Verastem, Inc. Q2 FY2025 earnings call

Key Milestones - Secured FDA approval for lead program ahead of schedule. - Successfully launched AVMAPKI FAKZYNJA CO-PACK with $2.1 million in net product revenue in first 6 weeks. - Advanced key clinical programs. - Strengthened balance sheet with $75 million private placement in April 2025. ### Launch Strategy - Focus on 3 key areas: reaching all HCPs, engaging and supporting patients, ensuring seamless access. - Engaged field and marketing teams to target academic and community-based physicians. - Built on patient advocacy relationships and used digital marketing efforts. - Activated distribution network with specialty pharmacies and engaged with payers for coverage. ### Clinical and Regulatory - FDA approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent LGSOC. - AVMAPKI FAKZYNJA CO-PACK listed in NCCN treatment guidelines as Category 2A recommendation. - Submitted RAMP 201 and FRAME publications to NCCN to expand recommendation for broader LGSOC population.

The key product segment is AVMAPKI FAKZYNJA CO-PACK. In the first 6 weeks of its launch, it generated $2.1 million in net product revenue. Cost of sales for the second quarter of 2025 was $0.4 million, compared to $0 in the second quarter of 2024. Research and development expense was $24.8 million in Q2 2025 vs $18.1 million in Q2 2024. SG&A expenses were $2.7 million in Q2 2025 vs $10.2 million in Q2 2024. Non-GAAP adjusted net loss was $41.4 million or $0.63 per share diluted in Q2 2025 compared to $16.5 million or $0.61 per share diluted in Q2 2024.

Forward-Looking - Continue reporting on AVMAPKI FAKZYNJA CO-PACK launch. - Advance VS-7375 trial, including enrollment in 101 trial and move towards initiating dose escalation combination cohort in Q4. - Enroll additional patients in RAMP205 frontline metastatic pancreatic cancer trial and complete enrollment in Q3. - Share interim safety and efficacy update for RAMP 203 KRAS G12C advanced NSCLC trial in Q4. - Complete planned enrollment in Phase III RAMP-301 trial evaluating combination in recurrent LGSOC regardless of KRAS mutation status.

Risk Factors - Actual results may differ materially from forward-looking statements due to factors discussed in SEC reports like Form 10-K filed March 2, 2025, Form 10-Q filed today, and other SEC reports. - Uncertainties around reimbursement trends, regulatory approvals in other regions (Japan, EU), and clinical trial outcomes.

Q: On the LGSOC launch, can you talk about the degree of off-label use and feedback from providers on continued use in wild type setting, and prescribing and reimbursement trends leading up to NCCN guideline update?

A: While not promoting off-label uses, have seen utilization in label and wild type populations. Reimbursement for these populations has not been an issue to date, and will follow patterns leading up to NCCN.

Q: On the KRAS program, scope of Q4 update and GenFleet's additional updates?

A: Expect magnitude of Q4 update to be roughly equivalent to Chinese data at ASCO. GenFleet will present additional data at 2 medical meetings later this year.

Q: Key indicators to gauge launch performance and key drivers for back half of year?

A: Early in launch, tracking breadth of data from specialty pharmacies, distributors, and GPOs. Key drivers include engagement with HCP community, seamless patient access, and working closely with patient population.

Q: Experience with payers, pushback, and honeymoon phase?

A: Honeymoon phase at beginning, but data package supports reimbursement. Reimbursement seen for mutant, wild-type, and off-label uses with minimal free drug giveaways.

Q: Launch curve evolution, breakdown of AVFAK patient history, and role of IQVIA?

A: Encouraged by strength of start, expect steady progression. Patient history includes mix of multiple prior lines and first recurrence. IQVIA partnership helped with digital and data infrastructure for launch.

Q: Use of specialty pharmacy, inventory channel stocking, and payer mix?

A: Minimal stocking with 2 specialty pharmacies initially. Gross to net dynamics and payer mix (commercial vs Medicare) monitored, but early insights still developing.

Q: Differences between patients in launch vs clinical study, and timeline for 7375 study indications?

A: Aligns with clinical study, with mix of patients from 1 to 10 prior lines and first relapse. Intend to move quickly with 7375 trial, leveraging Chinese data in IND to shorten time frame.

Q: Sales force size for launch, and regulatory pathway for AVMAPKI in Japan and EU?

A: Launched with 16-person sales team, no plans to increase. Ramping up accrual for bridging study in Japan for conditional approval; engaged in EU with orphan drug designation, but reimbursement in EU likely requires randomized study.