Exact Sciences Announces First-Quarter 2025 Results
First quarter highlights
-
Delivered total first quarter revenue of
$707 million , an increase of 11% on a reported and core revenue basis, including Screening revenue of$540 million and Precision Oncology revenue of$167 million -
Raised full-year 2025 revenue and adjusted EBITDA guidance midpoints by
$40 million and$15 million , respectively - Launched the Cologuard Plus™ test, the company's next-generation colon cancer screening test
-
Presented data in the
Journal of Surgical Oncology demonstrating the clinical strength of the Oncodetect™ test, the company’s molecular residual disease (“MRD”) and recurrence monitoring test
“Our strong first quarter results pave the way for 2025 to mark our most transformative year yet,” said
First-quarter 2025 financial results
For the three-month period ended
-
Total revenue was
$707 million , an increase of 11% on a reported and core revenue basis -
Screening revenue was
$540 million , an increase of 14% -
Precision Oncology revenue was
$167 million , an increase of 2%, or 4% on a core revenue basis - Gross margin was 71%, and adjusted gross margin was 74%, an increase of nearly 50 basis points
-
Net loss was
$101 million , or$0.54 per share, an improvement of$9 million and$0.06 per share, respectively -
Adjusted EBITDA was
$63 million , an increase of$24 million or 61%, and adjusted EBITDA margin was 9%, an increase of 280 basis points -
Operating cash flow was
$31 million and free cash flow was break-even, increases of$113 million and$120 million , respectively -
Cash, cash equivalents, and marketable securities were
$786 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX® and therapy selection tests.
Platform and pipeline advancements
In the first quarter,
In April,
2025 outlook
The Company has updated its full-year 2025 revenue and adjusted EBITDA guidance:
|
Prior guidance |
|
|
|
Change at midpoint |
|
Y/Y growth rate |
Total revenue |
|
|
|
|
|
|
12% |
Screening |
|
|
|
|
|
|
14% |
Precision Oncology |
|
|
|
|
|
|
5% |
Adjusted EBITDA |
|
|
|
|
|
|
36% |
First-quarter 2025 conference call & webcast
Company management will host a conference call and webcast on
Non-GAAP disclosure
In addition to the Company's financial results determined in accordance with
Core revenue — Core revenue is calculated to adjust for recent acquisitions and divestitures and foreign currency exchange rate fluctuations. Revenue from recent acquisitions is adjusted for the 12 months following acquisition when the periods are not comparable. To exclude the impact of change in foreign currency exchange rates from the prior period under comparison, the Company converts the current period non-
Adjusted EBITDA and adjusted EBITDA margin — The Company defines adjusted EBITDA as net loss adjusted for interest expense, income tax expense or benefit, depreciation expense, amortization of acquired intangible assets, investment income or loss, and certain other items which include significant non-cash items and other charges or benefits resulting from transactions or events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations. These items are discussed in more detail below in the tables captioned “U.S. GAAP to Non-GAAP Reconciliation”. Adjusted EBITDA margin is calculated as adjusted EBITDA divided by total revenue.
Adjusted gross profit, adjusted research and development expenses, adjusted sales and marketing expenses, adjusted general and administrative expenses, adjusted loss from operations, adjusted net loss before tax, adjusted income tax expense (benefit), adjusted net loss, and adjusted earnings per share — The Company refers to various “adjusted” amounts or measures on an “adjusted” basis, which exclude the impact of amortization of intangible assets and certain charges or benefits resulting from transactions or events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations. These items are described in more detail below in the tables captioned “U.S. GAAP to Non-GAAP Reconciliation”. The Company also presents certain of these adjusted measures as a percentage of revenue including adjusted gross margin.
Free cash flow — The Company defines free cash flow as net cash used in or provided by operating activities, reduced by purchases of property, plant and equipment. Management uses free cash flow as a liquidity measure.
