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Dec 31, 2024
Biohaven Q4 2024 Earnings Report
Biohaven reported its fourth quarter and full year 2024 financial results, highlighting progress in clinical development and financial performance.
Key Takeaways
Biohaven reported a net loss of $186.8 million for Q4 2024, with R&D expenses increasing to $167.5 million. The company announced FDA acceptance and Priority Review for troriluzole NDA and positive degrader data for BHV-1300, while maintaining a strong cash position.
FDA accepted and granted Priority Review for troriluzole NDA in all-genotype spinocerebellar ataxia, with a PDUFA date in 3Q 2025.
Cash, cash equivalents, marketable securities and restricted cash totaled approximately $489 million as of December 31, 2024.
Reported positive degrader data for BHV-1300, showing up to 84% reduction of total IgG in Phase 1 study.
Net loss for Q4 2024 was $186.8 million, compared to $144.8 million in Q4 2023.
Biohaven
Biohaven
Forward Guidance
Biohaven anticipates significant clinical and regulatory milestones in 2025 and 2026 across its diverse portfolio, including potential commercial launches and advancements in multiple therapeutic programs.
Positive Outlook
- Commercial launch of troriluzole in SCA expected in 2025, pending FDA approval.
- Phase 1 studies for BHV-1400 and BHV-1600 expected to be completed in 1H 2025.
- Initiation of BHV-8000 Phase 2/3 study in Parkinson's disease in 1H 2025.
- Initiation of taldefgrobep alfa Phase 2 study in obesity in 1H 2025.
- Initiation of Phase 1 trial of BHV-1530 (FGFR3 ADC) in 1H 2025.
Challenges Ahead
- Topline data from two Phase 3 OCD trials for troriluzole expected in 1H 2025 and 2H 2025, indicating ongoing development.
- BHV-7000 bipolar mania 3-week study did not statistically separate from comparator, with ongoing analyses.
- Major depressive disorder topline results for BHV-7000 expected in 2H 2025.
- Focal epilepsy study topline results for BHV-7000 expected in 1H 2026.
- Proof-of-concept in migraine for BHV-2100 is ongoing, with data from laser-evoked potential study expected in 1H 2025.