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Viridian Therapeutics, Inc.\DE (VRDN)·Q4 2024 Earnings Summary

Executive Summary

  • Fourth quarter results reflected typical pre-commercial biotech P&L dynamics: minimal collaboration revenue ($0.07M) and net loss of $79.7M, with common diluted EPS of $(0.81); cash and investments ended at $717.6M, extending runway into the second half of 2027 .
  • Operational highlight: veligrotug (VRDN-001) maintained a differentiated efficacy/safety profile across both Phase 3 programs; THRIVE-2 in chronic TED achieved PRR 56% and clinically meaningful diplopia responses/resolutions after five infusions, supporting BLA submission in 2H 2025 .
  • R&D investment stepped up to $72.0M in Q4, driving pivotal readouts and progress on subcutaneous VRDN-003 (REVEAL-1/2 topline in 1H 2026) and FcRn inhibitors VRDN-006 (PoC IgG reduction in Q3 2025) and VRDN-008 (IND planned YE 2025) .
  • S&P Global consensus estimates for Q4 2024 were unavailable during this session due to access limits; comparisons vs Street not provided (see Estimates Context) [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • Veligrotug met all primary/secondary endpoints in THRIVE and THRIVE-2, with rapid onset and robust proptosis and diplopia benefits; management emphasized potential “treatment-of-choice” profile and BLA timing in 2H 2025 (“on track”) .
  • Safety profile improved vs prior study with low hearing impairment rates (THRIVE-2 placebo-adjusted 9.6%; most events mild tinnitus) and high completion (94% of subjects) .
  • Liquidity strengthened: cash/short-term investments of $717.6M (Dec 31, 2024) with runway into 2H 2027, supporting BLA, commercial readiness, REVEAL toplines, and FcRn catalysts .

What Went Wrong

  • Continued large operating losses typical of late-stage biotech: Q4 net loss $(79.7)M versus $(66.9)M prior-year quarter; R&D stepped up to $72.0M as pivotal and Phase 3/IND programs advanced .
  • Minimal revenue base ($0.07M) highlights reliance on financing and disciplined cash management until commercial launch; G&A decreased y/y due to nonrecurring severance in 2023, but overall opex rose with program scale-up .
  • Street estimate comparisons were not available via S&P Global in-session, limiting external validation of EPS/revenue relative to consensus (see Estimates Context) [GetEstimates error].

Financial Results

P&L and Cash (USD)

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Total Revenue ($USD Millions)$0.072 $0.072 $0.086 $0.072
Research & Development ($USD Millions)$38.558 $56.193 $69.158 $71.959
General & Administrative ($USD Millions)$32.993 $16.066 $14.408 $15.585
Net Loss ($USD Millions)$(66.860) $(64.993) $(76.689) $(79.725)
Diluted EPS (Common, $USD)$(0.97) $(1.02) $(1.15) $(0.81)
Weighted Avg Shares (Common)49.682M 63.855M 66.420M 80.052M
Cash, Cash Equivalents & ST Investments ($USD Millions)$477.370 (FY-end) $571.366 $753.240 $717.584
Consensus Revenue (S&P Global)N/A*N/A*N/A*N/A*
Consensus EPS (S&P Global)N/A*N/A*N/A*N/A*

*Values retrieved from S&P Global were unavailable due to access limits; consensus comparisons could not be provided in-session.

Clinical KPIs (TED programs)

KPITHRIVE (Active TED, Sep 2024)THRIVE-2 (Chronic TED, Dec 2024)
Proptosis Responder Rate (Week 15)70% vs 5% placebo (p<0.0001) 56% vs 8% placebo (48% placebo-adjusted; p<0.0001)
Proptosis Mean Reduction−2.89 mm vs −0.48 mm placebo (p<0.0001) −2.34 mm vs −0.46 mm placebo (p<0.0001)
Diplopia Responder Rate63% vs 20% placebo (p<0.0001) 56% vs 25% placebo (31% placebo-adjusted; p=0.0006)
Diplopia Complete Resolution54% vs 12% placebo (p<0.0001) 32% vs 14% placebo (18% placebo-adjusted; p=0.0152)
CAS 0–164% vs 18% placebo (p<0.0001) 54% vs 24% placebo (p=0.006)
Hearing Impairment (AE)5.5% placebo-adjusted 9.6% placebo-adjusted; majority mild tinnitus

