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FORM 20-F
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Israel
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2 HaMa’ayan Street
Modi’in 7177871, Israel |
(Jurisdiction of incorporation or organization)
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(Address of principal executive offices)
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Title of each class
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Name of each exchange on which registered
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American Depositary Shares, each representing 15 ordinary shares, par value NIS 0.10 per share
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Nasdaq Capital Market
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Ordinary shares, par value NIS 0.10 per share
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Nasdaq Capital Market*
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Large accelerated filer ☐
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Accelerated filer ☒
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Non-accelerated filer ☐
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Emerging growth company ☐
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U.S. GAAP ☐
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International Financial Reporting Standards as issued by the
International Accounting Standards Board ☒
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Other ☐
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i | |
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1 | |
1 | |
1 | |
1 | |
28 | |
51 | |
51 | |
60 | |
79 | |
81 | |
81 | |
82 | |
93 | |
94 | |
96 | |
96 | |
96 | |
97 | |
97 | |
97 | |
97 | |
97 | |
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98 | |
98 | |
99 | |
99 | |
99 | |
99 | |
100 | |
100 | |
100 | |
103 |
• |
references to “BioLineRx,” the “Company,” “us,”
“we” and “our” refer to BioLineRx Ltd., an Israeli company, and its consolidated subsidiaries; |
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references to “ordinary shares,” “our shares” and similar
expressions refer to the Company’s ordinary shares, NIS 0.10 nominal (par) value per share; |
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references to “ADS” or “ADSs” refer to the Company’s
American Depositary Shares; |
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references to “dollars,” “U.S. dollars” and “$”
are to United States Dollars; |
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references to “shekels” and “NIS” are to New Israeli Shekels,
the Israeli currency; |
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references to the “Companies Law” are to Israel’s Companies Law,
5759-1999, as amended; |
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and references to the “SEC” are to the U.S. Securities and Exchange Commission.
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the clinical development, commercialization and market acceptance of our therapeutic candidates, including the degree and pace of
market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients;
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the initiation, timing, progress and results of our preclinical studies, clinical
trials and other therapeutic candidate development efforts; |
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our ability to advance our therapeutic candidates into clinical trials or to successfully
complete our preclinical studies or clinical trials; |
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whether the clinical trial results for APHEXDA will be predictive of real-world results;
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our receipt of regulatory approvals for our therapeutic candidates, and the timing
of other regulatory filings and approvals; | |
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whether access to APHEXDA is achieved in a commercially viable manner and whether
APHEXDA receives adequate reimbursement from third-party payors; | |
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our ability to establish, manage, and maintain corporate collaborations, as well as
the ability of our collaborators to execute on their development and commercialization plans; |
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our ability to integrate new therapeutic candidates and new personnel, as well as
new collaborations; |
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the interpretation of the properties and characteristics of our therapeutic candidates
and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials; |
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the implementation of our business model and strategic plans for our business and
therapeutic candidates; |
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the scope of protection that we are able to establish and maintain for intellectual
property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property
rights of others; |
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estimates of our expenses, future revenues, capital requirements and our need for
and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercialization of APHEXDA;
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risks related to changes in healthcare laws, rules and regulations in the United States
or elsewhere; |
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competitive companies, technologies and our industry; |
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statements as to the impact of the political and security situation in Israel on our
business, including the impact of Israel’s war with Hamas and other militant groups, which may exacerbate the magnitude of the factors
discussed above; and |
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those factors referred to in “Item 3.D. Risk Factors,” “Item 4.
Information on the Company,” and “Item 5. Operating and Financial Review and Prospects”, as well as in this annual report
on Form 20-F generally. |
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We have incurred significant losses since inception and expect to incur additional losses in the future
and may never be profitable. |
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We cannot assure investors that our existing cash and investment balances will be sufficient to meet our
future capital requirements. |
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If we default under our secured loan agreement with Kreos, all or a portion of our assets could be subject
to forfeiture. |
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We have only recently transitioned from a development stage biopharmaceutical company
to a commercial stage biopharmaceutical company, which may make it difficult for you to evaluate the success of our business to date and
to assess our future viability. |
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APHEXDA has been launched in the United States and there is significant competition
in this marketplace. Since this is our first independently marketed therapeutic, the timing of uptake and distribution efforts are unpredictable
and there is a risk that we may not achieve and sustain commercial success for APHEXDA. |
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APHEXDA, or any other therapeutic candidate that may receive marketing approval in
the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical
community necessary for commercial success and the market opportunity for APHEXDA or any other therapeutic candidate may be smaller than
our estimates. |
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If we or our collaborators are unable to obtain and/or maintain U.S. and/or foreign
regulatory approval for our therapeutic candidates, in a timely manner or at all, we will be unable to commercialize our therapeutic candidates.
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We may not obtain additional marketing approvals for motixafortide in other indications or initial approval
for any other therapeutic candidates we may develop in the future. |
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Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier
studies and trials may not be predictive of future trial results. |
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Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory
review and if we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business
would be seriously harmed. |
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We generally rely on third parties to conduct our preclinical studies and clinical trials and to provide
other services, and those third parties may not perform satisfactorily, including by failing to meet established deadlines for the completion
of such services. |
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We have in the past and may depend in the future on out-licensing arrangements for late-stage development,
marketing and commercialization of our therapeutic candidates. |
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If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic
candidates, which could have a material adverse effect on our business. |
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We have partnered with and may seek to partner with third-party collaborators with respect to the development
and commercialization of motixafortide, and we may not succeed in establishing and maintaining collaborative relationships, which may
significantly limit our ability to develop and commercialize our therapeutic candidates successfully, if at all. |
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If our competitors develop and market therapeutics that are more effective, safer or less expensive than
our current or future therapeutic candidates, our prospects will be negatively impacted. |
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APHEXDA, or any other therapeutic candidate that we or our collaborators are able to commercialize, may
become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of
which could harm our business. |
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We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization,
of APHEXDA. If we manufacture any therapeutic candidates in the future, we will be required to incur significant costs and devote significant
efforts to establish and maintain manufacturing capabilities. |
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Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental
authorities and third-party payors may adversely affect our business. |
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If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that
are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase. |
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Our business has a substantial risk of clinical trial and product liability claims. If we are unable to
obtain and maintain appropriate levels of insurance, a claim could adversely affect our business. |
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Significant disruptions of our information technology systems or breaches of our data security could adversely
affect our business. |
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We deal with hazardous materials and must comply with environmental, health and safety laws and regulations,
which can be expensive and restrict how we do business. |
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We are currently party to, and may in the future, become subject to litigation or claims arising in or
outside the ordinary course of business that could negatively affect our business operations and financial condition. |
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Our access to most of the intellectual property associated with our therapeutic candidates
results from in-license agreements with biotechnology companies and a university, the termination of which would prevent us from commercializing
the associated therapeutic candidates. |
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Our business, operating results and growth rates may be adversely affected by current or future unfavorable
economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. |
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The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial
losses by our investors. |
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Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.
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Raising additional capital by issuing securities may cause dilution to existing shareholders. |
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We conduct a substantial part of our operations in Israel and therefore our results may be adversely affected
by political, economic and military instability in Israel and its region. | |
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Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our
company, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
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It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the
United States, or to serve process on our officers and directors. |
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Your rights and responsibilities as a shareholder will be governed by Israeli law, which may differ in
some respects from the rights and responsibilities of shareholders of U.S. companies. |
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Revenue sharing payments. These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third
parties for further development and commercialization of our drug products. These payments are generally fixed at a percentage of the
total revenues we earn from these sublicenses. |
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Milestone payments. These payments are generally linked to the successful achievement of milestones in the development and approval
of drugs, such Phases 1, 2 and 3 of clinical trials and approvals of NDAs, and achievement of sales milestones. |
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Royalty payments. To the extent we elect to complete the development, licensing and marketing of a therapeutic candidate, we are
generally required to pay our licensors royalties on the sales of the end drug product. These royalty payments are generally based on
the net revenue from these sales. In certain instances, the rate of the royalty payments decreases upon the expiration of the drug’s
underlying patent and its transition into a generic drug. |
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Additional payments. In addition to the above payments, certain of our in-license agreements provide for a one-time or periodic payment
that is not linked to milestones. Periodic payments may be paid until the commercialization of the product, either by direct sales or
sublicenses to third parties. Other agreements provide for the continuation of these payments even following the commercialization of
the licensed drug product. |
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The motixafortide drug product composition of matter and methods of manufacturing thereof are covered by patent applications pending
in Israel, USA, Europe, Japan, Canada, Australia, China, India, Mexico, Brazil, Hong-Kong and Korea. Corresponding patents, if granted,
will expire in December 2041, not including any applicable patent term extension, which may add an additional term of up to five years
for the U.S. patents. We also have an exclusive license to a patent family that covers motixafortide combined with a PD1 antagonist for
the treatment of cancer. Patents of this family have been granted in the U.S., Israel, Australia, China and Hong Kong; and member patent
applications are pending in Australia, Hong Kong, Europe, Japan, China, Canada, India, Korea, Mexico and Brazil. The granted U.S. patent
and patents to issue in the future based on pending patent applications in this family will expire in 2036, not including any applicable
patent term extension. In addition, we have an exclusive license to nineteen other patent families pending or granted worldwide directed
to methods of synthesis of motixafortide and methods of use of motixafortide either alone or in combination with other drugs for the treatment
of certain types of cancer and other indications. Furthermore, we have Orphan Drug status for AML, pancreatic cancer and stem cell mobilization,
as well as data exclusivity protection afforded to motixafortide as an NCE. |
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With respect to BL-5010, we have an exclusive license to a patent family directed to a novel applicator uniquely configured for applying
the BL-5010 composition to targeted skin tissue safely and effectively. Patents in this family have been granted in the U.S., Europe,
Israel, Japan, China, Australia and New Zealand. The patents will expire in 2033-2034. |
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preclinical laboratory tests, animal studies and formulation development; |
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submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing; |
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adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish
the exposure levels; |
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submission to the FDA of an application for marketing approval; |
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and
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FDA review and approval of the drug and drug labeling for marketing. |
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Consistent rules for conducting clinical trials throughout the EU; |
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Making information on the authorization, conduct and results of each clinical trial carried out in the EU publicly available;
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Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states; |
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Improved collaboration, information sharing and decision-making between and within member states; |
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Increased transparency of information on clinical trials; and |
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Higher standards of safety for all participants in EU clinical trials. |
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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting,
offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to
induce or reward either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment
may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; |
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the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which
prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government,
claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to
the federal government; |
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws
that prohibit, among other things, knowingly and willingly executing, or attempting to execute, a scheme or making false statements in
connection with the delivery of or payment for health care benefits, items, or services; |
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which
also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
individually identifiable health information on covered entities and their business associates that associates that perform certain functions
or activities that involve the use or disclosure of protected health information on their behalf; |
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the Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making, or offering or promising
to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment;
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the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable
Care Act, as amended by the Health Care Education Reconciliation Act, or collectively the ACA, which requires certain manufacturers of
drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health
Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, within HHS,
information related to payments and other transfers of value to certain healthcare providers and teaching hospitals and information regarding
ownership and investment interests held by physicians and their immediate family members; and |
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare
items or services that are reimbursed by non-governmental third-party payors, including private insurers. |
Project |
Status |
Expected Near Term Milestones | ||
motixafortide |
1. |
FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients.
|
1. |
Commercialization ongoing |
2. |
Reported data from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line
PDAC. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 5
(45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%) experienced
stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, study was substantially revised
to a multi-institution, randomized trial of 108 patients |
2. |
First patient dosed in February 2024 and currently enrolling* | |
3. |
Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections
|
3. |
Data from the study is anticipated in 2024* | |
4. |
Phase 1 study for gene therapies in SCD |
4. |
First patient does in December 2023 and data from the study is expected in the second half of 2024*
| |
5. |
Pivotal bridging study in SCM in China under license agreement with Gloria |
5. |
Initiation of the study is expected in second half of 2024
| |
6. |
Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria |
6. |
IND submission and protocol finalization expected in 2024 and study initiation in 2025 |
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the number of sites included in the clinical trials; |
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the length of time required to enroll suitable patients; | |
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the number of patients that participate, and are eligible to participate, in the clinical
trials; |
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the duration of patient follow-up; | |
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whether the patients require hospitalization or can be treated on an outpatient basis;
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the development stage of the therapeutic candidate; and |
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the efficacy and safety profile of the therapeutic candidate. |
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identify the contract with a customer; |
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identify the performance obligations in the contract; |
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determine the transaction price; |
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allocate the transaction price to the performance obligations in the contract; and
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recognize revenue when (or as) the entity satisfies a performance obligation.
