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Verve Therapeutics, Inc. (VERV)·Q1 2025 Earnings Summary

Executive Summary

  • Verve reported Q1 2025 collaboration revenue of $33.0M, reduced net loss of $31.0M ($0.35 per share), and cash/marketable securities of $497.1M; cash runway guided into mid-2027 .
  • Positive initial Heart-2 data for VERVE-102 showed dose-dependent LDL-C reductions (mean 53%, max 69% at 0.6 mg/kg) with favorable safety; FDA IND clearance and Fast Track designation strengthen regulatory momentum toward a Phase 2 initiation in H2 2025 .
  • Lilly collaboration progressed (milestone payment for LPA program VERVE-301) while Vertex ended a prior collaboration; opt-in decision on the PCSK9 program expected in H2 2025 .
  • Street consensus from S&P Global for Q1 2025 EPS and revenue was unavailable; results primarily reflect collaboration revenue recognition tied to Vertex termination and ongoing services with Lilly .
  • Stock narrative catalysts: clinical efficacy signals and clean safety for VERVE-102, FDA IND clearance and Fast Track, and clarity on the Lilly opt-in/Phase 2 timing .

What Went Well and What Went Wrong

What Went Well

  • Heart-2 initial data demonstrated compelling LDL-C lowering after a single infusion of VERVE-102 (mean 53%, max 69% at 0.6 mg/kg) with dose-dependent PD and favorable safety (no treatment-related SAEs, no clinically significant lab abnormalities) .
  • Regulatory momentum: FDA IND clearance for VERVE-102 and receipt of Fast Track designation for hyperlipidemia/high lifetime CV risk populations .
  • Strengthened balance sheet visibility: $497.1M cash/marketable securities and reiterated cash runway into mid-2027; Lilly milestone for VERVE-301 underscores external validation .

What Went Wrong

  • Revenue mix remains non-commercial and dependent on collaboration recognition; Q1 revenue uplift included remaining deferred revenue recognized upon Vertex termination, highlighting non-recurring elements .
  • Operating profile continues to be loss-making with high R&D intensity; Q1 total operating expenses rose to $69.6M (+11% y/y), generating an operating loss of $(36.6)M despite higher collaboration revenue .
  • Program risk remains: Heart-2 still in dose escalation (0.7 mg/kg enrolling) and key external decision (Lilly opt-in) and Phase 2 start are in H2 2025, preserving execution/regulatory timing risk .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Collaboration Revenue ($USD Millions)$6.865 $13.080 $32.976
Total Operating Expenses ($USD Millions)$63.775 $69.147 $69.612
Loss from Operations ($USD Millions)$(56.910) $(56.067) $(36.636)
Net Loss ($USD Millions)$(50.133) $(50.035) $(31.033)
EPS (Basic & Diluted, $USD)$(0.59) $(0.58) $(0.35)
Cash & Marketable Securities ($USD Millions)$539.920 $524.281 $497.077
Net Loss Margin (%)(730.5%) (382.3%) (94.1%)
Operating Margin (%)(829.6%) (428.5%) (111.1%)

Notes:

  • Net loss margin (%) = Net Loss / Collaboration Revenue (computed from cited values) .
  • Operating margin (%) = Loss from Operations / Collaboration Revenue (computed from cited values) .

Consensus vs Actual (Q1 2025):

MetricActualConsensus (S&P Global)Surprise
Collaboration Revenue ($USD Millions)$32.976 N/A – S&P Global consensus unavailableN/A
EPS ($USD)$(0.35) N/A – S&P Global consensus unavailableN/A

Segment breakdown: Not applicable (no commercial product revenue reported; collaboration revenue only) .

KPIs (Clinical/Operational):

KPIQ3 2024Q4 2024Q1 2025
VERVE-102 participants dosed (Heart-2)7 (0.3/0.45 mg/kg) Dosing ongoing through 0.6 mg/kg 14 across 0.3/0.45/0.6 mg/kg
LDL-C mean reduction (0.6 mg/kg)N/AN/A53% mean; max 69%
PCSK9 protein mean reduction (0.6 mg/kg)N/AN/A60% mean
PD by total RNA dose 50–60 mgN/AN/ALDL-C 59% mean; PCSK9 65% mean
Safety (Heart-2)No SAEs; no clinically significant lab abnormalities observed Well-tolerated; no treatment-related SAEs; no clinically significant lab abnormalities Favorable safety; no treatment-related SAEs; no clinically significant lab abnormalities; one Grade 2 infusion reaction
Regulatory status (VERVE-102)CTAs cleared in Israel/NZ; enrollment ongoing in AU/CA/UK Continuing; initial Heart-2 data expected Q2 2025 FDA IND cleared (Mar); Fast Track designation (Apr); 0.7 mg/kg cohort enrolling

