UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02. | Results of Operations and Financial Condition. |
On February 24, 2022, Natera, Inc. issued a press release announcing its results for its fourth quarter and year ended December 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 February 24, 2022. | |
| 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: February 24, 2022
Exhibit 99.1
Natera Reports Fourth Quarter and Full Year 2021 Financial Results
AUSTIN, Texas, February 24, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided an update on recent business progress and financial outlook.
Recent Accomplishments & Highlights
| ● | Generated total revenues of $173.0 million in the fourth quarter of 2021 compared to $112.4 million in the fourth quarter of 2020, an increase of 53.9%. Product revenues grew 51.1% over the same period. |
| ● | Generated total revenues of $625.5 million in the year 2021 compared to $391.0 million in the year 2020, an increase of 60.0%, exceeding the 2021 revenue guidance range previously provided. |
| ● | Processed approximately 438,800 tests in the fourth quarter of 2021, compared to approximately 295,000 tests processed in the fourth quarter of 2020, an increase of 48.7%. |
| ● | Received final local coverage determination for pan-cancer immunotherapy monitoring using its Signatera test issued by the CMS Molecular Diagnostics Services Program. |
| ● | Panorama SMART study results on both aneuploidies and 22q11.2 deletion published in the American Journal of Obstetrics and Gynecology. |
| ● | Announced successful initial readout of Trifecta study, the largest prospective, fully biopsy-matched kidney dataset to date. |
| ● | Presented data at ASCO-GI from landmark CIRCULATE-Japan study demonstrating Signatera is predictive of chemotherapy benefit in colorectal cancer. |
“Our Q4 performance capped a transformational 2021 for Natera,” said Steve Chapman, Natera’s Chief Executive Officer. “We released landmark data in multiple fields, generated breakout volume growth in Signatera and Prospera, and grew total revenues by 60% for the full year 2021. Our 2022 guidance reflects the strong trends across our business we have seen so far in 2022.”
Fourth Quarter and Year Ended December 31, 2021 Financial Results
Total revenues were $173.0 million in the fourth quarter of 2021 compared to $112.4 million for the fourth quarter of 2020, an increase of 53.9%. The increase in total revenues was driven primarily by an increase in product revenues compared to the fourth quarter of 2020. Product revenues were $160.9 million in the fourth quarter of 2021 compared to $106.5 million in the fourth quarter of 2020, an increase of 51.1%. The increase in product revenues was driven by an increase in test volumes compared to the fourth quarter of 2020. Natera processed approximately 438,800 tests in the fourth quarter of 2021, including approximately 424,200 tests accessioned in its laboratory, compared to approximately 295,000 tests processed, including approximately 281,000 tests accessioned in its laboratory, in the fourth quarter of 2020.
In the three months ended December 31, 2021, Natera recognized revenue on approximately 410,900 tests for which results were reported to customers in the period (tests reported), including approximately 397,100 tests reported from its laboratory, compared to approximately 281,400 tests reported, including approximately 268,300 tests reported from its laboratory, in the fourth quarter of 2020, an overall increase of 46.0% for the quarter.
Total revenues for 2021 were approximately $625.5 million compared to $391.0 million in 2020, which represents an increase of 60%. In 2021, Natera processed approximately 1,570,000 tests including approximately 1,513,400 tests accessioned in its laboratory, compared to approximately 1,026,500 tests processed in 2020, including approximately 974,400 tests accessioned in its laboratory.
In 2021, Natera recognized revenue on approximately 1,453,500 tests reported, including approximately 1,400,100 tests reported from its laboratory, compared to approximately 961,500 tests reported, including approximately 912,500 tests reported from its laboratory, in 2020, an overall increase of 51.2% for the year.
