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ARVINAS, INC. (ARVN)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 revenue fell to $22.4M (vs. $76.5M YoY; $188.8M in Q1), driven by lapping 2024 Novartis tech-transfer revenue and reduced Pfizer collaboration revenue after removal of Phase 3 combo trials; GAAP diluted EPS was $(0.84) vs. $(0.49) YoY .
- Versus S&P Global consensus, ARVN posted an EPS beat (actual $(0.84) vs. $(0.89)) and a revenue miss (actual $22.4M vs. $34.4M), reflecting the expected step-down in collaboration revenue after 1H24 Novartis and plan changes with Pfizer (17 estimates each)*. Values retrieved from S&P Global.
- Cash, cash equivalents, and marketable securities were $861.2M; management reaffirmed runway into 2H 2028 as restructuring savings begin to flow through starting Q3 .
- Regulatory catalyst: FDA accepted the NDA for vepdegestrant with a PDUFA action date of June 5, 2026 (first potential PROTAC approval); ARVN and Pfizer are renegotiating their collaboration economics with scenarios ranging from Pfizer retaining more economics to rights potentially returning to ARVN, which would then seek a new partner .
What Went Well and What Went Wrong
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What Went Well
- FDA accepted the NDA for vepdegestrant; PDUFA June 5, 2026, underscoring a path to the first potential PROTAC approval .
- ARV-102 (LRRK2 degrader) showed blood-brain barrier penetration and >50% LRRK2 reduction in CSF at clinically achievable doses in healthy volunteers; patient dosing in PD is underway with initial patient data expected in 2H 2025 .
- Cost discipline: restructuring complete; CFO expects full cost-reduction benefits to start in Q3; cash runway reaffirmed into 2H 2028 .
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What Went Wrong
- Collaboration revenue step-down: YoY revenue declined by $54.1M, driven by completion of 2024 Novartis tech transfer (-$45.6M), lower Pfizer ARV‑471 development plan revenue (-$6.8M), and Bayer termination (-$1.6M) .
- Strategic contraction in vepdegestrant combinations: first-line and second-line pivotal combo trials removed from the Pfizer plan in early 2025, reducing near-term combo optionality and related collaboration revenue .
- Leadership transition creates overhang: CEO John Houston plans to retire after a successor is appointed; he will remain Chairperson, but transition adds uncertainty to execution optics .
Financial Results
Income statement snapshot (chronological: oldest → newest)
Values retrieved from S&P Global: items marked with *.
Year-over-year margin comparison
Balance sheet liquidity
Non-GAAP operating metrics
Revenue drivers (Q2 2025 vs. Q2 2024)
Estimate comparisons (S&P Global)
Values retrieved from S&P Global.
Context and drivers
- Sequential revenue declined as Q1 benefitted from revenue recognition mechanics tied to the reduction in the vepdegestrant program budget (higher percentage-of-completion revenue), which did not repeat in Q2 .
- R&D fell YoY as vepdegestrant and ARV‑766 spend declined, partially offset by increased ARV‑102 and ARV‑806 investment; G&A fell on lower personnel/infrastructure and professional fees, partially offset by commercial-prep costs .
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “The recent submission of a New Drug Application to the U.S. Food and Drug Administration for vepdegestrant represents a truly significant first for Arvinas… the first ever new drug application submitted for a PROTAC.” — John Houston, CEO .
- “Should the negotiations lead to [vepdegestrant] being returned… we are prepared to seek a party to commercialize and further develop [it].” — John Houston .
- “ARV‑102… demonstrated blood-brain barrier penetration… and reduction of pathway biomarkers… ARV‑102 was generally safe and well tolerated with no serious adverse events.” — Company update .
- “The announced restructuring is now complete and the full benefit in terms of cost reduction will be seen starting in the third quarter.” — Andrew Saik, CFO .
- “Our whole process with the FDA has gone very smoothly… we haven’t seen [timeline] pressures yet with our interactions on [vepdegestrant].” — John Houston .
