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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 8, 2023

 

 

 

Natera, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-37478   01-0894487

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.) 

 

13011 McCallen Pass
Building A Suite 100

Austin, TX 78753

(Address of principal executive offices, including zip code)

 

(650) 980-9190

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class  

Trading Symbol(s)

 

Name of each exchange on which registered 

Common Stock, par value $0.0001 per share   NTRA  

Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On November 8, 2023, Natera, Inc. issued a press release announcing the results for its third quarter ended September 30, 2023 and provided a related investor presentation. A copy of the press release and a copy of the investor presentation are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 and Exhibit 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description  
99.1   Press Release dated November 8, 2023.
99.2   Investor Presentation.
104   Cover Page Interactive Data File (formatted as inline XBRL).

 

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Natera, Inc.
     
  By: /s/ Michael Brophy  
    Michael Brophy
    Chief Financial Officer (Principal Financial and Accounting Officer)

 

Dated: November 8, 2023

 

 

 

EX-99.1 2 tm2329774d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Natera Reports Third Quarter 2023 Financial Results

 

 

AUSTIN, Texas, November 8, 2023 /PRNewswire/ — Natera, Inc. (NASDAQ:  NTRA), a global leader in cell-free DNA testing, today reported financial results for the third quarter ended September 30, 2023.

 

Recent Strategic and Financial Highlights

 

Generated total revenues of $268.3 million in the third quarter of 2023, compared to $210.6 million in the third quarter of 2022, an increase of approximately 27%. Product revenues grew approximately 33% over the same period.
Delivered gross margin of 45.1% in the third quarter of 2023, compared to 44.7% in the third quarter of 2022.
Reduced cash burn to approximately $38 million in the third quarter of 2023, a decrease of approximately 66% compared to the third quarter of 2022.
Processed approximately 626,000 tests in the third quarter of 2023, compared to approximately 517,500 tests in the third quarter of 2022, an increase of approximately 21%.
Performed approximately 89,000 oncology tests in the third quarter of 2023, compared to approximately 53,000 in the third quarter of 2022, an increase of approximately 68%. This includes approximately 81,000 Signatera™ clinical units in the third quarter of 2023, an increase of 85% compared to the prior year period and one of Natera’s best quarters on record in terms of absolute unit growth for Signatera in the clinical channel.
Raised 2023 annual guidance for revenue to a new range of $1.035 billion to $1.05 billion and gross margin to a range of 43% to 44%; significantly reduced cash burn guidance for 2023, lowering the range to $260 million to $280 million.
Published results from RenaCARE study, demonstrating significant diagnostic and clinical utility of Renasight™ test in chronic kidney disease.
Presented large, updated analysis on GALAXY arm of CIRCULATE-Japan reinforcing prognostic and predictive value of Signatera in colorectal cancer; published or presented additional key data on Signatera across multiple indications.
Announced randomized, phase III trial in early-stage breast cancer, adding to pipeline of clinical trials related to treatment on molecular relapse.
Announced broad clinical launch and Medicare coverage of FoundationOne®Tracker, in partnership with Foundation Medicine.

 

“We delivered robust volume and revenue growth in the third quarter, while demonstrating operational discipline with a significant reduction in cash burn,” said Steve Chapman, chief executive officer of Natera. “We continued to deliver on our strategic clinical roadmap with the publication of the landmark RenaCARE study in chronic kidney disease and key Signatera evidence across multiple cancer indications. As reflected in our revised guidance for the remainder of the year, we’ve increased our revenue target while reducing our cash burn goal, so we are well-positioned to help more patients than ever before.”

 

Third Quarter Ended September 30, 2023 Financial Results

 

Total revenues were $268.3 million in the third quarter of 2023, compared to $210.6 million for the third quarter of 2022, an increase of 27.4%. Product revenues were $265.2 million in the third quarter of 2023, compared to $199.8 million in the third quarter of 2022, an increase of 32.7%. Growth in product revenues was mainly driven by an increase in test volumes as well as average selling price improvements.

 

Natera processed approximately 626,000 tests in the third quarter of 2023, including approximately 609,800 tests accessioned in its laboratory. This compares to approximately 517,500 tests processed in the third quarter of 2022, including approximately 502,900 tests accessioned in its laboratory, an increase of 21.0%.