Gross profit* for the three months ended December 31, 2021 and 2020 was $78.9 million and $52.5 million, respectively, representing a gross margin of 45.6% and 47.0%, respectively. Natera had lower margins in the fourth quarter of 2021 compared to the fourth quarter 2020 primarily as a result of increased volumes of lower margin products for which Natera does not receive reimbursement. Gross profit for the year ended December 31, 2021 and 2020 was $307.1 million and $187.4 million, respectively, representing a gross margin of 49.1% and 48.0%, respectively. Natera was able to achieve higher gross margins in the year 2021 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 fourth quarter of 2021 were $218.6 million, compared to $126.5 million in the same period of the prior year, an increase of 72.8%. Total operating expenses in the year ended December 31, 2021 were $775.2 million, an increase of approximately 92.0% compared to $403.7 million in the prior year. The increases were primarily driven by headcount growth to support new product offerings.
Loss from operations for the fourth quarter of 2021 was $139.7 million compared to $74.0 million for the same period of the prior year. Loss from operations for the year 2021 was $468.2 million compared to $216.3 million compared to the prior year.
Net loss for the fourth quarter of 2021 was $140.6 million, or ($1.48) per diluted share, compared to net loss of $76.4 million, or ($0.89) per diluted share, for the same period in 2020. Weighted average shares outstanding were approximately 94.8 million in the fourth quarter of 2021 compared to 85.7 million in the fourth quarter of the prior year. Net loss for the full year 2021 was $471.7 million, or ($5.21) per diluted share, compared to net loss of $229.7 million, or ($2.84) per diluted share, for the full year 2019. Weighted average shares outstanding were 90.6 million in 2021 compared to 81.0 million in 2020.
At December 31, 2021, Natera held approximately $914.5 million in cash, cash equivalents, short-term investments and restricted cash, compared to $737.5 million as of December 31, 2020. As of December 31, 2021, Natera had a total outstanding debt balance of $330.4 million, comprised of $50.1 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 $280.4 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 December 31, 2021.
Financial Outlook
Natera anticipates 2022 total revenue of $770 million to $790 million; 2022 gross margin to be approximately 46% to 48% of revenues; selling, general and administrative costs to be approximately $560 million to $590 million; research and development costs to be $340 million to $360 million, and net cash consumption to be $370 million to $400 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 2022 to be between $310 million and $340 million) and GAAP net purchases of property and equipment (estimated for 2022 to be approximately $60 million).
Test Volume Summary
| Unit | Q4 2021 | Q4 2020 | FY 2021 | FY 2020 | Definition | |||||||||||||
| Tests processed | 438,800 | 295,000 | 1,570,000 | 1,026,500 | Tests accessioned in our laboratory plus units processed outside of our laboratory | |||||||||||||
| Tests accessioned | 424,200 | 281,000 | 1,513,400 | 974,400 | Test accessioned in our laboratory | |||||||||||||
| Tests reported in our laboratory | 397,100 | 268,300 | 1,400,100 | 912,500 | Total tests reported in our laboratory less units reported outside of our laboratory | |||||||||||||
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 Fourth Quarter and Fiscal 2021 Financial Results Conference Call |
| Date: | Thursday, February 24, 2022 |
| Time: | 1:30 p.m. PT (4:30 p.m. ET) |
| Live Dial-In: | (877) 823-0171, Domestic |
| (617) 500-6932, International | |
| Password: | 5675026 |
| Webcast: | https://edge.media-server.com/mmc/p/xjiitdj3 |
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 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 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 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.
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 [email protected]
Natera, Inc.
