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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

  • 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 .
  • 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)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($M)76.5 188.8 22.4
Diluted EPS ($)(0.49) 1.14*(0.84)
R&D Expense ($M, GAAP)93.7 90.8 68.6
G&A Expense ($M, GAAP)31.3 26.6 25.3
Total Operating Expenses ($M)125.0 93.9

Values retrieved from S&P Global: items marked with *.

Year-over-year margin comparison

MetricQ2 2024Q2 2025
Net (Loss) Income ($M)(35.2) (61.2)
Net Income Margin %(46.0%) (273.2%)

Balance sheet liquidity

MetricDec 31, 2024Jun 30, 2025
Cash & Cash Equivalents ($M)100.5 114.9
Marketable Securities ($M)938.9 746.3
Cash, Cash Equivalents & Marketable Securities ($M)~1,040 861.2

Non-GAAP operating metrics

MetricQ2 2024Q2 2025
R&D (Non-GAAP) ($M)83.0 59.5
G&A (Non-GAAP) ($M)20.4 20.2

Revenue drivers (Q2 2025 vs. Q2 2024)

DriverYoY Δ ($M)
Novartis license/asset agreements completed by 12/31/24(45.6)
Pfizer ARV‑471 collaboration (plan changes removing trials)(6.8)
Bayer collaboration termination (Aug 2024)(1.6)

Estimate comparisons (S&P Global)

MetricQ4 2024Q1 2025Q2 2025
Revenue Actual ($M)59.2*188.8*22.4*
Revenue Consensus ($M)62.8*41.9*34.4*
EPS Actual ($)(0.63)*1.14*(0.84)*
EPS Consensus ($)(0.96)*(0.97)*(0.89)*
# Estimates (Rev / EPS)18 / 18*17 / 15*17 / 17*

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

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti‑yearInto 2H 2028 (post‑restructuring) Into 2H 2028 reaffirmed Maintained
Cost reductions timing2025 phasingSavings fully realized by Q4’25 Full benefit begins in Q3’25; restructuring complete Pulled forward realization
Vepdegestrant NDAU.S.NDA submission planned/underway in 2025 FDA accepted; PDUFA June 5, 2026 Upgraded to accepted with PDUFA date
Vepdegestrant development planGlobalRemoval of 1L & 2L combo Phase 3s aligned with Pfizer (Q1) Continuing to rework collaboration economics with Pfizer; exploring partner if rights return Strategic collaboration renegotiation underway
ARV‑102 (LRRK2)2H 2025–202650% CSF degradation target; SAD HV data at AD/PD; start PD SAD/MAD Final HV SAD/MAD data 2H’25; initial PD SAD data 2H’25; MAD PD initiation 2H’25; PSP Ph1b in 1H’26 Timeline reaffirmed/clarified
ARV‑393 (BCL6)2H 2025Initial Ph1 data by YE’25 Preliminary clinical data 2H’25; preclinical combo with glofitamab 2H’25 Maintained with added combo milestone
ARV‑806 (KRAS G12D)2025IND safe‑to‑proceed; start Ph1 in 2H’25 Ph1 enrollment initiated; preclinical data from clinical‑stage program in 2H’25 Advanced to clinical; new 2H’25 update

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24, Q1’25)Current Period (Q2’25)Trend
Vepdegestrant regulatory pathPreparing for VERITAC‑2 readout; pre‑NDA meeting completed; planning 1L/2L combo Ph3 (later removed) NDA submitted (Jun 6) and FDA accepted with PDUFA 6/5/26; collaboration economics under renegotiation Positive regulatory momentum; strategic shift on collaboration
Collaboration with PfizerInitially broad 50/50 co‑dev/commercial; planned combos Removal of combo trials makes 50/50 less attractive; scenarios include Pfizer retaining more economics or returning rights Rebalancing economics; partner optionality
Cost structure/runwayCash into 2027 (Q4); extended into 2H’28 post‑restructuring (Q1) Restructuring complete; full benefits begin Q3; runway reiterated into 2H’28 Discipline sustained
ARV‑102 (LRRK2)First‑in‑human data planned; >50% CSF degradation target HV data show BBB penetration and target degradation; PD SAD complete; multiple-dose PD starting; 2H’25 readouts planned Execution on neuro strategy
ARV‑393 (BCL6)Preclinical combo data promising; Ph1 enrolling; 2025 data planned Enrollment progressing; 2H’25 preliminary data; mechanistic rationale for bispecific combinations; aims for clean heme tox profile Progressing to clinical signal
ARV‑806 (KRAS G12D)IND safe‑to‑proceed; strong preclinical potency vs inhibitors/degraders Ph1 initiated; preclinical differentiation reiterated (potency, resynthesis resistance); plan combos (EGFR, chemo) From preclinical → clinical; competitive positioning
LeadershipCEO retirement planned; will remain Chair; formal search underway Managed transition

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 *.