8-K
Natera, Inc. (NTRA)
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 eventreported): November 4, 2021
Natera, Inc.
(Exact name of registrant as specifiedin its charter)
| Delaware | 001-37478 | 01-0894487 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
13011 McCallen Pass
Building A Suite 100
Austin, TX 78753
(Address of principal executive offices, includingzip code)
(650) 249-9090
(Registrant’s telephone number,including area code)
N/A
(Former name or former address, if changedsince 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<br>Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the<br>Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)<br>under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)<br>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<br> on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | NTRA | Nasdaq Stock Market LLC<br><br> <br>(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. | Resultsof Operations and Financial Condition. |
|---|
On November 4, 2021, Natera, Inc. issued a press release announcing its results for its third quarter ended September 30, 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. | FinancialStatements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release dated November 4, 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: November 4, 2021
Exhibit 99.1
Natera Reports Third Quarter 2021 FinancialResults
AUSTIN, Texas, November 4, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing, today reported financial results for the third quarter ended September 30, 2021 and provided an update on recent business progress and financial outlook.
Recent Accomplishments & Highlights
| ● | Generated<br> total revenues of $158.1 million in the third quarter of 2021 compared to $98.1 million in<br> the third quarter of 2020, an increase of 61.1%. Product revenues grew 61.5% over the same<br> period. |
|---|---|
| ● | Processed<br> approximately 407,300 tests in the third quarter of 2021, compared to approximately 262,000<br> tests processed in the third quarter of 2020, an increase of 55.4%. |
| --- | --- |
| ● | Secured<br> an exclusive license from Aarhus University to a biobank of up to 40,000 prospectively collected<br> colorectal cancer screening samples for development and validation of a test in early cancer<br> detection. |
| --- | --- |
| ● | Announced<br> positive results from the Trifecta Study, the largest prospective, multi-site, fully biopsy-matched study ever performed in the kidney transplant space. |
| --- | --- |
| ● | Launched<br> Prospera™ Kidney with Quantification supported by validation data published in the<br> Journal of the American Society of Nephrology. |
| --- | --- |
| ● | Announced the validation and launch of the Prospera<br>transplant assessment test in both heart and lung transplant settings: |
| --- | --- |
| ● | Presented largest prospective validation of a commercial<br>cell-free DNA test in lung transplantation. |
| --- | --- |
| ● | Prospera Heart data shows excellent performance while maintaining<br>ease of use and minimizing cost to the system. |
| --- | --- |
| ● | Announced an agreement with NRG Oncology, a National Cancer<br>Institute (NCI)-funded group, to use Signatera® for NRG Oncology's landmark CIRCULATE-US<br>study of MRD-guided treatment in stage II-III colon cancer. |
| --- | --- |
| ● | Announced<br> new publication in Clinical Cancer Research validating Signatera velocity metric. |
| --- | --- |
“Natera's strong commercial momentum continued in the third quarter and we are pleased to be raising our revenue guidance once again," said Steve Chapman, Natera's Chief Executive Officer. "We are thrilled to be announcing multiple major new features, development programs, and product launches in the transplant and oncology settings."
Third Quarter Ended September 30, 2021 FinancialResults
Total revenues were $158.1 million in the third quarter of 2021 compared to $98.1 million for the third quarter of 2020, an increase of 61.1%. Product revenues were $150.7 million in the third quarter of 2021 compared to $93.3 million in the third quarter of 2020, an increase of 61.5%. The increase in product revenues was driven by an increase in test volumes compared to the third quarter of 2020. Natera processed approximately 407,300 tests in the third quarter of 2021, including approximately 394,200 tests accessioned in its laboratory, compared to approximately 262,000 tests processed, including approximately 249,300 tests accessioned in its laboratory, in the third quarter of 2020.
In the three months ended September 30, 2021, Natera recognized revenue on approximately 373,100 tests for which results were reported to customers in the period (tests reported), including approximately 360,700 tests reported from its laboratory, compared to approximately 238,600 tests reported, including approximately 226,700 tests reported from its laboratory, in the third quarter of 2020, an overall increase of 56.4% for the quarter.
Gross profit* for the three months ended September 30, 2021 and 2020 was $76.7 million and $46.3 million, respectively, representing a gross margin of 48.5% and 47.2%, respectively. Natera was able to achieve higher margins in the third quarter of 2021 compared to the third quarter 2020 primarily as a result of increased revenues.
Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the third quarter of 2021 were $226.9 million, compared to $102.1 million in the same period of the prior year, an increase of 122.2%. The increases were primarily driven by headcount growth to support the Company’s expansion, volume growth, and product development.
