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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): May 9, 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 May 9, 2023, Natera, Inc. issued a press release announcing the results for its first quarter ended March 31, 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 May 9, 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: May 9, 2023

 

 

Exhibit 99.1 

 

Natera Reports First Quarter 2023 Financial Results

 

 

 

AUSTIN, Texas, May 9, 2023 — Natera, Inc. (NASDAQ:  NTRA), a global leader in cell-free DNA testing, today reported financial results for the first quarter ended March 31, 2023.

 

Recent Strategic and Financial Highlights

 

Generated total revenues of $241.8 million in the first quarter of 2023, compared to $194.1 million in the first quarter of 2022, an increase of 24.5%. Product revenues grew 25.2% over the same period.
Processed approximately 626,200 tests in the first quarter of 2023, compared to approximately 489,300 tests in the first quarter of 2022, an increase of 28.0%.
Performed 71,000 oncology tests in the first quarter of 2023, compared to approximately 35,100 units in the first quarter of 2022, an increase of 102.2%.
Reinforced Panorama NIPT differentiation and data leadership with three papers (2 published, 1 accepted), including new evidence from the SMART study.
Received Medicare coverage for Prospera in heart transplantation.
Secured first commercial coverage decisions for Signatera, including pan-cancer coverage policy from Blue Shield of California.
New study published in Cancer highlights Signatera’s performance in stages III – IV melanoma.
Expanded I-SPY2 study published in Cancer Cell demonstrates prognostic and predictive value of Signatera for breast cancer patients in the neoadjuvant setting.
Raising 2023 annual revenue guidance from $990 million to $1.0 billion to a new range of $995 million to $1.015 billion.

 

“We are off to an excellent start in 2023,” said Steve Chapman, Natera’s Chief Executive Officer. “We published important new data sets in the women’s health and oncology settings, received the first commercial coverage policies for Signatera, and secured Medicare reimbursement for Prospera in heart transplantation. Our performance demonstrates the strength of our technology, and we look forward to helping millions of additional patients and advancing our mission to transform the management of disease.”

 

First Quarter Ended March 31, 2023 Financial Results

 

Total revenues were $241.8 million in the first quarter of 2023, compared to $194.1 million for the first quarter of 2022, an increase of 24.5%. Product revenues were $237.8 million in the first quarter of 2023, compared to $190.0 million in the first quarter of 2022, an increase of 25.2%. The growth in product revenues was driven by an increase in test volumes compared to the first quarter of 2022.

 

Natera processed approximately 626,200 tests in the first quarter of 2023, including approximately 607,700 tests accessioned in its laboratory. This compares to approximately 489,300 tests processed in the first quarter of 2022, including approximately 473,200 tests accessioned in its laboratory, an increase of 28.0%.

 

In the three months ended March 31, 2023, Natera recognized revenue on approximately 583,400 tests for which results were reported to customers in the period (tests reported), including approximately 566,000 tests reported from its laboratory, compared to approximately 456,100 tests reported, including approximately 440,900 tests reported from its laboratory, in the first quarter of 2022, an increase of 27.9% for the quarter.

 

 

 

 

Gross profit* for the three months ended March 31, 2023 and 2022 was $93.6 million and $90.9 million, respectively, representing a gross margin of 38.7% and 46.8%. Natera had lower margins in the first quarter of 2023 compared to the first quarter of 2022 primarily due to increased labor, overhead costs, and third-party services driven by volume growth and product support.

 

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the first quarter of 2023 were $231.9 million, compared to $228.0 million in the same period of the prior year, an increase of 1.7%. The increase was primarily driven by additional headcount to support the Company’s expansion, volume growth, and product development. Loss from operations for the first quarter of 2023 was $138.3 million, compared to $137.1 million for the same period of the prior year.

 

The Company reported a net loss for the first quarter of 2023 of $136.9 million, or ($1.23) per diluted share, compared to a net loss of $138.6 million, or ($1.45) per diluted share, for the same period in 2022. Weighted average shares outstanding were approximately 111.8 million in the first quarter of 2023, compared to 95.6 million in the first quarter of the prior year.

