With Chairman and CEO Kevin Conroy predicting that 2025 is on track to be the most productive year in Exact Sciences’ history, the company reported better-than-expected 10% revenue growth for both the fourth quarter of 2024 and 10% revenue growth over the full year during its quarterly earnings call on Wednesday.
Best known for its noninvasive Cologuard colon cancer screening test, which has been used to screen for colorectal cancer (CRC) 18 million times since its launch in 2014, the company reported quarterly revenue of $713 million, an increase of 10% over the same quarter of 2023. This includes screening revenue — primarily laboratory service revenue from its Cologuard tests — of $553 million and precision oncology revenue of $161 million.
Total 2024 revenue was $2.76 billion, an increase of 10% over the previous year on screening revenue of $2.1 billion and precision oncology revenue of $655 million.
While quarterly revenue beat forecasts of $694 million, Exact posted a quarterly net loss of $865 million, or $4.67 per share, attributable to the company’s one-time recognition of an $830 million noncash impairment charge related to the 2021 acquisition of Thrive Earlier Detection Corp.
Shares of Exact Sciences fell 1.5% in after-hours trading, opened Thursday down 3.9% at $48.52 per share, and by 11:15 a.m. eastern time, they fell to $48.04, down 4.99% from their Feb. 19 close.
On the Wednesday earnings call, Conroy was upbeat about 2025 due to the continuing market penetration of Cologuard and the planned launch of three new cancer tests this year.
Those new products are Cologuard Plus, its next-generation colorectal cancer screening test, which will be available in the second quarter to Medicare fee-for-service patients, who represented about 15% of Cologuard volumes last year; Oncodetect, a molecular residual disease (MRD) test; and Cancerguard, a multicancer screening test.
Conroy said the company’s efforts to get more people screened with Cologuard are setting the stage for a strong 2025. “The number of people eligible for their next Cologuard test grows about 30%, to 2 million this year and the rate of rescreening is at an all-time high,” he said. “Health systems and payers are turning to Cologuard as the standard of care within large organized screening programs.”
In addition, he said the company’s expanded field sales team is deployed in new territories and is connecting with the highest potential ordering providers. He characterized Cologuard Plus as one of the most accurate cancer screening tests ever developed
“These tailwinds will fuel growth for years to come, improve screening rates, and help decrease sales and marketing costs as a percentage of revenue over time,” he said.
In 2025, Exact Sciences expects total revenue between $680 and $695 million for the first quarter and between $3.025 and $3.085 billion for the full year. The high end of its annual revenue estimate would represent an increase of 11.8%. This assumes screening revenue between $520 and $530 million for the first quarter and between $2.35 and $2.39 billion for the year, and precision oncology revenue between $160 million and $165 million for the first quarter and between $675 million and $695 million for the full year.
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics, a Marshfield genetic testing laboratory acquired by Exact Sciences in 2021. Precision Oncology includes laboratory service revenue from the company’s global Oncotype DX and therapy selection tests.
Testing 1, 2, 3
The FDA-approved Cologuard Plus test features novel biomarkers — molecules, proteins, genes, enzymes, or other biological factors in the human body that indicate a specific health condition or process. It is expected to reduce false positives by nearly 40%, which would minimize unnecessary follow-up colonoscopies. Exact Sciences expects to launch the Cologuard Plus test with Medicare coverage for the estimated 110 million U.S. adults ages 45 or older who are at average risk for CRC.
Meanwhile, the Cancerguard test, which is still in development, is designed to detect multiple cancers in their earliest stages from a single blood draw.
Also in 2025, the Oncodetect molecular residual disease test is scheduled to become part of Exact Sciences’ Precision Oncology portfolio, a suite of products designed to deliver genomic insights and inform medical prognosis and cancer treatment following a diagnosis.
One established product in the suite is the Oncotype DX Breast Recurrence Score test, which the company says is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The test is included in all major breast cancer treatment guidelines.