Loss from operations for the third quarter of 2021 was $150.2 million compared to $55.8 million for the same period of the prior year.
Net loss for the third quarter of 2021 was $151.3 million, or ($1.63) per diluted share, compared to net loss of $58.3 million, or ($0.72) per diluted share, for the same period in 2020. Weighted average shares outstanding were approximately 92.6 million in the third quarter of 2021 compared to 80.9 million in the second quarter of the prior year.
At September 30, 2021, Natera held approximately $1.0 billion in cash, cash equivalents, short-term investments and restricted cash, compared to $737.5 million as of December 31, 2020. As of September 30, 2021, Natera had a total outstanding debt balance of $330.1 million, comprised of $50.0 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $280.1 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 September 30, 2021.
Financial Outlook
Natera anticipates 2021 total revenue of $615 million to $625 million; 2021 gross margin to be approximately 49% to 52% of revenues; selling, general and administrative costs to be approximately $500 million to $520 million; research and development costs to be $240 million to $260 million, and net cash consumption to be $300 million to $340 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 2021 to be between $255 million and $295 million) and GAAP net purchases of property and equipment (estimated for 2021 to be approximately $45 million).
TestVolume Summary
| Unit | Q3 2021 | Q3 2020 | Definition | ||
|---|---|---|---|---|---|
| Tests processed | 407,300 | 262,000 | Tests accessioned in our laboratory plus units processed outside of our laboratory | ||
| Tests accessioned | 394,200 | 249,300 | Test accessioned in our laboratory | ||
| Tests reported in our laboratory | 360,700 | 226,700 | Total tests reported in our laboratory less units reported outside of our laboratory |
About Natera
Natera is a leader in personalized genetic testing and diagnostics, transforming how we make critical health care decisions. Our tests help clinicians and their patients protect their health and enable earlier and more targeted interventions that lead to better outcomes. Natera’s tests are validated by more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women’s health and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California.
Conference Call Information
| Event: | Natera's<br> Third Quarter 2021 Financial Results Conference Call |
|---|---|
| Date: | Thursday,<br> November 4, 2021 |
| Time: | 1:30<br> p.m. PT (4:30 p.m. ET) |
| Live<br> Dial-In: | (877)<br> 823-0171, Domestic |
| (617)<br> 500-6932, International | |
| Password: | 5577215 |
| Webcast: | https://edge.media-server.com/mmc/p/mc3bdxct |
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 2021, 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 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 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 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.
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
Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com
Natera, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| December 31, | |||||
|---|---|---|---|---|---|
| 2020 | |||||
| (1) | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 95,103 | $ | 48,668 | ||
| Restricted cash | 228 | 187 | |||
| Short-term investments | 928,596 | 688,606 | |||
| Accounts receivable, net of allowance of 2,965 in 2021 and 3,080 in 2020 | 110,416 | 78,565 | |||
| Inventory | 28,022 | 20,031 | |||
| Prepaid expenses and other current assets, net | 28,858 | 26,606 | |||
| Total current assets | 1,191,223 | 862,663 | |||
| Property and equipment, net | 59,293 | 33,348 | |||
| Operating lease right-of-use assets | 47,656 | 21,399 | |||
| Other assets | 13,202 | 14,743 | |||
| Total assets | 1,311,374 | $ | 932,153 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 8,181 | $ | 8,096 | ||
| Accrued compensation | 35,331 | 30,371 | |||
| Other accrued liabilities | 96,486 | 60,407 | |||
| Deferred revenue, current portion | 9,667 | 50,125 | |||
| Short-term debt financing | 50,049 | 50,054 | |||
| Total current liabilities | 199,714 | 199,053 | |||
| Long-term debt financing | 280,085 | 202,493 | |||
| Deferred revenue, long-term portion | 22,706 | 22,805 | |||
| Operating lease liabilities, long-term portion | 48,388 | 21,246 | |||
| Other long-term liabilities | 1,464 | 320 | |||
| Total liabilities | 552,357 | 445,917 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity: | |||||
| Common stock (2) | 10 | 9 | |||
| Additional paid in capital | 2,011,788 | 1,411,286 | |||
| Accumulated deficit | (1,254,272 | ) | (929,318 | ) | |
| Accumulated other comprehensive gain | 1,491 | 4,259 | |||
| Total stockholders’ equity | 759,017 | 486,236 | |||
| Total liabilities and stockholders’ equity | 1,311,374 | $ | 932,153 |
All values are in US Dollars.
| (1) | The<br> condensed, consolidated balance sheet at December 31, 2020 has been derived from the audited<br> consolidated financial statements at that date included in the Company’s Annual Report<br> on Form 10-K for the year ended December 31, 2020. |
|---|---|
| (2) | As<br> of September 30, 2021, there were approximately 94,538,000<br> shares of common stock issued and outstanding. |
| --- | --- |
Natera, Inc.
