UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
(
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
|
(Nasdaq Global Select Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
On May 8, 2025, Natera, Inc. issued a press release announcing the results for its first quarter ended March 31, 2025 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 8, 2025. | |
| 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 8, 2025
Exhibit 99.1
Natera Reports First Quarter 2025 Financial Results
AUSTIN, Texas, May 8, 2025 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today reported its financial results for the first quarter ended March 31, 2025.
Recent Strategic and Financial Highlights
| · | Generated total revenues of $501.8 million in the first quarter of 2025, compared to $367.7 million in the first quarter of 2024, an increase of 36.5%. Product revenues grew 37.1% over the same period. |
| · | Generated a gross margin of 63.1% in the first quarter of 2025, compared to a gross margin of 56.7% in the first quarter of 2024. |
| · | Processed approximately 855,100 tests in the first quarter of 2025, compared to approximately 735,800 tests in the first quarter of 2024, an increase of 16.2%. |
| · | Performed approximately 167,700 oncology tests in the first quarter of 2025, compared to approximately 114,800 in the first quarter of 2024, an increase of 46.1%. |
| · | Achieved positive cash flow of approximately $23.2 million1 in the first quarter of 2025. |
“We delivered another strong quarter, with volume growth across the business, including a record growth quarter for Signatera,” said Steve Chapman, chief executive officer of Natera. “Our progress reflects the strength of our technology and the breadth and quality of the clinical data. With multiple high-impact datasets reading out and trials underway, we believe we’re in a strong position to help millions of patients in the future.”
First Quarter Ended March 31, 2025 Financial Results
Total revenues were $501.8 million in the first quarter of 2025 compared to $367.7 million in the first quarter of 2024, an increase of 36.5%. The increase in total revenues was driven primarily by a 37.1% increase in product revenues, which were $500.0 million in the first quarter of 2025 compared to $364.7 million in the first quarter of 2024. The increase in product revenues was primarily driven by an increase in volume and average selling price improvements, as well as cash receipts that were collected during the quarter in excess of initial revenue estimates for tests delivered in prior quarters.
Natera processed approximately 855,100 tests in the first quarter of 2025, including approximately 840,800 tests accessioned in its laboratory, compared to approximately 735,800 tests processed, including approximately 718,700 tests accessioned in its laboratory, in the first quarter of 2024, an increase of 16.2% from the prior period.
In the first quarter of 2025, Natera recognized revenue on approximately 804,800 tests for which results were reported to customers in the period (tests reported), including approximately 791,400 tests reported from its laboratory, compared to approximately 679,400 tests reported, including approximately 663,500 tests reported from its laboratory, in the first quarter of 2024, an increase of 18.5% from the prior period.
Gross profit2 for the three months ended March 31, 2025 and 2024 was $316.8 million and $208.6 million, respectively, representing a gross margin of 63.1% and 56.7%, respectively. Natera had higher gross margin in the first quarter of 2025 primarily as a result of higher revenues, continued progress in reducing cost of revenues associated with tests processed, as well as incremental cash receipts during the quarter in excess of initial revenue estimates for tests delivered in the prior period. Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the first quarter of 2025 were $395.9 million, compared to $282.9 million in the same period of the prior year, an increase of 39.9%. The increase was primarily driven by headcount growth to support new product offerings as well as increases in consulting and legal expenses.
Loss from operations for the first quarter of 2025 was $79.2 million compared to $74.3 million for the same period of the prior year.
Natera reported a net loss for the first quarter of 2025 of $66.9 million, or ($0.50) per diluted share, compared to a net loss of $67.6 million, or ($0.56) per diluted share, for the same period in 2024. Weighted average shares outstanding were approximately 134.8 million in the first quarter of 2025 compared to 120.8 million in the first quarter of the prior year.
At March 31, 2025, Natera held approximately $991.6 million in cash, cash equivalents, short-term investments and restricted cash, compared to $968.3 million as of December 31, 2024. As of March 31, 2025, Natera had a total outstanding debt balance of $80.3 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day SOFR plus 50 bps.
