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ARVINAS, INC. (ARVN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $59.2M versus $(43.1)M in Q4 2023, reflecting positive collaboration revenue and lapping a negative revenue adjustment in the prior year; net loss improved to $(45.1)M and EPS to $(0.63) from $(154.8)M and $(2.53) in Q4 2023 .
  • Management reiterated a major near-term catalyst: top-line data from VERITAC-2, the first-ever Phase 3 PROTAC trial, expected in Q1 2025, with potential to support the first NDA and a transition to commercial stage if successful .
  • Arvinas plans Phase 3 combinations in 2025: first-line vepdegestrant + Pfizer’s CDK4 inhibitor atirmociclib, and second-line vepdegestrant + a CDK4/6 inhibitor; VERITAC-3 (first-line vepdegestrant + palbociclib) will not proceed beyond study lead-in, reflecting strategy updates .
  • Cash, cash equivalents and marketable securities were $1,039.4M at December 31, 2024, with runway into 2027, supporting clinical and commercial preparation ahead of VERITAC-2 readout and Phase 3 combo starts .

What Went Well and What Went Wrong

What Went Well

  • Vepdegestrant program momentum: VERITAC-2 top-line timing confirmed for Q1 2025; management highlighted the possibility of first NDA and commercial transition, underscoring strategic execution .
  • Combination data signals: Preliminary Phase 1b vepdegestrant + abemaciclib showed clinical benefit rate >60% and ORR ~27% in CDK4/6-experienced patients, supporting combinability and late-line activity .
  • Neuroscience progress: ARV-102 Phase 1 SAD data to be presented at AD/PD in April, demonstrating oral bioavailability, brain penetration, and dose-dependent CSF exposure; Parkinson’s patient dosing has begun .

Management quotes:

  • “We expect to have data in hand from VERITAC-2… If positive, these results will support our first new drug application and mark our potential transition to a commercial stage company.”
  • “These data confirm that ARV-102 is orally bioavailable and brain penetrant with dose-dependent exposure in the CSF.”
  • “We are in a strong financial position with cash on hand sufficient to support operations into 2027.”

What Went Wrong

  • Operating expense intensity: Total operating expenses were $117.4M in Q4 (R&D $83.3M; G&A $34.1M), reflecting commercial build and portfolio investment; G&A rose YoY driven by commercial operations and fees .
  • Revenue comparability: Q4 2023’s negative revenue from contract estimate changes complicates YoY comparison; the Q4 2024 increase partly reflects lapping those adjustments .
  • VERITAC-3 curtailed: First-line vepdegestrant + palbociclib program will not proceed beyond study lead-in, indicating a pivot to atirmociclib for first line, which may require additional regulatory alignment and data maturity .

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$(43.1) $76.5 $102.4 $59.2
Net Loss ($USD Millions)$(154.8) $(35.2) $(49.2) $(45.1)
EPS (Basic/Diluted, $USD)$(2.53) $(0.49) $(0.68) $(0.63)
Total Operating Expenses ($USD Millions)$122.2 $125.0 $162.7 $117.4
Loss from Operations ($USD Millions)$(165.2) $(48.5) $(60.3) $(58.2)
Cash & Cash Equivalents ($USD Millions)$311.7 $154.8 $85.2 $100.5
Marketable Securities ($USD Millions)$949.3 $1,073.9 $1,036.4 $938.9

Notes:

  • The YoY revenue swing reflects Q4 2023 negative revenue from changes in contract estimates; Q4 2024 also benefited from Novartis agreement revenue recognition and higher Pfizer collaboration revenue .
  • No segment breakdown is provided; revenue primarily reflects collaboration/licensing agreements (Pfizer, Novartis, Bayer, etc.) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
VERITAC-2 Top-line ReadoutQ4 2024/Q1 20254Q24 or 1Q25 1Q25 confirmed Maintained (timing refined)
First-line Phase 3 Combo2025 startFirst-line combo with atirmociclib or palbociclib under consideration Initiate first-line Phase 3 vepdegestrant + atirmociclib in 2025 (pending feedback) Raised specificity (atirmociclib chosen)
Second-line Phase 3 Combo2025 startPalbociclib and/or another CDK4/6 under consideration Initiate second-line Phase 3 vepdegestrant + CDK4/6 inhibitor in 2025 (pending feedback) Maintained (CDK4/6 confirmed)
VERITAC-3 (1L vepdegestrant + palbociclib)2024–2025Study lead-in completed; evaluating dose selection Will not proceed beyond study lead-in Lowered (program curtailed)
Financial RunwayInto 2027Into 2027 Into 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
VERITAC-2 timing and NDA pathEnrollment completion and top-line timing guided to 4Q24/1Q25; NDA envisioned if successful Top-line disclosure later this quarter; first-ever Phase 3 PROTAC; no added Q&A detail due to proximity Steady, approaching catalyst
First-line combo strategyConsidering palbociclib vs CDK4; regulatory contribution-of-components discussed First-line Phase 3 with atirmociclib planned in 2025; no need for 6 months data before regulator discussions Clarified partner (atirmociclib)
Second-line combo strategyPalbociclib and/or other CDK4/6 under consideration Plan for Phase 3 vepdegestrant + CDK4/6 in 2025; supportive abemaciclib signals (CBR >60%, ORR ~30%) Advancing toward Phase 3
ARV-102 (LRRK2)MAD in HV initiated; CSF biomarker effects in NHP; program timelines to 2025 SAD HV data at AD/PD; PD patient SAD ongoing; aim ~50% brain LRRK2 reduction; MAD PD later in 2025 Execution progressing
ARV-393 (BCL6)Phase 1 NHL initiated; preclinical potency and tumor regression data Phase 1 enrollment advancing; AACR preclinical combination data planned Building data set
KRAS G12DIND planned 2025; pan-KRAS also in discovery IND filing planned 2025; degrader potency vs Astellas noted; differentiation claims Advancing toward clinic
Commercial readinessPreparing for commercial launch with Pfizer; strong leadership build U.S. lead with Pfizer; runway in place; interim CCO appointed after departure Infrastructure maturing