 

As of March 31, 2023, Natera held approximately $812.0 million in cash, cash equivalents, short-term investments and restricted cash, compared to $898.4 million as of December 31, 2022. As of March 31, 2023, Natera had a total outstanding debt balance of $362.4 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 $282.0 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 March 31, 2023.

 

Financial Outlook

 

Natera is raising its expectations for 2023 total revenue from $980 million to $1.0 billion to a new range of $995 million to $1.015 billion, and continues to expect 2023 gross margin to be approximately 41% to 44% of revenues; selling, general and administrative costs to be approximately $510 million to $540 million; research and development costs to be $325 million to $345 million, and net cash consumption to be approximately $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 $250 million to $275 million) and GAAP net purchases of property and equipment (estimated for 2023 to be approximately $50 million).

 

Test Volume Summary

 

Unit  Q1 2023   Q1 2022   Definition
Tests processed   626,200    489,300   Tests accessioned in our laboratory plus units processed outside of our laboratory
Tests accessioned   607,700    473,200   Test accessioned in our laboratory
Tests reported in our laboratory   566,000    440,900   Total tests reported in our laboratory less units reported outside of our laboratory
Tests reported   583,400    456,100   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 100 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 First Quarter 2023 Financial Results Conference Call
Date:  Tuesday, May 9, 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/726007467

 

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., [email protected]

 

 

 

 

Natera, Inc.

Consolidated Balance Sheets

(Unaudited)

(in thousands, except par value per share amount)

 

   March 31,   December 31, 
   2023   2022 
       (1) 
Assets          
Current assets:          
Cash, cash equivalents and restricted cash  $403,154   $466,091 
Short-term investments   408,858    432,301 
Accounts receivable, net of allowance of $5,134 and $3,830 at March 31, 2023 and December 31, 2022, respectively   246,785    244,385 
Inventory   40,683    35,406 
Prepaid expenses and other current assets, net   29,988    33,634 
Total current assets   1,129,468    1,211,817 
Property and equipment, net   100,587    92,453 
Operating lease right-of-use assets   69,537    71,874 
Other assets   19,288    18,330 
Total assets  $1,318,880   $1,394,474 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $36,123   $31,148 
Accrued compensation   39,231    44,010 
Other accrued liabilities   118,638    144,214 
Deferred revenue, current portion   16,579    10,777 
Short-term debt financing   80,398    80,350 
Total current liabilities   290,969    310,499 
Long-term debt financing   281,973    281,653 
Deferred revenue, long-term portion   21,511    20,001 
Operating lease liabilities, long-term portion   73,854    76,577 
Total liabilities   668,307    688,730 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Common stock (2)   11    11 
Additional paid-in capital   2,741,932    2,664,730 
Accumulated deficit   (2,079,572)   (1,942,635)
Accumulated other comprehensive loss   (11,798)   (16,362)
Total stockholders’ equity   650,573    705,744 
Total liabilities and stockholders’ equity  $1,318,880   $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 March 31, 2023 and December 31, 2022, there were approximately 113,359 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 
   March 31, 
   2023   2022 
Revenues          
Product revenues  $237,797   $190,002 
Licensing and other revenues   3,959    4,131 
Total revenues   241,756    194,133 
Cost and expenses          
Cost of product revenues   147,754    102,670 
Cost of licensing and other revenues   370    545 
Research and development   82,306    80,414 
Selling, general and administrative   149,627    147,634 
Total cost and expenses   380,057    331,263 
Loss from operations   (138,301)   (137,130)
Interest expense   (3,061)   (2,087)
Interest and other income, net   4,585    801 
Loss before income taxes   (136,777)   (138,416)
Income tax expense   (160)   (179)
Net loss  $(136,937)  $(138,595)
Unrealized gain (loss) on available-for-sale securities, net of tax   4,564    (11,617)
Comprehensive loss  $(132,373)  $(150,212)
           
Net loss per share:          
Basic and diluted  $(1.23)  $(1.45)
Weighted-average number of shares used in computing basic and diluted net loss per share:          
Basic and diluted   111,767    95,578 

 

