Sign in

You're signed outSign in or to get full access.

VT

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)

MetricQ2 2024Q1 2025Q2 2025
Revenue72 72 75
R&D Expense56,193 76,835 86,626
G&A Expense16,066 17,103 20,216
Total Operating Expenses72,259 93,938 106,842
Net Loss(64,993) (86,912) (100,735)
EPS (GAAP, Common, $)(0.77) (0.87) (1.00)

Balance sheet and KPIs

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash, Cash Equivalents & Short-term Investments ($USD Millions)717.6 636.6 563.4
Shares Outstanding (as-converted)99,663,246 100,258,627 100,320,386
Cash Runway2H 2027 2H 2027 2H 2027

Q2 2025 vs. S&P Global consensus

MetricActualConsensusBeat/Miss
Revenue ($USD Thousands)75 47*Beat
EPS (GAAP, $)(1.00) (0.98)*Miss

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious Guidance (Q1 2025)Current Guidance (Q2 2025)Change
Veligrotug BLA submission (U.S.)Timing2H 2025 2H 2025 Maintained
Veligrotug U.S. commercial launchTiming2026, if approved 2026, if approved Maintained
Veligrotug MAA (EU)Timing1H 2026 1H 2026 Maintained
VRDN-003 topline data (REVEAL-1/2)Timing1H 2026 1H 2026 Maintained
VRDN-003 BLATimingBy YE 2026 By YE 2026 Maintained
VRDN-006 phase 1 HV dataTimingQ3 2025 Q3 2025 Maintained
VRDN-008 INDTimingYE 2025 YE 2025 Maintained
Cash runwayLiquidityInto 2H 2027 Into 2H 2027 Maintained
FDA Breakthrough Therapy DesignationRegulatoryNot disclosed BTD granted in May 2025 New
Japan licensing economics (Kissei)PartnershipNot disclosed $70M upfront; up to $315M milestones; 20s–mid-30s royalties New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
Regulatory/designationsBLA on track 2H’25; no BTD noted BTD for veligrotug; eligibility for Priority Review Positive acceleration
Commercial readinessEarly commercial preparations underway (U.S. 2026 launch goal) “Launch-ready” on Priority Review timeline if received Building momentum
Clinical durability/safetyRobust phase 3 data; low hearing AEs noted 70% proptosis durability at week 52; generally well-tolerated Strengthening dataset
Partnerships/BDNone highlighted Kissei deal in Japan (upfront/milestones/royalties) New external validation
FcRn portfolioVRDN-006 PoC Q3’25; VRDN-008 IND YE’25 Timelines reiterated; NHP data supports VRDN-008 profile On track
EU pathMAA planned 1H’26 MAA still 1H’26 Unchanged

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 .