 


 

In the three months ended September 30, 2023, Natera recognized revenue on approximately 590,000 tests for which results were reported to customers in the period (tests reported), including approximately 575,000 tests reported from its laboratory, compared to approximately 482,900 tests reported, including approximately 469,200 tests reported from its laboratory, in the third quarter of 2022, an increase of 22.2% for the quarter.

 

Gross profit* for the three months ended September 30, 2023 and September 30, 2022 was $121.0 million and $94.1 million, respectively, representing a gross margin of 45.1% and 44.7%. Natera had higher gross margin in the third quarter of 2023 compared to the third quarter of 2022 primarily as a result of increased revenues and continuous reductions in cost of goods sold associated with tests processed.

 

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, were $232.0 million for the third quarter of 2023, compared to $213.2 million in the same period of the prior year, an increase of 8.8%. The increase was primarily driven by an increase in payroll and payroll-related expenses as well as a one-time benefit for a research and development expense related to earnout milestone payments in the third quarter of 2022. Loss from operations for the third quarter of 2023 was $111.0 million, compared to $119.1 million for the same period of the prior year.

 

The Company reported a net loss of $109.0 million, or ($0.95) per diluted share, for the third quarter of 2023, compared to a net loss of $121.5 million, or ($1.25) per diluted share, for the same period in 2022. Weighted average shares outstanding were approximately 115.2 million in the third quarter of 2023, compared to 97.1 million in the third quarter of the prior year.

 

As of September 30, 2023, Natera held approximately $936.6 million in cash, cash equivalents, short-term investments and restricted cash, compared to $898.4 million as of December 31, 2022. As of September 30, 2023, Natera had a total outstanding debt balance of $363.0 million, comprised of $80.4 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day SOFR plus 121 basis points and a net carrying amount of $282.6 million under its seven-year convertible senior notes issued in April 2020. The gross principal balance outstanding for the convertible senior notes was $287.5 million as of September 30, 2023. In October 2023, the interest rate for the Credit Line was subsequently changed to the 30-day SOFR average, plus 50 basis points.

 

Financial Outlook

 

Natera is revising its 2023 annual guidance. The Company now expects annual revenue to be in a range of $1.035 billion to $1.05 billion, up from its previous range of $1.015 billion to $1.035 billion; and gross margin to be in a range of approximately 43% to 44% of revenues, revised from its previous range of 41% to 44%. The Company continues to expect selling, general and administrative costs to be approximately $540 million to $580 million, and research and development costs to be approximately $325 million to $345 million. In addition, net cash consumption is now expected to be approximately $260 million to $280 million, down from its previous range of $300 million to $325 million**.

 

* Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.

 

** Cash consumption is calculated as the sum of GAAP net cash used by operating activities (estimated for 2023 to be approximately $210 million to $230 million) and GAAP net purchases of property and equipment (estimated for 2023 to be approximately $50 million).

 


 

Test Volume Summary

 

Unit   Q3 2023     Q3 2022     Definition
Tests processed     626,000       517,500     Tests accessioned in our laboratory plus units processed outside of our laboratory
Tests accessioned     609,800       502,900     Test accessioned in our laboratory
Tests reported in our laboratory     575,000       469,200     Total tests reported in our laboratory less units reported outside of our laboratory
Tests reported     590,000       482,900     Total tests reported

 

About Natera

 

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 150 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

 

Conference Call Information

Event: 

 

Natera's Third Quarter 2023 Financial Results Conference Call

Date:  Wednesday, November 8, 2023 
Time:  1:30 p.m. PT (4:30 p.m. ET)
Live Dial-In: (888) 770-7321, Domestic
  (929) 201-7107, International
Conference ID: 7684785
   
Webcast Link: https://events.q4inc.com/attendee/156437855

 

Forward-Looking Statements

 

This press release contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including the company’s financial guidance for fiscal 2022, its ability to continue to increase its revenues, its product development plans and its ability to maintain and grow its business operations in light of the COVID-19 pandemic, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved.

