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Biohaven Ltd. (BHVN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results reflected heavy R&D investment ahead of multiple 2025–2026 catalysts: net loss of $186.8M and GAAP EPS of -$1.85; non-GAAP adjusted net loss of $173.3M and adjusted EPS of -$1.71 .
  • Liquidity remained strong with $489M in cash, cash equivalents, marketable securities and restricted cash at 12/31/2024; Q3 benefitted temporarily from the October equity raise ($642M as of 10/2/2024) .
  • Key positive readouts and regulatory milestones: FDA accepted the troriluzole NDA for SCA with Priority Review (PDUFA in Q3 2025); BHV-1300 MoDE™ degrader achieved up to 84% total IgG reduction with median 80% after weekly 1,000 mg SC dosing in Phase 1 .
  • Operational headwinds: BHV-7000 bipolar mania 3-week study did not statistically separate on the primary outcome; SMA Phase 3 did not meet its overall primary endpoint though subgroup and body composition signals support further work (including obesity Phase 2) .
  • Near-term stock catalysts: SCA Priority Review trajectory, BHV-2100 migraine/laser-evoked potential data in 1H 2025, BHV-1300 Phase 1 completion 1H 2025, BHV-8000 Parkinson’s Phase 2/3 initiation, and ADC interim data in 2H 2025 .

What Went Well and What Went Wrong

What Went Well

  • FDA acceptance and Priority Review for troriluzole NDA in all-genotype SCA; commercial launch preparation underway pending approval (PDUFA Q3 2025) .
  • Strong degrader platform execution: BHV-1300 optimized SC dosing achieved rapid, deep (up to 84%, median 80% at 1,000 mg weekly) and sustained IgG reductions; doses up to 2,000 mg were safe and well-tolerated .
  • Strategic pipeline momentum and confidence: “The selectivity of MoDE and TRAP degraders demonstrated to date has the potential to redefine the immune-modulating treatment paradigm” — Vlad Coric, M.D., CEO .

What Went Wrong

  • Bipolar mania trial signal: BHV-7000 did not statistically differentiate from comparator on the YMRS primary endpoint in the 3-week study, though safety and tolerability were favorable; analyses ongoing .
  • SMA Phase 3 topline: taldefgrobep did not meet the overall primary endpoint, but subgroup analyses (e.g., Caucasian/myostatin-positive) showed clinically meaningful improvements; robust body composition benefits support obesity development .
  • Financial optics: other income declined QoQ (Q4 $3.1M vs. Q3 $17.8M) and YoY (Q4 2023 $7.7M), while R&D and G&A increased YoY due to advancing late-stage programs .

Financial Results

Sequential Performance (Q2 → Q3 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
R&D Expenses ($USD Millions)$314.8 $157.6 $167.5
G&A Expenses ($USD Millions)$19.0 $20.6 $22.5
Other Income, Net ($USD Millions)$14.2 $17.8 $3.1
Net Loss ($USD Millions)$319.8 $160.3 $186.8
GAAP EPS ($USD)-$3.64 -$1.70 -$1.85
Non-GAAP Adjusted Net Loss ($USD Millions)$307.4 $164.1 $173.3
Non-GAAP Adjusted EPS ($USD)-$3.50 -$1.74 -$1.71

Year-over-Year (Q4 2023 vs Q4 2024)

MetricQ4 2023Q4 2024
R&D Expenses ($USD Millions)$134.8 $167.5
G&A Expenses ($USD Millions)$18.9 $22.5
Other Income, Net ($USD Millions)$7.7 $3.1
Net Loss ($USD Millions)$144.8 $186.8
GAAP EPS ($USD)-$1.81 -$1.85

Liquidity and Share Metrics

MetricQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents, Marketable Securities & Restricted Cash ($USD Millions)$440 $642 $489
Weighted Avg. Shares (Basic & Diluted)87,766,069 94,372,159 101,054,895

Note: BHVN does not report product revenues; operating lines comprise R&D and G&A with no margin constructs provided .

Guidance Changes

MetricPeriodPrevious Guidance (Q2/Q3 2024)Current Guidance (Q4 2024)Change
Troriluzole NDA (SCA)2025NDA re-submission on track for 4Q 2024 FDA accepted NDA with Priority Review; PDUFA in Q3 2025; preparing for potential US launch in 2025 Raised/Advanced
BHV-1300 (IgG MoDE)1H 2025Phase 1 SAD/MAD update in 2H 2024; optimized SC formulation update Phase 1 completion expected 1H 2025; deep IgG reductions with optimized SC dosing; Phase 2 Graves’ mid-2025 Clarified timeline/Expanded
BHV-2100 (TRPM3)1H 2025Phase 2 trial initiation in acute migraine; POC pain study 2H 2024 Laser-evoked potential and migraine data expected 1H 2025; POC ongoing Maintained with timing
BHV-7000 (Kv7)2H 2025/1H 20265 ongoing Phase 2/3 trials; 2025 data readouts Pivotal MDD topline in 2H 2025; focal epilepsy topline in 1H 2026; bipolar mania 3-week study did not separate Mixed (timeline intact; efficacy miss in mania)
BHV-8000 (TYK2/JAK1)1H 2025Advance to Phase 2 after Phase 1; registrational programs enabled Initiate Phase 2/3 Parkinson’s in 1H 2025; advance AD/MS/ARIA programs Maintained/Specified
Taldefgrobep (Myostatin)1H 2025SMA Phase 3 topline in 4Q 2024; initiate obesity Phase 2 in 4Q 2024/early 2025 SMA subgroup/body composition signals; FDA meeting in 1H 2025; initiate obesity Phase 2 in 1H 2025 Adjusted focus (obesity, subgroup path)
ADC Portfolio (BHV-1510, BHV-1530)2025BHV-1510 dosing; combo with Libtayo in 4Q 2024 BHV-1510 interim Phase 1 data in 2H 2025; BHV-1530 Phase 1 initiation in 1H 2025; expanded GeneQuantum/Merus collaborations Expanded milestones

