NEW YORK – Exact Sciences is gearing up to launch a multi-cancer, blood-based early cancer detection and screening test before the end of this year, alongside a circulating tumor DNA test for detection of minimal residual disease, as volume and revenue growth within its established stool-based colorectal cancer screening business continue to buoy the company.
Exact reported after the close of the market on Wednesday that its fourth quarter 2024 revenues were up 10 percent over the same period of 2023, or 11 percent on an adjusted basis.
CEO Kevin Conroy said in a call with investors that the firm's growth was led by momentum in adoption amongst providers, health systems, and payors for its core cancer screening test, Cologuard. On average, more than 900 providers became new Cologuard customers each week, he said.
For the three months ended Dec 31, the cancer diagnostics and screening firm brought in $713.4 million in revenues compared to $646.9 million in Q4 2023, beating analysts' average estimate of $701.5 million.
This included $552.6 million in screening revenue, up 14 percent from $486.7 million, as well as $160.9 million from precision oncology testing, which was nearly flat compared to the $160.2 million it reported for Q4 2023.
With Cologuard advancing steadily, the company has slowly been shifting its focus to developing new products for blood-based testing, and it appears that the coming year will be a tipping point for those efforts.
Exact Sciences has been cautious in describing precise details of the ultimate makeup of its clinical multi-cancer early detection (MCED) platform after acquiring Johns Hopkins spinout Thrive Earlier Detection in and University of Oxford spinout Base Genomics in late 2020.
Last month, Exact committed to launching its MCED test, now dubbed Cancerguard, within the coming year, marking its entrance into a novel screening market thus far dominated by Illumina spinoff Grail.
Exact shared new data late last year demonstrating nearly 99 percent specificity and around 62 percent overall sensitivity for Cancerguard in a trial called ASCEND 2.
Investigators associated with the development of Base Genomics' sequencing technology also published new data recently on the application of their platform to early cancer detection, but Exact has not detailed whether or how that may have been incorporated into Cancerguard.
"We remain on track for the launch of a laboratory-developed-test version in the second half of 2025," Conroy said during a call with investors.
"We're also making progress with our blood-based colon cancer screening test and remain on track to share top line results from our pivotal BLUE-C study by the middle of 2025," he added.
The company is also gearing up to advance its minimal residual disease (MRD) technology before the end of the year. It recently published data in the Journal of Surgical Oncology demonstrating that its MRD assay, dubbed Oncodetect, identifies residual disease up to 10 months earlier than imaging, and that a positive test result was associated with a 50 percent likelihood of cancer recurrence.
"We arguably have one of the strongest, if not the strongest brands … [and] we intend to utilize that playbook and those skills to propel Oncodetect forward," Conroy said.
Exact expects to launch Oncodetect with reimbursement in colorectal cancer after submitting validation data to Medicare earlier this month, and the company is now shifting its research focus to new indications, including breast cancer, Conroy said.
Although that data remains unpublished, the company suggested that its test's sensitivity and specificity, when testing patients serially over time, is "very competitive" with other assays on the market.
Exact's net loss for the fourth quarter of 2024 was $864.6 million, or $4.67 per share, compared to a net loss of $49.8 million, or $0.27 per share in Q4 2023. On an adjusted basis, the company reported a loss of $.06 per share. Analysts, on average, had expected a loss per share of $.19.
The company's R&D spending was $97.7 million for the quarter, down 15 percent from $115.2 million in the same period of 2023. Its Q4 SG&A costs rose about 5 percent to $435.6 million from $413.0 million.
The firm's total revenue for 2024 was $2.76 billion, also up 10 percent from $2.50 billion in 2023, or 11 percent on a core revenue basis, beating the Wall Street estimate of $2.75 billion
Exact's full-year screening revenue rose 13 percent to $2.10 billion from $1.86 billion in 2023, and its precision oncology test revenue was $655.0 million, up 4 percent from $629.1 million.
Its net loss for 2024 was $1.03 billion, or $5.59 per share, compared to $204.1 million, or $1.13 per share, in 2023. On an adjusted basis, Exact said its full-year loss per share was $.23. Analysts had predicted a net loss per share of $.57.
Exact's full-year R&D expenses totaled $431.2 million, up about 1 percent from $426.9 million in 2023. Its SG&A costs rose about 3 percent to $1.68 billion from $1.63 billion
The company ended 2024 with $600.9 million in cash and cash equivalents and $437.1 million in marketable securities.
For 2025, Exact Sciences is projecting total revenues between $3.03 billion and $3.09 billion. This includes between $2.35 billion and $2.39 billion in screening revenue and $675 million to $695 million from precision oncology testing.