 

 


 

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving our financial projections and goals; we may be unable to further increase the use and adoption of our products through our direct sales efforts or through our laboratory partners; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; our quarterly results may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate; we may be unable to compete successfully with existing or future products or services offered by our competitors; we may engage in acquisitions, dispositions or other strategic transactions that may not achieve our anticipated benefits and could otherwise disrupt our business, cause dilution to our stockholders or reduce our financial resources; we may need to raise additional capital to support our business plans, which may not be available when necessary or on favorable terms; we may not be successful in commercializing our cloud-based distribution model; our products may not perform as expected; the results of our clinical studies, including our SNP-based Microdeletion and Aneuploidy RegisTry, or SMART, Study, may not be compelling to professional societies or payors as supporting the use of our tests, particularly for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our primary CLIA-certified laboratories becomes inoperable, we will be unable to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand, obtain or maintain third-party payer coverage and reimbursement for Panorama, Horizon and our other tests, and we may be required to refund reimbursements already received; third-party payers may withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors; if the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associated with complying with post-market controls; litigation or other proceedings, including investigations, subpoenas, demands, disputes, litigation, requests for information and other regulatory or administrative actions or proceedings, or resulting from either third party claims of intellectual property infringement or asserting infringement by third parties of our technology, is costly, may result in substantial business and financial penalties, may be time-consuming and could limit our ability to commercialize our products or services; any inability to effectively protect our proprietary technology could harm our competitive position or our brand; and we cannot guarantee that we will be able to service and comply with our outstanding debt obligations or achieve our expectations regarding the conversion of our outstanding convertible notes.

 

Additional risks and uncertainties that could affect our financial results are included under the captions, "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available on our website at www.natera.com under the Investor Relations section and on the SEC’s website at www.sec.gov.

 

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Natera assumes no obligation to, and does not currently intend to, update any such forward-looking statements after the date of this release.

 

Contacts

 

Natera, Inc.

 

Investor Relations
Mike Brophy, CFO, Natera, Inc., 510-826-2350

 

Media
Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

 

 


 

Natera, Inc.

Consolidated Balance Sheets

(Unaudited)

(in thousands, except par value per share amount)

 

    September 30,     December 31,  
    2023     2022  
            (1)  
Assets                
Current assets:                
Cash, cash equivalents and restricted cash   $ 668,710     $ 466,091  
Short-term investments     267,847       432,301  
Accounts receivable, net of allowance of $6,034 and $3,830 at September 30, 2023 and December 31, 2022, respectively     255,147       244,385  
Inventory     42,076       35,406  
Prepaid expenses and other current assets, net     33,496       33,634  
Total current assets     1,267,276       1,211,817  
Property and equipment, net     104,830       92,453  
Operating lease right-of-use assets     58,206       71,874  
Other assets     16,208       18,330  
Total assets   $ 1,446,520     $ 1,394,474  
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable   $ 21,321     $ 31,148  
Accrued compensation     39,415       44,010  
Other accrued liabilities     133,740       144,214  
Deferred revenue, current portion     15,012       10,777  
Short-term debt financing     80,435       80,350  
Total current liabilities     289,923       310,499  
Long-term debt financing     282,619       281,653  
Deferred revenue, long-term portion     21,033       20,001  
Operating lease liabilities, long-term portion     68,287       76,577  
Total liabilities     661,862       688,730  
                 
Commitments and contingencies                
                 
Stockholders’ equity:                
Common stock (2)     11       11  
Additional paid-in capital     3,089,448       2,664,730  
Accumulated deficit     (2,299,405 )     (1,942,635 )
Accumulated other comprehensive loss     (5,396 )     (16,362 )
Total stockholders’ equity     784,658       705,744  
Total liabilities and stockholders’ equity   $ 1,446,520     $ 1,394,474  

 

(1) The consolidated balance sheet at December 31, 2022 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

(2) As of September 30, 2023 and December 31, 2022, there were approximately 118,990 and 111,255 shares of common stock issued and outstanding, respectively.