Earnings Call Themes & Trends

Note: Q4 2024 earnings call transcript was not available in our corpus; themes synthesized from the Q4 8‑K and Q2/Q3 earnings releases.

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
Glutamate modulation (Troriluzole)Positive pivotal SCA RWE; NDA re-submission planned; EMA MAA under review FDA accepted NDA; Priority Review; PDUFA Q3 2025; commercialization planning Advancing toward approval
MoDE/TRAP degradersBHV-1300 Phase 1 SAD/MAD with SC formulation; 3 INDs expected Deep IgG lowering with SC BHV-1300; Phase 1 completion 1H 2025; BHV-1400 (IgAN), BHV-1600 (PPCM) first-in-human dosing Accelerating platform
Ion channels (Kv7/BHV-7000)5 registrational trials; 2025 readouts; AES data on extended-release safety Bipolar mania trial did not differentiate; timelines intact for MDD 2H 2025 and epilepsy 1H 2026 Mixed efficacy; solid tolerability
TRPM3 (BHV-2100)Phase 2 acute migraine initiated; POC pain study launched Laser-evoked potential and migraine data expected in 1H 2025 On track
TYK2/JAK1 (BHV-8000)Phase 1 completed with biomarker engagement; registrational programs enabled Parkinson’s Phase 2/3 initiation 1H 2025; AD/MS/ARIA work advancing Moving to pivotal
Myostatin (Taldefgrobep)SMA topline pending; obesity Phase 2 to start Overall primary not met; subgroup efficacy and body composition benefits; obesity Phase 2 initiation 1H 2025 Pivot to targeted paths
Oncology ADCsBHV-1510 dosing; Libtayo combo planned BHV-1510 interim Phase 1 in 2H 2025; BHV-1530 Phase 1 start in 1H 2025; collaboration expansion Broadening pipeline

Management Commentary

  • “Multiple doses of BHV-1300 lowered serum IgG by up to 84% from baseline… Our next generation TRAP™ degraders offer the additional advantage of selectively removing antigen-specific targets while sparing off-target effects… potential to redefine the immune-modulating treatment paradigm.” — Vlad Coric, M.D., CEO .
  • “We believe we are poised to deliver important milestones in 2025 and beyond… FDA accepting our troriluzole NDA… topline pivotal results with BHV-7000… initiate Phase 2/3 Parkinson’s… significantly advancing our ADC portfolio.” — Vlad Coric, M.D. .

Q&A Highlights

  • Not available; the Q4 2024 earnings call transcript could not be found in our document corpus and earnings-call-transcript search returned no results for BHVN. We relied on the 8‑K Item 2.02 and associated press materials instead .

Estimates Context

  • Wall Street consensus (S&P Global) EPS and revenue estimates for Q4 2024 were unavailable due to access limits at the time of query. As BHVN reports no product revenue, comparisons are primarily anchored on EPS and operating expense trajectories; we cannot provide a formal “vs. estimates” comparison this quarter.
  • We will default to S&P Global for consensus in future periods when available.

Key Takeaways for Investors

  • BHVN remains a high-catalyst, clinical-stage story: troriluzole Priority Review (Q3 2025 PDUFA) is the principal binary event; commercial preparation signals confidence .
  • Degrader platform de-risking: BHV-1300’s deep, rapid, sustained IgG lowering with optimized SC delivery and favorable safety profile strengthens the immunology thesis; Phase 2 in Graves’ targeted for mid-2025 .
  • Ion channel platform is extensive but mixed: strong safety/tolerability and multiple registrational trials, offset by the bipolar mania efficacy miss; watch MDD (2H 2025) and epilepsy (1H 2026) readouts for value inflection .
  • SMA readout reshapes strategy: while the overall primary was not met, subgroup efficacy and body composition benefits (fat reduction, lean mass, bone density) justify continued exploration and pivot to obesity (Phase 2 in 1H 2025) .
  • Cash runway supports execution across platforms; watch financing cadence versus milestone timing given ~$489M liquidity at year-end and rising OpEx .
  • Near-term trading: headline risk around interim data (BHV-2100, BHV-1300 completion) and regulatory interactions (taldefgrobep in SMA path) likely drive volatility; medium-term thesis hinges on SCA approval and first-in-class degrader validation .
  • No formal financial guidance provided; monitor expense discipline and non-GAAP loss trajectory as programs enter later-stage, alongside potential partnering to balance capital needs .