Verastem, Inc. Q4 FY2025 earnings call

2025 was a transformative year as Veristem became a commercial stage company with FDA approval of the first treatment for KRAS mutated recurrent low-grade serous ovarian cancer. The commercial launch showed steady growth. The NCCN ovarian cancer guidelines didn't expand the recommendation for avutametinib plus defactinib to include KRAS wild-type patients, but Veristem is committed to advancing clinical evidence. The R&D team made progress in clinical trials, including RAMP205 in pancreatic cancer and VS7375 in KRAS G12D-driven cancers. Mike Crowther discussed commercial performance, launch progress, and 2026 plans like a new promotional campaign and expanded educational plans. Michael Kaufman updated on clinical trials for avutametinib plus defactinib and VS7375, including enrollment and data updates.

For the launch period from May to December 2025, Veristem achieved net product revenue of 30.9 million and $17.5 million in the fourth quarter. Cost of sales were $2.6 million in the fourth quarter of 2025 and $4.6 million for the full year 2025. R&D expenses were $31.7 million in the fourth quarter of 2025 and $114.6 million for the full year. SG&A expenses were $24.4 million in the fourth quarter and $81.1 million for the full year. Non-GAAP adjusted net loss was $39.8 million or 48 cents per share diluted in the fourth quarter of 2025 and $163.1 million or $2.35 per share diluted for the full year 2025. The LGSOC franchise is expected to be self-sustaining in the second half of 2026 with COPAC revenues funding commercial operations and ongoing clinical trials for avutametinib plus defactinib.

Veristem believes the LGSOC franchise will be self-sustaining in the second half of 2026. In 2026, key strategies are maximizing COPAC commercial launch, generating data with VS-7375 for registration, continuing RAMP 301 trial, and maintaining capital management. Goals include maximizing COPAQ adoption, sharing update on Ramp 205 expansion cohort in Q2, and sharing update on VS7375 101 trial in the first half of 2026 with Phase II registration-directed protocols for pancreatic, lung, and colorectal cancers.

Actual results may differ from forward-looking statements due to SEC filing risks. There could be payer pushback on totally off-label uses. Differences in safety profiles between US and China studies for VS7375 and uncertainties in dose selection and combination strategy for VS7375 are risks.

Q: On NCCN non-update, visibility into thought process and confidence in wild-type reimbursement.

A: Disappointed, no direct feedback, team doing well on reimbursement regardless of mutation.

Q: On 7375 safety, dose modifications, selection, and combination strategy.

A: Low dose modifications, two-dimensional dose escalation, combination strategy for regulatory and future studies.

Q: On NCCN plan and FDA feedback on 7375.

A: Intend to continue developing evidence, FDA feedback led to separating study into disease-specific protocols.

Q: On COPAC prescribing dynamics and financing.

A: Prescribers growing, 75% of top institutions adopted, financing based on G12D program data.

Q: On 7375 safety insights, kinetics, and formulation.

A: Safety data encouraging, different from China possibly due to bone marrow support, looking into formulation improvements.

Q: On protocol update impact and dose titration.

A: Administrative change, no significant timeline hit, no need to reduce dose yet.

Q: On RAMP201J trial next steps and US launch payer coverage.

A: Converting institutions to confirmatory study, working on PMDA filing, good payer coverage for wild-type patients but some pushback on totally off-label uses