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the progress and costs of our preclinical studies, clinical trials and other research
and development activities; |
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the scope, prioritization and number of our clinical trials and other research and
development programs; |
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the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
| |
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the costs of the development and expansion of our operational infrastructure;
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the costs and timing of obtaining regulatory approval of our therapeutic candidates;
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our success in effecting out-licensing arrangements with third parties; |
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the ability of our collaborators and licensees to achieve development milestones,
marketing approval and other events or developments under our collaboration and out-licensing agreements; |
• |
the costs of filing, prosecuting, enforcing and defending patent claims and other
intellectual property rights; |
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the costs and timing of securing manufacturing arrangements for clinical or commercial
production; |
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the costs of establishing sales and marketing capabilities or contracting with third
parties to provide these capabilities for us; |
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the costs of acquiring or undertaking development and commercialization efforts for
any future therapeutic candidates; |
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the magnitude of our general and administrative expenses; |
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interest and principal payments on the loan from Kreos Capital; |
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any cost that we may incur under current and future licensing arrangements relating to our therapeutic
candidates; |
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market conditions; |
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payments to the IIA; and |
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the impact of any resurgence of the COVID-19 pandemic, the Russian invasion of Ukraine,
and the military campaigns by Israel against Hamas and other terrorist organizations (including the declaration of war by Israel against
Hamas), which may exacerbate the magnitude of the factors discussed above. |
|
Total |
Less than 1 year |
1-3 years |
4-5 years |
More than 5 years |
|||||||||||||||
|
(in thousands of U.S. dollars) |
|||||||||||||||||||
|
||||||||||||||||||||
Car leasing obligations |
300 |
161 |
139 |
- |
- |
|||||||||||||||
Premises leasing obligations |
2,231 |
575 |
584 |
613 |
459 |
|||||||||||||||
Purchase commitments |
6,911 |
6,578 |
308 |
25 |
- |
|||||||||||||||
Total |
9,442 |
7,314 |
1,031 |
638 |
459 |
Name |
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Age |
|
Position(s) |
|
|
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Philip A. Serlin, CPA, MBA |
|
64 |
|
Chief Executive Officer |
Mali Zeevi, CPA |
|
48 |
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Chief Financial Officer |
Ella Sorani, Ph.D. |
|
56 |
|
Chief Development Officer |
Holly W. May, MBA |
|
62 |
|
U.S. President |
Aharon Schwartz, Ph.D. (1) |
|
81 |
|
Chairman of the Board of Directors, Class III Director |
Rami Dar, MBA (1)(2)(3)(4) |
|
67 |
|
Class I Director |
B.J. Bormann, Ph.D. (1)(3) |
|
65 |
|
Class II Director |
Raphael Hofstein, Ph.D. (1)(2)(3) |
|
74 |
|
Class II Director |
Avraham Molcho, M.D. (1)(2)(3) |
|
66 |
|
Class I Director |
Sandra Panem, Ph.D. (1) |
|
77 |
|
Class III Director |
Shaoyu Yan, Ph.D. |
|
59 |
|
Class III Director |
Gal Cohen (1) |
|
51 |
|
Class I Director |
(1) |
Independent director under applicable Nasdaq Capital Market, as affirmatively determined
by our board of directors. |
|
|
(2) |
A member of our audit committee. |
|
|
(3) |
A member of our compensation committee. |
|
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(4) |
A member of our investment monitoring committee |
|
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Salaries, fees,
commissions
and bonuses |
|
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Pension,
retirement,
options and
other similar benefits |
| ||
|
|
(in thousands of U.S. dollars) |
| |||||
All directors and senior management as a group, consisting of 14 persons |
|
|
2,483 |
|
|
|
1,259 |
|
Name and Position |
|
Salary |
|
|
Social Benefits(1)
|
|
|
Bonuses |
|
|
Value of Options Granted(2)
|
|
|
All Other
Compensation(3)
|
|
|
Total |
| ||||||
|
|
(in thousands of U.S. dollars) |
| |||||||||||||||||||||
Philip A. Serlin
Chief Executive Officer |
|
|
280 |
81 |
215 |
354 |
22 |
952 |
| |||||||||||||||
Mali Zeevi |
||||||||||||||||||||||||
Chief Financial Officer |
182 |
53 |
119 |
69 |
20 |
443 |
||||||||||||||||||
Ella Sorani
Chief Development Officer |
|
|
206 |
70 |
156 |
68 |
20 |
520 |
| |||||||||||||||
Holly W. May
President BioLineRx USA, Inc. |
|
|
420 |
130 |
160 |
304 |
- |
1,014 |
| |||||||||||||||
Tami Rachmilewitz |
||||||||||||||||||||||||
Chief Medical Officer * |
157 |
54 |
- |
- |
15 |
226 |
(1) |
“Social Benefits” include payments to the National Insurance Institute,
advanced education funds, managers’ insurance and pension funds, vacation pay and recuperation pay as mandated by Israeli law.
|
(2) |
Consists of amounts recognized as share-based compensation expense on the Company’s
statement of comprehensive loss for the year ended December 31, 2023. |
(3) |
“All Other Compensation” includes automobile-related expenses pursuant
to the Company’s automobile leasing program, telephone, basic health insurance and holiday presents.
|
|
• |
the Class I directors, consisting of Dr. Avraham Molcho, Mr. Rami Dar and Gal Cohen,
will hold office until our annual general meeting of shareholders to be held in 2024; |
|
• |
the Class II directors, consisting of Dr. B.J. Bormann and Dr. Raphael Hofstein, will hold office until our annual general meeting
of shareholders to be held in 2025; and |
|
• |
the Class III directors, consisting of Dr. Sandra Panem, Dr. Aharon Schwartz and Dr. Shaoyu Yan, will hold office until our annual
general meeting of shareholders to be held in 2026. |
Country of Principal Executive Offices |
Israel | |||||||
Foreign Private Issuer |
Yes | |||||||
Disclosure Prohibited under Home Country Law |
No | |||||||
Total Number of directors |
8 | |||||||
Part I: Gender Identity |
Female |
|
Male |
|
Non-Binary |
|
Did Not Disclose
Gender | |
directors |
2 |
|
6 |
|
0 |
|
0 | |
Part II: Demographic Background |
| |||||||
Underrepresented Individual in Home Country Jurisdiction |
0 | |||||||
LGBTQ+ |
0 | |||||||
Did Not Disclose Demographic Background |
0 |
• |
oversight of the company’s independent registered public accounting firm and
recommending the engagement, compensation or termination of engagement of our independent registered public accounting firm to our board
of directors in accordance with Israeli law; |
• |
recommending the engagement or termination of the office of our internal auditor;
and |
• |
reviewing and pre-approving the terms of audit and non-audit services provided by
our independent auditors. |
• |
to make recommendations to the board of directors for its approval of (i) a compensation
policy for officer holders, (ii) once every three years whether to extend the then current compensation policy (approval of either a new
compensation policy or the continuation of an existing compensation policy must in any case occur every three years); and (iii) periodic
updates to the compensation policy which may be required from time to time. In addition, the compensation committee is required
to periodically examine the implementation of the compensation policy; and |
• |
to approve transactions relating to terms of office and employment of company office
holders that require the approval of the compensation committee pursuant to the Companies Law (including determining whether the compensation
terms of a candidate for chief executive officer of the company need not be brought to approval of the shareholders). |
• |
the majority of the votes voted in favor includes at least a majority of all the votes
of shareholders who are not controlling shareholders of the company and shareholders who do not have a personal interest in the compensation
policy, present and voting on the matter(excluding abstentions); or |
• |
the total of opposing votes from among the shareholders who are non-controlling shareholders
and shareholders who do not have a personal interest in the matter does not exceed 2% of all the voting rights in the company. |
• |
a person (or a relative of a person) who holds more than 5% of the company’s
shares; |
• |
a person (or a relative of a person) who has the power to appoint a director or the
general manager of the company; |
• |
an executive officer or director of the company (or a relative thereof); or
|
• |
a member of the company’s independent accounting firm. |
• |
information on the advisability of a given action brought for his or her approval
or performed by virtue of his or her position; and |
• |
all other important information pertaining to these actions. |
• |
refrain from any act involving a conflict of interest between the performance of his
or her duties in the company and his or her other duties or personal affairs; |
• |
refrain from any activity that is competitive with the business of the company;
|
• |
refrain from exploiting any business opportunity of the company for the purpose of
gaining a personal advantage for himself or herself or others; and |
• |
disclose to the company any information or documents relating to the company’s
affairs which the office holder received as a result of his or her position as an office holder. |
• |
a transaction other than in the ordinary course of business; |
• |
a transaction that is not on market terms; or |
• |
a transaction that may have a material impact on the company’s profitability, assets or liabilities.
|
• |
Executive officers other than the Chief Executive
Officer. A transaction with an office holder in a public company who is neither a director nor the chief executive officer
regarding his or her terms of office and employment requires approval by the (i) compensation committee; and (ii) the board of directors.
Approval of terms of office and employment for such officers which do not comply with the compensation policy may nonetheless be approved
subject to two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having
taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect a compensation policy,
and (ii) the shareholders of the company have approved the terms by means of the following special majority requirements, or the Special
Majority Requirements, as set forth in the Companies Law, pursuant to which the shareholder approval must either include at least a majority
of the shares held by non-controlling shareholders and disinterested shareholders who are present and vote on the matter (excluding abstentions),
or, alternatively, the total shareholdings of the non-controlling shareholders and disinterested shareholders who vote against the transaction
must not represent more than 2% of the voting rights in the company. However, a company’s compensation committee and board of directors,
may, in special circumstances approve a transaction despite shareholder rejection, provided that the compensation committee and thereafter
the board of directors have determined to approve the transaction based on detailed reasoning, after each having re- discussed the terms
of office and employment, and taken the shareholder rejection into consideration. |
• |
Chief Executive Officer. A transaction
with the chief executive officer in a public company regarding his or her terms of office and employment requires approval by the (i)
compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority Requirements. Approval
of terms of office and employment for the chief executive officer which do not comply with the compensation policy may nonetheless be
approved subject to two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms
after having taken into account the various considerations and mandatory requirements set forth in the Companies Law with respect to a
compensation policy and (ii) the shareholders of the company have approved the terms by means of the Special Majority Requirements, as
detailed above. However, a company’s compensation committee and board of directors, may, in special circumstances approve a transaction
with a chief executive officer (who is not a director) that is not approved by shareholders despite shareholder rejection, provided that
the company’s compensation committee and thereafter the board of directors have determined to approve the transaction, based on
detailed reasoning, after each having re-discussed the terms of office and employment, and taken the shareholder rejection into consideration.
In addition, the compensation committee may exempt from shareholder approval the terms of office and employment of a candidate for the
office of chief executive officer where such officer has no relationship with the controlling shareholder or the company, if it has found,
based on detailed reasons, that bringing the transaction to the approval of the shareholders meeting shall prevent the employment of such
candidate by the company. provided that the terms of office and employment are in accordance with the company’s compensation policy.
