF 1.0 million or the ordinary shares represent 10% or more of our share capital.
International Automatic Exchange of Information in Tax Matters
Switzerland has concluded a multilateral agreement with the EU on the international automatic exchange of information (“AEOI”) in tax matters, which applies to all EU member states. In addition, Switzerland signed the multilateral competent authority agreement on the automatic exchange of financial account information (the “MCAA”) and a number of bilateral AEOI agreements with other countries, most of them on the basis of the MCAA. Based on these agreements and the implementing laws of Switzerland, Switzerland collects and exchanges data in respect of financial assets held in, and income derived thereon and credited to, accounts or deposits (including ordinary shares held in such accounts or deposits) with a paying agent in Switzerland for the benefit of individuals resident in an EU member state or in another treaty state.
An up-to-date list of the AEOI agreements to which Switzerland is a party that are in effect, or signed but not yet in effect, can be found on the website of the State Secretariat for International Financial Matters.
Swiss Facilitation of the Implementation of FATCA
The United States and Switzerland entered into an intergovernmental agreement (the “U.S.-Switzerland IGA”) to facilitate the implementation of FATCA. Under the U.S.-Switzerland IGA, financial institutions acting out of Switzerland generally are directed to become participating foreign financial institutions. The U.S.-Switzerland IGA ensures that accounts held by U.S. persons with Swiss financial institutions (including accounts in which ordinary shares are held) are disclosed to the U.S. tax authorities either with the consent of the account holder or by means of group requests within the scope of administrative assistance, on the basis of the Treaty. The Treaty, as amended in 2019, includes a mechanism for the exchange of information in tax matters upon request between Switzerland and the United States, which is in line with international standards, and allows the United States to make group requests under FATCA concerning non-consenting U.S. accounts and non-participating foreign financial institutions for periods from June 30, 2014. Furthermore, the Swiss Federal Council approved a mandate for negotiations with the United States on October 8, 2014, with regard to a change from the current direct-notification-based regime to a regime where the relevant information is sent to the Swiss Federal Tax Administration, which in turn provides the information to the U.S. tax authorities. On June 27, 2024, Switzerland and the United States negotiated and signed the mandate adopted on October 8, 2014 (Model 1 of the FATCA agreement), which provides for the reciprocal automatic exchange of information between Switzerland and the U.S. The implementation of this new mandate is to be enforced starting January 1, 2027.
Material U.S. Federal Income Tax Consequences for U.S. Holders
The following is a description of the material U.S. federal income tax consequences to U.S. Holders, as defined below, of owning and disposing of our ordinary shares. It does not describe all tax consequences that may be relevant to a particular person’s decision to acquire ordinary shares.
This discussion applies only to a U.S. Holder that holds ordinary shares as capital assets for U.S. federal income tax purposes within the meaning of Section 1221 of the Code (generally, property held for investment). In addition, it does not describe any tax consequences other than U.S. federal income tax consequences, including state and local tax consequences and estate or gift tax consequences, and does not describe all of the U.S. federal income tax consequences that may be relevant in light of the U.S. Holder’s particular circumstances, including alternative minimum tax consequences, the special tax accounting rules under Section 451(b) of the Code, the potential application of the Medicare contribution tax on net investment income, and tax consequences applicable to U.S. Holders subject to special rules, such as:
•certain banks, insurance companies, and other financial institutions;
•brokers, dealers, or traders in securities who use a mark-to-market method of tax accounting;
•persons holding ordinary shares as part of a straddle, wash sale, conversion transaction or other integrated transaction, or persons entering into a constructive sale with respect to the ordinary shares;
•persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar;
•entities or arrangements classified as partnerships or S corporations for U.S. federal income tax purposes and investors in such entities;
•tax-exempt entities, including an “individual retirement account” or “Roth IRA” or governmental entities;
•real estate investment trusts or regulated investment companies;
•former U.S. citizens or long-term residents of the United States;
•persons that own or are deemed to own 10% or more of the voting power or value of our shares; or
•persons holding ordinary shares in connection with a trade or business conducted outside of the United States or in connection with a permanent establishment or other fixed place of business outside of the United States.
If an entity or arrangement that is classified as a partnership for U.S. federal income tax purposes holds ordinary shares, the U.S. federal income tax treatment of a partner will generally depend on the status of the partner and the activities of the partnership. Partnerships holding ordinary shares and partners in such partnerships should consult their tax advisors as to the particular U.S. federal income tax consequences of owning and disposing of the ordinary shares in their particular circumstances.
This discussion is based on the Code, administrative pronouncements, judicial decisions, final, temporary and proposed Treasury regulations, and the Treaty, all as of the date hereof, any of which is subject to change or differing interpretations, possibly with retroactive effect.
A “U.S. Holder” is a holder who, for U.S. federal income tax purposes, is a beneficial owner of ordinary shares, who is eligible for the benefits of the Treaty and who is:
•an individual who is a citizen or resident of the United States;
•a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia; or
•an estate or trust, the income of which is subject to U.S. federal income taxation regardless of its source.
U.S. Holders should consult their tax advisors concerning the U.S. federal, state, local, and non-U.S. tax consequences of owning and disposing of ordinary shares in their particular circumstances.
Treasury regulations that apply to taxable years beginning on or after December 28, 2021 (the “Foreign Tax Credit Regulations”), may in some circumstances prohibit a U.S. person from claiming a foreign tax credit with respect to certain non-U.S. taxes that are not creditable under applicable income tax treaties. Accordingly, U.S. investors that are not eligible for Treaty benefits should consult their tax advisors regarding the creditability or deductibility of any Swiss taxes imposed on dividends on, or dispositions of, the ordinary shares. The discussions below regarding the creditability or deductibility of Swiss taxes, if any, do not apply to investors in this special situation. However, the Internal Revenue Service released a notice that provides relief from certain
of the provisions of the Treasury regulations described above for taxable years ending before the date that a
notice or other guidance withdrawing or modifying the temporary relief is issued (or any later date specified in
such notice or other guidance).
Passive Foreign Investment Company Rules
Under the Code, we will be a PFIC for any taxable year in which, after the application of certain “look-through” rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production of, “passive income.” For purposes of the above calculations, we will be treated as if we hold our proportionate share of the assets of, and receive directly our proportionate share of the income of, any other corporation in which we directly or indirectly own at least 25%, by value, of the shares of such corporation. Passive income generally includes dividends, interest, rents, certain non-active royalties and capital gains.
Cash is generally characterized as a passive asset for these purposes. Goodwill, is generally characterized as a non-passive or passive asset based on the nature of the income produced in the activity to which the goodwill is attributable. The extent to which our goodwill should be characterized as a non-passive asset is not entirely clear. We hold a substantial amount of cash, and while this continues to be the case our PFIC status for any taxable year will depend largely on the value of our goodwill and the characterization of our goodwill as passive or non-passive. The value of our goodwill for any taxable year may be determined in large part by reference to the average of our market capitalization for that year.
Although we believe that we were a PFIC for our 2022 taxable year, based the nature of our operations and assets, as well as certain as to our income and the relative values of our assets during our 2023 and 2024 taxable years, we believe that we were not a PFIC for our 2023 and 2024 taxable years (subject to the discussion in the next paragraph with respect to U.S. Holders who held our ordinary shares during our 2022 taxable year). There can be no assurance that the IRS will agree with our conclusion. In addition, we have not obtained any valuation of our assets (including goodwill). U.S. Holders should consult their tax advisors regarding the value and characterization of our assets for purposes of the PFIC rules, which are subject to some uncertainties. In addition, our PFIC status is a factual annual determination that can be made only after the end of the relevant taxable year and will depend on the composition of our income and assets and the value of our assets from time to time. Accordingly, our PFIC status for 2025 and any future taxable year is uncertain.
If we are a PFIC for any year during which a U.S. Holder holds ordinary shares, we would generally continue to be treated as a PFIC with respect to such holder for all succeeding years during which such holder holds ordinary shares, even if we ceased to meet the threshold requirements for PFIC status. Accordingly, since we believe that we were a PFIC for our 2022 taxable year, we believe that we will remain a PFIC with respect to a U.S. Holder that held our ordinary shares during our 2022 taxable year. U.S. Holders should consult their tax advisors regarding the advisability of making a “deemed sale” election that will allow them to eliminate the continuing PFIC status under certain circumstances, but may require them to recognize gain taxed under the general PFIC rules described in this section. Additionally, in the event that the U.S. Holder made a qualified electing fund (“QEF”) or mark to market election (as described below) for the year that we were a PFIC, special rules may apply that mitigate the rules described in this paragraph.
If we were a PFIC for any taxable year and any of our subsidiaries or other companies in which we owned or were treated as owning equity interests were also a PFIC (any such entity, a “Lower-tier PFIC”), a U.S. Holder would be deemed to own a proportionate amount (by value) of the shares of each Lower-tier PFIC and would be subject to U.S. federal income tax according to the rules described in the subsequent paragraph on (i) certain distributions by a Lower-tier PFIC and (ii) dispositions of shares of Lower-tier PFICs, in each case as if such holder held such shares directly, even though such holder will not have received the proceeds of those distributions or dispositions.
If we are a PFIC for any taxable year during which a U.S. Holder holds any of our ordinary shares, such holder will generally be subject to adverse tax consequences. Unless a U.S. Holder makes a timely “mark to market” election or QEF election, each as discussed below, gain recognized upon a disposition (including, under certain circumstances, a pledge) of ordinary shares will be allocated ratably over a U.S. Holder’s holding period for the ordinary shares. The amounts allocated to the taxable year of disposition and to years before we became a PFIC will be taxed as ordinary income. The amount allocated to each other taxable year will be subject to tax at the highest rate in effect for that taxable year for individuals or corporations, as appropriate, and an interest charge will be imposed on the tax on such amount. Further, to the extent that any distributions received on a U.S. Holder’s ordinary shares during a taxable year exceed 125% of the average of the annual distributions on those shares during the preceding three years or such holder’s holding period, whichever is shorter, those distributions will be subject to taxation in the same manner as gain, described immediately above.
Alternatively, if we are a PFIC and if the ordinary shares are “regularly traded” on a “qualified exchange,” a U.S. Holder will be eligible to make a mark-to-market election that will result in tax treatment different from the general tax treatment for PFICs described above. The ordinary shares will be treated as “regularly traded” if more than a de minimis amount of the ordinary shares are traded on a qualified exchange on at least 15 days during each calendar quarter (the “15-Day Test”). The Nasdaq, on which the ordinary shares are listed, is a qualified exchange for this purpose. Once made, the election cannot be revoked without the consent of the IRS unless the shares cease to be marketable.
If a U.S. Holder makes the mark-to-market election, such holder will generally recognize as ordinary income any excess of the fair market value of such holder’s ordinary shares at the end of each taxable year over their adjusted tax basis, and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of the ordinary shares over their fair market value at the end of the taxable year (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. Holder makes the election, such holder’s tax basis in their ordinary shares will be adjusted to reflect these income or loss amounts. Any gain recognized on the sale or other disposition of ordinary shares in a year when we are a PFIC will be treated as ordinary income and any loss will be treated as an ordinary loss (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). This election will not apply to any of our non-U.S. subsidiaries. Accordingly, a U.S. Holder may continue to be subject to tax under the PFIC excess distribution regime with respect to any Lower-tier PFICs notwithstanding a mark-to-market election for the ordinary shares.
In addition, if we are a PFIC for any taxable year in which we pay a dividend or for the prior taxable year, the preferential dividend rates discussed below with respect to dividends paid to certain non-corporate U.S. Holders will not apply.
If a company that is a PFIC provides certain information to U.S. Holders, a U.S. Holder can then avoid certain adverse tax consequences described above by making a QEF election to be taxed currently on its proportionate share of the PFIC’s ordinary income and net capital gains.
The QEF election is made on a shareholder-by-shareholder basis and, once made, can be revoked only with the consent of the IRS. A U.S. Holder generally makes a QEF election by attaching a completed IRS Form 8621, including the information provided in a PFIC Annual Information Statement, to a timely filed U.S. federal income tax return for the taxable year to which the election relates. U.S. Holders should consult their tax advisors regarding the availability and tax consequences of a retroactive QEF election under their particular circumstances. In order to comply with the requirements of a QEF election, a U.S. Holder must receive a PFIC Annual Information Statement from us.
If a U.S. Holder owns ordinary shares during any year in which we are a PFIC, such holder must generally file annual reports containing such information as the U.S. Treasury may require on IRS Form 8621 (or any successor form) with respect to us, generally with such holder’s federal income tax return for that year.
The rules dealing with PFICs and with the mark-to-market and QEF elections are complex and are affected by various factors in addition to those described above. Accordingly, U.S. Holders should consult their tax advisors concerning the application of the PFIC rules to our ordinary share under their particular circumstances. As discussed above, special rules may apply if a U.S. Holder made a QEF election with respect to our 2022 taxable year. U.S. Holders who made a QEF election for our 2022 taxable year should consult their tax advisors.
Information Returns
If a U.S. Holder owns ordinary shares during any year in which we are a PFIC or in which we hold a direct or indirect equity interest in a Lower-tier PFIC, the U.S. Holder generally must file an annual report on IRS Form 8621 with respect to each such PFIC containing such information as the U.S. Treasury may require, generally with the U.S. Holder’s U.S. federal income tax return for the relevant year. A U.S. Holder’s failure to file the annual report will cause the statute of limitations for such U.S. Holder’s U.S. federal income tax return to remain open with respect to the items required to be included in such report until three years after the U.S. Holder files the annual report and, unless such failure is due to reasonable cause and not willful neglect, the statute of limitations for the U.S. Holder’s entire U.S. federal income tax return will remain open during such period.
PROSPECTIVE U.S. HOLDERS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE CONSEQUENCES OF OUR POTENTIAL PFIC STATUS ON AN INVESTMENT IN ORDINARY SHARES.
Taxation of Distributions
The following is subject to the discussion regarding the PFIC rules described above.
As discussed above under “Item 8. Financial Information— A. Consolidated Statements and Other Financial Information—Dividends and Dividend Policy,” we do not currently expect to make distributions on our ordinary shares. In the event that we do make distributions of cash or other property, distributions paid on ordinary shares, other than certain pro rata distributions of ordinary shares, will generally be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we do not maintain calculations of our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders as dividends. For so long as our ordinary shares are listed on the Nasdaq or we are eligible for benefits under the Treaty, dividends paid to certain non-corporate U.S. Holders will be eligible for taxation as “qualified dividend income” and therefore, subject to applicable holding period requirements, will be taxable at rates not in excess of the long-term capital gain rate applicable to such U.S. Holder.
The amount of a dividend will include any amounts withheld by us in respect of Swiss income taxes. The amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will be included in a U.S. Holder’s income on the date of the U.S. Holder’s receipt of the dividend. The amount of any dividend income paid in Swiss francs will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars at that time. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt.
Subject to applicable limitations, some of which vary depending upon the U.S. Holder’s particular circumstances, Swiss income taxes withheld from dividends on ordinary shares (at a rate not exceeding the rate provided by the Treaty) may be creditable against the U.S. Holder’s U.S. federal income tax liability. The rules governing foreign tax credits are complex and U.S. Holders should consult their tax advisors regarding the creditability of foreign taxes in their particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including any Swiss income tax, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year.
Sale or Other Disposition of Ordinary Shares
The following is subject to the discussion regarding the PFIC rules described above.
Gain or loss realized by a U.S. Holder on the sale or other disposition of ordinary shares will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder’s holding period for such ordinary shares was more than one year as of the date of the sale or other disposition. The amount of the gain or loss will equal the difference between the U.S. Holder’s tax basis in the ordinary shares disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. Long-term capital gain recognized by a non-corporate U.S. Holder is subject to U.S. federal income tax at rates lower than the rates applicable to ordinary income and short-term capital gains, while short-term capital gains are subject to U.S. federal income tax at the rates applicable to ordinary income. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to various limitations.
Information Reporting and Backup Withholding
Payments of dividends and sales proceeds that are made within the United States or through certain U.S.-related financial intermediaries generally are subject to information reporting, and may be subject to backup withholding, unless (i) the U.S. Holder is a corporation or other exempt recipient or (ii) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and certifies that it is not subject to backup withholding.
The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against the U.S. Holder’s U.S. federal income tax liability and may entitle it to a refund, provided that the required information is timely furnished to the IRS.
Information with Respect to Foreign Financial Assets
Certain U.S. Holders who are individuals (and, under proposed regulations, certain entities) may be required to report information relating to an interest in our ordinary shares, subject to certain exceptions (including an exception for ordinary shares held in accounts maintained by certain U.S. financial institutions). Such U.S. Holders who fail to timely furnish the required information may be subject to a penalty. Additionally, if a U.S. Holder does not file the required information, the statute of limitations with respect to tax returns of the U.S. Holder to which the information relates may not close until three years after such information is filed. U.S. Holders should consult their tax advisors regarding the effect, if any, of this legislation on their ownership and disposition of the ordinary shares.
H. Documents on Display
We are subject to the informational requirements of the Exchange Act. Accordingly, we file reports and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains an Internet site at www.sec.gov that contains reports, proxy and information statements and other information we have filed electronically with the SEC. As a foreign private issuer, we are exempt under the Exchange Act from, among other things, the rules prescribing the furnishing and content of proxy statements, and our executive officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act.
Additionally, pursuant to Swiss law, any shareholder of record has the right to receive a free copy of this Annual Report and to inspect this Annual Report at any time at our registered office in Rolle, Canton of Vaud, Switzerland.
We also make available on our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Our website address is www.sophiagenetics.com. The reference to our website is an inactive textual reference only, and information contained therein or connected thereto is not incorporated into this Annual Report.
J. Annual Report to Security Holders
If we are required to provide an annual report to security holders in response to the requirements of Form 6-K, we will submit the annual report to security holders in electronic format in accordance with the EDGAR Filer Manual.
Item 11. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We had cash and cash equivalents totaling $80.2 million and $123.3 million as of December 31, 2024 and 2023, respectively, which are comprised of money market funds and bank and short-term deposits with maturities up to three months. Our cash and cash equivalents are subject to market risk due to changes in interest rates. Fixed rate securities may have their market value adversely affected due to a rise in interest rates. Due in part to these factors, our future investment income may fall short of expectation due to changes in interest rates or we may suffer losses in principal if we are forced to sell securities that decline in market value due to changes in interest rates.
As of December 31, 2024, we currently have $15.0 million of debt outstanding under the Perceptive Credit Agreement. Based on the terms of the Perceptive Credit Agreement, the monthly interest expense fluctuates based on the SOFR reference rate that is two business days prior to the first day of the preceding calendar month. Given our outstanding debt under this agreement, we are subject to interest rate risk related to debt obligations if the SOFR were to move significantly.
We do not believe that a hypothetical 100 basis points change in interest rates would have a material effect on our business, financial condition, or results of operations. We do not enter into investments for trading or speculative purposes. We do not use any financial instruments to manage our interest rate risk exposure.
Foreign Exchange Risk
We operate internationally and a portion of our revenue, expenses, assets, liabilities, and cash flows are denominated in currencies other than our presentation currency. As a result, we are exposed to fluctuations in foreign exchange rates.
The sensitivity of our income to possible changes in foreign exchange rates is measured at the local entity level as it depends on the functional currency of each entity. For the years ended December 31, 2024 and 2023, we were exposed principally to movements in four cross-currency pairs.
The sensitivity of our loss before tax to such changes was as follows:
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December 31, |
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2024 |
|
2023 |
|
2022 |
| Increase / (decrease) in USD/CHF exchange rate by 10% |
|
562 |
|
/ |
(562) |
|
3,034 |
|
/ |
(3,034) |
|
6,614 |
|
/ |
(6,614) |
| Increase / (decrease) in EUR/CHF exchange rate by 10% |
|
(75) |
|
/ |
75 |
|
508 |
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/ |
(508) |
|
(94) |
|
/ |
94 |
| Increase / (decrease) in GBP/CHF exchange rate by 10% |
|
25 |
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/ |
(25) |
|
(23) |
|
/ |
23 |
|
(83) |
|
/ |
83 |
| Increase / (decrease) in USD/EUR exchange rate by 10% |
|
(2,605) |
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/ |
2,605 |
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(513) |
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/ |
513 |
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503 |
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/ |
(503) |
We do not believe that foreign exchange risk associated with other cross-currency pairs is material to our business, financial condition or results of operations.
Credit Risk
We are exposed to credit risk from our operating activities, primarily trade receivables. Credit risk is the risk that a counterparty will be unable to meet its obligations under a financial instrument or customer contract. Allowance is made for lifetime expected credit losses as invoices are issued. The amount of allowance initially recognized is based on historical experience, tempered by expected changes in future cash collections, due to, for example, expected improved customer liquidity or more active credit management.
We do not believe that credit risk had a material effect on our business, financial condition, or results of operations. The largest outstanding balance represented 18% of trade and other receivables in 2024, which is attributable to one of our biopharma customers. This is due to a large invoice related to significant portions of contracts completed as of December 2024.The customer is one of the largest biopharma firms in the world and has a strong payment history and is in good standing with us. Our cash and cash equivalents are deposited with reputable financial institutions. If customers representing a significant percentage of our trade receivables are unable to meet their payment obligations to us, we may suffer harm to our business, financial condition, or results of operations.
Inflation Risk
We believe our business is able to pass along increases in the costs of providing our applications, products, and services caused by inflation by increasing the prices of our applications, products, and services. For multi-year contracts, our general terms and conditions allow us to increase prices, at minimum on an annual basis. However, we do not believe that inflation had a material effect on our business, financial condition, or results of operations. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition or results of operations.
Item 12. Description of Securities Other than Equity Securities
Not applicable.
PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies.
None.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
On July 22, 2021, the SEC declared effective our Registration Statement on Form F-1 (No. 333-257646) filed in connection with our initial public offering. J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Cowen and Company, LLC and Credit Suisse Securities (USA) LLC acted as underwriters in the initial public offering. In the initial public offering, we issued and sold a total of 13,519,493 ordinary shares, including 519,493 ordinary shares pursuant to the underwriters’ exercise of their option to purchase additional shares. The public offering price was $18.00 per share. Our net proceeds from the initial public offering was $220.2 million, after deducting underwriting discounts and commissions of $17.0 million and offering expenses of $6.2 million. There has been no material changes in the planned use of proceeds as described in the our prospectus dated July 22, 2021, filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act.
On July 27, 2021, in a private placement exempt from registration under Section 4(a)(2) of the Securities Act and the rules and regulations promulgated thereunder, we issued and sold ordinary shares to GE Healthcare. No underwriter or placement agent acted on our behalf in the private placement. In the private placement, we issued and sold 1,111,111 ordinary shares. The offering price was $18.00 per share. Our net proceeds from the private placement was $19.6 million, after deducting offering expenses of $0.4 million. We intend to use the net proceeds from the private placement for working capital and general corporate purposes.
On May 2, 2024, in connection with the Perceptive Credit Agreement and in a private placement exempt from registration under Section 4(a)(2) of the Securities Act and the rules and regulations promulgated thereunder, we issued and sold to Perceptive Credit Holdings IV, LP a warrant certificate (the “Warrant Certificate”) representing the right to purchase up to 400,000 ordinary shares at $4.9992 per share, with the right to purchase 200,000 ordinary shares available immediately and the right to purchase an additional 200,000 ordinary shares to be available upon the drawdown of the second tranche of the term loans. The purchase rights represented by the Warrant Certificate are exercisable after becoming available, on a cash basis, at the option of the holder at any time prior to 5:00 p.m., Eastern time on the tenth anniversary of the applicable date of availability. The Warrant Certificate contains customary anti-dilution adjustments. We did not receive any proceeds from the sale of the Warrant Certificate beyond our entry into and borrowings under the Perceptive Credit Agreement.
Item 15. Controls and Procedures
A. Disclosure Controls and Procedures
As required by Rule 13a-15 under the Exchange Act, management, including our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Disclosure controls and procedures refer to controls and other procedures designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding our required disclosures.
The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures as of the end of the period covered by this report. Based on such evaluations, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, our disclosure controls and procedures were effective.
B. Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed by or under the supervision of the Chief Executive Officer and Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external reporting purposes in accordance with the IFRS Accounting Standards as issued by the IASB.
As of December 31, 2024, our management conducted an assessment of the effectiveness of the Company’s internal control over financial reporting based on the criteria established in the Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on this assessment, our management has determined that the Company’s internal control over financial reporting as of December 31, 2024 is effective.
C. Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of the company’s independent registered public accounting firm because we are an emerging growth company under the JOBS Act.
D. Changes in Internal Control Over Financial Reporting
There were no changes to internal control over financial reporting during the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 16A. Audit Committee Financial Expert
Our board of directors has determined that each of Didier Hirsch and Tomer Berkovitz are considered an “audit committee financial expert” as defined by the SEC. Our board of directors has determined that each of Didier Hirsch, Tomer Berkovitz, and Kathy Hibbs satisfy the “independence” requirements under Nasdaq listing standards and Rule 10A-3 under the Exchange Act.
Item 16B. Code of Ethics
We have adopted the Code of Ethics, which is applicable to all of our employees, executive officers and directors. The Code of Ethics is available on our website www.sophiagenetics.com. Our board of directors is responsible for overseeing the Code of Ethics and will be required to approve any waivers of the Code of Ethics for our executive officers and directors. We expect that any amendments to the Code of Ethics, or any waivers of its requirements, will be disclosed on our website. For the year ended December 31, 2024, we did not grant any waivers of the Code of Ethics.
Item 16C. Principal Accountant Fees and Services
Fees
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For the year ended December 31, |
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2024 |
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2023 |
| Audit fees |
|
$ |
890,945 |
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$ |
905,525 |
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| Audit-related fees |
|
5,204 |
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5,916 |
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| Tax fees |
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— |
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— |
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| All other fees |
|
3,924 |
|
|
9,875 |
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| Total fees |
|
$ |
900,073 |
|
|
$ |
921,316 |
|
For the year ended December 31, 2024 and 2023, PricewaterhouseCoopers SA was the Company’s auditor for the IFRS Accounting Standards and statutory accounts.
Audit fees include the standard audit work performed each fiscal year necessary to allow the auditor to issue an opinion on our financial statements and to issue an opinion on the local statutory financial statements. Audit fees also include services that can be provided only by the external auditor such as reviews of quarterly financial results and review of our securities offering documents.
Audit-related fees consist of fees billed for assurance and related services reasonably related to the performance of the audit or review of our financial statements or for services traditionally performed by an external auditor.
Tax services represent tax compliance, assistance with historical tax matters, and other tax-related services.
Other services include services performed for statutory non-financial requirements and other reporting guidance databases.
Pre-Approval Policies and Procedures
In accordance with the requirements of the Sarbanes-Oxley Act and rules issued by the SEC, we review and pre-approve of any services performed by PricewaterhouseCoopers SA. The procedures require that all proposed future engagements of PricewaterhouseCoopers SA for audit and permitted non-audit work are submitted to the audit committee of our board of directors for approval prior to the beginning of any such service. In accordance with this policy, all services performed by and fees paid to PricewaterhouseCoopers SA in this Item 16C were approved by the audit committee.
Item 16D. Exemptions from the Listing Standards for Audit Committees
None.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Issuer Purchases of Equity Securities
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| Period |
Total number of shares purchased |
Average price paid per share |
Total number of shares purchased as part of publicly announced plans or programs |
Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs |
January 1, 2024 to January 31, 2024 |
— |
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N/A |
— |
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— |
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February 1, 2024 to February 28, 2024 |
— |
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N/A |
— |
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— |
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March 1, 2024 to March 31, 2024 |
— |
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N/A |
— |
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— |
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April 1, 2024 to April 30, 2024 |
— |
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N/A |
— |
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— |
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May 1, 2024 to May 31, 2024 |
— |
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N/A |
— |
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— |
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June 1, 2024 to June 30, 2024 |
— |
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N/A |
— |
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— |
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July 1, 2024 to July 31, 2024 |
— |
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N/A |
— |
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— |
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August 1, 2024 to August 31, 2024 |
— |
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N/A |
— |
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— |
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September 1, 2024 to September 30, 2024 |
— |
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N/A |
— |
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— |
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October 1, 2024 to October 31, 2024 |
— |
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N/A |
— |
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— |
|
November 1, 2024 to November 30, 2024 |
— |
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N/A |
— |
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— |
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December 1, 2024 to December 31, 2024 |
— |
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N/A |
— |
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— |
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| Total |
— |
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N/A |
— |
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— |
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Item 16F. Change in Registrant’s Certifying Accountant
None.
Item 16G. Corporate Governance
As a “foreign private issuer,” as defined by the SEC, we are permitted to follow home country corporate governance practices instead of certain corporate governance standards required by Nasdaq for U.S. companies. Accordingly, we follow Swiss corporate governance rules in lieu of certain of Nasdaq’s corporate governance requirements. The significant differences between our Swiss corporate governance rules and Nasdaq’s corporate governance requirements are set forth below:
•Exemption from the requirement that a majority of the board of directors be comprised of independent directors and that there be regularly scheduled meetings with only the independent directors present. Swiss law does not have such a requirement.
•Exemption from the requirements that the compensation committee and the nomination and corporate governance committee be comprised of independent directors. Swiss law does not have such requirements.
•Exemption from quorum requirements applicable to meetings of shareholders. Swiss law does not have such quorum requirements.
•Exemption from the requirement that independent directors meet at regularly scheduled executive sessions. Swiss law does not have such a requirement.
•Exemption from the requirement to disclose within four business days of any determination to grant a waiver of the Code of Ethics to directors and executive officers. Although we will require approval by our board of directors for any such waiver, we may choose not to disclose the waiver in the manner set forth in the Nasdaq listing standards.
•Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans. Our articles of association provide that our board of directors is authorized, in certain instances, to issue a certain number of ordinary shares without re-approval by our shareholders.
Furthermore, Nasdaq Rule 5615(a)(3) provides that a foreign private issuer may rely on home country corporate governance practices in lieu of certain of the rules in the Nasdaq Rule 5600 Series and Rule 5250(d), provided that it nevertheless complies with Nasdaq’s Notification of Noncompliance requirement (Rule 5625) and the Voting Rights requirement (Rule 5640) and that it has an audit committee that satisfies Rule 5605(c)(3), consisting of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii). We intend to use these exemptions for as long as we continue to qualify as a foreign private issuer.
Item 16H. Mine Safety Disclosure
Not applicable.
Item 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
Item 16J. Insider Trading Policies
We have adopted insider trading policies and procedures governing the purchase, sale and other dispositions of our securities by our directors, senior management and employees that are reasonably designed to promote compliance with applicable insider trading laws, rules and regulations and applicable listing standards. Our Insider Trading Policy and Rule 10b5-1 Plan Policy are filed as Exhibits 11.1 and 11.2, respectively, of this Annual Report. In addition, it is our policy not to engage in transactions in company securities while aware of material nonpublic information relating to the company or its securities.
Item 16K. Cybersecurity
At SOPHiA GENETICS, cybersecurity risk management is an integral part of our enterprise risk management program. Our cybersecurity risk management program is derived from the ISO27001 family of standards and underpins our Information Security Management System (“ISMS”) framework. This determines how we design our polices, guidelines, controls, and best practices to manage the organization’s information security risks while permitting us to leverage NIST, STRIDE, and SANS frameworks to inform our handling of cybersecurity threats and incidents. Additionally, we are certified in accordance to and maintain our cybersecurity framework consistent with ISO 27001 standards.
The scope of applicability includes our globally accessible cloud-native solution offering along with all physical associated geographical locations: Switzerland, the U.S., and France. This is designed to achieve comprehensive global risk coverage across operations, application development, wet-lab analysis, and R&D. Many of these capabilities are delivered in-house, however third-party services are engaged in a modest capacity to support specific activities, such as security operations center capabilities and annual penetration testing. Where engaged, the organization has vendor management procedures in place that require cross-functional participation from the areas of Quality, Procurement, Regulatory, Legal, and Cybersecurity. These procedures are also interlinked directly with cybersecurity’s ISMS.
Our framework includes tools and processes to identify and assess the severity of cybersecurity threats and incidents including, but not limited to, data loss, theft, and system penetration.
Additionally our framework allows us to identify if the threat or incident is associated with a third-party provider, dynamically implementing cybersecurity countermeasures and mitigation strategies and informing management and our board of directors of material cybersecurity threats and incidents
The cybersecurity team is further responsible for assessing our cybersecurity risk management program and communicating these risks to senior leadership and the Board. Although the assessment is solely performed within the cybersecurity team, external engagements influence such determination e.g.:
–Annual penetration testing and Tabletop exercises
–Quarterly phishing exercises
–Monthly SOC read-out calls
–External threat feeds
–Cyber insurance evaluation
–External Audit activities (ISO27001, ISO15485)
–Board and Executive team feedback
The cybersecurity team is also responsible for providing all employee training, awareness, and education. It performs this by carrying out:
–Quarterly phishing exercises
–Digital awareness campaigns through intranet posts, email updates, digital presentations
–Reach-out engagements to cross-functional teams aligned to their delivery schedules.
Our board of directors has overall oversight responsibility for our risk management and delegates cybersecurity risk management oversight to the audit committee of the board of directors. The audit committee is responsible for ensuring that management has processes in place designed to identify and evaluate cybersecurity risks to which the company is exposed and implement processes and programs to manage cybersecurity risks and mitigate cybersecurity incidents. The audit committee also reports material cybersecurity risks to our full board of directors. Management is responsible for identifying, considering and assessing material cybersecurity risks on an ongoing basis, establishing processes to ensure that such potential cybersecurity risk exposures are monitored, putting in place appropriate mitigation measures and maintaining cybersecurity programs. Our cybersecurity programs are under the direction of our Chief Technology Officer (“CTO”), who has over 20 years of technology leadership, receives reports from our cybersecurity team and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents. Our dedicated personnel hold a multitude of certifications, including but not limited to Certified information systems security professional (“CISSP”), Certified Ethical Hacker, and experienced information systems security professionals and information security managers with many years of experience. Management, including the CTO and our cybersecurity team, update the audit committee on the company’s cybersecurity programs, material cybersecurity risks and mitigation strategies and provide cybersecurity reports annually that cover, among other topics, such as, key performance metrics, developments in cybersecurity and updates to the company’s cybersecurity programs and mitigation strategies.
In 2024, we did not identify any cybersecurity incidents that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced an undetected cybersecurity incident. For more information about these risks, please see “Item 3. Key Information—D. Risk Factors—Risks Related to Our Business and Industry— Cybersecurity or data privacy breaches, other unauthorized or improper access, or (distributed) denial service lack of access (e.g., ransomware, persistent DoS/DDoS) could result in additional costs, service outages, loss of revenue, significant liabilities, harm to our brand and decreased/denied use of our SOPHiA DDM Platform and related solutions, applications, products, or services.” in this annual report on Form 20-F.
PART III
Item 17. Financial Statements
See “Item 18—Financial Statements.”
Item 18. Financial Statements
The financial statements are filed as part of this Annual Report, beginning on page F-1.
Item 19. Exhibits
The following documents are filed as part of Annual Report on Form 20-F:
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Incorporation by Reference |
| Exhibit No. |
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Description |
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Form |
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File No. |
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Exhibit No. |
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Filing Date |
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| 1.1 |
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| 2.1 |
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| 4.1# |
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F-1 |
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333-257646 |
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10.1 |
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July 2, 2021 |
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| 4.2# |
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F-1 |
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333-257646 |
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10.2 |
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July 2, 2021 |
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4.3# |
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F-1 |
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333-257646 |
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10.5 |
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July 2, 2021 |
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4.4# |
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F-1 |
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333-257646 |
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10.6 |
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July 2, 2021 |
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4.5# |
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F-1 |
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333-257646 |
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10.7 |
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July 2, 2021 |
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4.6# |
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F-1 |
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333-257646 |
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10.8 |
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July 2, 2021 |
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4.7#† |
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20-F |
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001-40627 |
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4.11 |
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March 15, 2022 |
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4.8# |
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4.9# |
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4.10 |
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6-K |
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001-40627 |
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99.4 |
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May 7, 2024 |
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4.11 |
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6-K |
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001-40627 |
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99.5 |
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May 7, 2024 |
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| 4.12 |
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4.13§ |
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F-1 |
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333-257646 |
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10.10 |
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July 2, 2021 |
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4.14§ |
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F-1 |
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333-257646 |
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10.13 |
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July 2, 2021 |
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8.1 |
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| 11.1 |
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| 11.2 |
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| 12.1 |
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| 12.2 |
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| 13.1 |
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| 15.1 |
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| 97.1 |
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20-F |
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001-40627 |
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97.1 |
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March 4, 2024 |
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| 101.INS |
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Inline XBRL Instance Document |
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| 101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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| 101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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| 101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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| 101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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| 101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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| 104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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# Portions of this exhibit have been omitted because they are both (i) not material and (ii) customarily and actually treated by the registrant as private or confidential.
† Certain schedules to this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule will be furnished supplementally to the SEC upon request; provided, however, that the parties may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any document so furnished.
§ Indicates a management contract or compensatory plan.
Signatures
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.
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SOPHiA GENETICS SA |
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By: |
/s/ Jurgi Camblong |
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Name: |
Jurgi Camblong |
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Title: |
Chief Executive Officer |
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Date: |
March 4, 2025 |
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of SOPHiA GENETICS SA
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of SOPHiA GENETICS SA and its subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of loss, comprehensive loss, changes in equity and cash flows for each of the three years in the period ended December 31, 2024, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024 in conformity with IFRS Accounting Standards as issued by the International Accounting Standards Board.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers SA
Pully, Switzerland
March 4, 2025
We have served as the Company’s auditor since 2020.
SOPHiA GENETICS SA, Rolle
Consolidated Statements of Loss
(Amounts in USD thousands, except per share data)
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Year ended December 31, |
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Notes |
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2024 |
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2023 |
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2022 |
| Revenue |
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4 |
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$ |
65,173 |
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$ |
62,371 |
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$ |
47,560 |
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| Cost of revenue |
|
5 |
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(21,236) |
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(19,458) |
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(16,306) |
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| Gross profit |
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43,937 |
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42,913 |
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31,254 |
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| Research and development costs |
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6 |
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(34,366) |
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(36,969) |
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(35,371) |
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| Selling and marketing costs |
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6 |
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(29,369) |
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(28,423) |
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(28,267) |
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| General and administrative costs |
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6 |
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(46,953) |
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(53,301) |
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(55,816) |
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| Other operating income, net |
|
7 |
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183 |
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|
954 |
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377 |
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| Operating loss |
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(66,568) |
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(74,826) |
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(87,823) |
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| Interest income |
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8 |
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3,362 |
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4,547 |
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|
1,324 |
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| Interest expense |
|
8 |
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(1,913) |
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|
(588) |
|
|
(639) |
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| Fair value adjustments on warrant obligations |
|
23 |
|
|
|
|
|
|
370 |
|
|
— |
|
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— |
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| Foreign exchange gains (losses), net |
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8 |
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3,479 |
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(7,628) |
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(447) |
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| Loss before income taxes |
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(61,270) |
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(78,495) |
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(87,585) |
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| Income tax expense |
|
9 |
|
|
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|
|
(1,223) |
|
|
(486) |
|
|
136 |
|
| Loss for the year |
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|
|
(62,493) |
|
|
(78,981) |
|
|
(87,449) |
|
| Attributable to the owners of the parent |
|
|
|
|
|
|
|
|
(62,493) |
|
|
(78,981) |
|
|
(87,449) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted loss per share |
|
10 |
|
|
|
|
|
|
$ |
(0.95) |
|
|
$ |
(1.22) |
|
|
$ |
(1.36) |
|
The Notes form an integral part of these consolidated financial statements
SOPHiA GENETICS SA, Rolle
Consolidated Statements of Comprehensive Loss
(Amounts in USD thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
Notes |
|
|
|
|
|
2024 |
|
2023 |
|
2022 |
| Loss for the period |
|
|
|
|
|
|
|
$ |
(62,493) |
|
|
$ |
(78,981) |
|
|
$ |
(87,449) |
|
| Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
| Items that may be reclassified to statement of loss |
|
|
|
|
|
|
|
|
|
|
|
|
| Currency translation adjustments |
|
|
|
|
|
|
|
(9,679) |
|
|
15,037 |
|
|
(4,336) |
|
| Total items that may be reclassified to statement of loss |
|
|
|
|
|
|
|
(9,679) |
|
|
15,037 |
|
|
(4,336) |
|
| Items that will not be reclassified to statement of loss (net of tax) |
|
|
|
|
|
|
|
|
|
|
|
|
| Remeasurement of defined benefit plans |
|
21 |
|
|
|
|
|
327 |
|
|
(212) |
|
|
2,154 |
|
| Total items that will not be reclassified to statement of loss |
|
|
|
|
|
|
|
327 |
|
|
(212) |
|
|
2,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other comprehensive (loss) income for the period |
|
|
|
|
|
|
|
$ |
(9,352) |
|
|
$ |
14,825 |
|
|
$ |
(2,182) |
|
| Total comprehensive loss for the period |
|
|
|
|
|
|
|
$ |
(71,845) |
|
|
$ |
(64,156) |
|
|
$ |
(89,631) |
|
| Attributable to owners of the parent |
|
|
|
|
|
|
|
$ |
(71,845) |
|
|
$ |
(64,156) |
|
|
$ |
(89,631) |
|
The Notes form an integral part of these consolidated financial statements
SOPHiA GENETICS SA, Rolle
Consolidated Balance Sheets
(Amounts in USD thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Notes |
|
|
2024 |
|
2023 |
| Assets |
|
|
|
|
|
|
|
| Current assets |
|
|
|
|
|
|
|
| Cash and cash equivalents |
|
11 |
|
|
$ |
80,226 |
|
|
$ |
123,251 |
|
|
|
|
|
|
|
|
|
| Accounts receivable |
|
12 |
|
|
7,436 |
|
|
13,557 |
|
| Inventory |
|
13 |
|
|
5,868 |
|
|
6,482 |
|
| Prepaids and other current assets |
|
14 |
|
|
5,875 |
|
|
4,757 |
|
| Total current assets |
|
|
|
|
99,405 |
|
|
148,047 |
|
| Non-current assets |
|
|
|
|
|
|
|
| Property and equipment |
|
15 |
|
|
5,209 |
|
|
7,469 |
|
| Intangible assets |
|
16 |
|
|
28,998 |
|
|
27,185 |
|
| Right-of-use assets |
|
17 |
|
|
14,168 |
|
|
15,635 |
|
| Deferred tax assets |
|
9 |
|
|
1,767 |
|
|
1,720 |
|
| Other non-current assets |
|
18 |
|
|
5,762 |
|
|
6,100 |
|
| Total non-current assets |
|
|
|
|
55,904 |
|
|
58,109 |
|
| Total assets |
|
|
|
|
$ |
155,309 |
|
|
$ |
206,156 |
|
| Liabilities and equity |
|
|
|
|
|
|
|
| Current liabilities |
|
|
|
|
|
|
|
| Accounts payable |
|
19 |
|
|
$ |
5,220 |
|
|
$ |
5,391 |
|
| Accrued expenses |
|
20 |
|
|
13,217 |
|
|
17,808 |
|
| Deferred contract revenue |
|
4 |
|
|
5,732 |
|
|
9,494 |
|
|
|
|
|
|
|
|
|
| Lease liabilities, current portion |
|
17 |
|
|
2,190 |
|
|
2,928 |
|
|
|
|
|
|
|
|
|
| Warrant obligations |
|
23 |
|
|
444 |
|
|
— |
|
| Total current liabilities |
|
|
|
|
26,803 |
|
|
35,621 |
|
| Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Borrowings |
|
23 |
|
|
13,237 |
|
|
— |
|
| Lease liabilities, net of current portion |
|
17 |
|
|
14,603 |
|
|
15,673 |
|
| Defined benefit pension liabilities |
|
21 |
|
|
3,839 |
|
|
3,086 |
|
| Other non-current liabilities |
|
|
|
|
337 |
|
|
334 |
|
| Total non-current liabilities |
|
|
|
|
32,016 |
|
|
19,093 |
|
| Total liabilities |
|
|
|
|
58,819 |
|
|
54,714 |
|
| Equity |
|
|
|
|
|
|
|
| Share capital |
|
|
|
|
4,188 |
|
|
4,048 |
|
| Share premium |
|
|
|
|
472,244 |
|
|
471,846 |
|
| Treasury shares |
|
|
|
|
(702) |
|
|
(646) |
|
| Other reserves |
|
|
|
|
61,037 |
|
|
53,978 |
|
| Accumulated deficit |
|
|
|
|
(440,277) |
|
|
(377,784) |
|
| Total equity |
|
|
|
|
96,490 |
|
|
151,442 |
|
| Total liabilities and equity |
|
|
|
|
$ |
155,309 |
|
|
$ |
206,156 |
|
The Notes form an integral part of these consolidated financial statements
SOPHiA GENETICS SA, Rolle
Consolidated Statements of Changes in Equity
(Amounts in USD thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes |
|
Shares |
|
Share
capital |
|
Treasury Shares |
|
Treasury Share
capital |
|
Share
premium |
|
Other
reserves |
|
Accumulated
deficit |
|
Total |
| January 1, 2022 |
|
|
|
63,857,604 |
|
|
$ |
3,328 |
|
|
— |
|
|
$ |
— |
|
|
$ |
470,887 |
|
|
$ |
12,539 |
|
|
$ |
(211,354) |
|
|
$ |
275,400 |
|
| Loss for the period |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(87,449) |
|
|
(87,449) |
|
| Other comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,182) |
|
|
— |
|
|
(2,182) |
|
| Total comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,182) |
|
|
(87,449) |
|
|
(89,631) |
|
| Share-based compensation |
|
22 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
13,613 |
|
|
— |
|
|
13,613 |
|
| Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Share options exercised and vesting of Restricted Stock Units |
|
22 |
|
— |
|
|
— |
|
|
373,616 |
|
|
19 |
|
|
736 |
|
|
(7) |
|
|
— |
|
|
748 |
|
| Issuance of shares to be held as treasury shares |
|
|
|
2,540,560 |
|
|
136 |
|
|
(2,540,560) |
|
|
(136) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| December 31, 2022 |
|
|
|
66,398,164 |
|
|
$ |
3,464 |
|
|
(2,166,944) |
|
|
$ |
(117) |
|
|
$ |
471,623 |
|
|
$ |
23,963 |
|
|
$ |
(298,803) |
|
|
$ |
200,130 |
|
| Loss for the period |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(78,981) |
|
|
(78,981) |
|
| Other comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
14,825 |
|
|
— |
|
|
14,825 |
|
| Total comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
14,825 |
|
|
(78,981) |
|
|
(64,156) |
|
| Share-based compensation |
|
22 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
15,242 |
|
|
— |
|
|
15,242 |
|
| Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Share options exercised and vesting of Restricted Stock Units |
|
22 |
|
— |
|
|
— |
|
|
999,339 |
|
|
55 |
|
|
223 |
|
|
(52) |
|
|
— |
|
|
226 |
|
| Issuance of shares to be held as treasury shares |
|
|
|
10,500,000 |
|
|
584 |
|
|
(10,500,000) |
|
|
(584) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| December 31, 2023 |
|
|
|
76,898,164 |
|
|
$ |
4,048 |
|
|
(11,667,605) |
|
|
$ |
(646) |
|
|
$ |
471,846 |
|
|
$ |
53,978 |
|
|
$ |
(377,784) |
|
|
$ |
151,442 |
|
| Loss for the period |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(62,493) |
|
|
(62,493) |
|
| Other comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(9,352) |
|
|
— |
|
|
(9,352) |
|
| Total comprehensive loss |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(9,352) |
|
|
(62,493) |
|
|
(71,845) |
|
| Share-based compensation |
|
22 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
16,488 |
|
|
— |
|
|
16,488 |
|
| Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Share options exercised and vesting of Restricted Stock Units |
|
22 |
|
— |
|
|
— |
|
|
1,456,526 |
|
|
84 |
|
|
398 |
|
|
(77) |
|
|
— |
|
|
405 |
|
| Issuance of shares to be held as treasury shares |
|
|
|
2,423,056 |
|
|
140 |
|
|
(2,423,056) |
|
|
(140) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| December 31, 2024 |
|
|
|
79,321,220 |
|
|
$ |
4,188 |
|
|
(12,634,135) |
|
|
$ |
(702) |
|
|
472,244 |
|
|
61,037 |
|
|
(440,277) |
|
|
96,490 |
|
The Notes form an integral part of these consolidated financial statements
SOPHiA GENETICS SA, Rolle
Consolidated Statements of Cash Flows
(Amounts in USD thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
Notes |
|
|
2024 |
|
2023 |
|
2022 |
| Operating activities |
|
|
|
|
|
|
|
|
|
| Loss before tax |
|
|
|
|
$ |
(61,270) |
|
|
$ |
(78,495) |
|
|
$ |
(87,585) |
|
| Adjustments for non-monetary items |
|
|
|
|
|
|
|
|
|
| Depreciation |
|
15,17 |
|
|
4,575 |
|
|
5,508 |
|
|
3,791 |
|
| Amortization |
|
16 |
|
|
4,021 |
|
|
2,828 |
|
|
1,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Finance (income) expense, net |
|
|
|
|
(5,210) |
|
|
2,934 |
|
|
(685) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Fair value adjustments on warrant obligations |
|
23 |
|
|
(370) |
|
|
— |
|
|
— |
|
| Expected credit loss allowance |
|
12 |
|
|
(523) |
|
|
214 |
|
|
(467) |
|
| Share-based compensation |
|
22 |
|
|
16,488 |
|
|
15,242 |
|
|
13,613 |
|
| Intangible assets write-off |
|
16 |
|
|
— |
|
|
— |
|
|
73 |
|
| Movements in provisions and pensions |
|
13,21 |
|
|
1,617 |
|
|
308 |
|
|
953 |
|
| Research tax credit |
|
6 |
|
|
(726) |
|
|
(1,129) |
|
|
(1,292) |
|
| Loss on disposal of property and equipment |
|
15 |
|
|
— |
|
|
28 |
|
|
— |
|
| Gain on disposal of lease liability |
|
|
|
|
— |
|
|
(733) |
|
|
— |
|
| Working capital changes |
|
|
|
|
|
|
|
|
|
| Decrease (Increase) in accounts receivable |
|
|
|
|
5,892 |
|
|
(6,500) |
|
|
1,332 |
|
| (Increase) decrease in prepaids and other assets |
|
|
|
|
(1,157) |
|
|
1,375 |
|
|
(977) |
|
| Decrease (Increase) in inventory |
|
|
|
|
69 |
|
|
(874) |
|
|
(200) |
|
| (Decrease) Increase in accounts payables, accrued expenses, deferred contract revenue, and other liabilities |
|
|
|
|
(7,385) |
|
|
6,871 |
|
|
(1,428) |
|
| Cash used in operating activities |
|
|
|
|
(43,979) |
|
|
(52,423) |
|
|
(71,092) |
|
| Income tax paid |
|
|
|
|
(536) |
|
|
(801) |
|
|
— |
|
| Interest paid |
|
|
|
|
(1,728) |
|
|
(6) |
|
|
(266) |
|
| Interest received |
|
|
|
|
3,421 |
|
|
4,655 |
|
|
1,265 |
|
| Net cash flows used in operating activities |
|
|
|
|
(42,822) |
|
|
(48,575) |
|
|
(70,093) |
|
| Investing activities |
|
|
|
|
|
|
|
|
|
| Purchase of property and equipment |
|
15 |
|
|
(244) |
|
|
(1,494) |
|
|
(4,097) |
|
| Acquisition of intangible assets |
|
16 |
|
|
(195) |
|
|
(263) |
|
|
(464) |
|
| Capitalized development costs |
|
16 |
|
|
(7,737) |
|
|
(7,469) |
|
|
(5,820) |
|
| Proceeds upon maturity of term deposits |
|
11 |
|
|
— |
|
|
17,546 |
|
|
78,533 |
|
| Purchase of term deposits |
|
11 |
|
|
— |
|
|
— |
|
|
(26,179) |
|
| Net cash flow (used in) provided from investing activities |
|
|
|
|
(8,176) |
|
|
8,320 |
|
|
41,973 |
|
| Financing activities |
|
|
|
|
|
|
|
|
|
| Proceeds from exercise of share options |
|
22 |
|
|
405 |
|
|
226 |
|
|
748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Proceeds from borrowings, net of transaction costs |
|
23 |
|
|
13,930 |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Payments of principal portion of lease liabilities |
|
17 |
|
|
(2,750) |
|
|
(3,043) |
|
|
(2,316) |
|
| Net cash flow provided from (used in) financing activities |
|
|
|
|
11,585 |
|
|
(2,817) |
|
|
(1,568) |
|
| Decrease in cash and cash equivalents |
|
|
|
|
(39,413) |
|
|
(43,072) |
|
|
(29,688) |
|
| Effect of exchange differences on cash balances |
|
|
|
|
(3,612) |
|
|
5,018 |
|
|
(1,969) |
|
| Cash and cash equivalents at beginning of the year |
|
|
|
|
123,251 |
|
|
161,305 |
|
|
192,962 |
|
| Cash and cash equivalents at end of the year |
|
|
|
|
$ |
80,226 |
|
|
$ |
123,251 |
|
|
$ |
161,305 |
|
The Notes form an integral part of these consolidated financial statements
SOPHiA GENETICS SA, Rolle
Notes to the Consolidated Financial Statements
1. Company information and operations
General information
SOPHiA GENETICS SA and its consolidated subsidiaries (NASDAQ: SOPH) (“the Company”) is a cloud-native software company in the healthcare space, incorporated on March 18, 2011, and headquartered in Rolle, Switzerland. The Company is dedicated to establishing the practice of data-driven medicine as the standard of care in healthcare and for life sciences research. The Company has built a cloud-native software platform capable of analyzing data and generating insights from complex multimodal datasets and different diagnostic modalities. This platform, commercialized as “SOPHiA DDMTM,” standardizes, computes, and analyzes digital health data and is used in decentralized locations to break down data silos. The Company collectively refers to SOPHiA DDM TM Platform and related products and solutions as “SOPHiA DDM Platform.”