Management believes that presentation of non-GAAP financial measures provides supplemental information useful to investors in understanding our underlying operating results and trends. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability of the Company's operating results across reporting periods. Management uses this non-GAAP financial information to establish budgets, manage the Company's business, and set incentive and compensation arrangements. Free cash flow provides useful information to management and investors since it measures our ability to generate cash from business operations. Non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with
About the Cologuard® and Cologuard Plus™ tests:
Developed in collaboration with
The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood associated with cancer and precancer in stool, allowing patients to use the test at home without special preparation or time off. It is covered by Medicare and included in national screening guidelines from both the
Building on this success, the FDA-approved Cologuard Plus test raises the performance bar even further and features novel biomarkers, improved laboratory processes, and enhanced sample stability. The Cologuard Plus test is expected to reduce false positives by nearly 40%, to help minimize unnecessary follow-up colonoscopies. Both tests demonstrate Exact Sciences’ commitment to improving CRC screening access and outcomes.
About the Oncodetect™ test
Molecular residual disease refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate that cancer is present. Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test enables the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.
About the Cancerguard™ test
The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research,
About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra® test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today.
About PreventionGenetics
Founded in 2004 and located in
About
A leading provider of cancer screening and diagnostic tests,
Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; expectations for development or launching of new or improved products and services and their impact on patients; insurance reimbursement potential; our strategies, commercialization efforts, positioning, competition, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts.
Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully develop and commercialize new products and services and assess potential market opportunities; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our reliance upon certain suppliers; our ability to retain and hire key personnel; approval and maintenance of adequate reimbursement rates for our products and services within and outside of the
Selected Unaudited Financial Information Condensed Consolidated Statements of Operations (Amounts in thousands, except per share data) |
|||||||
|
Three Months Ended
|
||||||
|
2025 |
|
2024 |
||||
Revenue |
$ |
706,785 |
|
|
$ |
637,524 |
|
|
|
|
|
||||
Cost of sales |
|
206,238 |
|
|
|
191,201 |
|
Gross profit |
|
500,547 |
|
|
|
446,323 |
|
|
|
|
|
||||
Operating expenses |
|
|
|
||||
Research and development |
|
105,310 |
|
|
|
110,869 |
|
Sales and marketing |
|
264,310 |
|
|
|
217,780 |
|
General and administrative |
|
220,686 |
|
|
|
219,652 |
|
Impairment of long-lived and indefinite-lived assets |
|
6,251 |
|
|
|
4,446 |
|
Total operating expenses |
|
596,557 |
|
|
|
552,747 |
|
|
|
|
|
||||
Other operating loss |
|
— |
|
|
|
(268 |
) |
Loss from operations |
|
(96,010 |
) |
|
|
(106,692 |
) |
|
|
|
|
||||
Other income (expense) |
|
|
|
||||
Investment income, net |
|
4,997 |
|
|
|
6,213 |
|
Interest expense |
|
(9,978 |
) |
|
|
(7,943 |
) |
Total other income (expense) |
|
(4,981 |
) |
|
|
(1,730 |
) |
|
|
|
|
||||
Net loss before tax |
|
(100,991 |
) |
|
|
(108,422 |
) |
|
|
|
|
||||
Income tax expense |
|
(224 |
) |
|
|
(1,806 |
) |
|
|
|
|
||||
Net loss |
$ |
(101,215 |
) |
|
$ |
(110,228 |
) |
|
|
|
|
||||
Net loss per share—basic and diluted |
$ |
(0.54 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
||||
Weighted average common shares outstanding—basic and diluted |
|
186,813 |
|
|
|
182,350 |
|
Selected Unaudited Financial Information Condensed Consolidated Balance Sheets (Amounts in thousands) |
|||||
|
2025 |
|
2024 |
||
Assets |
|
|
|
||
Cash and cash equivalents |
$ |
347,127 |
|
$ |
600,889 |
Marketable securities |
|
439,048 |
|
|
437,137 |
Accounts receivable, net |
|
279,800 |
|
|
248,968 |
Inventory |
|
176,574 |
|
|
162,383 |
Prepaid expenses and other current assets |
|
127,792 |
|
|
122,046 |
Property, plant and equipment, net |
|
697,907 |
|
|
693,673 |
Operating lease right-of-use assets |
|
126,659 |
|
|
116,952 |
|
|
2,367,111 |
|
|
2,366,676 |
Intangible assets, net |
|
988,873 |
|
|
1,009,693 |
Other long-term assets, net |
|
160,182 |
|
|
169,722 |
Total assets |
$ |
5,711,073 |
|
$ |
5,928,139 |
|
|
|
|
||
Liabilities and stockholders’ equity |
|
|
|
||
Convertible notes, net, current portion |
$ |
— |
|
$ |
249,153 |
Current liabilities |
|
502,465 |
|
|
483,034 |
Convertible notes, net, less current portion |
|
2,322,574 |
|
|
2,321,067 |
Other long-term liabilities |
|
320,225 |
|
|
315,503 |
Operating lease liabilities, less current portion |
|
168,902 |
|
|
157,133 |
Total stockholders’ equity |
|
2,396,907 |
|
|
2,402,249 |
Total liabilities and stockholders’ equity |
$ |
5,711,073 |
|
$ |
5,928,139 |
Core Revenue (Unaudited) (Amounts in thousands) |
||||||||||||||||||||
|
|
GAAP |
|
|
|
|
|
|
||||||||||||
|
|
Three Months Ended |
|
|
|
|
|
|
||||||||||||
|
|
2025 |
|
2024 |
|
% Change |
|
|
|
|
|
|
||||||||
Screening |
|
$ |
540,007 |
|
|
$ |
474,798 |
|
|
14 |
% |
|
|
|
|
|
|
|||
Precision Oncology |
|
|
166,778 |
|
|
|
162,726 |
|
|
2 |
% |
|
|
|
|
|
|
|||
Total |
|
$ |
706,785 |
|
|
$ |
637,524 |
|
|
11 |
% |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
Non-GAAP |
|
|
|
|
|
|
||||||||||||
|
|
Three Months Ended |
|
|
||||||||||||||||
|
|
2025 (1) |
|
2024 (1) |
|
% Change |
|
Foreign Currency Impact (2) |
|
Core Revenue (3) |
|
% Change (3) |
||||||||
Screening |
|
$ |
540,007 |
|
|
$ |
474,798 |
|
|
14 |
% |
|
$ |
— |
|
$ |
540,007 |
|
14 |
% |
Precision Oncology |
|
|
166,778 |
|
|
|
160,659 |
|
|
4 |
% |
|
|
540 |
|
|
167,318 |
|
4 |
% |
Total |
|
$ |
706,785 |
|
|
$ |
635,457 |
|
|
11 |
% |
|
$ |
540 |
|
$ |
707,325 |
|
11 |
% |
________________ |
(1) Excludes revenue from the divested Oncotype DX Genomic Prostate Score test.