 

 

 

Exhibit 99.2

 

Natera, Inc. Investor presentation First Quarter 2023 Earnings Call May 9, 2023

 

 

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 diffe r 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 t hro ugh 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 res ults 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 produ cts 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 bu sin ess, 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 ou r 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 f or 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 unab le 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 fi nd 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 co uld 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 reimbu rsement 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 c lea rance 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 thi rd 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 ou r 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 outstand ing 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 o f O perations” 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 e mer ge 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 ca use 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 thi s 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 t o 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

 

 

Not for reproduction or further distribution. Recent highlights Strong Q1’23 Financial Results / 2023 Guidance Continued Data Leadership Reimbursement & Medical Society Endorsements • Reinforced Panorama NIPT differentiation and data leadership with three papers (2 published, 1 accepted), including new evidence from the SMART study • New study published in Cancer highlights Signatera’s performance in stages III - IV melanoma • Expanded I - SPY2 study published in Cancer Cell demonstrates prognostic/predictive value of Signatera for breast cancer patients in neoadjuvant setting • ~25% growth in revenues YoY (total revenues of $242M) • ~28% growth in processed tests YoY (626K tests processed) • ~102% growth in oncology volumes YoY ( 71 K tests performed) • Raising 2023 revenue guidance to $995M – $1.015B • O n track to reduce cash burn ~$150M YoY • Secured pan - cancer coverage policy from Blue Shield of California; first major commercial coverage decision for Signatera • Received Medicare coverage for Prospera Heart • Recent medical society endorsements of dd - cfDNA testing for transplant patients from the American Society of Transplant Surgeons and the American Society of Transplantation 3

 

 

Not for reproduction or further distribution. Record Q1 23 volume of 626,000 units Core Volume Drivers • Serving large, underpenetrated markets • Differentiated technology backed by strong evidence Strategic Volume Initiatives • NIPT growth in CA • Market share gains due to competitor carrier screening exits • Growth in Signatera clinical as margin profile matures 200 K 195 K 200 K 209 K 235 K 234 K 262 K 295 K 348 K 376 K 407 K 439 K 489 K 500 K 518 K 560K 626K Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 4

 

 

Not for reproduction or further distribution. 173M 194M 198M 211M 217M 242M Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Strong sequential revenue growth in Q1 • ~25% revenue growth over Q1’22 • ~12% revenue growth over Q4’22 • Strong volume growth • Significant growth in Signatera ASP Total revenues: year on year trend ($ in millions) 2 % 6 % 3 % 12 % 12 % 5

 

 

Not for reproduction or further distribution. Three new publications reinforce Panorama data leadership 1. Goldring G, Trotter C, Meltzer JT, et al. Maternal Malignancy After Atypical Findings on Single - Nucleotide Polymorphism - Based Prenatal Cell - Free DNA Screening . Obstetrics and Gynecology 2023 Mar 09. 2. Norton ME, MacPherson C, Demko Z et al. Obstetrical, perinatal and genetic outcomes associated with non - reportable prenatal cell free DNA screening results . American Journal of Obstetrics and Gynecology 2023 Mar 23, Supplementary Table 1. 3. Martin K, Norton M, MacPherson C, et al. Performance Analysis of cfDNA in Predicting Sex Chromosome Count in an Unselected Po pul ation. 32nd World Congress on Ultrasound in Obstetrics and Gynecology. Hybrid Meeting, London, UK. Poster Presentation. 2022 Sep 16 - 18. New SMART study publication on Panorama’s ability to identify certain patients at risk of adverse outcomes Identified a sub - category of ~1 in 200 pregnancies with a significant increased risk for adverse outcomes: • > 4x risk for preeclampsia • >4x risk for preterm birth <37 weeks • >10x risk for preterm birth <28 weeks Review of Panorama “suspected maternal malignancy” result type: • Review of >2M Panorama tests • 1:53,000 suspicious for maternal malignancy While rare, these Panorama results have high PPV and provide critical health information: • Cancer diagnosis confirmed in 66.7% (20/30) of these patients with clinical follow up • Authors recommend investigation for malignancy for all pregnant patients with this result type Largest, prospective clinical validation study of sex chromosome aneuploidies : • >17,000 pregnancies with confirmed outcomes Strong results with SNP - based NIPT: • Real world SCA screening results consistent with previous studies • 100% accuracy in calling fetal sex in 14,476 pregnancies Pregnancy Complications 2 Maternal Findings 1 Sex Chromosomes 3 6