On June 26, 2023, during the Company’s Annual General Meeting, the move of the statutory seat from Saint-Sulpice, Canton Vaud, Switzerland to Rolle, Canton Vaud, Switzerland was approved.
As of December 31, 2024, the Company had the following wholly-owned subsidiaries:
|
|
|
|
|
|
|
|
|
| Name |
|
Country of domicile |
| SOPHiA GENETICS S.A.S. |
|
France |
| SOPHiA GENETICS LTD |
|
U.K. |
| SOPHiA GENETICS, Inc. |
|
U.S. |
| SOPHiA GENETICS Intermediação de Negócios LTDA |
|
Brazil |
| SOPHiA GENETICS PTY LTD |
|
Australia |
| SOPHiA GENETICS S.R.L. |
|
Italy |
The Company’s Board of Directors approved the issue of the consolidated financial statements on March 4, 2025.
Issued share capital
As of December 31, 2024, the Company had issued 79,321,220 shares of which 66,687,085 are outstanding and 12,634,135 are held by the Company as treasury shares. As of December 31, 2023, the Company had issued 76,898,164 shares of which 65,230,559 are outstanding and 11,667,605 are held by the Company as treasury shares. All shares were considered paid as of December 31, 2024.
At the next ordinary Annual General Meeting, the Board of Directors will not propose any dividend in respect of the year ended December 31, 2024.
Treasury shares
During the first quarter of 2022, the Company issued 2,540,560 registered shares to SOPHiA GENETICS LTD pursuant to a share delivery and repurchase agreement, which were immediately exercised, and repurchased the shares to hold as treasury shares for the purposes of administering the Company's equity incentive programs. During the second quarter of 2023, the Company issued 10,500,000 registered shares to SOPHiA GENETICS LTD pursuant to a share delivery and repurchase agreement, which were immediately exercised, and repurchased the shares to hold as treasury shares. During the third quarter of 2024, the Company issued 2,423,056 registered shares to SOPHiA GENETICS LTD pursuant to a share delivery and repurchase agreement, which were immediately exercised, and repurchased the shares to hold as treasury shares for the purposes of administering the Company's equity incentive programs. The Company held 12,634,135 and 11,667,605 treasury shares as of December 31, 2024 and 2023, respectively.
Treasury shares are recognized at acquisition cost and recorded as treasury shares at the time of the transaction. Upon exercise of share options or vesting of restricted stock units, the treasury shares are subsequently transferred. Any consideration received is included in shareholders’ equity.
2. Material accounting policies
Basis of preparation
Compliance with International Financial Reporting Standards
The consolidated financial statements of the Company have been prepared in accordance with IFRS Accounting Standards and interpretations issued by the IFRS Interpretations Committee (“IFRS IC”) applicable to companies reporting under IFRS. The consolidated financial statements comply with IFRS Accounting Standards as issued by the International Accounting Standards Board (“IASB”).
Basis of consolidation
A subsidiary is an entity over which the Company has control. The Company controls an entity when it has the power to direct its activities and has rights to its variable returns. Subsidiaries are fully consolidated from the date on which control is transferred to the Company and deconsolidated from the date that control ceases.
During the consolidation process intercompany transactions, balances, and unrealized gains on transactions between companies are eliminated. Unrealized losses are also eliminated unless there is evidence of an impairment of the transferred asset. In order to ensure consistency with the accounting policies of the Company, the accounting policies of subsidiaries have been changed where necessary.
Foreign currency translation
Items included in the consolidated financial statements of each of the Company’s entities are measured using the currency of the primary economic environment in which the entity operates (“functional currency”). In individual entities, transactions in foreign currencies are translated as of transaction date. Monetary assets and liabilities in foreign currencies are translated at month end rates. The Company’s reporting currency of the Company’s consolidated financial statements is the U.S. dollar (“USD”). Assets and liabilities denominated in foreign currencies are translated at the month-end spot exchange rates, income statement accounts are translated at average rates of exchange for the period presented, and equity is translated at historical exchange rates.
On consolidation, assets and liabilities of foreign operations reported in their local functional currencies are translated into USD. Differences arising from the retranslation of opening net assets of foreign operations, together with differences arising from the translation of the net results for the year of foreign operations, are recognized in other comprehensive income under currency translation adjustments. Gains or losses resulting from foreign currency transactions are included in net income.
The Company selected the U.S. dollar as its presentation currency for purposes of its consolidated financial statements instead of the Company’s functional currency, the Swiss franc, because of the global nature of its business, its expectation that an increasing portion of revenues and expenses will be denominated in USD, and its plans to continue to access U.S. capital markets.
Use of estimates
The preparation of consolidated financial statements in conformity with IFRS Accounting Standards requires the use of accounting estimates. It also requires management to exercise judgment in applying the Company’s accounting policies. The Company’s significant estimates and judgments included in the preparation of the consolidated financial statements are related to revenue recognition, capitalized internal software development costs, share-based compensation, expected credit loss, goodwill, defined benefit pension liabilities, uncertain tax positions, and derivatives.
Disclosed in the corresponding sections within the footnotes are the areas which require a high degree of judgment, significant assumptions, and/or estimates.
Going concern basis
The consolidated financial statements have been prepared on a going concern basis (See Note 27 – “Capital management”).
Historical cost convention
The consolidated financial statements have been prepared on a historical cost basis except for certain assets and liabilities, which are carried at fair value.
Accounting policies
The material accounting policies adopted in the preparation of the consolidated financial statements have been consistently applied, unless otherwise stated.
Provisions and contingencies
Provisions comprise liabilities of uncertain timing or amount. The provisions and liabilities are recognized when the Company has a present legal or constructive obligation as a result of past events, it is probable that an outflow of resources will be required to settle the obligation, and the amount can be reliably estimated. Provisions are not recognized for future operating losses. Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present obligation at the end of the reporting period, unless the impact of discounting is immaterial. The discount rate used to determine the present value is a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the liability. The increase in the provision due to the passage of time is recognized as interest expense.
Contingent liabilities are possible obligations that arise from past events and whose existence will be confirmed only by the occurrence or non-occurrence of one or more uncertain future events not fully within the control of the Company.
The likelihood of occurrence of provisions and contingent liabilities requires use of judgment. Judgment is also required to determine if an outflow of economic resources is probable, or possible but not probable. Where it is probable, a liability is recognized, and further judgment is used to determine the level of the provision. Where it is possible but not probable, further judgment is used to determine if the likelihood is remote, in which case no disclosures are provided; if the likelihood is not remote then judgment is used to determine the contingent liability disclosed.
Financial assets classification
Upon recognition, financial assets are classified on the basis of how the financial assets are measured: at amortized cost or fair value through income.
The classification of financial assets at initial recognition depends on the financial asset’s contractual cash flow characteristics and the Company’s business model for managing them. Except for accounts receivable that do not contain a significant financing component, the Company initially measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through income, transaction costs. Accounts receivable that do not contain a significant financing component are measured at the transaction price.
The Company’s business model for managing financial assets is defined by whether cash flows will result from collecting contractual cash flows, selling the financial assets, or both. Financial assets held in order to collect contractual cash flows are measured at amortized cost. Financial assets held both to collect contractual cash flows and for sale are measured at fair value through other comprehensive income/loss.
Purchases or sales of financial assets that require delivery of assets within a time frame established by regulation or convention in the marketplace (regular way trades) are recognized on the trade date, i.e., the date that the Company commits to purchase or sell the asset.
Financial assets measured at amortized cost
Financial assets initially measured at amortized cost are subsequently measured using the effective interest rate (“EIR”) method and are subject to impairment. Gains and losses are recognized in income when the asset is derecognized, modified, or impaired.
The Company’s financial assets at amortized cost include cash and accounts receivable.
Financial assets—derecognition
A financial asset (or, where applicable, a part of a financial asset or part of a group of similar financial assets) is primarily derecognized (i.e., removed from the Company’s consolidated balance sheet) when:
•the rights to receive cash flows from the asset have expired or;
•the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a ‘pass-through’ arrangement; and either;
•the Company has transferred substantially all the risks and rewards of the asset, or;
•the Company has neither transferred nor retained substantially all the risks and rewards of the asset but has transferred control of the asset.
When the Company has transferred its rights to receive cash flows from an asset or has entered into a pass-through arrangement, it evaluates if, and to what extent, it has retained the risks and rewards of ownership.
When the Company has neither transferred nor retained substantially all of the risks and rewards of the asset, nor transferred control of the asset, the Company continues to recognize the transferred asset to the extent of its continuing involvement. In that case, the Company also recognizes an associated liability. The transferred asset and the associated liability are measured on a basis that reflects the rights and obligations that the Company has retained.
Continuing involvement that takes the form of a guarantee over the transferred asset is measured at the lower of the original carrying amount of the asset and the maximum amount of consideration that the Company could be required to repay.
Financial assets—impairment
For cash and cash equivalents, the Company invests in short-term highly liquid assets where it has never incurred and does not expect to incur credit losses.
For accounts receivable the Company recognizes a loss allowance based on lifetime estimated credit losses (“ECL”) at each reporting date. When estimating the ECL the Company takes into consideration: readily available relevant and supportable information (this includes quantitative and qualitative data), the Company’s historical experience and forward-looking information specific to the receivables and the economic environment.
See Note 12 – “Accounts receivable” for further information about the Company’s accounting for trade receivables.
Financial liabilities classification
Financial liabilities are classified upon initial recognition as financial liabilities measured at fair value through income or at amortized cost. The Company’s financial liabilities include accounts payable and debt (including borrowings and lease liabilities), which are measured at amortized cost, and derivatives, which are measured at fair value through income.
Interest-bearing borrowings are initially recognized at fair value less directly attributable costs and subsequently measured at amortized cost using the EIR method. Gains and losses are recognized in income when the liabilities are derecognized as well as through the EIR amortization process.
Amortized cost is calculated by taking into account any discount or premium on acquisition and fees or costs that are an integral part of the EIR. The EIR amortization is included as interest expense in the statement of loss.
Financial liabilities—derecognition
A financial liability is derecognized when the obligation under the liability is discharged or canceled or expires. When an existing financial liability is replaced by another from the same lender on substantially different terms, or the terms of an existing liability are substantially modified, such an exchange or modification is treated as the derecognition of the original liability and the recognition of a new liability. The difference in the respective carrying amounts is recognized in the statements of loss.
New standards, amendments to standards and interpretations
New standards, amendments to standards, and interpretations issued recently effective
As of January 1, 2024 the amendments to paragraphs 69 to 76 of IAS 1, Presentation of Financial Statements (“IAS 1”), as issued by the IASB became effective. The Company assessed the changes to the accounting standard and determined the amendments did not have a material impact on the Company’s financial statements.
New standards, amendments to standards, and interpretations issued not yet effective
In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements, was issued to achieve comparability of the financial performance of similar entities. The standard, which will replace IAS 1 impacts the presentation of primary financial statements and notes, including the statement of profit and loss where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management-defined performance measures to be explained and included in a separate note within the consolidated financial statements. The standard is effective for annual reporting periods beginning on or after January 1, 2027, and requires retrospective application. The Company is currently evaluating the new standard to determine if it will have a material impact on the Company’s financial statements.
There are no other IFRS Accounting Standards or IFRS IC interpretations that are not yet effective and that could have a material impact to the consolidated financial statements.
3. Segment reporting
The Company operates in a single operating segment. The Company’s financial information is reviewed, and its performance assessed as a single segment by the senior management team led by the Chief Executive Officer (“CEO”), the Company’s Chief Operating Decision Maker (“CODM”).
For the years ended December 31, 2024 and 2023, respectively, the Company had a physical presence in three countries outside of its headquarters in Switzerland: France, the United States, and Brazil. An analysis of the location of non-current assets other than financial instruments and deferred tax assets by country is as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2024 |
|
2023 |
| Switzerland |
|
$ |
44,282 |
|
|
$ |
46,370 |
|
| France |
|
2,184 |
|
|
3,000 |
|
| United States |
|
1,906 |
|
|
913 |
|
|
|
|
|
|
| Brazil |
|
3 |
|
|
6 |
|
Total non-current assets other than financial instruments
and deferred tax assets |
|
$ |
48,375 |
|
|
$ |
50,289 |
|
4. Revenue
Critical accounting estimates and judgments
The Company recognizes revenue when control of promised goods or services is transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services. Significant judgment is required to determine the stand-alone selling price (“SSP”) for each performance obligation in the SOPHiA DDM Platform, the amount allocated to each performance obligation and whether it depicts the amount that the Company expects to receive in exchange for the related product and/or service.
The Company enters into arrangements with multiple performance obligations where it could be difficult to determine the performance obligations under a sales agreement; in such cases, how and when revenue should be recognized is subject to certain estimates or assumptions. Should these judgments and estimates not be correct, revenue recognized for any reporting period could be adversely affected.
Accounting policies
Revenue represents amounts received and receivable from third parties for goods supplied and services rendered to customers. Revenues are reported net of rebates and discounts and net of sales and value added taxes in an amount that reflects the consideration that is expected to be received for goods or services. The majority of the sales revenue is recognized: (i) when customers generate analyses on their patient data through the SOPHiA DDM Platform, (ii) when consumables, namely DNA enrichment kits, are delivered to customers at which point control transfers, (iii) when services, namely set-up programs, are performed and (iv) over the duration of the software licensing arrangements for the Alamut software offerings.
Products and services are sold both directly to customers and through distributors, generally under agreements with payment terms typically of 30 to 60 days with payment terms extended up to 180 days. Therefore, contracts do not contain a significant financing component.
For all contracts with customers the following steps are performed to determine the amount of revenue to be recognized and when it should be recognized: (1) identify the contract or contracts; (2) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (3) measure the transaction price, including the constraint on variable consideration; (4) allocate the transaction price to the performance obligations based on estimated selling prices; and (5) recognize revenue when (or as) each performance obligation is satisfied.
SOPHiA DDM Platform
The majority of the SOPHiA DDM Platform revenue is derived from each use of the SOPHiA DDM Platform by customers to generate analyses on their patient data. Analysis revenue is recognized as analysis results are made available to the customer on the SOPHiA DDM Platform. The Company recognizes accrued contract revenue in accounts receivable for any analyses performed by customers that have not been invoiced at the reporting date and where the right to consideration is unconditional. Any payments received in advance of customers generating analyses are recorded as deferred contract revenue until the analyses are performed.
Customers use the SOPHiA DDM Platform to perform analyses under three different models: dry lab access; bundle access; and integrated solutions.
For dry lab contracts, customers use the testing instruments and consumables of their choice and the SOPHiA DDM Platform and algorithms for variant detection and identification. In these arrangements, the Company has identified one performance obligation, which is the delivery of the analysis result to the customer.
For bundle arrangements, customers purchase a DNA enrichment kit along with each analysis. Customers use the DNA enrichment kit in the process of performing their own sequencing of each sample. Customers then upload their patient data to the SOPHiA DDM Platform for analysis. In these arrangements, the Company has identified two performance obligations: the delivery of the DNA enrichment kits and the performance of the analyses. Revenue is recognized for the DNA enrichment kits when control of products has transferred to the customer, which is generally at the time of delivery, as this is when title and risk of loss have been transferred. Revenue for the performance of the analyses is recognized on delivery of the analysis results to the customer.
Refer to "—Arrangements with multiple performance obligations” below for how revenue is allocated between the performance obligations.
Deferred contract revenue balances relating to analyses not performed within 12 months from the date of the delivery date are recognized as revenue. This policy is not based on contractual conditions but on the Company’s experience of customer behavior and expiration dates of the kits associated with the analyses.
For integrated arrangements, customers have their samples processed and sequenced through selected SOPHiA DDM Platform partners within the clinical network and access their data through the SOPHiA DDM Platform. The Company has identified one performance obligation, which is delivery of the analysis results to the customer through the SOPHiA DDM Platform.
The Company also sells access to its Alamut software application (“Alamut”) through the SOPHiA DDM Platform. Some arrangements with customers allow customers to use Alamut as a hosted software service over the contract period without the customer taking possession of the software. Other customers take possession of the software, but the utility of that software is limited by access to the Company’s proprietary SOPHiA database, which is provided to the customer on a fixed term basis. Under both models, revenue is recognized on a straight-line basis over the duration of the agreement.
The Company also derives revenue from the SOPHiA DDM Platform by providing services to biopharma customers who engage the Company to (i) develop and perform customized genomic analyses and/or (ii) access the database for use in clinical trials and other research projects.
The Company does enter into biopharma contracts that contain multiple products or services or non-standard terms and conditions. The biopharma contracts are generally unique in nature and each contract is assessed upon execution. Contracts may contain multiple performance obligations or performance obligations that are recognized overtime, at a point-in-time, or a combination depending on the Company’s ability to satisfy the requirements to recognize revenue over time and reasonably estimate the amount of revenue to recognize. See "—Arrangements with multiple performance obligations” below for further discussion on treatment of biopharma contracts.
Generally, the primary performance obligation in these arrangements is the delivery of analysis results in the form of a final report, resulting in revenue being recognized, in most cases, upon the issuance of the final report or successful recruitment of clinical trial participants.
Workflow materials and services
Revenue from workflow materials and services includes all revenue from the sale of materials and services that do not form part of a contract for the provision of platform services. These include the provision of set-up programs and training and the sale of kits and tests that are not linked to use of the platform. Set-up programs and training are typically combined with a customer’s first order prior to the customer beginning to use the SOPHiA DDM Platform.
Revenue from services is generally recognized when the services are performed. Revenue from materials is recognized when control of the goods is transferred to the customer, generally at the time of delivery. This category of revenue also includes the revenue from the sale of DNA sequencing automation equipment accounted for under IFRS 16, Leases (“IFRS 16”), leasing and the fees charged for the maintenance of this equipment.
Arrangements with multiple performance obligations
The Company sells different combinations of analyses, consumables, and services to its customers under its various SOPHiA DDM Platform models.
The Company has determined that the stand-alone selling prices for services and DNA enrichment kits are directly observable. For set-up programs and training sold along with dry lab arrangements or bundle arrangements, the stand-alone selling price of these services is determined on a time and materials basis. For DNA enrichment kits sold as part of a bundle, the SSP is based on an expected cost-plus-margin approach of the kit portion of the bundle.
The Company has determined that the SSP for the analyses, in both a dry lab arrangement and bundle arrangement, is highly variable and therefore a representative SSP is not discernible from past transactions. As a result, the residual approach is used to determine the stand-alone selling price of the analyses in dry lab arrangements that include services and in bundle arrangements that include DNA enrichment kits and, in some cases, services.
The Company also has a small number of bundle contracts with a fixed term that also include providing the customer with DNA sequencing automation equipment, which the Company has determined is an IFRS 16 leasing component. In these arrangements the Company provides DNA sequencing automation equipment to the customer over the fixed term and at completion of the contract term the customer takes possession of the equipment. The Company has determined that it is a dealer lessor and provision of this equipment to the customer is classified as a finance lease. As a result, upon delivery of the leased equipment at the inception of the arrangement, a selling profit is recognized based on the fair value of the underlying equipment less the cost of the equipment. Over the term of the agreement, the minimum lease payment is deducted from the proceeds of the bundle sales in order to reduce the net investment in the corresponding lease receivable over the contract term and interest income is recognized as the discount on the lease receivable unwinds. The remaining proceeds from the contract are accounted for under IFRS 15, Revenue from Contracts with Customers (“IFRS 15”), using the policies described above.
The Company assesses biopharma contracts upon execution of each contract given their unique nature. The Company establishes each performance obligation within the contract and determines the appropriate value to be ascribed to each performance obligation. When relevant the Company utilizes previous established SSPs of its dry lab and bundle solutions or other service. When the performance obligation is specific to only the contract the Company utilizes all available information to reasonably estimate the correct value allocated to the performance obligation.
Contract balances
Deferred contract costs
Deferred contract costs comprise deferred fulfillment costs related to biopharma, prepayments on contracts, and prepaid maintenance costs relating to DNA sequencing automation equipment.
Costs are incurred to fulfill obligations under certain contracts once obtained, but before transferring goods or services to the customer. Fulfillment costs are recognized as an asset, provided these costs are not addressed by other accounting standards, if the following criteria are met: (i) the costs relate directly to a contract or an anticipated contract that the Company can specifically identify, (ii) the costs generate or enhance resources of the Company that will be used in satisfying (or continuing to satisfy) performance obligations in the future and (iii) the costs are expected to be recovered.
The asset recognized from deferring the costs to fulfill a contract is recorded in the consolidated balance sheet as deferred contract costs within other current assets and amortized on a systematic basis consistent with the pattern of the transfer of the goods or services to which the asset relates, which depends on the nature of the performance obligation(s) in the contract. The amortization of these assets is recorded in cost of revenue.
The timing of revenue recognition and billings can result in accrued contract revenue, which is presented within accounts receivable in the consolidated balance sheet and deferred contract revenue which is presented on the face of the consolidated balance sheet.
Accrued contract revenue
Accrued contract revenue relates to revenue recognized from satisfied performance obligations prior to invoicing and is primarily related to Dry Lab to be invoiced for the most recently completed month and some portions of biopharma contracts.
Deferred contract revenue
Deferred contract revenue relates to prepayments received from customers before revenue is recognized and is primarily related to SOPHiA DDM Platform analyses invoiced in advance of the customers performing the analyses, deferred Alamut software revenue, and progress payments received as part of biopharma contracts.
Deferred contract revenue brought forward as of January 1, 2024 and 2023 amounts to $9.5 million and $3.4 million, respectively. During the twelve months ended December 31, 2024 and 2023, the Company satisfied the performance obligations associated with that deferred contract revenue to the extent that revenue was recognized of $9.5 million and $3.4 million, respectively.
The majority of the platform revenue is derived from contracts with an original expected length of one year or less. There are also certain biopharma and Alamut contracts in which performance obligations extend over multiple years, however, these contracts are immaterial. The Company has elected to apply the practical expedient not to disclose the value of remaining performance obligations associated with these types of contracts.
Disaggregated revenue
When disaggregating revenue, the Company considered all of the economic factors that may affect its revenues. The Company assesses its revenues by four geographic regions Europe, the Middle East, and Africa (“EMEA”); North America (“NORAM”); Latin America (“LATAM”); and Asia-Pacific (“APAC”). Additionally, the Company assesses revenues generated in its domiciled country and any country with significant revenue. The following table disaggregates the Company's revenue from contracts with customers by geographic market (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
|
|
|
|
2024 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
| Switzerland |
|
|
|
|
|
$ |
1,494 |
|
|
$ |
1,432 |
|
|
$ |
1,340 |
|
| France |
|
|
|
|
|
10,333 |
|
|
10,076 |
|
|
7,252 |
|
| Italy |
|
|
|
|
|
9,983 |
|
|
8,554 |
|
|
6,761 |
|
| Spain |
|
|
|
|
|
5,788 |
|
|
6,512 |
|
|
4,665 |
|
| Rest of EMEA |
|
|
|
|
|
19,331 |
|
|
17,384 |
|
|
14,860 |
|
| EMEA |
|
|
|
|
|
$ |
46,929 |
|
|
$ |
43,958 |
|
|
$ |
34,878 |
|
|
|
|
|
|
|
|
|
|
|
|
| United States |
|
|
|
|
|
$ |
9,323 |
|
|
$ |
9,465 |
|
|
$ |
5,581 |
|
| Rest of NORAM |
|
|
|
|
|
1,977 |
|
|
1,261 |
|
|
1,151 |
|
| NORAM |
|
|
|
|
|
$ |
11,300 |
|
|
$ |
10,726 |
|
|
$ |
6,732 |
|
|
|
|
|
|
|
|
|
|
|
|
| LATAM |
|
|
|
|
|
$ |
2,890 |
|
|
$ |
3,990 |
|
|
$ |
3,003 |
|
|
|
|
|
|
|
|
|
|
|
|
| APAC |
|
|
|
|
|
$ |
4,054 |
|
|
$ |
3,697 |
|
|
$ |
2,947 |
|
| Total revenue |
|
|
|
|
|
$ |
65,173 |
|
|
$ |
62,371 |
|
|
$ |
47,560 |
|
Revenue streams
The Company’s revenue from contracts with customers has been allocated to the revenue streams indicated in the table below (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
|
|
|
|
2024 |
|
2023 |
|
2022 |
| SOPHiA DDM Platform |
|
|
|
|
|
$ |
63,546 |
|
|
$ |
60,904 |
|
|
$ |
45,679 |
|
| Workflow equipment and services |
|
|
|
|
|
1,627 |
|
|
1,467 |
|
|
1,881 |
|
| Total revenue |
|
|
|
|
|
$ |
65,173 |
|
|
$ |
62,371 |
|
|
$ |
47,560 |
|
Workflow equipment and services includes revenues from payments from leased equipment recognized under IFRS 16, Leases, no revenue, $0.1 million, and $0.1 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Major Customers
Revenues from one customer, a distributor for the Company, represented approximately $8.2 million of the Company’s total revenues for the fiscal year ended December 31, 2024. The Company did not have revenues greater than 10% from a single customer in the fiscal year ended December 31, 2023 and 2022, respectively.
5. Cost of revenue
Accounting policies
Cost of revenue comprises costs directly incurred in earning revenue, including computer costs and data storage fees paid to hosting providers, manufacturing costs, materials and consumables, the cost of equipment leased out under finance leases, personnel-related expenses and amortization of capitalized development costs.
6. Operating expense
Accounting policies
Research and development
Research and development costs consist of personnel and related expenses for technology, application, and product development, depreciation and amortization, laboratory supplies, consulting services, computational and data storage fees paid to hosting providers related to research and development, and allocated overhead costs. These costs are stated net of government grants for research and development and innovation received as tax credits and net of capitalized costs.
Government grants for research and development and innovation received as tax credits
The Company receives government grants in France for research and development and innovation by way of tax credits. Total government grants for research and development and innovation recognized in the statement of loss amounts to $0.7 million, $1.1 million, and $1.3 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Selling and marketing costs
Selling and marketing costs consist of personnel and related expenses for the employees of the sales and marketing organization, costs of communications materials that are produced to generate greater awareness and utilization of the platform among customers, costs of third-party market research, costs related to transportation and distribution of products and allocated overhead costs, and commissions to sales employees. The Company also records increases to, reversals of, and write-offs of the allowance for expected credit losses to selling and marketing costs.
The Company pays sales commission to its employees for obtaining contracts. These costs are expensed as part of employee compensation in selling and marketing costs. They are not capitalized as contract costs as the commissions either represent bonuses payable for revenue earned in the period or have a service condition attached.
General and administrative costs
General and administrative costs consist of personnel and related expenses for executive, accounting and finance, legal, quality, support and human resources functions, depreciation and amortization, professional services fees incurred by these functions, general corporate costs and allocated overhead costs, which include occupancy costs and information technology costs.
Operating expense by nature
The table presents operating expenses by nature (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Changes in inventories of finished goods and work in progress |
|
$ |
(183) |
|
|
$ |
145 |
|
|
$ |
47 |
|
| Raw materials and consumables used |
|
(17,529) |
|
|
(17,504) |
|
|
(13,341) |
|
| Employee benefit expenses |
|
(56,900) |
|
|
(60,323) |
|
|
(59,333) |
|
| Social charges |
|
(10,514) |
|
|
(11,956) |
|
|
(11,480) |
|
|
|
|
|
|
|
|
| Research tax credit |
|
726 |
|
|
1,129 |
|
|
1,292 |
|
| Share-based compensation |
|
(16,488) |
|
|
(15,242) |
|
|
(13,613) |
|
| Depreciation |
|
(4,575) |
|
|
(5,508) |
|
|
(3,791) |
|
| Amortization |
|
(4,021) |
|
|
(2,828) |
|
|
(1,780) |
|
| Professional fees |
|
(10,987) |
|
|
(14,245) |
|
|
(13,837) |
|
| Laboratory and office expenses |
|
(5,088) |
|
|
(6,279) |
|
|
(6,635) |
|
| Travel |
|
(3,115) |
|
|
(3,087) |
|
|
(3,217) |
|
| Marketing |
|
(2,872) |
|
|
(1,767) |
|
|
(2,213) |
|
| Licenses |
|
(4,120) |
|
|
(4,235) |
|
|
(3,949) |
|
| Less: capitalized software development costs ("Note 16 - Intangible assets”) |
|
7,737 |
|
|
7,469 |
|
|
5,820 |
|
| Other expense |
|
(3,995) |
|
|
(3,920) |
|
|
(9,730) |
|
| Total |
|
$ |
(131,924) |
|
|
$ |
(138,151) |
|
|
$ |
(135,760) |
|
Depreciation and amortization have been charged in the following expense categories (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
|
|
Depreciation |
|
Amortization |
|
Depreciation |
|
Amortization |
|
Depreciation |
|
Amortization |
| Cost of revenue |
|
$ |
— |
|
|
$ |
(3,524) |
|
|
$ |
— |
|
|
$ |
(2,099) |
|
|
$ |
— |
|
|
$ |
(1,133) |
|
| Research and development costs |
|
(1,961) |
|
|
— |
|
|
(2,494) |
|
|
— |
|
|
(1,748) |
|
|
— |
|
| Selling and marketing costs |
|
(1,349) |
|
|
— |
|
|
(1,468) |
|
|
— |
|
|
(906) |
|
|
— |
|
| General and administrative costs |
|
(1,265) |
|
|
(497) |
|
|
(1,546) |
|
|
(729) |
|
|
(1,137) |
|
|
(647) |
|
| Total |
|
$ |
(4,575) |
|
|
$ |
(4,021) |
|
|
$ |
(5,508) |
|
|
$ |
(2,828) |
|
|
$ |
(3,791) |
|
|
$ |
(1,780) |
|
The table presents employee costs by function, which consists of “Employee benefit expenses”, “Social charges” and “Share-based compensation” from the operating expense table (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Research and development costs |
|
31,321 |
|
|
31,280 |
|
|
29,169 |
|
| Selling and marketing costs |
|
20,038 |
|
|
20,174 |
|
|
20,216 |
|
| General and administrative costs |
|
32,543 |
|
|
36,067 |
|
|
35,041 |
|
| Total |
|
$ |
83,902 |
|
|
$ |
87,521 |
|
|
$ |
84,426 |
|
7. Other operating income, net
Accounting policies
The Company records income and expenses that are not regularly occurring or normal business income and expense to other operating income, net. Other operating income, net consists of gains and losses related to the disposal of tangible assets, write-offs of intangible assets and other operating income (expense).
8. Interest income, Interest expense and Foreign exchange gains (losses), net
Accounting policies
Interest income consists of interest income earned on cash and cash equivalents, short-term investments, and lease receivables. Interest expense consists of interest expense incurred on lease liabilities and loans, which includes, interest on commercial borrowings. The foreign exchange gains and losses arise principally on intercompany receivable balances in the parent company, whose functional currency is the Swiss Franc.
Interest income
The table presents interest income (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Interest income |
|
$ |
3,362 |
|
|
$ |
4,547 |
|
|
$ |
1,324 |
|
| Total interest income |
|
$ |
3,362 |
|
|
$ |
4,547 |
|
|
$ |
1,324 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
The table presents interest expense (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Interest on loans |
|
(1,339) |
|
|
— |
|
|
— |
|
| Interest on lease liabilities |
|
(567) |
|
|
(545) |
|
|
(422) |
|
| Other interest |
|
(7) |
|
|
(43) |
|
|
(217) |
|
| Total interest expense |
|
$ |
(1,913) |
|
|
$ |
(588) |
|
|
$ |
(639) |
|
|
|
|
|
|
|
|
Foreign exchange gains (losses), net
The table presents foreign exchange gains (losses), net (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
| Foreign exchange gains (losses), net |
|
3,479 |
|
|
(7,628) |
|
|
(447) |
|
| Total foreign exchange gains (losses), net |
|
$ |
3,479 |
|
|
$ |
(7,628) |
|
|
$ |
(447) |
|
9. Income tax
Critical accounting estimates and judgments
Uncertain tax positions
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates and is therefore subject to tax examination by various taxing authorities. In the normal course of business, the Company is subject to examination by local tax authorities in Switzerland, France, Italy, Brazil, Australia, the U.K. and the U.S. In 2022 a tax assessment examination was rendered by the French tax authority during an audit of the Company’s 2018 and 2019 tax returns. In 2023, a tax assessment was rendered by the French tax authority during the review of the 2022 tax return as discussed below. In 2024, a tax assessment was rendered by the Swiss tax authority regarding the Company’s 2019 through 2023 tax returns. The Company is not aware of any additional issues that could result in any other significant payments, accruals or material deviation from its tax positions. There are no tax examinations in progress as of December 31, 2024.
The Company records tax liabilities or benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available at the reporting date. There is inherent uncertainty in quantifying income tax positions, especially considering the complex tax laws and regulations in each of the jurisdictions in which the Company operates.
Accounting policies
The Company is subject to taxes in different countries. Taxes and related fiscal assets and liabilities recognized in the Company’s consolidated financial statements reflect management’s best estimate of the outcome based on the facts known at the balance sheet date in each individual country. These facts may include but are not limited to change in tax laws and interpretation thereof in the various jurisdictions where the Company operates. They may have an impact on the income tax as well as the resulting income tax assets and liabilities. Any differences between tax estimates and final tax assessments are charged to the statement of loss in the period in which they are incurred. Taxes include current and deferred taxes on income as well as actual or potential withholding taxes on current and expected transfers of income from subsidiaries and tax adjustments relating to prior years. Income tax is recognized in the statement of loss, except to the extent that it relates to an item directly taken to other comprehensive income/loss or equity, in which case it is recognized against other comprehensive income/loss or equity, respectively.
Current income tax liabilities refer to the portion of the tax on the current year taxable profit (as determined according to the rules of the taxation authorities) and includes uncertain tax liabilities. The Company determines the taxable profit (tax loss), tax bases, unused tax losses, unused tax credits and tax rates consistently with the tax treatment used or planned to be used in its income tax filings if the Company concludes it is probable that the taxation authority will accept an uncertain tax treatment.
Otherwise, the Company reflects the effect of uncertainty using either the most likely outcome or the expected value outcome, depending on which method the entity expects to better predict the resolution of the uncertainty.
Deferred taxes are based on the temporary differences that arise when taxation authorities recognize and measure assets and liabilities with rules that differ from the accounting policies of the Company’s consolidated financial statements. They also arise on temporary differences stemming from tax losses carried forward. Deferred taxes are measured at the rates of tax expected to prevail when the temporary differences reverse, subject to such rates being substantively enacted at the balance sheet date. Any changes of the tax rates are recognized in the statement of loss unless related to items directly recognized against other comprehensive income. Deferred tax liabilities are recognized on all taxable temporary differences excluding non-deductible goodwill. Deferred tax assets are recognized for unused tax losses, unused tax credits and deductible temporary differences to the extent that it is probable that future taxable profits will be available against which they can be used. Future taxable profits are determined based on the reversal of relevant taxable temporary differences. If the amount of taxable temporary differences is insufficient to recognize a deferred tax asset in full, then future taxable profits, adjusted for reversals of existing temporary differences, are considered, on the basis of the business plans for individual subsidiaries in the Company. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized; such reductions are reversed when the probability of future taxable profits improves.
The tax impact of a transaction or item can be uncertain until a conclusion is reached with the relevant tax authority or through a legal process. The Company uses in-house tax experts when assessing uncertain tax positions and seeks the advice of external professional advisors where appropriate. The assessment of the uncertain tax position is done by first making a determination of whether it is more likely than not that a tax position would be sustained upon an examination, and then by calculating the amount of the benefit, of that tax position that meets the more likely than not threshold, that should be recognized in the financial statements.
As of December 31, 2024, and 2023, the Company recorded a provision of $0.2 million and less than $0.1 million, respectively, for unrecognized tax liabilities including interest and penalties. The Company records interest and penalties related to income tax amounts as a component of income tax expense.
France tax audit
The French tax authority issued a tax assessment in December 2022 that reduced the balance of the Company’s tax losses carryforward in France by $1.8 million ($0.4 million tax effected amount) stemming from a review of the Company’s transfer pricing policy. The tax assessment in France has resulted in no other material tax liability or payment. In 2023, the French tax authority performed a review of the Company’s 2022 French tax return. No additional tax liabilities resulted from the review of the 2022 French tax return.
Presentation of income tax (expense) benefits
The following table presents the current and deferred income tax (expense) benefits (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Current income tax expense |
|
|
|
|
|
|
| Current year |
|
$ |
(1,115) |
|
|
$ |
(215) |
|
|
$ |
(310) |
|
| Uncertain tax positions |
|
(155) |
|
|
(40) |
|
|
328 |
|
| Total current income tax expense |
|
$ |
(1,270) |
|
|
$ |
(255) |
|
|
$ |
18 |
|
|
|
|
|
|
|
|
| Deferred income tax (expense) benefit |
|
|
|
|
|
|
| Origination and reversal of temporary differences |
|
$ |
47 |
|
|
$ |
(231) |
|
|
$ |
118 |
|
|
|
|
|
|
|
|
| Total deferred income tax (expense) benefit |
|
$ |
47 |
|
|
$ |
(231) |
|
|
$ |
118 |
|
|
|
|
|
|
|
|
| Total income tax (expense) benefit |
|
$ |
(1,223) |
|
|
$ |
(486) |
|
|
$ |
136 |
|
The following table presents the reconciliation of the expected tax expense to the tax expense report in the statement of loss (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Loss before tax |
|
$ |
(61,270) |
|
|
$ |
(77,893) |
|
|
$ |
(87,585) |
|
| Tax at Swiss statutory rate |
|
8,222 |
|
|
10,453 |
|
|
11,749 |
|
| Effect of tax rates in foreign jurisdictions |
|
(893) |
|
|
(833) |
|
|
(292) |
|
| Tax effect of: |
|
|
|
|
|
|
| Unrecognized deferred tax assets |
|
(6,025) |
|
|
(8,879) |
|
|
(9,386) |
|
| Income not subject to tax |
|
249 |
|
|
303 |
|
|
325 |
|
| Expense not deductible for tax purposes |
|
(2,263) |
|
|
(2,085) |
|
|
(2,265) |
|
| Uncertain tax positions |
|
(155) |
|
|
(40) |
|
|
328 |
|
| Recognition of deferred tax assets from previously unrecognized tax assets |
|
— |
|
|
— |
|
|
509 |
|
| 2018-2019 French tax assessment |
|
— |
|
|
— |
|
|
(427) |
|
| Other |
|
(358) |
|
|
595 |
|
|
(405) |
|
| Income tax (expense)/benefit |
|
$ |
(1,223) |
|
|
$ |
(486) |
|
|
$ |
136 |
|
Movement in the deferred tax balances
During the year ended December 31, 2024, the Company recognized deferred tax assets for its foreign subsidiaries due to intercompany transfer pricing arrangements that will assure realization of their respective deferred tax assets in each country. The following table presents the changes in the Company’s deferred tax assets and deferred tax liabilities (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation &
amortization |
|
|
|
Accrued pension |
|
ROU asset |
|
Lease liability |
|
Other |
|
Net operating loss
carryforward |
|
Total |
| January 1, 2024 |
|
$ |
(19) |
|
|
|
|
$ |
— |
|
|
$ |
(761) |
|
|
$ |
794 |
|
|
$ |
696 |
|
|
$ |
1,010 |
|
|
$ |
1,720 |
|
| Recognized in profit or loss |
|
(123) |
|
|
|
|
— |
|
|
(166) |
|
|
287 |
|
|
(91) |
|
|
140 |
|
|
47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Currency translation differences |
|
6 |
|
|
|
|
— |
|
|
30 |
|
|
(34) |
|
|
(2) |
|
|
— |
|
|
— |
|
| December 31, 2024 |
|
$ |
(136) |
|
|
|
|
$ |
— |
|
|
$ |
(897) |
|
|
$ |
1,047 |
|
|
$ |
603 |
|
|
$ |
1,150 |
|
|
$ |
1,767 |
|
| Deferred tax assets |
|
— |
|
|
|
|
— |
|
|
— |
|
|
1,047 |
|
|
670 |
|
|
1,150 |
|
|
2,867 |
|
| Deferred tax liabilities |
|
(136) |
|
|
|
|
— |
|
|
(897) |
|
|
— |
|
|
(67) |
|
|
— |
|
|
(1,100) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation &
amortization |
|
|
|
Accrued pension |
|
ROU asset |
|
Lease liability |
|
Other |
|
Net operating loss
carryforward |
|
Total |
| January 1, 2023 |
|
$ |
(80) |
|
|
|
|
$ |
9 |
|
|
$ |
(302) |
|
|
$ |
511 |
|
|
$ |
852 |
|
|
$ |
950 |
|
|
$ |
1,940 |
|
| Recognized in profit or loss |
|
62 |
|
|
|
|
54 |
|
|
(447) |
|
|
270 |
|
|
(155) |
|
|
36 |
|
|
(180) |
|
| Recognized in OCI |
|
— |
|
|
|
|
(64) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(64) |
|
| Currency translation differences |
|
(1) |
|
|
|
|
1 |
|
|
(12) |
|
|
13 |
|
|
(1) |
|
|
24 |
|
|
24 |
|
| December 31, 2023 |
|
$ |
(19) |
|
|
|
|
$ |
— |
|
|
$ |
(761) |
|
|
$ |
794 |
|
|
$ |
696 |
|
|
$ |
1,010 |
|
|
$ |
1,720 |
|
| Deferred tax assets |
|
— |
|
|
|
|
— |
|
|
— |
|
|
794 |
|
|
806 |
|
|
1,010 |
|
|
2,610 |
|
| Deferred tax liabilities |
|
(19) |
|
|
|
|
— |
|
|
(761) |
|
|
— |
|
|
(110) |
|
|
— |
|
|
(890) |
|
Unrecognized deferred tax assets
As of December 31, 2024 and 2023, the Company recognized deferred tax assets to the extent that it was probable that they would be realized. The following table consists of the gross tax loss carryforwards and the deferred tax assets that have not been recognized because it is not probable that there will be future taxable profits to use these benefits (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
|
Gross amount |
|
Tax effect |
|
Gross amount |
|
Tax effect |
| Deductible temporary differences |
|
$ |
4,623 |
|
|
$ |
661 |
|
|
$ |
4,652 |
|
|
$ |
710 |
|
| Net operating loss carryforwards |
|
347,533 |
|
|
46,544 |
|
|
344,887 |
|
|
44,614 |
|
| Total |
|
$ |
352,156 |
|
|
$ |
47,205 |
|
|
$ |
349,539 |
|
|
$ |
45,324 |
|
Net operating loss carryforwards
As of December 31, 2024 and 2023, the Company had various net operating loss (“NOL”) carryforwards in Switzerland, the U.K., the U.S., and Brazil that are available to reduce future taxable income and income taxes, the majority of which will expire at various dates through 2031. As of December 31, 2024 and 2023, the Company had the following expiring amounts of unrecognized NOL carryforwards (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| One year |
|
$ |
15,853 |
|
|
$ |
17,873 |
|
| Two years |
|
23,958 |
|
|
17,103 |
|
| Three years |
|
49,729 |
|
|
25,846 |
|
| Four years |
|
68,886 |
|
|
53,648 |
|
| Thereafter and unlimited |
|
189,107 |
|
|
230,417 |
|
| Net operating loss carryforwards |
|
$ |
347,533 |
|
|
$ |
344,887 |
|
Future realization of the tax benefits of existing temporary differences and NOL carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period. As of December 31, 2024, the Company performed an evaluation to determine the likelihood of realization of these tax benefits. In assessing the realization of the deferred tax assets, the Company considered whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company considered all available evidence, both positive and negative, which included the results of operations for the current and preceding years. The Company determined that it was not possible to reasonably quantify future taxable income and determined that it is not probable that all of the deferred tax assets will be realized in Switzerland and Brazil but has recognized deferred tax assets in France, Italy, the U.K. and the U.S.
Unrecognized deferred tax liability on retained earnings of subsidiaries
The Company reviews its plan to indefinitely reinvest on a periodic basis for each one of its foreign subsidiaries. In making its decision to indefinitely reinvest, the Company evaluates its plans of reinvestment, its ability to control repatriation and to mobilize funds without triggering basis differences, and the profitability of its Swiss operations and associated cash requirements and the need, if any, to repatriate funds. If the assessment of the Company with respect to any earnings of its foreign subsidiaries’ changes, deferred Swiss income taxes, foreign income taxes, and foreign withholding taxes may have to be accrued.
The Company does not provide for foreign income and withholding taxes, Swiss income taxes or tax benefits on the excess of the financial reporting basis over the tax basis of its investments in foreign subsidiaries to the extent that such amounts are indefinitely reinvested to support operations and continued growth plans outside of Switzerland, or if the Company has determined that no tax liability would arise in case of distribution.
As of December 31, 2024, the Company plans to indefinitely reinvest any undistributed foreign earnings for all its foreign subsidiaries except France. During the year 2024, the Company received a dividend payment from its French subsidiary in the amount of $3.3 million, paid on October 8, 2024. During the year 2023, the Company received a dividend payment from its French subsidiary in the amount of $2.4 million.
The Company has determined that the repatriation of foreign earnings from France does not trigger a tax liability, based on the application of Swiss Participation Exemption rules and exemptions provided by the Double Tax Treaty signed between France and Switzerland, based on which dividends are exempt from withholding tax. The total amount of temporary differences associated with the other investments in subsidiaries is not material.
10. Loss per share
The Company’s shares comprised of ordinary shares. Each share has a nominal value of $0.05 (CHF 0.05). The basic loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares in issue during the period excluding treasury shares, which are owned by the Company. The table presents the loss for the year ended December 31, 2024, 2023, and 2022, respectively (in USD thousands, except shares and loss per share):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Net loss attributed to shareholders |
|
$ |
(62,493) |
|
|
$ |
(78,981) |
|
|
$ |
(87,449) |
|
| Weighted average number of shares in issue |
|
66,062,205 |
|
|
64,750,886 |
|
|
64,099,213 |
|
| Basic and diluted loss per share |
|
$ |
(0.95) |
|
|
$ |
(1.22) |
|
|
$ |
(1.36) |
|
For the year ended December 31, 2024, the potential impact, on the calculation of loss per share, of the existing potential ordinary shares related to the share option plans and warrants are not presented, as the impact would be to dilute a loss, which causes them to be deemed “non-dilutive” for the purposes of the required disclosure, for additional details refer to Note 22 — “Share-Based Compensation” and Note 23 — “Borrowings”.
11. Cash and cash equivalents
Accounting policies
Cash and cash equivalents include cash on hand, deposits held at call with external financial institutions, money market funds, and short-term deposits and other short-term highly liquid investments with original maturities of three months or less. They are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of changes in interest rates. Amounts held in money market funds are classified as cash equivalents and are measured as level 1 fair value financial instruments.
The following table presents the allocation between the Company’s cash and cash equivalents (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Cash on hand |
|
$ |
13,783 |
|
|
$ |
16,068 |
|
| Total cash |
|
$ |
13,783 |
|
|
$ |
16,068 |
|
|
|
|
|
|
| Money market funds |
|
$ |
39,586 |
|
|
$ |
60,683 |
|
| Term deposits less than 3 months |
|
26,857 |
|
46,500 |
| Total cash equivalents |
|
$ |
66,443 |
|
|
$ |
107,183 |
|
|
|
|
|
|
| Cash and cash equivalents |
|
$ |
80,226 |
|
|
$ |
123,251 |
|
Designated cash
Previously, the Company had designated cash in a separate bank account to be used exclusively to settle potential liabilities arising from claims against Directors and Officers covered under the Company’s Directors and Officers Insurances Policy (“D&O Policy”). Setting up the designated account significantly reduced the premiums associated with the D&O Policy. As of December 31, 2023 the Company had $15 million of designated cash in a separate bank account to be used exclusively to settle potential liabilities arising from claims against Directors and Officers covered under the Company’s D&O Policy. In June 2024, the Company renewed the policy and under the new D&O policy removed the requirement for the Company to maintain a designated cash amount. The new D&O policy and elimination of designated cash went into effect in July 2024.
12. Accounts receivable
Critical accounting estimates and judgments
The Company has adopted the simplified method indicated in IFRS 9, Financial Instruments (“IFRS 9”), to build its allowance for expected credit losses (“ECL”). The Company uses a matrix based on a calculation of collectability rates according to historical accounts receivable. Allowance is made for lifetime expected credit losses as invoices are issued or when accrued revenue is recognized. The amount of allowance initially recognized is based on historical experience, tempered by expected changes in future cash collections, due to, for example, expected improved customer liquidity or more active credit management.
Accounting policies
Accounts receivable-trade balances are non-interest bearing and payment terms are generally under agreements with payment terms typically between 30 and 60 days with payment terms extended up to 180 days. The Company’s customers primarily consist of government-owned or government-funded hospitals, laboratories with low credit risk, and biopharmaceutical companies. The Company has had minimal instances of actual credit losses and believes that this will continue to be the case.
The following table presents the trade receivable, accrued contract revenue, and lease receivable less the expected credit loss (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2024 |
|
2023 |
| Trade receivable |
|
$ |
7,088 |
|
|
$ |
10,259 |
|
| Accrued contract revenue |
|
742 |
|
|
4,451 |
|
| Lease receivable |
|
— |
|
|
28 |
|
| Allowance for expected credit losses |
|
(394) |
|
|
(1,181) |
|
| Net accounts receivable |
|
$ |
7,436 |
|
|
$ |
13,557 |
|
The Company records increases to, reversals of, and write-offs of the allowance for expected credit losses as “Selling and Marketing” expenses within its consolidated statements of loss. The following table provides a rollforward of the allowance for expected credit losses for the year ended December 31, 2024 and 2023, that is deducted from the amortized cost basis of accounts receivable to present the net amount expected to be collected (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
| As of January 1 |
|
$ |
1,181 |
|
|
$ |
1,095 |
|
| Increase |
|
114 |
|
|
1,311 |
|
| Reversals |
|
(637) |
|
|
(1,097) |
|
| Write-off |
|
(213) |
|
|
(226) |
|
| Currency translation adjustments |
|
(51) |
|
|
98 |
|
| As of December 31 |
|
$ |
394 |
|
|
$ |
1,181 |
|
As of December 31, 2024 and 2023, the Company’s largest customer balance represented 18% and 24% of accounts receivable, respectively. All customer balances that individually exceeded 1% of accounts receivable in aggregate amounted to $5.0 million and $6.7 million as of December 31, 2024 and 2023, respectively.
Accounts receivable includes amounts receivable that relate to leases. The Company is the lessor under finance leases related to the leasing out of DNA sequencing automation equipment. The Company recorded no long-term lease receivables as of December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, the Company recorded no net lease receivables and less than $0.1 million, respectively.
13. Inventory
Accounting policies
Raw materials and finished goods are stated at the lower of cost calculated using the first-in, first-out (“FIFO”) method and net realizable value. Work in progress is stated at the lower of its weighted average cost and net realizable value. Cost comprises direct materials, direct labor, and an appropriate proportion of variable and fixed overhead expenditure, the latter being allocated on the basis of normal operating capacity.
Inventory consists of the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Raw materials |
|
$ |
5,526 |
|
|
$ |
7,007 |
|
| Work in progress |
|
1,321 |
|
|
1,482 |
|
| Finished goods |
|
105 |
|
|
127 |
|
| Provision |
|
(1,084) |
|
|
(2,134) |
|
| Total |
|
$ |
5,868 |
|
|
$ |
6,482 |
|
Inventory provision movement for the years ended December 31, 2024 and 2023, respectively are as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
| As of January 1 |
|
$ |
(2,134) |
|
|
$ |
(1,503) |
|
| Increase |
|
(770) |
|
|
(1,276) |
|
| Reversals |
|
486 |
|
|
136 |
|
| Write-off |
|
1,241 |
|
|
692 |
|
| Currency translation adjustment |
|
93 |
|
|
(183) |
|
| As of December 31 |
|
$ |
(1,084) |
|
|
$ |
(2,134) |
|
14. Prepaids and other current assets
The following table presents prepaids and other current assets (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Prepayments |
|
$ |
3,786 |
|
|
$ |
2,764 |
|
| VAT receivable |
|
1,254 |
|
|
1,483 |
|
| Government grants receivable |
|
— |
|
|
165 |
|
| Other |
|
835 |
|
|
345 |
|
| Total |
|
$ |
5,875 |
|
|
$ |
4,757 |
|
15. Property and equipment
Accounting policies
Property and equipment include leasehold improvements, computer hardware, machinery, and furniture and fixtures.
Property and equipment are shown on the balance sheet at their historical cost. The cost of an asset, less any residual value, is depreciated using the straight-line method over the useful life of the asset. For this purpose, assets with similar useful lives have been grouped as follows:
•Leasehold improvements—Shorter of the useful life of the asset or the remaining term of the lease
•Computer hardware—Three to five years
•Machinery and equipment—Five years
•Furniture and fixtures—Five years
Useful lives, components, and residual amounts are reviewed annually. Such a review takes into consideration the nature of the assets, their intended use, including but not limited to the closure of facilities, and the evolution of the technology and competitive pressures that may lead to technical obsolescence. Depreciation of property and equipment is allocated to the appropriate headings of expenses by function in the statement of loss.
Reviews of the carrying amount of the Company’s property and equipment are performed when there is an indication of impairment. If any such indication exists, then the asset’s recoverable amount is estimated. The recoverable amount of an asset is the greater of its value in use and its fair value less costs of disposal. In assessing the value in use, the estimated future cash flows are discounted to their present value, based on the time value of money and the risks specific to the country where the assets are located.