Q&A Highlights
- Vepdegestrant collaboration economics: ARVN and Pfizer aligned on maximizing value; given removal of combo trials, 50/50 no longer makes sense; outcomes include Pfizer launching with greater economics or rights returning to ARVN, which would immediately seek a new partner; ARVN is not building out a salesforce and intends minimal market-prep spend near term .
- LRRK2 program expectations: PD patients have higher baseline LRRK2; ARV‑102 aims to replicate >50% CSF degradation and demonstrate biomarker movement in MAD; management views degraders as superior to inhibitors on brain penetration and comprehensive target function removal .
- BCL6 combos: Near-term goal is to establish monotherapy dose; high interest in combinations (e.g., bispecifics) given preclinical CD20 upregulation and potential synergy; clean heme toxicity profile emphasized .
- KRAS G12D: Early Ph1 dose escalation with strong investigator interest; preclinical data suggest higher potency vs inhibitors and prior degraders and ability to overcome KRAS resynthesis; combination plans include EGFR inhibitors and chemotherapy .
- FDA process/timelines: Interactions “excellent”; awaiting and then received NDA acceptance post-call, later disclosed with PDUFA date (June 5, 2026) .
Estimates Context
- Q2 2025 actual vs. S&P Global consensus: Revenue $22.4M vs. $34.4M* (miss); EPS $(0.84) vs. $(0.89)* (beat). 17 estimates each*. The shortfall reflects the non-recurring nature of 2024 Novartis revenue and reduced Pfizer plan scope; cost actions supported EPS vs. expectations. Values retrieved from S&P Global.
- Trailing quarters: Q1 2025 revenue $188.8M vs. $41.9M*; EPS $1.14 vs. $(0.97)* (significant beat tied to revenue recognition from Pfizer plan reduction). Q4 2024 revenue $59.2M vs. $62.8M*; EPS $(0.63) vs. $(0.96)*. Values retrieved from S&P Global .
- Estimate implications: With collaboration plan changes and lapping Novartis, Street models likely shift lower on near-term revenue while focusing on opex trajectory and binary regulatory/collaboration catalysts into 2026 (PDUFA). Values retrieved from S&P Global .
Key Takeaways for Investors
- Regulatory milestone secured: FDA accepted vepdegestrant NDA; PDUFA June 5, 2026—path to potential first PROTAC approval and a major platform validation event .
- Collaboration optionality as a stock driver: Near-term outcome of Pfizer renegotiation (retain more economics vs. rights return to ARVN and re‑partner) is a major valuation swing factor; ARVN not investing to self-commercialize .
- Operating leverage visible: Restructuring complete; savings to show up beginning Q3; runway into 2H 2028 supports pipeline without near-term financing .
- Neuro upside case: ARV‑102 human BBB penetration and target degradation de‑risk mechanism; 2H 2025 PD data are a meaningful catalyst vs. LRRK2 inhibitor competitors .
- Hem/Onc innovation breadth: ARV‑393 approaching initial clinical data with combo rationale (CD20 upregulation); ARV‑806 now clinical with preclinical differentiation vs. inhibitors/degraders .
- Revenue modeling: Expect near-term collaboration revenue to remain below 2024 levels absent new BD; YoY headwinds from Novartis tech transfer completion and Pfizer plan adjustments already evidenced in Q2 .
- Leadership transition monitored: CEO succession underway; Houston to remain Chairperson, reducing governance risk while a successor is recruited .
Additional Details and Data
- Non-GAAP adjustments: Q2 2025 non-GAAP R&D was $59.5M (excludes $0.6M restructuring and $8.5M SBC); non-GAAP G&A was $20.2M (excludes $0.4M restructuring and $4.7M SBC) .
- Cash flow context: 1H 2025 decrease in cash/securities of $178.2M primarily from cash used in operations ($177.0M) plus capex and minor debt repayment, partially offset by ESPP proceeds .
- Vepdegestrant efficacy context: VERITAC‑2 showed a 2.9‑month median PFS improvement vs. fulvestrant in ESR1m patients; ITT PFS did not reach statistical significance; safety and tolerability favorable with low GI AEs .
Values retrieved from S&P Global: All items marked with *.