Consolidated Balance Sheets
(in thousands)
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (1) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 84,386 | $ | 48,668 | ||||
| Restricted cash | 228 | 187 | ||||||
| Short-term investments | 829,896 | 688,606 | ||||||
| Accounts receivable, net of allowance of $2,429 in 2021 and $3,080 in 2020 | 122,074 | 78,565 | ||||||
| Inventory | 26,909 | 20,031 | ||||||
| Prepaid expenses and other current assets | 29,645 | 26,606 | ||||||
| Total current assets | 1,093,138 | 862,663 | ||||||
| Property and equipment, net | 65,516 | 33,348 | ||||||
| Operating lease right-of-use assets | 59,013 | 21,399 | ||||||
| Other assets | 18,820 | 14,743 | ||||||
| Total assets | $ | 1,236,487 | $ | 932,153 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 27,206 | $ | 8,096 | ||||
| Accrued compensation | 40,941 | 30,371 | ||||||
| Other accrued liabilities | 93,353 | 60,407 | ||||||
| Deferred revenue, current portion | 7,404 | 50,125 | ||||||
| Short-term debt financing | 50,052 | 50,054 | ||||||
| Total current liabilities | 218,956 | 199,053 | ||||||
| Long-term debt financing | 280,394 | 202,493 | ||||||
| Deferred revenue, long-term portion | 21,318 | 22,805 | ||||||
| Operating lease liabilities, long-term portion | 61,036 | 21,246 | ||||||
| Other long-term liabilities | 1,479 | 320 | ||||||
| Total liabilities | 583,183 | 445,917 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock (2) | 10 | 9 | ||||||
| Additional paid in capital | 2,050,417 | 1,411,286 | ||||||
| Accumulated deficit | (1,394,836 | ) | (929,318 | ) | ||||
| Accumulated other comprehensive gain (loss) | (2,287 | ) | 4,259 | |||||
| Total stockholders’ equity | 653,304 | 486,236 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,236,487 | $ | 932,153 | ||||
| (1) | The 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, 2021 and 2020, there were approximately 95,140,000 and 86,223,000 shares of common stock issued and outstanding, respectively. |
Natera, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands)
| Year ended December 31, | ||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| Revenues | ||||||||||||
| Product revenues | $ | 567,149 | $ | 367,211 | $ | 269,881 | ||||||
| Licensing and other revenues | 58,337 | 23,794 | 32,447 | |||||||||
| Total revenues | 625,486 | 391,005 | 302,328 | |||||||||
| Cost and expenses | ||||||||||||
| Cost of product revenues | 302,663 | 185,865 | 162,604 | |||||||||
| Cost of licensing and other revenues | 15,755 | 17,755 | 12,866 | |||||||||
| Research and development | 264,208 | 100,035 | 51,357 | |||||||||
| Selling, general and administrative | 511,034 | 303,627 | 206,176 | |||||||||
| Gain from disposal of business | — | — | (14,388 | ) | ||||||||
| Total cost and expenses | 1,093,660 | 607,282 | 418,615 | |||||||||
| Loss from operations | (468,174 | ) | (216,277 | ) | (116,287 | ) | ||||||
| Interest expense | (8,305 | ) | (15,082 | ) | (10,693 | ) | ||||||
| Interest and other income, net | 5,381 | 7,562 | 4,152 | |||||||||
| Loss on debt extinguishment | — | (5,848 | ) | — | ||||||||
| Loss before income taxes | (471,098 | ) | (229,645 | ) | (122,828 | ) | ||||||
| Income tax expense | (618 | ) | (98 | ) | (1,999 | ) | ||||||
| Net loss | $ | (471,716 | ) | $ | (229,743 | ) | $ | (124,827 | ) | |||
| Unrealized gain (loss) on available-for-sale securities, net of tax | (6,546 | ) | 3,340 | 1,471 | ||||||||
| Comprehensive loss | $ | (478,262 | ) | $ | (226,403 | ) | $ | (123,356 | ) | |||
| Net loss per share: | ||||||||||||
| Basic and diluted | $ | (5.21 | ) | $ | (2.84 | ) | $ | (1.79 | ) | |||
| Weighted-average number of shares used in computing basic and diluted net loss per share: | ||||||||||||
| Basic and diluted | 90,558 | 81,011 | 69,555 | |||||||||
Exhibit 99.2
