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Biohaven Ltd. (BHVN)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 loss narrowed year over year as Biohaven’s R&D expense normalized versus the prior-year period that had a large one-time Knopp buyback charge; GAAP net loss was $198.1M ($1.94/sh) vs. $319.8M ($3.64/sh) in Q2 2024, while non-GAAP net loss was $166.4M ($1.63/sh) .
  • Cash, cash equivalents, marketable securities and restricted cash totaled $408.2M at 6/30/25, bolstered by a $250M first-tranche note financing with Oberland completed on 4/30/25; notes payable were $257.1M at quarter-end .
  • Troriluzole (VYGLXIA) SCA review timeline extended by FDA to 4Q 2025 (from 3Q), but post-quarter FDA determined an Advisory Committee is no longer needed—removing a potential overhang; clinical inspections completed with no observations .
  • Pipeline execution accelerated: MoDE/TRAP degraders showed deep target reductions (IgG up to 87%; Gd‑IgA1 up to 81%), TYK2/JAK1 (BHV‑8000) entered a pivotal PD Phase 2/3, and Trop2 ADC (BHV‑1510) displayed early responses in combination with cemiplimab—key medium-term catalysts .

What Went Well and What Went Wrong

  • What Went Well

    • Deep, rapid target knockdown across degrader platforms: BHV‑1300 achieved IgG reductions up to 87% (median max 83% within 18 days); BHV‑1400 achieved up to 81% Gd‑IgA1 reduction after a single dose, selective over other immunoglobulins .
    • Oncology traction: Early activity with BHV‑1510; tumor reductions in first 6/6 patients in combination with cemiplimab with favorable tolerability (“differentiated, manageable safety profile”) .
    • Regulatory/process positives: FDA clinical trial inspections for troriluzole completed “without observations or findings”; later, FDA removed the need for an AdComm—maintaining 4Q 2025 PDUFA .
    • Management quote: “We are excited about the prospects of launching the first treatment for SCA if VYGLXIA is approved by the FDA…our commercial team is taking the appropriate steps to ensure an efficient launch” .
  • What Went Wrong

    • Regulatory timing pushed out: FDA extended the PDUFA date by three months to 4Q 2025, introducing a near‑term timing delay to the SCA decision .
    • OCD discontinuation: Phase 3 OCD program ended after no efficacy signal—resources being redeployed .
    • OpEx pressures remain: G&A rose to $27.3M (vs. $19.0M LY), partly from note financing fees; R&D included $25M of one-time milestones (BHV‑8000 $15M; BHV‑1530 $10M), weighing on profitability despite YoY OpEx normalization .

Financial Results

Metric (USD)Q2 2024Q4 2024Q1 2025Q2 2025
Research & Development$314.8M $167.5M $187.6M $184.4M
General & Administrative$19.0M $22.5M $34.0M $27.3M
Total Operating Expenses$333.8M $189.9M $221.6M $211.7M
Other Income (Net)$14.2M $3.1M $0.5M $13.8M
GAAP Net Loss$(319.8)M $(186.8)M $(221.7)M $(198.1)M
GAAP Diluted EPS$(3.64) $(1.85) $(2.17) $(1.94)
Non‑GAAP Net Loss$(308.6)M $(173.3)M $(166.8)M $(166.4)M
Non‑GAAP Diluted EPS$(3.52) $(1.71) $(1.64) $(1.63)
Cash, Cash Equivalents, Marketable Securities & Restricted Cash (EOQ)$489.0M (12/31/24) $518.0M (4/30/25) $408.2M (6/30/25)
Notes Payable (EOQ)$257.1M

Notes: Q2’24 comps reflect the prior-year quarter. Cash figures include restricted cash where specified by the company.

Estimate versus Actual (Q2 2025)

MetricConsensusActualDelta
Primary EPS (Normalized)$(1.87)*$(1.63) +$0.24 (beat)
GAAP EPS$(1.87)*$(1.94) $(0.07) (miss)
EBITDA$(155.3)M*$(209.7)M*$(54.4)M (miss)
Revenue$0.0M*$0.0M (implied) In line

Values with (*) retrieved from S&P Global.