Management Commentary

  • “Together with Pfizer… soon, we expect to have data in hand from VERITAC-2… If positive, these results will support our first new drug application and mark our potential transition to a commercial stage company.” — John Houston .
  • “We plan to initiate a Phase III trial with vepdeg plus Pfizer’s novel investigational CDK4 inhibitor, atirmociclib… and a second line Phase III combination trial evaluating vepdeg with a CDK4/6 inhibitor.” — John Houston .
  • “During the quarter, we recorded $59.2 million in revenue… We are well capitalized… with the potential for an exciting milestone-rich year, beginning with our first Phase III top line results expected later this quarter.” — Andrew Saik .
  • “These data confirm that ARV-102 is orally bioavailable and brain penetrant with dose-dependent exposure in the CSF.” — Noah Berkowitz .

Q&A Highlights

  • First-line design gating: Decisions are mostly safety-driven; health authority discussions do not require six months of combo follow-up; the shift away from palbociclib use supports atirmociclib selection .
  • Abemaciclib combo efficacy/safety: Late-line CBR >60% and ORR ~30% presented; no significant drug–drug interactions; supports second-line Phase 3 combo planning .
  • Commercial launch prep: Arvinas will be U.S. lead with Pfizer; despite a CCO departure for personal reasons, an experienced interim CCO is in place; “we haven’t missed a beat” .
  • LRRK2 program targets: Aim to reduce brain LRRK2 ~50%; biomarkers for neuroinflammation and lysosome function informed by MJFF initiatives; PD patient SAD dosing underway .
  • Competitive landscape: Management expects oral SERD+CDK4/6 Phase 3 data from peers may raise excitement but sees PROTAC mechanism as potentially stronger; differentiation emphasized for KRAS G12D program vs prior degrader safety issues .

Estimates Context

  • We attempted to retrieve S&P Global (Capital IQ) consensus EPS and revenue estimates for Q4 2024 and prior quarters, but data were unavailable due to a service limit; therefore, we cannot assess beats/misses versus Wall Street consensus for this quarter. Values would have been retrieved from S&P Global if available.
  • Given this limitation, investors should focus near-term on the VERITAC-2 top-line catalyst and management’s updated 2025 Phase 3 combination plans to gauge directional estimate revisions post-readout .

Key Takeaways for Investors

  • Near-term binary catalyst: VERITAC-2 top-line in Q1 2025 could unlock the first NDA for a PROTAC and transition Arvinas to commercial stage; management declined to add readout specifics due to proximity, signaling disciplined communications ahead of data .
  • Strategic pivot in first line: Prioritization of atirmociclib as CDK4 partner reflects evolving CDK4/6 landscape and internal combo data; VERITAC-3 (palbociclib) will not proceed, reducing program complexity and sharpening differentiation .
  • Combination viability: Consistent late-line signals (abemaciclib) and DDI neutrality improve the case for vepdegestrant as an ER backbone in combos across lines of therapy .
  • Balance sheet strength: ~$1.04B cash and securities with runway into 2027 supports VERITAC-2 outcome scenarios and 2025 Phase 3 combo initiations without near-term financing pressure .
  • Neuroscience optionality: ARV-102’s brain-penetrant PK/PD and CSF biomarker data in HVs, plus patient SAD initiation, broaden Arvinas’ platform impact beyond oncology, with additional data slated for 2025 .
  • Program breadth: ARV-393 (BCL6) and KRAS G12D IND plans add mid-term pipeline catalysts, supporting a multi-product thesis if breast cancer milestones hit .
  • Trading lens: Expect narrative-driven moves tied to VERITAC-2 top-line and Phase 3 combo design disclosures; peer SERD+CDK4/6 data may act as sentiment comparables, but management argues PROTACs can be stronger mechanistically .

Appendices and Sources

  • Q4 2024 earnings call transcript (Feb 11, 2025) –; alternate transcript –.
  • Q4 2024 press release (Feb 11, 2025), including financial statements –.
  • 8-K Item 2.02 (Feb 11, 2025), press release furnished as Exhibit 99.1 –.
  • Q3 2024 press release and call (Oct 30, 2024), financials and program updates – –.
  • Q2 2024 press release (Jul 30, 2024), program and financial updates –.