 

 


 

Natera, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except per share data)

 

    Three months ended     Nine months ended  
    September 30,     September 30,  
    2023     2022     2023     2022  
Revenues                        
Product revenues   $ 265,218     $ 199,831     $ 761,271     $ 584,415  
Licensing and other revenues     3,088       10,806       10,195       18,555  
Total revenues     268,306       210,637       771,466       602,970  
Cost and expenses                                
Cost of product revenues     146,962       115,436       437,524       326,862  
Cost of licensing and other revenues     349       1,076       1,060       2,102  
Research and development     77,235       65,510       237,714       228,504  
Selling, general and administrative     154,742       147,667       456,877       444,769  
Total cost and expenses     379,288       329,689       1,133,175       1,002,237  
Loss from operations     (110,982 )     (119,052 )     (361,709 )     (399,267 )
Interest expense     (3,252 )     (2,330 )     (9,490 )     (6,567 )
Interest and other income, net     5,406       87       14,509       1,165  
Loss before income taxes     (108,828 )     (121,295 )     (356,690 )     (404,669 )
Income tax benefit (expense)     (202 )     (185 )     (80 )     (557 )
Net loss   $ (109,030 )   $ (121,480 )   $ (356,770 )   $ (405,226 )
Unrealized gain (loss) on available-for-sale securities, net of tax     3,807       (3,212 )     10,966       (17,322 )
Comprehensive loss   $ (105,223 )   $ (124,692 )   $ (345,804 )   $ (422,548 )
                                 
Net loss per share                                
Basic and diluted   $ (0.95 )   $ (1.25 )   $ (3.14 )   $ (4.20 )
Weighted-average number of shares used in computing basic and diluted net loss per share:                                
Basic and diluted     115,171       97,052       113,559       96,408  

 

 

 

EX-99.2 3 tm2329774d1_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

Natera, Inc. Investor presentation Third Quarter 2023 Earnings Call November 8, 2023 Confidential Draft Not for reproduction or further distribution.


This presentation contains forward - looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our market opportunities, our proposed products and launch schedules, our reimbu rse ment coverage and our product costs, our commercial partners and potential acquisitions, our user experience, our clinical trials and studies and related publications, including timelines, our financi al performance, our strategies, our anticipated revenue and financial outlook, our goals and general business and market conditions, are forward - looking statements. These forward - looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including : we face numerous uncertainties and challenges in achieving our financial projections and goals ; we may be unable to further increase the use and adoption of our products through our direct sales efforts or through our laboratory partners ; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future ; our quarterly results may fluctuate from period to period ; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate ; we may be unable to compete successfully with existing or future products or services offered by our competitors ; we may engage in acquisitions, dispositions or other strategic transactions that may not achieve our anticipated benefits and could otherwise disrupt our business, cause dilution to our stockholders or reduce our financial resources ; we may not be successful in commercializing our cloud - based distribution model ; our products may not perform as expected ; the results of our clinical studies, including our SNP - based Microdeletion and Aneuploidy Registry, or SMART, Study, may not be compelling to professional societies or payors as supporting the use of our tests, particularly for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances ; if either of our primary CLIA - certified laboratories becomes inoperable, we will be unable to perform our tests and our business will be harmed ; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers ; if we are unable to successfully scale our operations, our business could suffer ; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources ; we may be unable to expand, obtain or maintain third - party payer coverage and reimbursement for Panorama, Horizon and our other tests, and we may be required to refund reimbursements already received ; third - party payers may withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors ; if the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associated with complying with post - market controls ; litigation or other proceedings, resulting from either third party claims of intellectual property infringement or third party infringement of our technology, is costly, time - consuming and could limit our ability to commercialize our products or services ; any inability to effectively protect our proprietary technology could harm our competitive position or our brand ; and we cannot guarantee that we will be able to service and comply with our outstanding debt obligations or achieve our expectations regarding the conversion of our outstanding convertible notes . We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our periodic reports on Forms 10 - K and 10 - Q and in other filings we make with the SEC from time to time . Moreover, we operate in a very competitive and rapidly changing environment . New risks emerge from time to time . It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statement . In light of these risks, uncertainties and assumptions, the forward - looking events and circumstances discussed in this presentation may not occur and our actual results could differ materially and adversely from those anticipated or implied . As a result, you should not place undue reliance on our forward - looking statements . Except as required by law, we undertake no obligation to update publicly any forward - looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations . We file reports, proxy statements, and other information with the SEC . Such reports, proxy statements, and other information concerning us is available at http : // www . sec . gov . Requests for copies of such documents should be directed to our Investor Relations department at Natera , Inc . , 13011 McCallen Pass, Building A Suite 100 , Austin, TX 78753 . Our telephone number is ( 650 ) 980 - 9190 . 2 Safe harbor statement Confidential Draft Not for reproduction or further distribution.