Financial Outlook
Natera anticipates 2025 total revenue of $1.94 billion to $2.02 billion; 2025 gross margin to be approximately 60% to 64% of revenues; selling, general and administrative costs to be approximately $0.975 billion to $1.05 billion; research and development costs to be $550 million to $590 million; and net cash inflow to be positive3.
Test Volume Summary
| Unit | Q1 2025 | Q1 2024 | Definition | |||
| Tests processed | 855,100 | 735,800 | Tests accessioned in our laboratory plus units processed outside of our laboratory | |||
| Tests accessioned | 840,800 | 718,700 | Test accessioned in our laboratory | |||
| Tests reported | 804,800 | 679,400 | Total tests reported | |||
| Tests reported in our laboratory | 791,400 | 663,500 | Total tests reported in our laboratory less units reported outside of our laboratory |
About Natera
Natera™ is a global leader in cell-free DNA and genetic 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 250 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 2025 Financial Results Conference Call |
| Date: | Thursday, May 8, 2025 |
| Time: | 1:30 p.m. PT (4:30 p.m. ET) |
| Live Dial-In: | 1-888-596-4144 (Domestic) 1-646-968-2525 (International) |
| Conference ID: | 7684785 |
| Webcast Link: | https://events.q4inc.com/attendee/454317205 |
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 statements regarding its market opportunity, anticipated products and launch schedules, reimbursement coverage and product costs, commercial and strategic partnerships and acquisitions, user experience, clinical trials and studies, and its strategies, goals and general business and market conditions, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved.
These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving our financial projections and goals; we may be unable to further increase the use and adoption of our products through our direct sales efforts or through our laboratory partners; we have incurred net losses since our inception and we anticipate that we will continue to incur net 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; our products may not perform as expected; the results of our clinical studies may not support the use and reimbursement of our tests, particularly for microdeletions screening, and may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our primary CLIA-certified laboratories becomes inoperable, we will be unable to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand, obtain or maintain third-party payer coverage and reimbursement for our 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; we could incur substantial costs and delays complying with governmental regulations, including recently enacted FDA regulations regarding LDTs; litigation and other regulatory or governmental proceedings, related to our intellectual property or the commercialization of our tests, are costly, time- consuming, could result in our obligation to pay material judgments or incur material settlement costs, and could limit our ability to commercialize our tests; and any inability to effectively protect our proprietary technology could harm our competitive position or our brand..
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 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.
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, 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.
References
| 1. | Positive cash flow for the quarter ended March 31, 2025, is derived from the GAAP Statement of Cash Flows as follows: net cash provided by operating activities of $44.5 million, net cash provided by financing activities of $0.5 million, offset by net cash used in investing activities for purchases of property and equipment of $21.8 million. |
| 2. | 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. |
| 3. | Cash (outflow) inflow is calculated as the sum of GAAP net cash provided by (used in) operating activities, GAAP net cash provided by (used in) financing activities, and GAAP net cash provided by (used in) investing activities for purchases of property and equipment, investment in related party, and acquisition of intangible assets. |
Contacts
Investor
Relations
Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media
Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Natera, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except shares)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (1) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and restricted cash | $ | 973,768 | $ | 945,587 | ||||