|
• |
Directors. A transaction with a director
who is not the chief executive officer of a public company regarding his or her terms of office and engagement requires approval by the
(i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company. Approval of terms of office and employment
for directors of a company which do not comply with the compensation policy may nonetheless be approved subject to two cumulative conditions:
(i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations
and mandatory requirements set forth in the Companies Law with respect to a compensation policy and (ii) the shareholders of the company
have approved the terms by means of the Special Majority Requirements, as detailed above. In addition, pursuant to a relief provided under
the Israeli Companies Regulations (Relief in Interested Party Transactions), 2000, the terms of office and engagement of a non-executive
director are exempt from shareholder approval if the compensation committee and board of directors determined that (i) such terms of office
are only for the benefit of the company, or (ii) the compensation terms of the director do not exceed the maximum compensation paid to
external directors pursuant to the applicable regulations. |
• |
at least a majority of the shares held by shareholders who have no personal interest in the transaction
who are present and voting at the meeting must be voted in favor of approving the transaction, excluding abstentions; or |
• |
the shares voted by shareholders who have no personal interest in the transaction who are present and vote
against the transaction represent no more than 2% of the voting rights in the company. |
• |
an amendment to the articles of association; |
• |
an increase in the company’s authorized share capital; |
• |
a merger; and |
• |
the approval of related party transactions and acts of office holders that require shareholder approval
under the Companies Law. |
• |
monetary liability imposed on him or her in favor of another person pursuant to a
judgment, including a settlement or arbitrator’s award approved by a court. However, if an undertaking to indemnify an office holder
with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the
board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount
or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail
the abovementioned foreseen events and amount or criteria; |
• |
reasonable litigation expenses, including attorneys’ fees, incurred by the office
holder (i) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation
or proceeding, provided that (1) no indictment was filed against such office holder as a result of such investigation or proceeding; and
(2) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or
proceeding or, if such financial liability (such as a criminal penalty) was imposed, it was imposed with respect to an offense that does
not require proof of criminal intent and (ii) in connection with a monetary sanction; |
• |
a monetary liability imposed on an office holder in favor of an injured party at an Administrative
Procedure (as defined below) pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; |
• |
expenses incurred by an office holder or certain compensation payments made to an injured
party that were instituted against an office holder in connection with an Administrative Procedure under the Israeli Securities Law, including
reasonable litigation expenses and reasonable attorneys’ fees; and |
• |
reasonable litigation expenses, including attorneys’ fees, incurred by the office
holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party or in connection
with criminal proceedings in which the office holder was acquitted or as a result of a conviction for an offense that does not require
proof of criminal intent. |
• |
a breach of duty of loyalty to the company, provided that the office holder acted in good faith and had
a reasonable basis to believe that the act would not prejudice the company; |
• |
a breach of duty of care to the company or to a third party, including a breach arising out of the negligent
(but not intentional or reckless) conduct of the office holder; |
• |
a financial liability imposed on the office holder in favor of a third party; |
• |
a monetary liability imposed on the office holder in favor of an injured party in an Administrative Procedure
pursuant to Section 52(54)(a)(1)(a) of the Israeli Securities Law; and |
• |
expenses, including reasonable litigation expenses and reasonable attorneys’ fees, incurred by an
office holder in connection with an Administrative Procedure instituted against him or her pursuant to certain provisions of the Israeli
Securities Law. |
• |
a breach of duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty
to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice
the company; |
• |
a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent
conduct of the office holder; |
• |
an act or omission committed with intent to derive illegal personal benefit; or |
• |
a fine, monetary sanction or forfeit levied against the office holder. |
|
|
December 31, |
| |||||||||
|
|
2021 |
|
|
2022 |
|
|
2023 |
| |||
|
|
|
|
|
|
|
|
|
| |||
Management and administration |
|
|
9 |
|
|
|
12 |
|
|
|
12 |
|
Research and development |
|
|
27 |
|
|
|
29 |
|
|
|
29 |
|
Commercialization and business development |
|
|
2 |
|
|
|
8 |
|
|
|
38 |
|
Total |
|
|
38 |
|
|
|
49 |
|
|
|
79 |
|
|
|
Number of |
|
|
|
| ||
|
|
Ordinary Shares |
|
|
|
| ||
|
|
Beneficially |
|
|
Percent of |
| ||
|
|
Held |
|
|
Class |
| ||
|
|
|
|
|
|
| ||
Directors |
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
Aharon Schwartz(1)
|
|
|
4,784,970 |
|
|
|
* |
|
B.J. Bormann(2) |
|
|
1,079,970 |
|
|
|
* |
|
Rami Dar(3) |
|
|
630,000 |
|
|
|
* |
|
Raphael Hofstein(4)
|
|
|
1,079,970 |
|
|
|
* |
|
Avraham Molcho(5)
|
|
|
1,079,970 |
|
|
|
* |
|
Sandra Panem(6) |
|
|
1,079,970 |
|
|
|
* |
|
Shaoyu Yan |
- |
|||||||
Gal Cohen |
- |
|||||||
|
|
|
|
|
|
|
|
|
Executive officers |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Philip A. Serlin(7)
|
|
|
12,120,645 |
|
|
|
1.1 |
% |
Mali Zeevi(8) |
|
|
3,348,030 |
|
|
|
* |
|
Ella Sorani(9) |
|
|
3,195,930 |
|
|
|
* |
|
Holly May (10) |
|
|
3,567,645 |
|
|
|
* |
|
|
|
|
|
|
|
|
| |
All directors and executive officers as a group (12 persons)(11)
|
|
|
31,967,100 |
|
|
|
2.9 |
% |
(1) |
Includes 3,705,000 Ordinary Shares and 1,079,970 Ordinary Shares issuable upon exercise
of outstanding options currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares
issuable upon exercise of outstanding options that are not exercisable within 60 days of March 15, 2024. |
(2) |
Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently
exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding
options that are not exercisable within 60 days of March 15, 2024. |
(3) |
Includes 630,000 Ordinary Shares issuable upon exercise of outstanding options currently
exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding
options that are not exercisable within 60 days of March 15, 2024. |
(4) |
Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently
exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding
options that are not exercisable within 60 days of March 15, 2024. |
(5) |
Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently exercisable
or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding options
that are not exercisable within 60 days of March 15, 2024. |
(6) |
Includes 1,079,970 Ordinary Shares issuable upon exercise of outstanding options currently
exercisable or exercisable within 60 days of March 15, 2024. Does not include 810,000 Ordinary Shares issuable upon exercise of outstanding
options that are not exercisable within 60 days of March 15, 2024. |
(7) |
Includes 171,900 Ordinary Shares and 11,948,745 Ordinary Shares issuable upon exercise
of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 11,996,775 Ordinary
Shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 15, 2024. |
(8) |
Includes 328,665 Ordinary Shares and 3,019,365 Ordinary Shares issuable upon exercise
of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 2,862,840 Ordinary
Shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 15, 2024. |
(9) |
Includes 66,150 Ordinary Shares and 3,129,780 Ordinary Shares issuable upon exercise
of outstanding options and PSUs currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 2,862,840 Ordinary
Shares issuable upon exercise of outstanding options and PSUs that are not exercisable within 60 days of March 15, 2024. |
(10) |
Includes 3,567,645 Ordinary Shares issuable upon exercise of outstanding options and
PSUs currently exercisable or exercisable within 60 days of March 15, 2024. Does not include 7,052,865 Ordinary Shares issuable upon exercise
of outstanding options and PSUs that are not exercisable within 60 days of March 15, 2024. |
(11) |
See footnotes (1)-(10) for certain information regarding beneficial ownership.
|
Name |
Number of
Ordinary Shares
Beneficially
Held |
Percent of
Class |
||||||
Hong Seng Technology Limited(1)
|
102,437,055 |
9.4 |
% |
(1) |
Based on Schedule 13D filed with the SEC on October 26, 2023. According to the Schedule 13D, includes 6,829,137 ADS, representing
102,437,055 ordinary shares held by Hong Seng Technology Limited. Lepu (Hong Kong) Co., Limited holds 66.67% equity interest of
Hong Seng Technology Limited. Lepu Holdings Limited holds 99.5% equity interest of Lepu (Hong Kong) Co., Limited. Lepu Medical
(Europe) Cooperatief U.A. holds 100% equity interest of Lepu Holdings Limited. Lepu Medical Technology (Beijing) Co., Ltd. holds 99.95%
equity interest of Lepu Medical (Europe) Cooperatief U.A. Lepu Medical Technology (Beijing) Co., Ltd. is a company publicly listed on
Shenzhen Stock Exchange in the PRC (300003.SZ). |
|
• |
amendments to our Articles of Association; |
|
• |
appointment, termination or the terms of service of our auditors; |
|
• |
appointment of external directors (if applicable); |
|
• |
approval of certain related party transactions; |
|
• |
increases or reductions of our authorized share capital; |
|
• |
a merger; and |
|
• |
the exercise of our board of directors’ powers by a general meeting, if our board of directors is unable to exercise its powers
and the exercise of any of its powers is required for our proper management. |
• |
the excess distribution or gain would be allocated ratably over the Non-Electing U.S.
Investor’s holding period for the ordinary shares or ADSs; |
• |
the amount allocated to the current taxable year and any year prior to us becoming
a PFIC would be taxed as ordinary income; and |
• |
the amount allocated to each of the other taxable years would be subject to tax at
the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed deferral benefit
would be imposed with respect to the resulting tax attributable to each such other taxable year. |
• |
taxes and other governmental charges; |
• |
any applicable transfer or registration fees; |
• |
certain cable, telex and facsimile transmission charges as provided in the deposit
agreement; |
• |
any expenses incurred in the conversion of foreign currency; |
• |
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery
of ADRs and the surrender of ADRs, including if the deposit agreement terminates; |
• |
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made
pursuant to the deposit agreement; |
• |
a fee for the distribution of securities pursuant to the deposit agreement;
|
• |
in addition to any fee charged for a cash distribution, a fee of $.05 or less per
ADS (or portion thereof) per annum for depositary services; |
• |
a fee for the distribution of proceeds of rights that the Depositary sells pursuant
to the deposit agreement; and |
• |
any other charges payable by the Depositary, any of the Depositary’s agents,
or the agents of the Depositary’s agents in connection with the servicing of ordinary shares or other Deposited Securities.
|
a. |
Disclosure Controls and Procedures
|
b. |
Management’s Annual Report on Internal
Control over Financial Reporting |
c. |
Attestation Report of Registered Public Accounting
Firm |
d. |
Changes in Internal Control over Financial
Reporting |
|
|
Year Ended December 31, |
| |||||
|
|
2022 |
|
|
2023 |
| ||
Services Rendered |
|
(in thousands of U.S. dollars) |
| |||||
|
|
|
|
|
|
| ||
Audit Fees(1) |
|
|
130 |
|
|
|
130 |
|
Audit-Related Fees(2)
|
|
|
4 |
|
|
|
17 |
|
Tax Fees(3) |
|
|
18 |
|
|
|
52 |
|
All Other Fees |
|
|
- |
|
|
|
- |
|
Total |
|
|
152 |
|
|
|
199 |
|
(1) |
Audit fees consist of services that would normally be provided in connection with statutory and regulatory
filings or engagements, including services that generally only the independent accountant can reasonably provide. |
|
|
(2) |
Audit-related services relate to reports to the IIA and work regarding a public listing or offering.
|
|
|
(3) |
Tax fees relate to tax compliance, planning and advice. |
• |
Distribution of periodic reports to shareholders.
Under Israeli law, a public company whose shares are traded on the TASE, is not required to distribute periodic reports directly to shareholders
and the generally accepted business practice in Israel is not to distribute such reports to shareholders but to make such reports publicly
available through a public website. We will only mail such reports to shareholders upon request. In addition, we make our audited financial
statements available to our shareholders at our offices. |
• |
Quorum. While the Nasdaq Rules require that
the quorum for purposes of any meeting of the holders of a listed company’s common voting stock, as specified in the company’s
bylaws, be no less than 33 1/3% of the company’s outstanding common voting stock, as permitted under the Companies Law, our Articles
of Association provide that a quorum of two or more shareholders holding at least 25% of the voting rights in person or by proxy is required
for commencement of business at a general meeting (and, with respect to an adjourned meeting, a quorum consists of any number of shareholders
present in person or by proxy). |
• |
Nomination of Directors.
We follow Israeli corporate governance practices instead of the requirements of the Nasdaq Rules with regard to the nomination committee
and director nomination procedures. Israeli law and practice does not require director nominations to be made by a nominating committee
of our board of directors consisting solely of independent directors, as required under the Nasdaq Rules. In accordance with Israeli
law and practice, directors are recommended by our board of directors for election by our shareholders (other than directors elected by
our board of directors to fill a vacancy), and certain of our shareholders may nominate candidates for election as directors by the general
meeting of shareholders in accordance with the Companies Law and our Articles of Association. |
• |
Compensation of Officers.
We follow Israeli law and practice with respect to the approval of officer compensation, pursuant to which transactions with office holders
regarding their terms of office and employment, and a transaction with a controlling shareholder in a company regarding his or her employment
and/or his or her terms of office with the company, generally require the approval of the compensation committee, the board of directors
and under certain circumstances (such as if the officer is a director or controlling shareholder) the shareholders, either in accordance
with our compensation policy or, in special circumstances in deviation therefrom, taking into account certain considerations set forth
in the Companies Law. See “Item 6.C— Directors, Senior Management and Employees — Board Practices — Compensation
Committee” for information regarding the Compensation Committee, and “Item 6.C — Directors, Senior Management and Employees
— Approval of Related Party Transactions under Israeli Law” for information regarding the approvals required with respect
to approval of terms of office and employment of office holders, pursuant to the Companies Law. |
• |
Approval of Related Party Transactions.
