Verastem, Inc. Q3 FY2025 earnings call

• Commercial launch: Third quarter net product revenue of $11.2 million exceeded expectations with strong adoption. Key objectives of physician engagement, patient initiation/retention, and streamlined reimbursement are trending positively.
• Clinical achievements: Completed enrollment of expansion cohort in RAMP-205 (first-line pancreatic cancer trial), planned enrollment completion of confirmatory Phase III trial RAMP-301 in recurrent LGSOC with a modest enrollment increase per IDMC recommendation, and shared initial safety data from VS-7375 program with no dose-limiting toxicities and minimal GI toxicities.
• Strategic priorities: Advancing AVMAPKI FAKZYNJA CO-PACK commercial launch and clinical path of VS-7375 program.

In the third quarter, Verastem Oncology achieved net product revenue of $11.2 million. This was driven by consistent adoption among academic centers and community oncologists. Approximately 65% of prescriptions were from top 100 organizations, more than half from academic settings, 60% from GYN oncologists and 40% from medical oncology. Specialty distributors are fully on board with a good mix of specialty pharmacies and distributors, and inventory stocking has been managed closely.

• Expect several important data readouts in H1 2026, including safety and efficacy results from RAMP-205 expansion cohort in first-line advanced pancreatic cancer and initial results from Phase I/IIa trial of VS-7375 in advanced G12D mutant solid tumors.
• Plan to advance VS-7375 trials in monotherapy and combination expansion cohorts in multiple cancers and engage with FDA in H1 2026 to discuss registration-enabling studies.

• Any statements made are forward-looking and actual results may differ materially due to factors discussed in the company's SEC filings, including risk factors in the most recent annual report on Form 10-K and current report on Form 10-Q.

Q: On the LGSOC launch, could you provide more comments on how the product is being used in the market in terms of patients having had prior lines of therapy and KRAS mutant versus wild-type use?

A: Early in the launch, seeing a mix of patients with prior lines of therapy and both KRAS mutant and wild-type, but exact numbers not fully visible through distribution channels.

Q: On the NCCN committee review in October, had you heard back on a recommendation for the labels to be expanded to include KRAS wild-type patients?

A: Don't know the outcome yet; committee met, but outcome not revealed, and time lines for hearing back are unclear.

Q: On the commercial launch, any color on new patient starts versus patients who are refilling prescriptions?

A: Not providing granular detail yet as it's too early; seeing significant new prescriptions and refills but waiting for more data.

Q: On the LGSOC market, details on patient retention and dropout rates?

A: Early to tell, but clinical trial DOR was around 18 months, and performance in the market is still early to provide specific commentary.

Q: On the VS-7375 study, any differences between treatment in U.S. and China?

A: Differences include patients in U.S. being fed and mandated to have prophylactic antiemetics, which wasn't in the China protocol, and early data shows no GI toxicities greater than grade 1.

Q: On the confirmatory trial, enrollment plan for KRAS mutant and wild-type patient populations?

A: Total enrollment planned for 270 with guardrails to keep 1/2 to 1/3 KRAS mutant, and IDMC recommended adding a couple more patients to both groups.

Q: On the commercial launch next steps, targeting more prescribers or higher prescriptions per doctor?

A: Both; continuing current efforts of reaching out to prescribers, ensuring existing prescribers continue, and working through the chain of early, mid, and late adopters.

Q: On patient journey, how long to refill and doctor visits?

A: Prescription is for a month supply, and doctor visits start closely monitored then decrease to every 3-6 months.

Q: On anecdotal updates from launch, usage and off-label use of wild-type versus mutant?

A: Vast majority of use seen is within KRAS mutant LGSOC population, but wild-type patients also have coverage through payers.

Q: On M&A in oncology space, any inbound interest?

A: Given launch trajectory, there is inbound interest, but specifics aren't discussed.