 

 

Not for reproduction or further distribution. Medicare coverage for Prospera Heart Estimated test TAM of >$500M per year MolDX Local Coverage Determination (LCD) • Confirmed coverage from CMS MolDX for Prospera Heart under local coverage determination #L38568 for solid organ transplant rejection • Prospera test now has Medicare coverage for both heart and kidney transplant patients • Prospera Heart CMS price: $2,753 7

 

 

Not for reproduction or further distribution. Endorsements of dd - cfDNA testing in transplantation 1. American Society of Transplant Surgeons. ASTS Statement on donor - derived cell - free DNA (dd cf - DNA) . asts.org 2023 Mar 06. 2. Kobashigawa J, Hall S, Shah P, et al. The evolving use of biomarkers in heart transplantation: consensus of an expert panel . American Journal of Transplantation 2023 Mar 02. 3. Velleca A, Shullo MA, Dhital K, et al. The International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the Care of Heart Transplant Recipients . The Journal of Heart and Lung Transplantation 2022 Dec 20. 4. The European Society for Organ Transplantation. ESOT TLJ Consensus Conference Highlights Report . esot.org 2023 Mar 17. American Society of Transplant Surgeons 1 European Society of Transplantation 4 Kidney Transplants : • Recommend use of dd - cfDNA for - cause use to rule out ABMR • Suggest surveillance use of dd - cfDNA to rule out sub - clinical rejection Heart Transplants : • Recommend dd - cfDNA surveillance and for - cause use in heart transplant patients Kidney Transplants : • Consensus in favor of surveillance and for - cause dd - cfDNA use to rule out rejection Heart Transplants : • Consensus in favor of dd - cfDNA to rule out sub - clinical rejection (both AMR and ACR) American Society of Transplantation 2 • “Currently, DSA and dd - cfDNA used in combination may be the optimal biomarker to assess clinical outcomes” in heart transplant recipients International Society for Heart & Lung Transplantation 3 • dd - cfDNA included in Class I, Level B guideline recommendation on tools for ongoing heart rejection monitoring 8

 

 

Not for reproduction or further distribution. Renasight – key study on track for H2 23 publication 1. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021 . US Department of Health and Human Services, Centers for Disease Control and Prevention 2021. 2. Internal company estimates based on publicly available data. RenaCARE Study for Renasight • Real - world, prospective, multi - center study to assess clinical utility of the Renasight genetic testing panel for patients with chronic kidney disease (CKD) • Completed enrollment in August 2022 with more than 1,600 patients across 30+ sites • Publication expected in H2 23 Key metrics for the RenaCARE study include: • Diagnostic yield – the number of CKD cases with positive genetic findings • Clinical utility – the number of patients that had changes in clinical management and treatment CKD is a large and growing area of healthcare that can be improved with genetic testing ~37M ~1M >10% patients living with CKD in the U.S. newly diagnosed CKD patients per year of the U.S. population has CKD and is eligible for testing 1 2 2 9

 

 

Not for reproduction or further distribution. Oncology continues to generate strong volume growth Signatera and Altera quarterly unit volumes • >30% of US oncologists have ordered Signatera in the quarter with continued increases in new accounts • Growth driven by both new patients and recurrence monitoring • Strong clinical volume growth in Q1 • Increase in utilization across indications 1 K 10 K 35K 71K Q1'20 Q1'21 Q1'22 Q1'23 10

 

 

Not for reproduction or further distribution. Major commercial carriers now covering Signatera • Blue Shield of California implemented new pan - cancer policy for Signatera • Effective 3/1/23, the policy covers adjuvant, recurrence monitoring, and treatment monitoring • Includes all solid tumors for stages I - IV cancer • BSCA serves 4.7M members • Coverage driven by payer - conducted clinical utility analysis demonstrating improved outcomes, reduced costs 11