We follow Israeli law and practice with respect to the approval of interested party acts and transactions, as set forth in sections 268
to 275 of the Companies Law, and the regulations promulgated thereunder, which generally require the approval of the audit committee,
the board of directors and, under certain circumstances (such as if the officer holder is a controlling shareholder) the shareholders,
as may be applicable, for specified transactions. See “Item 6.C— Directors, Senior Management and Employees —Board Practices
— Approval of Related Party Transactions under Israeli Law” for information regarding the approvals required with respect
to approval of related party transactions pursuant to the Companies Law. |
• |
Shareholder Approval. We intend to seek shareholder
approval for all corporate actions requiring such approval in accordance with the requirements of the Companies Law, which are different
or in addition to the requirements for seeking shareholder approval under Nasdaq Listing Rule 5635, rather than seeking approval for corporation
actions in accordance with such listing rules. |
• |
Equity Compensation Plans. We do not necessarily
seek shareholder approval for the establishment of, and amendments to, stock option or equity compensation plans (as set forth in Nasdaq
Listing Rule 5635(c)), as such matters are not subject to shareholder approval under Israeli law and practice. However, any equity-based
compensation arrangement with a director or the chief executive officer or the material amendment of such an arrangement must be approved
by our Compensation Committee, board of directors and shareholders, in that order. |
Exhibit
Number |
|
Exhibit Description |
2.2
* |
|
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
|
||
|
||
|
||
|
||
|
||
|
* |
Filed herewith. |
† |
Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential
treatment request. |
(1) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on February 23, 2021.
|
(2) |
Incorporated by reference to Exhibit 1 of the Registration Statement on Form F-6EF (No. 333-218969) filed
by the Bank of New York Mellon on June 26, 2017 with respect to the Registrant’s American Depositary Shares. |
(3) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2017.
|
(4) |
Incorporated by reference to the Registrant’s Registration Statement on Form 20-F (No. 001-35223)
filed on July 1, 2011. |
(5) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 10, 2016.
|
(6) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on May 31, 2016.
|
(7) |
Incorporated by reference to the Registrant’s Form 6-K filed on October 3, 2018. |
(8) |
Incorporated by reference to the Registrant’s Form 6-K filed on May 27, 2022. |
(9) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 12, 2020.
|
(10) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2015.
|
(11) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on September 22,
2015. |
(12) |
Incorporated by reference to the Registrant’s Form 6-K filed on February 7, 2019. |
(13) |
Incorporated by reference to the Registrant’s Form 6-K filed on January 21, 2021. |
(14) |
Incorporated by reference to the Registrant’s Form 6-K filed on September 3, 2021. |
(15) |
Incorporated by reference to the Registrant’s Form 6-K filed on September 15, 2022. |
(16) |
Incorporated by reference to the Registrant’s Form 6-K filed on September 21, 2022. |
(17) |
Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 16, 2022.
|
(18) |
Incorporated by reference to the Registrant’s Form 6-K filed on August 30, 2023. |
|
BIOLINERX LTD. |
| |
|
|
|
|
|
By: |
/s/ Philip A. Serlin |
|
|
|
Philip A. Serlin |
|
|
|
Chief Executive Officer |
|
Page | |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman & Kesselman C.P.A.s and PCAOB ID No. 1309)
|
F-2
|
CONSOLIDATED FINANCIAL STATEMENTS:
|
|
F-5
|
|
F-6
|
|
F-7
|
|
F-8
|
|
F-10
|
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management's revenue recognition process including controls over the determination of estimated standalone selling prices and the estimated hours to complete the PDAC license and support services performance obligation. The procedures also included, among others, (i) reading the related agreements; (ii) evaluating and testing management’s process for determining the estimated standalone selling prices and the estimated hours to complete the PDAC license and support services performance obligation which included evaluating the reasonableness of the valuation methodology and significant assumptions, including the estimated expected support hours, used by management and considering the factors that can affect the accuracy of those estimates. Professionals with specialized skill and knowledge were used to assist in the evaluation of the Company’s model.
/s/ Kesselman & Kesselman
|
Certified Public Accountants (Isr.)
|
A member firm of PricewaterhouseCoopers International Ltd.
|
Tel Aviv, Israel
|
March 26, 2024
|
Note
|
December 31,
|
|||||||||||
2022
|
2023
|
|||||||||||
in USD thousands
|
||||||||||||
Assets
|
||||||||||||
CURRENT ASSETS
|
||||||||||||
Cash and cash equivalents
|
5
|
10,587
|
4,255
|
|||||||||
Short-term bank deposits
|
6
|
40,495
|
38,739
|
|||||||||
Trade receivables
|
-
|
358
|
||||||||||
Prepaid expenses
|
198
|
1,048
|
||||||||||
Other receivables
|
18a
|
|
721
|
830
|
||||||||
Inventory
|
7
|
-
|
1,953
|
|||||||||
Total current assets
|
52,001
|
47,183
|
||||||||||
NON-CURRENT ASSETS
|
||||||||||||
Property and equipment, net
|
8
|
726
|
473
|
|||||||||
Right-of-use assets, net
|
10
|
1,772
|
1,415
|
|||||||||
Intangible assets, net
|
9
|
21,885
|
14,854
|
|||||||||
Total non-current assets
|
24,383
|
16,742
|
||||||||||
Total assets
|
76,384
|
63,925
|
||||||||||
Liabilities and equity
|
||||||||||||
CURRENT LIABILITIES
|
||||||||||||
Current maturities of long-term loans
|
11
|
1,542
|
3,145
|
|||||||||
Contract liabilities
|
16
|
-
|
12,957
|
|||||||||
Accounts payable and accruals:
|
||||||||||||
Trade
|
18b
|
6,966
|
10,869
|
|||||||||
Other
|
18b
|
1,744
|
3,353
|
|||||||||
Current maturities of lease liabilities
|
10
|
427
|
528
|
|||||||||
Total current liabilities
|
10,679
|
30,852
|
||||||||||
NON-CURRENT LIABILITIES
|
||||||||||||
Warrants
|
12c
|
4,509
|
11,932
|
|||||||||
Long-term loans, net of current maturities
|
11
|
8,626
|
6,628
|
|||||||||
Lease liabilities
|
10
|
1,729
|
1,290
|
|||||||||
Total non-current liabilities
|
14,864
|
19,850
|
||||||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
15
|
- | - | |||||||||
Total liabilities
|
25,543
|
50,702
|
||||||||||
EQUITY
|
12
|
|||||||||||
Ordinary shares
|
27,100
|
31,355
|
||||||||||
Share premium
|
338,976
|
355,482
|
||||||||||
Warrants
|
1,408
|
1,408
|
||||||||||
Capital reserve
|
14,765
|
17,000
|
||||||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||||||
Accumulated deficit
|
(329,992
|
)
|
(390,606
|
)
|
||||||||
Total equity
|
50,841
|
13,223
|
||||||||||
Total liabilities and equity
|
76,384
|
63,925
|
F-5
Note
|
Year ended December 31,
|
|||||||||||||||
2021
|
2022
|
2023
|
||||||||||||||
in USD thousands
|
||||||||||||||||
REVENUES
|
18c
|
-
|
-
|
4,800
|
||||||||||||
COST OF REVENUES
|
18d
|
-
|
-
|
(3,692
|
)
|
|||||||||||
GROSS PROFIT
|
-
|
-
|
1,108
|
|||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
18e
|
(19,466
|
)
|
(17,629
|
)
|
(12,519
|
)
|
|||||||||
SALES AND MARKETING EXPENSES
|
18f
|
(1,003
|
)
|
(6,462
|
)
|
(25,270
|
)
|
|||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
18g
|
(4,308
|
)
|
(5,066
|
)
|
(6,310
|
)
|
|||||||||
IMPAIRMENT OF INTANGIBLE ASSETS
|
9
|
-
|
-
|
(6,703
|
)
|
|||||||||||
OPERATING LOSS
|
(24,777
|
)
|
(29,157
|
)
|
(49,694
|
)
|
||||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
18h
|
(1,830
|
)
|
5,670
|
(10,819
|
)
|
||||||||||
FINANCIAL INCOME
|
18i
|
559
|
694
|
2,068
|
||||||||||||
FINANCIAL EXPENSES
|
18j
|
(1,006
|
)
|
(2,158
|
)
|
(2,169
|
)
|
|||||||||
LOSS AND COMPREHENSIVE LOSS
|
(27,054
|
)
|
(24,951
|
)
|
(60,614
|
)
|
||||||||||
in USD
|
||||||||||||||||
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
|
14
|
(0.04
|
)
|
(0.03
|
)
|
(0.06
|
)
|
|||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
14
|
662,933,695
|
773,956,973
|
963,365,525
|
F-6
Ordinary shares
|
Share premium
|
Warrants
|
Capital reserve
|
Other
comprehensive
loss |
Accumulated
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2021
|
9,870
|
279,241
|
-
|
12,322
|
(1,416
|
)
|
(277,987
|
)
|
22,030
|
|||||||||||||||||||
CHANGES IN 2021:
|
||||||||||||||||||||||||||||
Issuance of share capital and warrants, net
|
8,956
|
40,476
|
975
|
-
|
-
|
-
|
50,407
|
|||||||||||||||||||||
Warrants exercised
|
2,235
|
18,967
|
-
|
-
|
-
|
-
|
21,202
|
|||||||||||||||||||||
Employee stock options exercised
|
5
|
41
|
-
|
(39
|
)
|
-
|
-
|
7
|
||||||||||||||||||||
Employee stock options expired
|
-
|
621
|
-
|
(621
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
1,495
|
-
|
-
|
1,495
|
|||||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(27,054
|
)
|
(27,054
|
)
|
||||||||||||||||||||
BALANCE AT DECEMBER 31, 2021
|
21,066
|
339,346
|
975
|
13,157
|
(1,416
|
)
|
(305,041
|
)
|
68,087
|
|||||||||||||||||||
CHANGES IN 2022:
|
||||||||||||||||||||||||||||
Issuance of share capital and warrants, net
|
6,029
|
(1,007
|
)
|
433
|
-
|
-
|
-
|
5,455
|
||||||||||||||||||||
Employee stock options exercised
|
5
|
14
|
-
|
(14
|
)
|
-
|
-
|
5
|
||||||||||||||||||||
Employee stock options expired
|
-
|
623
|
-
|
(623
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
2,245
|
-
|
-
|
2,245
|
|||||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
(24,951
|
)
|
(24,951
|
)
|
||||||||||||||||||||
BALANCE AT DECEMBER 31, 2022
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES IN 2023:
|
||||||||||||||||||||||||||||
Issuance of share capital, net
|
3,242
|
10,847
|
-
|
-
|
-
|
-
|
14,089
|
|||||||||||||||||||||
Warrants exercised
|
1,000
|
5,559
|
-
|
-
|
-
|
-
|
6,559
|
|||||||||||||||||||||
Employee stock options exercised
|
13
|
45
|
-
|
(31
|
)
|
-
|
-
|
27
|
||||||||||||||||||||
Employee stock options expired
|
-
|
55
|
-
|
(55
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
2,321
|
-
|
-
|
2,321
|
|||||||||||||||||||||
Comprehensive loss for the year
|
-
|
-
|
-
|
-
|
-
|
(60,614
|
)
|
(60,614
|
)
|
|||||||||||||||||||
BALANCE AT DECEMBER 31, 2023
|
31,355
|
355,482
|
1,408
|
17,000
|
(1,416
|
)
|
(390,606
|
)
|
13,223
|
F-7
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||||||
Loss
|
(27,054
|
)
|
(24,951
|
)
|
(60,614
|
)
|
||||||
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
3,481
|
(1,289
|
)
|
38,006
|
||||||||
Net cash used in operating activities
|
(23,573
|
)
|
(26,240
|
)
|
(22,608
|
)
|
||||||
CASH FLOWS - INVESTING ACTIVITIES
|
||||||||||||
Investments in short-term deposits
|
(78,000
|
)
|
(44,000
|
)
|
(47,588
|
)
|
||||||
Maturities of short-term deposits
|
39,873
|
48,322
|
49,329
|
|||||||||
Purchase of property and equipment
|
(97
|
)
|
(131
|
)
|
(116
|
)
|
||||||
Purchase of intangible assets
|
-
|
(185
|
)
|
(181
|
)
|
|||||||
Net cash provided by (used in) investing activities
|
(38,224
|
)
|
4,006
|
1,444
|
||||||||
CASH FLOWS - FINANCING ACTIVITIES
|
||||||||||||
Issuance of share capital and warrants, net of issuance costs
|
50,407
|
14,359
|
14,089
|
|||||||||
Exercise of warrants
|
10,907
|
-
|
2,928
|
|||||||||
Employee stock options exercised
|
7
|
5
|
27
|
|||||||||
Proceeds from long-term loan, net of issuance costs
|
-
|
9,126
|
-
|
|||||||||
Repayments of loans
|
(3,376
|
)
|
(2,832
|
)
|
(1,543
|
)
|
||||||
Repayments of lease liabilities
|
(196
|
)
|
(220
|
)
|
(445
|
)
|
||||||
Net cash provided by financing activities
|
57,749
|
20,438
|
15,056
|
|||||||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
(4,048
|
)
|
(1,796
|
)
|
(6,108
|
)
|
||||||
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
16,831
|
12,990
|
10,587
|
|||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
207
|
(607
|
)
|
(224
|
)
|
|||||||
CASH AND CASH EQUIVALENTS - END OF YEAR
|
12,990
|
10,587
|
4,255
|
F-8
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
APPENDIX
|
||||||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||||||
Income and expenses not involving cash flows:
|
||||||||||||
Depreciation and amortization
|
703
|
654
|
1,384
|
|||||||||
Exchange differences on cash and cash equivalents
|
(207
|
)
|
607
|
224
|
||||||||
Fair value adjustments of warrants
|
1,936
|
(6,425
|
)
|
11,054
|
||||||||
Share-based compensation
|
1,495
|
2,245
|
2,321
|
|||||||||
Interest and exchange differences on short-term deposits
|
(262
|
)
|
(672
|
)
|
15
|
|||||||
Interest on loans
|
301
|
1,117
|
1,148
|
|||||||||
Warrant issuance costs
|
-
|
171
|
-
|
|||||||||
Exchange differences on lease liabilities
|
55
|
(224
|
)
|
(42
|
)
|
|||||||
Intangible assets impairment
|
-
|
-
|
6,703
|
|||||||||
4,021
|
(2,527
|
)
|
22,807
|
|||||||||
Changes in operating asset and liability items:
|
||||||||||||
Increase in trade receivables
|
-
|
-
|
(358
|
)
|
||||||||
Increase in inventory
|
-
|
-
|
(1,953
|
)
|
||||||||
Decrease (increase) in prepaid expenses and other receivables
|
24
|
(650
|
)
|
(959
|
)
|
|||||||
Increase (decrease) in accounts payable and accruals
|
(564
|
)
|
1,888
|
5,512
|
||||||||
Increase in contract liabilities
|
-
|
-
|
12,957
|
|||||||||
(540
|
)
|
1,238
|
15,199
|
|||||||||
3,481
|
(1,289
|
)
|
38,006
|
|||||||||
Supplemental information on interest received in cash
|
138
|
342
|
2,020
|
|||||||||
Supplemental information on interest paid in cash
|
682
|
593
|
1,111
|
|||||||||
Supplemental information on non-cash transactions:
|
||||||||||||
Changes in right-of-use asset and lease liabilities
|
183
|
706
|
149
|
|||||||||
Warrant issuance costs
|
-
|
262
|
-
|
|||||||||
Purchase of property and equipment
|
-
|
28
|
-
|
|||||||||
Fair value of exercised warrants (portion related to accumulated fair value adjustments)
|
10,295
|
-
|
3,631
|
F-9
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
General
|
b.