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024)Current Guidance (Q1 2025)Change
Heart-2 initial data (VERVE-102)Q2 2025Initial data expected Q2 2025 Initial data reported; positive efficacy/safety disclosed Achieved (executed)
Heart-2 final dose-escalation dataH2 2025Final data in H2 2025 Final data in H2 2025 Maintained
Phase 2 initiation (VERVE-102)H2 2025Initiate Phase 2 in H2 2025 First patient dosing planned H2 2025 Maintained
Lilly opt-in decision (PCSK9 program)H2 2025Lilly opt-in decision expected H2 2025 Deliver opt-in package and receive decision H2 2025 Maintained
IND clearance (VERVE-102)Q1/Q2 2025Not previously guidedFDA IND cleared March 2025 New (achieved)
Fast Track designation (VERVE-102)Q2 2025Not previously guidedFast Track designation received April 2025 New (achieved)
Cash runwayThrough/mid-2027Into mid-2027 Into mid-2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 & Q4 2024)Current Period (Q1 2025)Trend
R&D execution (VERVE-102)Heart-2 enrollment ongoing; 7 dosed; well-tolerated; moving to 0.6 mg/kg Initial data: dose-dependent LDL-C/PCSK9 reductions; favorable safety; advancing to 0.7 mg/kg Improving efficacy signals; continued dose escalation
Regulatory milestonesCTAs cleared (AU/CA/UK/Israel/NZ) FDA IND cleared; Fast Track designation Accelerating regulatory momentum
PartnershipsLilly collaboration; Vertex terminates liver program; Verve regains rights Lilly milestone for VERVE-301; Lilly opt-in decision H2 2025 Strengthening in Lp(a); clarity pending on PCSK9 opt-in
Product performance (Heart-1 durability)Heart-1 durability data: sustained LDL-C lowering up to 18 months; lab abnormality driver linked to prior LNP Heart-2 efficacy confirms dose-dependent reduction with new GalNAc-LNP Positive mechanistic continuity
Cash runwayThrough 2026 Into mid-2027 Extended and reaffirmed
Trial geographiesAU/CA/UK; additions Israel/NZ Enrolling in UK, Canada, Israel, Australia, New Zealand Broader multinational footprint

Management Commentary

  • “2025 is off to a strong start... VERVE-102... was well-tolerated and led to compelling, dose-dependent reductions in LDL-C... suggest a product profile that could fundamentally transform the journey... to a one dose future.” — Sekar Kathiresan, M.D., CEO .
  • “With cash runway into mid-2027, we are well-positioned to achieve our goals... dose the first patient in the Phase 2 clinical trial of VERVE-102 in the second half of 2025.” — Sekar Kathiresan, M.D., CEO .
  • “The IND clearance from the U.S. FDA represents an important step... Verve’s medicines are designed to deliver lifelong cholesterol lowering after a single course of treatment.” — Sekar Kathiresan, M.D., CEO .
  • “We anticipate additional milestones in the second half of 2025, including final data... delivery of the opt-in package and an opt-in decision from Lilly...” — Sekar Kathiresan, M.D., CEO .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available in the document catalog; management’s disclosures are drawn from the Q1 2025 8-K earnings press release and concurrent press releases .
  • Guidance clarifications: timing for Heart-2 final data, Phase 2 initiation, and Lilly opt-in remained H2 2025; regulatory updates (IND, Fast Track) were newly disclosed and achieved .

Estimates Context

  • S&P Global consensus for Q1 2025 EPS and revenue was unavailable for VERV due to missing mapping; as a result, no Street comparison could be made for the quarter [GetEstimates error, S&P Global].
  • Given non-recurring collaboration revenue recognition (Vertex termination) and R&D-driven losses, future estimate revisions may focus on timing/scale of collaboration revenue and the expected transition to later-stage clinical development costs .

Key Takeaways for Investors

  • Clinical efficacy and safety signals for VERVE-102 are emerging with meaningful LDL-C reductions at 0.6 mg/kg and clean tolerability; continued dose escalation (0.7 mg/kg) is a near-term data catalyst .
  • Regulatory milestones (FDA IND clearance, Fast Track) de-risk elements of development and enable U.S. site activation and expedited interactions; Phase 2 initiation in H2 2025 sets the stage for broader clinical validation .
  • Cash of $497.1M supports operations into mid-2027, providing multi-year runway to reach key clinical and partnership decision points (including Lilly opt-in) without near-term financing pressure .
  • Revenue remains collaboration-driven and lumpy; Q1’s $33.0M uplift included remaining deferred revenue from Vertex termination, so investors should normalize for non-recurring items .
  • Watch H2 2025 for three major inflections: final Heart-2 dose-escalation data (efficacy/durability/safety), Lilly PCSK9 opt-in decision (strategic validation/co-funding), and first Phase 2 patient dosing (development acceleration) .
  • The narrative is tilting toward a “one-dose” paradigm enabled by GalNAc-LNP delivery and base editing; durability data from Heart-1 and dose-dependent effects in Heart-2 support the thesis .
  • Risk factors remain around clinical outcomes at higher doses, regulatory pathways in broader populations, and collaboration dynamics; however, the recent IND/Fast Track and multinational enrollment reduce operational/regulatory uncertainty .