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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 6, 2021

 

 

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) 249-9090

(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 (see General Instruction A.2):

 

¨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 6, 2021, Natera, Inc. issued a press release announcing its results for its first quarter ended March 31, 2021 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 6, 2021.
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 6, 2021

 

   

 

Exhibit 99.1

 

Natera Reports First Quarter 2021 Financial Results

 

 

AUSTIN, Texas, May 6, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ:  NTRA), a pioneer and global leader in cell-free DNA testing, today reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business progress and financial outlook.

 

Recent Accomplishments & Highlights

 

Generated total revenues of $152.3 million in the first quarter of 2021 compared to $94.0 million in the first quarter of 2020, an increase of 62%. Product revenues grew 36% over the same period. First quarter 2021 revenues include a one-time revenue recognition of $28.6 million from the conclusion of the Qiagen partnership.

Processed approximately 348,200 tests in the first quarter of 2021, compared to approximately 235,500 tests processed in the first quarter of 2020, an increase of 48%.

Raising full year 2021 revenue guidance by $50M given overall strong momentum.

Implemented first wave of Panorama AI improvements with immediate impact on test performance, patient experience and cost of goods sold.

Received new local coverage decision from CMS which opens the pathway to Prospera reimbursement in multiple organs.

Initiated second phase 3 trial with Genentech using Signatera as a companion diagnostic in early-stage muscle invasive bladder cancer.

Received two additional breakthrough device designations for Signatera in new indications.

Positive Signatera data presented in ovarian cancer at AACR and multiple myeloma data expected at ASCO.

 

“Q1 was yet another record quarter for Natera,” said Steve Chapman, Natera’s Chief Executive Officer. “Our volumes continued to accelerate, we launched Panorama AI, and we expanded our market opportunity with positive new data in both organ health and oncology. As a result of our Q1 performance and the current momentum in the business, we are increasing our revenue forecast for the year by $50 million.”

 

First Quarter Ended March 31, 2021 Financial Results

 

Total revenues were $152.3 million in the first quarter of 2021 compared to $94.0 million for the first quarter of 2020, an increase of 62%. The product revenues were $118.4 million in the first quarter of 2021 compared to $87.0 million in the first quarter of 2020, an increase of 36%. The increase in product revenues was driven by an increase in test volumes compared to the first quarter of 2020. Licensing and other revenues increased by approximately $27.0 million over the same period, mainly due to revenue recognized from the Qiagen arrangement of approximately $28.6 million of previously deferred revenue. Natera processed approximately 348,200 tests in the first quarter of 2021, including approximately 333,400 tests accessioned in its laboratory, compared to approximately 235,500 tests processed, including approximately 222,400 tests accessioned in its laboratory, in the first quarter of 2020.

 

   

 

 

In the three months ended March 31, 2021, Natera recognized revenue on approximately 313,800 tests for which results were reported to customers in the period (tests reported), including approximately 300,000 tests reported from its laboratory, compared to approximately 221,500 tests reported, including approximately 209,200 tests reported from its laboratory, in the first quarter of 2020, an overall increase of 42% for the quarter.

 

Gross profit* for the three months ended March 31, 2021 and 2020 was $85.5 million and $49.0 million, respectively, representing a gross margin of 56% and 52%, respectively. Natera was able to achieve higher margins in the first quarter of 2021 compared to the first quarter 2020 as a result of increased other revenue recognized from the Qiagen arrangement.

 

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the first quarter of 2021 were $148.5 million, compared to $83.9 million in the same period of the prior year, an increase of 77%. The increases were primarily driven by headcount growth to support the Company’s expansion, volume growth, and product development.

 

Loss from operations for the first quarter of 2021 was $63.0 million compared to $34.9 million for the same period of the prior year.

 

Net loss for the first quarter of 2021 was $63.9 million, or ($0.74) per diluted share, compared to net loss of $35.4 million, or ($0.45) per diluted share, for the same period in 2020. Weighted average shares outstanding were approximately 86.7 million in the first quarter of 2021 compared to 78.3 million in the first quarter of the prior year.