The Company records property and equipment under accrued expense for amounts to be paid within the next 12 months. For the year ended December 31, 2024, no amounts were recorded in accrued expense for property and equipment, and for the year ended December 31, 2023, $0.2 million was recorded.
Property and equipment, net movement for the years ended December 31, 2024 and 2023, respectively are as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvements |
|
Machinery and equipment |
|
Computer hardware |
|
Furniture and fixtures |
|
Total |
| January 1, 2024 |
|
$ |
6,855 |
|
|
$ |
1,975 |
|
|
$ |
1,460 |
|
|
$ |
1,310 |
|
|
$ |
11,600 |
|
| Additions |
|
86 |
|
|
115 |
|
|
1 |
|
|
15 |
|
|
217 |
|
| Disposals |
|
— |
|
|
(66) |
|
|
(14) |
|
|
— |
|
|
(80) |
|
| Currency Translation Adjustment |
|
(485) |
|
|
(163) |
|
|
(86) |
|
|
(81) |
|
|
(815) |
|
| December 31, 2024 |
|
$ |
6,456 |
|
|
$ |
1,861 |
|
|
$ |
1,361 |
|
|
$ |
1,244 |
|
|
$ |
10,922 |
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated depreciation |
|
|
|
|
|
|
|
|
|
|
| January 1, 2024 |
|
$ |
(1,576) |
|
|
$ |
(993) |
|
|
$ |
(831) |
|
|
$ |
(731) |
|
|
$ |
(4,131) |
|
| Additions |
|
(1,182) |
|
|
(269) |
|
|
(208) |
|
|
(276) |
|
|
(1,935) |
|
| Disposals |
|
— |
|
|
— |
|
|
14 |
|
|
— |
|
|
14 |
|
| Currency Translation Adjustment |
|
143 |
|
|
92 |
|
|
52 |
|
|
52 |
|
|
339 |
|
| December 31, 2024 |
|
$ |
(2,615) |
|
|
$ |
(1,170) |
|
|
$ |
(973) |
|
|
$ |
(955) |
|
|
$ |
(5,713) |
|
| Net book value at December 31, 2024 |
|
$ |
3,841 |
|
|
$ |
691 |
|
|
$ |
388 |
|
|
$ |
289 |
|
|
$ |
5,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvements |
|
Machinery and equipment |
|
Computer hardware |
|
Furniture and fixtures |
|
Total |
| January 1, 2023 |
|
$ |
6,182 |
|
|
$ |
1,626 |
|
|
$ |
1,633 |
|
|
$ |
1,108 |
|
|
$ |
10,549 |
|
| Additions |
|
937 |
|
|
176 |
|
|
359 |
|
|
118 |
|
|
1,590 |
|
| Disposals |
|
(854) |
|
|
— |
|
|
(623) |
|
|
(4) |
|
|
(1,481) |
|
| Currency Translation Adjustment |
|
590 |
|
|
173 |
|
|
91 |
|
|
88 |
|
|
942 |
|
| December 31, 2023 |
|
$ |
6,855 |
|
|
$ |
1,975 |
|
|
$ |
1,460 |
|
|
$ |
1,310 |
|
|
$ |
11,600 |
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated depreciation |
|
|
|
|
|
|
|
|
|
|
| January 1, 2023 |
|
$ |
(1,165) |
|
|
$ |
(665) |
|
|
$ |
(1,143) |
|
|
$ |
(447) |
|
|
$ |
(3,420) |
|
| Additions |
|
(1,147) |
|
|
(246) |
|
|
(229) |
|
|
(240) |
|
|
(1,862) |
|
| Disposals |
|
844 |
|
|
— |
|
|
604 |
|
|
4 |
|
|
1,452 |
|
| Currency Translation Adjustment |
|
(108) |
|
|
(82) |
|
|
(63) |
|
|
(48) |
|
|
(301) |
|
| December 31, 2023 |
|
$ |
(1,576) |
|
|
$ |
(993) |
|
|
$ |
(831) |
|
|
$ |
(731) |
|
|
$ |
(4,131) |
|
| Net book value at December 31, 2023 |
|
$ |
5,279 |
|
|
$ |
982 |
|
|
$ |
629 |
|
|
$ |
579 |
|
|
$ |
7,469 |
|
16. Intangible Assets
Critical accounting estimates and judgments
Goodwill impairment testing
The Company operates as one segment or as a single cash-generating unit (“CGU”). As a single CGU, goodwill is tested by considering its recoverability in terms of the entire business. Management assesses the recoverable value of goodwill by comparing the Company’s equity value, either from observable market prices or based on discounted cash flow forecasts, to the net assets as reported in the Company’s consolidated financial statements. Impairment testing is performed on an annual basis as of October 1.
Capitalized internally developed software costs
Capitalized costs are based on the employment costs of individuals working on software development and based on timesheets. Special attention is paid to distinguishing between costs incurred on developing new software or software upgrades, which typically are eligible for capitalization, and costs incurred in maintenance and in the correction of problems, which are not eligible.
Judgment is required in identifying whether individual projects meet all of the criteria required to permit capitalization, in particular, whether the software will generate probable future economic benefits.
Accounting policies
Goodwill
Goodwill is initially measured as the difference between the aggregate of the value of the consideration transferred and the fair value of net assets acquired. Goodwill is not amortized but it is tested for impairment annually, or more frequently if events or changes in circumstances indicate that it might be impaired and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold.
Impairment testing
Intangible assets are allocated to CGUs for the purpose of impairment testing. The allocation is made to those CGUs or groups of CGUs that are expected to benefit from the business combination in which the goodwill arose. The CGUs or groups of CGUs are identified at the lowest level at which goodwill is monitored for internal management purposes, being the operating segments. As the Company operates as a single operating segment or CGU, the Company has only a single cash generating unit for impairment testing.
Management assesses the recoverable value of goodwill by comparing the Company’s equity value, either inferred from the public prices of share issues based on the fair value less cost of disposal (“FVLCOD”) method or based on discounted cash flow forecasts, with the net assets as reported in its consolidated financial statements based on the value in use (“ViU”) method. The discounted cash flow approach involves key assumptions that leave considerable scope for judgment. The Company typically compares the two methods and utilizes the greater recoverable amount for the purposes of its impairment testing. Impairment testing is performed on an annual basis as of October 1.
Purchased software
The costs of accessing software services are not capitalized if the Company does not have any contractual right to take possession of the software at any time during the term of the agreement and it is not feasible for the Company either to run the software on its own hardware or to contract with a third party unrelated to the vendor. Such costs represent software as a service costs and are expensed as incurred.
The Company does capitalize software implementation costs, such as fees paid to outside consultants to set up a software arrangement.
For cloud computing costs, the Company capitalized costs for certain configuration and customization costs paid by a customer in a cloud computing or hosting arrangement. IAS 38 Intangible assets (“IAS 38”) aligns the accounting treatment of these costs incurred in a hosting arrangement treated as a service contract with the requirements for capitalization and amortization costs to develop or obtain an intangible asset.
Purchased software and associated capitalized costs are amortized using the straight-line method over an estimated life of five years.
Capitalized internally developed software costs
Costs incurred in the internal development of software are capitalized as intangible assets when they satisfy the criteria required by IAS 38 as set out below.
Software development costs consist entirely of capitalized internally generated costs that are directly attributable to the design, testing, and enhancement of identifiable and unique software applications and products controlled by the Company and incorporated principally within the Company’s SOPHiA DDM Platform. They are recognized as intangible assets where the following criteria are met:
•it is technically feasible to complete the software so that it will be available for use;
•management intends to complete the software and use or sell it;
•there is an ability to use or sell the software;
•it can be demonstrated how the software will generate probable future economic benefits;
•adequate technical, financial, and other resources to complete the development and to use or sell the software are available, and;
•the expenditure attributable to the software during its development can be reliably measured.
Directly attributable costs that are capitalized as part of the software comprise principally employee costs. Capitalized development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight-line basis over its expected useful life. Capitalized software development costs are amortized using the straight-line method over an estimated life of five years.
Intangible assets, net movement for the years ended December 31, 2024 and 2023, respectively are as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
Purchased software |
|
Capitalized internally developed software costs |
|
Total intangible assets |
| January 1, 2024 |
|
$ |
8,999 |
|
|
$ |
4,162 |
|
|
$ |
21,367 |
|
|
$ |
34,528 |
|
| Additions |
|
— |
|
|
195 |
|
|
7,737 |
|
|
7,932 |
|
|
|
|
|
|
|
|
|
|
| Currency Translation Adjustment |
|
(657) |
|
|
(311) |
|
|
(1,783) |
|
|
(2,751) |
|
| December 31, 2024 |
|
$ |
8,342 |
|
|
$ |
4,046 |
|
|
$ |
27,321 |
|
|
$ |
39,709 |
|
|
|
|
|
|
|
|
|
|
| Accumulated amortization |
|
|
|
|
|
|
|
|
| January 1, 2024 |
|
$ |
— |
|
|
$ |
(3,001) |
|
|
$ |
(4,342) |
|
|
$ |
(7,343) |
|
| Additions |
|
— |
|
|
(484) |
|
|
(3,537) |
|
|
(4,021) |
|
|
|
|
|
|
|
|
|
|
| Currency Translation Adjustment |
|
— |
|
|
240 |
|
|
413 |
|
|
653 |
|
| December 31, 2024 |
|
$ |
— |
|
|
$ |
(3,245) |
|
|
$ |
(7,466) |
|
|
$ |
(10,711) |
|
| Net book value at December 31, 2024 |
|
$ |
8,342 |
|
|
$ |
801 |
|
|
$ |
19,855 |
|
|
$ |
28,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
Purchased software |
|
Capitalized internally developed software costs |
|
Total intangible assets |
| January 1, 2023 |
|
$ |
8,188 |
|
|
$ |
3,530 |
|
|
$ |
12,191 |
|
|
$ |
23,909 |
|
| Additions |
|
— |
|
|
263 |
|
|
7,469 |
|
|
7,732 |
|
| Disposals |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Currency Translation Adjustment |
|
811 |
|
|
369 |
|
|
1,707 |
|
|
2,887 |
|
| December 31, 2023 |
|
$ |
8,999 |
|
|
$ |
4,162 |
|
|
$ |
21,367 |
|
|
$ |
34,528 |
|
|
|
|
|
|
|
|
|
|
| Accumulated amortization |
|
|
|
|
|
|
|
|
| January 1, 2023 |
|
$ |
— |
|
|
$ |
(2,052) |
|
|
$ |
(1,894) |
|
|
$ |
(3,946) |
|
| Additions |
|
— |
|
|
(698) |
|
|
(2,130) |
|
|
(2,828) |
|
| Disposals |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Currency Translation Adjustment |
|
— |
|
|
(251) |
|
|
(318) |
|
|
(569) |
|
| December 31, 2023 |
|
$ |
— |
|
|
$ |
(3,001) |
|
|
$ |
(4,342) |
|
|
$ |
(7,343) |
|
| Net book value at December 31, 2023 |
|
$ |
8,999 |
|
|
$ |
1,161 |
|
|
$ |
17,025 |
|
|
$ |
27,185 |
|
Goodwill arose from the Company’s acquisition of Interactive Biosoftware (“IBS”) in June 2018. Through this acquisition the Company added Alamut (a genomic mutation interpretation software) to its existing SOPHiA DDM Platform.
Goodwill is tested for impairment on an annual basis as of October 1 and at the occurrence of a potential indication of impairment. A triggering assessment is performed each quarter to ensure no occurrence of impairment triggering events. As of December 31, 2024 and 2023, respectively, no impairment charges were recorded related to the Company’s goodwill.
As of October 1, 2024 and 2023, respectively, the Company utilized the equity method (“FVLCOD”) to perform its annual assessment. The estimated equity value of the Company as of October 1, 2024 was $242.5 million, which exceeds the reported net assets of the Company of $113.5 million at that date by $129.0 million. The estimated equity value of the Company as of October 1, 2023 was $165.8 million, which exceeds the reported net assets of the Company of $158.4 at that date by $7.3 million.
On the basis of the analyses performed, the Company concludes that the recoverable amount exceeds the carrying amount of the goodwill and no impairment is needed as of December 31, 2024 and 2023.
17. Leases
Accounting policies
Lessee
The Company assesses at inception of the contract whether a contract is or contains a lease. This assessment involves determining whether the Company obtains substantially all the economic benefits from the use of that asset, and whether the Company has the right to direct the use of the asset. When these conditions are met, the Company recognizes a right-of-use (“ROU”) asset and a lease liability at the lease commencement date, except for short-term leases of 12 months or less, which are expensed in the statements of loss on a straight-line basis over the lease term.
At inception, the ROU asset comprises the initial lease liability, initial direct costs, and any obligations to refurbish the asset, less any incentives granted by the lessors.
The ROU asset is depreciated over the shorter of the duration of the lease contract (including contractually agreed optional extension periods whose exercise is deemed to be reasonably certain) and the useful life of the underlying asset.
The ROU asset is subject to testing for impairment if there is an indicator for impairment, as for owned assets.
The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the interest rate implicit in the lease or, if that is not readily determinable, the incremental borrowing rate (“IBR”) at the lease commencement date. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the ROU asset in a similar economic environment. Lease payments can include fixed payments; variable payments that depend on an index or rate known at the commencement date; and extension option payments or purchase options that the Company is reasonably certain to exercise.
The lease liability is subsequently measured at amortized cost using the effective interest rate method and remeasured (with a corresponding adjustment to the related ROU asset) when there is a change in future lease payments due to renegotiation, changes in an index or rate, or a reassessment of options.
Some of the Company’s leases include options to extend the lease, and these options are included in the lease term to the extent they are reasonably certain to be exercised.
Lessor
The Company leases out laboratory equipment to certain customers. These leases are classified as finance leases as the Company transfers substantially all the risks and rewards incidental to ownership of the asset to the customer.
At the commencement of the lease term, the Company records revenue and the associated costs of sales, being the sale proceeds at fair value of the asset (computed at cost plus a margin) and the cost of the asset, derecognizes the leased asset from inventory, and recognizes a finance lease receivable on the balance sheet equal to the net investment in the lease. The Company notes these lease agreements ended during 2023, and as of December 31, 2024 and 2023, the Company did not have any leases of laboratory equipment.
Company leases
During the year ended December 31, 2024, the Company entered into one office lease as described below.
Rolle office
On March 3, 2021, the Company entered into a 120-month lease for office space in Rolle, Switzerland primarily to support the expansion of the research and development department. The lease in total is for approximately 65,860 square feet, including an additional 21,258 square feet based on a lease amendment as described below, with the Company gaining access to areas on prescribed dates. The Company gained access to 38,761 square feet on July 1, 2021, 5,840 square feet on January 1, 2022, and the remaining 21,258 square feet on February 1, 2023. The expected lease commitments resulting from this contract are less than $0.1 million in 2021, $0.5 million in 2022, $1.0 million in 2023, and $1.14 million from 2024 onward. The expected lease commitments are linked to changes in the Swiss Consumer Price Index as published by Swiss Federal Statistical Office.
On January 25, 2022, the Company entered into an amendment to the lease for office space in Rolle, Switzerland. The amendment provides the Company with an additional floor of approximately 21,258 square feet with lease commencement initiating on April 1, 2022. Upon commencement of the lease, the Company recorded a right-of-use asset of $4.5 million and a lease liability of $4.5 million.
The Company makes fixed payments and additional variable payments depending on the usage of the asset during the contract period. Upon commencement of the lease, the Company recorded a ROU asset of $7.7 million and a lease liability of $8.5 million. The difference between the ROU and lease liability of $0.8 million is driven by lease incentives and expected restoration costs.
Boston office
On June 27, 2024, the Company entered into a 73-month lease for office space in Boston, Massachusetts primarily to support the expansion of the Company’s growth in the United States. The lease in total is for approximately 12,807 square feet. The Company makes fixed payments and additional variable payments depending on the usage of the asset during the contract period. Upon gaining access to the space in September 2024, the Company recorded a right-of-use asset of $2.0 million and a lease liability of $1.9 million. The difference between the ROU and lease liability of less than $0.1 million is driven by initial direct costs to obtain the lease.
Bidart office
On June 1, 2023, the Company entered into a 108-month lease for office space in Bidart, France primarily to support the expansion of the research and development department and the Company’s administrative functions. The lease in total is for approximately 13,509 square feet. Upon commencement of the lease, the Company recorded a right-of-use asset of $2.3 million and a lease liability of $2.3 million. The expected lease commitments resulting from this contract are $0.1 million in 2023 and $0.3 million per year from 2024 onward.
Leases
Generally, lease terms for office buildings are between one and ten years. Any leases with terms less than 12 months and/or with low value are expensed in accordance with the IFRS 16 practical expedients for short-term leases and low-value leases. These expenses amounted to $0.1 million, less than $0.1 million, and $0.2 million for the years ended December 31, 2024, 2023, and 2022, respectively. The Company had cash outflows related to leases less than 12 months and/or with low value of $0.1 million, less than $0.1 million, and $0.2 million for the years ended December 31, 2024, 2023, and 2022, respectively.
The Company has lease liabilities amounting to $12.1 million and $17.8 million for the years ended December 31, 2024 and 2023, respectively, that are linked to consumer price indices in Switzerland and France.
The future cash flow in relation to short-term leases and leases of low value assets is disclosed in Note 25 — “Commitments and contingencies.”
The future cash flow in relation to leases accounted for under IFRS 16 is disclosed in Note 26 — “Financial instruments and risks.”
The Company has several leases with extension and termination options. Management determines, on the basis of the business needs, whether they expect to exercise these options.
The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the interest rate implicit in the lease or, if that is not readily determinable, the IBR at the lease commencement date. The IBR is the rate of interest that the Company would have had to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the ROU asset in a similar economic environment. On the basis of this policy, the IBRs used by the Company to discount lease payments outstanding at December 31, 2024 and 2023, respectively, in the countries in which it has recognized right-of-use assets and lease liabilities have been in the range of 2.76% to 11.42% and 2.61% to 4.82%, respectively. The Company notes the variation in IBRs used is due to the timing of lease commencement as well as geographical differences based on the physical location of the lease.
The following table presents the movements in the ROUs (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
| As of January 1 |
|
$ |
15,635 |
|
|
$ |
14,268 |
|
| Additions |
|
2,159 |
|
|
3,814 |
|
| Depreciation charge |
|
(2,640) |
|
|
(3,646) |
|
| Currency translation effects |
|
(986) |
|
|
1,199 |
|
| As of December 31 |
|
$ |
14,168 |
|
|
$ |
15,635 |
|
The following table presents the movements in the lease liabilities (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
| As of January 1 |
|
$ |
18,601 |
|
|
$ |
16,743 |
|
| Additions |
|
2,152 |
|
|
2,249 |
|
| Principal paid |
|
(2,750) |
|
|
(2,816) |
|
| Interest paid |
|
(574) |
|
|
(545) |
|
| Non-cash interest |
|
574 |
|
|
545 |
|
| Currency translation effects |
|
(1,210) |
|
|
2,425 |
|
| As of December 31 |
|
$ |
16,793 |
|
|
$ |
18,601 |
|
18. Other non-current assets
Other non-current assets consist of the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Research tax credit receivable |
|
$ |
4,244 |
|
|
$ |
4,743 |
|
| Guarantee deposits |
|
1,518 |
|
|
1,357 |
|
| Total |
|
$ |
5,762 |
|
|
$ |
6,100 |
|
19. Accounts payable
Accounts payable consist of the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2024 |
|
2023 |
| Trade payables |
|
1,932 |
|
|
2,256 |
|
| Employee related payables |
|
2,630 |
|
|
2,366 |
|
| VAT, sales, and other taxes |
|
658 |
|
|
769 |
|
| Total |
|
$ |
5,220 |
|
|
$ |
5,391 |
|
20. Accrued expenses
Accrued expenses consist of the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2024 |
|
2023 |
| Accrued compensation |
|
$ |
10,781 |
|
|
$ |
13,578 |
|
| Accrued professional fees |
|
1,422 |
|
|
2,612 |
|
| Accrued inventory purchases |
|
121 |
|
|
340 |
|
| Accrued IT support |
|
570 |
|
|
613 |
|
| Accrued legal fees |
|
— |
|
|
79 |
|
| Accrued other |
|
323 |
|
|
586 |
|
| Total |
|
$ |
13,217 |
|
|
$ |
17,808 |
|
21. Post-employment benefits
Critical accounting estimates and judgments
The liability or asset recognized on the balance sheet in respect of defined benefit pension plans is the present value of the defined benefit obligation at the end of the reporting period less the fair value of plan assets. The defined benefit obligation is calculated annually by independent actuaries using the projected unit credit method.
The present value of the defined benefit obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms approximating to the terms of the related obligation. In countries where there is no deep market in such bonds, the market rates on government bonds are used.
The net interest cost is calculated by applying the discount rate to the net balance of the defined benefit obligation and the fair value of plan assets. This cost is included in employee benefit expense in the statement of loss.
Remeasurement gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized in the period in which they occur, directly in other comprehensive income. The remeasurement gains and losses are included in retained earnings in the statement of changes in equity and on the balance sheet.
Changes in the present value of the defined benefit obligation resulting from plan amendments or curtailments are recognized immediately in income as past service costs.
For defined contribution plans, the Company pays contributions to publicly or privately administered pension insurance plans. Employee contributions to these plans is voluntary and these contributions are matched by the employer. The Company has no further payment obligations once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available. Contributions are charged to the statement of loss as incurred.
Accounting policies
The Company operates defined benefit and defined contribution pension plans. Funded schemes are generally funded through payments to insurance companies or trustee-administered funds, determined by periodic actuarial calculations. A defined contribution plan is a pension plan under which the Company pays fixed contributions into a separate entity (a fund) and has no legal or constructive obligations to pay further contributions if the fund does not hold sufficient assets to pay all employees the benefits relating to employee service in the current and prior periods. A defined benefit plan is a pension plan that is not a defined contribution plan. Typically, defined benefit plans define an amount of pension benefit that an employee will receive on retirement, usually dependent on one or more factors such as age, years of service and compensation.
The actual return on plan assets, excluding interest income measured at the discount rate, is recognized in other comprehensive income/loss within defined benefit plan remeasurements.
The Company has a funded defined benefit plan in Switzerland, an unfunded defined benefit plan in France, and a defined contribution plan in the U.S. The Company has no occupational pension plans in the U.K. and Brazil.
Swiss pension plan
The Company contracted with the Swiss Life Collective BVG Foundation based in Zurich for the provision of occupational benefits. All benefits in accordance with the regulations are reinsured in their entirety with Swiss Life SA within the framework of the corresponding contract. This pension solution fully reinsures the risks of disability, death and longevity with Swiss Life. Swiss Life invests the vested pension capital and provides a 100% capital and interest guarantee. The pension plan is entitled to an annual bonus from Swiss Life comprising the effective savings, risk and cost results. As of January 1, 2025, the Company switched from Swiss Life Collective BVG Foundation to Profond for the provision of occupational benefits.
Although the amount of ultimate pension benefit is not defined, certain legal obligations of the plan create constructive obligations on the employer to pay further contributions to fund an eventual deficit; this results in the plan nevertheless being accounted for as a defined benefit plan.
French pension plan
In France, the bulk of pensions are paid by national pension schemes, which are unfunded. In addition, French employers are obliged by law to pay a retirement indemnity. Its amount depends on the last salary of the employee and on the period of activity with its employer. Rights to this benefit are acquired during the service life with the same employer on the condition that the employee will be with its employer at retirement date; it means that the rights are only vested on retirement date. This indemnity is in substance a defined benefit plan.
The following table provides additional details on the defined benefit plans’ funded status (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Present value of defined benefit obligation |
|
$ |
(23,199) |
|
|
$ |
(23,013) |
|
| Fair value of plan assets |
|
19,360 |
|
|
19,927 |
|
| Net pension liability |
|
$ |
(3,839) |
|
|
$ |
(3,086) |
|
The following table presents the movement in the defined benefit obligation (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
|
|
Funded |
|
Unfunded |
|
Total |
|
Funded |
|
Unfunded |
|
Total |
| January 1 |
|
$ |
(22,972) |
|
|
$ |
(41) |
|
|
$ |
(23,013) |
|
|
$ |
(19,221) |
|
|
$ |
(31) |
|
|
$ |
(19,252) |
|
| Service Cost |
|
(2,625) |
|
|
(12) |
|
|
(2,637) |
|
|
(1,311) |
|
|
(10) |
|
|
(1,321) |
|
| of which current service cost |
|
(1,683) |
|
|
(12) |
|
|
(1,695) |
|
|
(1,748) |
|
|
(10) |
|
|
(1,758) |
|
| of which past service cost including effects from curtailment |
|
(942) |
|
|
— |
|
|
(942) |
|
|
437 |
|
|
— |
|
|
437 |
|
| Interest expense |
|
(293) |
|
|
(1) |
|
|
(294) |
|
|
(413) |
|
|
(1) |
|
|
(414) |
|
| Actuarial gains (losses) |
|
(1,342) |
|
|
— |
|
|
(1,342) |
|
|
401 |
|
|
2 |
|
|
403 |
|
| Actual plan participants’ contributions |
|
(1,295) |
|
|
— |
|
|
(1,295) |
|
|
(1,441) |
|
|
— |
|
|
(1,441) |
|
| Transfers (in) out due to (joiners) leavers |
|
3,644 |
|
|
— |
|
|
3,644 |
|
|
1,037 |
|
|
— |
|
|
1,037 |
|
| Currency translation differences |
|
1,736 |
|
|
2 |
|
|
1,738 |
|
|
(2,024) |
|
|
(1) |
|
|
(2,025) |
|
| December 31 |
|
$ |
(23,147) |
|
|
$ |
(52) |
|
|
$ |
(23,199) |
|
|
$ |
(22,972) |
|
|
$ |
(41) |
|
|
$ |
(23,013) |
|
The service cost and interest expense are charged to the statement of loss as research and development, general and administrative costs, selling and marketing, and interest income, net, respectively. Actuarial gains (losses) are credited or charged to other comprehensive income (loss) as defined benefit plan remeasurements.
As of December 31, 2024, the Swiss and French plans had 209 and 84 active members, respectively. As of December 31, 2023, the Swiss and French plans had 233 and 97 active members, respectively.
As a result of the reduction in conversion factors, the Company incurred a past service cost gain including curtailment of $0.4 million for the year ended December 31, 2023.
The following table presents the movement in the defined benefit plans’ assets (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| As of January 1 |
|
$ |
19,927 |
|
|
$ |
16,577 |
|
| Interest income |
|
270 |
|
|
387 |
|
| Return on plan assets, excl. interest income |
|
1,668 |
|
|
(654) |
|
| Administrative expenses |
|
(61) |
|
|
(70) |
|
| Employer contributions |
|
1,390 |
|
|
1,531 |
|
| Employee contributions |
|
1,295 |
|
|
1,441 |
|
| Transfers in (out) due to joiners (leavers) |
|
(3,644) |
|
|
(1,037) |
|
| Currency translation differences |
|
(1,485) |
|
|
1,752 |
|
| As of December 31 |
|
$ |
19,360 |
|
|
$ |
19,927 |
|
The following table presents the defined benefit plan assets, which include the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Cash |
|
$ |
465 |
|
|
$ |
528 |
|
| Insurance policies |
|
18,895 |
|
|
19,399 |
|
| Total |
|
$ |
19,360 |
|
|
$ |
19,927 |
|
The Swiss Life Collective BVG Foundation, to which the Swiss pension plan is affiliated, manages its funds in the interests of all members, with due attention to the priorities of liquidity, security, and return. The Company’s pension plan benefits from the economies of scale and diversification of risk available through this affiliation. The Company has no influence over the investment policy.
The following table presents the pension costs recognized in statement of loss (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
|
|
Funded |
|
Unfunded |
|
Total |
|
Funded |
|
Unfunded |
|
Total |
|
Funded |
|
Unfunded |
|
Total |
| Service cost |
|
$ |
(2,625) |
|
|
$ |
(12) |
|
|
$ |
(2,637) |
|
|
$ |
(1,311) |
|
|
$ |
(10) |
|
|
$ |
(1,321) |
|
|
$ |
(1,759) |
|
|
$ |
(90) |
|
|
$ |
(1,849) |
|
| Interest cost |
|
(23) |
|
|
(1) |
|
|
(24) |
|
|
(413) |
|
|
(1) |
|
|
(414) |
|
|
(154) |
|
|
(2) |
|
|
(156) |
|
| Total recognized |
|
$ |
(2,648) |
|
|
$ |
(13) |
|
|
$ |
(2,661) |
|
|
$ |
(1,724) |
|
|
$ |
(11) |
|
|
$ |
(1,735) |
|
|
$ |
(1,913) |
|
|
$ |
(92) |
|
|
$ |
(2,005) |
|
The following table presents the pension remeasurement recognized in statement of other comprehensive loss (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
|
|
Funded |
|
Unfunded |
|
Total |
|
Funded |
|
Unfunded |
|
Total |
|
Funded |
|
Unfunded |
|
Total |
| Changes in demographic assumptions |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
700 |
|
|
$ |
— |
|
|
$ |
700 |
|
|
$ |
— |
|
|
$ |
223 |
|
|
$ |
223 |
|
| Changes in financial assumptions |
|
(1,908) |
|
|
— |
|
|
(1,908) |
|
|
(901) |
|
|
(2) |
|
|
(903) |
|
|
2,311 |
|
|
12 |
|
|
2,323 |
|
| Experience adjustments |
|
566 |
|
|
— |
|
|
566 |
|
|
602 |
|
|
4 |
|
|
606 |
|
|
(201) |
|
|
15 |
|
|
(186) |
|
| Total actuarial gains (losses) |
|
(1,342) |
|
|
— |
|
|
(1,342) |
|
|
401 |
|
|
2 |
|
|
403 |
|
|
2,110 |
|
|
250 |
|
|
2,360 |
|
| Return on plan assets |
|
1,668 |
|
|
— |
|
|
1,668 |
|
|
(654) |
|
|
— |
|
|
(654) |
|
|
(204) |
|
|
— |
|
|
(204) |
|
| Currency translation differences |
|
— |
|
|
1 |
|
|
1 |
|
|
37 |
|
|
2 |
|
|
39 |
|
|
(4) |
|
|
2 |
|
|
(2) |
|
| Total recognized |
|
$ |
326 |
|
|
$ |
1 |
|
|
$ |
327 |
|
|
$ |
(216) |
|
|
$ |
4 |
|
|
$ |
(212) |
|
|
$ |
1,902 |
|
|
$ |
252 |
|
|
$ |
2,154 |
|
Demographic assumptions had no impact for 2024 as these assumptions had no significant changes from 2023.
The positive impact of changes in demographic assumptions in 2023 was due principally to an increase in the weighted turnover from 15.80% to 19.50%.
The negative impact of changes in financial assumptions for the funded plan in 2024 was due to a decrease in the discount rate from 1.50% to 0.95%.
The negative impact of changes in financial assumptions in 2023 was due to a decrease in the discount rate from 2.25% to 1.50%.
The positive experience adjustments for the funded plan in 2024 was primarily due to the surplus between the additional defined benefit obligation attributable to new joiners and the assets that were transferred into the plan.
The positive experience adjustments in 2023 was due largely to the surplus between the additional defined benefit obligation attributable to new joiners and the assets that they transferred into the plan.
Key actuarial assumptions by plan
Discount rate
In estimating the defined benefit obligation, the discount rates used were, for the Swiss plan, 0.95% and 1.50% and, for the French plan, 3.55% and 3.55% for the years ended December 31, 2024 and 2023, respectively.
Expected rate of salary increase
The expected rate of annual salary increase was assumed to be, for the Swiss plan, 2.50% and 2.75% and, for the French plan, 3.00% and 3.00% for the years ended December 31, 2024 and 2023, respectively.
Pension plan modified duration
The weighted average modified duration of the Swiss plan is 13.6 and 11.7 years and of the French plan 15.3 and 16.1 years for the years ended December 31, 2024 and 2023, respectively.
Interest rates
For the Swiss plan, the interest on old age accounts is based, for the LPP account, on the LPP interest rate, which was 2.30% and 1.50% and, for the extra mandatory part, is equivalent to the discount rate, which was 2.30% and 1.50% for the years ended December 31, 2024 and 2023, respectively.
Inflation
The expected annual rate of inflation was assumed to be, for the Swiss plan, 1.00% and 1.25%, for the French plan 2.00% and 2.00% for the years ended December 31, 2024 and 2023, respectively. The expected annual rate of inflation for the Swiss plan is based on the inflation forecast of the Swiss National Bank. and for the French plan is based on the inflation forecast of the European Central Bank.
Mortality tables
Assumptions regarding future mortality experience are set based on actuarial advice provided in accordance with published statistics and experience and are based on the mortality generational tables BGV 2020 (Swiss) and TH/TF 00-02 (French). For the Swiss plan, the average life expectancy in years after retirement of a pensioner retiring at age 65 (male) and 65 (female) on the balance sheet date is, respectively, 22.82 and 24.59 and 22.82 and 24.59, for the years ended December 31, 2024 and 2023, respectively.
Sensitivity analysis
The following tables demonstrate the sensitivity of the defined benefit obligations to changes in the discount rate, expected rates of salary increase, interest credited on savings accounts (interest rate), inflation, and life expectancy at retirement age.
The table below presents the sensitivity analysis for the funded plans (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Discount rates |
|
|
|
|
Increase of 25 basis points |
|
(682) |
|
|
(464) |
|
Decrease of 25 basis points |
|
738 |
|
|
500 |
|
| Expected rates of salary increases |
|
|
|
|
Increase of 25 basis points |
|
140 |
|
|
91 |
|
Decrease of 25 basis points |
|
(137) |
|
|
(98) |
|
| Interest rate |
|
|
|
|
Increase of 25 basis points |
|
231 |
|
|
160 |
|
Decrease of 25 basis points |
|
(226) |
|
|
(157) |
|
| Inflation |
|
|
|
|
Increase of 25 basis points |
|
(19) |
|
|
91 |
|
Decrease of 25 basis points |
|
18 |
|
|
(90) |
|
| Life expectancy |
|
|
|
|
Increase of 1 year |
|
170 |
|
|
92 |
|
Decrease of 1 year |
|
(171) |
|
|
(92) |
|
The table below presents the sensitivity analysis for the unfunded plans (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Discount rates |
|
|
|
|
Increase of 50 basis points |
|
(4) |
|
|
(3) |
|
Decrease of 50 basis points |
|
4 |
|
|
3 |
|
| Expected rates of salary increases |
|
|
|
|
Increase of 50 basis points |
|
4 |
|
|
3 |
|
Decrease of 50 basis points |
|
(4) |
|
|
(3) |
|
The above sensitivity analyses are based on a change in an assumption while holding all other assumptions constant. In practice, this is unlikely to occur, and changes in some of the assumptions may be correlated. When calculating the sensitivity of the defined benefit obligation to significant actuarial assumptions the same method (present value of the defined benefit obligation calculated with the projected unit credit method at the end of the reporting period) has been applied as when calculating the pension liability recognized on the balance sheet.
The methods and types of assumptions used in preparing the sensitivity analysis did not change compared to the prior period.
Future employer contributions
Expected employer contributions to the Swiss defined benefit pension plan for the year ending December 31, 2025 amount to $1.5 million.
Defined contribution plans
U.S. pension plan
The Company has a multiple employer 401(k) defined contribution plan in the U.S. The expense recognized in respect of the defined contribution plan in the U.S. was $0.3 million and $0.4 million and for the years ended December 31, 2024 and 2023, respectively.
22. Share-based compensation
Critical accounting estimates and judgments
Share-based Compensation
For the years ended December 31, 2024, 2023, and 2022, the Company granted share options under one plan - the SOPHiA GENETICS 2021 Equity Incentive Plan (the “2021 Equity Incentive Plan” or the “2021 EIP”). Under this plan, directors may offer options to directors, employees, and advisors. The exercise price of the share options is set at the time they are granted. Options, once vested, can be exchanged for an equal number of ordinary shares.
Measuring the cost of share options
The fair value of the options under all plans are measured at each grant date using the Black-Scholes option pricing model, taking into account the terms and conditions upon which the options were granted.
For options up to September 2020, the fair value at grant date is independently determined using an adjusted form of the Black-Scholes option pricing model that takes into account the strike price, the fair value of the share at grant date, the expected life of the award, the expected price volatility of the underlying share, the risk-free interest rate for the term of the award, and the expected dividend yield. For options granted on and subsequent to September 2020 until July 22, 2021, the fair value at grant date is based on a probability-weighted expected returns method that takes account of both the value derived by using an adjusted form of the Black-Scholes option pricing model, as described above, and a discounted estimate of the price that might be achieved in a future transaction.
For options granted on and subsequent to July 22, 2021, the fair value at grant date is determined by using the Black-Scholes option pricing model.
The Company has used an independent valuation firm to assist in calculating the fair value of the award grants per participant.
The key inputs used in the valuation model, for the stock options granted in the years ended December 31, 2024, 2023, and 2022, respectively, are outlined below. Stock options were only granted under the 2021 Equity Incentive Plan (“2021 EIP”). No grants have been made under the 2019 Incentive Share Option Plan (“2019 ISOP”) since 2021 and the SOPHiA GENETICS Incentive Share Option Plan (“2013 ISOP”) since 2019.
Prior to the Company’s IPO, the price of the ordinary shares at grant date, which represents a critical input into this model, has been determined on one of the following two bases:
•By reference to a contemporaneous transaction involving another class of share, using an adjusted form of the Black-Scholes option pricing model as described above, and considering the timing, amount, liquidation preferences, and dividend rights of issues of other classes of shares.
•On the basis of discounted cash flow forecasts, where there was no contemporaneous or closely contemporaneous transaction in another class of share and the time interval was too large to permit an assumption that there had been no significant change in the Company’s equity value.
Subsequent to the IPO, the price of the ordinary shares at grant date, which represents a critical input into this model, has been determined on the most recent close price of the Company’s stock price on the date of grant.
Accounting policies
The Company has three share option plans for directors, employees, and advisors which are accounted for as equity-settled share-based compensation plans.
The fair value of options granted under these plans is recognized as an employee benefits expense, with a corresponding increase in equity. The total amount to be expensed is determined by reference to the fair value of the options granted:
•including any market performance conditions (e.g., the entity’s share price);
•excluding the impact of any service and non-market performance vesting conditions (e.g., profitability, sales growth; targets and remaining an employee of the entity over a specified time period), and;
•including the impact of any non-vesting conditions (e.g., the requirement for employees to save or hold shares for a specific period of time).
The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each period, the entity revises its estimates of the number of options that are expected to vest based on the non-market vesting and service conditions. It recognizes the impact of the revision to original estimates, if any, in income, with a corresponding adjustment to equity.
Estimating fair value for share-based payment transactions requires determination of the most appropriate valuation model, which depends on the terms and conditions of the grant. This estimate also requires determination of the most appropriate inputs to the valuation model including the share price, or the fair value of a share, the expected life of the share option, the volatility of the share price, the risk-free interest rate, the dividend yield, and making certain assumptions about the inputs. The assumptions used for estimating fair value for share-based payment transactions are disclosed below.
The volatility used in the estimation of fair value is calculated utilizing a mix of the Company’s own share price volatility and the volatility of the share prices of a set list of publicly traded peer companies based on a defined proportion. Share price volatility is calculated for each tranche of share options on a historical basis over a period of time equal to the average life of the share options granted in each tranche.
In the event that a company used in the volatility calculation has not been publicly traded for the requisite amount of time, the entirety of its trading history was used.
If the shares are not listed, estimating their fair value also requires determination of the most appropriate valuation model, such as:
•By reference to a contemporaneous transaction involving another class of share, using an adjusted form of an option pricing model above, and considering the timing, amount, liquidation preferences and dividend rights of issues of other classes of shares;
•On the basis of discounted cash flow forecasts, where there was no contemporaneous or closely contemporaneous transaction in another class of share and the time interval was too large to permit an assumption that there had been no significant change in the Company’s equity value;
•Share based compensation expense is measured at the fair value of the options at the grant date and recognized over the vesting period. Share based compensation expense is presented in the statement of loss and allocated to the various expense categories based on the functions of the employees to whom the options are granted (e.g., research and development, selling and marketing, general & administrative).
The calculation of the cost of the Company’s share option grants and of the fair value of the ordinary shares at the grant date requires the selection of an appropriate valuation model and is based on key assumptions that leave considerable scope for judgment.
Recognizing the cost of share options
At each reporting date, the Company recognizes expense for the vested options granted and for partially earned but non-vested portions of options granted. This results in a front-loaded expense to the statement of loss. The Company accounts for these plans as equity-settled transactions. The charge to the statements of loss therefore results in a corresponding credit being booked to “Other reserves” within equity.
The plans
The Company has three share option plans: the 2013 ISOP (launched in September 2013), the 2019 ISOP (launched March 2019), and the 2021 EIP (launched June 2021). Under these plans, directors may offer options to directors, employees, and advisors. The exercise price of the share options is set at the time they are granted. Options, once vested, can be exchanged for an equal number of ordinary shares. Under the 2021 EIP, the Company can grant restricted stock units (“RSUs”) which represent the right to receive ordinary shares upon meeting specific vesting requirements. RSUs are able to be granted to directors, executives, and employees.
The options have a life of ten years. Options under the 2013 ISOP vest 50% on the second anniversary of the grant date and a further 50% on the third anniversary of the grant date. Options under the 2019 ISOP vest 25% on each anniversary of the grant date over four years. The options under the 2021 EIP vest either 25% on the first anniversary of the grant date and the remaining 75% vesting ratably on a monthly basis over the remaining three years, 25% on the first anniversary of the grant date and the remaining 75% vesting ratably on a quarterly basis over the remaining three years, on the second anniversary of the grant date, or annually over four years on each anniversary of the grant date. Refer to Restricted Stock Units below for the vesting schedules of the RSUs under the 2021 EIP.
On April 22, 2021, the Board amended the 2019 ISOP to the effect that, in the event of a successful IPO or public listing of the Company’s shares, only those unvested options that otherwise would vest within six months following the effective date of the IPO or such public listing should become fully vested immediately as of such date (accelerated vesting). The remaining unvested options (i.e., unvested options that would only vest after the six-month period following the effective date of the IPO or public listing) would not be subject to accelerated vesting and, subject to certain conditions, would vest on the basis of the original vesting schedule. Additionally, the Board instituted a black-out period, irrespective of a successful IPO or public listing of the Company, in which no options could be exercised from May 1, 2021 to January 19, 2022, and to accelerate the vesting of options that would otherwise vest during that period.
2013 ISOP
Activity for the year ended December 31, 2024, under the 2013 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2024 |
|
606,980 |
|
|
$ |
3.00 |
|
|
3.49 |
| Exercised |
|
(32,000) |
|
|
3.16 |
|
|
— |
|
| Forfeited |
|
(14,000) |
|
|
1.75 |
|
|
— |
|
| Outstanding as of December 31, 2024 |
|
560,980 |
|
|
$ |
3.03 |
|
|
2.54 |
| Exercisable as of December 31, 2024 |
|
560,980 |
|
|
$ |
3.03 |
|
|
2.54 |
Activity for the year ended December 31, 2023, under the 2013 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2023 |
|
657,980 |
|
|
$ |
2.92 |
|
|
4.24 |
| Exercised |
|
(39,000) |
|
|
2.52 |
|
|
— |
|
| Forfeited |
|
(12,000) |
|
|
0.05 |
|
|
— |
|
| Outstanding as of December 31, 2023 |
|
606,980 |
|
|
$ |
3.00 |
|
|
3.49 |
| Exercisable as of December 31, 2023 |
|
606,980 |
|
|
$ |
3.00 |
|
|
3.49 |
Activity for the year ended December 31, 2022, under the 2013 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2022 |
|
859,540 |
|
|
$ |
2.75 |
|
|
5.08 |
| Exercised |
|
(193,560) |
|
|
2.44 |
|
|
— |
|
| Forfeited |
|
(8,000) |
|
|
3.19 |
|
|
— |
|
| Outstanding as of December 31, 2022 |
|
657,980 |
|
|
$ |
2.92 |
|
|
4.24 |
| Exercisable as of December 31, 2022 |
|
657,980 |
|
|
$ |
2.92 |
|
|
4.24 |
Options outstanding as of December 31, 2024, under the 2013 ISOP expire between 2025 and 2029.
The weighted average share price at the date of exercise were $4.72, $4.82, and $7.41 for the years ended December 31, 2024, 2023, and 2022, respectively.
2019 ISOP
Activity for the year ended December 31, 2024, under the 2019 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2024 |
|
2,402,510 |
|
|
$ |
4.97 |
|
|
6.30 |
| Exercised |
|
(38,250) |
|
|
4.12 |
|
|
— |
|
| Forfeited |
|
(55,500) |
|
|
5.46 |
|
|
— |
|
| Outstanding as of December 31, 2024 |
|
2,308,760 |
|
|
$ |
4.97 |
|
|
5.40 |
| Exercisable as of December 31, 2024 |
|
2,033,490 |
|
|
$ |
4.80 |
|
|
5.31 |
Activity for the year ended December 31, 2023, under the 2019 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2023 |
|
2,629,516 |
|
|
$ |
4.96 |
|
|
7.21 |
|
|
|
|
|
|
|
| Exercised |
|
(32,000) |
|
|
4.06 |
|
|
— |
|
| Forfeited |
|
(195,006) |
|
|
4.94 |
|
|
— |
|
| Outstanding as of December 31, 2023 |
|
2,402,510 |
|
|
$ |
4.97 |
|
|
6.30 |
| Exercisable as of December 31, 2023 |
|
1,651,493 |
|
|
$ |
4.64 |
|
|
6.03 |
Activity for the year ended December 31, 2022, under the 2019 ISOP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2022 |
|
2,812,500 |
|
|
$ |
5.83 |
|
|
8.61 |
|
|
|
|
|
|
|
| Exercised |
|
(47,000) |
|
|
7.25 |
|
|
— |
|
| Forfeited |
|
(135,984) |
|
|
5.15 |
|
|
— |
|
| Outstanding as of December 31, 2022 |
|
2,629,516 |
|
|
$ |
4.96 |
|
|
7.21 |
| Exercisable as of December 31, 2022 |
|
1,476,744 |
|
|
$ |
4.41 |
|
|
6.56 |
Options outstanding as of December 31, 2024, under the 2019 ISOP expire between 2028 and 2031.
The weighted average share price at the date of exercise were $4.70, $4.65, and $6.19 for the years ended December 31, 2024, 2023, and 2022, respectively.
2021 EIP
Activity for the year ended December 31, 2024, under the 2021 EIP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2024 |
|
5,708,059 |
|
|
$ |
7.84 |
|
|
8.74 |
| Granted |
|
3,840,087 |
|
|
4.78 |
|
|
— |
|
| Exercised |
|
(49,119) |
|
|
2.87 |
|
|
— |
|
| Forfeited |
|
(454,420) |
|
|
5.37 |
|
|
— |
|
| Outstanding as of December 31, 2024 |
|
9,044,607 |
|
|
$ |
6.69 |
|
|
8.40 |
| Exercisable as of December 31, 2024 |
|
2,806,356 |
|
|
$ |
10.22 |
|
|
7.37 |
Activity for the year ended December 31, 2023, under the 2021 EIP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2023 |
|
2,624,297 |
|
|
$ |
12.32 |
|
|
8.88 |
| Granted |
|
3,734,266 |
|
|
4.44 |
|
|
— |
|
| Exercised |
|
(5,194) |
|
|
2.63 |
|
|
— |
|
| Forfeited |
|
(645,310) |
|
|
6.43 |
|
|
— |
|
| Outstanding as of December 31, 2023 |
|
5,708,059 |
|
|
$ |
7.84 |
|
|
8.74 |
| Exercisable as of December 31, 2023 |
|
1,155,231 |
|
|
$ |
14.64 |
|
|
7.57 |
Activity for the year ended December 31, 2022, under the 2021 EIP was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of options |
|
Weighted average exercise price |
|
Weighted average remaining life in years |
| Outstanding as of January 1, 2022 |
|
1,576,069 |
|
|
$ |
17.96 |
|
|
9.57 |
| Granted |
|
1,336,284 |
|
|
6.03 |
|
|
— |
|
|
|
|
|
|
|
|
| Forfeited |
|
(288,056) |
|
|
14.00 |
|
|
— |
|
| Outstanding as of December 31, 2022 |
|
2,624,297 |
|
|
$ |
12.32 |
|
|
8.88 |
| Exercisable as of December 31, 2022 |
|
528,693 |
|
|
$ |
17.98 |
|
|
8.04 |
The valuation inputs for the 2021 EIP grants were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Share price at grant date (in USD) |
|
$3.40 |
- |
$4.96 |
|
$2.53 |
- |
$4.72 |
|
$2.06 |
- |
$8.36 |
| Expected life of share options (years) |
|
5.50 |
- |
7.00 |
|
5.50 |
- |
7.00 |
|
5.50 |
- |
7.00 |
| Expected volatility (%) |
|
72.86 |
% |
- |
74.95% |
|
69.50 |
% |
- |
74.96% |
|
62.65 |
% |
- |
69.43% |
| Risk free interest rate (%) |
|
3.50 |
% |
- |
4.40% |
|
3.45 |
% |
- |
4.67% |
|
2.42 |
% |
- |
4.00% |
| Dividend yield (%) |
|
—% |
|
—% |
|
—% |
Options outstanding as of December 31, 2024, under the 2021 EIP expire between 2025 and 2034.
The weighted average share price at the date of exercise were $4.59 and $3.79 for the years ended December 31, 2024 and 2023, respectively; and no options were exercised for the year ended December 31, 2022.
Share options granted during the year
The weighted average fair value of options granted during the years ended December 31, 2024, 2023, and 2022, respectively (in USD):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
| 2021 EIP |
|
$ |
3.27 |
|
|
$ |
2.91 |
|
|
$ |
3.62 |
|
Restricted Stock Units
As part of the 2021 EIP, the Company initiated granting of RSUs, which represent the right to receive shares of ordinary shares upon meeting specified vesting requirements. In the year ended December 31, 2024, the Company granted 1,373,816 RSUs under the 2021 plan. Under the terms of the 2021 plan, 1,168,896 of the RSUs granted are subject to a four-year vesting schedule with 25% vesting on the first anniversary of the grant date and the remaining 75% ratably on a quarterly basis over the remaining three years, and the remaining 204,920 of the RSUs granted to non-executive members of the Company’s board of directors are subject to a vesting period set to be completed upon the Company’s 2025 Annual General Meeting. The activity for the year ended December 31, 2024 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of RSUs |
|
Weighted-average grant date fair value per share |
| Unvested as of January 1, 2024 |
|
3,335,268 |
|
|
$ |
4.77 |
|
| Granted |
|
1,373,816 |
|
|
$ |
4.71 |
|
| Vested |
|
(1,331,731) |
|
|
$ |
4.95 |
|
| Forfeited |
|
(324,277) |
|
|
$ |
4.56 |
|
| Unvested as of December 31, 2024 |
|
3,053,076 |
|
|
$ |
4.69 |
|
In the year ended December 31, 2023, the Company granted 2,658,150 RSUs under the 2021 plan. Under the terms of the 2021 plan, 2,260,649 of the RSUs granted are subject to a four-year vesting schedule with 25% vesting on the first anniversary of the grant date and the remaining 75% ratably on a quarterly basis over the remaining three years, 107,647 are subject to a two year vesting period on the second anniversary from the date of grant, and the remaining 289,854 of the RSUs granted to non-executive members of the Company’s board of directors are subject to a vesting period set to be completed upon the Company’s 2024 Annual General Meeting. The activity for the year ended December 31, 2023 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of RSUs |
|
Weighted-average grant date fair value per share |
| Unvested as of January 1, 2023 |
|
1,865,433 |
|
|
$ |
5.20 |
|
| Granted |
|
2,658,150 |
|
|
4.42 |
|
| Vested |
|
(927,155) |
|
|
4.65 |
|
| Forfeited |
|
(261,160) |
|
|
4.75 |
|
| Unvested as of December 31, 2023 |
|
3,335,268 |
|
|
$ |
4.77 |
|
In the year ended December 31, 2022, the Company granted 1,776,832 RSUs under the 2021 plan. Under the terms of the 2021 plan, 1,396,366 of the RSUs granted are subject to a four-year vesting schedule with 25% vesting on the first anniversary of the grant date and the remaining 75% ratably on a monthly basis over the remaining three years, and the remaining 380,466 of the RSUs granted to non-executive members of the Company’s board of directors are subject to a vesting period set to be completed upon the Company’s 2023 Annual General Meeting. The activity for the year ended December 31, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of RSUs |
|
Weighted-average grant date fair value per share |
| Unvested as of January 1, 2022 |
|
287,575 |
|
|
$ |
17.97 |
|
| Granted |
|
1,776,832 |
|
|
4.30 |
|
| Vested |
|
(133,056) |
|
|
17.99 |
|
| Forfeited |
|
(65,918) |
|
|
10.72 |
|
| Unvested as of December 31, 2022 |
|
1,865,433 |
|
|
$ |
5.20 |
|
Share-based compensation expense
Movements in the share-based compensation reserve were as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
Total |
| January 1, 2022 |
|
$ |
11,462 |
|
| Movement in the period |
|
13,613 |
|
| December 31, 2022 |
|
25,075 |
|
| Movement in the period |
|
15,242 |
|
| December 31, 2023 |
|
40,317 |
|
| Movement in the period |
|
16,488 |
|
| December 31, 2024 |
|
$ |
56,805 |
|
Share-based compensation expense by financial statement caption for all stock awards consists of the following (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Research and development |
|
$ |
4,370 |
|
|
$ |
3,440 |
|
|
$ |
2,245 |
|
| Sales and marketing |
|
1,357 |
|
|
1,266 |
|
|
1,462 |
|
| General and administrative |
|
10,761 |
|
|
10,536 |
|
|
9,906 |
|
| Total |
|
$ |
16,488 |
|
|
$ |
15,242 |
|
|
$ |
13,613 |
|
23. Borrowings
Perceptive Credit Agreement
On May 2, 2024 (the “closing date”), the Company and its subsidiary SOPHiA GENETICS, Inc. entered into a credit agreement and guaranty (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings IV, LP, as lender and administrative agent, pursuant to which the Company may borrow up to $50.0 million principal amount of term loans, including (i) an initial tranche of $15.0 million principal amount of term loans on the closing date and (ii) up to $35.0 million principal amount of term loans that the Company may draw upon on or prior to March 31, 2026, subject to satisfaction of certain customary conditions. The term loans are scheduled to mature on the fifth anniversary of the closing date and accrue interest at Term Secured Overnight Financing Rate (“SOFR”) plus 6.25% per annum; provided that upon the occurrence and during the continuation of any event of default, the term loans will accrue interest at Term SOFR plus 9.25% per annum.