|
Israel-Hamas war
|
F-10
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – GENERAL INFORMATION (cont.)
c.
|
Going concern
|
d.
|
Approval of consolidated financial statements
|
F-11
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Basis of presentation
|
F-12
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
b.
|
Functional and reporting currency
|
c.
|
Inventory
|
d.
|
Property and equipment
|
%
|
|
Computers and communications equipment
|
33
|
Office furniture and equipment
|
6
|
Laboratory equipment
|
15
|
F-13
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
e.
|
Intangible assets
|
f.
|
Impairment of non-financial assets
|
g.
|
Warrants
|
F-14
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
h.
|
Borrowings
|
F-15
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
i.
|
Revenues
|
•
|
identify the contract with a customer;
|
•
|
identify the performance obligations in the contract;
|
•
|
determine the transaction price;
|
•
|
allocate the transaction price to the performance obligations in the contract; and
|
•
|
recognize revenue when (or as) the entity satisfies a performance obligation.
|
1.
|
Distribution fees - The Company pays distribution fees to its three main distributors. The distribution fees are paid based on contractually determined rates from the gross consideration. When the service is received and the products sold to distributors, it is recognized as a reduction of revenues in the period the related revenues from the sale of products are recognized.
|
2.
|
Rebates and patient discount programs - The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. The Company estimates the allowance for these rebates, based on the estimated utilization of the rebate and discount programs, at the time the revenues are recognized. These estimates are recognized as a reduction of revenues.
|
3.
|
Product returns - The Company offers customers a right of return as part of the distributor agreements. The Company estimates the amount of product sales that may be returned by its customers and records this estimate as a reduction of revenues at the time of sale, based on estimates of product returns based on its own sales information, its visibility into the inventory remaining in the distribution channel, and product dating.
|
F-16
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
i.
|
Revenues (cont.)
|
1)
|
Development milestones: Variable payments, contingent on achieving additional milestones, are included in the transaction price based on the most likely amount method. Amounts included in the transaction price are recognized only when it is highly probable that a material reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement.
|
2)
|
Sales-based royalties and sales-based milestones are recognized as the related sale occurs, due to the specific exception of IFRS 15 for sales-based royalties from licensing of intellectual properties.
|
F-17
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
j.
|
Research and development expenses
|
k.
|
Share-based payments
|
l.
|
Loss per share
|
1) |
Basic
|
2) |
Diluted
|
F-18
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – MATERIAL ACCOUNTING POLICIES (cont.)
m.
|
Leases
|
Years
|
|
Property
|
11
|
Motor vehicles
|
3
|
F-19
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
n.
|
New International Financial Reporting Standards, amendments to standards and new interpretations:
|
F-20
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Market risk
|
1)
|
Concentration of currency risk
|
December 31, 2023
|
||||||||||||||||||||
Income (loss)
|
Value on
|
Income (loss)
|
||||||||||||||||||
Sensitive instrument
|
10% increase
|
5% increase
|
balance sheet
|
5% decrease
|
10% decrease
|
|||||||||||||||
in USD thousands
|
||||||||||||||||||||
NIS-linked balances:
|
||||||||||||||||||||
Cash and cash equivalents
|
(132
|
)
|
(69
|
)
|
1,457
|
77
|
162
|
|||||||||||||
Short term deposit
|
(251
|
)
|
(131
|
)
|
2,758
|
145
|
306
|
|||||||||||||
Other receivables
|
(31
|
)
|
(16
|
)
|
344
|
18
|
38
|
|||||||||||||
Trade payables
|
243
|
127
|
(2,670
|
)
|
(141
|
)
|
(297
|
)
|
||||||||||||
Other payables
|
169
|
89
|
(1,853
|
)
|
(98
|
)
|
(207
|
)
|
||||||||||||
Total NIS-linked balances
|
(2
|
)
|
0
|
36
|
1
|
2
|
||||||||||||||
Euro-linked trade payables
|
(117
|
)
|
(61
|
)
|
(1,283
|
)
|
67
|
142
|
||||||||||||
Total
|
(119
|
)
|
(61
|
)
|
(1,247
|
)
|
68
|
144
|
December 31, 2022
|
||||||||||||||||||||
Income (loss)
|
Value on
|
Income (loss)
|
||||||||||||||||||
Sensitive instrument
|
10% increase
|
5% increase
|
balance sheet
|
5% decrease
|
10% decrease
|
|||||||||||||||
in USD thousands
|
||||||||||||||||||||
NIS-linked balances:
|
||||||||||||||||||||
Cash and cash equivalents
|
(416
|
)
|
(218
|
)
|
4,573
|
241
|
508
|
|||||||||||||
Other receivables
|
(66
|
)
|
(34
|
)
|
721
|
38
|
80
|
|||||||||||||
Trade payables
|
38
|
20
|
(416
|
)
|
(22
|
)
|
(46
|
)
|
||||||||||||
Other payables
|
114
|
60
|
(1,257
|
)
|
(66
|
)
|
(140
|
)
|
||||||||||||
Total NIS-linked balances
|
(330
|
)
|
(172
|
)
|
3,621
|
191
|
402
|
|||||||||||||
Euro-linked trade payables
|
(144
|
)
|
(76
|
)
|
(1,590
|
)
|
84
|
177
|
||||||||||||
Total
|
(474
|
)
|
(248
|
)
|
2,031
|
275
|
579
|
F-21
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a. |
Market risk (cont.)
|
1) |
Concentration of currency risk (cont.)
|
|
December 31, 2022
|
December 31, 2023
|
|||||||||||||||||||||||
Dollar
|
NIS
|
Other currencies
|
Dollar
|
NIS
|
Other Currencies
|
|||||||||||||||||||
USD in thousands
|
USD in thousands
|
|||||||||||||||||||||||
Assets:
|
||||||||||||||||||||||||
Current assets:
|
||||||||||||||||||||||||
Cash and cash equivalents
|
5,685
|
4,573
|
329
|
2,768
|
1,457
|
30
|
||||||||||||||||||
Short term bank deposits
|
40,495
|
-
|
-
|
35,981
|
2,758
|
-
|
||||||||||||||||||
Other receivables
|
-
|
721
|
-
|
480
|
350
|
-
|
||||||||||||||||||
46,180
|
5,294
|
329
|
39,229
|
4,565
|
30
|
|||||||||||||||||||
Liabilities:
|
||||||||||||||||||||||||
Current liabilities:
|
||||||||||||||||||||||||
Current maturities of long-term loans
|
1,542
|
-
|
-
|
3,145
|
-
|
-
|
||||||||||||||||||
Accounts payable and accruals:
|
||||||||||||||||||||||||
Trade
|
4,359
|
416
|
2,191
|
6,663
|
2,670
|
1,536
|
||||||||||||||||||
Other
|
487
|
1,257
|
-
|
1,500
|
1,853
|
-
|
||||||||||||||||||
Non-current liabilities
|
||||||||||||||||||||||||
Long-term loans, net of current maturities
|
8,626
|
-
|
-
|
6,628
|
-
|
-
|
||||||||||||||||||
15,014
|
1,673
|
2,191
|
17,936
|
4,523
|
1,536
|
|||||||||||||||||||
Net balance
|
31,166
|
3,621
|
(1,862
|
)
|
21,293
|
42
|
(1,506
|
)
|
F-22
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Market risk (cont.)
|
|
2) |
Fair value of financial instruments
|
3) |
Exposure to market risk and management thereof
|
4) |
Interest rate risk
|
b.
|
Credit risk
|
December 31,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Assets:
|
||||||||
Cash and cash equivalents
|
10,587
|
4,255
|
||||||
Short-term bank deposits
|
40,495
|
38,739
|
||||||
Trade receivables
|
-
|
358
|
||||||
Other receivables
|
721
|
830
|
||||||
Total
|
51,803
|
44,182
|
F-23
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
c.
|
Liquidity risk
|
d.
|
Fair value of financial instruments
|
Level 1
|
Quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
Level 2
|
Inputs, other than quoted prices included within level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (derived from prices).
|
Level 3
|
Inputs for the asset or liability that are not based on observable market data (unobservable inputs).
|
F-24
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
e.
|
Changes in financial liabilities with cash flows included in financing activities
|
Long-term loans
|
Warrants
|
Total
|
||||||||||
in USD thousands
|
||||||||||||
Balance as of January 1, 2021
|
5,832
|
10,218
|
16,050
|
|||||||||
Changes during the year 2021:
|
||||||||||||
Principal and interest payments
|
(3,814
|
)
|
-
|
(3,814
|
)
|
|||||||
Share premium resulting from exercise of warrants
|
(10,295
|
)
|
(10,295
|
)
|
||||||||
Amounts recognized through profit and loss
|
739
|
1,936
|
2,675
|
|||||||||
Balance as of December 31, 2021
|
2,757
|
1,859
|
4,616
|
|||||||||
Changes during the year 2022:
|
||||||||||||
Net proceeds
|
9,126
|
9,075
|
18,201
|
|||||||||
Principal and interest payments
|
(3,177
|
)
|
-
|
(3,177
|
)
|
|||||||
Amounts recognized through profit and loss
|
1,462
|
(6,425
|
)
|
(4,963
|
)
|
|||||||
Balance as of December 31, 2022
|
10,168
|
4,509
|
14,677
|
|||||||||
Changes during the year 2023:
|
||||||||||||
Principal payments or received
|
(1,543
|
)
|
-
|
(1,543
|
)
|
|||||||
Amounts recognized through profit and loss
|
1,148
|
11,054
|
12,202
|
|||||||||
Share premium resulting from exercise of warrants
|
-
|
(3,631
|
)
|
(3,631
|
)
|
|||||||
Balance as of December 31, 2023
|
9,773
|
11,932
|
21,705
|
f.