 

At March 31, 2021, Natera held $653.7 million in cash, cash equivalents, short-term investments and restricted cash, compared to $405.9 million as of March 31, 2020. As of March 31, 2021, Natera had a total outstanding debt balance of $329.6 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $279.5 million under its seven-year convertible senior notes. The convertible senior notes were issued in April 2020 for net proceeds of $278.3 million. The gross principal balance outstanding for the convertible senior notes was $287.5 million as of March 31, 2021.

 

Financial Outlook

 

Natera anticipates 2021 total revenue of $550 million to $575 million; 2021 gross margin to be approximately 52% to 55% of revenues; selling, general and administrative costs to be approximately $440 million to $460 million; research and development costs to be $165 million to $185 million, and net cash burn to be $230 million to $250 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 burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2021 to be between $210 million and $230 million) and GAAP net purchases of property and equipment (estimated for 2021 to be approximately $20 million).

 

Test Volume Summary

 

Unit  Q1 2021   Q1 2020   Definition
Tests processed   348,200    235,500   Tests accessioned in our laboratory plus units processed outside of our laboratory
Tests accessioned   333,400    222,400   Test accessioned in our laboratory
Tests reported in our laboratory   300,000    209,200   Total tests reported in our laboratory less units reported outside of our laboratory

 

   

 

 

About Natera

 

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform.

 

Conference Call Information

 

Event:  Natera's First Quarter 2021 Financial Results Conference Call 
Date:  Thursday, May 6, 2021 
Time:  1:30 p.m. PT (4:30 p.m. ET)
Live Dial-In:  (877) 823-0171, Domestic 
  (617) 500-6932, International
   
Password:   7557308
Webcast:  https://edge.media-server.com/mmc/p/29k86t7p

 

Forward-Looking Statements

 

This release contains forward-looking statements, including regarding the company's business operations in light of the COVID-19 pandemic. Any forward-looking statements contained in this 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. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.

 

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 maintain our business and operations as planned in light of the COVID-19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and successfully commercialize new products, including Signatera and Prospera; 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 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 in the average-risk pregnancy population or for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our CLIA-certified laboratory facilities 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 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, such as the increased focus by third-party payers on requiring that prior authorization be obtained prior to conducting a test; 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.

 

   

 

 

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.

 

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
Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]

 

   

 

 

Natera, Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands)

 

   March 31,   December 31, 
   2021   2020 
   (Unaudited)   (1) 
Assets          
Current assets:          
Cash and cash equivalents  $65,126   $48,668 
Restricted cash   163    187 
Short-term investments   588,446    688,606 
Accounts receivable, net of allowance of $2,970 in 2021 and $3,080 in 2020   87,562    78,565 
Inventory   23,676    20,031 
Prepaid expenses and other current assets, net   26,430    26,606 
Total current assets   791,403    862,663 
Property and equipment, net   40,177    33,348 
Operating lease right-of-use assets   49,526    21,399 
Other assets   12,406    14,743 
Total assets  $893,512   $932,153 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $4,682   $8,096 
Accrued compensation   25,870    30,371 
Other accrued liabilities   77,296    60,407 
Deferred revenue, current portion   9,069    50,125 
Short-term debt financing   50,052    50,054 
Total current liabilities   166,969    199,053 
Long-term debt financing   279,471    202,493 
Deferred revenue, long-term portion   23,816    22,805 
Operating lease liabilities, long-term portion   50,811    21,246 
Other long-term liabilities       320 
Total liabilities   521,067    445,917 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Common stock (2)   9    9 
Additional paid in capital   1,356,212    1,411,286 
Accumulated deficit   (986,973)   (929,318)
Accumulated other comprehensive gain   3,197    4,259 
Total stockholders’ equity   372,445    486,236 
Total liabilities and stockholders’ equity  $893,512   $932,153 

 

(1)The condensed, consolidated balance sheet at December 31, 2020 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, 2020.

(2)As of December 31, 2020, there were approximately 87,430,000 shares of common stock issued and outstanding.

 

   

 

 

Natera, Inc.