Natera, Inc. Investor presentation Fourth Quarter 2021 Earnings 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 reimburs eme nt 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 ant icipated 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 maintain our business and operations as planned due to dis ruptions 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 an ticipate 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 marke t g rowth 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, disposit ion s 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 m ay 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 profe ssional 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 la ter 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 immediatel y t ransition 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 su bst antial 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 fo r 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 F DA 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 w ith 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, tim e - c onsuming 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 cann ot 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 thes e a nd 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 re por ts 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 ti me. 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 a ctu al 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 statem ents. 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 availa ble 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 . O ur telephone number is (650) 249 - 9090. Safe harbor statement
3 Not for reproduction or further distribution. ● 1.57M total tests processed in FY 2021; ~53% growth vs 2020 and >5K more than preannounce – ~439K total tests processed in Q4 2021 ● FY 2021 total revenue of $625.5M; ~60% growth vs 2020, and above top end of previous guidance range – Total revenue of $173M in Q4 2021 ● Landmark CIRCULATE - Japan study shows Signatera Œ MRD is predictive of chemotherapy benefit in colorectal cancer ● SMART 22q11.2 deletion study published in the American Journal of Obstetrics and Gynecology : landmark 5 - year, 20,000 patients enrolled in trial ● Successful readout of Trifecta study – largest prospective, fully biopsy - matched, kidney dataset to date ● Guiding 2022 total revenue of $770M to $790M; 31% 1 growth at the midpoint over 2021 Recent highlights 1. Pro forma for the one - time Qiagen revenue recognition of $28.3M in 2021
4 Not for reproduction or further distribution. Volume acceleration in 2021 310K 447K 515K 668K 803K 1,027K 1,570K K 200K 400K 600K 800K 1,000K 1,200K 1,400K 1,600K 1,800K 2015 2016 2017 2018 2019 2020 2021 53 % 28% 20% 30% 15% 44% Total processed units (in thousands)
5 Not for reproduction or further distribution. Strong growth trends in Q4 Total revenues ($ in millions) Tests processed (thousands) $54 $67 $83 $112 $173 Q4 2017 Q4 2018 Q4 2019 Q4 2020 Q4 2021 138 174 209 295 439 Q4 2017 Q4 2018 Q4 2019 Q4 2020 Q4 2021 24% 24% 54% 35% 26% 20% 49% 41%
6 Not for reproduction or further distribution. New products contributing to growth trajectory Includes pharma and clinical units Signatera and Altera unit volumes Prospera and Renasight unit volumes 3,000 18,000 > 76,000 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 2019 2020 2021 400 11,000 > 42,000 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 45,000 2019 2020 2021
7 Not for reproduction or further distribution. Rapid NIPT adoption, opportunity to help even more patients 1. Internal estimates and CDC, National Vital Statistics Reports Volume 70, Number 2 March 23, 2021. Estimates based on number o f p regnancies at week 5. Est. U.S. NIPT Volume 1 (thousands) ~ 1,200 ~ 1,750 0 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2,000 2020 2021 Potential > 4,400 Broad p renatal offering Panorama NIPT : • Robust validation in largest prospective NIPT trial • Expanded share in 2021 even as market grew rapidly • ACOG guideline in place Panorama 22Q deletion: • Only 22q NIPT validated in large prospective multi - site trial Horizon Carrier Screening : • Key conditions recommended by ACOG for all pregnancies