|
Fair value measurement of warrants using significant unobservable inputs (level 3)
|
Warrants
|
||||
in USD thousands
|
||||
Balance as of January 1, 2021
|
10,218
|
|||
Changes during 2021:
|
||||
Exercises
|
(10,295
|
)
|
||
Changes in fair value through profit and loss
|
1,936
|
|||
Balance as of December 31, 2021
|
1,859
|
|||
Changes during 2022:
|
||||
Issuances
|
9,075
|
|||
Changes in fair value through profit and loss
|
(6,425
|
)
|
||
Balance as of December 31, 2022
|
4,509
|
|||
Changes during 2023:
|
||||
Exercises
|
(3,631
|
)
|
||
Changes in fair value through profit and loss
|
11,054
|
|||
Balance as of December 31, 2023
|
11,932
|
F-25
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
F-26
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
•
|
The allocation of consideration between the license agreement and the SPA, based on the fair value of the Company’s shares on the date considered as the closing date of the transaction
|
•
|
The estimated stand-alone, selling-price value between the contract components (i.e., between the main therapeutic areas covered by the contract), as well as the performance obligations relating to each of the components
|
•
|
The period of time over which revenue should be recognized for each component. The revenue recognition method is the ratio of support hours to the total hours expected to be incurred.
|
December 31,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Cash on hand and in bank
|
3,623
|
3,154
|
||||||
Short-term bank deposits
|
6,964
|
1,101
|
||||||
10,587
|
4,255
|
F-27
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
December 31,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Raw materials
|
-
|
903
|
||||||
Work-in-progress
|
-
|
471
|
||||||
Finished goods
|
-
|
579
|
||||||
-
|
1,953
|
F-28
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2022
|
2023
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2023
|
||||||||||||||||||||||||||||||||||||||||
Office furniture and equipment
|
244
|
8
|
-
|
252
|
138
|
27
|
-
|
165
|
106
|
87
|
||||||||||||||||||||||||||||||
Computers and communications equipment
|
961
|
101
|
-
|
1,062
|
712
|
108
|
-
|
820
|
249
|
242
|
||||||||||||||||||||||||||||||
Laboratory equipment
|
1,606
|
7
|
-
|
1,613
|
1,578
|
20
|
-
|
1,598
|
28
|
15
|
||||||||||||||||||||||||||||||
Leasehold improvements
|
2,036
|
-
|
-
|
2,036
|
1,693
|
214
|
-
|
1,907
|
343
|
129
|
||||||||||||||||||||||||||||||
4,847
|
116
|
-
|
4,963
|
4,121
|
369
|
-
|
4,490
|
726
|
473
|
F-29
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
- |
$6.7 million recorded as a result of the acquisition of Agalimmune, primarily related to its main drug candidate, AGI-134 (see Note 1a). In December 2023, the Company made a decision to terminate the development of AGI-134. Accordingly, the intellectual property related to AGI-134 has been written-off in the 2023 financial statements.
|
- |
$15.0 million associated with BL-8040 were recorded following an amendment to the in-licensing agreement with Biokine Therapeutics Ltd. ("Biokine"). This amendment reduced the payments owed by the Company on sublicense receipts (as defined in the license agreement) from 40% to 20%. This intellectual property is amortized proportionally with the revenues recognized from the licensing transaction with HST and Gloria in Asia (see Note 16), as well as in accordance with the lifespan of the patents in the U.S., following commencement of self-commercialization of motixafortide towards the end of 2023.
|
Cost
|
Accumulated depreciation and impairment
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Disposal
|
Balance at
|
Balance at
|
Additions
|
Impairment
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2022
|
2023
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2023
|
||||||||||||||||||||||||||||||||||||||||
Intellectual property
|
21,792
|
-
|
450
|
21,342
|
96
|
-
|
6,703
|
6,799
|
21,696
|
14,543
|
||||||||||||||||||||||||||||||
Computer software
|
801
|
181
|
-
|
982
|
612
|
59
|
-
|
671
|
189
|
311
|
||||||||||||||||||||||||||||||
22,593
|
181
|
450
|
22,324
|
708
|
59
|
6,703
|
7,470
|
21,885
|
14,854
|
F-30
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
A.
|
Right-of-use assets
|
Cost
|
Accumulated depreciation
|
|||||||||||||||||||||||||||||||||||||||
Balance at
|
Additions
|
Deletions
|
Balance at
|
Balance at
|
Additions
|
Deletions
|
Balance at
|
Net book value
|
||||||||||||||||||||||||||||||||
beginning
|
during
|
during
|
end of
|
beginning
|
during
|
during
|
end of
|
December 31,
|
||||||||||||||||||||||||||||||||
of year
|
year
|
year
|
year
|
of year
|
year
|
year
|
year
|
2022
|
2023
|
|||||||||||||||||||||||||||||||
in USD thousands
|
in USD thousands
|
in USD thousands
|
||||||||||||||||||||||||||||||||||||||
Composition in 2023
|
||||||||||||||||||||||||||||||||||||||||
Property
|
2,097
|
-
|
-
|
2,097
|
582
|
388
|
-
|
970
|
1,515
|
1,127
|
||||||||||||||||||||||||||||||
Motor vehicles
|
336
|
149
|
117
|
368
|
79
|
118
|
117
|
80
|
257
|
288
|
||||||||||||||||||||||||||||||
2,433
|
149
|
117
|
2,465
|
661
|
506
|
117
|
1,050
|
1,772
|
1,415
|
B.
|
Lease liabilities
|
Balance at
|
Additions
|
Deletions
|
Interest expense
|
Exchange differences
|
Payments
|
Balance at
|
||||||||||||||||||||||
beginning
|
during
|
during
|
during
|
during
|
during
|
end of
|
||||||||||||||||||||||
of year
|
year
|
year
|
year
|
year
|
year
|
year
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
Composition in 2023
|
||||||||||||||||||||||||||||
Property
|
1,920
|
- |
-
|
236
|
(38
|
)
|
(562
|
)
|
1,556
|
|||||||||||||||||||
Motor vehicles
|
236
|
149
|
-
|
37
|
(4
|
)
|
(156
|
)
|
262
|
|||||||||||||||||||
2,156
|
149
|
-
|
273
|
(42
|
)
|
(718
|
)
|
1,818
|
F-31
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
C.
|
Additional disclosures
|
1)
|
The Company leases two premises – its corporate headquarters and development facilities in Modi’in, Israel, and its U.S. commercial headquarters in Waltham, Massachusetts.
|
a.
|
The Company leases its premises in Israel under a lease agreement entered into in August 2014. Payments under the lease commenced in June 2015, and the initial term of the lease expired in June 2020. The Company exercised its option to extend the lease through June 30, 2025, and has the option to extend the lease for two additional lease periods totaling up to five additional years, each option at a 5% increase to the preceding lease payment amount. The monthly lease payment is approximately $25,000. In addition, the Company pays building maintenance charges of approximately $8,000 per month.
|
b.
|
The Company leases its premises in Boston under a lease agreement entered into and commenced in October 2022. The term of the lease will expire in December 2024. The monthly lease fee is approximately $24,000.
|
2)
|
The Company has entered into lease agreements in connection with a number of vehicles. The lease periods are generally for three years. The annual lease fees, linked to the CPI, are approximately $303,000. To secure the terms of the lease agreements, the Company has prepaid two months of lease payments to the leasing companies.
|
3)
|
As of December 31, 2023, minimum future rental payments (taking into consideration the aforementioned extension periods) under the leases are as follows:
|
Year
|
Property
|
Motor vehicles
|
Total
|
|||||||||
in USD thousands
|
||||||||||||
2024
|
575
|
161
|
736
|
|||||||||
2025
|
292
|
113
|
405
|
|||||||||
2026
|
292
|
26
|
317
|
|||||||||
2027
|
306
|
-
|
306
|
|||||||||
2028-2030
|
766
|
-
|
766
|
|||||||||
2,231
|
300
|
2,531
|
F-32
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a. |
Share capital
|
The Company’s share capital is composed of ordinary shares, as follows:
Number of Ordinary Shares
|
||||||||
December 31,
|
||||||||
2022
|
2023
|
|||||||
Authorized share capital
|
2,500,000,000
|
2,500,000,000
|
||||||
Issued and paid-up share capital
|
922,958,942
|
1,086,589,165
|
In USD and NIS Amounts
|
||||||||
December 31,
|
||||||||
2022
|
2023
|
|||||||
Authorized share capital (in NIS)
|
250,000,000
|
250,000,000
|
||||||
Issued and paid-up share capital (in NIS)
|
92,295,894
|
108,658,916
|
||||||
Issued and paid-up share capital (in USD)
|
27,100,201
|
31,355,056
|
F-33
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
b.
|
Rights related to shares
|
c.
|
Changes in the Company’s equity
|
1)
|
In connection with the loan agreement with Kreos Capital signed in October 2018 (see Note 10), Kreos Capital received warrants to purchase 63,837 ADSs at an exercise price of $14.10 per ADS. The warrants issued have been classified as a financial liability due to a net settlement provision. The warrant is exercisable for a period of ten years from the date of issuance.
|
2)
|
In February 2019, the Company completed an underwritten public offering of 1,866,667 of its ADSs and warrants to purchase 1,866,667 ADSs, at a public offering price of $8.25 per ADS and accompanying warrant. The warrants were exercisable immediately, were to expire five years from the date of issuance and had an exercise price of $11.25 per ADS. The offering raised a total of $15.4 million, with net proceeds of $14.1 million, after deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was $5.0 million. Total issuance costs initially allocated to the warrants were $0.4 million.
|
F-34
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
c.
|
Changes in the Company’s equity (cont.)
|
|
3)
|
In May and June 2020, the Company sold in registered direct offerings an aggregate of 7,653,145 ADSs at a price of $1.75 per ADS. The Company also issued to investors in the offerings unregistered warrants to purchase 7,653,145 ADSs. The warrants were exercisable immediately, were to expire two and half years from the date of issuance and had an exercise price of $2.25 per ADS. In addition, the Company granted to the placement agent’s designees, as part of the placement fees, warrants to purchase 382,657 ADSs. These warrants were exercisable immediately, were set to expire two and half years from the date of issuance and had an exercise price of $2.1875 per ADS. The offerings raised a total of $13.4 million, with net proceeds of $12.0 million, after deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was $5.7 million. Total issuance costs initially allocated to the warrants were $0.6 million.
|
4)
|
In January 2021, the Company completed an underwritten public offering of 14,375,000 of its ADSs at a public offering price of $2.40 per ADS. The offering raised total gross proceeds of $34.5 million, with net proceeds of $31.4 million after deducting fees and expenses. In addition, warrants to purchase 718,750 ADSs were granted to the underwriters. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $3.00 per ADS.
|
F-35
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
c.
|
Changes in the Company’s equity (cont.)
|
|
5)
|
In September 2022, the Company completed a registered direct offering of 13,636,365 ADSs at a price of $1.10 per ADS. The Company also issued to investors in the offering unregistered warrants to purchase 13,636,365 ADSs. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.15 per ADS. In addition, the Company granted to the placement agent in the offering, as part of the placement fee, warrants to purchase 681,818 ADSs. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.375 per ADS. Gross proceeds from the offering totaled $15.0 million, with net proceeds of $13.5 million, after deducting fees and expenses. The offering consideration allocated to the placement agent warrants amounted to $0.4 million.
|
6)
|
On August 27, 2023, the Company entered into a securities purchase agreement, pursuant to which the Company agreed to sell in a private placement an aggregate of 6,829,137 ADSs of the Company, at a purchase price of $2.136 per ADS. Aggregate gross proceeds from the sale, which were received by the Company at closing, amounted to $14.6 million, with related issuance costs amounting to approximately $0.9 million. Pursuant to IFRS 15, approximately $12.0 million of gross proceeds and $0.7 million of issuance costs were recognized as equity. (see Note 16).
|
F-36
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
d. |
Share purchase agreements
|
1) |
In September 2020, the Company entered into an ATM sales agreement with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which the Company was entitled, at its sole discretion, to offer and sell through HCW, acting as sales agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remained in effect. The Company agreed to pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. Expenses associated with establishment of the ATM facility with HCW, amounting to $0.2 million, were recorded in 2020 as non-operating expenses. In September 2021, the Company terminated the agreement. During 2021, the Company issued a total of 4,745,368 ADSs under the agreement for total gross proceeds of $18.5 million. From the effective date of the agreement through its termination, 7,381,101 ADSs were sold under the program for total gross proceeds of approximately $24.5 million.
|
2) |
In September 2021, the Company entered into a new $25.0 million ATM sales agreement with HCW under substantially identical terms to the previous agreement. Expenses associated with establishment of the ATM facility with HCW, amounting to $0.1 million, were recorded in non-operating expenses during the period. During 2023, the Company issued a total of 1,501,207 ADSs under the program for total gross proceeds of approximately $2.9 million. From the effective date of the agreement through the issuance date of this report, 2,109,858 ADSs have been sold under the program for total gross proceeds of approximately $4.4 million and a total fees of approximately $0.1 million.