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

(Unaudited)

 

   Three months ended 
   March 31, 
   2021   2020 
(in thousands, except per share data)      (1) 
Revenues          
Product revenues  $118,382   $87,046 
Licensing and other revenues   33,934    6,966 
Total revenues   152,316    94,012 
Cost and expenses          
Cost of product revenues   61,322    41,520 
Cost of licensing and other revenues   5,491    3,458 
Research and development   40,188    18,225 
Selling, general and administrative   108,332    65,681 
Total cost and expenses   215,333    128,884 
Loss from operations   (63,017)   (34,872)
Interest expense   (2,073)   (2,464)
Interest and other income, net   1,371    1,987 
Loss before income taxes   (63,719)   (35,349)
Income tax expense   (134)   (23)
Net loss  $(63,853)  $(35,372)
Unrealized gain (loss) on available-for-sale securities, net of tax   (1,062)   4,747 
Comprehensive loss  $(64,915)  $(30,625)
           
Net loss per share:          
Basic and diluted  $(0.74)  $(0.45)
Weighted-average number of shares used in computing basic and diluted net loss per share:          
Basic and diluted   86,689    78,287 

 

(1)The condensed, consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2020 have been derived from the audited consolidated financial statements for the periods included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

 

   

 

 

Exhibit 99.2

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page001.jpg  Natera, Inc. Investor presentation May 2021 Q1 2021 earnings call

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page002.jpg Safe harbor statement 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 the market opportunity, products and launch schedules, reimbursement coverage and product costs, commercial partners, user experience, clinical trials, financial performance, strategies, anticipated revenue and financial outlook and goals and general business conditions of Natera, Inc. (“Natera”, the “Company”, “we” or “us”), 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 maintain our business and operations as planned due to disruptions and economic uncertainty caused by the COVID-19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and successfully commercialize new products, including Signatera and Prospera; 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 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 in the average-risk pregnancy population or 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 laboratory facilities 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, such as the increased focus by third-party payers on requiring that prior authorization be obtained prior to conducting a test; 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 with respect to our ability to service and comply with our outstanding debt obligations and 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. Given these uncertainties, you should not place undue reliance on the forward-looking statements. 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 its 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 actual results could differ materially and adversely from those anticipated or implied. 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) 249-9090.

 

 

Recent highlights Processed 348,000 tests in Q1,18% growth versus Q4 and 47% YoY unit growth vs Q1 2020 Total revenues of ~$152M, including $28.6M in Qiagen revenue recognition. Product revenues up 36% vs Q1 2020 Raising revenue guide by $50M given overall strong momentum Implemented first wave of Panorama AI improvements with immediate impact on patient experience and COGS Received new local coverage decision from CMS which opens the pathway to Prospera reimbursement in multiple organs Initiated phase 3 trial with Genentech using Signatera as a companion diagnostic in early-stage muscle invasive bladder cancer Received two additional breakthrough device designations for Signatera in new indications Positive Signatera data presented: ovarian cancer data at AACR and multiple myeloma data at ASCO Interim readout for prospective Circulate-IDEA trial: >1500 patients enrolled, and >93% longitudinal sensitivity to relapse

 

 

Record Q1 volume of ~350,000 units Total processed units (in thousands) Strong market share gains in Women’s Health Continued momentum in Transplant and Oncology 164K 163K 167K 174K 200K 194K 200K 209K 236K 234K 262K 295K 348K Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page005.jpg Q1 revenues exceed expectations Volume-out performance combined with improving NIPT ASPs New products gaining momentum Total revenues ($ in millions) 24% 24% $67 $54 35% $83 36% $112 $152 Product revenues1 ($ in millions) 36% $87 $118 Q4 2017 Q4 2018 Q4 2019 Q4 2020 Q1 2020 Q1Q1 20202021 Excludes licensing and other revenues 5

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page006.jpg Panorama AI Phase 1 implemented Performance validated in SMART with >20,000 enrolled patients PPV for 22q11.2 deletion syndrome improved from 24% to industry-leading 53%, complementing highest sensitivity 50% reduction of no-call rate while maintaining best-in-class aneuploidy sensitivity AI enabled COGS reductions Upcoming launches designed to further improve performance and reduce no-call rate