Condensed Consolidated Statements of Operationsand Comprehensive Loss
(Unaudited)
| Three months ended | Nine months ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Revenues | ||||||||||||
| Product revenues | $ | 150,651 | $ | 93,286 | $ | 406,265 | $ | 260,746 | ||||
| Licensing and other revenues | 7,465 | 4,857 | 46,193 | 17,881 | ||||||||
| Total revenues | 158,116 | 98,143 | 452,458 | 278,627 | ||||||||
| Cost and expenses | ||||||||||||
| Cost of product revenues | 76,838 | 46,873 | 211,387 | 131,124 | ||||||||
| Cost of licensing and other revenues | 4,533 | 4,948 | 12,909 | 12,614 | ||||||||
| Research and development | 98,457 | 26,421 | 192,397 | 67,651 | ||||||||
| Selling, general and administrative | 128,485 | 75,678 | 364,273 | 209,547 | ||||||||
| Total cost and expenses | 308,313 | 153,920 | 780,966 | 420,936 | ||||||||
| Loss from operations | (150,197 | ) | (55,777 | ) | (328,508 | ) | (142,309 | ) | ||||
| Interest expense | (2,078 | ) | (4,270 | ) | (6,226 | ) | (10,772 | ) | ||||
| Interest and other income, net | 1,274 | 1,749 | 4,230 | 5,661 | ||||||||
| Loss on debt extinguishment | — | — | — | (5,848 | ) | |||||||
| Loss before income taxes | (151,001 | ) | (58,298 | ) | (330,504 | ) | (153,268 | ) | ||||
| Income tax expense | (272 | ) | (25 | ) | (648 | ) | (63 | ) | ||||
| Net loss | $ | (151,273 | ) | $ | (58,323 | ) | $ | (331,152 | ) | $ | (153,331 | ) |
| Unrealized gain (loss) on available-for-sale securities, net of tax | (950 | ) | (600 | ) | (2,768 | ) | 4,251 | |||||
| Comprehensive loss | $ | (152,223 | ) | $ | (58,923 | ) | $ | (333,920 | ) | $ | (149,080 | ) |
| Net loss per share: | ||||||||||||
| Basic and diluted | $ | (1.63 | ) | $ | (0.72 | ) | $ | (3.72 | ) | $ | (1.93 | ) |
| Weighted-average number of shares used in computing basic and diluted net loss per share: | ||||||||||||
| Basic and diluted | 92,558 | 80,908 | 89,130 | 79,430 |
Exhibit 99.2
Investor presentation Natera, Inc. Q3 2021 e arnings call
2 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 opportunity, our proposed products and launch schedules, our reimbursement coverage and our product costs, our commercial partners and potential acquisitions, our user experience, our clinical trials and studies, our financial 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 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 ; we may be unable 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 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 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 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 ) 249 - 9090 . Safe harbor statement
3 Not for reproduction or further distribution. ● Continued outperformance in volumes and revenues: – 407,000 tests processed in Q3, 55% growth vs Q3 2020 – Total revenues of $158M, 61% growth vs Q3 2020 – Product revenues of $151M, up 62% vs Q3 2020 ● Raising revenue guide again: was $600M – $620M, now $615M – $625M, increase of $100M from start of year ● Launched Prospera with Quantification in kidney transplant supported by JASN publication and Trifecta study ● Announced initial positive results from the Trifecta Study, the largest prospective multi - site fully biopsy matched study ● Major expansion in organ health with commercial launch of Prospera Heart and Prospera Lung: ● Announced new publication validating Signatera velocity metric to improve cancer management ● Signatera selected for NRG Oncology ‘s landmark CIRCULATE - US study ● BGI announced use of Signatera in prospective GI cancer trial in China ● Secured access to a biobank of 40K prospectively collected colorectal cancer screening samples from Aarhus University for development and validation of a test in early cancer detection Recent highlights
4 Not for reproduction or further distribution. ● ~ 55% volume growth over Q3 2020 ● Continued momentum across all products Q3 volume momentum continues: 407,000 units in Q3 Total processed units 163K 167K 174K 200K 195K 200K 209K 236K 234K 262K 295K 348K 407K Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 376K
5 Not for reproduction or further distribution. Accelerating revenues 1. Excludes licensing and other revenues $93 Q3 Q3 Product revenues 1 ($ in millions) 2020 2021 62 % $151 $54 $65 $78 $98 $158 Q3 2017 Q3 2018 Q3 2019 Q3 2020 Q3 2021 20 % 20 % 61% 26% Total revenues ($ in millions) ● Volume - out performance combined with improving ASPs ● New products gaining momentum
6 Not for reproduction or further distribution. ● Prospera Kidney, Heart and Lung commercially available ● Large multi - site prospective data available ● Innovation driving exceptional AUC’s Organ Health updates
7 Not for reproduction or further distribution. Prospera Kidney gaining significant market adoption Validation Data 45 of the top 100 transplant centers routinely using Prospera ~2,500 patients enrolled in ProActive Registry trial
8 Not for reproduction or further distribution. Only Prospera Kidney offers quantification 1. Vora N., et al. (2012). Prenat Diagn., 32(9):912 – 914. doi:10.1002/pd.3919 2. Ahmed A., et al. (2016). Clin Lab., 62(12):2395 - 2404. 3. Anker, P., et al. (2000). Medicina (B Aires), 60, 99 – 702. 4. Qi, Y., et al. (2016). Anesthesiology Research and Practice Volume 2016:2794364. 5. Page, K., et al. (2013). PLoS One 8(10):e77963. doi: 10.1371/journal.pone.0077963 6. Swystun, L. et al. (2011). Journal of Thrombosis and Haemostasis, 9:2313 – 2321. 7. Stroun, M., et al. (2001). Clin Chim Acta, 313(1 - 2): 139 – 142. 8. Chang, R., et al. Chimica Acta, 327(1 - 2):95 - 101. 9. Tovbin, N., et al. (2012). Nephrology Dialysis Transplantation, 27(10), 3929 - 3935 Absolute quantity of dd - cfDNA (copies per mL) Total quantity of cfDNA (copies per mL) % dd - cfDNA = • High body mass index • Infection • Age • Surgery • Shipment & storage • Chemotherapy • Normal variation • Myocardial infarction • Hemodialysis • Rejection Factors that may influence total cfDNA 1 - 10
9 Not for reproduction or further distribution. Overall sensitivity 7 / 9 77.8% Specificity 29 / 32 90.6% Overall sensitivity 9 / 9 >99% Specificity 28 / 32 87.5% Prospera with Quantification improves sensitivity Original method with dd - cfDNA fraction Performance of the enhanced algorithm 1 1. Bunnapradist, S. Using both fraction and quantity of donor - derived cell - free DNA to detect kidney allograft rejection, J Amer So c Nephrology 2021
10 Not for reproduction or further distribution. Results from Trifecta Study further validates Prospera with Quantification Largest prospective fully biopsy - matched, multi - site cohort of dd - cfDNA for kidney transplant recipients 1 Details of study ● More than 300 biopsy - matched samples ● Over 100 biopsy - confirmed rejections ● From more than 20 US & international sites Key results: Rejection from non - rejection using BANFF 2019 as truth 0.81 Rejection from non - rejection using molecular pathology as truth 0.89 Rejection from ‘quiescence’ using BANFF 2019 as truth 2 0.91 Area under the c urve 1. Halloran, et al. Manuscript in preparation, 2021 2. Quiescence: No signs of rejection on pathology or DSA
11 Not for reproduction or further distribution. Most publications compare rejection to non - rejection, recent multi - modality studies compare rejection to ‘quiescent’ patients (only the most clinically stable of non - rejection patients) Limitations of rejection vs quiescence Quiescent Rejection Non - rejection and Non - quiescent Akalin, et al. Clinical Validation of an Immune Quiescence Gene Expression Signature in Kidney Transplantation. Kidney360 Sep tem ber 2021, 10.34067/KID.0005062021; https://doi.org/10.34067/KID.0005062021 Khilnani, et al. Two can be better than one: Improving Non - invasive Diagnostics in Kidney Transplantation. CJASN 16: 1462 - 1463 , 2021; https://doi.org/10.2215/CJN.10630821 ”The limitations of the current study include the number of rejection samples and limited scope of the patient population .” - Akalin, et al. “The authors specifically excluded biopsies that contained other common pathologies found in kidney allografts — including infection, chronic tubular injury/fibrosis, calcineurin inhibitor toxicity, recurrent primary disease, and others — that could confound the diagnostic utility of the assays. How the two assays will behave in a more heterogeneous and unselected cohort remains unclear.” - Khilnani, et al.
12 Not for reproduction or further distribution. Validation of a novel donor - derived cell - free DNA assay for the detection of acute rejection in heart transplantation 1 Launch of the Prospera Heart transplant assessment test ● In partnership with University of Utah and University of California, San Diego ● Included >250 samples from a prospective trial run in 2020 - 2021 ● Combined with a >100 sample cohort of previously collected samples ● Total validation study size >350 samples Area under the curve 0.844 Area under the curve with Quantification 0.88 ● Single, noninvasive test with excellent performance ● Easy - to - use: no spin down or shipment on dry ice ● Less cost to the system 1. Kim et al, Manuscript submitted for publication
13 Not for reproduction or further distribution. ● Performed in collaboration with Ohio State University ● 195 samples ● 103 patients ● 35 biopsy confirmed acute rejection cases Launch of the Prospera lung test - validation results presented at CHEST 2021 Acute rejection vs stable 0.91 Acute/chronic rejection or infection vs stable 0.76 Area under the curve Largest prospective trial of commercial dd - cfDNA test for lung transplant assessment 1 Results from the VALID study 1 1. Natera clinical validation data. Publication pending
14 Not for reproduction or further distribution. ● Planned study with access to up to 40,000 prospectively collected colorectal cancer screening samples with matched outcomes data ● More than 50% of affected cases collected in Stage I / Stage II ● Exclusive option to license IP, access to Aarhus’ methylation signature data ● Multi factor technology approach: DNA signature derived from thousands of proprietary exomes + methylation signature ● Potential to add additional cancer types in the study Announcing asymptomatic screening program About the study
15 Not for reproduction or further distribution. ● US arm of international CIRCULATE trial for colorectal cancer, enrolling ~2,000 patients ● Primary endpoint disease free survival ● Definitive prospective US trial for MRD - guided management of CRC 1. Patients in Cohort A (Arm 2) who develop a ctDNA positive assay during serial monitoring may transition to the ctDNA positive co hort (Cohort B) and undergo a second randomization Signatera selected for landmark CIRCULATE - US Study Post - operative management of stage II / III CRC patients u sing Signatera Stage II / III CRC patients after surgery MRD - positive ⊕ Chemo escalation MRD - n egative ⊝ No chemo, active s urveillance 1 Adjuvant chemo Adjuvant chemo R R Signatera
16 Not for reproduction or further distribution. 1. Henriksen TV, et al., Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward s a ssessment of adjuvant therapy efficacy and clinical behavior of recurrences. Clin Cancer Res. 2021 Data validates Signatera velocity metric Only MRD test on the market validated for tumor velocity measurement Prospective phase III trial 1 : ● 168 stage III CRC patients undergoing curative intent treatment ● MRD assessment before and after surgery, and then at regular intervals throughout adjuvant chemotherapy (ACT) and surveillance for up to 3 years Tumor growth type ctDNA rate of change 3 - year overall survival Slow 27% increase/mo. 100% Fast 137% increase/mo. 43%
17 Not for reproduction or further distribution. Q3 financial overview ($ in millions, except for per share data) Balance sheet Sep 30, 2021 Jun 30, 2021 Change Q/Q Cash & investments 2 $1,023.9 $580.5 $443.4 UBS line of credit $50.0 $50.0 - Convertible senior notes 3 $280.1 $279.8 $0.3 P&L Q3’21 Q3’20 Change Product revenues $150.7 $93.3 $57.4 Licensing and other revenues $7.5 $4.9 $2.6 Total revenues $158.1 $98.1 $60.0 Gross margin% 1 48.5% 47.2% 134 bps R&D $98.5 $26.4 $72.1 SG&A $128.5 $75.7 $52.8 Net loss per diluted share ($1.63) ($0.72) ($0.91) 1. Gross margin is calculated as gross profit divided by GAAP total revenues. Gross profit is calculated as GAAP total revenues les s GAAP cost of revenues. 2. Cash and investments also include cash equivalents and restricted cash. 3. 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 September 30, 2021.
18 Not for reproduction or further distribution. Raising 2021 revenue guidance again Guide $ (millions) Original Q1 Guide Q2 Guide Current Key drivers Revenue $500 – $525 $550 – $575 $600 – $620 $615 – $625 Continued volume & ASP momentum Gross margin % revenue 47% – 52% 52% – 55% 52% – 55% 49% – 52% Strong NIPT margins balanced by growth - related costs in new products SG&A $430 – $450 $440 – $460 $500 – $520 $500 – $520 Commercial investments ramping as planned R&D $160 – $180 $165 – $185 $220 - $230 $240 - $260 Accelerating MRD clinical trials, oncology product launches Cash burn $230 - $250 $230 - $250 $300 - $340 $300 - $340 Balance sheet remains strong
19 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.