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 May 5, 2022, Natera, Inc. issued a press release announcing its results for its first quarter ended March 31, 2022 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 5, 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: May 5, 2022
Exhibit 99.1
Natera Reports First Quarter 2022 Financial Results
AUSTIN, Texas, May 5, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported financial results for the first quarter ended March 31, 2022 and provided an update on recent business progress and financial outlook.
Recent Accomplishments & Highlights
| ● | Generated total revenues of $194.1 million in the first quarter of 2022. Product revenues were $190.0 million in the first quarter of 2022, an increase of 57.8% from the first quarter of 2021. |
| ● | Processed approximately 489,300 tests in the first quarter of 2022, compared to approximately 348,200 tests processed in the first quarter of 2021, an increase of 40.5%. |
| ● | Increased 2022 revenue guidance from $770-790 million to $790-810 million. | |
| ● | Board and executive leaders elect to take 100% equity compensation for the remainder of 2022. |
| ● | Ten Signatera abstracts, including seven poster presentations, across multiple tumor types to be presented at the 2022 ASCO Annual Meeting. |
| ● | New CIRCULATE study colorectal cancer data presented at the 2022 Society for Surgical Oncology conference demonstrates 75% detection of recurrence from a single timepoint 4 weeks post-surgery. | |
| ● | Signatera ADLT reimbursement rate increased to $3,920 effective April 2022. | |
| ● | Dr. Sangeeta Bhorade joins Natera as VP of Medical Affairs for Organ Health. |
| ● | Large, real-world study for Renasight published, demonstrating high diagnostic yield for positive genetic findings for patients with chronic kidney disease. | |
| ● | Large, multi-site clinical validation studies published for heart and lung transplant. |
“Given the strong traction we experienced in Q1 across the business, we are raising our 2022 revenue forecast by $20 million,” said Steve Chapman, Natera’s Chief Executive Officer. “We saw strong volume growth in the quarter with an even higher increase in product revenue, especially in our Signatera clinical volumes. We are rapidly gaining scale on the investment in our oncology and transplant commercial channels, and we believe we have a clear path to reaching cash flow breakeven.”
First Quarter Ended March 31, 2022 Financial Results
Total revenues were $194.1 million in the first quarter of 2022 compared to $152.3 million for the first quarter of 2021, an increase of 27.5%. Total revenues, excluding the Qiagen revenue of $28.6 million in the first quarter of 2021, increased by 56.9% in the first quarter of 2022 compared to the first quarter of 2021. The increase in total revenues was driven primarily by an increase in product revenues compared to the first quarter of 2021. Product revenues were $190.0 million in the first quarter of 2022 compared to $120.4 million in the first quarter of 2021, an increase of 57.8%. The increase in product revenues was driven by an increase in test volumes compared to the first quarter of 2021. Natera processed approximately 489,300 tests in the first quarter of 2022, including approximately 473,200 tests accessioned in its laboratory, compared to approximately 348,200 tests processed, including approximately 333,400 tests accessioned in its laboratory, in the first quarter of 2021.
In the three months ended March 31, 2022, Natera recognized revenue on approximately 456,100 tests for which results were reported to customers in the period (tests reported), including approximately 440,900 tests reported from its laboratory, compared to approximately 313,800 tests reported, including approximately 300,000 tests reported from its laboratory, in the first quarter of 2021, an overall increase of 45.3% for the quarter.
Gross profit* for the three months ended March 31, 2022 and 2021 was $90.9 million and $85.5 million, respectively, representing a gross margin of 46.8% and 56.1%, respectively. Natera had lower margins in the first quarter of 2022 compared to the first quarter 2021 primarily due to the revenue recognition of approximately $28.6 million in the first quarter of 2021 as a result of the conclusion of its collaboration with Qiagen.
Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the first quarter of 2022 were $228.0 million, compared to $148.5 million in the same period of the prior year, an increase of 53.5%. 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 2022 was $137.1 million compared to $63.0 million for the same period of the prior year.