| Short-term investments | 17,832 | 22,689 | ||||||
| Accounts receivable, net of allowance of $7,434 and $7,259 at March 31, 2025 and December 31, 2024, respectively | 318,233 | 314,165 | ||||||
| Inventory | 50,367 | 44,744 | ||||||
| Prepaid expenses and other current assets, net | 56,185 | 48,635 | ||||||
| Total current assets | 1,416,385 | 1,375,820 | ||||||
| Property and equipment, net | 180,453 | 162,046 | ||||||
| Operating lease right-of-use assets | 94,631 | 86,149 | ||||||
| Other assets | 40,897 | 36,720 | ||||||
| Total assets | $ | 1,732,366 | $ | 1,660,735 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 39,240 | $ | 34,922 | ||||
| Accrued compensation | 47,086 | 62,114 | ||||||
| Other accrued liabilities | 178,449 | 146,893 | ||||||
| Deferred revenue, current portion | 20,557 | 19,754 | ||||||
| Short-term debt financing | 80,345 | 80,362 | ||||||
| Total current liabilities | 365,677 | 344,045 | ||||||
| Deferred revenue, long-term portion and other liabilities | 23,958 | 24,682 | ||||||
| Operating lease liabilities, long-term portion | 103,056 | 96,588 | ||||||
| Total liabilities | 492,691 | 465,315 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock (2) | 12 | |||||||
| Additional paid-in capital | 3,874,656 | 3,763,614 | ||||||
| Accumulated deficit | (2,634,798 | ) | (2,567,862 | ) | ||||
| Accumulated other comprehensive loss | (197 | ) | (344 | ) | ||||
| Total stockholders’ equity | 1,239,675 | 1,195,420 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,732,366 | $ | 1,660,735 | ||||
| (1) | The consolidated balance sheet at December 31, 2024 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, 2024. |
| (2) | As of March 31, 2025 and December 31, 2024, there were approximately 135,932,000 and 132,646,000 shares of common stock issued and outstanding, respectively. |
Natera, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share data)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | ||||||||
| Product revenues | $ | 500,036 | $ | 364,672 | ||||
| Licensing and other revenues | 1,794 | 3,069 | ||||||
| Total revenues | 501,830 | 367,741 | ||||||
| Cost and expenses | ||||||||
| Cost of product revenues | 184,613 | 158,833 | ||||||
| Cost of licensing and other revenues | 452 | 307 | ||||||
| Research and development | 129,078 | 88,637 | ||||||
| Selling, general and administrative | 266,864 | 194,278 | ||||||
| Total cost and expenses | 581,007 | 442,055 | ||||||
| Loss from operations | (79,177 | ) | (74,314 | ) | ||||
| Interest expense | (1,005 | ) | (3,124 | ) | ||||
| Interest and other income, net | 13,419 | 10,267 | ||||||
| Loss before income taxes | (66,763 | ) | (67,171 | ) | ||||
| Income tax expense | (173 | ) | (428 | ) | ||||
| Net loss | $ | (66,936 | ) | $ | (67,599 | ) | ||
| Unrealized gain on available-for-sale securities, net of tax | 147 | 893 | ||||||
| Comprehensive loss | $ | (66,789 | ) | $ | (66,706 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.50 | ) | $ | (0.56 | ) | ||
| Weighted-average number of shares used in computing basic and diluted net loss per share: | ||||||||
| Basic and diluted | 134,750 | 120,814 | ||||||
May 8, 2025 Natera, Inc. Q1’2025 Earnings Presentation |
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 anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partnerships and potential acquisitions, our user experience, our clinical trials and studies, our strategies, 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 further increase the use and adoption of our products through our direct sales efforts or through our laboratory partners; we have incurred net losses since our inception and we anticipate that we will continue to incur net 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; our products may not perform as expected; the results of our clinical studies may not support the use and reimbursement of our tests, particularly for microdeletions screening, and may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our primary CLIA-certified laboratories becomes inoperable, we will be unable to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand, obtain or maintain third-party payer coverage and reimbursement for our 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; we could incur substantial costs and delays complying with governmental regulations, including recently enacted FDA regulations regarding LDTs; litigation and other regulatory or governmental proceedings, related to our intellectual property or the commercialization of our tests, are costly, time- consuming, could result in our obligation to pay material judgments or incur material settlement costs, and could limit our ability to commercialize our tests; and any inability to effectively protect our proprietary technology could harm our competitive position or our brand. 