8 Not for reproduction or further distribution. Landmark SMART study published in AJOG SMART publication Key results Only 22q test validated in real - world, multi - site prospective study: • Robust validation with confirmed outcomes in >18,000 patients 22q results exceeded expectations : • High i ncidence 1/1,524 , e xcellent sensitivity and specificity • High PPV of 53% (>10X better than historically accepted screening tests) High clinical utility for 22q screening: • One of the leading causes of congenital heart defects in the general population 1 • Helps to avoid post - natal diagnostic odyssey – average of 4.7 years to diagnose • Early interventions can improve outcomes 1. McDonald - McGinn et al. 22q11.2 deletion syndrome in Nature Reviews Disease Primers
9 Not for reproduction or further distribution. Source: Internal estimates Transplant: Significant opportunity to help patients >1M tests per year < 10% of transplant recipients tested today Tests per year < 10% Total ~1.2M Heart, lung, other Kidney
10 Not for reproduction or further distribution. Large clinical studies planned for 1H 2022 publication 1. Halloran, et al. Manuscript submitted for publication, 2022. 2. Kim, et al. Manuscript submitted for publication, 2022. 3. Rosenheck , et al. Manuscript submitted for publication, 2022 Trifecta Study 1 Multi - Site Validation Trial 2 VALID Study 3 • Largest prospective, fully biopsy - matched, and multi - site study to date of dd - cfDNA for kidney transplant recipients 1 • >300 biopsy - matched samples ⎻ Includes >100 biopsy - confirmed rejections • 20+ US & international sites • Includes >250 prospectively collected biopsy - matched samples • Area Under the Curve (AUC): > 0.84 • Could eliminate the need for costly and cumbersome multi - modality testing • Largest prospective study in lung transplant recipients to date for commercially available dd - cfDNA assay • AUC 0.91 for rejection vs stable • 195 biopsy - matched samples Prospera Heart Prospera Kidney with Quantification Prospera Lung
11 Not for reproduction or further distribution. Source: Internal estimates Expanding Oncology TAM opportunity ctDNA / liquid biopsy Therapy selection $6B Early detection $30B Monitoring/MRD $15B
12 Not for reproduction or further distribution. Signatera staged for efficiency and growth • Commercial footprint built – ready for future growth, currently at only 10% capacity • Median t urnaround time 19 days for first test including tumor exome; 6 days for subsequent tests • Online portals and EMR integration for easy test ordering and reporting • Intuitive recurring order infrastructure Commercial Reach Robust Operations Cutting - edge UX • >100 studies in the clinical pipeline • >20 publications expected in 2022 Clinical Data
13 Not for reproduction or further distribution. Circulate - IDEA Japan: Largest prospective MRD study • ~1200 patients enrolled • ~800 patients analyzed • Disease free survival stratified by MRD status: ⎻ Mean ~ 6 months ⎻ Max ~10 months • ~3000 patients enrolled • ~1000 patients analyzed • Disease free - survival stratified by MRD status and by treatment status : ⎻ Mean ~ 12 months ⎻ Max ~20 months 2022: ASCO - GI 2021: ASCO, ESMO IO Building evidence that could change society practice guidelines
14 Not for reproduction or further distribution. MRD - positive patients benefit significantly from ACT HR was adjusted by sex, and performance status. ACT, adjuvant chemotherapy; DFS, disease - free survival; HR, hazard ratio; CI, co nfidential interval. DFS curve was estimated by the Kaplan - Meier method. HR and 95%CI were calculated by the Cox proportional hazard model. DFS in post - op - 4w MRD - positive population Number at risk W/ ACT W/O ACT 9 9 3 0 13 7 1 0 65 58 24 0 25 8 2 0 22 16 4 0 46 13 1 0 High - risk pStage II pStage III pStage IV 100 80 60 40 20 0 DFS % 0 6 12 18 Months after surgery Months after surgery Months after surgery 100 80 60 40 20 0 % 0 6 12 18 Adjusted HR = 9.4 95% CI, 1.1 to 79.1, P=0.04 Adjusted HR = 8.8 95% CI, 3.9 to 19.5, P<0.001 100 80 60 40 20 0 % 0 5 15 18 W/ ACT W/O ACT Adjusted HR = 2.4 95% CI, 1.1 to 5.2, P=0.02 Events/N 6M - DFS (95%CI) 12M - DFS (95%CI) W/ ACT 1/9 100% (100 – 100) 88.9% (43.3 – 98.4) W/O ACT 7/13 53.8% (24.8 – 76.0) 46.2% (19.2 – 69.6) Events/N 6M - DFS (95%CI) 12M - DFS (95%CI) W/ ACT 17/65 89.2% (78.7 – 94.7) 68.3% (53.4 – 79.2) W/O ACT 19/25 32.0% (15.2 – 50.2) 24.0% (9.8 – 41.7) Events/N 6M - DFS (95%CI) 12M - DFS (95%CI) W/ ACT 9/22 72.7% (49.1 – 86.7) 53.7% (28.4 – 73.6) W/O ACT 35/46 28.3% (16.2 – 41.6) 22.3% (11.2 – 35.7)
15 Not for reproduction or further distribution. No significant treatment benefit for MRD - negative patients HR was adjusted by age, performance status, pStage , and MSI status that are imbalanced between two groups. ACT, adjuvant chemotherapy; DFS, disease - free survival; HR, hazard ratio; CI, confidential interval. DFS curve was estimated by the Kaplan - Meier method. HR and 95%CI were calculated by the Cox proportional hazard model. DFS in post - op - 4w MRD - negative population (High risk stage II - III) Months after surgery 100 80 60 40 20 0 DFS 0 6 12 18 W/ ACT W/O ACT Adjusted HR = 1.3 95% CI, 0.5 to 3.6, P=0.63 ctDNA Events/N 6M - DFS (95%CI) 12M - DFS (95%CI) W/ ACT 7/214 98.6% (95.7 - 99.5) 96.2% (92.1 – 98.2) W/O ACT 12/317 97.5% (95.0 - 98.7) 94.7% (90.5 – 97.1) % 214 211 79 0 317 309 117 0 Median follow - up time: 11.4 months. Data cutoff: Nov 19, 2021 Number at risk W/ ACT W/O ACT
16 Not for reproduction or further distribution. Circulate Japan ASCO GI 22 key takeaways 1. Kotaka et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorec ta l cancer from an observational GALAXY study in CIRCULATE - Japan. ASCO GI 2022. Circulate Japan ASCO GI 22 1 • Signatera - positive post surgery: benefit significantly from adjuvant chemo (HR 8.8 - 9.4 in high - risk Stage II or III) • Signatera - negative post surgery: no significant benefit from adjuvant chemo (Absolute risk reduction of only 1.5% at 12 months DFS) • Signatera ctDNA clearance: predictive of treatment efficacy (HR 15.8 clearance vs. no clearance) Predictive results Prognostic results 12M - DFS for MRD - positives 55.5% 12M - DFS for MRD - negatives 95.2% Hazard Ratio (HR) for MRD - positive vs. MRD - negative 13.3 Sensitivity at 4w post - op 67.6%
17 Not for reproduction or further distribution. Significant unmet need served by one technology platform and one commercial team ~4.5M ~13M Total Source: Internal estimates Tests per year (M) Total 0 3 6 9 12 Short term eligible population Mid term population Published/presented indications Studies underway *Esophageal, pancreatic, anal cancers
18 Not for reproduction or further distribution. Signatera coverage roadmap • Colorectal, stages II - IV • Immunotherapy response monitoring, pan - cancer • ADLT status from CMS MRD leadership with data from > 3,500 patients, > 15 peer - reviewed publications 100+ clinical studies in pipeline to drive coverage and practice guidelines • NCCN guidelines in CRC • Coverage for 5+ additional cancer types • Private payor initial coverage • Readouts from definitive, phase 3 studies • Pan - cancer coverage 2022 – 2023 goals 2020 – 2021 2024 onward
19 Not for reproduction or further distribution. FY21 financial overview ($ in millions, except for per share data) Balance sheet Dec 31, 2021 Dec 30, 2020 Change Cash & investments 2 $914.5 $737.5 $177.0 UBS line of credit $50.1 $50.1 $ — Convertible senior notes 3 $280.4 $202.5 $77.9 P&L FY21 FY20 Change Product revenues $567.1 $367.2 $199.9 Licensing and other revenues $58.3 $23.8 $34.5 Total revenues $625.4 $391.0 $234.4 Gross margin% 1 49.1% 47.9% 117 bps R&D $264.2 $100.0 $164.2 SG&A $511.0 $303.6 $207.4 Net loss per diluted share ($5.21) ($2.84) ($2.37) 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 December 31, 2021.
20 Not for reproduction or further distribution. 2022 annual guidance Guide $ (millions) Key drivers Revenue $770 - $790 Continued volume growth, conservative ASPs, growing contribution from new products Gross margin % revenue 46% – 48% Conservative ASP assumptions, rapid growth in pan - cancer Signatera , new patients getting the upfront exome SG&A $560 – $590 Full commercial teams for Oncology, Organ Health in place R&D $340 - $360 Large clinical trials designed to drive broad adoption in oncology and transplant Cash burn $370 - $400 Maturing OpEx supporting multi - year revenue growth
21 Not for reproduction or further distribution. ©2020 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution. ©2022 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution.