NEW YORK – Exact Sciences said after the close of the market on Wednesday that its second quarter revenues were up 12 percent, or 13 percent on a core basis. Separately, the firm announced a licensing agreement with TwinStrand Biosciences related to cell-free nucleic acid sequencing.
For the period ended June 30, the company reported $699.3 million in total revenues, compared to $622.1 million in Q2 2023, beating analysts' average estimate of $690 million.
This included $531.6 million from its cancer screening business, up 15 percent year over year from $462.8 million, and $167.7 million from precision oncology testing, up 7 percent from $157.2 million in Q2 2023.
Exact said that it screened more than 1 million people for colorectal cancer with Cologuard for the first time in a single quarter during Q2. It also said it tested a record number of cancer patients with its Oncotype DX breast cancer assay but did not disclose a total volume.
Exact Sciences CEO Kevin Conroy did not cite a data source but said during a call with investors that the US Centers for Disease Control and Prevention have recognized Cologuard as a major factor in recent increases in CRC screening rates.
He called the second quarter of 2024 a "hallmark period" for Exact's pipeline, which is focused on improved colorectal cancer screening technology and expanding into molecular residual disease detection and multi-cancer screening.
"We plan to share performance data from each of these programs by the end of the year," he said, adding that Exact expects US Food and Drug Administration approval for its next-generation CRC stool test, Cologuard Plus, "in the coming months."
The company is also developing a blood-based colon cancer screening assay that is poised to compete with Guardant Health's Shield assay, which received FDA approval this week.
Conroy said that based on a recent study running its own blood-based tests on approximately 2,900 prospectively collected samples from healthy individuals, 90 advanced adenoma samples, and 60 retrospectively collected cancer samples, the firm has confidence that its test will be "at least comparable to others and will meet the Medicare requirements."
Exact will share these retrospective results ahead of top-line results from its prospective BLUE-C study, which is planned for the fourth quarter of this year.
Conroy also hinted at positive data for the firm's Oncodetect assay, a blood-based test designed to detect minimal, or molecular, residual disease. "These findings will be published in a scientific journal later this year, and we're on track to launch with reimbursement next year 2025," he said during the firm's conference call.
Finally, Conroy highlighted the fact that Exact's multi-cancer screening test was recently authorized by the FDA to be used in a real-world evidence study, which offers the opportunity to test 25,000 people over the next three years.
For Oncotype DX, an assay intended to help guide treatment in early-stage breast cancer, Conroy said that Exact believes that around 70 percent of the market outside the US has yet to adopt testing, representing a "major opportunity" for the company.
"Thanks to our team's commitment, we've increased Oncotype DX adoption internationally by about 10 percentage points over the past year … and our goal is to make sure all people eligible for Oncotype DX have access around the world," he said.
Exact's Q2 net loss was $15.8 million, or $.09 per share, compared to $81.0 million, or $.45 per share, in the same period of 2023. Analysts on average had predicted a per-share loss of $.32.
Its R&D costs totaled $120.9 million, up about 16 percent from $104.1 million in Q2 2023. Its SG&A expenses dropped almost 7 percent to $387.2 million from $414.5 million in the same period last year.
Exact ended the quarter with $530.2 million in cash and cash equivalents and $416.6 million in marketable securities.
The firm said that it is maintaining its full-year 2024 revenue guidance of $2.81 billion to $2.85 billion, including screening revenues of approximately $2.16 billion to $2.18 billion and precision oncology revenues of $655 million to $675 million.
Also on Wednesday afternoon, TwinStrand Biosciences said that it had entered an agreement to exclusively license to Exact Sciences its patent estate in the cell-free nucleic acid sequencing space, including patent portfolios licensed from the University of Washington and the University of Texas Southwestern.
In a statement, Conroy said that the agreement "represents a significant advancement in Exact Sciences' ability to pioneer new frontiers in early cancer detection and precision oncology."
According to TwinStrand, the license is related to its Duplex Sequencing error-correction technology, which increases the accuracy of next-generation sequencing to enhance the detection of ultra-low frequency mutations that might otherwise be lost to background noise.
The agreement provides Exact the ability to use, commercialize, and sublicense the intellectual property acquired. TwinStrand described Exact's rights as "broadly exclusive with respect to cell-free nucleic acid sequencing" but "subject to certain nonexclusive relationships in the field."
In morning trade on the Nasdaq, Exact Sciences' shares were up more than 21 percent at $55.49.