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Viridian Therapeutics, Inc.\DE (VRDN)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 was execution-heavy ahead of veligrotug’s BLA in 2H 2025, highlighted by Breakthrough Therapy Designation (BTD) and a Japan out-licensing to Kissei ($70M upfront, up to $315M milestones, tiered royalties in the 20s–mid-30s) .
- Results: revenue of $75k and GAAP EPS of $(1.00); revenue beat S&P Global consensus ($47k)* while EPS missed (consensus $(0.98)*) .
- Operating spend rose as multiple late-stage programs advanced: R&D $86.6M (+54% y/y) and G&A $20.2M (+26% y/y), reflecting phase 3 activity and commercial buildout .
- Liquidity remains solid: $563.4M cash/short-term investments (runway into 2H 2027), providing capacity to file and prepare for a potential 2026 U.S. launch .
- Near-term stock catalysts: BLA filing in 2H 2025 (BTD supports eligibility for Priority Review), 52-week durability data (70% maintained proptosis response), and VRDN-006 phase 1 healthy volunteer readout in Q3 2025 .
What Went Well and What Went Wrong
What Went Well
- Regulatory momentum: FDA BTD for veligrotug in May supports Priority Review eligibility and accelerates launch timing if received .
- Partner validation and non-dilutive capital: Kissei deal secured $70M upfront, up to $315M milestones, and 20s–mid-30s tiered royalties; Kissei funds Japan development/commercialization .
- Durability and tolerability: 70% of proptosis responders at week 15 maintained response at week 52 (40 weeks after last dose); veligrotug “generally well-tolerated” in pivotal trials .
- CEO tone: “We are making extraordinary progress on our commercial preparation and we plan to be launch-ready on a Priority Review designation timeline, if we receive it” .
What Went Wrong
- EPS modestly missed consensus given high OpEx into multiple phase 3s; GAAP net loss widened to $(100.7)M vs $(65.0)M y/y as trials and commercial prep ramped .
- Cash burn increased sequentially (cash/short-term investments down from $636.6M in Q1 to $563.4M in Q2), reflecting program cadence before potential revenue generation .
- Limited revenue line (collaboration revenue only) means margins are not yet a meaningful indicator; investors remain reliant on regulatory and clinical catalysts to underwrite the path to commercialization .
Financial Results
P&L highlights ($USD Thousands, except per-share)
Balance sheet and KPIs
Q2 2025 vs. S&P Global consensus
Values marked with * retrieved from S&P Global.
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “Veligrotug’s recent Breakthrough Therapy Designation … showcase the momentum Viridian is building as we approach our planned BLA filing and expected commercial launch.” — Steve Mahoney, President & CEO .
- “We are making extraordinary progress on our commercial preparation and we plan to be launch-ready on a Priority Review designation timeline, if we receive it.” — Steve Mahoney .
- “We are thrilled to partner with Kissei to bring these potential best-in-class medicines to TED patients in Japan.” — Steve Mahoney (Kissei agreement) .
Q&A Highlights
- We did not locate a Q2 2025 earnings call transcript in company filings or the investor news archive; third-party calendars indicated a call around early August, but no transcript was accessible from the company’s site as of our review .
Estimates Context
- Q2 2025: Revenue $75k vs S&P Global consensus $47k* (beat); GAAP EPS $(1.00) vs $(0.98)* (miss) .
- Street models are likely to emphasize regulatory timing and potential revenue recognition from partnerships; the Kissei upfront, recognized in Q3, materially affects near-term revenue baselines versus prior expectations .
Values marked with * retrieved from S&P Global.
Key Takeaways for Investors
- Regulatory de-risking: BTD plus strong durability and safety profile improve the probability and potential pace of approval; watch for BLA submission in 2H 2025 and Priority Review designation .
- Commercial readiness: Management aims to be “launch-ready” for an expected 2026 U.S. launch, suggesting continued G&A build and investment in market access and medical affairs .
- Non-dilutive funding/validation: The Kissei deal adds upfront cash and future potential milestones/royalties while validating veligrotug/VRDN-003 in a key ex-U.S. market .
- Cash runway into 2H 2027 provides sufficient liquidity to reach multiple catalysts (BLA, VRDN-006 PoC, VRDN-003 phase 3 toplines) without near-term financing pressure .
- Near-term catalyst map: BLA filing (2H 2025), VRDN-006 HV data (Q3 2025); monitor for potential Priority Review and updates on EU MAA timing .
- Risk lens: Elevated OpEx continues as late-stage programs progress; absence of product revenue keeps P&L leverage muted until approval/launch .
- Positioning: The TED profile (IV veligrotug with durable effect; SC VRDN-003 following) targets a broad patient set, potentially supporting meaningful share capture upon launch if approved .
Appendix: Additional Source Details
- Q2 2025 press release and 8-K (financials, BTD, durability, runway) .
- Q1 2025 press release and 8-K (runway, timelines, OpEx) .
- Q4/FY 2024 press release and 8-K (baseline cash, timelines) .
- Japan Kissei licensing economics .