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) 980-9190. 2 Safe harbor statement Not for reproduction or further distribution. |
Revenue of $502M in Q1 2025 vs $368M in Q1 2024; year-over-year growth of 37%. 855K total tests processed in Q1 2025 vs 736K in Q1 2024; year-over-year growth of 16%. 161K clinical oncology tests in Q1 2025 vs 106K in Q1 2024; year-over-year growth of 52%. Clinical oncology units grew 16.5K units over Q4 2024, a new record for sequential quarter growth. Gross margin1 of 63% in Q1 2025 vs 57% in Q1 2024; generated ~$23M in cash inflow2 in Q1 2025. Increasing 2025 financial outlook: revenue of $1.94B – $2.02B (pro-forma revenue growth of ~26%); gross margin of 60% – 64%; and positive cash flow generation2 . Compelling Prospera Heart datasets, with readout of DEFINE-HT and DQS publication in American Journal of Transplantation. Proliferation of Signatera readouts across indications such as sarcoma and breast cancer underscores MRD leadership. 3 Q1 2025 highlights and recent business updates Not for reproduction or further distribution. 1. Non-GAAP gross margin percentage is computed as follows: GAAP revenues minus GAAP cost of product revenues and licensing and other revenues divided by GAAP revenues. 2. Non-GAAP cash inflow / outflow are calculated based on GAAP Statement of Cash Flows amounts including net cash from operating activities, net cash from investing activities excluding amounts related to short-term investments, and net cash from financing activities excluding proceeds from public offerings. Please refer to our website at www.investor.natera.com/financials for a reconciliation of non-GAAP cash inflow / outflow to the most directly comparable GAAP financial measure. Management uses non-GAAP cash flow as an indicator of the Company’s operational cash generating capabilities. |
736K 760K 776K 793K 855K 660K 680K 700K 720K 740K 760K 780K 800K 820K 840K 860K 880K 1Q24 2Q24 3Q24 4Q24 1Q24 Volumes continue to ramp: sharp step up in Q1 vs. Q4 Core Volume Drivers 8% Not for reproduction or further distribution. 1Q25 4 • Strong performance across all product areas • New data and features in women’s health • Guidelines/publications driving organ health • Signatera continues to ramp |
61K 72K 81K 91K 106K 118K 130K 145K 161K 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 4Q24 1Q25 5 Signatera clinical units jump again in Q1: up ~16.5K units vs. Q4 Signatera clinical tests processed ~16.5K Not for reproduction or further distribution. |
$94M $152M $194M $242M $368M $502M Q1'20 Q1'21 Q1'22 Q1'23 Q1'24 Q1'25 6 Total revenues jump 37% from Q1’24 Not for reproduction or further distribution. $311M $368M $413M $440M $476M $502M Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Total revenues: last 6 quarters Total revenues: YoY Q1 trend 37% |
39% 45% 45% 51% 57% 59% 62% 63% 63% 35% 40% 45% 50% 55% 60% 65% 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 4Q24 1Q25 7 ASPs and COGS execution ahead of plan • Underlying gross margins (excluding true ups) increased ~110 bps in Q1 2025 over Q4 2024 • Generated $23M in cash flow in Q1 • Continued sequential step up in ASPs • Cash collection exceeding expectations, driving true-ups Gross margins quarterly trend ~2% true up benefit ~4% true up benefit ~4% true up benefit ~3% true up benefit ~3% true up benefit Not for reproduction or further distribution. ~3% true up benefit |
New data in top-tier journal supports Prospera Heart with DQS Data published in American Journal of Transplantation shows strong performance of Prospera Heart with donor quantity score (DQS) in detection of allograft rejection compared to donor fraction (dd-cfDNA %)-alone Technology dd-cfDNA % dd-cfDNA % + DQS Sensitivity 78.20% 86.48% Specificity 76.92% 83.57% AUC (Area Under the Curve) 0.865 0.881 37.3% reduction in the number of false-positive cases Prior Method Prospera Heart with DQS 8 Not for reproduction or further distribution. |