Net loss for the first quarter of 2022 was $138.6 million, or ($1.45) per diluted share, compared to net loss of $63.9 million, or ($0.74) per diluted share, for the same period in 2021. Weighted average shares outstanding were approximately 95.6 million in the first quarter of 2022 compared to 86.7 million in the first quarter of the prior year.
At March 31, 2022, Natera held approximately $752.2 million in cash, cash equivalents, short-term investments and restricted cash, compared to $653.7 million as of March 31, 2021. As of March 31, 2022, Natera had a total outstanding debt balance of $330.7 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 $280.7 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, 2022.
Financial Outlook
Natera anticipates 2022 total revenue of $790 million to $810 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 | Q1 2022 | Q1 2021 | Definition | |||||||
| Tests processed | 489,300 | 348,200 | Tests accessioned in our laboratory plus units processed outside of our laboratory | |||||||
| Tests accessioned | 473,200 | 333,400 | Test accessioned in our laboratory | |||||||
| Tests reported in our laboratory | 440,900 | 300,000 | 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 First Quarter 2022 Financial Results Conference Call |
| Date: | Thursday, May 5, 2022 |
| Time: | 1:30 p.m. PT (4:30 p.m. ET) |
| Live Dial-In: | (877) 823-0171, Domestic |
| (617) 500-6932, International | |
| Password: | 9390955 |
| Webcast: | https://edge.media-server.com/mmc/p/jtnp5swk |
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)
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 158,298 | $ | 84,386 | ||||
| Restricted cash | 228 | 228 | ||||||
| Short-term investments | 593,660 | 829,896 | ||||||
| Accounts receivable, net of allowance of $2,392 in 2022 and $2,429 in 2021 | 167,862 | 122,074 | ||||||
| Inventory | 25,048 | 26,909 | ||||||
| Prepaid expenses and other current assets, net | 35,130 | 29,645 | ||||||
| Total current assets | 980,226 | 1,093,138 | ||||||
| Property and equipment, net | 78,361 | 65,516 | ||||||
| Operating lease right-of-use assets | 64,401 | 59,013 | ||||||
| Other assets | 21,676 | 18,820 | ||||||
| Total assets | $ | 1,144,664 | $ | 1,236,487 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 18,070 | $ | 27,206 | ||||
| Accrued compensation | 32,396 | 40,941 | ||||||
| Other accrued liabilities | 116,637 | 93,353 | ||||||
| Deferred revenue, current portion | 13,914 | 7,404 | ||||||
| Short-term debt financing | 50,055 | 50,052 | ||||||
| Total current liabilities | 231,072 | 218,956 | ||||||
| Long-term debt financing | 280,706 | 280,394 | ||||||
| Deferred revenue, long-term portion | 20,543 | 21,318 | ||||||
| Operating lease liabilities, long-term portion | 67,477 | 61,036 | ||||||
| Other long-term liabilities | 2,531 | 1,479 | ||||||
| Total liabilities | 602,329 | 583,183 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock (2) | 10 | 10 | ||||||
| Additional paid in capital | 2,089,660 | 2,050,417 | ||||||
| Accumulated deficit | (1,533,431 | ) | (1,394,836 | ) | ||||
| Accumulated other comprehensive loss | (13,904 | ) | (2,287 | ) | ||||
| Total stockholders’ equity | 542,335 | 653,304 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,144,664 | $ | 1,236,487 | ||||
| (1) | The consolidated balance sheet at December 31, 2021 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, 2021. |
| (2) | As of March 31, 2022 and December 31, 2021, there were approximately 96,259,000 and 95,140,000 shares of common stock issued and outstanding, respectively. |
Natera, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| (1) | ||||||||
| Revenues | ||||||||
| Product revenues | $ | 190,002 | $ | 120,384 | ||||
| Licensing and other revenues | 4,131 | 31,932 | ||||||
| Total revenues | 194,133 | 152,316 | ||||||
| Cost and expenses | ||||||||
| Cost of product revenues | 102,670 | 65,832 | ||||||
| Cost of licensing and other revenues | 545 | 981 | ||||||
| Research and development | 80,414 | 40,188 | ||||||
| Selling, general and administrative | 147,634 | 108,332 | ||||||
| Total cost and expenses | 331,263 | 215,333 | ||||||
| Loss from operations | (137,130 | ) | (63,017 | ) | ||||
| Interest expense | (2,087 | ) | (2,073 | ) | ||||
| Interest and other income, net | 801 | 1,371 | ||||||
| Loss before income taxes | (138,416 | ) | (63,719 | ) | ||||
| Income tax expense | (179 | ) | (134 | ) | ||||
| Net loss | $ | (138,595 | ) | $ | (63,853 | ) | ||
| Unrealized loss on available-for-sale securities, net of tax | (11,617 | ) | (1,062 | ) | ||||
| Comprehensive loss | $ | (150,212 | ) | $ | (64,915 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (1.45 | ) | $ | (0.74 | ) | ||
| Weighted-average number of shares used in computing basic and diluted net loss per share: | ||||||||
| Basic and diluted | 95,578 | 86,689 | ||||||
| (1) | The condensed, consolidated Statements of Operations and Comprehensive Loss for the year ended December 31, 2021 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, 2021. |
Exhibit 99.2
Natera, Inc. Investor presentation First Quarter 2022 Earnings Call May 5, 2022
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. • Total revenues of $194M; ~57% growth over Q1 21 1 • 489K total tests processed in Q1 2022; ~41% growth vs. Q1 21 • 2022 revenue guidance raised: Total revenues now expected to be $790M – $810M • Board and executive leaders elect to take 100% equity compensation for the remainder of 2022 • Clinical validation studies published in heart and lung transplant • Dr. Sangeeta Bhorade joins Natera as VP of Medical Affairs for Organ Health • New CIRCULATE CRC data demonstrates 75% detection from a single timepoint 4 weeks post surgery; paper now in submission • Signatera performance in breast cancer highlighted in two analyses presented at AACR • 10 Signatera abstracts, including 7 posters, to be presented at ASCO in early June • Signatera ADLT pricing revised upward from $3,500 to $3,920 Recent Highlights 1. Pro forma for the one - time Qiagen revenue recognition of $28.6M in 2021
4 Not for reproduction or further distribution. Record Q1 22 Volume of 489,000 Units Total processed units (in thousands) • ~ 41% volume growth over Q1 2021 • Strong market share gains in Women’s Health • Continued momentum in Transplant and Oncology 200 K 195 K 200 K 209 K 235 K 234 K 262 K 295 K 348 K 376 K 407 K 439 K 489 K Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22
5 Not for reproduction or further distribution. $124 $142 $158 $173 $194 $100 $110 $120 $130 $140 $150 $160 $170 $180 $190 $200 Q121 Q221 Q321 Q421 Q122 Revenues Accelerating with Volume Growth $62 $67 $94 $124 $194 – $50 $100 $150 $200 $250 Q1 2018 Q12019 Q1 2020 Q1 2021 Q1 2022 Total revenues: year on year trend ($ in millions) 8% 41% 32% 1 57% 1 Total revenues: sequential quarters 1 ($ in millions) Q1 2019 1. YOY growth rates are pro forma for the $28.6mm of Qiagen rev in Q1 21
6 Not for reproduction or further distribution. Prospera Heart – Strong Clinical Validation Study Results DEDUCE study publication Key results Multi - site clinical validation study of Prospera Heart for the assessment of acute rejection in heart transplant patients: • Demonstrated exceptional performance, including 0.87 AUC in the prospective arm and 0.86 AUC overall. 1. Transplantation Direct 2022;8: e1317; doi: 10.1097/TXD.0000000000001317 Additional studies • NIH - supported DTRT study – Fully - enrolled, prospective, multi - center study with >150 heart transplant recipients followed up to 2 years post - transplant. • Natera - sponsored DETECT trial – First randomized controlled trial comparing dd - cfDNA surveillance to endomyocardial biopsy surveillance in patients of all risk profiles from 30 days post - transplant.
7 Not for reproduction or further distribution. Renasight – Large Unmet Medical Need U.S. Unmet Need RenaCARE • Real - world, prospective, multi - center study to assess clinical utility of the Renasight genetic testing panel • Already enrolled 1,600 patients across 25 U.S. sites • Enrollment expected to complete in Q2 22 • Expected to submit study for publication in late 2022 Ali Gharavi , M.D., Chief of the Division of Nephrology at New York - Presbyterian/ Columbia University Irving Medical Center. 1. Groopman EE, Marasa M, Cameron - Christie S, et al. Diagnostic Utility of Exome Sequencing for Kidney Disease. N Engl J Med . 2019; 380:142 - 151 DOI: 10.1056/NEJMoa1806891 2. Bleyer AJ, Westemeyer M, Xie J, et al. Genetic Etiologies for Chronic Kidney Disease Revealed through Next - Generation Renal Gene Panel. Am J Nephrol . 2022 Mar 24:1 - 10. doi: 10.1159/000522226. Renasight 1000 • 37 million patients with chronic kidney disease (CKD), with 750,000 patients newly diagnosed each year • 2019 NEJM study found ~10% of patients had a genetic basis for their CKD; similar diagnostic yield to cancer 1 • For patients with a positive genetic finding, 89% of patients had clinical utility • Renasight study on the commercial experience of 1,000 Renasight tests "We’re optimistic that this study will show that next - generation sequencing (NGS) multi - gene assays can be used in a real world setting, to inform and guide disease management and help improve patient outcomes.”
8 Not for reproduction or further distribution. Key Updates on Signatera in Colorectal Cancer (CRC) Updated CIRCULATE - Japan data CIRCULATE - US trial activation • CIRCULATE - US trial: National, prospective, multi - center, randomized clinical trial to investigate MRD - guided treatment for patients with early - stage CRC • FDA recently granted an investigational device exemption (IDE) for the study Analysis presented at SSO 2022: Demonstrated single timepoint detection of 75% for recurrence in stage II - III CRC patients at 4 weeks post surgery • Updated from ASCO GI data that had 68% singe timepoint MRD detection for disease - free survival • Paper in submission to leading medical journal
9 Not for reproduction or further distribution. BESPOKE CRC Study Enrolls First 1,000 Patients 1. ClinicalTrials.gov Identifier: NCT04264702; BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer Study Objective: Assess the impact of Signatera test results on changes in treatment decisions and clinical outcomes for patients diagnosed with Stage I - IV colorectal cancer through a prospective registry trial Summary Upcoming Interim Analysis: Clinical investigators expect to conduct an interim analysis later in 2022 for presentation or publication in H1 23 Enrollment: Upwards of 2,000 patients at over 100 sites
10 Not for reproduction or further distribution. Breast Cancer Data Presented at AACR 1. All Patient Invasive Disease - Free Survival (IDFS); Clinical Outcome associated with ctDNA in plasma during/post - chemotherapy. B EATRICE study used a custom ctDNA test. 2. Note: ctDNA+ survival outcomes shown in orange . Survival based on ctDNA measured after neoadjuvant chemo. Phase 3 BEATRICE study I - SPY 2 study • Data from I - SPY 2 phase II trial demonstrates the prognostic value of ctDNA in both HR+/HER2 - and TNBC (measured by pathological complete response (pCR) and residual cancer burden (RCB)) • Demonstrated the prognostic value of ctDNA monitoring in early - stage TNBC patients • 19.9% of patients had detectable ctDNA after surgery, strongly associated with inferior outcomes • Lead time between first ctDNA positivity and radiographic recurrence was 6.1 months at median and up to 30.5 months pCR for HR+ / HER 2 - breast cancer patients 2 1.0 0.8 0.6 0.4 0.2 0.0 Survival Probability 0 1 3 5 2 4 6 Time in Years All patient IDFS by post - baseline ctDNA 1 1.0 0.8 0.6 0.4 0.2 0.0 Survival Probability 0 10 30 50 Event Free Rate at 36 Months Negative 92.4% Positive 47.5% 20 40 60 70 Month to Event or Censoring Negative, MST NA Positive, MST 32.27 pCR_ctDNA No_pCR_ctDNA - _HR+HER2 - No_pCR_ctDNA+_HR+HER2 - p = 0.00022
11 Not for reproduction or further distribution. Indication Poster Title Breast Serial postoperative ctDNA monitoring of breast cancer recurrence Lung Minimal residual disease (MRD) detection by ctDNA in relation to radiographic disease progression in patients with stage I - III non – small cell lung cancer (NSCLC) treated with definitive radiation therapy. Sarcoma Circulating tumor DNA (ctDNA) detection of molecular residual disease (MRD) as a potential biomarker in localized soft tissue sarcoma (STS). Merkel Cell The relationship between circulating tumor DNA with Merkel cell carcinoma tumor burden and detection of recurrence. Renal Cell Monitoring efficacy of neoadjuvant sunitinib in metastatic renal cell carcinoma using a personalized and tumor informed ctDNA assay. Colon Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE - US) Colon NSABP FC - 12: A single - arm, phase II study to evaluate treatment with gevokizumab in patients with stage II/III colon cancer who remain ctDNA+ after curative surgery and adjuvant chemotherapy New Signatera Data to be Presented 1. 2022 ASCO Annual Meeting (https://conferences.asco.org/am/attend).
12 Not for reproduction or further distribution. New FDA Draft Guidance for MRD - Guided Drug Development Formal pathway for drug developers, how to incorporate tumor - informed ctDNA testing into clinical trials Potential for use of ctDNA as an early endpoint to support drug approval Summary
13 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
14 Not for reproduction or further distribution. Q1 22 Financial Overview ($ in millions, except for per share data) Balance sheet March 31, 2022 Dec 31, 2021 Change Q/Q Cash & investments 3 $752.2 $914.5 ($162.3) UBS line of credit $50.1 $50.1 $ — Convertible senior notes 4 $280.7 $280.4 $0.3 P&L Q1’22 Q1’21 Change Y/Y Product revenues $190.0 $120.4 $69.6 Licensing and other revenues 1 $4.1 $31.9 ($27.8) Total revenues $194.1 $152.3 $41.8 Gross margin% 2 46.8% 46.0% 80 bps R&D $80.4 $40.2 $40.2 SG&A $147.6 $108.3 $39.3 Net loss per diluted share ($1.45) ($0.74) ($0.71) 1. Q1 21 Licensing and other revenues includes one - time Qiagen revenue recognition of $28.6M. 2. Q1 21 Gross margin is adjusted to exclude one - time Qiagen revenue of $28.6M. 3. Cash and investments also include cash equivalents and restricted cash. 4. This balance reflects net carrying value for the Convertible Senior Notes under ASC 470 - 20 while the gross principal amounts out standing is $287.5 million as of March 31, 2022.
15 Not for reproduction or further distribution. Raising 2022 Annual Guidance Guide $ (millions) Original Current Key drivers Revenue $770 - $790 $790 - $810 • Volume outperformance • Increasing ASPs Gross margin % revenue 46% – 48% 46% – 48% • Improving ASP trends in Q1 SG&A $560 – $590 $560 – $590 • Commercial teams built - out R&D $340 - $360 $340 - $360 • Foundational clinical trials and lab workflow expansion Cash burn $370 - $400 $370 - $400 • Poised to decline in 2023 and beyond
16 Not for reproduction or further distribution. Path to cash flow breakeven: Estimated P&L progression Cash burn expected to drop significantly in 2023 • Existing product portfolio driving continued revenue growth in large, under - penetrated markets • Commercial teams already in place • Stable R&D spend focused on low technical risk, high ROIC projects: – New versions of proven products – COGS reduction projects – Lab expansion – Prospective clinical trials 2022 Cash Flow Breakeven Steady state ~55% gross margins $ 790m - $810m $ 1.3bn - $ 1.5bn $ 2bn+ 70%+ gross margins 25%+ EBIT margins ~55% gross margins 2022 Investments Designed to Scale Revenues for Years 46 - 48% gross margins
17 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.