|
e. |
Share-based payments
|
1)
|
Share Incentive plan – general
|
F-37
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
e. |
Share-based payments (cont.)
|
|
1)
|
Share Incentive plan – general (cont.)
|
2) |
Employee share incentive plan:
|
Year ended December 31,
|
||||||||||||||||||||||||
2021
|
2022
|
2023
|
||||||||||||||||||||||
Number
of options
|
Weighted average exercise price
(in NIS)
|
Number
of options
|
Weighted average exercise price
(in NIS)
|
Number
of options
|
Weighted average exercise price
(in NIS)
|
|||||||||||||||||||
Outstanding at beginning of year
|
35,981,579
|
1.5
|
40,956,214
|
0.7
|
89,871,858
|
0.4
|
||||||||||||||||||
Granted
|
6,588,200
|
0.4
|
53,696,305
|
0.3
|
64,855,380
|
0.2
|
||||||||||||||||||
Forfeited and expired
|
(1,438,642
|
)
|
3.0
|
(4,618,062
|
)
|
0.8
|
(3,804,175
|
)
|
0.7
|
|||||||||||||||
Exercised
|
(174,923
|
)
|
0.1
|
(162,599
|
)
|
0.1
|
(493,238)
|
|
0.2
|
|||||||||||||||
Outstanding at end of year*
|
40,956,214
|
0.7
|
89,871,858
|
0.4
|
150,429,825
|
0.3
|
||||||||||||||||||
Exercisable at end of year
|
18,663,353
|
1.7
|
26,663,961
|
0.8
|
51,970,635
|
0.5
|
* |
As of December 31, 2021, 2022 and 2023, includes 4,084,748, 10,482,277, and 12,219,465 PSUs at an exercise price of 0.10 NIS (par value of ordinary shares), for which performance obligations have not been met.
|
|
F-38
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
e. |
Share-based payments (cont.)
|
2) |
Employee share incentive plan (cont.):
|
|
As of December 31,
|
||||||||||||||||||
2022
|
2023
|
|||||||||||||||||
Range of
exercise prices
(in NIS)
|
Number
of options outstanding
|
Weighted average remaining contractual life (in yrs.)
|
Number
of options outstanding
|
Weighted average remaining contractual life (in yrs.)
|
||||||||||||||
Up to 0.49
|
58,488,372
|
9.2
|
120,593,415
|
8.8
|
||||||||||||||
0.5-0.99
|
17,175,120
|
7.8
|
16,147,110
|
6.9
|
||||||||||||||
1.00-2.00
|
13,668,366
|
5.5
|
13,149,390
|
4.7
|
||||||||||||||
2.01-3.4
|
540,000
|
4.2
|
539,910
|
3.2
|
||||||||||||||
89,871,858
|
8.4
|
150,429,825
|
8.2
|
The fair value of equity instruments granted to employees through December 31, 2023 has been determined using the Black-Scholes option-pricing model. These values are based on the following assumptions as of the applicable grant dates:
2021
|
2022
|
2023
|
||||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Expected volatility
|
67
|
%
|
67
|
%
|
69
|
%
|
||||||
Risk-free interest rate
|
1
|
%
|
4
|
%
|
4
|
%
|
||||||
Expected life of options (in years)
|
6
|
6
|
6
|
F-39
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
e. |
Share-based payments (cont.)
|
|
3)
|
Stock options to consultants
|
F-40
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a. |
Corporate taxation
|
b. |
Tax loss carryforwards
|
c. |
Tax assessments
|
d. |
Theoretical taxes
|
Year ended December 31,
|
||||||||||||||||||||||||
2021
|
2022
|
2023
|
||||||||||||||||||||||
in USD
|
in USD
|
in USD
|
||||||||||||||||||||||
thousands
|
thousands
|
thousands
|
||||||||||||||||||||||
Loss before taxes
|
23.0
|
%
|
(27,045
|
)
|
23.0
|
%
|
(24,951
|
)
|
23.0
|
%
|
(60,614
|
)
|
||||||||||||
Theoretical tax benefit
|
(6,220
|
)
|
(5,739
|
)
|
(13,941
|
)
|
||||||||||||||||||
Disallowed deductions (tax exempt income):
|
||||||||||||||||||||||||
Loss (gain) on adjustment of warrants to fair value
|
480
|
(1,478
|
) |
2,542
|
||||||||||||||||||||
Share-based compensation
|
343
|
516
|
534
|
|||||||||||||||||||||
Impairment of intangible asset
|
- | - | 1,542 | |||||||||||||||||||||
Other
|
11
|
11
|
11
|
|||||||||||||||||||||
Increase in taxes for tax losses and timing differences incurred in the reporting year for which deferred taxes were not created
|
5,386
|
6,690
|
9,312
|
|
||||||||||||||||||||
Taxes on income for the reported year
|
-
|
-
|
-
|
F-41
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Loss attributed to ordinary shares
|
(27,054
|
)
|
(24,951
|
)
|
(60,614
|
)
|
||||||
in thousands
|
||||||||||||
Number of shares used in basic calculation
|
662,934
|
773,957
|
963,366
|
|||||||||
in USD
|
||||||||||||
Basic and diluted loss per ordinary share
|
(0.04
|
)
|
(0.03
|
)
|
(0.06
|
)
|
a. |
Commitments
|
1) |
Obligation to pay royalties to the State of Israel
|
2)
|
In connection with the in-licensing of motixafortide from Biokine Therapeutics Ltd. (“Biokine”), and as a condition to IIA consent to the transaction, the Company agreed to abide by any obligations resulting from funds previously received by Biokine from the IIA. The contingent liability to the IIA assumed by the Company relating to this transaction amounts to $3.2 million as of December 31, 2023. In this regard, and in connection with the outlicensing transaction in Asia (see Note 16), as well as the commercial launch of motixafortide in the U.S., the royalty rate agreed with the IIA for motixafortide consideration received is 3.9% for sub-license consideration and 4% for direct product sales. The Company has a full right of offset for amounts payable to the IIA from all payments due to Biokine in the future.
|
F-42
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Commitments (cont.)
|
3) |
Licensing agreements
|
F-43
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Commitments (cont.)
|
3) |
Licensing agreements (cont.)
|
F-44
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a.
|
Commitments (cont.)
|
4) |
Commitments in respect of Agalimmune and Biokine
|
5) |
Purchase orders
|
b. |
Guarantees
|
F-45
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
c. |
Contingent liabilities
|
F-46
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
•
|
TheOf the total consideration received wasamounting to $29.6 million; approximately, $12.0 million were allocated to the Purchase Agreement, and $1417.6 million were allocated to the share purchase agreement, and license agreement respectively.License Agreement
|
•
|
Costs in the amount of $0.7 million directly attributable to the share purchase agreementPurchase Agreement were recognized as a deduction fromreduction in equity in the amount of $0.704 million.
|
1.
|
SCM license
|
2.
|
SCM support services
|
3.
|
PDAC license and related support services
|
With regard to PDAC, the Company determined that the license, together with the associated support services, should be combined into a single performance obligation, since the Licensee cannot benefit from the license without the associated support services. The support services are highly specialized for the licensed product in this indication.
F-47
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
The fixed transaction price has been allocated among the performance obligations based on similar price offers received by the Company, with the assistance of a valuation specialist. The variable consideration related to the performance obligations was not taken into account in the fixed transaction price due to uncertainty.
a.
|
Revenue for the SCM license was recognized in Q4 2023, upon the transfer of control over the license to the licensee, in the amount of approximately $2.0 million.
|
b.
|
Revenue from providing the SCM support services will be recognized using the input method, which is based on costs incurred and labor hours expended, expected to result in straight-line revenue recognition over six months, totaling approximately $0.1 million.
|
c.
|
Revenue from the PDAC performance obligation will be recognized over time, with the percentage of completion determined based on support hours incurred, and expected to be recognized over twelve monthsthrough the end of 2024, in the total amount of $15.5 million.
|
F-48
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Benefits to related parties:
|
||||||||||||
Compensation and benefits to senior management, including benefit component of equity instrument grants
|
2,302
|
2,968
|
3,155
|
|||||||||
Compensation and benefits to directors, including benefit component of equity instrument grants
|
300
|
507
|
587
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Salaries and other short-term employee benefits
|
1,883
|
2,298
|
2,425
|
|||||||||
Post-employment benefits
|
136
|
131
|
256
|
|||||||||
Other long-term benefits
|
35
|
35
|
31
|
|||||||||
Share-based compensation
|
548
|
1,011
|
1,030
|
|||||||||
2,602
|
3,475
|
3,742
|
F-49
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
a. |
Other receivables
|
December 31,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Advance payments
|
-
|
480
|
||||||
Government institutions |
687 | 245 | ||||||
Other
|
34
|
105
|
||||||
721
|
830
|
b. |
Accounts payable and accruals
|
December 31,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
1) Trade:
|
||||||||
Accounts payable:
|
||||||||
Overseas
|
6,061
|
7,704
|
||||||
In Israel
|
905
|
3,165
|
||||||
6,966
|
10,869
|
|||||||
2) Other:
|
||||||||
Payroll and related expenses
|
931
|
2,184
|
||||||
Accrued expenses |
352
|
662
|
||||||
Accrual for vacation and recreation pay
|
377
|
419
|
||||||
Other
|
84
|
88
|
||||||
1,744
|
3,353
|
c. |
Revenues
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
License revenues (see Note 16)
|
-
|
-
|
4,610
|
|||||||||
Product sales, net
|
-
|
-
|
190
|
|||||||||
-
|
-
|
4,800
|
F-50
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
d. |
Cost of revenues
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Cost related to license revenues
|
-
|
-
|
3,230
|
|||||||||
Amortization of intangible asset in respect of license revenues |
- | - | 450 | |||||||||
Cost of product sales
|
-
|
-
|
12
|
|||||||||
-
|
-
|
3,692
|
e. |
Research and development expenses
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Research and development services
|
12,088
|
9,296
|
4,603
|
|||||||||
Payroll and related expenses
|
4,074
|
4,495
|
4,452
|
|||||||||
Lab, occupancy and telephone
|
882
|
902
|
969
|
|||||||||
Professional fees
|
595
|
954
|
935
|
|||||||||
Share-based compensation |
971 |
1,198 |
760 |
|||||||||
Depreciation and amortization
|
660
|
615
|
583
|
|||||||||
Other
|
196
|
169
|
217
|
|||||||||
19,466
|
17,629
|
12,519
|
f. |
Sales and marketing expenses
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Payroll and related expenses |
308 | 947 | 8,868 | |||||||||
Medical Affairs
|
-
|
1,316
|
4,824
|
|||||||||
Marketing
|
700
|
1,805
|
4,091
|
|||||||||
Office related expenses
|
-
|
519 | 1,923 | |||||||||
Market Access |
- | 1,023 | 1,606 | |||||||||
Business Analytics |
- | 106 | 1,005 | |||||||||
Travel | 25 | 84 | 986 | |||||||||
Share-based compensation
|
(59
|
)
|
112
|
751
|
||||||||
Professional fees
|
-
|
521
|
745
|
|||||||||
Depreciation and amortization
|
-
|
-
|
314
|
|||||||||
Other
|
29
|
29
|
158
|
|||||||||
1,003
|
6,462
|
25,270
|
F-51
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
g. |
General and administrative expenses
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Payroll and related expenses
|
1,408
|
1,706
|
2,117
|
|||||||||
Professional fees
|
1,103
|
1,248
|
2,028
|
|||||||||
Insurance
|
1,064
|
1,046
|
939
|
|||||||||
Share-based compensation
|
583
|
895
|
780
|
|||||||||
Depreciation
|
42
|
39
|
37
|
|||||||||
Other
|
108
|
132
|
409
|
|||||||||
4,308
|
5,066
|
6,310
|
h. |
Non-operating income (expenses), net
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Changes in fair value of warrants
|
(1,936
|
) |
6,425
|
(11,054
|
) | |||||||
Issuance costs
|
-
|
(762
|
)
|
-
|
||||||||
Other
|
106
|
7
|
235
|
|||||||||
(1,830
|
)
|
5,670
|
(10,819
|
)
|
i. |
Financial income
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Interest income
|
277
|
694
|
2,007
|
|||||||||
Exchange differences, net
|
282
|
-
|
61
|
|||||||||
559
|
694
|
2,068
|
j. |
Financial expenses
|
Year ended December 31,
|
||||||||||||
2021
|
2022
|
2023
|
||||||||||
in USD thousands
|
||||||||||||
Interest expense
|
984
|
1,786
|
2,144
|
|||||||||
Bank commissions
|
22
|
26 | 25 | |||||||||
Exchange differences, net
|
-
|
346
|
-
|
|||||||||
1,006
|
2,158
|
2,169
|
F-52
|
• |
taxes and other governmental charges;
|
|
• |
any applicable transfer or registration fees;
|
|
• |
certain cable, telex and facsimile transmission charges as provided in the deposit agreement;
|
|
• |
any expenses incurred in the conversion of foreign currency;
|
|
• |
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the deposit agreement terminates;
|
|
• |
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;
|
|
• |
a fee for the distribution of securities pursuant to the deposit agreement;
|
|
• |
in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;
|
|
• |
a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and
|
|
• |
any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the servicing of ordinary shares or other Deposited Securities.
|
|
1. |
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
|
|
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:
|
|
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):
|
|
1. |
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
|
|
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;
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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:
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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):
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(i) |
the accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2023 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as
applicable, of the Securities Exchange Act of 1934, as amended; and
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(ii) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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(i) |
the accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2023 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the
Securities Exchange Act of 1934, as amended; and
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(ii) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Tel-Aviv, Israel
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/s/ Kesselman & Kesselman
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March 26, 2024
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Certified Public Accountants (Isr.)