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page007.jpg Well positioned to serve >4.5 million pregnancies 2M+ tests performed 1.3M+ patients studied 23 peer reviewed publications 9 points of clinical differentiation Source: Natera internal company data7

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page008.jpg COVID-19 causes elevated background cf-DNA UCLA study highlights COVID-19 impact on background cf-DNA levels1 Prospera is the only test that flags high levels of background cf-DNA revealing potentially masked rejection Extremely High Cell-free DNA Levels Observed in Renal Allograft Patient With SARS-CoV-2 Infection, Transplantation Direct: May 2021 - Volume 7 - Issue 5 8

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page009.jpg Prospera pathway to multiple organs LCD covers broad range of solid organ transplants for dd-DNA testing Creates accelerated pathway to reimbursement for Prospera test beyond kidney transplants

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page010.jpg Second Phase 3 trial in bladder cancer launched Results from IMvigor 0101 AnnouncingIMvigor 0112 1.00 Overall survival 0.50 0.25 0.00 MRD-negative (63%) HR, 1.31 P=0.32 MRD-positive: (37%) HR, 0.59 P=0.0059 Atezolizumab Observation 01020304050 Months Phase III trial, evaluating adjuvant immunotherapy with atezolizumab Eligible patients to be screened with Signatera after surgery 500 patients who test MRD-positive will be randomized to receive either atezolizumab or placebo Powles T, Assaf ZJ, Davarpanah N, et al. Clinical outcomes in post-operative ctDNA (+) muscle-invasive urothelial carcinoma patients after atezolizumab adjuvant therapy. ESMO IO, Dec 2020 https://clinicaltrials.gov/ct2/show/NCT04660344?term=imvigor+011&draw=2&rank=1

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page011.jpg Circulate-IDEA Japan: largest prospective MRD study – interim readout1 Confirms market leading Signatera clinical metrics Pre-surgical Sensitivity2,3 >94% Longitudinal Sensitivity to relapse2 >93% TNP Rate2,4 <3% Enrollment above expectation with >1500 patients enrolled to date Final results will be presented at future conferences Preliminary analysis, subject to change with additional patient enrollment, For stage II / III CRC patients TNP rate is a combination of tissue and plasma failure

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page012.jpg Signatera vs. Reveal performance comparison Not for reproduction or further distribution. **Three in ten post-surgical positive patients cleared ct-DNA with adjuvant chemotherapy and did not relapse. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131. Data presented at conferences or published 2017-2021. Data on file CIRCULATE data on file Parikh AR, et al. Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients. Clin Cancer Res April 29, 202112 Vidal J, et al. Clinical impact of presurgery circulating tumor DNA after total neoadjuvant treatment in locally advanced rectal cancer: A biomarker study from the GEMCAD 1402 Trial. Clin Cancer Res. April 1, 2021. Not for reproduction or further distribution

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page013.jpg Positive data in major new cancer indications AACR – Ovarian cancerASCO – Multiple myeloma 2 pubs soon to be published Abstract # 8029 | Personalized, ctDNA analysis to detect minimal residual disease and identify patients at high risk of relapse with multiple myeloma 1. Circulating tumor DNA predicts disease recurrence in ovarian cancer patients, AACR poster, April 2021 13

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page014.jpg Oncology MRD market opportunity Tests per year 700K3.1M 800K 100K 90K 240K 150K 1M Total Source: internal estimates14

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page015.jpg Q1 Financial overview ($ in millions, except for per share data) Gross margin is calculated as gross profit divided by GAAP total revenues. Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Cash and investments also include cash equivalents and restricted cash. 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 March 31, 2021. The change reflects the accounting impact to the Convertible Senior Notes’ net carrying value following the adoption of ASU 2020-06 as of January 1, 2021.15

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page016.jpg Raising 2021 Annual guidance Natera expects the Women’s Health business to reach cash flow breakeven in 2021 16

 

 

15387-1-kk_page210505 -page001qpage021 earnings call vpage015_page017.jpg  17 Not for reproduction or further distribution.©2020 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution. ©2021 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution.