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Biohaven Ltd. (BHVN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was a non-revenue quarter with continued heavy R&D investment; GAAP net loss was $221.7M ($2.17/sh), while non-GAAP adjusted net loss was $166.8M ($1.64/sh), a modest EPS beat versus S&P Global consensus of -$1.72 as reported by S&P Global’s dataset* .
  • Balance sheet strengthened via up to $600M non-dilutive Oberland Capital financing ($250M funded on Apr 30), boosting post-quarter liquidity to ~$518M as of Apr 30 from ~$327M at Mar 31 .
  • Regulatory path for troriluzole (SCA) shifted: after mid-cycle completion and no AdCom indicated earlier, FDA extended the PDUFA date by three months to 4Q 2025 and now plans an AdCom, raising timeline risk into year-end .
  • Pipeline momentum remained a bright spot: multiple AAN presentations; Phase 2/3 initiation for BHV-8000 (TYK2/JAK1, early Parkinson’s); ADC update showed 6/6 tumor reductions in BHV-1510 + cemiplimab; R&D Day highlighted deeper, sustained degrader activity (BHV-1300 up to 87% IgG reduction; BHV-1400 up to 81% Gd-IgA1 reduction) .

What Went Well and What Went Wrong

What Went Well

  • Secured significant non-dilutive capital: Up to $600M from Oberland Capital with $250M funded 4/30, enhancing flexibility for SCA launch planning and pipeline execution . CEO: “Our recent $600 million financing agreement with Oberland Capital will provide financial flexibility to advance our troriluzole commercialization plans, accelerate clinical development… across our five platforms” .
  • Pipeline execution across platforms: 13 AAN abstracts; R&D Day showed BHV-1300 achieved up to 87% IgG reductions, and BHV-1400 up to 81% reductions in pathogenic Gd‑IgA1 with sustained effects, supporting pivotal plans in Graves’ disease (2H25) and IgAN (2026) .
  • Early oncology signal: BHV‑1510 (Trop2 ADC) plus cemiplimab produced tumor shrinkage in first 6/6 patients, including confirmed partial responses, with manageable safety; first patient dosed with FGFR3 ADC BHV‑1530 .

What Went Wrong

  • Regulatory timing setback: FDA extended troriluzole’s PDUFA decision by three months to 4Q 2025 and now plans an AdCom, adding uncertainty and potentially delaying a 2025 launch .
  • Elevated operating spend: Total operating expenses rose to $221.6M (vs. $183.2M YoY) driven by higher non-cash SBC ($53.1M total; R&D SBC $35.2M; G&A SBC $17.8M) and increased program spend; GAAP net loss widened to $221.7M .
  • Less favorable other income: Other income declined to $0.5M (from $4.3M YoY) on derivative fair value changes tied to the Knopp agreement, partially offsetting investment income .

Financial Results

Quarterly P&L snapshot (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.0 (implied; Loss from ops = OpEx) $0.0 (implied; Loss from ops = OpEx) $0.0 (implied; Loss from ops = OpEx)
R&D Expense ($USD Millions)$157.6 $167.5 $187.6
G&A Expense ($USD Millions)$20.6 $22.5 $34.0
Total Operating Expenses ($USD Millions)$178.2 $189.9 $221.6
GAAP Net Loss ($USD Millions)$(160.3) $(186.8) $(221.7)
GAAP EPS (Basic & Diluted)$(1.70) $(1.85) $(2.17)
Non-GAAP Adjusted EPS$(1.74) $(1.71) $(1.64)

Notes: Revenue implied as $0.0 given Loss from operations equals Total operating expenses in all periods . Non-GAAP adjustments primarily add back SBC and derivative fair value changes .

Q1 2025 results vs S&P Global consensus

MetricConsensusActualSurprise
Primary EPS-$1.72*-$1.64 +$0.08 (beat)*
Revenue ($USD Millions)$0.0*$0.0 (implied) In line*
Number of EPS Estimates12*——
Number of Revenue Estimates10*——

Values marked with * retrieved from S&P Global.

Liquidity and shares

MetricQ3 2024 (Oct 2)Q4 2024 (Dec 31)Q1 2025 (Mar 31)Apr 30, 2025
Cash, cash equivalents, marketable securities & restricted cash ($USD Millions)~$642 ~$489 ~$327 ~$518
Weighted Avg Shares (Basic & Diluted)94.37M 101.05M 101.94M —

Non-GAAP reconciliation elements in Q1 2025: SBC $53.1M; derivative FV loss $1.8M .

KPIs (operational)

  • AAN outputs: 13 abstracts (3 oral, 10 posters) across Kv7, MoDE/TRAP degraders, TYK2/JAK1, glutamate, TRPM3 .
  • Pipeline milestones (selected): BHV-8000 Phase 2/3 initiated in early PD (May 29) ; ADC update with BHV‑1510 + cemiplimab tumor shrinkage 6/6 and first BHV‑1530 patient dosed ; R&D Day degrader data (BHV-1300 up to 87% IgG↓; BHV-1400 up to 81% Gd‑IgA1↓) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Troriluzole (SCA) FDA decision (PDUFA)2025Priority Review; PDUFA 3Q 2025 PDUFA extended to 4Q 2025; AdCom planned Delayed (3 months); AdCom added
Troriluzole commercial launch prep (US)2025Preparing for 2025 launch if approved Timing risk increased with PDUFA shift and AdCom Risk heightened
BHV-8000 (TYK2/JAK1)1H 2025Initiate Phase 2/3 in 1H 2025 Phase 2/3 initiated May 29 Initiated
BHV-7000 (Kv7) MDD topline2H 20252H 2025 2H 2025 (maintained) Maintained
BHV-7000 focal epilepsy topline1H 20261H 2026 1H 2026 (maintained) Maintained
BHV-2100 (TRPM3) PoC data1H 20251H 2025 1H 2025 (maintained) Maintained
BHV-1300 Graves’ Phase 2 startMid-2025Mid-2025 Mid-2025 (maintained) Maintained
BHV-1400 pivotal (IgAN) plan2026Plan emerging (1H25 completion of Ph1) Pivotal trial initiation targeted 2026 (UPCR AA pathway) Clarified plan
Capital plan2025—Up to $600M Oberland; $250M funded Apr 30 New financing

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not found in the document set; themes below synthesize management communications across Q3’24, Q4’24, and Q1’25 press materials.

TopicQ3 2024 (Previous-2)Q4 2024 (Previous-1)Q1 2025 (Current)Trend
Regulatory (Troriluzole SCA)Positive pivotal RWE topline; NDA planned 4Q24 NDA accepted; Priority Review; 3Q25 PDUFA Mid-cycle completed; then FDA extended PDUFA to 4Q25 with AdCom planned Neutral → Slightly negative (timing risk)
Degraders (MoDE/TRAP)Progress; multiple INDs planned; BHV‑1300 update guided BHV‑1300 up to 84% IgG↓; BHV‑1400 rapid 60–70% Gd‑IgA1↓; BHV‑1600 Ph1 underway R&D Day: BHV‑1300 up to 87% IgG↓; BHV‑1400 up to 81% Gd‑IgA1↓; sustained reductions Improving
TYK2/JAK1 (BHV‑8000)Complete SAD/MAD; advance to Ph2 Initiation planned 1H25 Phase 2/3 initiated (early PD) Improving
ADC platformBHV‑1510 in Ph1/2; combo with Libtayo® planned Advancing; BHV‑1530 Ph1 start in 1H25 6/6 tumor reductions in BHV‑1510+cemi; first BHV‑1530 patient dosed Improving
Capital markets/liquidity$269.9M raised Oct 2 $489M YE cash/securities Up to $600M Oberland; $250M funded; $518M liquidity as of Apr 30 Improving
TRPM3 (BHV‑2100)Ph2 migraine initiated 1H25 PoC data guided Data expected 1H25 (maintained) Stable

Management Commentary

  • CEO strategic focus: “Our team has remained… focused on strategic execution and creating a strong financial balance sheet… We expect to complete three separate Phase 1 studies in 1H 2025… and look forward to delivering key clinical readouts, including pivotal topline data with troriluzole in OCD… and BHV-7000 in MDD in 2H 2025.” .
  • On financing and readiness: “Our recent $600 million financing agreement with Oberland Capital will provide financial flexibility to advance our troriluzole commercialization plans, accelerate clinical development and operational execution across our five platforms…” .
  • CFO on Oberland: “This flexible, long-term, non-dilutive financing… speaks to the vast potential of troriluzole… and confidence in our broader portfolio… providing support and flexibility to continue advancing our pipeline as we make launch preparations in parallel” .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available in the document set; management indicated further discussion at R&D Day (May 28) covering degraders, ADCs, and broader pipeline updates .

Estimates Context

  • EPS beat: Q1 2025 Primary EPS was -$1.64 vs S&P Global consensus -$1.72 (beat of $0.08)*. Company-reported non-GAAP adjusted EPS was -$1.64, consistent with the S&P “actual” figure .
  • Revenue in line: Consensus revenue $0; company reported no revenue in Q1 (implied) as Loss from operations equaled Total operating expenses.* .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Troriluzole’s PDUFA delay and planned AdCom push the regulatory outcome into 4Q25, heightening timing and event risk; shares are likely to trade on AdCom scheduling and briefing docs .
  • Liquidity is solid post-Oberland ($250M funded) with ~$518M as of Apr 30, supporting runway through multiple 2025–2026 readouts and potential SCA launch preparation if approved .
  • Pipeline momentum is tangible: BHV‑8000 P2/3 started; ADCs showing early activity; degrader data deepening—multiple “shots on goal” that diversify binary SCA risk .
  • Expense intensity remains high (Q1 OpEx $221.6M) as programs scale; expect elevated SBC and development costs as registrational and pivotal programs expand .
  • Near-term catalysts: OCD Phase 3 toplines (H1/H2’25), BHV‑7000 MDD topline (2H’25), TRPM3 PoC (H1’25), incremental ADC updates—portfolio news flow could offset SCA headline risk .
  • Regulatory narrative shifted from smooth Priority Review to extended review with AdCom; position sizing should reflect elevated volatility around the panel and potential label/scope discussions .