Exact Sciences CEO Kevin Conroy Highlights Transformative Start to 2025 with Launch of Cologuard Plus and Oncodetect

02 May 2025 | Friday | Company results

Backed by strong Q1 results, expanded diagnostics portfolio, and raised full-year outlook, Exact Sciences accelerates toward its mission to eradicate cancer through early detection and personalized treatment.

 

  • 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

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the Company generated revenue of $707 million for the first quarter ended March 31, 2025, compared to $638 million for the same period of 2024.

“Our strong first quarter results pave the way for 2025 to mark our most transformative year yet,” said Kevin Conroy, chairman and CEO. “The Exact Sciences team just launched two innovative tests: Cologuard Plus, our next-generation colon cancer screening test, and Oncodetect, our molecular residual disease test. These additions expand our portfolio and move us closer to our goal of helping to eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment. With growing momentum in our commercial organization and improved profitability, we raised our full-year outlook and continue to build a foundation for sustained, long-term growth.”

First-quarter 2025 financial results

For the three-month period ended March 31, 2025, as compared to the same period of 2024 (where applicable):

  • 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, Exact Sciences launched the Cologuard Plus test, the company’s next-generation colon cancer screening test. The Cologuard Plus test detects cancers and precancerous polyps with even greater sensitivity than the Cologuard test while reducing false positives by nearly 40 percent. This advancement enhances the Company’s screening capabilities and reinforces its commitment to delivering high-quality, non-invasive options for patients. The Company launched the Cologuard Plus test with Medicare coverage and secured HEDIS guideline inclusion in March 2025.

In April, Exact Sciences launched the Oncodetect test, its molecular residual disease and recurrence monitoring test. Oncodetect identifies residual disease up to two years earlier than imaging, the current standard of care. The Company expects to obtain Medicare reimbursement in colon cancer in the second quarter of 2025.

Exact Sciences is on track for the launch of CancerguardTM EX, a laboratory-developed multi-cancer screening test, in the second half of 2025. Additionally, Exact Sciences is on track to share results from the pivotal BLUE-C study supporting its colon cancer blood test in mid-summer of 2025. The Company will bring both tests to patients through its large commercial organization and unique ExactNexusTM technology platform.

2025 outlook

The Company has updated its full-year 2025 revenue and adjusted EBITDA guidance:

 

Prior guidance

 

May 1 update

 

Change at midpoint

 

Y/Y growth rate

Total revenue

$3.025 - $3.085 billion

 

$3.070 - $3.120 billion

 

$40.0 million

 

12%

Screening

$2.350 - $2.390 billion

 

$2.390 - $2.425 billion

 

$37.5 million

 

14%

Precision Oncology

$675 - $695 million

 

$680 - $695 million

 

$2.5 million

 

5%

Adjusted EBITDA

$410 - $440 million

 

$425 - $455 million

 

$15.0 million

 

36%

First-quarter 2025 conference call & webcast

Company management will host a conference call and webcast on Thursday, May 1, 2025, at 5 p.m. ET to discuss first-quarter 2025 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.

Non-GAAP disclosure

In addition to the Company's financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents the following non-GAAP measures:

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-U.S. dollar denominated revenue using the prior year comparative period exchange rates.

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 U.S. GAAP. For example, adjusted gross margin and adjusted gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. Additionally, adjusted EBITDA and other adjusted operating result metrics exclude a number of expense items that are included in net loss. As a result, positive adjusted EBITDA, adjusted operating income, or adjusted earnings per share may be achieved while a significant net loss persists. For more information on these non-GAAP financial measures, see the tables captioned “U.S. GAAP to Non-GAAP Reconciliation.” The Company presents certain forward-looking statements about the Company's future financial performance that include non-GAAP measures. These non-GAAP measures include adjustments like stock-based compensation, acquisition and integration costs including gains and losses on contingent consideration, and other significant charges or gains that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally, management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is therefore not available without unreasonable effort and is not provided. The occurrence, timing, and amount of any of the items excluded from GAAP to calculate non-GAAP could significantly impact the Company's GAAP results.

 

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