Term SOFR means the SOFR reference rate that is two business days prior to the first day of the preceding calendar month. The Company has the right to prepay the term loans at any time subject to applicable prepayment premiums. The Perceptive Credit Agreement also contains certain mandatory prepayment provisions, including prepayments from the proceeds from certain asset sales and casualty events (subject to a right to reinvest such proceeds in assets used in the Company’s business within 180 days) and from issuances or incurrences of non-permitted debt, which will also be subject to prepayment premiums. The obligations under the Perceptive Credit Agreement are secured by substantially all of the Company’s and certain of the Company’s subsidiaries’ assets and are guaranteed initially on the closing date by SOPHiA GENETICS SA and SOPHiA GENETICS, Inc. The Perceptive Credit Agreement contains customary covenants, including an affirmative covenant to maintain qualified cash of at least $3.0 million, an affirmative last twelve months revenue covenant of $51.8 million as of December 31, 2024. The last twelve months revenue covenant is tested on a quarterly basis beginning June 30, 2024, and negative covenants including limitations on indebtedness, liens, fundamental changes, asset sales, investments, dividends and other restricted payments and other matters customarily restricted in such agreements. The Perceptive Credit Agreement also contains customary events of default, including payment defaults, material inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against the Company and the Company’s subsidiaries and change in control, the occurrence of which gives the lenders the right to declare the term loans and all obligations under the Perceptive Credit Agreement immediately due and payable. The Company remains in full compliance with all covenants contained in the Perceptive Credit Agreement as of December 31, 2024.
In addition, the Company issued to Perceptive Credit Holdings IV, LP a warrant certificate (the “Warrant Certificate”) representing the right to purchase up to 400,000 ordinary shares at $4.9992 per share, with the right to purchase 200,000 ordinary shares available immediately and the right to purchase an additional 200,000 ordinary shares to be available upon the drawdown of the second tranche of the term loans. The purchase rights represented by the Warrant Certificate are exercisable after becoming available, on a cash basis, at the option of the holder at any time prior to 5:00 p.m., Eastern time on the tenth anniversary of the applicable date of availability. The Warrant Certificate contains customary anti-dilution adjustments.
Critical accounting estimates and judgments
Accounting for Tranche A
The Company accounted for Tranche A of the term loans and warrants as two separate financial instruments, with the $15.0 million draw down: (i) a warrant obligation and (ii) a loan.
i) The warrant obligation is presented in the consolidated balance sheet as a short-term liability given the warrants are not settled in the entity’s functional currency and thus are not considered to be settled in a fixed amount and can be exercised currently without restriction or right to defer. The warrant obligation was initially measured at fair value using a Black-Scholes pricing model and is subsequently remeasured to fair value at each reporting date. Changes in the fair value (gains or losses) of the warrant obligation at the end of each period are recorded in the consolidated statement of loss. The Company determined the Tranche A warrant obligation qualified as a level 2 fair value liability as inputs to the fair value measurement are derived principally from or corroborated by observable market data by correlation or other means. Refer to Note 26 — “Financial instruments and risks” for the current fair value amount for the warrant obligation.
ii) The term loan was initially recorded at its amortized cost of $15.0 million less any capitalized expenses and fees payable upon the issuance (“transaction costs”) and after allocating a portion of the proceeds to the fair value of the warrant obligation. The loan is presented as a long-term financial liability in the consolidated balance sheet.
The Company assessed the allocation of transaction costs in accordance with IFRS 9 and determined the allocation to warrants was immaterial, as such the Company allocated the total amount of the transaction costs to the term loan. The transaction costs are presented net of the term loan on the consolidated balance sheet. The transaction costs are amortized as non-cash interest expense recorded to the consolidated statement of loss as the difference between the stated interest rate and the EIR. The EIR was determined upon the initial draw down of Tranche A at 15.2% and reassessed based on changes in the variable interest rate from the Perceptive Credit Agreement.
The Company estimated the EIR over the three months from December 31, 2024 to March 31, 2025 as 14.8%.
The Company calculated the fair value of the warrant obligation on issuance using the Black-Scholes pricing model. The warrant obligation was recorded at an initial fair value of $0.7 million on May 2, 2024. Key inputs for the valuation of the warrant obligation upon issuance were as follows:
|
|
|
|
|
|
|
|
|
|
|
As of May 2, 2024 |
| Exercise price in USD |
|
$5.00 |
| Share price in USD |
|
$5.08 |
| Risk-free interest rate |
|
4.53% |
| Expected volatility (annualized) |
|
71.77% |
| Expected term (years) |
|
10 |
| Dividend yield |
|
—% |
| Black-Scholes value in USD |
|
$4.06 |
The Company remeasures the fair value of the warrant obligation on a quarterly basis. Key inputs for the remeasurement of the warrant obligation as of December 31, 2024 were as follows:
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2024 |
| Exercise price in USD |
|
$5.00 |
| Share price in USD |
|
$3.07 |
| Risk-free interest rate |
|
4.51% |
| Expected volatility |
|
72.52% |
| Expected term (years) |
|
9.33 |
| Dividend yield |
|
—% |
| Black-Scholes value in USD |
|
$2.22 |
The loan was recorded at an initial amortized cost of $13.3 million on May 2, 2024. This amount represents the residual amount of the $15.0 million draw down after allocating $0.7 million for the fair value of the warrant obligation and the $1.1 million of transaction costs to be amortized as interest expense over the life of the loan. The following table presents the allocation of the loan proceeds and any movements in the liability for the year ended December 31, 2024, (in USD thousands):
|
|
|
|
|
|
|
|
|
| Loan issuance amount |
|
$ |
15,000 |
|
| Warrant obligation |
|
(656) |
|
| Transaction costs |
|
(1,070) |
|
| Initial loan amortized cost |
|
13,274 |
|
|
|
|
| Interest expense |
|
1,290 |
|
| Interest paid |
|
(1,152) |
|
| Currency translation adjustments |
|
(175) |
|
| Net amortized cost as of December 31, 2024 |
|
$ |
13,237 |
|
The Company notes there were no outstanding amounts under this credit agreement for the year ended December 31, 2023.
Revolving credit facility
On April 23, 2024 the Company terminated its existing credit agreement with Credit Suisse SA for up to CHF 5.0 million ($5.5 million). Additionally, the Company entered into a new credit agreement with Credit Suisse SA for up to CHF 0.1 million ($0.1 million) to be used for cash credits, contingent liabilities, or as margin for OTC derivative transactions. Borrowings under the new credit agreement will bear interest at a rate to be established between the Company and Credit Suisse SA at the time of each draw down. As of December 31, 2024, the Company had no borrowings outstanding under the Credit Facility.
24. Related parties
Related parties comprise the Company’s executive officers and directors, including their affiliates, and any person that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control, with the Company.
Key management personnel comprised of six Executive Officers and Directors and six Non-Executive Directors for the year ended December 31, 2024. Key management personnel comprised of six Executive Officers and Directors and seven Non-Executive Directors for the year ended December 31, 2023. Key management personnel comprised of six Executive Officers and Directors and seven Non-Executive Directors for the year ended December 31, 2022.
Compensation for key management and non-executive directors recognized during the year comprised (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
| Salaries and other short-term employee benefits |
|
$ |
4,206 |
|
|
$ |
4,234 |
|
|
$ |
3,782 |
|
| Pension costs |
|
253 |
|
|
228 |
|
|
196 |
|
| Share-based compensation expense |
|
12,327 |
|
|
10,597 |
|
|
8,936 |
|
| Total |
|
$ |
16,786 |
|
|
$ |
15,059 |
|
|
$ |
12,914 |
|
25. Commitments and contingencies
Commitments
The Company has no commitments for future lease payments under short-term leases not recognized on the balance sheet as of December 31, 2024 and 2023.
The Company has a minimum purchase agreement with a vendor related to computational and hosting-related costs. As part of the agreement, the Company has a total minimum commitment of approximately $70.7 million from the period beginning November 1, 2022 through October 31, 2027 and an additional one-year grace period to meet the minimum commitment by October 31, 2028. As of December 31, 2024 and 2023, the Company has remaining commitments of $58.8 million and $70.3 million, respectively.
Contingencies
As of December 31, 2024 and 2023 the Company had no contingent assets or liabilities.
26. Financial instruments and risks
A financial instrument is any contract that gives rise to a financial asset of one entity and a financial liability or equity instrument of another entity.
The Company holds the following financial instruments (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
| Financial assets at amortized cost |
|
|
|
|
| Cash and cash equivalents |
|
$ |
80,226 |
|
|
$ |
123,251 |
|
|
|
|
|
|
| Accounts receivable |
|
7,436 |
|
|
13,557 |
|
| Other financial non-current assets |
|
994 |
|
|
1,382 |
|
| Total financial assets at amortized cost |
|
$ |
88,656 |
|
|
$ |
138,190 |
|
| Financial assets at fair value through statement of loss |
|
|
|
|
| Total financial assets |
|
$ |
88,656 |
|
|
$ |
138,190 |
|
| Financial liabilities at amortized cost |
|
|
|
|
| Accounts payable |
|
5,220 |
|
|
5,391 |
|
| Accrued expenses |
|
13,217 |
|
|
17,808 |
|
| Lease liabilities |
|
16,793 |
|
|
18,601 |
|
| Borrowings |
|
13,237 |
|
|
— |
|
| Total financial liabilities at amortized cost |
|
48,467 |
|
|
41,800 |
|
| Financial liabilities at fair value through statement of loss |
|
|
|
|
| Warrant obligations |
|
444 |
|
|
— |
|
| Total financial liabilities |
|
$ |
48,911 |
|
|
$ |
41,800 |
|
The Company’s exposure to various risks associated with the financial instruments is discussed below in “Financial risk management.” The maximum exposure to credit risk at the end of the reporting period is the carrying amount of each class of financial assets mentioned above. See Note 12 – “Accounts receivable” for expected credit loss provisions on accounts receivable.
Fair value measurement
As of December 31, 2024 and 2023, the carrying amount was a reasonable approximation of fair value for the following financial assets and liabilities:
Financial assets
•Cash and cash equivalents
•Accounts receivable
•Other non-current assets—lease deposits
Financial liabilities
•Accounts payable
•Accrued liabilities
•Lease liabilities
•Borrowings
Fair value measurement methodology
The Company measures financial instruments at fair value at each balance sheet date. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value measurement is based on the presumption that the transaction to sell the asset or transfer the liability takes place either in the principal market for the asset or liability or, in the absence of a principal market, in the most advantageous market for the asset or liability.
The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest.
A fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset or by selling it to another market participant.
The Company uses valuation techniques to measure fair value maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
All assets and liabilities for which fair value is measured or disclosed in the consolidated financial statements are categorized within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole:
Level 1—Quoted (unadjusted) market prices in active markets for identical assets or liabilities.
Level 2—Valuation techniques for which the lowest level input that is significant to the fair value measurement is directly or indirectly observable.
Level 3—Valuation techniques for which the lowest level input that is significant to the fair value measurement is unobservable.
For assets and liabilities that are recognized in the consolidated financial statements at fair value on a recurring basis, the Company determines whether transfers have occurred between levels in the hierarchy by re-assessing categorization (based on the lowest level input that is significant to the fair value measurement as a whole) at the end of each reporting period.
Management determines the policies and procedures for both recurring fair value measurement and for non-recurring measurement with the involvement of experts and external consultants when needed.
The Company holds money market funds which are classified as cash equivalents which are measured as a level 1 valuation. Refer to Note 11 – “Cash and cash equivalents.” The Company also has warrant obligations related to the Perceptive Credit Agreement, which are measured as a level 2 valuation. Refer to Note 23 — “Borrowings”.
Recurring fair-value measurements
The following table presents the Company’s fair value hierarchy for its financial assets and financial liabilities that were measured at fair value on a recurring basis as of December 31, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
| Financial assets: |
|
|
|
|
|
|
| Cash and cash equivalents: |
|
|
|
|
|
|
| Money market funds |
|
$ |
39,586 |
|
|
$ |
— |
|
|
$ |
— |
|
| Total financial assets |
|
$ |
39,586 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
| Financial liabilities: |
|
|
|
|
|
|
| Warrant obligation: |
|
|
|
|
|
|
| Perceptive Credit Holdings warrants |
|
$ |
— |
|
|
$ |
444 |
|
|
$ |
— |
|
| Total financial liabilities |
|
$ |
— |
|
|
$ |
444 |
|
|
$ |
— |
|
The following table presents the Company’s fair value hierarchy for its financial assets that were measured at fair value on a recurring basis as of December 31, 2023 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
| Financial assets: |
|
|
|
|
|
|
| Cash and cash equivalents |
|
|
|
|
|
|
| Money market funds |
|
$ |
60,683 |
|
|
$ |
— |
|
|
$ |
— |
|
| Total financial assets |
|
$ |
60,683 |
|
|
$ |
— |
|
|
$ |
— |
|
The Company had no financial liabilities measured at fair value on a recurring basis as of December 31, 2023.
In 2024 and 2023 there were no significant changes in the business or economic circumstances that affect the fair value of the Company’s financial assets and financial liabilities. There were also no transfers between categories.
Financial risk management
Financial risks
Senior management regularly reviews the Company’s cash forecast and related risks. They also perform the risk assessment, define any necessary measures and ensure the monitoring of the internal control system.
The Company’s principal financial liabilities include borrowings and accounts payable. The Company’s principal financial assets include cash and cash equivalents and accounts receivable.
In the course of its business, the Company is exposed to a number of financial risks including credit and counterparty risk, funding and liquidity risk, and market risk (i.e. foreign currency risk and interest rate risk). This note presents the Company’s objectives, policies, and processes for managing these risks.
Credit and counterparty risk management
Credit risk is the risk that a counterparty will not meet its obligations under a financial instrument or customer contract, leading to a financial loss. The Company is exposed to credit risk from its operating activities, primarily accounts receivable.
Concentration risk arises when a number of counterparties are engaged in similar business activities, or activities in the same geographical region, or have economic features that would cause their ability to meet contractual obligations to be similarly affected by changes in economic, political, or other conditions.
The Company’s policy with regard to assessing and providing for expected credit losses on accounts receivable is set out in Note 12 – “Accounts receivable.”
Credit risk from balances with banks and financial institutions is managed by the Company’s treasury department in accordance with the Company’s policy.
Financial transactions are predominantly entered into with investment grade financial institutions and in principle the Company requires a minimum long-term rating of A3/A- for its cash investments and term deposits. The Company may deviate from this requirement from time to time for operational reasons. The highest exposure to a single financial counterparty within cash and cash equivalents and term deposits amounted to $26.1 million and $43.7 million as of December 31, 2024 and 2023, respectively.
Other non-current financial assets include cash deposits for leases.
Funding and liquidity risk management
Funding and liquidity risk is the risk that a company may encounter difficulties in meeting its obligations associated with financial liabilities that are settled by delivering cash or other financial assets. Such risk may result from inadequate market depth or disruption or refinancing problems.
The Company views equity funding as its primary source of liquidity only partly complemented with revenue generated from the sale of the platform, applications, products, and services and borrowings. The Company has $15.0 million of outstanding term loans under the Perceptive Credit Agreement, see Note 23 – “Borrowings” for additional information. Short term liquidity is managed based on projected cash flows. As of December 31, 2024 and 2023, the Company’s liquidity consisted of $80.2 million and $123.3 million in cash and cash equivalents, respectively. On the basis of the current operating performance and liquidity position, management believes that the available cash balances will be sufficient for operating activities, working capital, interest, capital expenditures and scheduled debt repayments for the next 12 months.
The table below summarizes the maturity profile of the Company’s financial liabilities based on contractual undiscounted cash flows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net carrying amount |
|
Within 1 year |
|
Between 1 and 5 years |
|
After 5 years |
|
Total |
| December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
| Lease liabilities |
|
$ |
16,793 |
|
|
$ |
2,739 |
|
|
$ |
12,518 |
|
|
$ |
4,469 |
|
|
$ |
19,726 |
|
| Accounts payable |
|
5,220 |
|
|
5,220 |
|
|
— |
|
|
— |
|
|
5,220 |
|
| Accrued expenses |
|
13,217 |
|
|
13,217 |
|
|
— |
|
|
— |
|
|
13,217 |
|
| Borrowings |
|
13,237 |
|
|
— |
|
|
15,000 |
|
|
— |
|
|
15,000 |
|
| Total contractual liabilities |
|
$ |
48,467 |
|
|
$ |
21,176 |
|
|
$ |
27,518 |
|
|
$ |
4,469 |
|
|
$ |
53,163 |
|
|
|
|
|
|
|
|
|
|
|
|
| December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
| Lease liabilities |
|
$ |
18,601 |
|
|
$ |
3,195 |
|
|
$ |
9,729 |
|
|
$ |
6,364 |
|
|
$ |
19,288 |
|
| Accounts payable |
|
5,391 |
|
|
5,391 |
|
|
— |
|
|
— |
|
|
5,391 |
|
| Accrued expenses |
|
17,808 |
|
|
17,808 |
|
|
— |
|
|
— |
|
|
17,808 |
|
| Total contractual liabilities |
|
$ |
41,800 |
|
|
$ |
26,394 |
|
|
$ |
9,729 |
|
|
$ |
6,364 |
|
|
$ |
42,487 |
|
Market risk
Market risk includes currency risk and interest rate risk.
Currency risk
Foreign currency risk is the risk that the fair value or future cash flows of an exposure will fluctuate because of changes in foreign exchange rates.
The significant exchange rates that have been applied to these consolidated financial statements are listed below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
For the twelve months ended December 31, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
2022 |
| Currency |
|
Spot rate |
|
Average rate |
| USD/CHF |
|
0.90740 |
|
|
0.84110 |
|
|
0.88064 |
|
|
0.89855 |
|
|
0.95500 |
|
| USD/EUR |
|
0.96530 |
|
|
0.90580 |
|
|
0.92455 |
|
|
0.92478 |
|
|
0.95146 |
|
| USD/GBP |
|
0.79870 |
|
|
0.78440 |
|
|
0.78267 |
|
|
0.80428 |
|
|
0.81177 |
|
| USD/BRL |
|
6.17360 |
|
|
4.85250 |
|
|
5.39155 |
|
|
4.97372 |
|
|
5.16678 |
|
The sensitivity of the Company’s income to possible changes in foreign exchange rates is measured at the local entity level as it depends on the functional currency of each entity. As of December 31, 2024, 2023, and 2022 the Company was exposed principally to movements in four cross currency pairs. The sensitivity of the Company’s loss before tax to such changes was as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
|
2022 |
Increase / (decrease) in USD/CHF exchange rate by 10% |
|
562 |
|
/ |
(562) |
|
3,034 |
|
/ |
(3,034) |
|
6,614 |
|
/ |
(6,614) |
Increase / (decrease) in EUR/CHF exchange rate by 10% |
|
(75) |
|
/ |
75 |
|
508 |
|
/ |
(508) |
|
(94) |
|
/ |
94 |
Increase / (decrease) in GBP/CHF exchange rate by 10% |
|
25 |
|
/ |
(25) |
|
(23) |
|
/ |
23 |
|
(83) |
|
/ |
83 |
Increase / (decrease) in USD/EUR exchange rate by 10% |
|
(2,605) |
|
/ |
2,605 |
|
(513) |
|
/ |
513 |
|
503 |
|
/ |
(503) |
The Company’s exposure to foreign currency changes for all other currencies is not material. The Company does not use derivative financial instruments to hedge exposures and under no circumstances may enter into derivative instruments for speculative purposes.
The sensitivity of the Company’s reported equity or net assets to possible changes in foreign exchange rates is measured at the consolidated level as it depends on the presentation currency selected for the consolidated financial statements. Such effects are reported not in income but in the currency translation account within other reserves. As of December 31, 2024 and 2023 the sensitivity of the Company’s equity to such changes, measured against the USD, was as follows (in USD thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2024 |
|
2023 |
Increase / (decrease) in USD/CHF exchange rate by 10% |
|
(1,520) |
/ |
1,520 |
|
(1,552) |
/ |
1,552 |
Increase / (decrease) in USD/EUR exchange rate by 10% |
|
2,244 |
/ |
(2,244) |
|
383 |
/ |
(383) |
Increase / (decrease) in USD/GBP exchange rate by 10% |
|
61 |
/ |
(61) |
|
18 |
/ |
(18) |
Interest rate risk
The Company’s cash and cash equivalents are subject to market risk associated with interest rate fluctuations. Fixed rate securities may have their market value adversely affected due to a rise in interest rates. The Company concluded that fluctuations in the interest rate did not have a material impact on the Company’s cash and cash equivalents balances.
As of December 31, 2024, the Company currently has $15.0 million of debt outstanding under the Perceptive Credit Agreement. Based on the terms of the Perceptive Credit Agreement, the monthly interest expense fluctuates based on the SOFR reference rate that is two business days prior to the first day of the preceding calendar month.
Given the Company’s outstanding debt under this agreement, the Company is subject to interest rate risk related to debt obligations if the SOFR were to move significantly.
27. Capital management
The Company considers equity as equivalent to the IFRS Accounting Standards equity on the balance sheet (including share capital, share premium, and all other equity reserves attributable to the owners of the Company).
The primary objective of the Company’s capital management is to maximize shareholder value. The Board regularly reviews its shareholders’ return strategy. For the foreseeable future, the Board will maintain a capital structure that supports the Company’s strategic objectives through managing funding and liquidity risks and optimizing shareholder return.
As of December 31, 2024 and 2023, the Company’s cash and cash equivalents amounted to $80.2 million and $123.3 million, respectively.
The Company also has access to $35 million which is still available under the Perceptive Credit Agreement.
The Board of Directors believes that the Company has sufficient financial resources to meet all of its obligations for at least the next twelve months. Moreover, the Company is not exposed to liquidity risk through requests for early repayment of loans.
28. Events after the reporting date
The Company has evaluated, for potential recognition and disclosure, events that occurred prior to the date at which the consolidated financial statements were available to be authorized for issuance. There were no material subsequent events.
EX-1.1
2
aoapostincreasejuly2024p.htm
EX-1.1
aoapostincreasejuly2024p
Articles of Association of SOPHiA GENETICS SA Statuts de SOPHiA GENETICS SA
Section 1 Name, registered office, purpose and duration of the Company Section 1 Raison sociale, siège, but et durée de la Société Article 1 Article 1 Name, registered office Under the name SOPHiA GENETICS SA (the Company) exists a corporation with its registered office in Rolle, Canton of Vaud, governed by these articles of association (the Articles of Association) and the Swiss Code of Obligations (CO). Raison sociale, siège Sous la raison sociale SOPHiA GENETICS SA (la Société) existe une société anonyme avec siège à Rolle, Canton de Vaud, régie par les présents statuts (les Statuts) et le Code suisse des obligations (CO). Article 2 Article 2 Purpose 1 The Company's purpose is the management, preservation and storage of archives of all types, in particular computer and paper archives, as well as the design, development, maintenance, sale and lease of systems, products and services in connection therewith; the development, management and transfer of licenses and franchise agreements in connection therewith, as well as the preservation and archiving of data in the genetic field. The Company may carry out any financial, commercial or industrial activities, in movable or real property, in direct or indirect connection with its purpose. 2 The Company may open branch offices and subsidiaries in Switzerland and abroad. It may also acquire participations or otherwise invest in other companies in Switzerland and abroad. But 1 La Société a pour but la gestion, la conservation et l'entreposage d'archives de toute nature, notamment d'archives informatiques et de papiers ainsi que la conception, la réalisation, la maintenance, la vente et la location de systèmes, produits et services s'y rapportant; le développement, la gestion et le transfert de licences et contrats de franchise y relatives, ainsi que la conservation et l'archivage de données dans le domaine de la génétique. La Société peut exercer toute activité financière, commerciale ou industrielle, mobilière ou immobilière, en rapport direct ou indirect avec son but. 2 La Société peut constituer des succursales et des filiales en Suisse et à l'étranger et participer à ou investir autrement dans d'autres entreprises en Suisse et à l'étranger.
3 The Company may acquire, hold, manage, mortgage, exploit and sell real estate and intellectual property rights in Switzerland and abroad and may also finance other companies. 3 La Société peut acquérir, détenir, gérer, gager, mettre en valeur et aliéner des immeubles et des droits de propriété intellectuelle en Suisse et à l'étranger, ainsi que financer d'autres sociétés. Article 3 Article 3 Duration The duration of the Company shall be unlimited. Durée La durée de la Société est illimitée. Section 2 Share capital, shares, restrictions of transferability Section 2 Capital-actions, actions et restrictions à la transmissibilité Article 4 Article 4 Share capital The share capital of the Company is CHF 3,966,061.- Capital-actions Le capital-actions de la Société est de and is divided into 79,321,220 fully paid in registered shares with a par value of CHF 0.05 each. CHF 3'966'061.- et est divisé en 79'321'220 actions nominatives entièrement libérées d'une valeur nominale de CHF 0.05 chacune. Article 4a Article 4a Capital Range 1 The Company has a capital range ranging from CHF 3,319,908.20 (lower limit) to CHF 4,979,862.30 (upper limit). The Board of Directors shall be authorized within the capital range to increase or reduce the share capital once or several times and in any amounts or to acquire or dispose of shares directly or indirectly, until June 24, 2029 or until an earlier expiry of the capital range. The capital increase or reduction may be effected by issuing up to 33,199,082 fully paid-in registered shares with a par value of CHF 0.05 each and cancelling up to 33,199,082 registered shares with a par value of CHF 0.05 each, as applicable, or by increasing or Marge de fluctuation du capital 1 La Société dispose d'une marge de fluctuation du capital allant de CHF 3'319'908.20 (limite inférieure) à CHF 4'979'862.30 (limite supérieure). Le Conseil d'Administration peut, dans les limites définies de la marge de fluctuation, et ce jusqu'au 24 juin 2029 ou jusqu'à l'expiration anticipée de la marge de fluctuation, augmenter ou réduire le capital-actions en une ou plusieurs fois, de quelque montant que ce soit, ou acquérir ou aliéner des actions directement ou indirectement. L'augmentation ou la réduction du capital peut se faire par l'émission de jusqu'à 33'199'082 actions nominatives d'une valeur nominale de CHF 0.05
reducing the par value of the existing shares within the limits of the capital range or by simultaneous reduction and re-increase of the share capital. 2 In the event of an issue of shares, the subscription and acquisition of the new shares, as well as any subsequent transfer of the shares, shall be subject to the restrictions pursuant to article 6 of these Articles of Association. 3 In the event of a capital increase within the capital range, the Board of Directors shall, to the extent necessary, determine the issue price, the type of contribution (including cash contributions, contributions in kind, set-off and conversion of reserves or of profit carried forward into share capital), the date of issue, the conditions for the exercise of pre-emptive rights and the beginning date for dividend entitlement. In this regard, the Board of Directors may issue new shares by means of a firm underwriting through a financial institution, a syndicate of financial institutions or another third party and a subsequent offer of these shares to the existing shareholders or third parties (if the pre-emptive rights of the existing shareholders have been withdrawn or have not been duly exercised). The Board of Directors is entitled to permit, to restrict or to exclude the trading of pre-emptive rights. It may permit the expiration of pre- emptive rights that have not been duly exercised, or it may place such rights or shares as to which pre-emptive rights have been granted, but not duly exercised, at market conditions or may use them otherwise in the interest of the Company. chacune, qui doivent être intégralement libérées, respectivement l'annulation de jusqu'à 33'199'082 actions nominatives d'une valeur nominale de CHF 0.05 chacune, ou par une augmentation ou une réduction, dans les limites de la marge de fluctuation, de la valeur nominale des actions nominatives existantes ou encore par une réduction et une nouvelle augmentation simultanées. 2 En cas d'émission d'actions, la souscription et l'acquisition des nouvelles actions, ainsi que tout transfert ultérieur des actions, sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des Statuts. 3 En cas d'augmentation du capital-actions dans le cadre de la marge de fluctuation, le Conseil d'Administration détermine, le cas échéant, le prix d'émission, la nature des apports (y compris la libération en espèces, les apports en nature, la compensation et la conversion de réserves ou de bénéfice reporté en capital-actions), le moment de l'émission, les conditions de l'exercice du droit de souscription préférentiel et le moment à partir duquel les actions donneront droit à des dividendes. A cet effet, le Conseil d'Administration peut émettre des nouvelles actions par voie de prise ferme par un établissement financier, un consortium bancaire ou un tiers et d'offre subséquente de ces actions aux actionnaires actuels ou à des tiers (si les droits de souscription préférentiels des actionnaires actuels ont été supprimés ou n'ont pas été valablement exercés). Le Conseil d'Administration est en droit d'autoriser, de limiter ou d'exclure le négoce des droits de souscription préférentiels. Le Conseil d'Administration peut laisser s'éteindre les droits de souscription préférentiels non exercés valablement; il peut aussi aliéner ceux-ci, respectivement les actions pour lesquelles des droits de souscription ont été accordés sans toutefois être
4 In the event of an issue of shares, the Board of Directors is further authorized to withdraw or restrict pre- emptive rights of existing shareholders and to allocate such rights to third parties, the Company or any of its group companies: (a) if the issue price of the new shares is determined by reference to the market price; or (b) for raising equity capital in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable conditions, without the exclusion of the pre-emptive rights of existing shareholders; or (c) for the acquisition of companies, part(s) of companies or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares; or (d) for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners including financial investors, or in connection with the listing of new shares on domestic or foreign stock exchanges; or (e) for purposes of granting an over-allotment option (Greenshoe) or an option to subscribe for additional shares in a placement or sale of shares to the respective initial purchaser(s) or valablement exercés, aux conditions du marché ou les utiliser autrement dans l'intérêt de la Société. 4 En cas d'émission d'actions, le Conseil d'Administration peut aussi exclure ou limiter les droits de souscription préférentiels des actionnaires actuels et les attribuer à des tiers, à la Société ou à une des sociétés du groupe: (a) si le prix d'émission des nouvelles actions est déterminé en fonction du prix du marché; ou (b) pour créer des fonds propres de manière rapide et flexible, ce qui ne serait pas possible ou possible qu'avec difficulté ou tardivement ou à des conditions nettement plus défavorables sans l'exclusion des droits de souscription préférentiels des actionnaires actuels; ou (c) pour l'acquisition de sociétés, de partie(s) de sociétés ou de participations, pour l'acquisition de produits, de propriété intellectuelle, ou licences par ou pour des projets d'investissement de la Société ou de l'une des sociétés du groupe, ou pour le financement ou le refinancement de telles transactions par le placement d'actions; ou (d) pour élargir le cercle des actionnaires de la Société dans certains marchés géographiques, financiers ou d'investisseurs, pour permettre la participation de partenaires stratégiques y compris d'investisseurs financiers, ou en relation avec la cotation de nouvelles actions sur des bourses nationales ou étrangères; ou (e) pour octroyer une option de surallocation (Greenshoe) ou une option de souscription d'actions supplémentaires lors d'un placement ou de la vente d'actions à un ou plusieurs acheteurs
underwriter(s); or initiaux ou souscripteurs; ou (f) for the participation of members of the Board of Directors (or equivalent corporate body), members of the executive management, employees, contractors, consultants, or other persons performing services for the benefit of, the Company or any of its group companies; or (g) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 15% of the share capital registered in the commercial register without having submitted to all other shareholders a takeover offer recommended by the Board of Directors; or (h) for the defense of an actual, threatened or potential takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find such takeover bid to be (i) financially fair to the shareholders or (ii) in the Company's interest. 5 After a change of the par value, new shares shall be issued within the capital range with the same par value as the existing shares. 6 If the share capital increases as a result of an increase from conditional capital pursuant to Article 4b of these articles of association, the upper and lower limits of the capital range shall increase in an amount corresponding to such increase in the share capital. (f) pour la participation de membres du conseil d'administration (ou d'un organe équivalent), de membres de la direction, d'employés, de co- contractants ou de consultants ou d'autres personnes exerçant des services au bénéfice de la Société ou de l'une des sociétés du groupe; ou (g) si un actionnaire ou un groupe d'actionnaires agissant de concert a acquis ou réuni une participation de plus de 15% du capital-actions inscrit au registre du commerce sans avoir présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil d'Administration; ou (h) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'Administration, après consultation d'un conseiller financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'Administration estime que l'offre publique d'achat n'est pas (i) équitable d'un point de vue financier vis-à-vis des actionnaires ou (ii) dans l'intérêt de la Société. 5 En cas de modification de valeur nominale, les nouvelles actions émises dans le cadre de la marge de fluctuation du capital doivent être émises avec la même valeur nominale que les actions nominatives existantes. 6 En cas d'augmentation du capital-actions en raison d'une augmentation conditionnelle du capital-actions conformément à l'article 4b, les limites supérieure et inférieure de la marge de fluctuation augmentent en fonction du montant de l'augmentation du capital- actions. 7 In the event of a reduction of the share capital within 7 En cas de réduction du capital-actions dans le cadre
the capital range, the Board of Directors shall, to the extent necessary, determine the use of the reduction amount. de la marge de fluctuation, le Conseil d'Administration détermine, si nécessaire, l'affectation du montant de la réduction. Article 4b Article 4b Conditional share capital for employee participation 1 The share capital may be increased in an amount not to exceed CHF 903,076.40 through the issuance of up to 18,061,528 fully paid in registered shares with a par value of CHF 0.05 per share through the direct or indirect issuance of shares, or through the exercise or mandatory exercise of rights to acquire shares or through obligations to acquire shares that were granted to or imposed on members of the Board of Directors (or equivalent corporate body), members of the executive management, employees, contractors or consultants of the Company or its group companies, or other persons providing services to the Company or its group companies. 2 The pre-emptive rights and advance subscription rights of the shareholders of the Company shall be excluded in connection with the issuance of any shares, options, other rights to receive shares, or subscription rights therefor. Shares, options, other rights to receive shares, or subscription rights therefore shall be issued pursuant to one or more plans, regulations or resolutions to be issued by the Board of Directors or, to the extent delegated to it, the Compensation Committee, and to the extent applicable, taking into account the compensation principles pursuant to article 28 of these Articles of Association. Such shares may be issued at a price lower than the respective market price quoted on the stock exchange and such rights or acquisition obligations may be granted below their intrinsic value. Capital-actions conditionnel pour la participation des employés 1 Le capital-actions peut être augmenté d'un montant maximum de CHF 903'076.40 par l'émission de 18'061’528 actions nominatives au plus, d'une valeur nominale de CHF 0.05 chacune, qui doivent être intégralement libérées, par l'émission directe ou indirecte d'actions ou par l'exercice ou l'exercice obligatoire de droits de souscription d'actions ou par des obligations d'acquisition d'actions accordées ou imposées à des membres du conseil d'administration (ou d'un organe équivalent), des membres de la direction, des employés, des co-contractants ou des consultants de la Société ou de l'une des sociétés du groupe, ou d'autres personnes exerçant des services au bénéfice de la Société ou de l'une des sociétés du groupe. 2 Le droit de souscription préférentiel ainsi que le droit de souscription préalable des actionnaires de la Société sont exclus en relation avec l'émission de toutes actions, options, autres droits à recevoir des actions ou des droits de souscription qui y sont attachés. L'émission d'actions, d'options, d'autres droits à recevoir des actions ou des droits de souscription qui y sont attachés est faite selon un ou plusieurs plans, règlements ou décisions adoptés par le Conseil d'Administration ou le Comité de Rémunération, dans la mesure où cette compétence lui a été déléguée, et, le cas échéant, en tenant compte des principes de rémunération selon l'article 28 des Statuts. L'émission de telles actions peut se faire à un prix inférieur au prix du marché et l'octroi de tels droits ou obligations
3 The direct or indirect acquisition of the new shares by persons listed in paragraph 1 of this article 4b in connection with an employee participation program, as well as any subsequent transfer of such shares, shall be subject to the restrictions of article 6 of these Articles of Association. 4 The declaration of acquisition of the shares based on this Article 4b shall refer to this Article 4b and be made in a form that allows proof by text. A waiver of the right to acquire shares based on this Article 4b may also occur informally or by lapse of time; this also applies to the waiver of the exercise and forfeiture of this right. d'acquisition peut se faire à un prix inférieur à leur valeur intrinsèque. 3 L'acquisition directe ou indirecte de nouvelles actions par des personnes mentionnées à l'alinéa 1 du présent article 4b dans le cadre d'un programme de participation des collaborateurs, ainsi que le transfert subséquent de ces actions, sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des Statuts. 4 La déclaration concernant l'acquisition d'actions fondée sur le présent article 4b doit faire référence à cet article 4b et doit être faite sous une forme permettant d'en établir la preuve par texte. La renonciation à un droit d'acquisition d'actions fondé sur le présent article 4b peut également avoir lieu de manière informelle ou par l'écoulement du temps; cela vaut également pour la renonciation é l'exercice et la déchéance de ce droit. Article 4c Article 4c Conditional share capital for financing, acquisitions and other purposes 1 The share capital may be increased including in connection with an intended takeover in an amount not to exceed CHF 1,079,954.10 through the issuance of up to 21,599,082 fully paid in registered shares with a par value of CHF 0.05 per share through the exercise or mandatory exercise of conversion, exchange, option, warrant or similar rights or obligations for the subscription of shares granted to shareholders or third parties on a stand-alone basis or in connection with bonds, notes, options, warrants or other securities or contractual obligations of the Company or any of its group companies (collectively, the Financial Instruments). 2 The pre-emptive rights of shareholders shall be excluded for the exercise of any Financial Instruments in Capital-actions conditionnel aux fins de financement, acquisitions ou d'autres buts 1 Le capital-actions peut être augmenté, y compris en lien avec une future offre publique d'acquisition, d'un montant maximum de CHF 1'079'954.10 par l'émission de 21'599’082 actions nominatives au plus, d'une valeur nominale de CHF 0.05 chacune, qui doivent être intégralement libérées par l'exercice ou l'exercice obligatoire de droits de conversion, d'échange, d'option, de warrant ou d'autres droits ou obligations similaires pour la souscription d'actions octroyés aux actionnaires ou à des tiers de manière autonome ou en rapport avec des obligations, effets, options, warrants ou autres instruments financiers ou obligations contractuelles de la Société ou de l'une des sociétés du groupe (collectivement, les Instruments Financiers). 2 Le droit de souscription préférentiel des actionnaires est exclu en relation avec l'émission d'actions à
connection with the issuance of shares. The then- current owners of such Financial Instruments shall be entitled to acquire the new shares issued upon conversion, exchange or exercise of any Financial Instruments. The main conditions of the Financial Instruments shall be determined by the Board of Directors. 3 The Board of Directors shall be authorized to restrict or withdraw advance subscription rights of shareholders in connection with the issuance of Financial Instruments by the Company or one of its group companies (1) if the issuance is for purposes of financing or refinancing, or the payment for, the acquisition of companies, parts of a company, participations, intellectual property rights, licenses or investments, (2) if the issuance occurs in domestic or international capital markets or through a private placement, (3) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 15% of the share capital registered in the commercial register without having submitted to all other shareholders a takeover offer recommended by the Board of Directors, (4) for the defense of an actual, threatened or potential takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find such takeover bid to be (i) financially fair to the shareholders or (ii) in the Company's interest, or (5) if the Financial Instruments are issued on appropriate terms. If the advance subscription rights are neither granted directly nor indirectly by the Board of Directors, the following shall apply: l'occasion de l'exercice d'Instruments Financiers. Les personnes qui détiendront alors de tels Instruments Financiers seront en droit d'acquérir les nouvelles actions émises à l'occasion de la conversion, de l'échange ou de l'exercice d'Instruments Financiers. Le Conseil d'Administration détermine les principales conditions des Instruments Financiers. 3 Le Conseil d'Administration est autorisé à limiter ou retirer le droit de souscription préalable des actionnaires en relation avec l'émission d'Instruments Financiers par la Société ou une des sociétés du groupe (1) si l'émission a pour but le financement, le refinancement ou le paiement de l'acquisition d'entreprises, de parties d'une entreprise, de participations, de droits de propriété intellectuelle, de licences ou d'investissements, (2) si l'émission a lieu sur les marchés de capitaux nationaux ou internationaux ou par le biais d'un placement privé, (3) si un actionnaire ou un groupe d'actionnaires agissant de concert a acquis ou réuni une participation de plus de 15% du capital-actions inscrit au registre du commerce sans avoir présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil d'Administration, (4) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'Administration, après consultation d'un conseiller financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'Administration estime que l'offre publique d'achat n'est pas (i) équitable d'un point de vue financier vis-à-vis des actionnaires ou (ii) dans l'intérêt de la Société, ou (5) si les Instruments Financiers sont émis à des conditions appropriées. Si le droit de souscription préalable n'est pas accordé, de manière directe ou indirecte, par le Conseil d'Administration, les règles suivantes
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 10 / 38 (a) the Financial Instruments shall be issued or entered into at market conditions; (b) the Financial Instruments may be converted, exchanged or exercised during a maximum period of 10 years from the date of issuance or contract conclusion; and (c) the conversion, exchange or exercise price of the Financial Instruments shall be set with reference to, and/or shall be subject to change based upon, the valuation of the Company's equity and/or market conditions. 4 The direct or indirect acquisition of the new shares acquired through the exercise of Financial Instruments, as well as any subsequent transfer of such shares, shall be subject to the restrictions of article 6 of these Articles of Association. 5 The declaration of acquisition of the shares based on this Article 4c shall refer to this Article 4c and be made in a form that allows proof by text. A waiver of the right to acquire shares based on this Article 4c may also occur informally or by lapse of time; this also applies to the waiver of the exercise and forfeiture of this right. s'appliquent: (a) les Instruments Financiers sont émis ou conclus aux conditions du marché; (b) les Instruments Financiers peuvent être convertis, échangés ou exercés durant une période maximale de 10 ans suivant la date de l'émission ou de la conclusion du contrat; et (c) le prix de conversion, d'échange ou d'exercice des Instruments Financiers est fixé en prenant en compte, et/ou peut être modifié en fonction, de la valorisation des fonds propres de la Société et/ou des conditions du marché. 4 L'acquisition de nouvelles actions acquises directement ou indirectement par l'exercice d'Instruments Financiers, ainsi que le transfert subséquent de ces actions, sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des Statuts. 5 La déclaration concernant l'acquisition d'actions fondée sur le présent article 4c doit faire référence à cet article 4c et doit être faite sous une forme permettant d'en établir la preuve par texte. La renonciation à un droit d'acquisition d'actions fondé sur le présent article 4c peut également avoir lieu de manière informelle ou par l'écoulement du temps; cela vaut également pour la renonciation à l'exercice et la déchéance de ce droit. Article 5 Article 5 Share certificates and intermediated securities 1 The Company may issue its registered shares in the form of single certificates, global certificates, uncertificated securities within the meaning of article 973c or 973d CO, or intermediated securities. Subject to applicable law, the Company may convert its Certificats d'actions et titres intermédiés 1 La Société émet ses actions nominatives sous forme de certificats individuels, de certificats globaux, de droits-valeurs au sens des articles 973c ou 973d CO ou des titres intermédiés. La Société est libre, dans les limites du droit applicable, en tout temps et sans
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 11 / 38 registered shares from one form into another form at any time and without the approval of the shareholders. The Company shall bear the cost associated with any such conversion. 2 A shareholder has no right to request a conversion of the registered shares issued in one form into another form. Each shareholder may, however, at any time request from the Company a written confirmation of the registered shares held by such shareholder, as reflected in the share register. 3 Intermediated securities based on registered shares of the Company cannot be transferred by way of assignment. A security interest in any such intermediated securities also cannot be granted by way of assignment. l'approbation des actionnaires, de convertir ses actions nominatives émises sous l'une des formes ci-dessus, en une autre forme. La Société supporte les coûts d'une telle conversion. 2 Un actionnaire n'a pas le droit de réclamer la conversion d'actions nominatives émises sous une certaine forme en une autre forme. Chaque actionnaire peut toutefois exiger en tout temps que la Société établisse une attestation relative aux actions nominatives qu'il détient selon le registre des actions. 3 Les titres intermédiés fondés sur des actions nominatives de la Société ne peuvent pas être transférés par cession. Il ne peut pas non plus être constitué de sûretés par cession sur ces titres intermédiés. Article 6 Article 6 Share register, restrictions on registration, Nominees 1 The Company shall maintain, itself or through a third party, a share register for the registered shares that lists the surname and name (the name of the company in case of a legal entity), the address and domicile (the registered office in case of a legal entity) of the shareholders or usufructuaries. A person registered in the share register shall notify the share registrar of any change of address. Until such notification has occurred, all written communications from the Company to persons registered in the share register shall be deemed to have been validly made if sent to the address previously recorded in the share register. 2 Persons acquiring shares shall be registered in the share register as shareholders with voting rights upon their request if they expressly declare to have acquired these shares in their own name and for their own account. Subject to paragraph 4 of this article 6 and Registre des actions, limitations à l'inscription, Nominees 1 La Société ou un tiers mandaté par elle tient un registre des actions qui mentionne le nom et le prénom (la raison sociale pour les personnes morales), l'adresse et le domicile (le siège pour les personnes morales) des propriétaires et des usufruitiers. Si une personne inscrite au registre des actions change d'adresse, elle doit le communiquer à la personne en charge de la tenue du registre. Aussi longtemps que cette communication n'a pas eu lieu, toutes les communications écrites de la Société aux personnes inscrites au registre des actions seront valablement envoyées à l'adresse inscrite au registre des actions. 2 Les personnes qui acquièrent des actions sont inscrites dans le registre des actions, à leur demande, comme actionnaires avec droit de vote, pour autant qu'elles déclarent expressément avoir acquis les actions en leur nom et pour leur propre compte. Sous réserve
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 12 / 38 article 685d para. 3 CO, no person or entity shall be registered in the share register as a shareholder with voting rights for, and no person or entity may directly or indirectly, formally, constructively or beneficially own, or otherwise control alone or together with third parties voting rights (whether exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register as a shareholder with voting rights. This restriction shall also apply to persons or entities who hold some or all of their shares through Nominees (as defined in paragraph 4 of this article 6). 3 Subject to Art. 652b para. 3 CO, this transfer restriction also applies in the case of the acquisition of shares by the exercise of subscription, option and conversion rights. The transfer restriction does not apply to acquisitions by inheritance, division of an estate or matrimonial property law. 4 The Board of Directors may, in its own discretion, register persons who declare in the registration application that they hold the shares as nominees (each, a Nominee) on behalf of third party beneficiaries (each, a Beneficial Owner) in the share register as shareholders with voting rights. If, however, any Beneficial Owner should as a result of such registration being made or upheld, directly or indirectly, formally, constructively or beneficially own, or otherwise control or direct, alone or together with third parties, voting rights (whether exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register, the Board of Directors may cancel the registration of the Nominee holding shares for the account of such Beneficial Owner with respect to any de l'alinéa 4 du présent article 6 et de l'article 685d al. 3 CO, aucune personne physique ou morale ne peut être inscrite au registre des actions comme actionnaire avec droit de vote et aucune personne physique ou morale ne peut détenir, directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôler autrement, seul ou avec des tiers, des droits de vote (exerçables ou non), par rapport à plus de 15% du capital-actions inscrit au registre du commerce en tant qu'actionnaire avec droit de vote. Cette restriction s'applique également aux personnes ou entités qui détiennent tout ou partie de leurs actions par l'intermédiaire de Nominees (tels que définis à l'alinéa 4 du présent article 6). 3 Sous réserve de l'art. 652b al. 3 CO, les restrictions au transfert s'appliquent également lors de l'acquisition d'actions dans le cadre de l'exercice d'un droit de souscription, d'option ou de conversion. Les restrictions au transfert ne s'appliquent pas lors d'acquisitions par succession, partage successoral ou en vertu du droit matrimonial. 4 Le Conseil d'Administration peut, à son entière discrétion, inscrire les personnes qui déclarent dans leur requête d'inscription qu'elles détiennent les actions en tant que nominees (chacun, un Nominee) pour le compte de tiers ayants droit économiques (chacun, un Ayant Droit Economique) en tant qu'actionnaires avec droit de vote. Toutefois, si suite à l'inscription ou à la confirmation de l'inscription, un Ayant Droit Economique détient directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôle ou dirige autrement, seul ou avec des tiers, des droits de vote (exerçables ou non) par rapport à plus de 15% du capital-actions inscrit au registre du commerce, le Conseil d'Administration peut annuler l'inscription du Nominee détenant les actions pour le compte d'un tel
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 13 / 38 shares in excess of such limit. The Board of Directors may make the registration with voting rights of the shares held by a Nominee subject to conditions, limitations and reporting requirements or may impose or adjust such conditions, limitations and requirements once registered. 5 Legal entities and partnerships or other groups of persons or joint owners who are interrelated to one another through capital ownership, voting rights, uniform management or are otherwise linked, as well as individuals or legal entities or partnerships who act in concert or otherwise act in a coordinated manner or acquire shares indirectly, thereby circumventing the restrictions or limits pursuant to paragraph 2 or 4 of this article 6 shall be treated as one single person, entity, Nominee or as a person acquiring shares, as applicable, for purposes of paragraphs 2 and 4 of this article 6. 6 The Board of Directors may grant exceptions from the restrictions or limits pursuant to paragraph 2 or 4 of this article 6 for justified reasons with the majority vote of two thirds of all its members. A justified reason may include the situation where a person extends an offer to purchase with respect to all other shares of the Company, which the Board of Directors, after having consulted an independent financial advisor, recommends to the shareholders. 7 Shareholders, other than Nominees, already being registered directly or through a Nominee with more than 15% at the time that this article 6 takes effect remain registered with voting rights for such shares. Such privilege may not be transferred by an indirect transfer of shares. Ayant Droit Economique pour les actions dépassant cette limite. Le Conseil d'Administration peut soumettre l'inscription avec droit de vote des actions détenues par un Nominee à des conditions, limitations, exigences de rapports ou peut imposer de telles conditions, limitiations ou exigences suite à l'inscription. 5 Les personnes morales et communautés de personnes ou autres groupes de personnes ou de copropriétaires qui sont liés par le capital, les droits de vote, la gestion commune ou de toute autre manière, de même que les personnes physiques ou morales ou communautés de personnes qui agissent de concert ou de manière coordonnée ou acquièrent indirectement des actions, et contournent ainsi les restrictions ou limites visées aux alinéas 2 ou 4 du présent article 6 sont traités comme une seule personne, personne morale, Nominee ou comme une personne acquérant des actions, selon le cas, aux fins des alinéas 2 et 4 du présent article 6. 6 Le Conseil d'Administration peut octroyer des dérogations aux restrictions et limites mentionnées aux alinéas 2 ou 4 du présent article 6 pour des raisons justifiées, à la majorité des deux tiers de l'ensemble de ses membres. Peut aussi être considérée comme une raison justifiée le fait qu'une personne étende une offre d'achat par rapport à l'ensemble des autres actions de la Société et que le Conseil d'Administration, après avoir consulté un conseiller financier indépendant, recommande aux actionnaires d'accepter cette offre. 7 Les actionnaires autres que les Nominees déjà inscrits directement ou par l'intermédiaire d'un Nominee pour plus de 15% au moment où le présent article 6 entre en vigueur demeurent enregistrés avec droit de vote pour ces actions. Ce privilège ne peut être transféré par un transfert indirect d'actions. 8 After hearing the registered shareholder or Nominee, 8 Le Conseil d'Administration peut, après avoir entendu
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 14 / 38 the Board of Directors may cancel such person's registration in the share register with retroactive effect as of the date of registration if such registration was made based on false or misleading information or if such information becomes untrue or misleading. The relevant shareholder or Nominee shall be promptly informed of the cancellation. 9 The Board of Directors shall regulate all details and issue the instructions necessary to ensure compliance with the preceding provisions. The Board of Directors may delegate its duties. l'actionnaire ou le Nominee, radier du registre des actions l'inscription qui a été faite sur la base d'informations fausses ou trompeuses données par l'acquéreur, ou si les informations deviennent fausses ou trompeuses. L'actionnaire ou le Nominee doit être informé immédiatement de la radiation. 9 Le Conseil d'Administration règle les détails et prend les mesures nécessaires au respect des dispositions ci- dessus. Le Conseil d'Administration peut déléguer ses tâches. Article 7 Article 7 Exercise of rights 1 The Company shall only accept one representative per share. 2 The voting right and the rights associated therewith may be exercised vis-à-vis the Company by a shareholder, usufructuary or Nominee only to the extent that such person is registered in the share register with voting rights. Exercice des droits 1 La Société ne reconnaît qu'un représentant par action. 2 Le droit de vote et les droits y relatifs ne peuvent être exercés à l'égard de la Société que par un actionnaire, un usufruitier ou un Nominee uniquement dans la mesure où celui-ci est inscrit avec droit de vote au registre des actions. Section 3 Corporate bodies Section 3 Organes A. The General Meeting A. L'Assemblée Générale Article 8 Article 8 Powers of the General Meeting 1 The general meeting of shareholders (the General Meeting) is the supreme corporate body of the Company. Pouvoirs de l'Assemblée Générale 1 L'assemblée générale des actionnaires (l'Assemblée Générale) est l'organe suprême de la Société.
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 15 / 38 2 The General Meeting shall have the following inalienable powers: 2 L'Assemblée Générale a le droit inaliénable: 1. the adoption and amendment of these Articles of Association; 2. the election of the members of the Board of Directors, the chair of the Board of Directors (the Chair) and the members of the Compensation Committee; 1. d'adopter et de modifier les Statuts; 2. de nommer les membres du Conseil d'Administration, le/la président/e du Conseil d'Administration (le/la Président/e) et les membres du Comité de Rémunération; 3. the election of the Auditors; 3. de nommer l'Organe de Révision; 4. the election of the independent voting rights representative; 5. the approval of the annual management report and the consolidated financial statements; 6. the approval of the annual financial statements as well as the resolution on the allocation of profit shown on the balance sheet, in particular the determination of dividends; 7. the determination of interim dividends and the approval of the interim financial statements required for this purpose; 8. the resolution on the repayment of the statutory capital reserve; 9. the discharge from liability of the members of the Board of Directors and the persons entrusted with management; 10. the approval of the compensation of the Board of Directors and of the executive committee of the Company (the Executive Committee) pursuant to article 26 of these Articles of Association; 4. de nommer le représentant indépendant; 5. d'approuver le rapport annuel et les comptes consolidés; 6. d'approuver les comptes annuels et de déterminer l'emploi du bénéfice résultant du bilan, en particulier de fixer le dividende; 7. de fixer le dividende intérimaire et d'approuver les comptes intermédiaires nécessaires à cet effet; 8. de décider du remboursement de la réserve légale issue du capital; 9. de donner décharge aux membres du Conseil d'Administration et aux personnes chargées de la gestion; 10. d'approuver la rémunération du Conseil d'Administration et de la direction exécutive de la Société (la Direction Exécutive) selon l'article 26 des Statuts; 11. the delisting of the Company's equity securities; 11. de procéder à la décotation des titres de
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 16 / 38 12. the approval of the report on non-financial matters pursuant to article 964c CO (if applicable); and 13. the adoption of resolutions on matters that are reserved to the General Meeting by law or these Articles of Association or that are, subject to article 716a CO, submitted to the General Meeting by the Board of Directors. participation de la société; 12. d'approuver le rapport sur les questions non finan- cières selon l'article 964c CO (si applicable); et 13. de prendre toutes les décisions qui lui sont réservées par la loi ou les Statuts ou qui lui sont soumises par le Conseil d'Administration, sous réserve de l'article 716a CO. Article 9 Article 9 Ordinary and extraordinary General Meetings 1 The ordinary General Meeting shall be held each year within six months of the close of the financial year of the Company. Assemblées générales ordinaires et extraordinaires 1 L'Assemblée Générale ordinaire a lieu chaque année dans les six mois qui suivent la clôture de l'exercice social de la Société. 2 Extraordinary General Meetings shall be held if 2 Des Assemblées Générales extraordinaires ont lieu lorsque (a) the Board of Directors or the Auditors deem it necessary; (a) le Conseil d'Administration ou l'Organe de Révision l'estime nécessaire; (b) so resolved by a General Meeting; or (b) une Assemblée Générale le décide; ou (c) shareholders who hold, alone or together, shares representing at least 5% of the share capital or votes so request in writing, indicating the matters to be discussed and the corresponding proposals and, in case of elections, the names of the nominated candidates. (c) des actionnaires représentant seuls ou ensemble 5% au moins du capital-actions ou des voix le requièrent par écrit en indiquant les objets de discussion et les propositions, et, en cas d'élections, les noms des candidats proposés. Article 10 Article 10 Notice 1 Notice of a General Meeting shall be given by the Board of Directors or, if necessary, by the Auditors, no later than 20 calendar days prior to the date of the meeting. Liquidators and representatives of bond- Convocation 1 L'Assemblée Générale est convoquée par le Conseil d'Administration ou, si nécessaire, par l'Organe de Révision au plus tard 20 jours calendaires avant le jour de l'assemblée. Les liquidateurs et les représentants de
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 17 / 38 holders are also entitled to call a General Meeting. détenteurs d'obligations ont également le droit de convoquer l'Assemblée Générale. 2 Notice of the General Meeting shall be given by way of a single announcement in the official means of publication of the Company pursuant to article 35 of these Articles of Association. Registered shareholders may in addition be notified in writing. 3 The annual report, the compensation report, the Auditors' reports and any other reports required by law shall be made available to the shareholders no later than 20 calendar days prior to the ordinary General Meeting. 4 The notice shall include: 1. date, beginning, ending, mode and venue of the General Meeting; 2. the agenda; 3. the proposals of the Board of Directors together with a brief statement of the reasons; 4. proposals of the shareholders, if any, together with a brief statement of the reasons; and 5. name and address of the independent voting rights representative. 2 La convocation à l'Assemblée Générale a lieu par une annonce unique dans l'organe de publication de la Société selon l'article 35 des Statuts. La convocation peut également être envoyée par écrit aux actionnaires inscrits. 3 Le rapport de gestion, le rapport de rémunération, les rapports de révision et tout autre rapport exigés par la loi sont mis à la disposition des actionnaires au plus tard 20 jours calendaires avant l'Assemblée Générale ordinaire. 4 La convocation doit mentionner: 1. la date, l'heure de début et de fin, le lieu et la forme de l'Assemblée Générale; 2. les objets portés à l'ordre du jour; 3. les propositions du Conseil d'Administration ac- compagnées d'une motivation succincte; 4. le cas échéant, les propositions des actionnaires, accompagnées d'une motivation succincte; et 5. le nom et l'adresse du représentant indépendant. . Article 11 Article 11 Agenda 1 Shareholders who, alone or together, hold at least 0.5% of the share capital or the votes may request that an item be included on the agenda or that a proposal relating to an agenda item be included in the notice convening the General Meeting. Such request must be received by the Company at least 45 calendar days prior to the General Meeting, specifying the agenda item and Objets à l'ordre du jour 1 Des actionnaires qui représentent, seuls ou ensemble, au moins 0,5% du capital-actions ou des voix peuvent requérir l'inscription d'un objet à l'ordre du jour, ainsi que l'inscription dans la convocation à l'Assemblée Générale de propositions concernant les objets portés à l'ordre du jour. La demande doit être reçue par la Société au moins 45 jours calendaires avant l'Assemblée Générale
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 18 / 38 the proposals of the shareholders. avec indication des objets à l'ordre du jour et des propositions des actionnaires. 2 No resolutions may be passed at a General Meeting on proposals concerning agenda items for which proper notice was not given. This provision shall not apply, however, to proposals made during a General Meeting to convene an extraordinary General Meeting or to initiate a special audit. Each request for inclusion of an item on the agenda shall include (i) a brief description of the agenda item and the reason for which it is to be discussed at the meeting; (ii) the motions regarding the agenda item; (iii) the name and address, as they appear on the Company's register of shareholders, of the shareholder proposing such business; (iv) the number of shares of the Company which are beneficially owned by such shareholder; (v) the dates upon which the shareholder acquired such shares; (vi) documentary support for any claim of beneficial ownership; (vii) any material interest of such shareholder in including the item in the agenda; (viii) a statement in support of the matter; and (ix) all other information required under applicable law and stock exchange rules. 3 No prior notice is required to bring motions related to items already on the agenda or for the discussion of matters on which no resolution is to be taken. 2 Aucune décision ne peut être prise par l'Assemblée Générale sur des objets qui n'ont pas été dûment portés à l'ordre du jour, à l'exception des propositions de convoquer une Assemblée Générale extraordinaire et d'instituer un contrôle spécial. Toute requête visant l'inscription d'un objet à l'ordre du jour doit inclure (i) une brève description de cet objet et la raison pour laquelle il doit être discuté lors de l'Assemblée Générale; (ii) les propositions relatives à cet objet; (iii) le nom et l'adresse, tels qu'ils apparaissent dans le registre des actions, de l'actionnaire proposant un tel objet; (iv) le nombre d'actions de la Société dont cet actionnaire est l'Ayant Droit Economique; (v) les dates auxquelles l'actionnaire a acquis ces actions; (vi) les pièces justificatives démontrant le statut d'Ayant Droit Economique; (vii) l'intérêt important de l'actionnaire à l'inscription de l'objet à l'ordre du jour; (viii) une déclaration à l'appui de la requête; et (ix) toute autre information requise par la loi ou les règles boursières applicables. 3 En revanche, il n'est pas nécessaire d'annoncer à l'avance les propositions entrant dans le cadre des objets portés à l'ordre du jour ni les délibérations qui ne doivent pas être suivies d'un vote. Article 11a Article 11a Venue 1 The Board of Directors shall determine the venue of the General Meeting, which may be held in Switzerland or abroad. 2 The Board of Directors can determine that the General Meeting be held simultaneously at different locations, provided that the contributions of the participants are transmitted directly in video and audio to all venues and Lieu de réunion 1 Le Conseil d'Administration détermine le lieu de l'Assemblée Générale, qui peut se tenir en Suisse ou à l'étranger. 2 Le Conseil d'Administration peut décider que l'Assemblée Générale se tiendra simultanément en plusieurs lieux, à condition que les votes des participants soient transmis directement par l'image et le
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 19 / 38 that shareholders who are not present at the venue(s) of the General Meeting may exercise their rights by electronic means. 3 Alternatively, the Board of Directors may provide that the General Meeting will be held by electronic means without a venue. son à tous les lieux de réunion et que les actionnaires qui ne sont pas présents au(x) lieu(x) de l'Assemblée Générale puissent exercer leurs droits par voie électronique. 3 Alternativement, le Conseil d'Administration peut prévoir que l'Assemblée Générale se déroule par voie électronique sans lieu de réunion. Article 12 Article 12 Chair, vote counters, minutes 1 The Chair of the Board of Directors shall chair the General Meeting. In his absence, the Vice-Chair of the Board of Directors, another member or a person designated by the Board of Directors shall chair the General Meeting. If no member of the Board of Directors is available and no other person has been designated by the Board of Directors, the acting chair shall be elected by the General Meeting. 2 The acting chair of the General Meeting shall appoint the secretary and the vote counter(s), none of whom need be shareholders. The minutes shall be signed by the acting chair of the General Meeting of and the secretary. 3 The acting chair of the General Meeting shall have all powers and authority necessary and appropriate to ensure the orderly conduct of the General Meeting. 4 The resolutions and election results shall be made available electronically within 15 calendar days after the General Meeting, stating the exact proportion of votes; each shareholder may request that the minutes be made available to him within 30 calendar days after the General Meeting. Présidence, scrutateurs, procès- verbal 1 Le/la Président/e du Conseil d'Administration préside l'Assemblée Générale. En son absence, le/la Vice- Président/e du Conseil d'Administration, un autre membre ou une personne désignée par le Conseil d'Administration préside l'Assemblée Générale. Si aucun membre du Conseil d'Administration n'est disponible et aucune personne n'a été désignée par le Conseil d'Administration, l'Assemblée Générale élit son/sa président/e. 2 Le/la président/e de l'Assemblée Générale désigne un rédacteur du procès-verbal et le ou les scrutateurs, qui ne doivent pas nécessairement être des actionnaires. Le procès-verbal doit être signé par le/la président/e de l'Assemblée Générale et le/la secrétaire. 3 Le/la président/e de l'Assemblée Générale a tous les pouvoirs nécessaires et appropriés pour s'assurer de la conduite régulière de l'Assemblée Générale. 4 Les décisions et le résultat des élections, avec indication de la répartition exacte des voix, doivent être rendus accessibles par voie électronique dans les 15 jours calendaires qui suivent l'Assemblée Générale; chaque actionnaire peut exiger que le procès-verbal soit mis à sa disposition dans les 30 jours calendaires qui suivent l'Assemblée Générale.
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 20 / 38 Article 13 Article 13 Voting rights, representation 1 Each share shall convey the right to one vote. The voting rights are subject to the conditions of articles 6 and 7 of these Articles of Association. 2 No shareholder or proxy may, directly or indirectly, exercise voting rights attached to own or represented shares that would collectively exceed 15% of the share capital as set forth in the commercial register. Legal entities and partnerships or other groups of persons or joint owners who are interrelated to one another through capital ownership, voting rights, uniform management or are otherwise linked, as well as individuals or legal entities or partnerships who act in concert or otherwise act in a coordinated manner, thereby circumventing the aforementioned restriction of voting rights, are deemed to be one shareholder for the purposes of such voting. 3 The restrictions of paragraph 2 of this article 13 shall not apply to the exercise of voting rights by (i) shareholders or their proxies, to the extent that their shares are registered in the share register with voting rights pursuant to article 6 paragraph 7 of these Articles of Association, (ii) Nominees, provided that Nominees' voting rights shall be subject to the same restrictions as set forth in article 6 paragraph 4 of these Articles of Association, and (iii) the independent voting rights representative to the extent that the latter has been appointed as proxy by shareholders. 4 The Board of Directors shall issue the rules regarding the participation in and representation at the General Meeting and determine the requirements as to proxies and instructions. A shareholder may be represented at Droit de vote, représentation 1 Chaque action donne droit à une voix. Les droits de vote sont soumis aux conditions des articles 6 et 7 des Statuts. 2 Aucun actionnaire ou mandataire ne peut exercer, directement ou indirectement, des droits de vote attachés à des actions propres ou représentées qui dépasseraient collectivement 15% du capital-actions tel qu'il figure au registre du commerce. Les personnes morales et les communautés de personnes ou autres groupes de personnes ou de copropriétaires qui sont liés par le capital, les droits de vote, la gestion commune ou de toute autre manière, de même que les personnes physiques ou morales ou communautés de personnes qui agissent de concert ou de manière coordonnée, contournant ainsi les restrictions ou limites susmentionnées, sont traités comme un seul actionnaire aux fins de ce vote. 3 Les restrictions citées à l'alinéa 2 du présent article 13 ne s'appliquent pas à l'exercice du droit de vote par (i) les actionnaires ou leurs mandataires, dans la mesure où leurs actions sont inscrites au registre des actions avec droit de vote conformément à l'article 6 alinéa 7 des Statuts, (ii) les Nominees, à condition que les droits de vote des Nominees soient soumis aux mêmes restrictions que celles énoncées à l'article 6 alinéa 4 des Statuts, et (iii) le représentant indépendant des droits de vote dans la mesure où ce dernier a été désigné comme mandataire par les actionnaires. 4 Le Conseil d'Administration prend les dispositions relatives à la participation et à la représentation à l'Assemblée Générale et détermine les exigences applicables aux procurations et instructions. Un
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 21 / 38 the General Meeting by the independent voting rights representative, its legal representative or, by means of a written proxy, by any other proxy who need not be a shareholder. All shares held by a shareholder may only be represented by one person. 5 The General Meeting shall elect the independent voting rights representative for a term of office until completion of the next ordinary General Meeting. Re-election is possible. 6 If the Company does not have an independent voting rights representative, the Board of Directors shall appoint the independent voting rights representative for the next General Meeting. actionnaire peut être représenté à l'Assemblée Générale par le représentant indépendant, par son représentant légal ou, au moyen d'une procuration écrite, par tout autre mandataire qui ne doit pas nécessairement être un actionnaire. Toutes les actions détenues par un actionnaire ne peuvent être représentées que par une seule personne. 5 L'Assemblée Générale nomme le représentant indépendant pour une durée de fonctions s'achevant à la fin de l'Assemblée Générale ordinaire suivante. La réélection est possible. 6 Dans le cas où la Société n'a pas de représentant indépendant, le Conseil d'Administration nommera le représentant indépendant pour l'Assemblée Générale suivante. Article 14 Article 14 Resolutions, elections 1 The General Meeting shall pass its resolutions and decide its elections by the majority of the votes attached to the shares represented, unless required otherwise by law or these Articles of Association. In the event of a tie, the resolution shall be deemed refused. 2 Two thirds of the votes represented and the majority of the par value of shares represented shall be required for the General Meeting to adopt resolutions on the following matters: Décisions, élections 1 Les décisions de l'Assemblée Générale sont prises à la majorité des voix attribuées aux actions représentées, à moins que la loi ou les Statuts n'en disposent autrement. En cas d'égalité de voix, la décision est refusée. 2 Une décision de l'Assemblée Générale recueillant au moins les deux tiers des voix attribuées aux actions représentées et la majorité des valeurs nominales représentées est nécessaire pour: 1. the amendment of the purpose of the Company; 1. la modification du but social de la Société; 2. the creation of shares with privileged voting rights; 2. l'introduction d'actions à droit de vote privilégié; 3. the restriction on the transferability of registered shares or their registration with voting rights and the cancelation of such a restriction; 3. la restriction de la transmissibilité des actions nominatives ou leur inscription avec droit de vote ainsi que la suppression d'une telle restriction; 4. the introduction of conditional share capital or the 4. la création d'un capital conditionnel ou l'institution
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 22 / 38 introduction of a capital range; d'une marge de fluctuation du capital; 5. an increase in share capital through the conversion of equity surplus, against contributions in kind, by set-off against a claim, or the granting of special benefits; 5. l'augmentation du capital-actions au moyen de la conversion de fonds propres, contre apport en nature ou par compensation de créance, ou l'octroi d'avantages particuliers; 6. the limitation or withdrawal of pre-emptive rights; 6. la limitation ou la suppression du droit de souscription préférentiel; 7. the change of currency of the share capital; 7. le changement de la monnaie dans laquelle le capital-actions est fixé; 8. the introduction of a casting vote for the person chairing the General Meeting; 9. the relocation of the registered office of the Company; 8. l'introduction de la voix prépondérante du président à l'Assemblée Générale; 9. le transfert du siège de la Société; 10. the delisting of the Company's equity securities; 10. la décotation des titres de participation de la Société; 11. the dissolution of the Company; 11. la dissolution de la Société; 12. the introduction of an arbitration clause in the articles of association; 13. mergers, demergers and conversions pursuant to the Swiss federal act on merger, demerger, conversion and transfer of assets and liabilities (the Merger Act); 14. the conversion of registered shares into bearer shares; 15. the removal of any member of the Board of Directors or of its Chair before the end of his/her term of office; 12. l'introduction d'une clause d'arbitrage dans les statuts; 13. une fusion, scission ou transformation conformément à la loi fédérale sur la fusion, la scission, la transformation et le transfert de patrimoine (la Loi sur la Fusion); 14. la conversion d'actions nominatives en actions au porteur; 15. la révocation de tout membre du Conseil d'Administration ou de son/sa Président/e avant la fin de son mandat; 16. the combination of shares; and 16. la réunion d'actions; et 17. the amendment or repeal of the following provisions of these Articles of Association, with the 17. la modification ou la suppression des dispositions suivantes des Statuts, à l'exception des
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 23 / 38 exception of editorial amendments that do not effectively change their content: (i) article 4a paragraph 1, 2, 4(g) and 4(h); (ii) article 4c paragraph 1, 3 and 4; (iii) article 6; (iv) article 13 paragraph 2 and 3; (v) article 14; (vi) article 15; (vii) article 18; and (viii) article 35a. 3 Resolutions and elections shall be decided by open ballot, unless the acting chair of the General Meeting decides that a secret ballot be held or that it be voted by electronic means. The acting chair of the General Meeting may at any time order that a resolution or election be repeated if he/she considers the vote to be in doubt. The resolution or election previously held shall then be deemed not to have taken place. modifications rédactionnelles qui ne modifient pas effectivement leur contenu: (i) article 4a alinéa 1, 2, 4(g) et 4(h); (ii) article 4c alinéa 1, 3 et 4; (iii) article 6; (iv) article 13 alinéa 2 et 3; (v) article 14; (vi) article 15; (vii) article 18; et (viii) article 35a. 3 Les décisions et élections ont lieu à main levée, à moins qu'un vote à bulletins secrets ou électronique ne soit ordonné par le/la président/e de l'Assemblée Générale. Le/la président/e de l'Assemblée Générale peut en tout temps ordonner qu'une décision ou élection soit répétée s'il/elle estime qu'il existe des doutes sur le résultat. Dans ce cas, la décision ou l'élection précédente est réputée ne pas avoir eu lieu. B. The Board of Directors B. Le Conseil d'Administration Article 15 Article 15 Number of directors The board of directors of the Company (the Board of Directors) shall consist of not less than 3 and not more than 8 members. Nombre de membres Le conseil d'administration de la Société (le Conseil d'Administration) se compose de 3 membres au moins et de 8 membres au plus. Article 16 Article 16 Election and term of office 1 The General Meeting shall elect the members of the Board of Directors and the Chair of the Board of Directors individually and for a term of office until the Élection et durée des fonctions 1 Les membres du Conseil d'Administration et le/la Président/e du Conseil d'Administration sont élus individuellement par l'Assemblée Générale pour une
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 24 / 38 completion of the next ordinary General Meeting. Re- election is possible. 2 If the office of the Chair of the Board of Directors is vacant, the Board of Directors shall appoint a new Chair from among its members for a term of office extending until completion of the next ordinary General Meeting. durée de fonctions s'achevant à la fin de l'Assemblée Générale ordinaire suivante. La réélection est possible. 2 Lorsque la fonction de Président/e du Conseil d'Administration est vacante, le Conseil d'Administration désigne un/une nouveau-elle Président/e parmi ses membres pour une durée de fonctions s'achevant à la fin de l'Assemblée Générale ordinaire suivante. Article 17 Article 17 Organization of the Board of Directors 1 Except for the election of the Chair of the Board of Directors and the members of the Compensation Committee by the General Meeting, the Board of Directors shall constitute itself. The Board of Directors may elect one or several vice-chairs (each, a Vice- Chair). The Board of Directors shall further appoint a secretary who need not be member of the Board of Directors. 2 Subject to these Articles of Association, the Board of Directors shall regulate its organization and the adoption of resolutions in the organizational regulations. Organisation du Conseil d'Administration 1 A l'exception de l'élection par l'Assemblée Générale du/de la Président/e du Conseil d'Administration et des membres du Comité de Rémunération, le Conseil d'Administration se constitue lui-même. Il peut désigner au besoin, un/une ou plusieurs vice-président/e(s) (chacun, un/e Vice-Président/e). Le Conseil d'Administration désigne en outre un/une secrétaire, qui ne doit pas nécessairement être membre du Conseil d'Administration. 2 Le Conseil d'Administration règle en outre son organisation et la manière de prendre des décisions dans un règlement d'organisation, sous réserve des Statuts. Article 18 Article 18 Reimbursement of expenses, indemnification 1 The members of the Board of Directors shall be entitled to the reimbursement of all expenses incurred in the interest of the Company. 2 To the extent not included in insurance coverage or paid by third parties, the Company shall indemnify and hold harmless, to the extent permitted by law, the existing and former members of the Board of Directors and Executive Committee, and their heirs, executors and administrators, out of the assets of the Company Remboursement des frais, indemnisation 1 Les membres du Conseil d'Administration ont droit au remboursement de tous les frais engagés dans l'intérêt de la Société. 2 Dans la mesure où la loi le permet, la Société indemnisera, à concurrence de la portion non couverte par une assurance ou payée par un tiers, sur ses propres biens les membres actuels et passés du Conseil d'Administration et de la Direction Exécutive ainsi que leurs héritiers, masse en faillite ou masse successorale
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 25 / 38 from and against all threatened, pending or completed actions, suits or proceedings – whether civil, criminal, administrative or investigative – and all costs, charges, losses, damages, and expenses which they or any of them, their heirs, executors or administrators, shall or may incur or sustain by or by reason of any actual or alleged actions, consents or omissions in or about the execution of their duty, or alleged duty, or by reason of the fact that he is or was a member of the Board of Directors or Executive Committee of the Company or the board of directors (or equivalent corporate body) or the management of one of its subsidiaries, or, while serving as a member of the Board of Directors or Executive Committee of the Company, is or was serving at the request of the Company as a director, member of the executive management, employee or agent of another corporation, partnership, joint venture, trust or other enterprise; provided, however, that this indemnity shall not extend to any matter in which any of said persons is found, in a final judgment or decree of a court or governmental or administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory duties as a member of the Board of Directors or Executive Committee. 3 Without limiting the foregoing paragraph 2 of this article 18, the Company shall advance costs and expenses idemnifiable thereunder to the existing and former members of the Board of Directors and Executive Committee to the extent not included in insurance coverage or advanced by third parties. The Company may however recover such advanced costs if any of said persons is found, in a final judgment or decree of a court or governmental or administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory contre toutes actions, procès ou poursuites, menaçants, en cours ou terminés, de nature civile, pénale, administrative ou autre, et tous les coûts, dépenses, pertes, dommages et frais qu'ils (ou leurs héritiers, masse en faillite ou masse successorale) subiraient ou pourraient subir en raison d'actions, consentements ou omissions, effectifs ou présumés, en relation avec l'exercice de leurs fonctions, leurs fonctions supposées ou en raison du fait d'être ou d'avoir été membres du Conseil d'Administration ou de la Direction Exécutive de la Société ou du conseil d'administration (ou d'un organe équivalent) ou de la direction de l'une de ses filiales ou, sur instruction de la Société en tant que membres du Conseil d'Administration ou de la Direction Exécutive, en raison du fait d'être ou d'avoir été administrateur, membre de la direction, employé ou mandataire d'une autre société, entreprise, coentreprise, personne morale dénuée de la personnalité ou trust. L'obligation d'indemnisation s'éteint dès qu'un jugement définitif et exécutoire d'un tribunal ou d'une autorité compétente a décidé que la personne en question a violé, volontairement ou par grave négligence, ses devoirs de membre du Conseil d'Administration ou de la Direction Exécutive. 3 Sans préjudice de l'alinéa 2 du présent article 18, la Société avancera les frais et les coûts indemnisables en vertu de la disposition précitée aux membres actuels et passés du Conseil d'Administration et de la Direction Exécutive, à concurrence de la portion non couverte par une assurance ou payée par un tiers. La Société peut cependant recouvrer ces avances de frais si l'une de ces personnes a été reconnue coupable de violation intentionnelle ou par négligence grave de ses devoirs de membre du Conseil d'Administration ou de la Direction Exécutive par un jugement ou une décision final et
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 26 / 38 duties as a member of the Board of Directors or Executive Committee. exécutoire d'un tribunal ou d'une autorité gouvernementale ou administrative compétente. Article 19 Article 19 Convening of meetings, resolutions, minutes 1 The Board of Directors shall meet at the invitation of its Chair or, if not available, of the Vice-Chair or of another member of the Board of Directors as often as the business of the Company shall require or if a member requests it in writing or via email or another form of electronic communication, indicating the reasons. 2 Unless the organizational regulations adopted by the Board of Directors or a board resolution taken with the applicable attendance quorum provide otherwise, the Board of Directors shall only have a quorum if a majority of the members of the Board of Directors is present. No attendance quorum shall be required for resolutions of the Board of Directors providing for the amendment and ascertainment of capital changes or a change in the currency of the share capital. 3 Except as otherwise provided in the organizational rules adopted by the Board of Directors or in a board resolution taken with the applicable attendance quorum, resolutions of the Board of Directors shall be adopted by the majority of the members present, provided that those present form a majority of the Board of Directors. In case of a tie, the Chair shall not have a casting vote. Convocation, décisions, procès- verbal 1 Le Conseil d'Administration est convoqué par son/sa Président/e ou, en cas d'empêchement de ce/cette dernier-ère, par son/sa Vice-Président/e ou par un autre membre du Conseil d'Administration, aussi souvent que cela apparaît nécessaire ou lorsqu'un membre du Conseil d'Administration le demande par écrit, par email ou par un autre moyen de communication électronique, avec indication des motifs. 2 A moins que le contraire ne résulte d'une disposition du règlement d'organisation adopté par le Conseil d'Administration ou d'une décision du Conseil d'Administration prise conformément aux dispositions applicables au quorum de présence, la majorité des membres du Conseil d'Administration doivent être présents afin de pouvoir prendre une décision. Ce quorum de présence n'est pas nécessaire pour les décisions de modification et de constatation du Conseil d'Administration en lien avec les modifications du capital-actions ou de changement de la monnaie du capital-actions. 3 Sauf disposition contraire du règlement d'organisation adopté par le Conseil d'Administration ou d'une décision du Conseil d'Administration prise conformément aux dispositions applicables au quorum de présence, les décisions du Conseil d'Administration sont prises à la majorité des voix émises par les membres présents, pourvu toutefois que ceux-ci forment la majorité du Conseil d'Administration. En cas de partage égal des voix, celle du/de la Président/e n'est pas prépondérante. 4 Resolutions may also be adopted by way of written 4 Les décisions du Conseil d'Administration peuvent
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 27 / 38 consent orelectronically, unless a member of the Board of Directors requests discussion thereof. 5 The decisions of the Board of Directors shall be recorded in minutes. The minutes shall be signed by the acting chair and the secretary. également être prises par voie de circulation ou par voie électronique, à moins qu'une discussion ne soit requise par l'un des membres du Conseil d'Administration. 5 Les décisions du Conseil d'Administration sont consignées dans un procès-verbal. Le procès-verbal est signé par le/la président/e et par le/la secrétaire. Article 20 Article 20 Powers of the Board of Directors 1 The Board of Directors may pass resolutions with respect to all matters which are not delegated to another corporate body of the Company by law, by these Articles of Association or by regulations. 2 It shall have the following non-transferable and inalienable duties: 1. the ultimate management of the Company and the issuance of necessary instructions; 2. the determination of the organization of the Company; 3. the structuring of the accounting system, of the financial controls and of the financial planning; 4. the appointment and dismissal of the persons entrusted with management and representation of the Company, and issuance of rules on the signature authority; 5. the ultimate supervision of the persons entrusted with management, in particular in view of compliance with the law, these Articles of Association, regulations and directives; 6. the preparation of the annual report, the compensation report and, if applicable, the report on non-financial matters pursuant to article 964c Attributions du Conseil d'Administration 1 Le Conseil d'Administration peut prendre des décisions sur toutes les affaires qui ne sont pas attribuées à un autre organe de la Société par la loi, les Statuts ou un règlement. 2 Il a les attributions intransmissibles et inaliénables suivantes: 1. exercer la haute direction de la Société et établir les instructions nécessaires; 2. fixer l'organisation de la Société; 3. fixer les principes de la comptabilité et du contrôle financier ainsi que le plan financier; 4. nommer et révoquer les personnes chargées de la gestion et de la représentation de la Société et réglementer le droit de signature; 5. exercer la haute surveillance sur les personnes chargées de la gestion pour s'assurer notamment qu'elles observent la loi, les Statuts, les règlements et les instructions données; 6. établir le rapport de gestion, le rapport de rémunération, et, le cas échéant, le rapport sur les questions non financières selon l'article 964c
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 28 / 38 CO and other reports as required by law, if any; CO et, le cas échéant, d'autres rapports exigés par la loi; 7. the preparation of the General Meeting and the implementation of its resolutions; 8. the adoption of resolutions on the change of the share capital to the extent that such power is vested in the Board of Directors, the ascertainment of capitalchanges, the preparation of the report on the capital increase, and the respective amendments of these Articles of Association (including deletions); 9. the non-transferable and inalienable duties and powers of the Board of Directors pursuant to the Merger Act; 10. the submission of a petition for debt-restructuring moratorium and the notification of the court in case of over-indebtedness; and 11. other powers and duties reserved to the Board of Directors by law or these Articles of Association. 3 In all other respects, the Board of Directors may delegate in whole or in part the management and the representation of the Company within the framework set forth by these Articles of Association and the law to one or several of its members or to third parties by means of organizational regulations or by adopting a resolution. 7. préparer l'Assemblée Générale et exécuter ses décisions; 8. prendre les décisions relatives aux modifications du capital-actions, dans la mesure où elles sont de la compétence du Conseil d'Administration, ainsi que les décisions relatives à la constatation des modifications de capital, à l'établissement du rapport d'augmentation du capital-actions et aux modifications des Statuts qui en résultent (radiation comprise); 9. les attributions et compétences intransmissibles et inaliénables du Conseil d'Administration selon la Loi sur la Fusion; 10. le dépôt d'une demande de sursis concordataire et l'avis au tribunal en cas de surendettement ; et 11. d'autres attributions et compétences réservées au Conseil d'Administration par la loi ou les Statuts. 3 En outre, le Conseil d'Administration peut déléguer en tout ou en partie la gestion ainsi que la représentation de la Société, dans le cadre des Statuts et de la loi, à un ou plusieurs de ses membres ou à des tiers conformément au règlement d'organisation ou d'une décision. C. The Compensation Committee C. Le Comité de Rémunération Article 21 Article 21 Number of members The compensation committee of the Board of Directors Nombre de Le comité de rémunération du Conseil d'Administration
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 29 / 38 (the Compensation Committee) shall consist of at least 2 members of the Board of Directors. membres (le Comité de Rémunération) se compose d'au moins 2 membres du Conseil d'Administration. Article 22 Article 22 Election and term of office 1 The General Meeting shall elect the members of the Compensation Committee individually for a term of office until the completion of the subsequent ordinary General Meeting. Only members of the Board of Directors may be elected. Re-election is possible. 2 If there are vacancies on the Compensation Committee, the Board of Directors may appoint substitute members from among its members for a term of office extending until completion of the next ordinary General Meeting. Election et durée de fonctions 1 L'Assemblée Générale élit individuellement les membres du Comité de Rémunération pour une durée de fonctions s'achevant à la fin de l'Assemblée Générale ordinaire suivante. Seuls des membres du Conseil d'Administration sont éligibles. La réélection est possible. 2 En cas de vacance au sein du Comité de Rémunération, le Conseil d'Administration peut désigner des substituts parmi ses membres pour une durée de fonctions s'achevant à la fin de l'Assemblée Générale ordinaire suivante. Article 23 Article 23 Organization of the Compensation Committee 1 The Compensation Committee shall constitute itself. Unless the organizational regulations provide otherwise, the Board of Directors shall elect a chair from among the Compensation Committee's members. 2 The Board of Directors shall issue regulations establishing the organization and decision-making process of the Compensation Committee, which may be part of the organizational regulations. Organisation du Comité de Rémunération 1 Le Comité de Rémunération se constitue lui-même. A moins que le règlement d'organisation n'en dispose autrement, le Conseil d'Administration élit le/la président/e du Comité de Rémunération parmi les membres du Comité de Rémunération. 2 Le Conseil d'Administration établit un règlement concernant l'organisation et le processus de décision du Comité de Rémunération, qui peut être intégré au règlement d'organisation. Article 24 Article 24 Duties and powers 1 The Compensation Committee shall support the Board of Directors in establishing and reviewing the Attributions 1 Le Comité de Rémunération assiste le Conseil d'Administration dans l'établissement et la révision de la
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 30 / 38 compensation strategy and guidelines as well as in preparing the proposals to the General Meeting regarding the compensation of the Board of Directors and the Executive Committee. It may submit proposals to the Board of Directors in other compensation-related issues. 2 The Board of Directors shall determine in regulations for which positions of the Board of Directors, the Executive Committee and other member of management (if any) the Compensation Committee shall submit proposals for the performance metrics, target values and/or the compensation of the members of the Board of Directors and the Executive Committee, and for which positions it shall itself determine, in accordance with these Articles of Association and the compensation guidelines established by the Board of Directors, such performance metrics, target values and/or the compensation. 3 The Board of Directors may delegate further tasks to the Compensation Committee. stratégie et des directives de rémunération, ainsi que dans la préparation des propositions à soumettre à l'Assemblée Générale concernant la rémunération du Conseil d'Administration et de la Direction Exécutive. Il peut soumettre au Conseil d'Administration des propositions en toutes autres matières relatives à la rémunération. 2 Le Conseil d'Administration détermine dans un règlement pour quelles fonctions du Conseil d'Administration, de la Direction Exécutive et d'autres membres de la direction (si applicable) le Comité de Rémunération proposera au Conseil d'Administration les mesures de performance, les valeurs cibles et/ou la rémunération des membres du Conseil d'Administration et de la Direction Exécutive, et pour quelles fonctions il aura la compétence de déterminer de son propre chef, en accord avec les Statuts et les directives de rémunération établies par le Conseil d'Administration, les mesures de performance, les valeurs cibles et/ou la rémunération. 3 Le Conseil d'Administration peut déléguer d'autres tâches au Comité de Rémunération. D. The Auditors D. L'Organe de Révision Article 25 Article 25 Auditors 1 The General Meeting shall elect the auditors of the Company (the Auditors) for a term of office of one financial year. Their term of office ends with the approval of the annual financial statements of the respective financial year by the ordinary General Meeting. Re- election is possible. Organe de révision 1 L'Assemblée Générale élit l'organe de révision de la Société (l'Organe de Révision) pour un mandat d'un exercice. Son mandat prend fin avec l'approbation des comptes annuels de l'exercice concerné par l’Assemblée Générale ordinaire. La réélection est possible. 2 The Auditors shall have the powers and duties vested 2 L'Organe de Révision a les pouvoirs et obligations que
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 31 / 38 in them by law. lui confère la loi. 3 The Board of Directors may mandate the Auditors at any time to perform special investigations, in particular interim audits, and to prepare a report on their findings. 3 Le Conseil d'Administration peut en tout temps charger l'Organe de Révision de procéder à des contrôles spéciaux, notamment des révisions intermédiaires, et de lui en soumettre un rapport. Section 4 Compensation of the members of the Board of Directors and the Executive Committee and related matters Section 4 Rémunération des membres du Conseil d'Administration et de la Direction Exécutive et affaires connexes Article 26 Article 26 Approval of the compensation by the General Meeting 1 The General Meeting shall approve the proposals of the Board of Directors in relation to the aggregate amounts of: 1. the maximum compensation of the Board of Directors until the completion of the next ordinary General Meeting; 2. the maximum fixed compensation of the Executive Committee for the following financial year; and 3. the maximum variable compensation of the Executive Committee for the current financial year. 2 The Board of Directors may submit for approval by the General Meeting deviating, additional or conditional proposals relating to the maximum aggregate amount or maximum partial amounts for the same or different periods and/or specific compensation components and/or in relation to additional amounts for specific compensation components. Approbation de la rémunération par l'Assemblée Générale 1 L'Assemblée Générale approuve les propositions du Conseil d'Administration en relation avec les montants maximaux suivants: 1. la rémunération maximale du Conseil d'Administration jusqu'à la fin de l'Assemblée Générale ordinaire suivante; 2. la rémunération fixe maximale de la Direction Exécutive pour l'année comptable suivante; et 3. la rémunération variable maximale de la Direction Exécutive pour l'exercice en cours. 2 Le Conseil d'Administration peut soumettre à l'approbation de l'Assemblée Générale des propositions divergentes, supplémentaires ou conditionnelles concernant le montant maximal total ou les montants maximaux partiels pour les mêmes périodes ou des périodes différentes et/ou des éléments de rémunération spécifiques et/ou en relation avec des montants additionnels pour des éléments de rémunération spécifiques.
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 32 / 38 3 In the event that the General Meeting does not approve a proposal of the Board of Directors, the Board of Directors shall determine, taking into account all relevant factors, the respective (maximum) aggregate amount or (maximum) partial amounts, and submit the amount(s) so determined for approval by a General Meeting. 3 Si l'Assemblée Générale n'approuve pas une proposition du Conseil d'Administration, le Conseil d'Administration détermine, en prenant en compte tous les critères pertinents, le montant (maximal) total ou des montants (maximaux) partiels respectifs, et soumet le(s) montant(s) ainsi déterminé(s) à l'approbation d'une Assemblée Générale. 4 The Company or companies controlled by it may pay or grant compensation prior to approval by the General Meeting, subject to subsequent approval. 5 If variable compensation is approved prospectively, the Board of Directors shall submit the compensation report to the General Meeting for a consultative vote. 4 La rémunération peut être versée ou octroyée par la Société ou les sociétés qu'elle contrôle avant l'approbation de l'Assemblée Générale, sous réserve d'une approbation ultérieure. 5 Si des rémunérations variables sont approuvées de manière prospective, le Conseil d'Administration soumet le rapport de rémunération au vote consultatif de l'Assemblée Générale. Article 27 Article 27 Supplementary amount for changes to the Executive Committee If the maximum aggregate amount of compensation already approved by the General Meeting is not sufficient to also cover the compensation of one or more persons who become members of the Executive Committee after the General Meeting has approved the compensation of the Executive Committee for the relevant period, then the Company or companies controlled by it shall be authorized to pay such member(s) a supplementary amount during the compensation period(s) already approved. The supplementary amount per compensation period per member shall not exceed 100% of the aggregate amount of (maximum) compensation of the Executive Committee last approved. Montant complémentaire en cas de changements au sein de la Direction Exécutive Si le montant global maximal de la rémunération déjà approuvé par l'Assemblée Générale n'est pas suffisant pour couvrir également la rémunération d'une ou plusieurs personnes devenant membre(s) de la Direction Exécutive après que l'Assemblée Générale a approuvé la rémunération de la Direction Exécutive pour la période visée, la Société ou toute autre société qu'elle contrôle est alors autorisée à verser à ce(s) membre(s) un montant complémentaire au cours de la (ou les) période(s) de rémunération déjà approuvée(s). Le montant complémentaire par période de compensation par membre ne doit pas dépasser 100% du montant global de la rémunération (maximale) de la Direction Exécutive approuvée en dernier.
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 33 / 38 Article 28 Article 28 General compensation principles 1 The compensation of the non-executive members of the Board of Directors may consist of fixed and variable compensation elements. Total compensation shall take into account the position and level of responsibility of the recipient. 2 The compensation of the members of the Executive Committee may consist of fixed and variable compensation elements. Fixed compensation comprises the base salary and may consist of other compensation elements. Variable compensation may take into account the achievement of specific performance targets. Total compensation shall take into account the position and level of responsibility of the recipient. 3 The performance targets may include individual targets, targets of the Company, group or parts thereof or targets in relation to the market, other companies or comparable benchmarks, taking into account the position and level of responsibility of the recipient. The Board of Directors or, to the extent delegated to it, the Compensation Committee shall determine the relative weight of the performance targets and the respective target values. 4 Compensation may be paid in the form of cash, shares, options or other share-based instruments or units, or in the form of other types of benefits. The Board of Directors or, to the extent delegated to it, the Compensation Committee shall determine grant, vesting, exercise, restriction and forfeiture conditions and periods. In particular, they may provide for continuation, acceleration or removal of vesting, exercise, restriction and forfeiture conditions and periods, for payment or grant of compensation based Principes généraux de rémunération 1 La rémunération des membres non-exécutifs du Conseil d'Administration peut être constituée d'éléments de rémunération fixes et variables. La rémunération totale prend en compte la position et le niveau de responsabilité du bénéficiaire. 2 La rémunération des membres de la Direction Exécutive peut être constituée d'éléments de rémunération fixes et variables. La rémunération fixe comprend le salaire de base et peut être constituée d'autres éléments de rémunération. La rémunération variable peut prendre en compte l'accomplissement d'objectifs de performance spécifiques. La rémunération totale prend en compte la position et le niveau de responsabilité du bénéficiaire. 3 Les objectifs de performance peuvent comprendre des objectifs personnels, des objectifs liés à la performance de la Société ou de tout ou partie du groupe ou des buts en relation avec le marché, d'autres sociétés ou d'autres repères comparables, prenant en compte la position et le niveau de responsabilité du bénéficiaire. Le Conseil d'Administration ou le Comité de Rémunération, dans la mesure où cette compétence lui est déléguée, détermine le poids relatif des objectifs de performance et les valeurs cibles respectives. 4 La rémunération peut être versée en espèces, sous forme d'actions, d'options ou d'instruments ou unités sur base d'actions ou d'autres types de prestations. Le Conseil d'Administration ou le Comité de Rémunération, dans la mesure où cette compétence lui a été déléguée, détermine les conditions et périodes d'octroi, d'acquisition (vesting), d'exercice, de restriction et de péremption. Ils peuvent en particulier prévoir la continuation, l'accélération ou la suppression des conditions ou périodes d'acquisition (vesting),
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 34 / 38 upon assumed target achievement, or for forfeiture, in each case in the event of pre-determined events such as a change of control or termination of an employment or mandate agreement. The Company may procure the required shares or other securities through purchases in the market, from treasury shares or by using conditional or authorized share capital. 5 Compensation may be paid by the Company or companies controlled by it. d'exercice, de restriction et de péremption, le versement ou l'octroi d'une rémunération supposant l'atteinte des objectifs ou encore la déchéance des droits, dans chaque cas lors d'événements prédéterminés tels que, notamment, un changement de contrôle ou la fin d'un contrat de travail ou de mandat. La Société peut se procurer les actions ou autres instruments des marchés financiers requis par le biais d'achats sur le marché ou d'actions propres, ou en utilisant son capital-actions conditionnel ou autorisé. 5 La rémunération peut être versée par la Société ou tout autre société qu'elle contrôle. Article 29 Article 29 Agreements with members of the Board of Directors and the Executive Committee 1 The Company or companies controlled by it may enter into agreements with non-executive members of the Board of Directors relating to their compensation for a fixed term or for an indefinite term. The duration and termination are subject to the term of office and the law. 2 The Company or companies controlled by it may enter into employment agreements with executive members of the Board of Directors and other members of the Executive Committee for a fixed term or for an indefinite term. Fixed term agreements may have a maximum duration of one year; renewal is possible. Agreements for an indefinite term may have a notice period of maximum twelve months. 3 The Company or companies controlled by it may enter into non-compete agreements with members of the Executive Committee for the time after termination of employment. Their duration shall not exceed two years, Contrats avec les membres du Conseil d'Administration et de la Direction Exécutive 1 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de durée déterminée ou indéterminée avec les membres non-exécutifs du Conseil d'Administration en relation avec leur rémunération. La durée et la résiliation doivent être conformes avec la durée des fonctions ainsi qu'avec les dispositions légales applicables. 2 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de travail de durée déterminée ou indéterminée avec les membres exécutifs du Conseil d'Administration et les autres membres de la Direction Exécutive. Les contrats de durée déterminée peuvent avoir une durée maximale d'une année; le renouvellement est possible. Les contrats de durée indéterminée peuvent prévoir un délai de congé d'au maximum douze mois. 3 La Société, ou toute société qu'elle contrôle, peut conclure des accords de non-concurrence avec les membres de la Direction Exécutive pour la période suivant la fin des rapports de travail. Leur durée ne peut
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 35 / 38 and consideration paid per year for such non-compete undertaking shall not exceed the average compensation of such member of the last three financial years. excéder deux ans et l'indemnisation par an versée en contrepartie d'un tel accord de non-concurrence ne peut excéder la moyenne de la rémunération du membre concerné des trois derniers exercices. Article 30 Article 30 Mandates outside of the group 1 The number of mandates on the Board of Directors, the Executive Committee or comparable functions at other enterprises with an economic purpose is limited: (a) for members of the Executive Committee, to 7 mandates, of which no more than 2 in a listed company; and (b) for members of the Board of Directors, to 15 mandates, of which no more than 5 in listed companies. 2 Mandates in different legal entities being part of the same group or for the same group are deemed to be one mandate. 3 Mandates in associations, charitable organizations, family trusts and foundations relating to post-retirement benefits as well as mandates held at the request of the Company or companies controlled by it are not subject to the above limitations. No member of the Board of Directors or the Executive Committee shall hold more than 10 such mandates. Mandats en dehors du groupe 1 Le nombre de mandats d'administrateur, au sein de la Direction Exécutive ou de fonctions similaires auprès d'autres entreprises poursuivant un but économique est limité: (a) pour les membres de la Direction Exécutive, à 7 mandats, dont pas plus de 2 au sein de sociétés cotées; et (b) pour les membres du Conseil d'Administration à 15 mandats, dont pas plus de 5 au sein de sociétés cotées. 2 Les mandats dans différentes entités juridiques appartenant au même groupe ou assumés pour le même groupe sont considérés comme un mandat. 3 Les mandats dans des associations, organisations caritatives, fondations de famille et fondations de prévoyance professionnelle ainsi que les mandats exercés à la demande de la Société ou des sociétés qu'elle contrôle ne sont pas soumis aux limites mentionnées ci-dessus. Aucun membre du Conseil d'Administration ou de la Direction Exécutive ne peut exercer plus de 10 mandats de ce genre. Article 31 Article 31 Post-retirement benefits The Company or companies controlled by it may grant to members of the Board of Directors and the Executive Committee post-retirement benefits beyond the Prestations de retraite La Société ou toute société qu'elle contrôle peut octroyer aux membres du Conseil d'Administration et de la Direction Exécutive des prestations de retraite allant
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 36 / 38 occupational benefit schemes which do not exceed the annual compensation of the respective member of the Board of Directors or the Executive Committee last paid or payable for the first time. au-delà du régime de prévoyance professionnelle n'excédant pas la rémunération annuelle du membre du Conseil d'Administration ou de la Direction Exécutive concerné versée ou à verser pour la première fois. Section 5 Financial year, profit allocation Section 5 Exercice, répartition du bénéfice Article 32 Article 32 Financial year, annual and compensation report 1 The Company's financial year shall be determined by the Board of Directors. 2 The Board of Directors shall prepare an annual report for each financial year, comprising the annual financial statements, if required, the management report and the consolidated financial statements, as well as a compensation report and any other report required by law. Exercice social, rapport de gestion et de rémunération 1 L'exercice est fixé par le Conseil d'Administration. 2 Le Conseil d'Administration établit pour chaque exercice un rapport de gestion, qui se compose des comptes annuels et, cas échéant, du rapport annuel et des comptes de groupe, ainsi qu'un rapport de rémunération et tout autre rapport requis par la loi. Article 33 Article 33 Allocation of profit shown on the balance sheet, reserves 1 The General Meeting shall resolve on the allocation of the profit as shown on the balance sheet in accordance with applicable law. The Board of Directors shall submit its proposals to the General Meeting. 2 In addition to the reserves required by law, the General Meeting may create other reserves. 3 Dividends that have not been collected within five years after their payment date shall inure to the Company and be allocated to the general statutory reserves. Utilisation du bénéfice résultant du bilan, réserves 1 L'Assemblée Générale détermine l'emploi du bénéfice résultant du bilan, sous réserve des prescriptions légales concernant la répartition du bénéfice. Le Conseil d'Administration lui soumet ses propositions. 2 En sus des réserves légales, l'Assemblée Générale peut constituer des réserves supplémentaires. 3 Les dividendes qui n'ont pas été perçus dans un délai de cinq ans après leur date de paiement sont prescrits et sont alloués aux réserves statutaires de la Société.
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 37 / 38 Section 6 Dissolution, liquidation Section 6 Dissolution, liquidation Article 34 Article 34 Dissolution, liquidation 1 The General Meeting may at any time resolve to dissolve and liquidate the Company in accordance with the law and the provisions set forth in these Articles of Association. 2 The liquidation shall be effected by the Board of Directors, unless the General Meeting appoints other persons as liquidators. 3 The liquidation of the Company shall be effected pursuant to applicable law. The liquidators shall be entitled to sell assets (real estate included) in private transactions. 4 Upon discharge of all liabilities of the Company, the assets shall be distributed to the shareholders in proportion to the share capital, unless these Articles of Association provide otherwise. Dissolution, liquidation 1 L'Assemblée Générale peut décider en tout temps de la dissolution et de la liquidation de la Société en conformité avec les prescriptions légales et statutaires. 2 La liquidation a lieu par les soins du Conseil d'Administration, à moins que l'Assemblée Générale ne désigne d'autres liquidateurs. 3 La liquidation de la Société s'effectue conformément au droit applicable. Les liquidateurs sont autorisés à vendre des actifs (immeubles y compris) de gré à gré. 4 Après paiement des dettes de la Société, l'actif est réparti entre les actionnaires au prorata du capital- actions, à moins que les Statuts n'en disposent autrement. Section 7Means of Publication, communications Section 7 Organe de publication, communications Article 35 Article 35 Notices, communications 1 The official means of publication of the Company shall be the Swiss Official Gazette of Commerce. Communications, organe de publication 1 L'organe de publication de la Société est la Feuille Officielle Suisse du Commerce. 2 In particular cases, the Board of Directors may specify additional means of publication. 3 Notices by the Company to the shareholders may, at the election of the Board of Directors, be validly given by 2 Le Conseil d'Administration peut désigner d'autres organes de publication dans certains cas particuliers. 3 Les communications aux actionnaires peuvent, au choix du Conseil d'administration, être valablement
Articles of Association of SOPHiA GENETICS SA / Statuts de SOPHiA GENETICS SA 38 / 38 publication in the Swiss Official Gazette of Commerce or in a form that allows proof by text. effectuées par publication dans la Feuille officielle suisse du commerce ou sous une forme permettant d'en établir la preuve par texte. Section 7a Jurisdiction Section 7a For Article 35a Article 35a Jurisdiction The exclusive place of jurisdiction for any disputes arising under, out of or in connection with or related to the corporate relationship shall be at the registered office of the Company. For exclusif Le for exclusif pour tout litige découlant de ou en rapport avec la Société se situe au siège de celle-ci. Section 8 Authoritative language Section 8 Langue faisant foi Article 36 Article 36 Authoritative language In the event of discrepancies between the French and English versions of these Articles of Association, the French version shall prevail. Langue faisant foi En cas de conflit entre la version française et la version anglaise, la version française des Statuts prévaut. Tannay, le 5 juillet Tannay, July, 5, 2024
EX-2.1
3
exhibit21descriptionofsecu.htm
EX-2.1
Document
DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
As of December 31, 2024, our share capital as registered with the commercial register of the Canton of Vaud, Switzerland (the “Commercial Register”) amounted to 79,321,220 ordinary shares, each with a par value of CHF 0.05 per share.
In 2023 we amended our Articles of Association to adapt to the revised Swiss corporate law, which came into effect in the same year.
Unless otherwise noted, the following is a summary of the material provisions of our share capital and our articles of association that are in effect on the date of this prospectus.
Changes in Our Share Capital During the Last Three Fiscal Years
In this section, share amounts are presented as of the date of the relevant transaction. Since January 1, 2021, our share capital has changed as follows:
•On June 25, 2021, our share capital as registered with the Commercial Register was updated to reflect the issuance 74,265 ordinary shares out of conditional share capital;
•In the one-to-twenty share split of all issued shares effected on June 30, 2021, each of our issued shares was split into 20 shares of the same class with a par value of CHF 0.05 per share;
•On July 26, 2021, our entire share capital as registered with the Commercial Register on July 27, 2021 was converted into ordinary shares;
•On July 26, 2021, our share capital as registered with the Commercial Register on July 27, 2021 was increased by issuing 14,111,111 ordinary shares;
•On August 24, 2021, our share capital as registered with the Commercial Register on August 25, 2021 was increased by issuing 519,493 ordinary shares;
•On April 26, 2022, our share capital as registered with the Commercial Register on May 4, 2022 was increased by issuing 2,540,560 ordinary shares;
•On June 26, 2023, our share capital as registered with the Commercial Register on July 4, 2023 was increased by issuing 10,500,000 ordinary shares; and
•On June 24, 2024, our share capital as registered with the Commercial Register on July 12, 2024 was increased by issuing 2,423,056 ordinary shares.
Articles of Association
Ordinary Capital Increase, Capital Range and Conditional Share Capital
Under Swiss law, we may increase our share capital (capital-actions) with a resolution of the general meeting of shareholders (ordinary capital increase) that must be carried out by the board of directors within six months of the respective general meeting in order to become effective. Under our articles of association and Swiss law, in the case of subscription and increase against payment of contributions in cash, a resolution passed by a majority of the shares represented at the general meeting of shareholders is required. In the case of subscription and increase against contributions in kind, by set-off against claims or to fund acquisitions in kind, when shareholders’ statutory pre-emptive subscription rights or advance subscription rights are limited or withdrawn or where transformation of freely disposable equity into share capital is involved, a resolution passed by two-thirds of the shares represented at the general meeting of shareholders and the majority of the par value of the shares represented is required.
As of January 1, 2023 companies can no longer adopt, increase or extend authorized share capital (capital-actions autorisé). Instead, companies may adopt a capital range as further explained below.
Under the Swiss Code of Obligations (Code des obligations) (the “Code of Obligations”), our shareholders, by a resolution passed by two-thirds of the shares represented at a general meeting of shareholders and the majority of the par value of the shares represented, can:
• adopt conditional share capital (capital-actions conditionnel) in the aggregate amount of up to 50% of the share capital for the purpose of issuing shares in connection with, among other things, option and conversion rights granted to shareholders, the creditors of bonds and similar debt instruments, employees, members of the board of directors of the Company or of any group company, or to any third parties; and
• may, in the form of capital range (marge de fluctuation du capital), empower our board of directors to increase and/or decrease our share capital by up to 50% of the share capital, by issuing or canceling shares, or by increasing or decreasing the par value of shares, including through the conditional share capital; such capital range is to be utilized by the board of directors within a period determined by the shareholders but not exceeding five years from the date of the shareholder approval.
Our shareholders at the annual general meeting held in 2023 have adopted a capital range, allowing our board of directors to increase or to lower the capital in the limits as stated in Article 4a of the Articles of Association, as well as conditional capital in Articles 4b and 4c. The capital range and the conditional capital have been amended at the annual general meeting held in 2024.
Pre-Emptive and Advance Subscription Rights
Pursuant to the Code of Obligations, shareholders have pre-emptive subscription rights (droits de souscription préférentiels) to subscribe for new issuances of shares. With respect to conditional capital, shareholders have (i) pre-emptive subscription rights for the subscription of option rights and (ii) advance subscription rights (droit de souscription prioritaire) for the subscription of bonds and similar debt instruments to which option or conversion rights are attached.
A resolution passed at a general meeting of shareholders by two-thirds of the shares represented and the majority of the par value of the shares represented may withdraw or limit, or authorize our board of directors to withdraw or limit, pre-emptive subscription rights or advance subscription rights in certain circumstances.
If pre-emptive subscription rights are granted, but not exercised, the board of directors may allocate the unexercised pre- emptive subscription rights at its discretion.
Our Capital Range
Under our articles of association, our board of directors is authorized at any time, including to prevent takeovers and changes in control, until June 24, 2029 at the latest to increase our nominal share capital by a maximum aggregate amount of CHF 1,659,954.10 through the issuance of not more than 33,199,082 shares, which would have to be fully paid-in, each with a par value of CHF 0.05 per share.
Increases in partial amounts are permitted. The board of directors has the power to determine the type of contributions, the issue price and the date on which the dividend entitlement starts.
With respect to our capital range, the board of directors is authorized by our articles of association to withdraw or to limit the pre-emptive subscription rights of shareholders, and to allocate them to third parties or to us or another company of our group, in the event that the newly issued shares are issued under the following circumstances:
• if the issue price of the new registered shares is determined by reference to the market price;
• for raising of capital (including private placements) in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable conditions, without the exclusion of the statutory pre-emptive subscription rights of the existing shareholders;
• for the acquisition of an enterprise, parts of an enterprise or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares;
• for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners, or in connection with the listing of new shares on domestic or foreign stock exchanges;
• for purposes of granting an over-allotment option or an option to purchase additional shares in a placement or sale of shares to the respective initial purchaser(s) or underwriter(s);
• for the participation of members of the board of directors, members of the executive committee, employees, contractors, consultants or other persons performing services for the benefit of the Company or any of its group companies;
• following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 15% of our share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors;
• for the defense of an actual, threatened or potential takeover bid, that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders acceptance on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest; or
• for other valid grounds in the sense of Article 652b para. 2 of the Code of Obligations.
In addition to the increase of share capital, our board of directors has the right to reduce the share capital to the minimum amount of CHF 3,319,908.20. According to the Articles of Association, our board of directors is entitled to determine the use of the reduction amount, to the extent necessary.
Our Conditional Share Capital
Conditional Share Capital for Financing, Acquisitions and Other Purposes
Our nominal share capital may be increased, including to prevent takeovers and changes in control, by a maximum aggregate amount of CHF 1,079,954.10 through the issuance of not more than 21,599,082 ordinary shares, which would have to be fully paid-in, each with a par value of CHF 0.05 per share, through the exercise or mandatory exercise of conversion, exchange, option, warrant or similar rights or obligations for the subscription of shares granted to shareholders or third parties on a stand-alone basis or in connection with bonds, notes, options, warrants or other securities or contractual obligations of the Company or any of its group companies. Shareholders will not have pre-emptive subscription rights in such circumstances, but will have advance subscription rights to subscribe for such warrants, convertible bonds or similar instruments. The holders of such warrants, convertible bonds or similar instruments are entitled to the new shares upon the occurrence of the applicable conversion feature.
When issuing such convertible bonds, warrants or similar instruments, the board of directors is authorized to withdraw or to limit the advance subscription right of shareholders:
• for the purpose of financing or refinancing, or the payment for, the acquisition of enterprises, parts of enterprises, participations, intellectual property rights, licenses or investments;
• if the issuance occurs in domestic or international capital markets, including private placements;
• following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 15% of the share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors;
• for the defense of an actual, threatened or potential takeover bid that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders to accept on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest; or
• if such convertible bonds, warrants or similar instruments are issued on appropriate terms.
To the extent that the advance subscription rights are withdrawn or limited, (i) the convertible bonds, warrants or similar instruments are to be issued at market conditions; (ii) the term to exercise the convertible bonds, warrants or similar instruments may not exceed ten years from the date of issue of the respective instrument and (iii) the conversion, exchange or exercise price of the convertible bonds, warrants or similar instruments has to be set with reference to or be subject to change based upon the valuation of the Company’s equity or market conditions.
Conditional Share Capital for Employee Participation
Our nominal share capital may, to the exclusion of the pre-emptive subscription rights and advance subscription rights of shareholders, be increased by a maximum aggregate amount of CHF 903,076.40 through the (direct or indirect) issuance of not more than 18,061,528 ordinary shares, which would have to be fully paid-in, each with a par value of CHF 0.05 per share, or through the exercise or mandatory exercise of rights to acquire shares or through obligations to acquire shares that were granted to or imposed on members of the board of directors (or equivalent corporate body), members of the executive management, employees, contractors or consultants of the Company or its group companies, or other persons providing services to the Company or its group companies through one or more equity incentive plans, regulations or resolutions to be issue by the board of directors or, to the extent delegated to it, by the compensation committee.
Uncertificated Securities
Our shares are in the form of uncertificated securities (droits-valeurs, within the meaning of Article 973c of the Code of Obligations). In accordance with Article 973c of the Code of Obligations, we maintain a non-public register of uncertificated securities (registre des droits-valeurs). We may at any time convert uncertificated securities into share certificates (including global certificates), one kind of certificate into another, or share certificates (including global certificates) into uncertificated securities. Following entry in the share register, a shareholder may at any time request from us a written confirmation in respect of his, her or its shares. Shareholders are not entitled, however, to request the conversion and/or printing and delivery of share certificates. We may print and deliver certificates for shares at any time.
General Meeting of Shareholders
Ordinary/Extraordinary Meetings, Powers
The general meeting of shareholders is our supreme corporate body. Under Swiss law, an annual general meeting of shareholders must be held annually within six months after the end of a corporation’s financial year. In our case, this generally means on or before June 30. In addition, extraordinary general meetings of shareholders may be held.
A general meeting of shareholders may take place at different places simultaneously if the votes of the participants are immediately transmitted to all meeting venues (multilocal shareholders’ meeting). If the articles of association so permit, a general meeting of shareholders may be held outside Switzerland. The board of directors may allow shareholders that are not present at the meeting venue of the general meeting of shareholders to participate and exercise their rights electronically (“hybrid shareholder meeting”). A general meeting of shareholders without a physical meeting venue but that takes place using electronic means (“virtual shareholder meeting”) may be held, subject to certain legal requirements and if the articles of association so allow. Our articles of association currently do not provide for general meetings of shareholders outside Switzerland or virtual shareholder meetings.
According to our articles of association, the following powers are vested exclusively in the general meeting of shareholders:
• adopting and amending the articles of association, including the change of a company’s purpose or domicile;
• electing the members of the board of directors, the chairman of the board of directors, the members of the compensation committee, the auditors and the independent proxy;
• approving the business report, the annual statutory and consolidated financial statements and deciding on the allocation of profits as shown on the balance sheet, in particular with regard to dividends;
• approving the aggregate amount of compensation of members of the board of directors and the executive committee;
• discharging the members of the board of directors and the executive committee from liability with respect to their conduct of business;
• dissolving the company with or without liquidation; and
• deciding matters reserved to the general meeting of shareholders by law or the articles of association or submitted to it by the board of directors.
In addition, the following powers are, inter alia, vested exclusively in the general meeting of shareholders by operation of statutory law: (i) determination of the interim dividend and approval of the requisite interim financial statements and (ii) repayment of the statutory capital reserve (réserve légale).
An extraordinary general meeting of shareholders may be called by a resolution of the board of directors or the general meeting of shareholders or, under certain circumstances, by a company’s auditors, liquidator or the representatives of bondholders, if any. In addition, our articles of association require the board of directors to convene an extraordinary general meeting of shareholders if shareholders representing at least 5% of our share capital request such general meeting of shareholders in writing. A request for an extraordinary general meeting of shareholders must set forth the items to be discussed and the proposals to be acted upon. Further, the board of directors must convene an extraordinary general meeting of shareholders and propose financial restructuring measures if, based on our stand-alone annual statutory balance sheet, half of our share capital and statutory reserves are not covered by our assets and a contemplated restructuring measure falls within the competence of the general meeting of shareholders.
Voting and Quorum Requirements
Shareholder resolutions and elections (including elections of members of the board of directors) require the affirmative vote of the majority of shares represented at the general meeting of shareholders, unless otherwise stipulated by law or our articles of association.
Under our articles of association, a resolution of the general meeting of shareholders passed by two- thirds of the votes and the majority of the par value of the shares, each as represented at the meeting, is required for:
• amending the Company’s corporate purpose;
• creating shares with preference rights;
• cancelling or amending the restriction on the transferability of shares or their registration with voting rights;
• creating conditional share capital;
• increasing share capital out of equity, against contributions in-kind or for the purpose of acquiring specific assets and granting specific benefits;
• limiting or withdrawing shareholders’ pre-emptive subscription rights;
• changing a company’s domicile;
• amending or repealing the voting and recording restrictions, the provision setting a maximum board size or the indemnification provision for the board of directors and the executive committee set forth in our articles of association;
• converting registered shares into bearer shares;
• removing the chairman or any member of the board of directors before the end of his or her term of office; and
• dissolving or liquidating the Company.
In addition, a resolution of the general meeting of shareholders passed by two-thirds of the votes and the majority of the par value of the shares, each as represented at the meeting is, by operation of statutory law required for: (i) a consolidation of shares (reverse split); (ii) a capital increase through contribution by set-off; (iii) the introduction of a capital range (marge de fluctuation du capital); (iv) a conversion of participation certificates into shares; (v) a change of currency of the share capital; (vi) the introduction of a casting vote of the chairperson at the general meeting of shareholders; (vii) a provision in the articles of association regarding the holding of the general meeting of shareholders outside Switzerland; (viii) a delisting of the equity securities; and (ix) the introduction of an arbitration clause in the articles of association.
The same voting requirements apply to resolutions regarding transactions among corporations based on Switzerland’s Federal Act on Mergers, Demergers, Transformations and the Transfer of Assets of 2003, as amended (the “Swiss Merger Act”). See “—Articles of Association—Compulsory Acquisitions; Appraisal Rights.”
In accordance with Swiss law and generally accepted business practices, our articles of association do not provide quorum requirements generally applicable to general meetings of shareholders. To this extent, our practice varies from Nasdaq listing standards, which require an issuer to provide in its bylaws for a generally applicable quorum and that such quorum may not be less than one-third of the outstanding voting shares.
Notice
General meetings of shareholders must be convened by the board of directors at least 20 days before the date of the meeting. The general meeting of shareholders is convened by way of a notice appearing in our official publication medium, currently the Swiss Official Gazette of Commerce. Registered shareholders may also be informed by ordinary mail or e- mail. The notice of a general meeting of shareholders must state the date, the starting time, the form and location of the meeting, the items on the agenda, the motions to the shareholders including a short explanation for these motions, the name and address of the independent representative and, in case of elections, the names of the nominated candidates. A resolution on a matter which is not on the agenda may not be passed at a general meeting of shareholders, except for motions to convene an extraordinary general meeting of shareholders or to initiate a special investigation, on which the general meeting of shareholders may vote at any time. No previous notification is required for motions concerning items included in the agenda or for debates that do not result in a vote.
All owners or representatives of our shares may, if no objection is raised, hold a general meeting of shareholders without complying with the formal requirements for convening general meetings of shareholders (a universal meeting). This universal meeting of shareholders may discuss and pass binding resolutions on all matters within the purview of the general meeting of shareholders, provided that the owners or representatives of all the shares are present at the meeting.
Agenda Requests
Pursuant to our articles of association, one or more shareholders whose combined shareholdings represent 0.5% of our voting rights or of our share capital have the right to request that an item including a proposal, or a proposal with respect to an existing agenda item, be included in the agenda of a general meeting of shareholders.
To be timely, the shareholder’s request must be received by us generally at least 45 calendar days in advance of the meeting. The request must be made in writing and contain, for each of the agenda items, the following information:
• a brief description of the business desired to be brought before the general meeting of shareholders and the reasons for conducting such business at the general meeting of shareholders;
• the motions regarding the agenda item;
• the name and address, as they appear in the share register, of the shareholder proposing such business;
• the number of shares which are beneficially owned by such shareholder (including documentary support of such beneficial ownership);
• the dates upon which the shareholder acquired such shares;
• any material interest of the proposing shareholder in the proposed business;
• a statement in support of the matter; and
• all other information required under the applicable laws and stock exchange rules.
In addition, if the shareholder intends to solicit proxies from the shareholders of a company, such shareholder shall notify the company of this intent in accordance with SEC Rule 14a-4 and/or Rule 14a-8.
Our business report, the compensation report and the auditors’ report must be made available for inspection by the shareholders no later than 20 days prior to the general meeting of shareholders. It said reports are not made available electronically, any shareholder may request delivery thereof.
Voting Rights
Each of our ordinary shares entitles a holder to one vote. The ordinary shares are not divisible. The right to vote and the other rights of share ownership may only be exercised by shareholders (including any nominees) or usufructuaries who are entered in the share register at a cut-off date determined by the board of directors. Those entitled to vote in the general meeting of shareholders may be represented by the independent proxy holder (annually elected by the general meeting of shareholders), by its legal representative or by another registered shareholder with written authorization to act as proxy.
The chairman has the power to decide whether to recognize a power of attorney.
Our articles of association contain provisions that prevent investors from acquiring voting rights exceeding 15% of our issued share capital. Specifically, if an individual or legal entity acquires ordinary shares and, as a result, directly or indirectly, has voting rights with respect to more than 15% of the registered share capital recorded in the Commercial Register, the registered shares exceeding the limit of 15% shall be entered in the share register as shares without voting rights (limitation à l’inscription). This restriction applies equally to parties acting in concert and to shares held or acquired via a nominee, including via Cede & Co., New York (or any successor), as the nominee of The Depository Trust Company (“DTC”), New York, acting in its capacity as clearing nominee. Specifically, if shares are being held by a nominee for third-party beneficiaries, which control (alone or together with third parties) voting rights with respect to more than 15% of the share capital recorded in the Commercial Register, our articles of association provide that the board of directors may cancel the registration of the shares with voting rights held by such nominee in excess of the limit of 15%. Furthermore, our articles of association contain provisions that allow the board of directors to make the registration with voting rights of shares held by a nominee subject to conditions, limitations and reporting requirements or to impose or adjust such conditions, limitations and requirements once registered.
However, any shareholders who held more than 15% prior to our initial public offering remain registered with voting rights for such shares. Furthermore, the board of directors may in special cases approve exceptions to these restrictions.
Dividends and Other Distributions
Our board of directors may propose to shareholders that a dividend or interim dividend or other distribution be paid but cannot itself authorize the distribution. Dividend and interim dividend payments require a resolution passed by a majority of the shares represented at a general meeting of shareholders. In addition, our auditors must confirm that the dividend proposal of our board of directors conforms to Swiss statutory law and our articles of association.
Under Swiss law, we may pay dividends only if we have sufficient distributable profits from the previous business year (bénéfice de l’exercice) or brought forward from the previous business years (report des bénéfices) or if we have distributable capital reserves (réserve légale issue du capital), each as evidenced by audited stand-alone statutory annual or interim financial statements prepared pursuant to Swiss law, and after allocations to reserves required by Swiss law and by the articles of association have been deducted.
Under the Code of Obligations, at least 5% of our annual profit must be retained as statutory profit reserve (réserve légale). If there is a loss carried forward, such loss must be eliminated before allocation to the statutory profit reserve. The statutory profit reserve shall be accumulated until it reaches, together with the statutory capital reserve, 50% of our share capital recorded in the Commercial Register. In addition, we have to allocate, among other things, the net proceeds of share issuances to the statutory capital reserve. The Code of Obligations permits us to accrue additional reserves. Further, a purchase of our own shares (whether by us or a subsidiary) reduces the distributable reserves in an amount corresponding to the purchase price of such own shares. Finally, the Code of Obligations under certain circumstances requires the creation of revaluation reserves which are not distributable.
Distributions out of issued share capital (i.e., the aggregate par value of our issued shares) are not allowed and may be made only by way of an ordinary capital reduction or within a capital range that (also) allows for a capital reduction (see “—Articles of Association—Ordinary Capital Increase, Capital Range and Conditional Share Capital”). An ordinary capital reduction requires a resolution passed by a majority of the shares represented at a general meeting of shareholders. The board of directors must publish a call to creditors in the Swiss Official Gazette of Commerce in which creditors are advised that they may request, subject to certain conditions, security for their claims within 30 days of the publication of the creditor call. A licensed audit expert must then confirm, based on the results of the call to creditors, that the claims of the creditors remain fully covered despite the reduction in our share capital recorded in the Commercial Register. If all requirements for an ordinary capital reduction have been met, the board of directors has to amend the articles of association in a public deed. Our share capital may be reduced below CHF 100,000 only if and to the extent that at the same time the statutory minimum share capital of CHF 100,000 is reestablished by sufficient new fully paid-up capital. An ordinary capital reduction must be completed within six months after the resolution of the general meeting of shareholders.
Our board of directors determines the date on which the dividend entitlement starts. Dividends are usually due and payable shortly after the shareholders have passed the resolution approving the payment, but shareholders may also resolve at the annual general meeting of shareholders to pay dividends in quarterly or other installments.
Transfer of Shares
Shares in uncertificated form (droits-valeurs) may only be transferred by way of assignment. Shares or the beneficial interest in shares, as applicable, credited in a securities account may only be transferred when a credit of the relevant intermediated securities to the acquirer’s securities account is made in accordance with applicable rules. Our articles of association provide that in the case of securities held with an intermediary such as a registrar, transfer agent, trust corporation, bank or similar entity, any transfer, grant of a security interest or usufructuary right in such intermediated securities and the appurtenant rights associated therewith requires the cooperation of the intermediary in order for such transfer, grant of a security interest or usufructuary right to be valid against us.
Voting rights may be exercised only after a shareholder has been entered in the share register (registre des actions) with his, her or its name and address (in the case of legal entities, the registered office) as a shareholder with voting rights. For a discussion of the restrictions applicable to the control and exercise of voting rights, see “——Articles of Association—Voting Rights.”
Inspection of Books and Records
Under the Code of Obligations, a shareholder has a right to inspect the share register with respect to his, her or its own shares and otherwise to the extent necessary to exercise his, her or its shareholder rights. No other person has a right to inspect the share register. Shareholders holding in the aggregate at least 5% of our nominal share capital or of our voting rights have the right to inspect our books and correspondence, subject to the safeguarding of our business secrets and other legitimate interests. Our board of directors is required to decide on an inspection request within four months after receipt of such request. Denial of the request will need to be justified in writing. If an inspection request is denied by the board of directors, shareholders may request the order of an inspection by the court within thirty days. See “—Comparison of Swiss Law and Delaware Law—Inspection of books and records.”
Special Investigation
If a shareholder has exercised its information or inspection rights, such shareholder may propose to the general meeting of shareholders that specific facts be examined by a special examiner in a special investigation. If the general meeting of shareholders approves the proposal, we or any shareholder may, within 30 calendar days after the general meeting of shareholders, request a court at our registered office (currently Rolle, Canton of Vaud, Switzerland) to appoint a special examiner. If the general meeting of shareholders rejects the request, one or more shareholders representing at least 5% of our share capital or voting rights may request that the court appoint a special examiner. The court will issue such an order if the petitioners can demonstrate that members of the board of directors or our executive committee infringed the law or our articles of association and that such violation is suitable to cause a damage to the Company or the shareholders. The costs of the investigation would generally be allocated to us and only in exceptional cases to the petitioners
Compulsory Acquisitions; Appraisal Rights
Business combinations and other transactions that are governed by the Swiss Merger Act (i.e., mergers, demergers, transformations and certain asset transfers) are binding on all shareholders. A statutory merger or demerger requires approval of two-thirds of the shares represented at a general meeting of shareholders and the majority of the par value of the shares represented.
If a transaction under the Swiss Merger Act receives all of the necessary consents, all shareholders are compelled to participate in such transaction.
Swiss corporations may be acquired by an acquirer through the direct acquisition of the shares of the Swiss corporation. The Swiss Merger Act provides for the possibility of a so-called “cash-out” or “squeeze-out” merger with the approval of holders of 90% of the issued shares. In these limited circumstances, minority shareholders of the corporation being acquired may be compensated in a form other than through shares of the acquiring corporation (for instance, through cash or securities of a parent corporation of the acquiring corporation or of another corporation). For business combinations effected in the form of a statutory merger or demerger and subject to Swiss law, the Swiss Merger Act provides that if equity rights have not been adequately preserved or compensation payments in the transaction are unreasonable, a shareholder may request the competent court to determine a reasonable amount of compensation.
In addition, under Swiss law, the sale of “all or substantially all of our assets” by us may require the approval of two-thirds of the number of shares represented at a general meeting of shareholders and the majority of the par value of the shares represented. Whether a shareholder resolution is required depends on the particular transaction, including whether the following test is satisfied:
• a core part of our business is sold, without which it is economically impracticable or unreasonable to continue to operate the remaining business;
• our assets, after the divestment, are not invested in accordance with our corporate purpose as set forth in the articles of association; and
• the proceeds of the divestment are not earmarked for reinvestment in accordance with our corporate purpose but, instead, are intended for distribution to our shareholders or for financial investments unrelated to our corporate purpose.
A shareholder of a Swiss corporation participating in certain major corporate transactions may, under certain circumstances, be entitled to appraisal rights. As a result, such shareholder may, in addition to the consideration (be it in shares or in cash) receive an additional amount to ensure that the shareholder receives the fair value of the shares held by the shareholder. Following a statutory merger or demerger, pursuant to the Swiss Merger Act, shareholders can file an appraisal action against the surviving company. If the consideration is deemed inadequate, the court will determine an adequate compensation payment.
Board of Directors
Our articles of association provide that the board of directors shall consist of at least three and not more than eight members.
The members of the board of directors and the chairman are elected annually by the general meeting of shareholders for a period until the completion of the subsequent annual general meeting of shareholders and are eligible for re-election. Each member of the board of directors must be elected individually.
Powers
According to our articles of association, the board of directors has the following non-delegable and inalienable powers and duties:
• the ultimate direction of the business of the Company and issuing of the relevant directives;
• laying down the organization of the Company;
• formulating accounting procedures, financial controls and financial planning;
• nominating and removing persons entrusted with the management and representation of the Company and regulating the power to sign for the Company;
• the ultimate supervision of those persons entrusted with management of the Company, with particular regard to adherence to law, our articles of association and regulations and directives of the Company;
• issuing the business report and the compensation report, and preparing for the general meeting of shareholders and carrying out its resolutions; and
• informing the court in case of over-indebtedness.
By operation of statutory law, the board of directors has, inter alia, the additional non-delegable and inalienable power and
duty to submit an application for debt-restructuring moratorium if needed.
The board of directors may, while retaining such non-delegable and inalienable powers and duties, delegate some of its powers, in particular direct management, to a single or to several of its members, committees or to third parties (such as executive officers) who need be neither members of the board of directors nor shareholders. Pursuant to Swiss law and our articles of association, details of the delegation and other procedural rules such as quorum requirements have been set in the organizational rules established by the board of directors.
Indemnification of Executive Officers and Directors
Subject to Swiss law, our articles of association provide for indemnification of the existing and former members of the board of directors and the executive committee and their heirs, executors and administrators against liabilities arising in connection with the performance of their duties in such capacity, and permits us to advance the expenses of defending any act, suit or proceeding to our directors and executive officers to the extent not included in insurance coverage or advanced by third parties.
In addition, under general principles of Swiss employment law, an employer may be required to indemnify an employee against losses and expenses incurred by such employee in the proper execution of his or her duties under the employment agreement with the employer. See “—Comparison of Swiss Law and Delaware Law—Indemnification of directors and executive officers and limitation of liability.”
Conflicts of Interest, Management Transactions
The members of the board of directors and the executive committee are required to immediately and fully inform the board of directors about conflicts of interests concerning them. The board of directors is furthermore required to take measures in order to protect the interests of the company. More generally, the Code of Obligations requires our directors and executive officers to safeguard the Company’s interests and imposes a duty of loyalty and duty of care on our directors and executive officers. This rule is generally understood to disqualify directors and executive officers from participation in decisions that directly affect them. Our directors and executive officers are personally liable to us for breaches of these obligations.
In addition, Swiss law contains provisions under which directors and all persons engaged in the Company’s management are liable to the Company, each shareholder and the Company’s creditors for damages caused by an intentional or negligent violation of their duties. Furthermore, Swiss law contains a provision under which payments made to any of the Company’s shareholders or directors or any person related to any such shareholder or director, other than payments made at arm’s length, must be repaid to the Company if such shareholder or director acted in bad faith.
Our board of directors has adopted a Code of Ethics and other policies that cover a broad range of matters, including the handling of conflicts of interest.
Principles of the Compensation of the Board of Directors and the Executive Committee
Pursuant to Swiss law, the aggregate amount of compensation of the board of directors and the persons whom the board of directors has, fully or partially, entrusted with the management (which we refer to as our “executive committee”) of the Company has to be submitted to our shareholders for approval each year. All of our executive officers named in “Management” are deemed to be members of our executive committee.
The board of directors must issue, on an annual basis, a written compensation report that must be reviewed by our auditors. The compensation report must disclose, among other things, all compensation granted by the Company, directly or indirectly, to current members of the board of directors and the executive committee and, to the extent related to their former role within the Company or not on customary market terms, to former members of the board of directors and former executive officers.
The disclosure concerning compensation, loans and other forms of indebtedness must include the aggregate amount for the board of directors and the executive committee, respectively, as well as the particular amount for each member of the board of directors and for the highest-paid executive officer, specifying the name and function of each of these persons.
We are prohibited from granting certain forms of compensation to members of our board of directors and executive committee, such as:
• severance payments (compensation due until the termination of a contractual relationship does not qualify as severance payment);
• advance compensation;
• incentive fees for the acquisition or transfer of companies, or parts thereof, by the Company or by companies being, directly or indirectly, controlled by us;
• loans, other forms of indebtedness, pension benefits not based on occupational pension schemes and performance-based compensation not provided for in the articles of association; and
• equity-based compensation not provided for in the articles of association.
Compensation to members of the board of directors and the executive committee for activities in entities that are directly or indirectly controlled by the Company is prohibited if (i) the compensation would be prohibited if it were paid directly by the Company, (ii) the articles of association do not provide for it, or (iii) the compensation has not been approved by the general meeting of shareholders.
Each year, the general meeting of shareholders has to vote on the proposals of the board of directors with respect to:
• the maximum aggregate amount of compensation of the board of directors for the term of office until the next annual general meeting of shareholders; and
• the maximum aggregate amount of fixed compensation of the executive committee for the following financial year; and
• the maximum aggregate amount of variable compensation of the executive committee for the current financial year.
The board of directors may submit for approval at the general meeting of shareholders deviating or additional proposals relating to the same or different periods.
If, at the general meeting of shareholders, the shareholders do not approve a compensation proposal of the board of directors, the board of directors must prepare a new proposal, taking into account all relevant factors, and submit the new proposal for approval by the same general meeting of shareholders at a subsequent extraordinary general meeting of shareholders or the next annual general meeting of shareholders.
In addition to fixed compensation, members of the board of directors and the executive committee may be paid variable compensation depending on the achievement of certain performance criteria. The performance criteria may include individual targets, targets of the Company or parts thereof and targets in relation to the market, other companies or comparable benchmarks, taking into account the position and level of responsibility of the recipient of the variable compensation. The board of directors or, where delegated to it, the compensation committee shall determine the relative weight of the performance criteria and the respective target values.
Compensation may be paid or granted in the form of cash, shares, financial instruments, in kind, or in the form of other types of benefits. The board of directors or, where delegated to it, the compensation committee shall determine grant, vesting, exercise and forfeiture conditions.
Borrowing Powers
Neither Swiss law nor our articles of association restricts our power to borrow and raise funds. The decision to borrow funds is made by or under the direction of our board of directors and no approval by the shareholders is required in relation to any such borrowing.
Repurchases of Shares and Purchases of Own Shares
The Code of Obligations limits our ability to repurchase and hold our own shares. We and our subsidiaries may repurchase shares only to the extent that (i) we have freely distributable reserves in the amount of the purchase price and (ii) the aggregate par value of all shares held by us does not exceed 10% of our share capital. Pursuant to Swiss law, where shares are acquired in connection with a transfer restriction set out in the articles of association, the foregoing upper limit is 20%. If we own shares that exceed the threshold of 10% of our share capital, the excess must be sold or cancelled by means of a capital reduction within two years.
Shares held by us or our subsidiaries are not entitled to vote at the general meeting of shareholders but are entitled to the economic benefits applicable to the shares generally, including dividends and pre-emptive subscription rights in the case of share capital increases.
In addition, selective share repurchases are only permitted under certain circumstances. Within these limitations, as is customary for Swiss corporations, we may, subject to applicable law, purchase and sell our own shares from time to time in order to meet imbalances of supply and demand, to provide liquidity and to even-out variances in the market price of shares.
Notification and Disclosure of Substantial Share Interests
The disclosure obligations generally applicable to shareholders of Swiss corporations under the Federal Act on Financial Market Infrastructures and Market Conduct in Securities and Derivatives Trading, or the Financial Market Infrastructure Act (the “FMIA”), do not apply to us since our shares are not listed on a Swiss exchange.
Mandatory Bid Rules
The obligation of any person or group of persons that acquires more than one third of a company’s voting rights to submit a cash offer for all the outstanding listed equity securities of the relevant company at a minimum price pursuant to the FMIA does not apply to us since our shares are not listed on a Swiss exchange.
Stock Exchange Listing
Our common shares are listed on Nasdaq under the symbol “SOPH.”
The Depository Trust Company
Each person owning a beneficial interest in common shares held through DTC must rely on the procedures thereof and on institutions that have accounts therewith to exercise any rights of a holder of the shares.
Transfer Agent and Registrar of Shares
Our share register is kept by Computershare Trust Company, N.A., which acts as transfer agent and registrar. The share register reflects only record owners of our shares. Swiss law does not recognize fractional share interests.
Comparison of Swiss Law and Delaware Law
The Swiss laws applicable to Swiss corporations and their shareholders differ from laws applicable to U.S. corporations and their shareholders. The following table summarizes significant differences in shareholder rights pursuant to the provisions of the Code of Obligations, by which our Company is governed (but see the introduction to this Exhibit 2.1 regarding the two-year transition period that currently applies), and the Delaware General Corporation Law applicable to companies incorporated in Delaware and their shareholders. Please note that this is only a general summary of certain provisions applicable to companies in Delaware. Certain Delaware companies may be permitted to exclude certain of the provisions summarized below in their charter documents.
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Mergers and similar arrangements
Under the Delaware General Corporation Law, with certain exceptions, a merger, consolidation, sale, lease or transfer of all or substantially all of the assets of a corporation must be approved by the board of directors and a majority of the outstanding shares entitled to vote thereon. A shareholder of a Delaware corporation participating in certain major corporate transactions may, under certain circumstances, be entitled to appraisal rights pursuant to which such shareholder may receive cash in the amount of the fair value of the shares held by such shareholder (as determined by a court) in lieu of the consideration such shareholder would otherwise receive in the transaction. The Delaware General Corporation Law also provides that a parent corporation, by resolution of its board of directors, may merge with any subsidiary, of which it owns at least 90.0% of each class of capital stock without a vote by the shareholders of such subsidiary. Upon any such merger, dissenting shareholders of the subsidiary would have appraisal rights.
Under Swiss law, with certain exceptions, a merger or a demerger of the corporation or a sale of all or substantially all of the assets of a corporation must be approved by two-thirds of the voting rights represented at the respective general meeting of shareholders as well as the majority of the par value of shares represented at such general meeting of shareholders. A shareholder of a Swiss corporation participating in a statutory merger or demerger pursuant to the Swiss Merger Act (Loi sur la fusion la scission, la transformation et le transfert de patrimoine) can file a lawsuit against the surviving company. If the consideration is deemed “inadequate,” such shareholder may, in addition to the consideration (be it in shares or in cash) receive an additional amount to ensure that such shareholder receives the fair value of the shares held by such shareholder. Swiss law also provides that if the merger agreement provides only for a compensation payment, at least 90% of all members in the transferring legal entity who are entitled to vote shall approve the merger agreement.
Shareholders’ suits
Class actions and derivative actions generally are available to shareholders of a Delaware corporation for, among other things, breach of fiduciary duty, corporate waste and actions not taken in accordance with applicable law. In such actions, the court has discretion to permit the winning party to recover attorneys’ fees incurred in connection with such action.
Class actions and derivative actions as such are not available under Swiss law. Nevertheless, certain actions may have a similar effect. A shareholder is entitled to bring suit against directors, officers or liquidators for breach of their duties and claim the payment of the company’s losses or damages to the corporation and, in some cases, to the individual shareholder. Likewise, an appraisal lawsuit won by a shareholder may indirectly compensate all shareholders. In addition, to the extent that U.S. laws and regulations provide a basis for liability and U.S. courts have jurisdiction, a class action may be available.
Under Swiss law, the winning party is generally entitled to recover a limited amount of attorneys’ fees incurred in connection with such action. The court has discretion to permit the shareholder who lost the lawsuit to recover attorneys’ fees incurred to the extent that he or she acted in good faith.
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Shareholder vote on board and management compensation
Under the Delaware General Corporation Law, the board of directors has the authority to fix the compensation of directors, unless otherwise restricted by the certificate of incorporation or bylaws.
Pursuant to Swiss law, the general meeting of shareholders has the non-transferable right, amongst others, to vote separately and bindingly on the aggregate amount of compensation of the members of the board of directors, of the executive committee and of the advisory boards.
Annual vote on board renewal
Unless directors are elected by written consent in lieu of an annual meeting, directors are elected in an annual meeting of shareholders on a date and at a time designated by or in the manner provided in the bylaws. Re-election is possible.
Classified boards are permitted.
The general meeting of shareholders elects the members of the board of directors, the chairperson of the board of directors and the members of the compensation committee individually and annually for a term of office until the end of the following general meeting of shareholders. Re-election is possible.
Indemnification of directors and executive officers and limitation of liability
The Delaware General Corporation Law provides that a certificate of incorporation may contain a provision eliminating or limiting the personal liability of directors and officers of the corporation for monetary damages for breach of a fiduciary duty as a director or officer, except no provision in the certificate of incorporation may eliminate or limit:
•the liability of a director or officer for any breach of the duty of loyalty to the corporation or its shareholder
•the liability of a director or officer for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
•a director’s statutory liability for unlawful payment of dividends or unlawful share purchase or redemption;
•the liability of a director or officer for any transaction from which the director or officer derived an improper personal benefit; or
•the liability of an officer in any action by or in the right of the corporation.
A Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any proceeding, other than an action by or on behalf of
the corporation, because the person is or was a director or officer, against liability incurred in connection with the proceeding if the director or officer acted in good faith and in a manner reasonably believed to be in, or not opposed to, the best interests of the corporation; and the director or officer, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Unless ordered by a court, any foregoing indemnification is subject to a determination that the director or officer has met the applicable standard of conduct
•by a majority vote of the directors who are not parties to the proceeding, even though less than a quorum;
•by a committee of directors designated by a majority vote of the eligible directors, even though less than a quorum;
•by independent legal counsel in a written opinion if there are no eligible directors or if the eligible directors so direct; or
•by the shareholders
Under Swiss corporate law, an indemnification by the corporation of a director or member of the executive committee in relation to potential personal liability is not effective to the extent the director or member of the executive committee intentionally or negligently violated his or her corporate duties towards the corporation (certain views advocate that at least a grossly negligent violation is required to exclude the indemnification). Furthermore, the general meeting of shareholders may discharge (release) the directors and members of the executive committee from liability for their conduct to the extent the respective facts are known to shareholders. Such discharge is effective only with respect to claims of the company and of those shareholders who approved the discharge or who have since acquired their shares in full knowledge of the discharge. Most violations of corporate law are regarded as violations of duties towards the corporation rather than towards the shareholders. In addition, indemnification of other controlling persons is not permitted under Swiss corporate law, including shareholders of the corporation.
The articles of association of a Swiss corporation may also set forth that the corporation shall indemnify and hold harmless, to the extent permitted by the law, the directors and executive managers out of assets of the corporation against threatened, pending or completed actions.
Also, a corporation may enter into and pay for directors’ and officers’ liability insurance, which may cover negligent acts as well.
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Moreover, a Delaware corporation may not indemnify a director or officer in connection with any proceeding in which the director or officer has been adjudged to be liable to the corporation unless and only to the extent that the court determines that, despite the adjudication of liability but in view of all the circumstances of the case, the director or officer is fairly and reasonably entitled to indemnity for those expenses which the court deems proper.
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Directors’ fiduciary duties
A director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components:
• the duty of care; and
• the duty of loyalty.
The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this
duty, a director must inform himself or herself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction.
The duty of loyalty requires that a director act in a manner he or she reasonably believes to be in the best interests of the corporation. He or she must not use his or her corporate position for personal gain or advantage. This duty prohibits self-dealing by a director and mandates that the best interest of the corporation and its shareholders take precedence over any interest possessed by a director, officer or controlling shareholder and not shared by the shareholders generally. In general, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties.
Should such evidence be presented concerning a transaction by a director, a director must prove the procedural fairness of the transaction and that the transaction was of fair value to the corporation.
The board of directors of a Swiss corporation manages the business of the corporation, unless responsibility for such management has been duly delegated to the executive committee based on organizational rules. However, there are several non-transferable duties of the board of directors:
• the overall management of the corporation and the issuing of all necessary directives;
• determination of the corporation’s organization;
• the organization of the accounting, financial control and financial planning systems as required for management of the corporation;
• the appointment and dismissal of persons entrusted with managing and representing the corporation;
• overall supervision of the persons entrusted with managing the corporation, in particular with regard to compliance with the law, articles of association, operational regulations and directives;
• compilation of the annual report, preparation for the general meeting of the shareholders, the compensation report and implementation of its resolutions; and
• the filing an application for a debt restructuring moratorium and notification of the court in the event that the company is over-indebted.
The members of the board of directors must perform their duties with all due diligence and safeguard the interests of the corporation in good faith. They must afford the shareholders equal treatment in equal circumstances.
The duty of care requires that a director act in good faith, with the care that an ordinarily prudent director would exercise under like circumstances.
The members of the board of directors and the executive committee are required to immediately and fully inform the board of directors about conflicts of interests concerning them. The board of directors is furthermore required to take measures in order to protect the interests of the company.
The duty of loyalty requires that a director safeguard the interests of the corporation and requires that directors act in the interest of the corporation and, if necessarily, put aside their own interests. If there is a risk of a conflict of interest, the board of directors must take appropriate measures to ensure that the interests of the company are duly taken into account.
The burden of proof for a violation of these duties is with the corporation or with the shareholder bringing a suit against the director.
The Swiss Federal Supreme Court has established a doctrine that restricts its review of a business decision if the decision has been taken following proper preparation, on an informed basis and without conflicts of interest.
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
Shareholder action by written consent
A Delaware corporation may, in its certificate of incorporation, eliminate the right of shareholders to act by written consent.
Shareholders of a Swiss corporation may exercise their voting rights in a general meeting of shareholders. Shareholders can only act by written consents if no shareholder requests a general meeting of shareholders. The articles of association must allow for (independent) proxies to be present at a general meeting of shareholders. The instruction of such (independent) proxies may occur in writing or electronically.
Shareholder proposals
A shareholder of a Delaware corporation has the right to put any proposal before the annual meeting of shareholders, provided it complies with the notice provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the governing documents, but shareholders may be precluded from calling special meetings.
At any general meeting of shareholders any shareholder may put proposals to the meeting if the proposal is part of an agenda item. No resolution may be taken on proposals relating to the agenda items that were not duly notified.
Unless the articles of association provide for a lower threshold or for additional shareholders’ rights:
• shareholders together representing at least 5% of the share capital or voting rights may demand that a general meeting of shareholders be called for specific agenda items and specific proposals; and
• shareholders together representing shares with a par value of at least 5%, or 0.5% in case of a listed company, of the share capital or the voting rights may demand that an agenda item including a specific proposal, or a proposal with respect to an existing agenda item, be put on the agenda for a scheduled general meeting of shareholders, provided such request is made with appropriate lead time.
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
Any shareholder can propose candidates for election as directors or make other proposals within the scope of an agenda item without prior written notice.
In addition, any shareholder is entitled, at a general meeting of shareholders and without advance notice, to (i) request information from the board of directors on the affairs of the company (note, however, that the right to obtain such information is limited), (ii) request information from the auditors on the methods and results of their audit,
(iii) request that the general meeting of shareholders resolve to convene an extraordinary general meeting, or (iv) request that the general meeting of shareholders resolve to appoint an examiner to carry out a special examination (“examen spécial”).
Cumulative voting
Under the Delaware General Corporation Law, cumulative voting for elections of directors is not permitted unless the corporation’s certificate of incorporation provides for it.
Cumulative voting is not permitted under Swiss corporate law. Pursuant to Swiss law, shareholders can vote for each proposed candidate, but they are not allowed to cumulate their votes for single candidates. An annual individual election of (i) all members of the board of directors, (ii) the chairperson of the board of directors, (iii) the members of the compensation committee, (iv) the election of the independent proxy for a term of
office of one year (i.e., until the following annual general meeting of shareholders), as well as the vote on the aggregate amount of compensation of the members of the board of directors, of the executive committee and of the members of any advisory board, is mandatory for listed companies. Re-election is permitted.
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
Removal of directors
A Delaware corporation with a classified board may be removed only for cause with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.
A Swiss corporation may remove, with or without cause, any director at any time with a resolution passed by a majority of the shares represented at a general meeting of shareholders. The articles of association may require the approval by a supermajority of the shares represented at a meeting for the removal of a director.
Transactions with interested shareholders
The Delaware General Corporation Law generally prohibits a Delaware corporation from engaging in certain business combinations with an “interested shareholder” for three years following the date that such person becomes an interested shareholder. An interested shareholder generally is a person or group who or which owns or owned 15.0% or more of the corporation’s outstanding voting shares within the past three years.
No such rule applies to a Swiss corporation.
Dissolution; Winding-up
Unless the board of directors of a Delaware corporation approves the proposal to dissolve, dissolution must be approved by shareholders holding 100.0% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority of the corporation’s outstanding shares. Delaware law allows a Delaware corporation to include in its certificate of incorporation a supermajority voting requirement in connection with dissolutions initiated by the board.
A dissolution of a Swiss corporation requires the approval by two-thirds of the voting rights represented at the respective general meeting of shareholders as well as the majority of the par value of shares represented at such general meeting of shareholders. The articles of association may increase the voting thresholds required for such a resolution.
Variation of rights of shares
A Delaware corporation may vary the rights of a class of shares with the approval of a majority of the outstanding shares of such class, unless the certificate of incorporation provides otherwise.
The general meeting of shareholders of a Swiss corporation may resolve that preference shares be issued or that existing shares be converted into preference shares with a resolution passed by a majority of the shares represented at the general meeting of shareholders. Where a company has issued preference shares, further preference shares conferring preferential rights over the existing preference shares may be issued only with the consent of both a special meeting of the adversely affected holders of the existing preference shares and of a general meeting of all shareholders, unless otherwise provided in the articles of association.
Shares with preferential voting rights are not regarded as preference shares for these purposes.
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
Amendment of governing documents
A Delaware corporation’s governing documents may be amended with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.
The articles of association of a Swiss corporation may be amended with a resolution passed by a majority of the shares represented at a general meeting of shareholders, unless otherwise provided in the articles of association.
There are a number of resolutions, such as an amendment of the stated purpose of the corporation, the introduction of a capital range and conditional capital and the introduction of shares with preferential voting rights that require the approval by two-thirds of the votes and a majority of the par value of the shares represented at such general meeting of shareholders. The articles of association may increase these voting thresholds. The articles of association of a Swiss corporation may be amended with a resolution passed by a majority of the shares represented at a general meeting of shareholders, unless otherwise provided in the articles of association.
Inspection of books and records
Shareholders of a Delaware corporation, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose and to obtain copies of list(s) of shareholders and other books and records of the corporation and its subsidiaries, if any, to the extent the books and records of such subsidiaries are available to the corporation.
Shareholders of a Swiss corporation holding in the aggregate at least 5% of the nominal share capital or voting rights have the right to inspect books and records, subject to the safeguarding of the company’s business secrets and other interests warranting protection. A shareholder is only entitled to receive information to the extent required to exercise his, her or its rights as a shareholder. The board of directors has to decide on an inspection request within four months after receipt of such request. Denial of the request will need to be justified in writing. If the board of directors denies an inspection request, shareholders may request the order of an inspection by the court within thirty days.
A shareholder’s right to inspect the share register is limited to the right to inspect his, her or its own entry in the share register .
Payment of dividends
The board of directors may approve a dividend without shareholder approval. Subject to any restrictions contained in its certificate of incorporation, the board may declare and pay dividends upon the shares of its capital stock either:
• out of its surplus; or
• in case there is no such surplus, out of its net profits for the fiscal year in which the dividend is declared and/or the preceding fiscal year.
Shareholder approval is required to authorize capital stock in excess of that provided in the charter. Directors may issue authorized shares without shareholder approval.
Dividend (including interim dividend) payments are subject to the approval of the general meeting of shareholders. The board of directors may propose to shareholders that a dividend shall be paid but cannot itself authorize the distribution
Payments out of a corporation’s share capital (in other words, the aggregate par value of the corporation’s shares) in the form of dividends are not allowed and may be made only by way of a share capital reduction. Dividends may be paid only from the profits of the previous business year or brought forward from previous or current business years or if the corporation has distributable reserves, each as evidenced by the corporation’s audited stand-alone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and the articles of association have been deducted.
DELAWARE CORPORATE LAW SWISS CORPORATE LAW
Creation and issuance of new shares
All creation of shares require the board of directors to adopt a resolution or resolutions, pursuant to authority expressly vested in the board of directors by the provisions of the company’s certificate of incorporation.
All creation of shares require a shareholders’ resolution. The creation of a capital range or conditional share capital requires at least two-thirds of the voting rights represented at the general meeting of shareholders and a majority of the par value of shares represented at such meeting. The board of directors may issue or cancel shares out of the capital range during a period of up to five years by a maximum amount of 50% of the current share capital. Shares are created and issued out of conditional share capital through the exercise of options or of conversion rights that the board of directors may grant to shareholders, creditors of bonds or similar debt instruments, employees, directors of the company or another group company or third parties.
EX-4.8
4
exhibit48watchmakeragreeme.htm
EX-4.8
Document
SUPPLY AGREEMENT
This SUPPLY AGREEMENT (the "Agreement") is dated and effective December 6th, 2021 (the "Effective Date"), by and between Watchmaker Genomics, Inc. a Delaware corporation with its principal offices at 5744 Central Avenue, Suite 100, Boulder, CO 80301 ("Watchmaker") and SOPHiA Genetics, Inc., a corporation having an office at 185 Dartmouth Street, Suite 502, Boston, MA 02116 ("SOPHiA"). Each of Watchmaker and SOPHiA is deemed a "Party" hereto, and collectively, the "Parties".
RECITALS
WHEREAS, Watchmaker manufactures and sells global genomics tools; and WHEREAS, SOPHiA wishes to purchase from Watchmaker certain components for
resale as components in, and for manufacture of, SOPHiA Kits (as defined below) and Watchmaker is willing to supply and sell such components to SOPHiA on the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants set forth in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, the Parties agree as follows:
AGREEMENT
1.DEFINITIONS
1.1."Affiliate" means an entity which controls, is controlled by, or is under common control with a Party hereto. For the purpose of this definition, "control" shall mean the holding of the voting majority or possession, direct or indirect, of the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract, or otherwise.
1.2."Applicable Law" means all applicable food, drug, device, cosmetic and other applicable laws, rules, regulations, codes, administrative and judicial orders and directives, or similar requirements or actions of any federal, state or local government, or any agency or administrative body of any of the foregoing.
1.3."SOPHiA Indemnified Parties" is defined in Section 12.2.
1.4."SOPHiA Kit(s)" means the kit(s) that contains one or more Products purchased from Watchmaker under this Agreement that is sold under SOPHiA's trademark, trade name and labeling.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
1.5."Confidential Information" means all information, data and know-how disclosed by or on behalf of a Party ("Disclosing Party") to the other Party ("Receiving Party") including, but not limited to, their business strategies, marketing strategies, pricing, technology or processes of the Disclosing Party or any of its Affiliates, customers or vendors, whether written, verbal, electronic, visual (e.g., obtained by observation of facilities) or in any other medium, whether tangible or intangible. Confidential Information includes, but is not limited to, any summaries, analyses, compilations, technical information, information, business plans and other materials prepared by either Party, their respective Affiliates, or any of its or their respective officers, directors, employees or agents that contain or are based in whole or in part on any other Confidential Information. Confidential Information also includes the existence and terms of this Agreement.
1.6."Customer(s)" means a Third Party (as defined below) to whom SOPHiA or SOPHiA's
Affiliate or SOPHiA's Distributor sells SOPHiA Kits for use (and not for resale).
1.7."Disclosing Party" is defined in Section 1.4.
1.8."Distributor" means a Third Party having an agreement with SOPHiA or an Affiliate of SOPHiA under which such Third Party is authorized to resell products manufactured by SOPHiA, including SOPHiA Kits, to Customers.
1.9."Field" means any field of use.
1.10."Force Majeure Event" is defined in Section 14.3
1.11."Information" is defined in Section 8.1.
1.12."Last Buy Order" is defined in Section 4.3.
1.13."Lot" is defined in Section 4.1.
1.14."Products" means the products listed and described in Schedule 1.
1.15."Price" is defined in Section 6.2.
1.16."Purchase Order" means the purchase order form that SOPHiA completes and delivers to Watchmaker in accordance with Section 3.
1.17."Receiving Party" is defined in section 1.4.
1.18."Shipment" is defined in Section 4.1.
1.19."Specifications" means the specifications for the Products, as set forth in Exhibit A.
1.20."Term" is defined in Section 11.1.
1.21."Territory" means worldwide.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
1.22."Third Party" means any person or entity that is not a Party or an Affiliate of a Party.
1.23."Warranty Period" is defined in Section 7.1.