(2) Foreign currency impact is calculating the change in current period non-
(3) Excludes revenue from the divested Oncotype DX Genomic Prostate Score test and the impact of foreign currency exchange rate fluctuations. |
Adjusted EBITDA (Unaudited) (Amounts in thousands) |
||||||||
|
|
Three Months Ended
|
||||||
|
|
2025 |
|
2024 |
||||
Net loss |
|
$ |
(101,215 |
) |
|
$ |
(110,228 |
) |
Interest expense |
|
|
9,978 |
|
|
|
7,943 |
|
Income tax expense |
|
|
224 |
|
|
|
1,806 |
|
Investment income |
|
|
(4,997 |
) |
|
|
(6,213 |
) |
Depreciation and amortization |
|
|
54,061 |
|
|
|
53,943 |
|
Stock-based compensation (1) |
|
|
65,880 |
|
|
|
73,538 |
|
Acquisition and integration costs (2) |
|
|
8,287 |
|
|
|
10,765 |
|
Impairment of long-lived and indefinite-lived assets (3) |
|
|
6,251 |
|
|
|
4,446 |
|
Loss on sale of asset (4) |
|
|
— |
|
|
|
268 |
|
Restructuring and business transformation (5) |
|
|
24,788 |
|
|
|
2,936 |
|
Adjusted EBITDA |
|
$ |
63,257 |
|
|
$ |
39,204 |
|
Adjusted EBITDA margin |
|
|
9 |
% |
|
|
6 |
% |
________________ |
Refer below the Reconciliations of |
(Unaudited) (Amounts in thousands) |
||||||||||||||||||||||||||||||||||||
|
|
Three Months Ended |
||||||||||||||||||||||||||||||||||
|
|
Gross Profit |
|
Research & Development Expenses |
|
Sales & Marketing Expenses |
|
General & Administrative Expenses |
|
Loss from Operations |
|
Net Loss Before Tax |
|
Income Tax Benefit (Expense) |
|
Net Loss |
|
Net Loss Per Share |
||||||||||||||||||
Reported |
|
$ |
500,547 |
|
|
$ |
105,310 |
|
|
$ |
264,310 |
|
|
$ |
220,686 |
|
|
$ |
(96,010 |
) |
|
$ |
(100,991 |
) |
|
$ |
(224 |
) |
|
$ |
(101,215 |
) |
|
$ |
(0.54 |
) |
Reported percent of revenue |
|
|
71 |
% |
|
|
15 |
% |
|
|
37 |
% |
|
|
31 |
% |
|
|
|
|
|
|
|
|
|
|
||||||||||
Amortization of acquired intangible assets |
|
|
20,768 |
|
|
|
(1,383 |
) |
|
|
(1,924 |
) |
|
|
(26 |
) |
|
|
24,101 |
|
|
|
24,101 |
|
|
|
(1,070 |
) |
|
|
23,031 |
|
|
|
0.12 |
|
Acquisition and integration costs (2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(8,287 |
) |
|
|
8,287 |
|
|
|
8,287 |
|
|
|
(20 |
) |
|
|
8,267 |
|
|
|
0.04 |
|
Impairment of long-lived and indefinite-lived assets (3) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6,251 |
|
|
|
6,251 |
|
|
|
— |
|
|
|
6,251 |
|
|
|
0.03 |
|
Restructuring and business transformation (5) |
|
|
342 |
|
|
|
(428 |
) |
|
|
(5,931 |
) |
|
|
(18,087 |
) |
|
|
24,788 |
|
|
|
24,788 |
|
|
|
(61 |
) |
|
|
24,727 |
|
|
|
0.13 |
|
Adjusted (non-GAAP) |
|
$ |
521,657 |
|
|
$ |
103,499 |
|
|
$ |
256,455 |
|
|
$ |
194,286 |
|
|
$ |
(32,583 |
) |
|
$ |
(37,564 |
) |
|
$ |
(1,375 |
) |
|
$ |
(38,939 |
) |
|
$ |
(0.21 |
) |
Adjusted percent of revenue (non-GAAP) |
|
|
74 |
% |
|
|
15 |
% |
|
|
36 |
% |
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
||||||||||||||||||||||||||||||||||
|
|
Gross Profit |
|
Research & Development Expenses |
|
Sales & Marketing Expenses |
|
General & Administrative Expenses |
|
Loss from Operations |
|
Net Loss Before Tax |
|
Income Tax Benefit (Expense) |
|
Net Loss |
|
Net Loss Per Share |
||||||||||||||||||
Reported |
|
$ |
446,323 |
|
|
$ |
110,869 |
|
|
$ |
217,780 |
|
|
$ |
219,652 |
|
|
$ |
(106,692 |
) |
|
$ |
(108,422 |
) |
|
$ |
(1,806 |
) |
|
$ |
(110,228 |
) |
|
$ |
(0.60 |