Positive readout of prospective DEFINE-HT clinical trial Key details Patients with elevated Prospera significantly more at risk for adverse events (HR: 2.56, p=0.0299) Biopsy-Positive 22% Prospera-Positive 67% Biopsy-Negative 78% Prospera-Negative 33% 0% 20% 40% 60% 80% 100% Prospera with DQS Patients w/ Graft Dysfunction (%) significantly outperformed donor fraction alone in predicting adverse outcomes 9 >1,100 samples included in the analysis Prospera predicted graft dysfunction 3X more than biopsy Not for reproduction or further distribution. |
Signatera >150 MTM Signatera 1-5 MTM Signatera (+) Signatera (-) I-SPY 2 breast cancer trial shows Signatera can predict recurrence at diagnosis and prior to treatment Marla Lipsyc-Sharf et al. Impact of circulating tumor DNA (ctDNA) surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study. ASCO Annual Meeting 2024. *For representative purposes only, HR/ OR for high grade clinicopathological features have varied in significance in previous publications https://www.mdpi.com/2077-0383/11/9/2332#:~:text=In%20multivariate%20analyses%2C%20the%20presence,after%20adjusting%20for%20confounding%20variables. Signatera quantification was a significant risk factor for recurrence Relative Risk of Recurrence Compare ctDNA status at diagnosis with long-term outcomes and clinical pathological risk factors (subtype, age, etc.) ctDNA quantification was most significant in a multivariate analysis 712 early-stage, high-risk breast cancer patients 14.0 10 Study Details Objective Key Result 5.2 3.1 1.0 |
Most comprehensive Signatera dataset in Sarcoma to date, presented at SSO Conference (>200 patients; >2,100 samples) Sarcoma is an aggressive cancer that is a collection of rare tumors impacting bone and soft-tissue (muscle, tendons, etc.) 17,000 diagnosed annually in the U.S. (comparable to esophageal, MIBC, cervical) 89% sensitivity and 100% specificity (observed overall in the study) 93% sensitivity and 100% specificity (observed for Leiomyosarcoma, the most common subtype in study cohort) 90% of patients who were treated upon progression had response and saw a corresponding decrease in ctDNA 11 Not for reproduction or further distribution. |
Merkel Cell Analysis 25+ presentations (including 6 orals) Key read-outs: Robust body of Signatera data at upcoming ASCO meeting 12 Not for reproduction or further distribution. ISPY-2 (breast) DARE (breast) GENOME (pan cancer) Evaluating Signatera across multiple cancer types Histologies: Gastrointestinal Breast Genitourinary Pan-cancer/other Real-World Evidence 5 posters 1 oral 4 posters 4 orals 3 posters 1 oral 7+ posters 2 posters |
Broad clinical launch of Signatera Genome 13 Not for reproduction or further distribution. Broadly available in CLIA, IUO and RUO Benefits from Natera’s proven mPCR-NGS method Uses a targeted and deep sequencing approach ASCO data: pan cancer validation study (>3K samples) shows detection significantly ahead of clinical recurrence Detects tiny traces of tumor DNA at frequencies as low as 1 PPM; RUO version can detect below 1 PPM |
14 FY25 Q1 financial overview 1. Cash and investments also include cash equivalents and restricted cash. ($ in millions, except for per share data) Balance sheet Mar 31, 2025 Dec 31, 2024 Change Y/Y Cash & investments1 $991.6 $968.3 $23.3 UBS line of credit $80.3 $80.4 ($0.1) FY25 Q1 FY24 Q1 Change Y/Y Product revenues $500.0 $364.7 $135.3 Licensing and other revenues $1.8 $3.1 ($1.3) Total revenues $501.8 $367.8 $134.0 Gross margin % 63.1% 56.7% 640 bps R&D $129.1 $88.6 $40.5 SG&A $266.9 $194.3 $72.6 Net loss per diluted share ($0.50) ($0.56) $0.06 Not for reproduction or further distribution. |
Guide ($ millions) Original Current Key drivers Revenue $1,870 – $1,950 $1,940 – $2,020 Continued volume growth, conservative ASPs, strong oncology contribution Gross margin % 60% – 64% 60% – 64% Building on Q1 progress for the balance of the year SG&A $950 – $975 $975 – $1,050 Commercial investments on track; incremental non-cash / non-recurring charges added to guide R&D $525 – $550 $550 – $590 Accelerating clinical trials, product investments Cash flow Positive Positive Reinvesting cash flows into operations to drive out year growth 15 Raising 2025 annual guidance |
©2025 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution. ® |