1.24."Watchmaker Indemnified Parties" is defined in Section 12.1.
2.AUTHORIZED USES AND USE RESTRICTIONS
2.1.Authorized Uses. Subject to the terms and conditions of this Agreement, Watchmaker authorizes SOPHiA, on a non-exclusive basis, (a) to use Products for internal research and development and manufacturing, (b) to use, develop, validate and manufacture SOPHiA Kits, and (c) to resell and transfer Products purchased under this Agreement solely as components of SOPHiA Kits (sold only under SOPHiA's label), to Customers, in the Field and in the Territory. For clarity, resale of Products as standalone products or as components of products other than SOPHiA Kits is expressly prohibited. SOPHiA shall not perform any analytical tests to ascertain the structure of, or otherwise reverse engineer the Products. The Products are manufactured for research use only and have not been qualified by Watchmaker for any other purpose, including clinical, diagnostic or therapeutic use. SOPHiA is solely responsible for testing and for determining the suitability of Products for use in SOPHiA Kits, and any intended use or application thereof, and will properly qualify, use, and, to the extent authorized, market any products containing Seller's Products in strict compliance with all Applicable Law. SOPHiA is responsible for obtaining all necessary approvals, intellectual property rights, licenses and permissions that may be required related to SOPHiA use of the Products, and for communicating any appropriate limitations or cautionary information to Customers.
2.2.Labeling; Trademark Use. SOPHiA shall use, sell and offer for sale, the SOPHiA Kits only under its or its Affiliates' own trademarks, trade names and labeling. SOPHiA shall not use Watchmaker's name or trademarks, trade names or labeling under any circumstances or for any reason, including any branding of the SOPHiA Kits. It shall be the responsibility of SOPHiA to ensure that its labeling of SOPHiA Kits complies with all Applicable Law.
2.3.Use of Distributors and Affiliates. SOPHiA may sell SOPHiA Kits to or through a Distributor, provided that such SOPHiA Kits must only be sold under SOPHiA's trademark and labeling and such Distributor shall not modify or change any Products. To the extent SOPHiA desires to use Distributors to sell SOPHiA Kits, SOPHiA shall ensure that each such Distributor sells the SOPHiA Kits in compliance with the terms of this Agreement. SOPHiA may exercise the rights granted under this Agreement through one or more Affiliates that exist as of the Effective Date, provided that SOPHiA shall be responsible for and liable for any acts or omissions of its Affiliates.
3.FORECASTS AND ORDERS
3.1.Purchase Orders. When SOPHiA desires delivery of any Products, it shall submit to Watchmaker a Purchase Order via email to [**]. Each such Purchase Order shall specify: the quantity of Products desired, the place of delivery (which may be that of SOPHiA, SOPHiA's Affiliate, or a contract manufacturer of SOPHiA or its Affiliate), the price(s),
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
and the date(s) of delivery. Watchmaker shall fulfill all Purchase Orders for quantities of Products which are consistent with the then applicable forecast for the calendar quarter in which delivery is required and in compliance with the lead- time described in Section 3.3, or as otherwise agreed upon by the Parties in writing.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Such Purchase Orders will be deemed accepted upon receipt, and Watchmaker shall acknowledge receipt and confirm estimated ship date within [**]business days of receiving the Purchase Order. Watchmaker shall use commercially reasonable efforts to accommodate Purchase Orders for quantities of Products that exceed the then applicable forecast for the calendar quarter in which delivery is required, subject to the lead times described in Section 3.3. Watchmaker shall respond to a Purchase Order that requests quantities in excess of those specified in the then applicable forecast within [**]business days of receiving the Purchase Order, notifying SOPHiA whether or not Watchmaker can manufacture the additional amount of Products requested therein.
3.2.Forecasts. SOPHiA shall provide Watchmaker with a rolling four-quarter forecast of its requirements at least [**]days prior to the beginning of each calendar quarter representing SOPHiA's good faith estimate of the number of Products that SOPHiA expects to purchase during the following four calendar quarters. The first such forecast is attached hereto as Schedule 2. Unless rejected by Watchmaker (which may only be in accordance with this Section 3.2), the first quarter of each such forecast shall be binding on SOPHiA. Forecasts will be updated on a rolling quarterly basis.
3.3.Lead Time; Delivery. SOPHiA will issue Purchase Orders that specify a delivery date for Products that is not less than [**]weeks subsequent to the date of the Purchase Order, unless such a Purchase Order is greater than [**]% but less than [**]% of the forecast provided under Section 3.2 and/or requires shipments from multiple lots, in which case the specified delivery date shall not be less than [**]weeks subsequent to the date of the Purchase Order. If SOPHiA requests a delivery date in a Purchase Order that is less than [**]weeks from the Purchase Order date, or quantities in excess of [**]% of the forecast provide under Section 3.2, Watchmaker shall use reasonable commercial efforts to meet such delivery date and/or excess quantities but shall not be in breach of this Agreement if the Products are not delivered by such delivery date.
3.4.No Other Terms and Conditions. If a sales acknowledgment, invoice, Purchase Order, or other document submitted by either Party contains terms or conditions conflicting with or additional to the terms and conditions of this Agreement, the Parties hereby reject such terms and conditions, and the terms and conditions of this Agreement shall prevail unless otherwise expressly agreed to in writing by both Parties.
3.5.Technical Support. SOPHiA will be responsible for all technical support of SOPHiA Kits.
3.6.Amendments to Schedule 1 - Products. In the event SOPHiA desires to purchase additional Watchmaker products from Watchmaker under the terms of this Agreement, and for use in SOPHiA Kits, Schedule 1 may be amended to include such additional Watchmaker products with the prior written approval of Watchmaker.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
4.MANUFACTURING AND QUALITY CONTROL
4.1.The Parties hereby agree to enter into a Supplier Quality Agreement that will dictate the obligations of the Parties regarding manufacturing and quality control. In the event that the terms of this Agreement contradict the terms of the Supplier Quality Agreement, the Supplier Quality Agreement shall govern.
4.2.Manufacture. Watchmaker shall have in place reasonable procedures and protocols to manufacture the Products substantially in accordance with the Specifications. Watchmaker manufactures the Products in lots or batches (each referred to herein as a "Lot").
4.3.Compliance with Laws. SOPHiA shall comply with all Applicable Laws Related to the transportation, storage, use, handling, disposal, marketing, sale, import and export of the Products. Watchmaker has and shall maintain during the Term of this Agreement all approvals, registrations, rights, and governmental permits, including without limitation health, safety and environmental permits, necessary to perform its obligations pursuant to this Agreement.
4.4.Product Changes. Watchmaker shall notify SOPHiA of any material changes which impact fit, form, or function of the Product, as defined by the Product Specifications, or any planned discontinuation of the manufacture or sale of the Product, > 180 days in advance. Such notification will include, at a minimum, a) a description of the planned change, b) rationale for the change, and c) implementation date. Notwithstanding the foregoing, changes mandated by regulatory authorities or that are outside of Watchmaker's reasonable control shall not require prior notice or prior written consent, and Watchmaker will notify SOPHiA promptly as soon as it is made aware of such changes.
4.5.No Exclusivity. Watchmaker shall have the right to manufacture for and sell to any Third Party any Products or any components that are the same or substantially similar to any of the Products.
4.6.Quality Control. SOPHiA agrees to the Specifications and that Watchmaker shall perform quality control testing according to those Specifications under Watchmaker's quality management system. Watchmaker shall provide a Certificate of Analysis with each Lot, emailed electronically to an email address designated by SOPHiA. Watchmaker shall make a copy of its quality assurance manual available to SOPHiA during an inspection as specified in this Section 4.5 if SOPHiA so requests. Watchmaker shall keep documentation of the quality assurance procedures and actions it has taken to ensure the quality of the Products ("Records"). Watchmaker shall maintain the Records in an orderly manner so that they are accessible to SOPHiA. Watchmaker shall retain such Records and samples for a period of two (2) years after the last shipment of Products hereunder. During the term of this Agreement and for [**]years thereafter, SOPHiA or its designee, at its own expense, may inspect and audit the facilities, including related books and records, in which the Products are produced or distributed from. Such audits will be conducted no more than once every [**]. SOPHiA shall provide Watchmaker with at least [**] days' notice prior to any such inspection, and shall provide an audit plan at least [**]an audit plan at least [**]no more than [**]representatives, and duration of the audit shall be no more than [**]business days, and shall not unreasonably hinder or delay Watchmaker's business operations when conducting such inspections. SOPHiA acknowledges Products are manufactured by Watchmaker for research use only and are not qualified by Watchmaker for any other use. SOPHiA shall be responsible for validating Products for any purposes other than research.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
5.ACCEPTANCE; REJECTION
5.1.Acceptance. SOPHiA shall have [**]business days from receipt of each delivery of the Products to inspect the delivery for accuracy, and to inspect the Products' packaging for visible defects. SOPHiA may notify Watchmaker of an inaccuracy, or reject visibly defective Products, within such time. If SOPHiA fails to notify Watchmaker within [**]business days from delivery of the Products, the Products shall be deemed accepted by the SOPHiA. SOPHiA shall have [**]calendar days from delivery to test the Products to determine whether the Products substantially conform to the Specifications and reject for nonconformance. Only the Specifications for the Products that are specifically set forth in Exhibit A of this Agreement will be used to determine SOPHiA's acceptance of Products supplied hereunder. If SOPHiA fails to notify Watchmaker within [**]calendar days from delivery of the Products, the Products shall be deemed to substantially conform to the Specifications.
5.2.Cure Upon Shortfall and Rejection. Upon notice to Watchmaker of a shortfall in the amount of Products delivered to SOPHiA under the applicable Purchase Order, Watchmaker shall deliver the shortfall amount as soon as commercially practicable, but no later than [**]calendar days from SOPHiA'S notice. Upon notice of rejection of Products for a failure to substantially conform to the Specifications, Watchmaker shall, at Watchmakers' discretion, either (i) replace such nonconforming Products or (ii) refund all amounts paid by SOPHiA for such nonconforming Products. The foregoing states Watchmaker's sole and exclusive obligation and SOPHiA's sole and exclusive remedy for nonconforming Products, shortages of Products delivered or other delivery errors.
6.DELIVERY; PRICING; PAYMENT
6.1.Shipment. Watchmaker shall package the Products in a manner designed to protect the Products from damage in the ordinary course of delivery. Watchmaker shall ship the Products DAP, freight prepaid and added to the invoice. Products shall be delivered no earlier than [**]days prior to the delivery date specified on the Purchase Order and no later than the specified delivery date (unless the delivery date is changed by written agreement of the Parties or a Force Majeure Event occurs).
6.2.Product Price. The price for each Product is set forth on the attached Schedule 1 in United States Dollars ($) ("Price"). The unit or pack price may be adjusted once per year, and the % of price adjustment will be based on actual change in fully loaded cost of goods, not to exceed the published United States Consumer Price Index. Any change in price must be communicated with [**]days advance notice, and Watchmaker will accept one advance order up to the amount forecasted for the then subsequent calendar quarter at the existing price. The Parties agree to meet annually to review pricing and make adjustments based on changes in firm volume commitments either per order or per year.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.3.Invoicing and Payment. Upon or after delivery of the Products, Watchmaker shall invoice SOPHiA for the amount and type of Products delivered. Each invoice issued by Watchmaker hereunder shall specify: (a) the Prices in respect of the Products delivered; (b) the quantity and type of Products delivered; (c) the amount of sales tax due (if any) in respect of the Products delivered; and (d) any other amounts reimbursable to Watchmaker (if any) pursuant to this Agreement. Invoiced amounts are payable in USD to the address as indicated in Watchmaker's invoice. SOPHiA shall make payments for the Products within [**]days following the date of the invoice, unless Watchmaker has notified SOPHiA in writing SOPHiA is required to prepay prior to delivery due to insufficient credit line.
6.4.Non-Payment. Watchmaker shall be entitled to interest on any overdue sum at a rate equal to [**] percent ([**]%) per month. In addition, Watchmaker will not be obligated to accept or honor SOPHiA's Purchase Orders or to make any shipments of Product(s) hereunder unless SOPHiA's account with Watchmaker is in good standing. SOPHiA agrees to pay all costs and expenses, including reasonable attorneys' fees, incurred by Watchmaker in the collection of any sum payable by SOPHiA to Watchmaker. If SOPHiA's payment is overdue (i) for [**]or more consecutive invoices or (ii) more than [**]times (whether or not consecutive) in any calendar year, then Watchmaker shall have the right, in its sole discretion, to change SOPHiA's payment terms under Section 6.3 effective immediately upon written notice to SOPHiA.
6.5.Taxes; Duties. Any use tax, sales tax, excise tax, duty, inspection or testing fee, or any other tax, fee or charge imposed on Watchmaker by any governmental authority, on or measured by the purchase of Products by SOPHiA shall be paid by SOPHiA in addition to the Prices quoted or invoiced. If Watchmaker is required to pay any such tax, fee or charge, SOPHiA shall reimburse Watchmaker therefore (within [**]days of receipt of notice from Watchmaker) or provide Watchmaker at the time the Purchase Order is submitted an exemption certificate or other document acceptable to the authority imposing the tax, fee or charge.
7.LIMITED WARRANTY
7.1.Watchmaker Warranties. Watchmaker hereby represents and warrants to SOPHiA that at the time of delivery by Watchmaker to SOPHiA, the Products shall substantially conform to the Specifications and, will be free from defects in workmanship and materials for the shelf life of such Products as set forth in Exhibit A (the "Warranty Period") when properly handled and stored in accordance with the Specifications and/or in accordance with Watchmaker's guidelines provided with delivery of the Products; the Products will be manufactured in accordance with reasonable skill, care and diligence and in compliance with all Applicable Laws. [**]
7.2.Exclusions and Limitations:
WATCHMAKER'S WARRANTIES DO NOT COVER DAMAGES DUE TO [**]. THE LIMITED WARRANTIES SET FORTH IN THIS AGREEMENT DO NOT AND SHALL NOT APPLY TO THIRD-PARTY PRODUCTS. ANY WARRANTY ON A THIRD-PARTY PRODUCT IS PROVIDED BY THE SUPPLIER, PROVIDER, OR ORIGINAL MANUFACTURER OF THAT THIRD- PARTY PRODUCT.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
ALL THIRD-PARTY PRODUCTS ARE PROVIDED UNDER THIS AGREEMENT "AS IS."
7.3.[**].
7.4.Disclaimer of Warranties. EXCEPT AS SET FORTH IN SECTION 7.1 OF THIS AGREEMENT, WATCHMAKER MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS. WATCHMAKER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WATCHMAKER MAKES NO REPRESENTATIONS OR WARRANTIES THAT PRODUCTS ARE SUITABLE FOR ANY CLINICAL, DIAGNOSTIC OR THERAPEUTIC USE.
8.SOPHiA REPRESENTATIONS AND WARRANTIES. SOPHiA hereby represents and warrants:
8.1.[**].
9.CONFIDENTIAL INFORMATION
9.1.Each Receiving Party agrees that (i) it shall not use the Confidential Information of the Disclosing Party for any purpose other than performance of its obligations or exercise of its rights under this Agreement; and (ii) it will not disclose any Confidential Information of the Disclosing Party to any third party except the Receiving Party’s employees, independent contractors, consultants and its Affiliates (and its Affiliates employees, independent contractors and consultants) to whom it is necessary to disclose the Confidential Information for the foregoing purposes and who shall be subject to obligations of confidentiality at least as restrictive as those specified herein. The Receiving Party shall protect the Disclosing Party's Confidential Information by using the same degree of care as the Receiving Party uses to protect its own Confidential Information, but in any event no less than a reasonable degree of care.
9.2.Notwithstanding any other provision of this Agreement, Confidential Information shall not include any item of information which: (a) is within the public domain prior to the time of the disclosure by the Disclosing Party to the Receiving Party or thereafter becomes within the public domain other than as a result of disclosure by the Receiving Party or any of its representatives in violation of this Agreement; (b) was, on or before the date of disclosure in the possession of the Receiving Party, as evidenced by records, however maintained; (c) is acquired by the Receiving Party from a Third Party not under an obligation of confidentiality; or (d) is hereafter independently developed by the Receiving Party, as evidenced by records, however maintained.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
9.3.Upon expiration or termination of this Agreement, the Receiving Party agrees to cease using all Confidential Information of the Disclosing Party and return all Confidential Information, including materials, received from the Disclosing Party within thirty (30) calendar days (or, with the Disclosing Party's permission, destroy it and certify as to such destruction), along with all copies and reproductions thereof. Notwithstanding the foregoing, (i) the Receiving Party may retain in its confidential files one (1) copy of written Confidential Information of the Disclosing Party in the files of its legal counsel for the sole purpose of proving what was disclosed; (ii) the Receiving Party is not required to return or destroy any Confidential Information of the Disclosing Party if doing so would violate any law, regulation or court order, (iii) the Receiving Party shall not be required to expunge any minutes or written consents of its board of directors (or equivalent governance body), and (iv) to the extent that the Receiving Party's computer back-up or archiving procedures create copies of Confidential Information of the Disclosing Party, the Receiving Party may retain such copies for the period it normally archives backed-up computer records, so long as such copies are not readily accessible and are not used or consulted for any purpose other than disaster recovery. Any Confidential Information retained pursuant to the foregoing sentence shall remain subject to this Agreement until destroyed or no longer deemed Confidential Information based on the exclusions to the definition of Confidential Information. Notwithstanding Section 9.1, either Party may disclose Confidential Information as required by law, regulation or court order or by the listing standards, rules or agreements of any public exchange on which any securities of the Receiving Party are listed so long as the Receiving Party (i) uses commercially reasonable efforts to give the Disclosing Party as much prior notice of such required disclosure as circumstances permit, (ii) allows the Disclosing Party to contest such disclosure or to seek a protective order or similar remedy, and reasonably cooperates with the Disclosing Party in such efforts, and (iii) limits the disclosure to only the information required to be disclosed.
9.4.Neither Party may publicly disclose the existence or terms of this Agreement without the prior written consent of the other Party; provided, however, that either Party may make such a disclosure to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded, or to prospective investors or purchasers of stock or assets of such Party, who, in any case, have entered into confidentiality obligations comparable in scope to the obligations set forth in this Agreement. In the event that such disclosure is made as aforesaid, the Disclosing Party shall provide the other Party with notice beforehand and to coordinate with the other Party to the maximum extent possible with respect to the wording and timing of any such disclosure.
9.5.As between the Parties, Confidential Information is and shall remain the property of the Disclosing Party, and the Disclosing Party shall retain all right, title and interest in and to its Confidential Information. Neither this Agreement nor the disclosure of Confidential Information hereunder grants or implies to the Receiving Party any right or license to use or practice any intellectual property of the Disclosing Party.
9.6.Neither Party shall make or issue any press release, statement or other public announcement regarding the contents, existence or formation of this Agreement and shall not otherwise use the name (except as required for regulatory compliance or reports to, submissions to, or correspondence with regulatory bodies), trademark(s), service mark(s) or logo(s) of the other Party in any advertisements or commercial promotions, without the prior written consent of the other Party.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
9.7.The non-use and confidentiality obligations of the Receiving Party set forth in this Section 9 will continue for a period of [**]years after expiration or termination of this Agreement; provided, that the Receiving Party's non-use and confidentiality obligations related to Confidential Information that is a trade secret will continue in perpetuity so long as the Disclosing Party treats such Confidential Information as a trade secret.
10.INTELLECTUAL PROPERTY
The sale of the Products furnished hereunder does not convey any license by implication, estoppel, or otherwise, under any proprietary or intellectual property rights of Watchmaker covering any combination of the Products with other materials. In all cases, intellectual property rights in and relating to the Products, including but not limited to their formulation, design and all improvement thereto, shall be and remain the exclusive property of Watchmaker. All rights not expressly granted herein are reserved.
11.TERM AND TERMINATION
11.1.Term. The initial term of this Agreement shall be five (5) years from the Effective Date hereof, unless sooner terminated as expressly provided for in this Agreement. After expiration of the initial term, this Agreement will renew automatically for additional one (1) year periods, provided that neither Party provides the other Party with written notice of that Party's desire not to renew the Agreement at least one hundred eighty (180) days prior to the expiration of the then-current term. Such initial period and any renewal period shall be referred to herein as the "Term".
11.2.Termination for Cause. Either Party may portion of the assets for the benefit of creditors by the other Party; provided, however, in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the Party consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof; or (iii) upon SOPHiA's rejection of [**] Lots of the same Product in a [**] month period where Watchmaker could not confirm non- conformance to the applicable Specifications. Termination by Watchmaker pursuant to (i) or (iii) shall, at Watchmaker's option, relieve Watchmaker of the obligation to deliver Products under an outstanding Purchase Order. Termination by SOPHiA pursuant to (i) or (iii) shall, at SOPHiA's option, relieve SOPHiA of the obligation to accept Products under an outstanding Purchase Order.
11.3.Termination by SOPHiA. SOPHiA may terminate this Agreement (i) upon [**] days' prior written notice to Watchmaker in the event SOPHiA is prevented from manufacturing and/or selling the SOPHiA Kits by any Applicable Laws.
11.4.Effect of Expiration or Termination. Except as may be set forth otherwise, all rights and obligations of the Parties set forth herein that expressly or by their nature survive the expiration or termination of this Agreement (including without limitation all rights under outstanding Purchase Orders) shall continue in full force and effect subsequent to and notwithstanding the expiration or termination of this Agreement until they are satisfied or by their nature expire and shall bind the Parties and their legal representatives, successors, and permitted assigns.
12.INDEMNITY
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
12.1.SOPHiA. SOPHiA shall indemnify, defend and hold harmless Watchmaker, its Affiliates, and their respective directors, officers, employees and agents (the "Watchmaker Indemnified Parties") from and against all losses, liabilities, costs, damages and expenses (including reasonable attorneys' fees and costs) that any of Watchmaker Indemnified Parties incur or suffer as a result of any claims, demands, actions or other proceedings made or instituted by any Third Party ("Action") and arising out of or relating [**].
12.2.Watchmaker. Watchmaker shall indemnify, defend and hold harmless SOPHiA, its Affiliates, and their respective directors, officers, employees and agents (the "SOPHiA Indemnified Parties") from and against all losses, liabilities, costs, damages and expenses (including reasonable attorneys' fees and costs) that any of SOPHiA Indemnified Parties incur or suffer as a result of any Action and arising out of or relating to [**].
12.3.Indemnification Procedure. [**].
13.LIMITATIONS OF LIABILITY
13.1.TO THE EXTENT PERMITTED BY APPLICABLE LAW AND NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY OR ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY OR LIMITATION OF LIABILITY, NEITHER PARTY OR ITS AFFILIATES SHALL, EXCEPT IN THE CASE OF [**], BE LIABLE TO THE OTHER PARTY, OR THE OTHER PARTY'S AFFILIATES, DISTRIBUTORS, OR CUSTOMERS FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (SUCH AS PUNITIVE DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE DISTRIBUTION, SALE OR USE OF THE PRODUCTS, WHETHER BASED ON CONTRACT, NEGLIGENCE, STRICT LIABILITY, OTHER TORT OR OTHERWISE, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
13.2.EXCEPT FOR A PARTY'S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, AND TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL EITHER PARTY'S LIABILITY ARISING OUT OF THE MANUFACTURE, SALE, SUPPLY, USE OR DISPOSITION OF THE PRODUCTS, WHETHER BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE, EXCEED [**].
13.3.The Parties acknowledge and agree that the limitations of liability contained in this Section 13 are a fundamental part of the basis of the bargain hereunder, and neither Party would enter into this Agreement absent such limitations.
14.MISCELLANEOUS
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
14.1.Regulatory Action. Each Party shall notify the other Party of any regulatory action or other action concerning the safety of any Product or SOPHiAs Kit, including but not limited to FDA inspection reports, warning letters or import alerts.
14.2.Recall. SOPHiA shall be responsible for conducting any recall or other necessary corrective action regarding SOPHiA Kits incorporating the Products supplied hereunder.
14.3.Force Majeure Event. Neither party will be liable for any loss, damage or penalty as a result of any delay in or failure to manufacture, deliver, or otherwise perform hereunder due to acts of God, failures of supply of raw materials, civil disturbance, fires, terrorism, war, pandemic, or other catastrophic economic or natural events or any other act beyond either party's reasonable control (a "Force Majeure Event"). In a Force Majeure Event, the non-performing Party will be excused from any further performance or observance of the obligation so affected only for as long as such circumstances prevail and such Party continues to use commercially reasonable efforts to recommence performance or observance as soon as practicable. Any Party whose performance is delayed or prevented by a Force Majeure Event will promptly notify the other Party thereof, the anticipated duration of the non-performance and the action(s) being taken to over come or mitigate the delay or failure to perform.
14.4.Insurance. Each Party shall maintain a comprehensive commercial general liability/product liability insurance policy, with limits of not less than $[**] per occurrence, and $[**]in aggregate, for general liability and product liability.
14.5.Notices. All notices, requests, demands, claims and other communication under this Agreement shall be given in writing and shall be delivered in person or by courier, sent by electronic facsimile (fax), delivered by overnight delivery service, or mailed by certified or
registered mail, postage prepaid, return receipt requested, and addressed to a Party at the address set forth below or to such other address as shall be given in accordance with this Section 14.5. If notice is given in person, by courier, or by fax, it shall be effective upon receipt; if notice is given by overnight delivery service, it shall be considered to have been duly delivered one (1) business day after deposit with the delivery service, and if notice is given by mail, it shall be effective five (5) business days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one (1) business day after it is sent for next business day delivery via a reputable international courier service, in each case to the intended recipient as set forth below:
If to Watchmaker:
Watchmaker Genomics Attn: Business Development
5744 Central Avenue, Suite 100
Boulder, CO 80301
[**]
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
If to SOPHiA:
Sophia Genetics 172 rue du centre 1025, St-Sulpice Switzerland
legal@sophiagenetics.com
14.6.Assignment. Neither this Agreement nor any right or obligation hereunder may be assigned or otherwise transferred (whether voluntarily, by operation of law or otherwise) by SOPHiA to any Third Party, without the prior express written consent of Watchmaker. Watchmaker may, without consent but with notification, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its business or business unit to which this Agreement pertains, or in the event of its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement. Any purported assignment or transfer in violation of this Section 14.6 shall be void.
14.7.Applicable Law; Dispute Resolution. This Agreement shall be governed by the laws of the State of Delaware without regard to its conflicts of laws rules. The parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement. Any disputes, actions, claims or causes of action arising out of or in connection with this Agreement (or the Products) shall be subject to the exclusive jurisdiction of the state and federal courts located in Delaware.
14.8.Entire Agreement. This Agreement, together with its attached Exhibits, constitutes the entire, full, and complete agreement between the Parties concerning the subject matter hereof, and supersedes all prior agreements, negotiations, representations, and discussions, written or oral, express or implied, between the Parties in relation thereto.
14.9.Relationship of the Parties. The relationship of the Parties is that of independent contractors, and nothing herein shall be construed as establishing one Party or any of its employees as the agent, legal representative, joint venturer, partner, employee, or servant of the other. Except as set forth herein, neither Party shall have any right, power or authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other. Neither Party shall hold itself out as being the agent, legal representative, joint venturer, partner, employee, or servant of the other Party or as having authority to represent or act for the other Party in any capacity whatsoever, except as authorized herein.
14.10.No Amendment. This Agreement shall not be amended except by an instrument in writing executed by both Parties.
14.11.No Waiver. The Parties hereto mutually covenant and agree that no waiver by either Party of any breach of the terms of this Agreement shall be deemed a waiver of any subsequent breach thereof.
14.12.Headings. Headings used herein are for descriptive purposes only and shall not control or alter the meaning of this Agreement as set forth in the text.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
14.13.Severability. Should one or more of the provisions contained in this Agreement be held invalid, illegal or unenforceable by a court or tribunal with jurisdiction to do so, then the validity, legality and enforceability of the remaining provisions contained herein shall not be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affect the Parties' substantive rights. In such instance, the Parties shall use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
14.14.Counterparts. This Agreement may be signed in two or more counterparts, all of which together shall constitute one and the same Agreement, binding on the Parties as if each had signed the same document.
14.15.Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
WATCHMAKER GENOMICS, INC. SOPHiA GENETICS, INC.
Title: SIGNED Title: SIGNED
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Schedule 1
Pricing & Kit Configurations Library Preparation Kits
[**]
Schedule 2 Forecast
[**]
Exhibit A
Product Specifications, Shipping and Storage Conditions
[**]
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
EX-4.9
5
exhibit49microsoftagreement.htm
EX-4.9
Document
Supplemental Terms.
The parties agree that the following new sections are added to and amend the Agreement. All terms used but not defined in these sections will have the same meaning provided in the Agreement.
The parties agree these Supplemental Terms only apply to the signing entity, except as otherwise stated in the Agreement.
Azure Credit
Customer will receive a one-time Azure Credit (“Credit”) to be applied to Customer’s Azure credit balance and used during the validity term.
Credit amount and validity term is detailed in the Proposal. Microsoft is under no obligation to extend or renew this Credit.
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Case ID |
Credit Amount |
Credit Currency |
Credit Start Date |
Credit Duration in Months |
[**] |
[**] |
CHF |
On order
acceptance
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[**] |
End-Customer Investment Funding (External)
This amendment with respect to End-Customer Investment Funding (External) (“ECIF Amendment”) is entered into between Microsoft and the Customer. It amends the Agreement. All terms used but not defined in this ECIF Amendment will have the same meanings provided in the Agreement.
The parties agree the following new section is added to the Agreement:
To assist Customer in the productive use of Microsoft Products, including Online Services, Microsoft will provide Customer with the following consulting and product support services in an amount not to exceed the value indicated at no charge to Customer (collectively, the “No-Charge Services”):
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End Customer Fund Project Id #
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Products applicable for No Charge services |
Description of No-Charge Services
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Value
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Start Date (YYYY-MM- DD)
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Expiration Date
(YYYY-MM- DD)
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[***] |
Azure |
Deployment Planning Services |
[**]
CHF
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2022-11-01 |
[**] |
The No-Charge Services will be provided by a Microsoft supplier partner of Customer’s choice (the “Supplier”), provided that Customer shall be responsible for any costs for services provided by the Supplier that exceed the amount of the No-Charge Services. The amount(s) for No-Charge Services will be available starting on the applicable start date(s) indicated in the table above. The entire amount(s) for No-Charge Services must be used by the date(s) indicated in the table above; any amount for a particular No-Charge Service that is not used by the date indicated will expire and no longer be available to Customer after that date.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Microsoft and the Supplier. A copy of the SOW will be provided to the customer. Once the work is completed, in accordance with the terms of the ECIF SOW (including, but not limited to, proof or execution requirements), Microsoft will pay the Supplier up to the amount of the No-Charge Services.
To the extent the cost of the service(s) the Supplier provides to Customer exceeds the amount of the No-Charge Services (the “Service Overage Amount”), Customer shall pay the Supplier for such service(s) directly and shall indemnify Microsoft from any costs incurred due to a claim by Supplier against Microsoft related to any Service Overage Amount.
Microsoft waives any and all entitlement to compensation from Customer for the No-Charge Services amount and the service(s) procured with such funds. Microsoft intends that the grant of No-Charge Services amount and the service(s) procured up to such amount be in compliance with applicable laws and regulations with respect to gratuitous services. It is specifically understood that all Services and Services Deliverables resulting from the No-Charge Services are for the sole benefit and use of Customer and are not provided for the personal use or benefit of any individual employee of Customer.
To be valid, Customer must communicate its acceptance of this ECIF Amendment to Microsoft no later than 2022-10-31(YYYY-MM-DD).
Except for changes made by this ECIF Amendment, the Agreement remains unchanged and in full force and effect. If there is any conflict between any provision in this ECIF Amendment and any provision in the Agreement, this ECIF Amendment shall control.
Azure Commitment Discount
The parties agree that the following new sections are added to the Agreement:
1.Definitions
a.“Azure Commitment Discount” means the discount percentage that Microsoft will apply to Consumption Rates for Microsoft Azure Services. The percentage will be applied to US Dollar published prices on portal.azure.com in the current month’s pricelist in the month it is used.
b.“Azure Commitment Discount Coverage Period” means the period for which the Azure Commitment Discount will be applied to Consumption Rates for Microsoft Azure Services as set forth in the Proposal.
c.“Proposal” means the quote issued via email to Customer by the Microsoft sales team with Proposal ID # [**] containing the Azure Commitment Discount and the Azure Commitment Discount Coverage Period.
2.Azure Commitment Discount
Microsoft will provide the Azure Commitment Discount indicated in the Proposal during the Azure Commitment Discount Coverage Period as indicated in the Proposal.
Microsoft is under no obligation to repeat the offer herein.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Publicity
Activities. Provided Microsoft is meeting its obligations under the Agreement to Customer’s satisfaction, Customer agrees to participate in the following activities related to its use of Microsoft products, technologies or services. Each party reserves the right to publicly disclose the existence of the Agreement and may make press releases or public announcements regarding this Agreement or any matter covered by this Agreement in line with the guidelines specified herein.
a.Microsoft Press and Social Media: Press releases, blog posts, and/or social media posts issued by Microsoft to press, media, and the general public via public relations and social media channels in order to make a newsworthy announcement relating to why Customer has chosen Microsoft’s technology, and the business benefits Customer has realized or anticipates.
b.Customer’s Press and Social Media: Press releases, blog posts, and/or social media posts issued by Customer to press, media and the general public via Customer’s PR and social media channels in order to make a newsworthy announcement relating to Customer’s commitment to Microsoft’s technology solutions and the realized or anticipated business benefits.
c.Media and Analyst Interviews: Customer agrees to make executive level spokesperson (at VP level or above) available for media or influencer interviews with business reporters or analysts either in person or via phone (as mutually agreed by both parties) to drive media coverage
related to Customer’s choice of Microsoft’s technology, and the realized or anticipated business benefits.
d.Case Study and Story: A document/story written, video and/or video sharing Customer’s vision and the choice and use of Microsoft’s technology as an enabler, and the realized or anticipated business benefits. Subject to reasonable notice, Customer agrees to make executive level employees and/or officers (at VP level or above) available to provide interviews and/or quotes for use in such story and/or video. Microsoft may use these items in public-facing content such as a press release, quote sheet, Microsoft blog, advertising, or marketing collateral.
e.Industry and Microsoft Events: Microsoft may invite Customer to speak at and/or demonstrate technology solutions on-stage at industry and/or Microsoft events (e.g., Microsoft CEO Summit, Microsoft BUILD, Microsoft Ignite, Microsoft Envision, Microsoft Inspire) during keynotes or other event-related activities to describe the choice of Microsoft’s technology solutions and the realized business benefits, including by making executive level employees and/or officers (at VP level or above) available to participate in such speeches and/or demonstrations.
f.Customer reference: Enrolled Affiliate agrees to speak with potential Microsoft customers about Customer’s experience using Microsoft products, technologies or services.
3.Terms. The following terms apply to all materials created under this Amendment (“Materials”).
a.How. Microsoft may name Customer as a Microsoft customer. Microsoft may interview, tape,
videotape, and record selected Customer’s employees and/or contractors to gather information for creating Materials, subject to Customer’s prior review and written approval of any such interview, tape, videotape, and recording. Customer agrees to work with Microsoft to obtain sufficient permissions from any of its employees and/or contractors whose quotes, names, or pictures appear in the documentation, in order to grant the rights described in this Amendment.
b.Trademarks. Microsoft may display Customer’s name, company trademark, company logo, and other identifying information in Materials, in accordance with Customer’s trademark usage
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
guidelines or as approved by Customer during review of the Materials. Each party retains ownership of its respective trademarks, logos and other identifying information, with the goodwill from any use inuring to the owner’s benefit. Any potential use of Microsoft’s name, company trademark, company logo, and other identifying information in Materials by the Customer must be reviewed and approved by the local Microsoft PR representative prior to Customer use.
Customer agrees to provide Microsoft with approval or comments in writing in a timely manner. Customer will not withhold or delay approval unreasonably.
In contributing to any of the activities above, Customer agrees to only make statements about
their chosen Microsoft technology that reflect Customer’s honest beliefs, opinions, or experiences, and that Customer has a reasonable basis to believe are accurate. In addition, the Microsoft customer reference team will work with Customer to ensure that we disclose the nature of its affiliation with Microsoft and whether Customer has received any compensation for providing the customer reference Material.
c.Ownership. Except for any of Customer’s trademarks, service marks, logos, and other identifying information contained in Materials, Microsoft will own the Materials, and grants Customer a royalty-free, worldwide license to use and distribute the Materials for its own advertising and marketing efforts, provided that Customer notifies Microsoft prior to each new use or distribution of the Materials.
d.Distribution. In addition to specific uses noted in Section 1, both parties will have the right to publish, use, reference, and display the final, approved Materials, in whole or through unedited excerpts, in all forms of media now or hereafter known. This may include Microsoft’s websites, events, and social media channels. The foregoing rights may be sublicensed to third parties, for example: allowing channel partners to include case studies on their websites. Both parties agree that the content of the Materials will not be altered without prior written consent from the other party. Both parties also agree to stop distributing, publicly referencing, and displaying the Materials at any time upon written request from the other party, or any involved individual.
This amendment is effective either (i) on the start date set forth below; or (ii) if no start date is specified below, on the order acceptance date, and expires on the earlier of (i) the termination date of the Agreement; or (ii) the end date set forth below.
Start Date (YYYY-MM-DD): 2022-11-01
End Date (YYYY-MM-DD): [**]
Microsoft Azure Consumption Commitment
The parties agree to the following MACC Amendment:
1.Definitions
a.“MACC Amendment” means the below terms of this Microsoft Azure Consumption Commitment between Microsoft Corp. (“Microsoft”) and Customer.
b.“Microsoft Sales Affiliate” means Microsoft Schweiz GmbH.
c.“Coverage Period” means the period during which the terms of this MACC Amendment are in effect, unless terminated earlier pursuant to Section 6.
d.“Commitment” means the total amount Customer agrees to purchase from Microsoft, under Customer’s Eligible Organization, for the consumption of Eligible Services and Offerings (as defined in Section 3) during the Coverage Period. The Commitment is inclusive of all fees associated with Eligible Services and Offerings, as well as any Azure Prepayment.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
e.“Azure Prepayment” refers to the purchase of Microsoft Azure Prepayment made during the Coverage Period for its use of eligible Microsoft Azure Services.
f.“Eligible Organization” means the Customer and Affiliates (if any) included within the lead billing account.
g. “Concession” refers to any incentive or offer made by Microsoft that results in a reduction in fees paid by Customer for any Eligible Services and Offerings.
Table A
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Microsoft Azure Consumption Commitment |
Coverage Period |
Start Date
(YYYY-MM-DD):2022- 11-01
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Length of period (Months):60 |
End Date (YYYY-MM-
DD):2027-10-31
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Commitment |
[**] |
Currency |
CHF |
2.Commitment and Payment
Customer agrees to pay Microsoft for the consumption and/or purchase of Eligible Services and Offerings in an amount equal to or greater than the Commitment amount during the Coverage Period, as described in Table A.
All fees associated with Eligible Services and Offerings used by the Eligible Organization will apply against the Commitment at their net value before taxes but after Concessions have been applied, if applicable.
3.Eligible Services and Offerings
“Eligible Services and Offerings” under the Commitment include the following:
•Microsoft Azure Services as defined in the Microsoft Product Terms
•Microsoft Reservations
•Third party Azure software plans available via the Azure Reservations program
•Azure Marketplace and AppSource listing transacted through the Commercial Marketplace and identified via instructions provided through this website (or successor website): https://aka.ms/MACCAzureMarketplace
The following are excluded from Eligible Services and Offerings under the Commitment:
•Azure Support Plans
•Azure User Plans
•Azure Infrastructure Plans
•Any Microsoft Commercial Marketplace listings not identified via instructions provided through this website (or successor website): https://aka.ms/MACCAzureMarketplace
Note that Azure Prepayments made at any time within the Coverage Period will be applied against the Commitment. For Azure Prepayment amounts (if any), please reference the original quote.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Any consumption or purchase of Eligible Services and Offerings covered by credits will not be applied against the Commitment.
Details on eligible consumption against the Commitment are located here: https://aka.ms/trackMACC.
4.End of Term
Upon the expiration of the Coverage Period specified in Table A, if the full value of the Commitment has not been reached, Customer agrees to pay the difference, equal to (a) the Commitment minus (b) the total amount invoiced for Eligible Services and Offerings during the Coverage Period.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
5.Grace Period
At the end of Coverage Period, should Customer incur an invoice associated with not fulfilling
Customer’s full Commitment value, as described in Section 4 (End of Term), Microsoft agrees to the following:
•[**].
6.Termination
This MACC Amendment shall terminate at the conclusion of the Coverage Period. Neither party will terminate this MACC Amendment for convenience during the Coverage Period.
Microsoft may terminate this MACC Amendment for cause upon [**] days’ written notice to Customer if Customer is found to be in material breach of any terms of use with Microsoft (or Microsoft Sales Affiliate) and previously agreed to by Customer, provided that such breach is not cured by Customer within the [**]-day notice period.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Signature Form
Customer or Purchasing Affiliate hereby accepts the terms and conditions of the Microsoft Customer Agreement including but not limited to the General Terms, any supplemental terms and amendments, and all documents incorporated by reference (collectively, the “Agreement”) and agrees to be bound by the Agreement as presented by Microsoft.
Customer or Purchasing Affiliate consents to its acceptance of the Agreement by electronic means and understands that it may be required to accept the terms of an electronic signature service provider suggested by Microsoft.
The individual signing below represents that he or she is authorized to accept the Agreement on behalf of Customer or Purchasing Affiliate. The Agreement will take effect upon this acceptance by Customer or Purchasing Affiliate.
Customer
|
|
|
|
|
|
Legal Entity Name |
Sophia Genetics |
Address 1 |
Rue du Centre 172 |
Address 2 |
|
City |
St-Sulpice |
State |
VD |
Country |
Switzerland |
Postal Code |
1025 |
|
Customer Signatory
|
|
Signer First Name |
[**] |
Signer Last Name |
[**] |
Phone Number |
|
Signer Email |
[**] |
| Signature |
|
Signature Date (YYYY-MM-DD) |
Oct 28, 2022
|
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Microsoft Affiliate
|
|
|
|
|
|
Company Name |
Microsoft Ireland Operations Limited |
Signer Name |
[**] |
Signature |
[**] |
Signature Date (YYYY-MM-DD) |
2022-10-28 |
Company Name |
Microsoft Ireland Operations Limited |
Address 1 |
One Microsoft Place |
Address 2 |
South County Industrial Park |
City |
Dublin 18 |
State |
Dublin |
Country |
Ireland |
Postal Code |
D18 P521 |
Microsoft Sales Affiliate
|
|
|
|
|
|
Company Name |
Microsoft Schweiz GmbH |
Signer First Name |
[**] |
Signer Last Name |
[**] |
|
Signature
|
|
Signature Date (YYYY-MM-DD) |
Oct 28, 2022 |
Company Name |
Microsoft Schweiz GmbH |
Address 1 |
The Circle 02 |
Address 2 |
Flughafen |
City |
Zurich |
State |
|
Country |
Switzerland |
Postal Code |
CH 8058 |
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
EX-4.12
6
exhibit412swisscantoagreem.htm
EX-4.12
Document
Contrat de bail pour locaux commerciaux
entre
Swisscanto Anlagestiftung,
Zürich
p.A. PRIVERA AG
3073 Gümligen
CHE-107.853.547 TVA
représenté par: PRIVERA SA
Route de Pré-Bois 20 1215 Genève
dénommé ci-après bailleur
dénommé ci-après représentant
et
Sophia Genetics SA Rue du Centre 172 1025 St-Sulpice
dénommé ci-après locataire(s)
concernant la location de locaux au sein de l'immeuble ZA La Pièce 12, 1180 Rolle
38001.03.420001.04
2.1Situation et dimensions 3
2.2Paiements des loyers 4
a i
2.3Façades, toitures et locaux communs 4
2.4Calcul des surfaces 4
3.1Type d'utilisation 4
a t , o c a
3.2Utilisation par des tiers 4
4Début du bail, durée du bail, droit d'option, prolongation et résiliation 5
4.1Début du bail 5
4.2Durée du bail/résiliation 5
4.3Résiliation anticipée 5
4.4Droit d’option 5
5.1Loyer de base à la conclusion du contrat 5
5.2Adaptation du loyer après le début du bail 5
5.3Frais accessoires 6
5.4Intérêts moratoires 6
5.5Taxe sur la valeur ajoutée 7
5.6Impôts, taxes et redevances 7
6.1Etat et usage de la chose louée 7
6.2Assurance / surveillance 10
6.3Enseignes d'entreprises, enseignes publicitaires lumineuses, inscriptions et activités publicitaires10
6.4Parkings 10
6.5Entretien à charge du locataire 11
6.6Remise des clés 11
6.7Droit de visite 11
6.8Sous-location 11
6.9Transfert du bail 12
9Dispositions finales 13
9.1Sûretés contractuelles 13
9.2Eléments faisant partie intégrante du contrat de bail 13
9.3Modifications du contrat 13
9.4Obligation de renseigner 13
9.5Notifications 13
9.7For et droit applicable 13
9.8Droit de préemption 14
9.9Surfaces communes bâtiment B2 14
9.10Validité du contrat 14
9.11Version du contrat 14
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
1Termes employés
Indépendamment de la forme de l'entreprise, du sexe et du nombre de personnes respectivement d'entités juridiques que comprend une partie, pour des raisons de lisibilité, les termes génériques
«Bailleur», «Représentant» et «Locataire» seront utilisés dans ce contrat.
2Chose louée
2.1Situation et dimensions
Le bailleur loue au locataire la surface (brut) décrite ci-après dans l'immeuble commercial mentionné, dont la situation et les dimensions sont encadrés en couleur sur les plans ci-joints (annexes 1 et 2). L'état et la nature de la chose louée sont également consignés dans la description jointe (annexe 4). Les surfaces mentionnées sont des valeurs indicatives et peuvent diverger des surfaces réelles. Tout éventuel écart n'influence ni le loyer déterminant, ni la clé de répartition des frais accessoires.
Le locataire loue un total de 3'600.00 m2 dans le bâtiment B2 à A-ONE, la location va se faire selon le tableau, ci-dessous :
Dès le 1er juillet 2021, le locataire Sophia Genetics SA loue une surface de 1'100.00m² au 2ème étage du bâtiment B2 aux conditions suivantes :
[**]
Dès le 1er janvier 2022, le locataire Sophia Genetics SA loue une surface supplémentaire de
700.00 m² au 2ème étage du bâtiment B2 aux conditions suivantes :
[**]
Enfin, dès le 1er février 2023, le locataire Sophia Genetics loue une nouvelle surface de 1'800.00 m²
au 1er étage du bâtiment B2 aux conditions suivantes
[**]
2.2Paiements des loyers
Le loyer est payable par mois d'avance au 1er jour du mois, au plus tard le premier de chaque mois et la première fois au prorata au début du bail.
A la signature du présent contrat le locataire dispose d’une gratuité de loyer comme suit :
[**]
▪.
2.3Façades, toitures et locaux communs
Le droit d'utilisation des murs, des façades, des toitures et de tous les locaux communs qui délimitent les espaces locatifs (murs de séparations des surfaces, fenêtres, gaines techniques, locaux techniques) revient exclusivement au bailleur.
2.4Calcul des surfaces
Le calcul des surfaces se fait d'un axe à l'autre, milieu des murs séparateurs et divisions, respectivement distance intérieure des surfaces générales. Ainsi calculées, les mesures de surface à la base de ce contrat sont considérées comme acceptées par les deux parties.
3Affectation / Obligation d'utilisation
3.1Type d'utilisation
Pendant toute la durée du contrat, le locataire est à la fois en droit et obligé d'utiliser et d'exploiter la chose louée comme suit : Bureau et laboratoire.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
La description de l'affectation fixe ainsi de manière contraignante le droit d'utilisation du locataire, mais ne décrit pas, en revanche, l'état dans lequel le bailleur doit mettre la chose louée au moment du début du bail.
3.2Utilisation par des tiers
La sous-location partielle ou intégrale de la chose louée (art. 262 CO) et le transfert du bail à un tiers avec toutes les obligations et droits qui y sont liés (art. 263 CO) sont uniquement permis avec le consentement préalable écrit du bailleur.
4 Début du bail, durée du bail, droit d'option, prolongation et résiliation
3.1Début du bail
Le bail commence le 1er juillet 2021. A partir de cette date, les frais accessoires et les loyers des places de parc sont dus.
La chose est louée au locataire conformément à la description de la chose louée et aux plans. Lors de la remise des clés, les éventuels défauts de la chose louée sont consignés dans l'état des lieux qui doit être signé par les deux parties. Si d'autres défauts apparaissent, en plus de ceux consignés dans l'état des lieux, le locataire est tenu de faire valoir ces derniers par écrit dans les 60 jours à partir de la remise des clés. En cas d'omission, il sera présumé que le locataire a repris la chose louée dans un état approprié à l'usage pour lequel elle a été louée et sans défaut.
3.2Durée du bail/résiliation
Le bail est conclu pour une durée de 10 ans, soit du 1er juillet 2021 au 30 juin 2031. Le bail prend fin à cette date sans qu’aucune résiliation ne soit nécessaire. La date de fin du bail est identique pour l’ensemble des surfaces, mêmes si ces dernières sont louées à des dates différentes.
3.3Résiliation anticipée
Le locataire a la possibilité unilatérale de résilier le présent contrat après 8 ans de location, soit au 30 juin 2029, moyennant un préavis écrit adressé 12 mois à l’avance. En cas de résiliation anticipée du présent contrat, le locataire s’engage à payer une pénalité de [**] en faveur du bailleur.
3.4Droit d’option
Un droit d’option permettant de prolonger le bail aux mêmes conditions est concédé au locataire.
S'il souhaite faire usage de ce droit, le locataire doit communiquer son intérêt au bailleur par écrit au plus tard 14 mois avant l'échéance du bail à loyer, soit le 28 février 2030 au plus tard.
5Loyer et frais accessoires
5.1Loyer de base à la conclusion du contrat
A la conclusion du contrat, le loyer annuel net s'élève à [**]
Dès le 1er janvier 2022, le loyer annuel net s’élève à [**]
Dès le 1er février 2023, le loyer annuel net s’élève à [**]
5.2Adaptation du loyer après le début du bail
5.2.1Généralités
Le loyer de base valable au début du bail sera adapté annuellement à l'indice suisse des prix à la consommation de l'Office fédéral de la statistique.
Clause d’indexation : 100% du loyer minimum valable au début du bail seront adaptés annuellement selon la formule suivante de l'indice suisse des prix à la consommation de l'Office fédéral de la statistique
loyer de base x nouvel indice = nouveau loyer dû indice de base
En tant qu'indice de base, on prendra l'indice décembre 2020 de 100.9 point (base 2015 = 100 points).
La première adaptation du loyer de base sera effectuée le 1er juillet 2022. D'autres adaptations pourront suivre une fois par an, à chaque fois au début d'un mois au choix.
5.3Frais accessoires
5.3.1Généralités
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Tous les frais accessoires mentionnés ci-après ne sont pas inclus dans le loyer de base et doivent être payés en supplément par le locataire. Le locataire doit anticiper un acompte de ces frais accessoires jusqu'au 1er de chaque mois de [**] excl. TVA et pour la première fois au prorata du début du bail.
Dès le 1er janvier 2022, les frais accessoires mentionnés ci-après s’élèvent à [**]
Dès le 1er février 2023, les frais accessoires mentionnés ci-après s’élèvent à [**]
Font partie des frais accessoires:
•frais de chauffage et d'eau chaude selon art. 5 OBLF Coûts d'exploitation:
•Eaux usées (y c. émoluments de base)
•Protection incendie
•Surveillance des bâtiments
•Sécurité / Alarmes
•Lignes téléphoniques + interphones
•Matériel de conciergerie
•Conciergerie (y.c. Service FM, piquet, surveillance des installations techniques, rondes de contrôle)
•Ordures (y c. émoluments de base)
•Ascenseurs
•Gestion du système d’accès de la zone commune, Building Management System (« BMS », gestion et entretien)
•Nettoyage canalisation
•Électricité générale
•Eau (y c. émoluments de base)
•Nettoyage (y c. fenêtres, façades et déneigement)
•Entretien installation de détartrage
•Tous les coûts occasionnés par l'exploitation de la chose louée, de ses surfaces communes ou publiques et de ses installations d'infrastructure, pour l'utilisation, la consommation, le nettoyage et l'entretien:
Portails et portes automatiques
Service d'abonnement pour contrôles du toit
Coûts de décompte (hors TVA)
•Honoraires de gérance, notamment la gestion financière, locative et administrative et technique ainsi que la gestion des frais accessoires et du service des immeubles les frais de publicité communs et les cotisations pour l'association d'intérêt etc. ne relèvent pas des frais de charges et sont facturés séparément.
5.3.2Décompte
Le bailleur établit annuellement un décompte des frais accessoires effectifs dont le solde est à régler dans les 30 jours suite à la présentation du décompte. Sur la base du décompte, le bailleur est autorisé à fixer un nouveau montant pour les acomptes et ce, également pendant la durée minimale de contrat.
Le décompte, respectivement la répartition des frais accessoires sur les différents locataires, est établi selon une clé de répartition fixée par un spécialiste.
Après s'être annoncé auprès du bailleur, le locataire est autorisé à consulter le décompte global avec les justificatifs de facture pendant 30 jours à partir de la facturation durant les horaires habituels de bureau. Si aucune opposition n'est faite par écrit pendant ce délai légal, le décompte global est considéré comme reconnu.
5.4Intérêts moratoires
Les dates de paiement convenues et susmentionnées sont des dates d’échéances, à partir desquelles le locataire tombe en demeure de paiement si les paiements ne sont pas réglés. Dans ce cas, l’intérêt moratoire s’élève à [**].