 

 

Not for reproduction or further distribution. Prospective/randomized CRC study pipeline in progress CRC commercial experience study (NR) Est. submission for publication (H2 23) Clinical experience of ~13,500 patients Est. publication of data (Q4 23) Predictive randomized CRC data Est. presentation of GALAXY data (Q4 23) 24 - month outcomes data on >2K CRC patients; expansion of the Nature Medicine paper published in Jan. ’23 Est. planned submission (2024) Enrollment complete, ~400 patients now have ~2 years of follow up Est. readout (mid - 2024) , publication thereafter Escalation/treatment on molecular recurrence study Est. readout (2026) De - escalation to observation Est. readout on first ~800 patients (2026) Escalation cohort Blinded RCT Biobank (not yet announced) (RCT) BESPOKE CRC study (NR) CIRCULATE - Japan (ALTAIR study) (RCT) CIRCULATE - Japan (VEGA study) (RCT) CIRCULATE - US (NRG 008 study) (RCT) GALAXY 24 - month follow up (NR) 2024 2025 2026 2023 NOTE: RCT refers to randomized controlled trial (prospective or retrospective). NR refers to non - randomized. All publication/pre sentation timeframes are estimates. 12

 

 

Not for reproduction or further distribution. New clinical evidence across multiple indications 1. Huffman BM, Aushev VN, Budde GL, et al. Analysis of circulating tumor DNA to predict risk of recurrence in patients with esophageal and gastric cancers . JCO Precision Oncology 2022 Dec 08. 2. Azzi G, Tavallai M, Aushev VA, et al. Using Tumor - Informed Circulating Tumor DNA (ctDNA) - Based Testing for Patients with Anal Squamous Cell Carcinoma . The Oncologist 2022 Dec 23. 3. Eroglu Z, Krinshpun S, Kalashnikova E, et al. Circulating tumor DNA - based molecular residual disease detection for treatment monitoring in advanced melanoma patients . Cancer 2023 Mar 04. 4. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high - risk early - stage HER2 - negative breast cancer receiving neoadj uvant chemotherapy . Cancer Cell 2023 May 04. Source: internal company data Journal Indication Description Patients, plasma time points Publication Status JCO Precision Oncology Gastroesophageal 1 Multi - center - RWE 295 patients 943 plasma time points Dec 2022 The Oncologist Anal squamous cell carcinoma 2 Multi - center - RWE 251 patients 817 plasma time points Dec 2022 Cancer Melanoma 3 Single center - RWE 69 patients 555 plasma time points Mar 2023 Cancer Cell Breast Cancer 4 I - SPY 2.0 neoadjuvant setting 283 patients 1024 plasma time points May 2023 Submitted for publication Breast Cancer EBLIS expanded cohort Long - term surveillance >175 patients >1200 plasma time points Expected 2H 2023 Planned submission in Q2 Pancreatic Multi - center - RWE >300 patients >1900 plasma time points Expected 2H 2023 To date, Signatera has been validated in >40 published peer - reviewed studies across >25 tumor types 13

 

 

Not for reproduction or further distribution. I - SPY 2 Results ( Cancer Cell, 2023 ) 2 I - SPY2: Signatera both prognostic and predictive in neoadjuvant setting • Approximately 50% get NAC (regardless of tumor subtype) • Guidelines recommend response assessment during NAC, but also state this can be difficult with current methods 1 • Individualization of NAC difficult, leads to possible over and undertreatment Neoadjuvant Therapy (NAC) Trends 1. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Breast Cancer, vers ion 4.2023. 2023 Mar 23. 2. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high - risk early - stage HER2 - negative breast cancer receiving neoadj uvant chemotherapy . Cancer Cell 2023 May 04. Prognostic • ctDNA - positivity before, during, and after NAC was significantly associated with inferior distant recurrence - free survival (DRFS) (p=0.02 to p<0.0001) 14 Predictive • Early ctDNA clearance at 3 weeks of NAC was a significant predictor of response (p=0.0002) • ctDNA - negativity after NAC was significantly associated with improved DRFS, even in patients with extensive residual cancer burden at surgery (p<0.0001)

 

 

Not for reproduction or further distribution. Extending Signatera data leadership at ASCO 2 Oral & 12 poster presentations American Society of Clinical Oncology (ASCO) annual meeting in June 2023 • Indications: Colorectal cancer, pancreatic, esophageal, cholangiocarcinoma, non - small cell lung cancer (NSCLC), muscle - invasive bladder cancer, melanoma and sarcoma • Poster Discussion: INTERCEPT Program MD Anderson (CRC) Patients: >1200 | Setting: Surveillance Title: Positive ctDNA - based MRD assays during surveillance is associated with high rates of concomitant radiographic recurrences in CRC • Poster Discussion: EMPOWER Lung - 1 (Advanced NSCLC) Patients: >150 | Setting: On - treatment ctDNA response Title: ctDNA dynamics and survival outcomes in patients with advanced NSCLC and high PD - L1 expression, randomized to cemiplimab and chemotherapy • Poster Discussion: Galaxy CIRCULATE - Japan (CRC) Patients: >2000 | Prospective, Observational Study Title: Circulating tumor DNA dynamics as an early predictor of recurrence in patients with radically resected colorectal cancer: Updated results from GALAXY study in the CIRCULATE - Japan 15

 

 

Q1 23 Financial Overview ($ in millions, except for per share data) Balance sheet March 31, 2023 Dec 31, 2022 Change Q/Q Cash & investments 1 $812.0 $898.4 ($86.4) UBS line of credit $80.4 $80.4 $ — Convertible senior notes 2 $282.0 $281.7 $0.3 P&L Q1’23 Q1’22 Change Y/Y Product revenues $237.8 $190.0 $47.8 Licensing and other revenues $4.0 $4.1 ($0.1) Total revenues $241.8 $194.1 $47.7 Gross margin% 38.7% 46.8% (810) bps R&D $82.3 $80.4 $1.9 SG&A $149.6 $147.6 $2.0 Net loss per diluted share ($1.23) ($1.45) $0.22 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 out standing is $287.5 million as of March 31, 2023. 16 Not for reproduction or further distribution.

 

 

Not for reproduction or further distribution. Cash burn reduction target on track • Expect cash burn reduction of ~$150M 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 Q1 on stable commercial footprint $162M $86M Q1'22 Q1'23 Quarterly cash burn 1 : year on year trend ($ in millions) 1. Cash burn for the period ended March 31, 2022, is derived from the GAAP Statement of Cash Flows and Stockholders’ Equity as f oll ows: net cash used in operating activities of $137.3 million, cash used in investing activities for purchases of property and equipment of $15.9 million, and $13.4 million in unrealized loss and amortization or accretion on investments, o ffs et by cash provided in financing activities of $4.2 million. Cash burn for the period ended March 31, 2023, is derived from the GAAP Statement of Cash Flows and Stockholders’ Equity as follows: net cash used in operating activities of $80.9 mi lli on, cash used in investing activities for purchases of property and equipment of $11.6 million, offset by cash provided in financing activities of $2.3 million, and $3.8 million unrealized gain and amortization or accretion on investments. 17

 

 

Not for reproduction or further distribution. Guide ($ millions) Original Current Key drivers Revenue $ 980 – $ 1,000 $ 995 – $ 1,015 Continued volume growth, conservative ASPs, strong oncology contribution Gross margin % revenue 4 1 % – 4 4 % 4 1 % – 4 4 % Conservative ASP assumptions, strong oncology growth, completing key COGS improvement projects in 2023 for future leverage SG&A $5 10 – $5 40 $5 10 – $5 40 Modest reduction in spend vs. 2022 on mature commercial platforms R&D $3 25 – $3 45 $3 25 – $3 45 Focused investments in COGS reduction projects, clinical trials intended to drive guideline adoption Cash burn $3 00 – $ 325 $3 00 – $ 325 ~$150M reduction vs. 2022 cash burn Raising 2023 annual revenue guidance 18

 

 

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