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A member firm of PricewaterhouseCoopers International Limited
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I. |
Purpose
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II. |
Definitions
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(a) |
“Accounting Restatement” shall mean an accounting
restatement (i) due to the material noncompliance of the Company with any financial reporting requirement under the securities laws, including any required accounting restatement to correct an error in previously issued financial
restatements that is material to the previously issued financial statements (a “Big R” restatement), or (ii) that corrects an error that is not material to previously issued financial statements, but would result in a material misstatement
if the error were corrected in the current period or left uncorrected in the current period (a “little r” restatement). Notwithstanding the foregoing, none of the following changes to the Company’s financial statements represent error
corrections and shall not be deemed an Accounting Restatement: (a) retrospective application of a change in accounting principle; (b) retrospective revision to reportable segment information due to a change in the structure of the Company’s
internal organization; (c) retrospective reclassification due to a discontinued operation; (d) retrospective application of a change in reporting entity, such as from a reorganization of entities under common control; and (e) retrospective
revision for share splits, reverse share splits, share dividends or other changes in capital structure.
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(b) |
“Board” shall mean the Board of Directors of the
Company.
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(c) |
“Clawback-Eligible Incentive Compensation” shall mean,
in connection with an Accounting Restatement, any Incentive-Based Compensation Received by a Covered Person (regardless of whether such Covered Person was serving at the time that Erroneously-Awarded Compensation is required to be repaid)
(i) on or after the Nasdaq Effective Date, (ii) after beginning service as a Covered Person, (iii) while the Company has a class of securities listed on a national securities exchange or national securities association and (iv) during the
Clawback Period.
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(d) |
“Clawback Period” shall mean, with respect to any
Accounting Restatement, the three completed fiscal years immediately preceding the Restatement Date and any transition period (that results from a change in the Company’s fiscal year) of less than nine months within or immediately following
those three completed fiscal years.
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(e) |
“Committee” shall mean the Compensation Committee of the
Board.
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(f) |
“Covered Person” shall mean any person who is, or was at
any time, during the Clawback Period, an Executive Officer of the Company. For the avoidance of doubt, Covered Person may include a former Executive Officer that left the Company, retired, or transitioned to an employee non-Executive
Officer role (including after serving as an Executive Officer in an interim capacity) during the Clawback Period, and this Policy applies regardless of whether the Covered Person was at fault for an accounting error or other action that
resulted in, or contributed to, the Accounting Restatement.
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(g) |
“Erroneously-Awarded Compensation” shall mean the amount
of Clawback-Eligible Incentive Compensation that exceeds the amount of Incentive-Based Compensation that otherwise would have been Received had it been determined based on the restated amounts. This amount must be computed without regard to
any taxes paid.
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(h) |
“Executive Officer” shall mean (i) the Company’s
president, principal financial officer, principal accounting officer (or if there is no such accounting officer, the controller), any vice-president in charge of a principal business unit, division, or function (such as sales,
administration, or finance), any other officer who performs a policy-making function, (ii) any other person (including an officer of the Company’s parent(s) or subsidiaries) who performs similar policy-making functions for the Company, or
(iii) an “Officer” within the meaning set forth in the Companies Law. For the sake of clarity, at a minimum, all persons who would be executive officers pursuant to Rule 401(b) under Regulation S-K shall be deemed “Executive Officers.”
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(i) |
“Financial Reporting Measures” shall mean measures that
are determined and presented in accordance with the accounting principles used in preparing the Company’s financial statements, and all other measures that are derived wholly or in part from such measures, including, without limitation,
measures that are “non-GAAP financial measures” for purposes of Exchange Act Regulation G and Item 10(e) of Regulation S-K, as well other measures, metrics and ratios that are not non- GAAP measures. For purposes of this Policy, Financial
Reporting Measures shall include stock price and total shareholder return (and any measures that are derived wholly or in part from stock price or total shareholder return). A Financial Reporting Measure need not be presented within the
Company’s financial statements or included in a Company filing with the SEC.
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(j) |
“Incentive-Based Compensation” shall have the meaning
set forth in Section III below.
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(k) |
“Nasdaq” shall mean The Nasdaq Stock Market.
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(l) |
“Nasdaq Effective Date” shall mean October 2, 2023.
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(m) |
“Policy” shall mean this Executive Officer Clawback
Policy, as the same may be amended and/or restated from time to time.
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(n) |
“Received” shall mean Incentive-Based Compensation
received, or deemed to be received, in the Company’s fiscal period during which the Financial Reporting Measure specified in the Incentive-Based Compensation is attained, even if the payment or grant occurs after the fiscal period.
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(o) |
“Repayment Agreement” shall have the meaning set forth
in Section V below.
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(p) |
“Restatement Date” shall mean the earlier of (i) the
date the Board, a committee of the Board or the officers of the Company authorized to take such action if Board action is not required, concludes, or reasonably should have concluded, that the Company is required to prepare an Accounting
Restatement, or (ii) the date that a court, regulator or other legally authorized body directs the Company to prepare an Accounting Restatement.
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(q) |
“SARs” shall mean stock appreciation rights.
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(r) |
“SEC” shall mean the U.S. Securities and Exchange
Commission.
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III. |
Incentive-Based Compensation
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• |
Non-equity incentive plan awards that are earned based, wholly or in part, based on satisfaction of a Financial Reporting Measure performance goal;
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• |
Bonuses paid from a “bonus pool,” the size of which is determined, wholly or in part, based on satisfaction of a Financial Reporting Measure performance goal;
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• |
Other cash awards based on satisfaction of a Financial Reporting Measure performance goal;
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• |
Restricted stock, restricted stock units, performance share units, stock options and SARs that are granted or become vested, wholly or in part, on satisfaction of a
Financial Reporting Measure performance goal; and
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• |
Proceeds received upon the sale of shares acquired through an incentive plan that were granted or vested based, wholly or in part, on satisfaction of a Financial
Reporting Measure performance goal.
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• |
Any base salaries (except with respect to any salary increases earned, wholly or in part, based on satisfaction of a Financial Reporting Measure performance goal);
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• |
Bonuses paid solely at the discretion of the Committee or Board that are not paid from a “bonus pool” that is determined by satisfying a Financial Reporting Measure
performance goal;
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• |
Bonuses paid solely upon satisfying one or more subjective standards and/or completion of a specified employment period;
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• |
Non-equity incentive plan awards earned solely upon satisfying one or more strategic measures or operational measures; and
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• |
Equity awards that vest solely based on the passage of time and/or satisfaction of one or more non-Financial Reporting Measures.
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IV. |
Determination and Calculation of Erroneously-Awarded Compensation
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(a) |
Cash Awards. With respect to cash awards, the
Erroneously-Awarded Compensation is the difference between the amount of the cash award (whether payable as a lump sum or over time) that was Received and the amount that should have been Received applying the restated Financial Reporting
Measure.
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(b) |
Cash Awards Paid From Bonus Pools. With respect to cash
awards paid from bonus pools, the Erroneously-Awarded Compensation is the pro rata portion of any deficiency that results from the aggregate bonus pool that is reduced based on applying the restated Financial Reporting Measure.
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(c) |
Equity Awards. With respect to equity awards, if the
shares, options, SARs or other equity awards are still held at the time of recovery, the Erroneously-Awarded Compensation is the number of such securities Received in excess of the number that should have been received applying the restated
Financial Reporting Measure (or the value in excess of that number). If the options, SARs or other equity awards have been exercised, vested, settled or otherwise converted into underlying shares, but the underlying shares have not been
sold, the Erroneously-Awarded Compensation is the number of shares underlying the excess options or SARs (or the value thereof). If the underlying shares have already been sold, the Erroneously-Awarded Compensation is the higher of the
value of the stock upon vesting, exercise or sale.
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(d) |
Compensation Based on Stock Price or Total Shareholder Return.
For Incentive-Based Compensation based on (or derived from) stock price or total shareholder return, where the amount of Erroneously-Awarded Compensation is not subject to mathematical recalculation directly from the information in the
applicable Accounting Restatement, the amount shall be determined by the Committee based on a reasonable estimate of the effect of the Accounting Restatement on the stock price or total shareholder return upon which the Incentive-Based
Compensation was Received (in which case, the Committee shall maintain documentation of such determination of that reasonable estimate and provide such documentation to Nasdaq in accordance with applicable listing standards).
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V. |
Recovery of Erroneously-Awarded Compensation
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(a) |
Cash Awards. With respect to cash awards, the Committee
shall either (i) require the Covered Person to repay the Erroneously-Awarded Compensation in a lump sum in cash (or such property as the Committee agrees to accept with a value equal to such Erroneously-Awarded Compensation) reasonably
promptly following the Restatement Date or (ii) if approved by the Committee, offer to enter into a Repayment Agreement. If the Covered Person accepts such offer and signs the Repayment Agreement within a reasonable time as determined by
the Committee, the Company shall countersign such Repayment Agreement.
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(b) |
Unvested Equity Awards. With respect to those equity
awards that have not yet vested, the Committee shall take all necessary action to cancel, or otherwise cause to be forfeited, the awards in the amount of the Erroneously-Awarded Compensation.
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(c) |
Vested Equity Awards. With respect to those equity
awards that have vested and the underlying shares have not been sold, the Committee shall take all necessary action to cause the Covered Person to deliver and surrender the underlying shares in the amount of the Erroneously-Awarded
Compensation.
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(d) |
Repayment Agreement. “Repayment Agreement” shall mean an
agreement (in a form reasonably acceptable to the Committee) with the Covered Person for the repayment of the Erroneously-Awarded Compensation as promptly as possible without unreasonable economic hardship to the Covered Person.
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(e) |
Effect of Non-Repayment. To the extent that a Covered
Person fails to repay all Erroneously-Awarded Compensation to the Company when due (as determined in accordance with this Policy), the Company shall, or shall cause one or more other members of the Company to, take all actions reasonable
and appropriate to recover such Erroneously-Awarded Compensation from the applicable Covered Person. Unless otherwise determined by the Committee in its discretion, the applicable Covered Person shall be required to reimburse the Company
for all expenses reasonably incurred (including legal fees) by the Company in recovering such Erroneously-Awarded Compensation in accordance with the immediately preceding sentence.
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VI. |
Discretionary Recovery
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(i) |
The direct expenses paid to a third party to assist in enforcing this Policy against a Covered Person would exceed the amount to be recovered, after the Company has
made a reasonable attempt to recover the applicable Erroneously-Awarded Compensation, documented such attempts and provided such documentation to Nasdaq;
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(ii) |
Recovery would violate home country law where that law was adopted prior to November 28, 2022, provided that, before determining that it would be impracticable to
recover any amount of Erroneously-Awarded Compensation based on violation of home country law, the Company has obtained an opinion of home country counsel, acceptable to Nasdaq, that recovery would result in such a violation and a copy of
the opinion is provided to Nasdaq; or
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(iii) |
Recovery would likely cause an otherwise tax-qualified retirement plan, under which benefits are broadly available to employees of the Company, to fail to meet the
requirements of 26 U.S.C. 401(a)(13) or 26 U.S.C. 411(a) and regulations thereunder.
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VII. |
Reporting and Disclosure Requirements
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VIII. |
Effective Date
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IX. |
No Indemnification
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X. |
Administration
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XI. |
Amendment; Termination
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XII. |
Other Recoupment Rights; No Additional Payments
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XIII. |
Successors
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Signature
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Name
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Date
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