KPI and Balance Sheet Highlights

  • Weighted average shares (basic/diluted): 102.37M in Q2’25 vs. 87.77M in Q2’24 .
  • Forward contract/derivative liability declined to $26.0M from $84.7M at 12/31/24; notes payable established at $257.1M with the Oberland financing .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Troriluzole (VYGLXIA) PDUFA decision timingFDA decision3Q 2025 (priority review) 4Q 2025 (3‑mo extension) Lowered (later timing)
FDA Advisory Committee planReview processFDA planned AdComm FDA determined AdComm no longer needed (8/21/25) Improved process clarity
Commercial readiness (SCA)2025Preparing for U.S. launch if approved Preparing for launch; inspections completed without observations Maintained
OpEx/Revenue/Margins guidance2025Not providedNot providedNo change
Capital2025+Exploring funding optionsUp to $600M Oberland notes ($250M funded; $150M on approval; +$200M optional) Enhanced liquidity, non‑dilutive structure

Earnings Call Themes & Trends

(Company did not publish a Q2 earnings call transcript; themes compiled from quarterly filings/press releases.)

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Troriluzole (SCA) regulatoryPriority Review; preparing for 2025 launch PDUFA moved to 4Q; no AdComm needed; inspections clean Timing delayed, process de‑risked
MoDE/TRAP degradersBHV‑1300 up to 84% IgG reduction; BHV‑1400 selective Gd‑IgA1 lowering BHV‑1300 IgG down up to 87% (median max 83%); BHV‑1400 Gd‑IgA1 down up to 81% Strengthened data set
TYK2/JAK1 (BHV‑8000)Phase 2/3 PD initiation planned 1H25 Pivotal PD Phase 2/3 initiated; broader neuro programs advancing Execution progressing
ADCs (BHV‑1510, BHV‑1530)Interim Phase 1 BHV‑1510 expected; BHV‑1530 to start BHV‑1510 early activity and PRs with cemiplimab; BHV‑1530 dosing commenced Momentum improving
Kv7 (BHV‑7000)Pivotal MDD 2H25; epilepsy 1H26 Compassionate‑use opakalim pediatric case benefit signals; pivotal timelines unchanged Mixed (new anecdotal benefit, timelines steady)
Financing / runwayNo Oberland yet (Q4); planning funding$250M funded, non‑dilutive notes; notes payable established Liquidity enhanced

Management Commentary

  • “We are excited about the prospects of launching the first treatment for SCA if VYGLXIA is approved by the FDA and our commercial team is taking the appropriate steps to ensure an efficient launch” — Vlad Coric, M.D., Chairman & CEO .
  • “We have observed compelling evidence of targeted protein degradation with our MoDE and TRAP degraders, BHV‑1300 and BHV‑1400… safety profiles… and convenient subcutaneous administration… support our belief in our degrader platform's ultimate potential” .
  • “We initiated a pivotal Phase 2/3 study in Parkinson's disease [with BHV‑8000]” .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available; no Q&A disclosures to extract [List search found none].

Estimates Context

  • Versus S&P Global consensus, Q2 2025 normalized EPS of $(1.63) beat by $0.24 (consensus $(1.87)), while GAAP EPS of $(1.94) missed on a GAAP basis; EBITDA was more negative than consensus (actual $(209.7)M vs. $(155.3)M) reflecting milestone and SBC impacts in R&D and financing-related costs in G&A . Values with (*) retrieved from S&P Global.
  • FY 2025 consensus: EPS $(6.61); Revenue $0.0M; Target Price Consensus Mean $26.30* (17 estimates). Values with () retrieved from S&P Global.

Key Takeaways for Investors

  • Troriluzole’s 4Q 2025 decision window remains the primary near-term catalyst; removal of an AdComm reduces headline risk, though timing was modestly delayed .
  • Degrader platforms (MoDE/TRAP) continue to validate with deep target reductions—material optionality beyond SCA (e.g., Graves’, RA, IgAN) and potential 2026 registrational starts, supporting medium‑term value creation .
  • Oncology optionality is emerging: early BHV‑1510 signals plus BHV‑1530 initiation broaden upside beyond neuro-immunology .
  • Liquidity boosted via non‑dilutive Oberland structure but adds revenue‑linked obligations; notes payable of $257.1M should be monitored against commercialization timelines .
  • Expense cadence: R&D normalized YoY without last year’s Knopp charge, but one-time milestones and SBC still drive losses; expect volatility around clinical milestones and launch prep .
  • Ending the OCD program removes a potential label expansion but concentrates focus and capital on nearer-term, higher‑probability programs .
  • Trading setup: clarity on PDUFA timing and AdComm removal, plus continued positive platform readouts, are likely the main stock drivers into year‑end and early 2026 .

Values with (*) retrieved from S&P Global.

Citations:

  • Q2 2025 8-K and press release: .
  • Q1 2025 filings/PR: .
  • Q4 2024 filings/PR: .
  • Oberland financing: .
  • FDA PDUFA extension and AdComm update: .