NEW YORK – Veracyte said Wednesday that its first quarter 2025 revenues were up 18 percent compared to the same quarter of 2024.
The firm's total revenues for the period ended March 31 were $114.5 million compared to $96.8 million in Q1 2024, beating analysts' average estimate of $110.9 million.
Testing revenue was $107.3 million, up 19 percent from $90.3 million in the year-ago quarter, driven by the firm's Decipher Prostate and Afirma tests.
During a conference call with investors, Veracyte CEO Marc Stapley said that its Q1 Decipher test volume was up 37 percent year over year with approximately 22,600 tests during the quarter. The firm also engaged with a record number of ordering providers, up over 20 percent from the prior year.
Stapley highlighted that Veracyte was recently able to share at least 18 new research abstracts for its Decipher Prostate and Bladder tests at the annual meeting of the American Urology Association, adding that the company is also progressing in its plan to expand the availability of Decipher Prostate to metastatic patients.
"As of late April, Decipher Prostate is available for use in the metastatic population on a limited basis and will be available broadly in June, meeting our expected launch timeline," he said.
Volume growth for the firm's Afirma thyroid test grew 10 percent year over year to approximately 15,500 tests, Stapley added, though revenue growth was lower than volume growth, due to a mistaken coverage policy change by the firm's lab benefit managers.
Veracyte is currently in the process of updating the test to a more cost-effective transcriptome sequencing technology, which will help it offset reagent list price increase expected in future years, as well as mitigate unpredictable tariff impacts.
Outside of clinical testing, the company's product revenue was $3.6 million, up 1 percent from $3.5 million in Q1 2024, while biopharmaceutical and other revenue was $3.6 million, up 19 percent from $3.0 million in the year-ago quarter.
Veracyte recently made the decision to no longer fund operations of its French subsidiary, Veracyte SAS, whose business includes support for the company's IVD development and manufacturing.
The firm updated investors on Wednesday that SAS has since filed a collective proceedings petition with the Marseille Commercial Court, which it expects will be completed by the end of 2025, at which time Veracyte would no longer own or operate the Marseille facility.
Stapley has stated previously that Veracyte does not intend to cease developing and offering IVDs, especially its Prosigna breast cancer assay. On Wednesday, he announced that Veracyte now also intends to begin offering Prosigna in the US as a laboratory-developed test.
The plan is to port the test to the same updated transcriptome platform as Afirma, with commercial availability beginning in mid-2026.
Prosigna, a gene expression assay that is based on the PAM 50 signature and is intended to guide treatment decision-making in early-stage breast cancer, would compete in the US LDT market primarily with Exact Sciences' Oncotype DX.
Meanwhile, Stapley said that while the process of divesting the Marseille facility will impact IVD product development timelines, the firm has made significant progress on new products, including a Decipher PCR IVD product, and has plans in place to move its work to US contractors.
"We are now in the process of reinitiating the Decipher development program working with a US-based contract manufacturer and expect to complete our joint development and manufacturing work by the end of next year," he said. "Similarly, we now expect to complete our Prosigna NGS IVD product development work by the end of 2026, as well, working with a different third-party contract manufacturer."
"We don’t believe this change in development and certification timelines meaningfully impacts our revenue models for the next five years. And in fact, we expect that any delay of IVD product revenue will be more than offset by the launch … of our Prosigna LDT," Stapley added.
Veracyte reported Q1 net income of $7.0 million, or $.09 per share, compared to a net loss of $1.9 million, or $.02 per share, for the same period last year. On an adjusted basis, the company calculated Q1 EPS of $.31, besting the Wall Street estimate of $.20.
The firm's Q1 R&D costs were $17.7 million, up 11 percent from $16.0 million a year ago, while its SG&A spending rose 17 percent to $58.3 million from $50.0 million in the same period last year.
The firm ended the quarter with $186.1 million in cash and cash equivalents and $101.2 million in short-term investments.