• $268M in total revenue, 27% growth over Q3 2022. Product revenues grew 33% year on year. • Processed 626K units, up 21% year on year. • Processed 81K Signatera clinical units, up 85% vs. Q3 2022 and up 9K units vs. Q2 2023, second largest unit growth quarter. • 45% gross margin on organic ASP and COGS improvements. • Cash burn 1 of $38M, ~50% reduction vs. Q2 2023 and ~68% reduction vs. Q3 2022. • Raising revenue guide to new range of $1,035M - $1,050M and gross margin to a range of 43% - 44%; reducing cash burn guide to $260M - $280M. • Published RenaCARE study for chronic kidney disease , demonstrating significant diagnostic and clinical utility of Renasight . • Presented 24 - mos data from GALAXY, reinforcing Signatera’s predictive and prognostic value in colorectal cancer. • Participating in randomized, Ph III EORTC trial in early - stage breast cancer, adding to pipeline of clinical trials studying treatment on molecular relapse. • Published additional studies in lung cancer, strengthening clinical evidence in this patient population. • Announced broad clinical launch and Medicare coverage of FoundationOne®Tracker . 3 Q3 highlights Confidential Draft 1. Cash burn for the period ended Sept. 30, 2022, is derived from the GAAP Statement of Cash Flows as follows: net cash used in ope rating activities of $102.2 million, cash used in investing activities for purchases of property and equipment of $12.2 million, offset by cash provided in financing activities of $1.4 million. Cash burn for the period ended Sept. 30, 2023, is d eri ved from the GAAP Statement of Cash Flows as follows: net cash used in operating activities of $29.6 million, cash used in investing activities for purchases of property and equipment of $9.1 million, offset by cash provided in financing activities of $0.6 million (which excludes the September 2023 equity offering cash inflow).


Not for reproduction or further distribution. 200K 262K 394K 503K 626K K 100K 200K 300K 400K 500K 600K 700K Q3'19 Q3'20 Q3'21 Q3'22 Q3'23 Quarterly processed volumes demonstrate continued momentum Core Volume Drivers • Serving large, underpenetrated markets • Differentiated technology backed by strong evidence • Growth in Signatera clinical as margin profile improves • Strong women’s health volume growth • Organ health tailwinds 407K 4 Confidential Draft 518K Not for reproduction or further distribution.


$65 $78 $98 $158 $211 $268 $0 $50 $100 $150 $200 $250 $300 Q3'18 Q3'19 Q3'20 Q3'21 Q3'22 Q3'23 Strong reimbursement and volumes driving revenues • Significant opportunity available across women’s health, organ health, oncology 5 Product revenues: year on year trend ($ in millions) Confidential Draft Total revenues: year on year trend ($ in millions) $63 $67 $93 $154 $200 $265 $ $50 $100 $150 $200 $250 $300 Q3'18 Q3'19 Q3'20 Q3'21 Q3'22 Q3'23 Not for reproduction or further distribution.


Volume - based initiatives impacting margin: CA NIPT, carrier screening, Signatera volume growth One - time benefits: COGS credit, lumpy pharma payment ASPs and COGS execution driving organic gross margin gains • Significant sequential step up in Signatera ASPs • Cash collections accelerating • Con tinued momentum in COGS projects Gross margin quarterly trend 6 41% 39% 45% 45% 36% 37% 38% 39% 40% 41% 42% 43% 44% 45% 46% 4Q22 1Q23 2Q23 3Q23 Organic: ASP, COGS trends ahead of plan Confidential Draft Not for reproduction or further distribution.


7 Publication of landmark RenaCARE study 1 Real - world, prospective study of comprehensive genetic testing in chronic kidney disease (1,600+ patients) 20.8% of patients had positive genetic findings 32.9% of positive patients had a change in treatment plan 37M US adults have CKD 2 Addressing unmet needs Significant diagnostic utility Strong clinical utility 48.8% of positive patients had a new or reclassified diagnosis 90.7% of positive patients had a change in management $85.4B in Medicare spend (23.5% of Medicare spend) in 2020 3 Confidential Draft 1. Dahl NK, Bloom MS, Chebib FT, et al. The Clinical Utility of Genetic Testing in the Diagnosis and Management of Adults with Chronic Kidney Disease. J Am Soc Nephrol . 2023;10.1681/ASN.0000000000000249. doi:10.1681/ASN.0000000000000249. 2. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2023. https://www.cdc.gov/kidneyd ise ase/publications - resources/ckd - national - facts.html. 2023. 3. United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States, 2022. ht tps://usrds - adr.niddk.nih.gov/2022. 2022.


Not for reproduction or further distribution. 8 RenaCARE findings address key diagnostic gaps in CKD 1 A genetic diagnosis unveils a prognosis and treatment options that are now patient - specific Non - specific CKD diagnoses Undefined CKD subtype Utilization of targeted therapies Unnecessary diagnostic biopsies Clinical diagnoses are often based on non - specific criteria that mask CKD’s true cause (e.g. diabetes, hypertension, hematuria, proteinuric glomerulopathy) Lack of a genetic diagnosis limits targeted therapeutic options and access to clinical trials Confidential Draft Unknown cause of CKD A causative diagnosis could not be derived from clinical features alone 18.2% of these patients received a positive genetic result 87.5% of positive patients received a new diagnosis 23.8% of positive patients had a change in treatment plan Without definitive genetic subtypes, specific treatment pathways can be obscured (as exemplified by PKD1 vs PKD2 in cystic nephropathy) Genetic testing can obviate the need for invasive, diagnostic biopsies 14.7% of these patients received a positive genetic result 70.0% of positive patients received a new or reclassified diagnosis 22.5% of positive patients had a change in treatment plan 49.6% of patients with cystic nephropathy had a positive genetic result 79.2% of positive patients received a genetic subtype confirming the clinical presentation 49.2% of positive patients had a change in treatment plan 35.5% of positive patients received a diagnosis that could make them eligible for 1 of 24 available therapeutics 270+ clinical trials of therapeutics across Renasight conditions 19.4% of patients with a biopsy prior to genetic testing had a positive genetic finding 71.1% of these patients received a new genetic diagnosis, suggesting the potential to avoid diagnostic biopsies if Renasight is done first 1. Dahl NK, Bloom MS, Chebib FT, et al. The Clinical Utility of Genetic Testing in the Diagnosis and Management of Adults with Chronic Kidney Disease. J Am Soc Nephrol . 2023;10.1681/ASN.0000000000000249. doi:10.1681/ASN.0000000000000249.


Not for reproduction or further distribution. RenaCARE study highlights utility of Renasight in CKD 1 A genetic diagnosis unveils a prognosis and treatment options that are now patient - specific Non - specific CKD diagnoses Undefined CKD subtype Clinical diagnoses are often based on non - specific criteria that mask CKD’s true cause (e.g. diabetes, hypertension, hematuria, proteinuric glomerulopathy) Confidential Draft Unknown cause of CKD A causative diagnosis could not be derived from clinical features alone 18.2% of these patients received a positive genetic result 87.5% of positive patients received a new diagnosis 23.8% of positive patients had a change in treatment plan Without definitive genetic subtypes, specific treatment pathways can be obscured (e.g. PKD1 / PKD2 in cystic nephropathy) 14.7% of these patients received a positive genetic result 70.0% of positive patients received a new or reclassified diagnosis 22.5% of positive patients had a change in treatment plan 49.6% of patients with cystic nephropathy had a positive genetic result 79.2% of positive patients received a new genetic subtype 49.2% of positive patients had a change in treatment plan 1. Dahl NK, Bloom MS, Chebib FT, et al. The Clinical Utility of Genetic Testing in the Diagnosis and Management of Adults with Chronic Kidney Disease. J Am Soc Nephrol . 2023;10.1681/ASN.0000000000000249. doi:10.1681/ASN.0000000000000249. Cutting cross clinical categories: • 35.5% of Renasight - positive patients were eligible for an approved targeted therapy • 71.1% of Renasight - positive patients with prior biopsy could have avoided the biopsy 9 Not for reproduction or further distribution.


Oncology continues to generate strong volume growth 10 Total oncology quarterly units processed 44K 53K 64K 71K 84K 89K K 10K 20K 30K 40K 50K 60K 70K 80K 90K 100K 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 Signatera clinical units processed 35K 44K 52K 61K 72K 81K K 10K 20K 30K 40K 50K 60K 70K 80K 90K 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 • Growth driven by new patient initiations, repeat testing in existing patients, and adoption by new physicians who had never o rde red Signatera before • 35% of US oncologists ordered Signatera in the quarter with continued increases in new accounts • Q3 clinical unit growth near all - time highs Confidential Draft Not for reproduction or further distribution.


11 Updated 24 Mos. GALAXY analysis at ESMO 2023 bodes well for readout of randomized ALTAIR + VEGA trials MRD - positive patients: significant chemo benefit (24M - DFS: 38.6% with chemo v. 16.1% w/o chemo) MRD - negative patients: no significant chemo benefit (24M - DFS: 88.3% with chemo v. 89.9% w/o chemo) ALTAIR trial readout: mid 2024 Hypothesis: TAS - 102 added to chemo will further improve DFS in MRD - positive patients VEGA trial readout: 2026 Hypothesis: MRD - negative patients don’t need adjuvant chemo Confidential Draft Not for reproduction or further distribution.


• New ctDNA - guided treatment approach, leveraging the power of serial testing • Objective: to delay/prevent overt recurrence with identification and treatment on molecular relapse • Significant interest from pharma and clinicians to treat on molecular relapse 12 Treatment on molecular relapse: major opportunity TREAT ctDNA Phase III breast cancer trial ALTAIR Phase III colorectal cancer trial Confidential Draft LEADER Phase II breast cancer trial DARE Phase II breast cancer trial - - + - Novel treatment Control arm (SOC) if testing ctDNA positive ctDNA negative - R - Quantity of ctDNA ctDNA clearance as early efficacy readout Not for reproduction or further distribution.


13 Growing body of evidence in lung cancer across settings Neoadjuvant setting Adjuvant setting Metastatic setting Stage I - III neoadjuvant NSCLC Cascone et al, 2023 NeoCoast platform trial evaluated dual IO combinations in stage I - III NSCLC patients. All patients experiencing MPR or pCR were molecular responders (>50% ctDNA reduction). Stage I - III unresectable NSCLC Lebow et al, 2023 82% pre - treatment detection 100% longitudinal sensitivity and specificity to progression. Stage I - III resectable NSCLC Abbosh et al, 2017 93% longitudinal recurrence sensitivity and 100% specificity. Empower - Lung1 1 ASCO 2023 Week 3 & 9 ctDNA dynamics were predictive of overall survival. IMpower131 1 Pellini et al, 2023 Monitoring with F1Tracker during induction chemoIO can inform maintenance therapy decisions. Confidential Draft 1. Studies conducted in collaboration with Foundation Medicine, Inc.


Not for reproduction or further distribution. FoundationOne®Tracker Now Available in US 14 Confidential Draft FoundationOne®Tracker Monitors treatment response for patients with advanced cancer across all solid tumors . Medicare coverage in place for immunotherapy (I/O) monitoring, effective 6/17/23. Two recent peer - reviewed publications 1,2 demonstrate strong clinical test performance for I/O monitoring . Personalized MRD assay design and analysis Genomic information derived from FoundationOne®CDx Monitors patient response to treatment 1. Kansara M, Bhardwaj N, Thavaneswaran S, et al. Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated wi th durvalumab and tremelimumab . Mol Oncol . 2023;17(2): 298 – 311. 2. Pellini B, Madison RW, Childress M, et al. Circulating Tumor DNA Monitoring on Chemo - immunotherapy for Risk Stratification in Advanced Non - Small Cell Lung Cancer. Clin Cancer Res . 2023.


Q3 23 financial overview ($ in millions, except for per share data) Balance sheet September 30, 2023 Dec 31, 2022 Change Q/Q Cash & investments 1 $936.6 $898.4 $38.2 UBS line of credit $80.4 $80.4 $ — Convertible senior notes 2 $282.6 $281.7 $0.9 P&L Q3’23 Q3’22 Change Y/Y Product revenues $265.2 $199.8 $65.4 Licensing and other revenues $3.1 $10.8 ($7.7) Total revenues $268.3 $210.6 $57.7 Gross margin% 45.1% 44.7% 41 bps R&D $77.2 $65.5 $11.7 SG&A $154.7 $147.7 $7.0 Net loss per diluted share ($0.95) ($1.25) $0.30 1. Cash and investments also include cash equivalents and restricted cash. 2. This balance reflects net carrying value for the Convertible Senior Notes under ASC 470 - 20 while the gross principal amounts outstanding is $287.5 million as of September 30, 2023. Confidential Draft 15 Not for reproduction or further distribution.


$162 2 $110 $113 1 $88 $86 2 $78 $38 1 $0 $20 $40 $60 $80 $100 $120 $140 $160 $180 1Q23 2Q23 3Q22 4Q22 1Q23 2Q23 3Q23 Cash burn reduction target ahead of plan • Expected cash burn reduction compared to 2022 of more than $200M on continued revenue growth and reduction in operating expenses. • Cash burn reductions will fluctuate quarter to quarter based on working capital dynamics. • Improved trends on DSOs and Signatera ASPs driven by broader coverage, reimbursement execution. • Strong sequential growth in Q3 on stable commercial footprint. Quarterly cash burn trend ($ in millions) 1. Cash burn for the period ended Sept. 30, 2022, is derived from the GAAP Statement of Cash Flows as follows: net cash used in ope rating activities of $102.2 million, cash used in investing activities for purchases of property and equipment of $12.2 million, offset by cash provided in financing activities of $1.4 million. Cash burn for the p eri od ended Sept. 30, 2023, is derived from the GAAP Statement of Cash Flows as follows: net cash used in operating activities of $29.6 million, cash used in investing activities for purchases of property and equipmen t o f $9.1 million, offset by cash provided in financing activities of $0.6 million (which excludes the September 2023 equity offering cash inflow). 2. Cash burn included $13.4 million change in unrealized loss and amortization or accretion on investments during the first quar ter 2022. Cash burn included $3.8 million change in unrealized gain and amortization or accretion on investments during the first quarter 2023. 16 Confidential Draft 1Q22 2Q22 Not for reproduction or further distribution.


Guide ($ millions) Original Q1 23 Q2 23 Current Key drivers Revenue $ 980 – $ 1,000 $ 995 – $ 1,015 $1,015 – $1,035 $1,035 – $1,050 Continued volume growth, conservative ASPs, strong oncology contribution Gross margin % revenue 4 1 % – 4 4 % 4 1 % – 4 4 % 4 1 % – 4 4 % 4 3 % – 4 4 % ASPs, COGS trends continue to mature SG&A $5 10 – $5 40 $5 10 – $5 40 $5 40 – $5 80 $5 40 – $5 80 Stable trend vs. 2022 on mature commercial platforms R&D $3 25 – $3 45 $3 25 – $3 45 $3 25 – $3 45 $3 25 – $3 45 Focused investments in COGS reduction projects, clinical trials Cash burn $3 00 – $ 325 $3 00 – $ 325 $3 00 – $ 325 $ 260 – $ 280 More than $200M reduction in cash burn vs. 2022 2023 guidance: raising revenue & gross margin; reducing cash burn 17 Confidential Draft

Rich slate of potential future growth catalysts 18 Not for reproduction or further distribution. Potential guideline inclusion for Signatera , 22Q, Expanded Carrier Screening, Organ Health New product launches in Oncology and Women’s health Key data readouts in oncology including Altair CRC, treatment on molecular recurrence, early cancer detection Continued core business momentum in volume growth, ASP improvements, COGS reductions Signatera commercial launch in Japan serving a very large unmet need

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