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Veligrotug BLA submission2H 2025“On track for 2H 2025” (Q2/Q3) “On track for 2H 2025” (Q4) Maintained
VRDN-003 topline (REVEAL-1/2)1H 20261H 2026 (Q2/Q3) 1H 2026 (Q4/Jan 2025) Maintained
VRDN-003 BLA submissionYE 2026YE 2026 (Q3) YE 2026 (Q4/Jan 2025) Maintained
VRDN-006 INDYE 2024On track YE 2024 (Q2/Q3) Submitted Dec 2024 (Jan update) Achieved
VRDN-006 PoC IgG reduction2H 20252H 2025 (Q3) Q3 2025 (Jan update) Refined timing
VRDN-008 INDYE 2025YE 2025 (Q3) YE 2025 (Q4/Jan 2025) Maintained
Cash runwayLiquidityInto 2H 2026 (Q2) Into 2H 2027 (Q3/Q4) Raised/extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
Veligrotug efficacy/safetyTHRIVE topline achieved all endpoints; low hearing AE; BLA 2H 2025 THRIVE-2 achieved PRR 56%, diplopia response/resolution; 9.6% placebo-adjusted hearing impairment; BLA prep underway Strengthening efficacy narrative; consistent safety
VRDN-003 developmentREVEAL-1/2 initiated; topline 1H 2026; best-in-class subcutaneous ambition REVEAL dosing ongoing; topline 1H 2026; read-through from THRIVE/THRIVE-2 On track; derisked by shared binding domain
FcRn portfolio (006/008)006 IND on track YE 2024; 008 NHP head-to-head half-life/IgG durability 006 IND submitted; 006 PoC IgG reduction Q3 2025; 008 additional preclinical and IND YE 2025 Execution milestones achieved; timelines reaffirmed
Commercial readinessFinancing strengthened; runway into 2H 2027; market education Early commercial preparations underway; concentrated prescriber base; labeling aspirations (chronic data) Building launch infrastructure
Regulatory trajectoryBLA veligrotug 2H 2025; MAA planned BLA veligrotug on track 2H 2025; MAA 1H 2026; VRDN-003 BLA YE 2026 Clear path; multi-product plan

Management Commentary

  • “The veligrotug BLA submission is on track for 2H 2025 and our early commercial preparations are underway... Both REVEAL studies are on track to report topline data in the first half of 2026, which would enable a BLA submission by the end of 2026.” — Steve Mahoney, President & CEO .
  • “We are extremely pleased to announce better-than-expected THRIVE-2 results... the first product candidate to demonstrate a diplopia response and resolution in a global chronic TED phase 3 study.” — Steve Mahoney .
  • “Veli was generally well tolerated... 94% of veligrotug-treated patients completed their treatment course; low 9.6% placebo-adjusted rate of hearing impairment.” — Company commentary .
  • Appointment: Radhika Tripuraneni, M.D., named Chief Medical Officer in Q4 update .

Q&A Highlights

  • Diplopia significance: Management underscored early and meaningful diplopia improvements/resolution in chronic TED and positioning for labeling; 32% complete resolution at week 15 (18% placebo-adjusted) .
  • Safety detail: Hearing AEs predominantly mild tinnitus; one moderate case with confounding inner ear infection; infusion-related reactions lower than prior study; one related SAE (vertigo) resolved and subject completed therapy .
  • Regulatory/filing: BLA timing governed by THRIVE-2 follow-up (37 weeks post last dose); submission targeted for 2H 2025; STRIVE safety database not on critical path .
  • Read-through to VRDN-003: Shared binding domain and exposure-matching rationale support expectation of similar clinical activity in SC regimen; site/CRO overlap to drive efficient execution .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was unavailable in-session due to access limits; as a result, quantitative comparisons vs Street cannot be provided here. If needed, we can refresh and append consensus later once access is restored [GetEstimates error].

Key Takeaways for Investors

  • Pivotal data across active and chronic TED positions veligrotug for a differentiated label (including chronic diplopia effects) and potential “treatment-of-choice” status; BLA in 2H 2025 is a central catalyst .
  • Safety profile continues to look class-competitive with lower hearing impairment rates and high completion, mitigating a key concern for IGF‑1R agents .
  • Liquidity of $717.6M end-2024 and runway into 2H 2027 supports launch readiness, VRDN-003 toplines (1H 2026), and FcRn milestones without near-term financing risk .
  • Near-term trading focus: Regulatory clarity (BLA progress), any medical meeting durability updates, and continued communication on commercialization strategy could drive sentiment; absence of Street comparisons limits immediate “beat/miss” framing this quarter .
  • Medium-term thesis: TED franchise build-out (IV then SC), potential label breadth, and FcRn pipeline optionality (006 PoC in Q3 2025; 008 IND YE 2025) create multiple shots on goal across 2025–2026 .
  • Watch for European MAA (1H 2026) and payer/label dynamics in chronic disease features (diplopia), which may materially impact adoption and market access .
  • Operating losses will persist pre-commercial; execution against milestones and regulatory timelines are the key value drivers, supported by robust cash .