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
En supplément, le locataire doit également rembourser au bailleur les frais de rappel de [**] au maximum.
5.5 Taxe sur la valeur ajoutée
La surface locative est assujettie à la taxe sur la valeur ajoutée (TVA), conformément à l'art. 22, al. 1 LTVA. La TVA sera prélevée sur le loyer convenu et les frais accessoires à son taux actuellement en vigueur (à partir du moment où l'assujettissement entre en vigueur). En cas de modification du taux de TVA, le bailleur est en droit de faire valoir les adaptations correspondantes du loyer au moment où cette modification entre en vigueur.
5.6 Impôts, taxes et redevances
Le locataire doit s'acquitter séparément des impôts, taxes, redevances, frais d'électricité, de gaz et de téléphone ainsi que tout autre coût découlant exclusivement de son exploitation. Les taxes de raccordement pour l'eau, l'électricité, la canalisation, etc. qui sont également dus aux aménagements pour les locataires sont également à régler par le locataire.
6Aménagement et usage de la chose louée
6.1Etat et usage de la chose louée
6.1.1Etat
La chose est louée au locataire en l'état brut. Le locataire accepte l’état de la chose louée conformément à la visite des locaux du 4 novembre 2020 (surface du 2ème étage). Les surfaces du 1er étage et rez-de-chaussée sont louées brut. Il a été tenu compte de cette circonstance lors du calcul du loyer de base. La description du bien loué qui fait partie intégrante du présent contrat de bail (annexe n°4) délimite de manière significative les coûts entre le bailleur et le locataire, en termes d'aménagement, d'entretien et de rénovation de la chose louée. Les prestations incombant au bailleur selon la description du bien loué sont/seront au plus tard intégralement fournies au moment de la remise de la chose louée. Sont considérés comme aménagements pour les locataires, les aménagements allant au-delà de la description de la chose louée et des aménagements de base qui y sont définis, même s'ils existaient déjà au moment de la remise de la chose louée (par exemple aménagement de l’ancien locataire repris par le nouveau locataire). Tous les coûts occasionnés par les aménagements pour les locataires, leur entretien et leur remise en état éventuellement exigée par le bailleur à échéance du rapport contractuel sont en tous cas exclusivement à charge du locataire. Le bailleur demande au locataire de remettre en état initial lors de son départ uniquement le laboratoire. Tout le reste de l’aménagement peut rester en état.
6.1.2Devoir de diligence et de tolérer
Le locataire est tenu d’user de la chose avec le soin nécessaire, dans le sens de l'art. 257f CO et en particulier, de le maintenir en bon état et propre. Il est tenu de verser des dommages-intérêts en cas de dommages dus à une utilisation impropre et non occasionnés par la force majeure. Le locataire doit déclarer immédiatement au propriétaire les défauts dont la réparation ne lui incombe pas. En cas d'omission, il est responsable des dommages qui en découlent. Le locataire s'engage à respecter les dispositions du règlement intérieur édicté par le bailleur qui règle, entre autres, la livraison, l'utilisation des ascenseurs, l'enlèvement des ordures, etc. Le locataire est tenu de tolérer sans dédommagement la conduite de canaux, tubes, câbles, etc. installés dans le plafond et le plancher.
6.1.3Affectation
L'utilisation et l'affectation de la chose louée s'orientent exclusivement aux dispositions de ce contrat et ne peuvent pas être modifiées en l'absence d'une approbation préalable écrite du bailleur. Les droits et besoins des autres locataires doivent être pris en compte dans la juste mesure.
6.1.4Voies d'évacuation et abris
Les voies d'évacuation doivent être en tout temps dégagées. Les abris utilisés à des fins étrangères à celle de la protection civile (entrepôts, archives, etc.) doivent toujours pouvoir être libérés dans les 24 heures pour la protection civile. Il est interdit de modifier les installations existantes dans les abris.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.1.5Responsabilité pour les atteintes à l'environnement
Si le locataire occasionne des atteintes à l'air, à l'eau (eaux de surface et souterraines, système de canalisation), au sol, à la flore et à la faune ou à la chose louée, en particulier à travers des salissures, contamination ou autres charges liquides, gazeuses ou solides, ou d'une autre manière, ce dernier est responsable de toutes les conséquences et de tous les coûts qui en découlent. Sont en particulier concernés toutes les dépenses, mesures de protection et de sécurité, coûts de remise en état, coûts consécutifs à l'interruption de l'exploitation ainsi qu'à d'autres dommages corporels et matériels liés directement ou indirectement à l'élimination/l'enlèvement/le rétablissement de l'état conforme.
La responsabilité convenue ci-avant s'applique également dans les cas où le bailleur répond des suites d'une atteinte à l'environnement ou peut être rendue responsable en raison de dispositions légales existantes.
Si dans une procédure juridique, des droits - à quelque titre que ce soit - sont fait valoir contre le bailleur dans le sens des paragraphes ci-avant, le locataire s'engage à le soutenir le mieux possible pendant la procédure.
6.1.6Modifications de la chose louée
Si le locataire souhaite rénover ou modifier lui-même la chose louée ou des installations à l'intérieur de la chose louée, il a besoin pour ce faire du consentement écrit du bailleur (art. 260 a al. 1 CO). Le bailleur peut subordonner le consentement correspondant à la constitution d'une garantie. Le montant de la garantie dépend du montant total du devis des travaux de transformation.
Si le locataire a l'intention d'entreprendre des aménagements au sein de la chose louée ou à la chose louée pendant la durée du bail, celui-ci est tenu de demander le consentement écrit du bailleur avant d'entamer les travaux correspondants. Pour ce faire, le bailleur doit avoir reçu tous les documents nécessaires à l'évaluation des travaux au moins deux mois avant leur démarrage prévu, en particulier des plans à l'échelle 1:50, une description des travaux structurés selon les positions CFC ainsi qu'un devis. Le bailleur est autorisé à refuser son consentement sans avoir à justifier sa décision ou de subordonner celui-ci à la constitution d'une garantie dans le sens du règlement. Si le consentement est donné, il est considéré
comme convenu le bailleur concède le droit au locataire de laisser en état son aménagement des bureaux y compris la boardroom. Cependant, le locataire s’engage à remettre en état initial (suppression des aménagements spécifiques tél que le monobloc en toiture existant en toiture, ventilation supplémentaire, cloisons spécifiques Clestra ou placo plâtre, installation supplémentaire de l’électricité, remise en état partiel à la suite de la dépose des faux-plafonds et sprinkler) la zone du laboratoire qui va se situer au 2ème étage de l’immeuble.
que le locataire, à échéance du bail, renonce à tout dédommagement même si les modifications apportées après coup à la construction pourraient représenter une plus-value.
Chaque projet de construction nécessite la conclusion d'une assurance responsabilité civile du maître d'ouvrage. Le bailleur est en droit, là où des interventions sont entreprises dans les parties communes du bâtiment, en particulier dans le domaine de la statique, des installations et de l'enveloppe du bâtiment, d'imposer les planificateurs et/ou entrepreneurs et les produits/systèmes. Il est interdit d'altérer la statique du bâtiment. Tout écart des prescriptions du bailleur ou des spécialistes qu'il a désignés est à présenter pour autorisation au bailleur avec, en pièce jointe, l'expertise d'un ingénieur correspondant.
Si les travaux de rénovation ou de modifications concernent les installations électriques, le locataire est tenu de faire parvenir spontanément au bailleur le rapport de sécurité correspondant d'un installateur électrique homologué, une fois les travaux terminés. Les coûts ainsi occasionnés sont à charge du locataire.
Dans le cas où le rapport de sécurité n'aura pas été présenté même après un délai imparti par écrit par le bailleur, ce dernier est en droit de charger, sans notification précédente, un spécialiste de son choix du contrôle des questions de sécurité et de l'établissement des documents nécessaires au rapport de sécurité et ce, aux frais du locataire.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.1.7Respect des dispositions juridiques émises par les autorités
Si le consentement aux aménagements spécifiques au locataire dépend du respect des dispositions juridiques ou des dispositions émises par les autorités et si ces aménagements nécessitent d'autres mesures de construction ou autres, par exemple, pour des raisons relevant de la police du feu, de la technique de sécurité, de l'écologie ou pour d'autres raisons (portes de secours, installations sprinkler, système de détection d'incendie, utilisation d'installations et de matériaux écologiques prescrites et enlèvement d'installations ou de matériaux nuisant à la santé tels que l'amiante, etc.), tous les coûts et frais y afférents seront exclusivement à charge du locataire. A la fin du contrat, aucun dédommagement ne sera dû par le bailleur et ce, même si les mesures correspondantes ne sont pas inversées.
6.1.8Exécutions des aménagements spécifiques au locataire
Le locataire s'engage à faire exécuter et entretenir dans les règles de l'art tout éventuel aménagement spécifique ainsi que de le faire surveiller par un spécialiste. Il s'engage, en particulier, à garantir le respect de toutes les dispositions légales (par ex. concernant la sécurité, la protection incendie, les nuisances sonores, la protection de l'environnement, etc.), des normes et directives spécifiques à la branche (normes SIA et DIN, prescriptions SUVA, etc.) et des règles généralement reconnues en matière de construction.
La capacité maximale de charge du sol ne doit pas dépasser 460 kg/m2 (charge maximale au niveau du béton et non faux-plancher). Le locataire répond de tout dommage corporel et matériel dû au manquement à cette obligation.
6.1.9Prise en compte des intérêts de tiers
Lors de l'exécution ou de l'entretien de travaux pour les aménagements spécifiques au locataire, il faut, par ailleurs, tenir compte le mieux possible des intérêts des autres locataires ou des autres utilisateurs de l'immeuble locatif.
6.1.10Garantie pour les aménagements spécifiques au locataire
Le locataire s'engage à garantir le montant prévu par le devis pour les aménagements spécifiques planifiés - ou l'acompte défini par le bailleur - par une garantie bancaire d'une grande banque suisse de renom. Cette garantie bancaire doit être valable au moins 24 mois après la date de fin des travaux des aménagements spécifiques au locataire. La banque garantissant le montant sera libérée de son obligation par une déclaration écrite du bailleur, lorsque le locataire prouvera par écrit que toutes les factures des entreprises mandatées concernant les aménagements spécifiques du locataire ont été payées.
6.1.11Hypothèque légale des artisans et entrepreneurs
Le locataire s'engage, dans le cas d'inscription d'hypothèque légale des artisans et entrepreneurs, conséquente à son mandat d'exécution des aménagements spécifiques au locataire de faire radier cette hypothèque légale du registre foncier, par exemple, en fournissant des garantis. L'engagement correspondant existe d'ores et déjà au stade de l'inscription provisoire et de toute hypothèque légale des artisans et entrepreneurs.
Le bailleur est en droit de résilier le contrat à titre exceptionnel et à faire valoir des dommages- intérêts si le locataire contrevient à son obligation de radiation de l'inscription d'hypothèque légale des artisans et entrepreneurs nonobstant sommation écrite du bailleur avec fixation d'un délai.
6.1.12Contribution du bailleur aux travaux du locataire
Le bailleur participe à hauteur total maximum de [**] inclus TVA pour l’ensemble des aménagements du locataire. Le paiement de la contribution sera effectué après l’exécution des travaux sur facture ainsi qu’une confirmation écrite de l’architecte du locataire qui confirme que le paiement des fournisseurs a été effectué pour les travaux d’aménagement du locataire. Le paiement sera échelonné par étage.
•Participation du bailleur sur les surfaces du 2ème étage, le montant de la participation est de
[**]
•Participation du bailleur sur les surfaces du 1ème étage, le montant de la participation est de
[**]
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.2Assurance / surveillance
6.2.1Responsabilité
Le bailleur conclut à ses frais, les assurances usuelles de responsabilité civile et de choses pour l'immeuble.
Les assurances pour l'exploitation de son affaire, telles que vol, responsabilité civile, interruption d'exploitation, personnel et mobilier ainsi que les assurances pour l'entreposage des marchandises, etc. doivent être conclues par le locataire et sont à sa charge. La conclusion d'une assurance responsabilité civile est obligatoire. Sur demande du bailleur, le locataire s'engage à conclure une assurance responsabilité civile et de documenter le versement ininterrompu des primes correspondantes. De même, tous les autres investissements et installations payés et réalisés directement par le locataire sont à assurer. Les adaptations des primes de l'assurance immobilière progressive directement conséquente aux aménagements spécifiques au locataire sont proportionnellement à la charge du locataire.
Le bailleur ne porte aucune responsabilité pour les étalages, inscriptions sur les vitrines, grilles à enroulement, vitres, revêtements de parois en verre, enseignes d'entreprises, enseignes lumineuses, etc. Il incombe au locataire de s'assurer suffisamment contre de tels dommages. Le locataire est seul responsable de la sécurité (effraction, vol) et de la surveillance des locaux loués.
6.2.2Délimitation entre bâtiment et mobilier
Les normes des établissements cantonaux d'assurance bâtiment en vigueur actuellement sont déterminantes dans la délimitation entre bâtiment et mobilier. En cas d'ambiguïté, le procès-verbal d'expertise des établissements cantonaux d'assurance bâtiment est déterminant.
6.3Enseignes d'entreprises, enseignes publicitaires lumineuses, inscriptions et activités publicitaires
6.3.1Signalisation et inscription
Les enseignes d'entreprises et publicitaires, les affiches, vitrines, etc. ne peuvent être installées qu'après accord du bailleur et uniquement dans des emplacements du bâtiment déterminés par le bailleur. Les coûts sont à charge du locataire. Le bailleur décide de la couleur, de la taille, de l'ordre des panneaux, étant entendu que ce dernier tiendra compte, dans la mesure du possible, des souhaits du locataire. Le locataire doit utiliser de préférence les inscriptions originales de son entreprise. En cas de remise en état ou de modification des façades et autres murs, le locataire doit assumer à ses propres frais l'enlèvement et le remontage des plaques et inscriptions.
Les demandes pour l'obtention d'autorisations officielles éventuellement nécessaires sont à présenter au bailleur pour signature. Tous les coûts et redevances qui y sont imputables sont à charge du locataire qui devra également payer les coûts de raccordement et l'éventuelle consommation d'électricité.
Le locataire est tenu de participer aux frais de panneaux de signalisation et de tours publicitaires éventuellement installés pour l'orientation générale des clients et de prendre en charge la part des coûts correspondants.
6.3.2Autres activités publicitaires
Les ventes, actions publicitaires et expositions hors des surfaces louées nécessitent l'accord du bailleur et éventuellement des autorités.
A l'extérieur de la chose louée, il est interdit d'installer et d'utiliser les installations de radio, télévision, vidéo et haut-parleurs sans le consentement du bailleur.
Dans sa publicité, le locataire est tenu de mentionner l'immeuble dans son intégralité et d'utiliser l'emblème officiel dans cette dernière.
6.4Parkings
Dans la mesure où un garage payant est à disposition des clients de l'immeuble commercial, les coûts de son utilisation, surveillance, nettoyage et entretien sont supportés par le bailleur ; ses revenus appartiennent au bailleur.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.5Entretien à charge du locataire
Le locataire est tenu de maintenir la chose louée, les installations et équipements qui s'y trouvent ainsi que les surfaces et installations communes qu'il utilise dans un état correct et propre.
L'entretien, la maintenance, la réparation, la rénovation et le remplacement des installations techniques propres au locataire incombent au locataire.
Le locataire doit garantir l'entretien régulier selon les recommandations du constructeur des installations, machines et appareils qui servent à lui seul et en assumer les frais.
6.5.1Attribution de mandats
Les travaux d'entretien et de réparation à la chose louée, en particulier des installations et équipements qui en font partie (également à l'extérieur de la chose louée) et qui sont ordonnés par le locataire doivent être réalisés par des spécialistes confirmés.
Le bailleur, respectivement la gérance qu'il a mandaté, doit être informé sur la nature, l'étendue et la durée des travaux avant leur exécution.
6.5.2Petites réparations
Le locataire doit, conformément à l’usage local, remédier à ses frais aux défauts qui peuvent être éliminés par les menus travaux de nettoyage ou de réparation indispensables à l’entretien normal de la chose (Art. 259 CO).
6.5.3Autorisations de construction et de la police du commerce
L'obtention de toutes les autorisations spéciales nécessaires à l'exploitation du locataire incombe au locataire qui prendra également en charge les coûts qui y sont liés.
6.6Remise des clés
Toutes les portes donnant sur l'extérieur sont équipées de cylindres de sécurité. Lors de la remise de la chose louée toutes les clés par cylindre de sécurité seront remises aux locataires. Toute clé supplémentaire est à charge du locataire. Le jour de la restitution de la chose louée, le locataire est tenu de remettre toutes les clés. En cas de perte de clé, le locataire est responsable de l'ensemble des frais découlant des modifications du plan de fermeture général de l'immeuble commercial.
6.7Droit de visite
S'il respecte un délai d'annonce de 24 heures, il est permis au bailleur d'inspecter les locaux pendant les horaires d'ouverture, lorsque cet examen est nécessaire à la protection des droits de propriété et à une location ultérieure.
6.8Sous-location
6.8.1Autorisation
La sous-location partielle ou complète des locaux requiert le consentement écrit du bailleur. Le bailleur ne peut refuser son consentement que pour de justes motifs, conformément aux dispositions de l'art. 262 CO. Les motifs de refus sont, entre autres, des modifications dans l'assortiment ou dans l'assujettissement à la TVA.
Le locataire s'engage à convenir de la sous-location par écrit, étant entendu que le sous-locataire sera soumis à toutes les obligations découlant de ce contrat, en particulier également celles concernant le calcul et la notification du chiffre d'affaires. Un exemplaire du contrat de sous- location doit être remis au bailleur.
6.8.2Responsabilité
Même en cas de sous-location, le locataire assume l'entière responsabilité quant au respect de l'ensemble des obligations contractuelles, en particulier en matière d'affectation de la chose louée et au paiement intégral du loyer, des frais annexes et des contributions publicitaires à l'association des locataires.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
6.9Transfert du bail
Si le locataire a l'intention de transférer le bail à un tiers, il doit joindre à sa demande de consentement les indications complètes de son successeur (extrait du registre du commerce et du registre des poursuites, etc.) ainsi que tous les accords et dispositions accessoires conclus avec ce dernier). Au demeurant, l'art. 263 CO sera appliqué.
Le bailleur est en droit de refuser son consentement au transfert de bail, en particulier si le nouveau locataire veut changer l'affectation permise de l'objet loué ou si, en vue de l'affectation visée, des modifications doivent être entreprises au niveau de la construction.
Il est interdit de convenir d'une commission (« pas-de-porte ou key money » ou autre dédommagement similaire pour le transfert du contrat de bail sans contrepartie adéquate). Si un tel accord est néanmoins pris, celui-ci autorise le bailleur à refuser son consentement au transfert. Si le bailleur n'apprend que successivement qu'un tel dédommagement a été convenu et/ou versé, ce fait représente une raison importante de résiliation extraordinaire du contrat vis-à-vis du locataire actuel. Toutes autres demandes de dommages-intérêts restent expressément réservées.
7Restitution de la chose louée
Le bailleur autorise le locataire Sophia Genetics à laisser en état d’aménagement du locataire la partie des surfaces bureaux y compris la boardroom, cependant une remise en état initial doit être faite pour la partie du laboratoire (remise en état détaillée dans l’article 6.1.6) sauf discussion ultérieure avec le propriétaire quant à la remise en état de ce dernier et ceci sans aucun frais supplémentaire pour le bailleur. La chose louée doit être remise nettoyée. Les inscriptions du locataire sont à faire enlever par un spécialiste.
Si le locataire contrevient à son obligation de restituer la chose louée en temps voulu dans l'état conforme au contrat, le bailleur n'est pas tenu de fixer un délai supplémentaire permettant au locataire de satisfaire à son obligation de restitution. Sans faire appel à l'autorisation d'un juge, ce dernier est autorisé à faire entreprendre les travaux et mesures nécessaires pour le rétablissement de l'état mentionné aux frais du locataire. Toutes autres demandes de dommages- intérêts restent expressément réservées, en particulier l'obligation de verser une somme correspondante au loyer jusqu'à la remise en état conforme au contrat ou à la relocation des locaux. Le locataire répond également des éventuels dommages allégués par le nouveau locataire en raison du retard ou si ce dernier exerce son droit de se départir du contrat.
8Résiliation extraordinaire du contrat
Outre les cas de résiliation extraordinaire du contrat prévus par la loi, le bailleur est en droit de résilier le contrat à la fin du mois suivant, sous réserve de respecter un délai de 30 jours, après avertissement écrit resté sans effet en cas de violation des droits suivants par le locataire :
modification de l'affectation de la chose louée sans consentement du bailleur
violation de l'obligation de libération de l'inscription d'hypothèque légale des artisans et entrepreneurs
violation de l'obligation d'entretenir de manière réglementaire les aménagements spécifiques au locataire
sous-location entière ou partielle de la chose louée sans consentement du bailleur (chiffre 7)
Si le bail est résilié avec anticipation en raison de circonstances imputables au locataire (art. 257 d, 257f, 264; 266g CO et les faits mentionnés plus haut), ce dernier répond de l'ensemble des dommages qui en découlent, en particulier du loyer jusqu'à relocation, de l'éventuelle différence de loyer jusqu'à la prochaine date de résiliation possible, des frais de gestion extraordinaire, des coûts d'insertion ordonnés par le bailleur en vue de la réduction du dommage et des dommages y relatifs.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
Le locataire s'engage à fournir une première garantie bancaire d'une grande banque suisse de renom d'un montant de [**] pour les surfaces du 2ème étage. Suite à la location de la surface supplémentaire du 1er étage, le locataire s’engage à fournir une nouvelle garantie bancaire de [**] pour satisfaire à toutes les prétentions du bailleur découlant du présent contrat. Cette garantie bancaire doit être valable encore au moins 12 mois après la première date possible de résiliation (y c. de modification due à l'exercice de droits d'option éventuellement concédés ou d'accord).
9.1.2 Date de la fourniture
Le certificat original de la garantie bancaire mentionnée doit être remis au bailleur à la signature du bail.
3.2Eléments faisant partie intégrante du contrat de bail
Les documents suivants ci-joints font partie intégrante du présent contrat de bail :
[**]
3.3Modifications du contrat
Les modifications et avenants au présent contrat de bail et à ses parties intégrantes nécessitent la forme écrite. Cette disposition vaut également pour l'annulation de la nécessité de la forme écrite.
3.4Obligation de renseigner
Le locataire est tenu de notifier immédiatement au bailleur toute modification de nature juridique et économique qui influence de manière déterminante la structure de l'entreprise. Tous les documents dont le bailleur a besoin doivent lui être mis gratuitement à disposition.
3.5Notifications
Jusqu'à révocation par lettre recommandée au bailleur, l'adresse suivante est considérée être l'adresse du domicile de notification juridiquement valable du locataire :
Adresse du domicile de notification du locataire :
Sophia Genetics SA Rue du Centre 172 1025 St-Sulpice
Conformément à ce contrat, les notifications des parties liées à un délai sont considérées comme remises en temps voulu lorsqu'elles ont été remises à la partie adverse ou qu'elles peuvent être retirées à l'office de poste par la partie adverse le dernier jour avant que ne commence à courir le délai. Sont exclues de ce règlement la menace de résiliation de bail en cas de retard de paiement (art. 257d CO) et autres adaptations de loyer / autres modifications unilatérales du contrat (art. 269 d CO) pour lesquelles la remise effective ou le 7e jour du délai de retrait à l'office postal sont déterminants pour la notification.
3.6Clause de sauvegarde
L'invalidité ou l'inapplicabilité de certaines dispositions de ce contrat n'affecte pas la validité du contrat dans son ensemble. La disposition invalide sera remplacée par une disposition qui se rapproche le plus possible de l'objectif économique et juridique de la disposition d'origine non exécutoire.
3.7For et droit applicable
Seul le droit suisse est applicable. Dans la mesure où le présent contrat ne contient pas de dispositions ou qu'il ne contient pas de dispositions divergentes, les dispositions 253 et suivantes, relatives au loyer, du Code des obligations sont applicables.
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
3.8Droit de préemption
En cas d’intérêt ferme du locataire quant à la location d’une surface d’environ 1'975 m2 au rez- de-chaussée (annexe 3) du bâtiment B2 pour un montant de CHF 250.00/m2/an pour le 1er décembre 2024. Cette dernière doit faire parvenir au bailleur un courrier de confirmation au plus tard une année avant cette date, soit au 30 novembre 2023. Le bailleur prend bonne note que le locataire ne reprend pas l’aménagement de la cuisine pour cette surface du rez-de-chaussée.
Le bailleur se réserve le droit d’utiliser cette surface du rez-de-chaussée pendant la période vacante. Le bailleur s’engage à resituer au locataire Sophia Genetics cette surface à la date de la prise d’effet du bail par le locataire, à savoir le 1er décembre 2024.
3.9Surfaces communes bâtiment B2
En cas de multiples locataires dans le bâtiment B2, l’entrée du bâtiment ainsi que les ascenseurs et escaliers des étages (rez-de-chaussée, 1er étage, 2ème étage) sont communs pour l’ensemble des locataires.
3.10Validité du contrat
La validité du présent contrat est conditionnée à la résiliation du contrat de bail du locataire [**] pour la surface du 1er étage d’ici le mois d’avril 2022.
3.11Version du contrat
Le présent contrat de bail est établi et signé en deux exemplaires. Il en sera remis un exemplaire au locataire et un exemplaire au bailleur.
Le présent contrat comprend tous les accords passés entre les parties. Le présent contrat n’acquiert son effet juridique que s’il est retourné au propriétaire par le locataire, dûment signé, avant le 15 mars 2021 (retour par courrier A/recommandé, retour dans les délais comme condition de validité). En cas de doute, le locataire doit prouver, au moyen d’un récépissé d’envoi de la Poste Suisse, qu’il a bien remis le contrat de location ce jour-là au plus tard à la Poste pour renvoi au propriétaire. En cas de remise personnelle du contrat de location, le propriétaire délivrera une quittance au locataire si celui- ci en fait la demande. Tout changement ou complément du contrat de location déjà signé unilatéralement par le propriétaire, apporté par le locataire avant sa contresignature, a pour conséquence un refus immédiat et automatique de l’offre du propriétaire concernant la conclusion du contrat de location envoyé. Le contrat de location n’acquiert pas son effet juridique si le propriétaire n’approuve pas expressément a posteriori ces changements et/ou compléments par écrit. Un consentement tacite du propriétaire aux changements et/ou compléments apportés par le locataire est ainsi exclu. Tous les changements, compléments et/ou corrections sont soumis au consentement écrit du propriétaire et ne seront fermes qu’avec sa contresignature écrite. Si la version du contrat retournée au propriétaire diffère de l’exemplaire restant auprès du locataire, l’exemplaire du propriétaire prévaut en cas de doute. Tout changement ou complément du présent contrat après entrée en vigueur du contrat de location conformément au paragraphe précédent ne sera valable qu’en revêtant la forme écrite (signature valable des deux parties contractantes). Cette clause s’applique également à l’annulation de la réserve de forme écrite.
Genève, 08.03.2021
Le bailleur / représentant: Le locataire:
PRIVERA SA Sophia Genetics SA
Certain confidential information contained in this document, marked by [**], has been omitted because SOPHiA GENETICS SA has determined that the information (i) is not material and (ii) is the type that SOPHiA customarily and actually treats as private or confidential.
EX-11.1
7
exhibit111insidertradingpo.htm
EX-11.1
Document
SOPHiA GENETICS
POLICY
Policy Against Insider Trading
1.PURPOSE & SCOPE
SOPHiA GENETICS SA and its subsidiaries (collectively, the “Company”) will, without exception, comply with all applicable laws and regulations in conducting its business. Each employee and each director is expected to abide by this policy against insider trading (the “Policy”). When carrying out Company business, employees and directors must avoid any activity that violates applicable laws or regulations. In order to avoid even an appearance of impropriety, the Company’s directors, officers and certain other employees are subject to pre-approval requirements and other limitations on their ability to enter into transactions involving the Company’s securities.
Although these limitations do not apply to transactions pursuant to written plans for trading securities that comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the entry into, amendment or termination of any such written trading plan is subject to pre-approval requirements and other limitations.
2.AUDIENCE
The prohibition against trading on inside information applies to directors, officers and all other employees, and to other people who gain access to that information. This prohibition also applies to:
•the spouses, domestic partners and minor children (even if financially independent) of such employees or directors;
•anyone to whom such employees or directors provide significant financial support; and
•any account over which employees, directors and the persons listed above have or share the power, directly or indirectly, to make investment decisions (whether or not such persons have a financial interest in the account) and those accounts established or maintained by such persons with their consent or knowledge and in which such persons have a direct or indirect financial interest.
Because of their access to confidential information on a regular basis, Company policy subjects its directors and certain employees (the “Window Group”) to additional restrictions on trading in Company securities. The restrictions for the Window Group are discussed in the section below. In addition, directors and certain employees with inside knowledge of material information may be subject to ad hoc restrictions on trading from time to time.
3.GENERAL RULE
The U.S. securities laws regulate the sale and purchase of securities in the interest of protecting the investing public. U.S. securities laws give the Company, its officers and directors, and other employees the responsibility to ensure that information about the Company is not used unlawfully in the purchase and sale of securities.
All employees and directors should pay particularly close attention to the laws against trading on “inside” information. These laws are based upon the belief that all persons trading in a company’s securities should have equal access to all “material” information about that company. For example, if an employee or a director of a company knows material nonpublic financial information, that employee or director is prohibited from buying or selling shares in the company until the information has been adequately disclosed to the public. This is because the employee or director knows information that will probably cause the share price to change, and it would be unfair for the employee or director to have an advantage (knowledge that the share price will change) that the rest of the investing public does not have. In fact, it is more than unfair; it is considered to be fraudulent and illegal. Civil and criminal penalties for this kind of activity are severe.
The general rule can be stated as follows: It is a violation of federal securities laws for any person to buy or sell securities if he or she is in possession of material inside information. Information is material if there is a substantial likelihood that a reasonable investor would consider it important in making an investment decision.
It is inside information if it has not been publicly disclosed in a manner making it available to investors generally on a broad-based non-exclusionary basis. Furthermore, it is illegal for any person in possession of material inside information to provide other people with such information or to recommend that they buy or sell the securities. (This is called “tipping”). In that case, they may both be held liable.
The U.S. Securities and Exchange Commission (the “SEC”), the stock exchanges and plaintiffs’ lawyers focus on uncovering insider trading. A breach of the insider trading laws could expose the insider or anyone who trades on information provided by an insider to criminal fines up to three times the profits earned and imprisonment for up to ten years, in addition to civil penalties (up to three times the profits earned), and injunctive actions. In addition, punitive damages may be imposed under applicable U.S. state laws.
Inside information does not belong to the individual directors, officers or other employees who may handle it or otherwise become knowledgeable about it. It is an asset of the Company. For any person to use such information for personal benefit or to disclose it to others outside the Company violates the Company’s interests. More particularly, in connection with trading in the Company’s securities, it is a fraud against members of the investing public and against the Company. The mere perception that an employee or director traded with the knowledge of material inside information could harm the reputation of both the Company and that employee or director.
4.OTHER COMPANIES’ SECURITIES
Employees and directors who learn material information about suppliers, customers, or competitors through their work at the Company, should keep it confidential and not buy or sell securities in such companies until the information becomes public. Employees and directors should not give tips about such securities.
5.HEDGING AND DERIVATIVES
Employees and directors are prohibited from engaging in any derivative transactions (including transactions involving options, puts, calls, prepaid variable forward contracts, equity swaps, collars and exchange funds or other derivatives) that are designed to hedge or speculate on any change in the market value of the Company’s equity securities. As discussed below, directors and employees are also prohibited from shorting the Company’s securities.
Trading in options or other derivatives is generally highly speculative and very risky. People who buy options are betting that the share price will move rapidly. For that reason, when a person trades in options in his or her employer’s shares, it will arouse suspicion in the eyes of the SEC that the person was trading on the basis of inside information, particularly where the trading occurs before a company announcement or major event. It is difficult for an employee or director to prove that he or she did not know about the announcement or event.
If the SEC or the stock exchanges were to notice active options trading by one or more employees or directors of the Company prior to an announcement, they would investigate. Such an investigation could be embarrassing to the Company (as well as expensive) and could result in severe penalties and expense for the persons involved. For all of these reasons, the Company prohibits its employees and directors from trading in options or other securities involving the Company’s ordinary shares. This Policy does not pertain to employee options granted by the Company. Employee options cannot be traded.
6.PLEDGING OF SECURITIES, MARGIN ACCOUNTS
Pledged securities may be sold by the pledgee without the pledgor’s consent under certain conditions. For example, securities held in a margin account may be sold by a broker without the customer’s consent if the customer fails to meet a margin call. Because such a sale may occur at a time when an employee or a director has material inside information or is otherwise not permitted to trade in Company securities, the Company prohibits employees and directors from pledging Company securities in any circumstance, including by purchasing Company securities on margin or holding Company securities in a margin account.
7.GENERAL GUIDELINES
The following guidelines should be followed in order to ensure compliance with applicable antifraud laws and with the Company’s policies:
•Nondisclosure. Material inside information must not be disclosed to anyone, except to persons within the Company whose positions require them to know it.
•Trading in Company Securities. No employee or director should place a purchase or sale order, or recommend that another person place a purchase or sale order in the Company’s securities when he or she has knowledge of material information concerning the Company that has not been disclosed to the public. This includes orders for purchases and sales of ordinary shares and convertible securities. The exercise of employee options is not subject to this Policy. However, ordinary shares that were acquired upon exercise of an employee option will be treated like any other shares, and may not be sold by an employee who is in possession of material inside information. Any employee or director who possesses material inside information should wait until the start of the third business day after the information has been publicly released before trading. There is no exception to this Policy, even for hardship to the employee or director or based on the use of proceeds (such as making a mortgage payment or for an emergency expenditure).
•Avoid Speculation. Investing in the Company’s ordinary shares provides an opportunity to share in the future growth of the Company. But investment in the Company and sharing in the growth of the Company does not mean short range speculation based on fluctuations in the market. Such activities put the personal gain of the employee or director in conflict with the best interests of the Company. Although this Policy does not mean that employees or directors may never sell shares, the Company encourages employees and directors to avoid frequent trading or speculating in Company shares.
•Trading in Other Securities. No employee or director should place a purchase or sale order, or recommend that another person place a purchase or sale order, in the securities of another corporation, if the employee or director learns in the course of his or her employment confidential information about the other corporation that is likely to affect the value of those securities. For example, it would be a violation of the securities laws if an employee or director learned through Company sources that the Company intended to purchase assets from another company, and then placed an order to buy or sell shares in that other company because of the likely increase or decrease in the value of its securities.
•Restrictions on the Window Group. The Window Group consists of (i) directors and executive officers of the Company and their assistants and household members, (ii) employees in the Finance and Investor Relations Departments and (ii) such other persons as may be designated from time to time and informed of such status by the Company’s General Counsel. The Window Group is subject to the following restrictions on trading in Company securities:
◦subject to the restrictions below, during a particular fiscal quarter (the “Current Fiscal Quarter”), trading is permitted (the “Window”) from the start of the third business day following an earnings release for the preceding fiscal period up to and including the later of (i) the fifteenth calendar day of the last month of the Current Fiscal Quarter and (ii) the eighth business day following the earnings release for the preceding fiscal period, provided that, notwithstanding the foregoing, in no case will the Window will extend into the next fiscal period (i.e., if not closed earlier in accordance with (i) and (ii) above, the Window will close on the first calendar day of the next fiscal period);
◦all trades are subject to prior review by the Legal Department;
◦clearance for all trades must be obtained from the Company’s General Counsel; ◦no trading is permitted outside the Window except for reasons of exceptional personal hardship and subject to prior review by the Chief Executive Officer and General Counsel; provided that, if one of these individuals wishes to trade outside the Window, it shall be subject to prior review by the other; and
◦individuals in the Window Group are also subject to the general restrictions on all employees.
Note that at times the General Counsel may determine that no trades may occur even during the Window when clearance is requested. No reasons may be provided and the closing of the Window itself may constitute material inside information that should not be communicated.
The foregoing Window Group restrictions do not apply to transactions pursuant to written plans for trading securities that comply with Rule 10b5-1 under the Exchange Act (“10b5-1 Plans”). However, Window Group members may not enter into, amend or terminate a 10b5-1 Plan relating to Company securities without the prior approval of the General Counsel, which will only be given during a Window period and only if the Window Group member does not have knowledge of material non-public information.
8.APPLICABILITY OF U.S. SECURITIES LAWS TO INTERNATIONAL TRANSACTIONS
All employees of the Company and its subsidiaries are subject to the restrictions on trading in Company securities and the securities of other companies. The U.S. securities laws may be applicable to trades in the Company’s securities executed outside the U.S., as well as to the securities of the Company’s subsidiaries or affiliates, even if they are located outside the United States. Transactions involving securities of subsidiaries or affiliates should be carefully reviewed by counsel for compliance not only with local law but also for possible application of U.S. securities laws.
9.OTHER LIMITATIONS ON SECURITIES TRANSACTIONS
9.1.Public Resales – Rule 144
The U.S. Securities Act of 1933, as amended (the “Securities Act”), requires every person who offers or sells a security to register such transaction with the SEC unless an exemption from registration is available. Rule 144 under the Securities Act is the exemption typically relied upon for (i) public resales by any person of “restricted securities” (i.e., unregistered securities acquired in a private offering or sale) and (ii) public resales by directors, officers and other control persons of a company (known as “affiliates”) of any of the Company’s securities, whether restricted or unrestricted.
The exemption in Rule 144 may only be relied upon if certain conditions are met. These conditions vary based upon whether the Company has been subject to the SEC’s reporting requirements for 90 days (and is therefore a “reporting company” for purposes of the rule) and whether the person seeking to sell the securities is an affiliate or not.
1. Holding Period. Restricted securities issued by a reporting company (i.e., a company that has been subject to the SEC’s reporting requirements for at least 90 days) must be held and fully paid for a period of six months prior to their sale. Restricted securities issued by a non-reporting company are subject to a one-year holding period. The holding period requirement does not apply to securities held by affiliates that were acquired either in the open market or in a public offering of securities registered under the Securities Act. Generally, if the seller acquired the securities from someone other than the Company or an affiliate of the Company, the holding period of the person from whom the seller acquired such securities can be “tacked” to the seller’s holding period in determining if the holding period has been satisfied.
2. Current Public Information. Current information about the Company must be publicly available before the sale can be made. The Company’s periodic reports filed with the SEC ordinarily satisfy this requirement. If the seller is not an affiliate of the Company issuing the securities (and has not been an affiliate for at least three months) and one year has passed since the securities were acquired from the issuer or an affiliate of the issuer (whichever is later), the seller can sell the securities without regard to the current public information requirement.
Rule 144 also imposes the following additional conditions on sales by persons who are “affiliates.” A person or entity is considered an “affiliate,” and therefore subject to these additional conditions, if it is currently an affiliate or has been an affiliate within the previous three months:
3. Volume Limitations. The amount of debt securities which can be sold by an affiliate during any three-month period cannot exceed ten percent (10%) of a tranche (or class when the securities are non-participatory preferred stock), together with all sales of securities of the same tranche sold for the account of the affiliate. The amount of equity securities that can be sold by an affiliate during any three-month period cannot exceed the greater of (i) one percent (1%) of the outstanding shares of the class or (ii) the average weekly reported trading volume for shares of the class during the four calendar weeks preceding the time the order to sell is received by the broker or executed directly with a market maker.
4. Manner of Sale. Equity securities held by affiliates must be sold in unsolicited brokers’ transactions, directly to a market-maker or in riskless principal transactions.
5. Notice of Sale. An affiliate seller must file a notice of the proposed sale with the SEC at the time the order to sell is placed with the broker, unless the amount to be sold neither exceeds 5,000 shares nor involves sale proceeds greater than USD 50,000. See “Filing Requirements” below.
Bona fide gifts are not deemed to involve sales of shares for purposes of Rule 144, so they can be made at any time without limitation on the amount of the gift. Donees who receive restricted securities from an affiliate generally will be subject to the same restrictions under Rule 144 that would have applied to the donor, depending on the circumstances.
9.2.Private Resales
Directors and officers also may sell securities in a private transaction without registration. Although there is no statutory provision or SEC rule expressly dealing with private sales, the general view is that such sales can safely be made by affiliates if the party acquiring the securities understands he or she is acquiring restricted securities that must be held for at least six months (if issued by a reporting company that meets the current public information requirements) or one-year (if issued by a non-reporting company) before the securities will be eligible for resale to the public under Rule 144.
Private resales raise certain documentation and other issues and must be reviewed in advance by the Company’s General Counsel.
9.3.Underwriter Lock-Up Agreements
All of the directors, executive officers and employees who are shareholders of the Company have agreed to additional limitations on their ability to transfer, pledge or convey any of the economic consequences of ownership of any Company securities prior to 180 days after the date of the Company’s initial public offering in the United States.
9.4.Restrictions on Purchases of Company Securities
In order to prevent market manipulation, the SEC adopted Regulation M under the Exchange Act. Regulation M generally restricts the Company or any of its affiliates from buying Company shares, including as part of a share buyback program, in the open market during certain periods while a distribution, such as a public offering, is taking place. You should consult with the Company’s General Counsel if you desire to make purchases of Company shares during any period that the Company is conducting an offering or buying shares from the public.
9.5. Filing Requirements.
Schedule 13D and 13G. Section 13(d) of the Exchange Act requires the filing of a statement on Schedule 13D (or on Schedule 13G, in certain limited circumstances) by any person or group that acquires beneficial ownership of more than five percent of a class of equity securities registered under the Exchange Act. The threshold for reporting is met if the shares owned, when coupled with the amount of shares subject to options exercisable within 60 days, exceeds the five percent limit.
A report on Schedule 13D is required to be filed with the SEC and submitted to the Company within ten days after the reporting threshold is reached. If a material change occurs in the facts set forth in the Schedule 13D, such as an increase or decrease of one percent or more in the percentage of shares beneficially owned, an amendment disclosing the change must be filed promptly. A decrease in beneficial ownership to less than five percent (5%) is per se material and must be reported.
A person is deemed the beneficial owner of securities for purposes of Section 13(d) if such person has or shares voting power (i.e., the power to vote or direct the voting of the securities) or dispositive power (i.e., the power to sell or direct the sale of the securities). As is true under Section 16(a) of the Exchange Act, a person filing a Schedule 13D may disclaim beneficial ownership of any securities attributed to him or her if he or she believes there is a reasonable basis for doing so.
Form 144. As described above under the discussion of Rule 144, an affiliate seller relying on Rule 144 must file a notice of proposed sale with the SEC at the time the order to sell is placed with the broker unless the amount to be sold during any three-month period neither exceeds 5,000 shares nor involves sale proceeds greater than USD 50,000.
10.CONTACT INFORMATION
All questions and inquiries regarding this Policy, should be addressed to the CLO-General Counsel and, in such person’s absence, the Corporate Secretary Team.
11.RELATED DOCUMENTS
•Disclosure Committee Charter
•Disclosure Guidelines
•Social Media Policy
•Insider Trading Guidelines
12.REVIEW & UPDATES
The Audit Committee may amend or modify this Policy at any time.
EX-11.2
8
exhibit11210b5-1planpolicy.htm
EX-11.2
Document
SOPHiA GENETICS
STANDARD OPERATING PROCEDURE
10b5-1 Plan policy
1.PURPOSE
A 10b5-1 plan that meets the requirements of Rule 10b5-1 under the Securities Exchange Act of 1934 (such plan, a “Trading Plan”) enables Eligible Persons as defined in 2. AUDIENCE below to buy or sell a predetermined number of shares in SOPHiA GENETICS SA, a public company incorporated, organized and existing under the laws of Switzerland and listed on Nasdaq with ticker symbol SOPH (“SOPH”) at a predetermined time, including during blackout periods, while providing an affirmative defense to insider trading for transactions made under the Trading Plan. A Trading Plan must either (i) specify the number of securities and the price at which and the date on which the securities are to be purchased or sold or (ii) include an objective formula or algorithm for determining the number of securities and the price and the date on which the securities are to be purchased or sold, and most importantly, in all cases, does not permit the Eligible Persons to exercise any subsequent influence over how, when or whether to effect purchases or sales.
A Rule 10b5-1 plan can be an effective solution for Insiders as defined in SOPH’s Policy against insider trading (as amended from time, the “SOPH Insider Policy”) to time who need to maintain ownership holding requirements or desire to partially divest out of their concentrated positions. This 10b5-1 Plan policy (this “Policy”) needs to be read in conjunction with the SOPH Insider Policy.
2.AUDIENCE
The Window Group, which consists of (i) directors and officers of SOPH and their assistants and family members, (ii) employees in the Finance, Corporate Development, Investor Relations and Legal departments of SOPH and (iii) such other persons as may be designated from time to time and informed of such status by SOPH’s Chief Legal Officer & General Counsel (the “CLO”), and other Insiders (collectively, “Eligible Persons”) may enter into Trading Plans, upon pre-approval of the CLO.
3.PRE-APPROVAL
An Eligible Person needs to receive pre-approval from the CLO or his or her designee to enter into a Trading Plan. An Eligible Person must enter into the Trading Plan within the period specified as part of the pre-approval.
Each Trading Plan must be reviewed by and needs a pre-approval from the CLO or his or her designee. The outcome of such review, i.e. a confirmation that the request for approval was denied or a confirmation of a pre-approval will be communicated to the Eligible Person via email. Eligible Persons must submit Trading Plans, also including their personal certification as described in 6. TRADING PLAN – PERSONAL CERTIFICATION, for pre-approval at least five business days prior to the anticipated adoption date of the Trading Plan.
If the Trading Plan is approved, no further pre-clearance will be required for transactions made pursuant to the terms and conditions of the Trading Plan.
4.REQUIREMENTS
1.1Adoption date
An Eligible Person may enter into a Trading Plan only if the following conditions are satisfied: (i) the adoption date occurs during an open trading window when the Eligible Person may trade securities under the SOPH Insider Policy; and (ii) the relevant Eligible Person does not have possession of any material non-public information (“MNPI”).
1.2Duration
Trading Plans may have a duration as pre-approved by the CLO, subject to securities laws and regulations as applicable from time to time.
1.3Commencement of Transactions
Transactions may not commence under a Trading Plan until the Trading Plan has been approved by the CLO and the “cooling-off period” ends. The “cooling-off period” ends on the later of (i) 90 days following the adoption of the Trading Plan, and (ii) two business days following the filing of SOPH’s Form 6-K or Form 20-F containing consolidated financial statements (and corresponding MD&A) covering the period in which the Trading Plan is adopted, subject to a maximum of 120 days after the adoption of the Trading Plan.
1.4Mandatory Suspension
Each Trading Plan must provide for suspension of trades under such plan if legal, regulatory or contractual restrictions are imposed on the Eligible Person, or if relevant guidelines are or this Policy is amended, or other events occur, that would prohibit sales under such Trading Plan.
1.5Modifications
Trading Plans may be modified only if the following conditions are satisfied: (i) pre-approval for such modification is obtained from the CLO; (ii) the modification occurs during an open trading window when the Eligible Person may trade securities under the SOPH Insider Policy; and (iii) the Eligible Person does not have possession of any MNPI.
Modification of one or more key terms and/or conditions of the Trading Plan, including but not limited to the amount, price or timing of transactions under the Trading Plan constitutes a termination of the Trading Plan. The Trading Plan can only resume after a modification after the cooling-off period described above has expired, as if a new Trading Plan was adopted.
1.6Prohibition on cancellation of transactions
Once a Trading Plan is adopted, individual transactions under the Trading Plan cannot be canceled. Instead, the Eligible Person may only terminate the entire Trading Plan by following the procedure below.
1.7Termination
1.1.1Termination prior to expiration
An Eligible Person should enter into a Trading Plan with the expectation that it will not be terminated prior to its stated term. Under extraordinary circumstances, the Eligible Person can terminate the relevant Trading Plan, only upon pre-approval from the CLO prior to terminating a Trading Plan. An Eligible Person who terminates a Trading Plan is prohibited from trading SOPH securities for 30 days following the termination date of the Trading Plan. As always, any transactions outside a Trading Plan must be made in compliance with the SOPH Insider Policy.
If an existing Trading Plan is terminated early and another Trading Plan is already in place, the first trade under the later-commencing plan must not be scheduled to occur until after the end of the cooling-off period following the termination of the earlier Trading Plan.
1.1.2Termination upon expiration
If a Trading Plan expires according to its terms (either because all securities have been sold or the Trading Plan has expired), an Eligible Person may enter into a new Trading Plan after obtaining pre-approval as described in this Policy.
5.PROHIBITED TRADING PLANS
1.1Multiple Trading Plans
An Eligible Person may have only one Trading Plan in effect at any time, but may initiate a new Trading Plan so long as transactions under the later-commencing Trading Plan is not authorized to begin until all transactions under the earlier-commencing Trading Plan are completed or expire without execution (and not modified or terminated) and the cooling-off period has lapsed after adoption of the later-commencing Trading Plan. A Trading Plan will not count towards this limit if it is a “sell-to-cover plan” meeting both of the following conditions: (1) the Trading Plan only authorizes sales of securities as necessary to satisfy tax withholding obligations arising solely from the vesting of compensatory awards (not including options) and (2) the Eligible Person is not permitted to exercise control over the timing of sales under the Trading Plan.
One Trading Plan may include multiple brokers so long as the Trading Plan acts as a single Trading Plan.
1.2Single-Trade Plans
A Trading Plan that is designed to effect the total amount of securities subject to the Trading Plan as one single transaction (“single-trade plan”) is prohibited. A Trading Plan does not constitute a single-trade plan if (i) it gives the Eligible Person’s agent discretion over whether to execute the plan as a single transaction or provides that the agent’s future acts depend on events or data not known at the time the plan is entered into and (ii) it is reasonably foreseeable at the time the plan is entered into that the plan results in multiple transactions. Sell-to-cover plans meeting the requirements described in 5.1. MULTIPLE TRADING PLANS are exempt from the limitations described above.
1.3Hedging
As described in the SOPH Insider Policy, hedging or similar transactions are prohibited. Further to this end, an Insider adopting a Trading Plan may not have entered into or altered a corresponding or hedging transaction or position with respect to the securities subject to the Trading Plan and must agree not to enter into any such transaction while the Trading Plan is in effect.
6.TRADING PLAN – PERSONAL CERTIFICATION
Eligible Persons must personally certify and expressly include in a new or modified Trading Plan that they are:
•Not aware of any MNPI about any SOPH security or SOPH; and
•Adopting the plan in good faith and not as part of a plan or scheme to evade the prohibitions of Rule 10b5-1.
In addition to the personal certification of good faith, the affirmative defense will only be available if the Eligible Person has “acted in good faith” throughout the duration of the plan.
7.COMPANY DISCLOSURE
SOPH will disclose in its Form 20-F information regarding Trading Plans adopted, modified or terminated by directors and officers as required by United States securities laws and regulations, including but not limited to the identity of the directors or officer, the date of adoption, modification or termination, the duration of the Trading Plan and the aggregate number of securities covered by the Trading Plan.
8.INSIDER DISCLOSURE
To the extent that sales made under a Trading Plan are made pursuant to Rule 144 under the Securities Act, Insiders are responsible for complying with Rule 144, including the filing of Forms 144. Insiders must footnote trades disclosed on Forms 144 to indicate that the trades were made pursuant to a Trading Plan.
9.CONTACT INFORMATION
All questions and inquiries regarding this Policy should be addressed to the CLO and, in such person’s absence, his or her designee.
10.ANNEXES
Not applicable
EX-12.1
9
exhibit121ceo302certificat.htm
EX-12.1
Document
CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jurgi Camblong, certify that:
1.I have reviewed this annual report on Form 20-F of SOPHiA GENETICS SA;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4.The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5.The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: March 4, 2025
/s/ Jurgi Camblong
Name: Jurgi Camblong
Title: Chief Executive Officer
EX-12.2
10
exhibit122cfo302certificat.htm
EX-12.2
Document
CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, George Cardoza, certify that:
1.I have reviewed this annual report on Form 20-F of SOPHiA GENETICS SA;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4.The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5.The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: March 4, 2025
/s/ George Cardoza
Name: George Cardoza
Title: Chief Financial Officer
EX-13.1
11
exhibit131ceo906certificat.htm
EX-13.1
Document
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
The certification set forth below is being submitted in connection with SOPHiA GENETICS SA’s annual report on Form 20-F for the year ended December 31, 2024 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
I, Jurgi Camblong, the Chief Executive Officer of SOPHiA GENETICS SA, certify that:
1.the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
2.the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of SOPHiA GENETICS SA.
Date: March 4, 2025
/s/ Jurgi Camblong
Name: Jurgi Camblong
Title: Chief Executive Officer
EX-13.2
12
exhibit132cfo906certificat.htm
EX-13.2
Document
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
The certification set forth below is being submitted in connection with SOPHiA GENETICS SA’s annual report on Form 20-F for the year ended December 31, 2024 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
I, George Cardoza, the Chief Financial Officer of SOPHiA GENETICS SA, certify that:
1.the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
2.the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of SOPHiA GENETICS SA.
Date: March 4, 2025
/s/ George Cardoza
Name: George Cardoza
Title: Chief Finanical Officer
EX-15.1
13
exhibit151pwcconsentfy24.htm
EX-15.1
Document
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-258121 and 333-258122) and Form F-3 (Nos. 333-266704 and 333-280060) of SOPHiA GENETICS SA of our report dated March 4, 2025 relating to the financial statements, which appears in this Form 20-F.
/s/ PricewaterhouseCoopers SA
Pully, Switzerland
March 5, 2024
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