ARVINAS, INC. Q1 FY2025 earnings call

John Houston discussed progress with Vepdegestrant, including positive pivotal data and plans for filing/registration. Aligned with Pfizer to remove two phase 3 combination trials from joint development plan. Company-wide cost reduction effort with workforce reduction, portfolio reprioritization, aiming for $80M annual cost reduction and $500M over 3 years, extending cash runway to second half of 2028. Noah Berkowitz reviewed clinical progress for Vepdegestrant, first-in-human data for ARV-102, preclinical combo data for ARV-393, and IND filing/FDA safe to proceed for ARV-806. Andrew Saik provided financial highlights, noting $954M cash on hand, revenue increase, and updated cash runway guidance.

Updated cash runway extended to second half of 2028. Restructuring and cost reduction efforts expected to yield $80M annual cost savings and $500M over 3 years. Anticipated data milestones include ASCO presentation for VERITAC-2, first phase 1 data for ARV-102 in PD patients, and first-in-human data for ARV-393.

Forward-looking statements involve risks, uncertainties, and assumptions outlined in press release and SEC filings. Potential impact of clinical trial results not meeting expectations, regulatory hurdles, and market competition.

Q: Michael Schmidt asked about decision to not advance CDK4/6 inhibitor combinations and VEPDEG positioning/commercial infrastructure.

A: John Houston discussed decision based on emerging data on ESR-1 mutant-only drugs, confidence in VEPDEG's positioning as best-in-class degrader, and 50-50 COCO with Pfizer for commercialization.

Q: Andrew Berens asked about future neuro efforts in LRRK2.

A: Noah Berkowitz discussed targeting >50% LRRK2 degradation, plans to use ARV-102 on top of standard of care in PD/PSP.

Q: Unidentified Analyst asked about VEPDEG market size and cost reduction cadence.

A: Noah Berkowitz discussed ~25,000 new patients annually in second line ESR1 mutant setting, Andrew Saik explained restructuring savings to be seen from Q2 with full impact in Q4.

Q: Unidentified Analyst asked about LRRK2 target risk and ARV-102 SAD cohort results.

A: Noah Berkowitz discussed de-risking through monitoring biomarkers and ongoing studies, expectation of >50% LRRK2 reduction in PD patients.

Q: Unidentified Analyst asked about VEPDEG first-line potential and BCL6 program data.

A: John Houston discussed decision to remove first-line study due to data maturation and Pfizer's view, Noah Berkowitz stated BCL6 program expected to share results later in year with ongoing dose escalation.

Q: Tazeen Ahmad asked about VEPDEG market opportunity and Pfizer milestones.

A: John Houston discussed ~6,000 oncologists driving prescriptions, Noah Berkowitz mentioned entitlement to milestone on first VEPDEG approval.

Q: Peter Lawson asked about VEPDEG sales force size and KAT6 combo.

A: John Houston discussed targeted sales force, Noah Berkowitz explained KAT6 combo as Pfizer-owned Phase 1 study exploring combinations.

Q: Paul Choi asked about VEPDEG pre-NDA meeting and LRRK2 data timeline.

A: Noah Berkowitz stated pre-NDA meeting completed, expectation to share SAD PD data later in year.

Q: Unidentified Analyst asked about Pfizer commitment to VEPDEG partnership and KAT6 combo role.

A: John Houston confirmed ongoing partnership with Pfizer, Noah Berkowitz explained KAT6 combo as exploratory Phase 1 study.

Q: Srikripa Devarakonda asked about ARV-393 enrollment and FDA communications.

A: Noah Berkowitz discussed ARV-393 enrollment steadying, John Houston mentioned no delay in FDA interactions.

Q: Yigal Nochomovitz asked about KAT6 combo preclinical work and supply chain.

A: John Houston discussed KAT6 combo rationale, Noah Berkowitz mentioned VEPDEG supply in Ireland, IT in US.

Q: Unidentified Analyst asked about LRRK2 competitive positioning and KAT6 study.

A: Noah Berkowitz discussed ARV-102's brain penetrance and potency vs competitors, Noah Berkowitz explained KAT6 study as exploratory Phase 1 with no timelines.

Q: Li Watsek asked about BD strategy and KAT6 study details.

A: John Houston mentioned openness to BD opportunities, Noah Berkowitz explained KAT6 study as exploratory for all comers.

Q: Jeet Mukherjee asked about NCCN guideline inclusion and ARC-806 comparison.

A: Noah Berkowitz discussed NCCN guideline potential, Noah Berkowitz compared ARC-806's potency vs competitors.

Q: Sudan Loganathan asked about ESR-1 mutant patient positioning and second-line patients.

A: John Houston explained ESR-1 mutant patient breakdown in first/second line settings and opportunities.