) |
Reported percent of revenue |
|
|
70 |
% |
|
|
17 |
% |
|
|
34 |
% |
|
|
34 |
% |
|
|
|
|
|
|
|
|
|
|
||||||||||
Amortization of acquired intangible assets |
|
|
21,100 |
|
|
|
(261 |
) |
|
|
(1,924 |
) |
|
|
(26 |
) |
|
|
23,311 |
|
|
|
23,311 |
|
|
|
675 |
|
|
|
23,986 |
|
|
|
0.13 |
|
Acquisition and integration costs (2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(10,765 |
) |
|
|
10,765 |
|
|
|
10,765 |
|
|
|
(25 |
) |
|
|
10,740 |
|
|
|
0.06 |
|
Impairment of long-lived and indefinite-lived assets (3) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,446 |
|
|
|
4,446 |
|
|
|
— |
|
|
|
4,446 |
|
|
|
0.02 |
|
Loss on sale of asset (4) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
268 |
|
|
|
268 |
|
|
|
— |
|
|
|
268 |
|
|
|
— |
|
Restructuring and business transformation (5) |
|
|
200 |
|
|
|
(2,393 |
) |
|
|
(222 |
) |
|
|
(121 |
) |
|
|
2,936 |
|
|
|
2,936 |
|
|
|
(10 |
) |
|
|
2,926 |
|
|
|
0.02 |
|
Adjusted (non-GAAP) |
|
$ |
467,623 |
|
|
$ |
108,215 |
|
|
$ |
215,634 |
|
|
$ |
208,740 |
|
|
$ |
(64,966 |
) |
|
$ |
(66,696 |
) |
|
$ |
(1,166 |
) |
|
$ |
(67,862 |
) |
|
$ |
(0.37 |
) |
Adjusted percent of revenue (non-GAAP) |
|
|
73 |
% |
|
|
17 |
% |
|
|
34 |
% |
|
|
33 |
% |
|
|
|
|
|
|
|
|
|
|
________________ |
(1) Represents stock-based compensation expense and 401(k) match expense. The Company matches a portion of
(2) Represents acquisition and related integration costs incurred as a result of the Company’s business combinations. Acquisition costs represent legal and professional fees incurred to execute the transaction. There were no acquisition costs incurred for the three months ended
(3) Represents impairment charges on the Company’s long-lived and indefinite-lived assets. For the three months ended
(4) Relates to the sale of the intellectual property and know-how related to the Company’s Oncotype DX Genomic Prostate Score test to MDxHealth SA. For the three months ended
(5) In 2023 the Company began closing a domestic laboratory facility in efforts to consolidate operations. For the three months ended |
Operating Cash Flow to Free Cash Flow (Unaudited) (Amounts in thousands) |
||||||||
|
|
Three Months Ended
|
||||||
|
|
2025 |
|
2024 |
||||
Net cash provided by (used in) operating activities |
|
$ |
30,809 |
|
|
$ |
(82,311 |
) |
Net cash used in investing activities |
|
|
(34,437 |
) |
|
|
(171,438 |
) |
Net cash used in financing activities |
|
|
(256,171 |
) |
|
|
(3,002 |
) |
Effects of exchange rate changes on cash and cash equivalents |
|
|
290 |
|
|
|
(1,140 |
) |
Net decrease in cash, cash equivalents and restricted cash |
|
|
(259,509 |
) |
|
|
(257,891 |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
606,636 |
|
|
|
609,675 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
347,127 |
|
|
$ |
351,784 |
|
|
|
|
|
|
||||
Reconciliation of free cash flow: |
|
|
|
|
||||
Net cash provided by (used in) operating activities |
|
$ |
30,809 |
|
|
$ |
(82,311 |
) |
Purchases of property, plant and equipment |
|
|
(31,174 |
) |
|
|
(37,649 |
) |
Free cash flow |
|
$ |
(365 |
) |
|
$ |
(119,960 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250501253431/en/
Investor Contact:
investorrelations@exactsciences.com
608-893-0009
Media Contact:
sspanos@exactsciences.com
608-556-4380
Source: