Biohaven Q4 2024 Earnings Report
Key Takeaways
Biohaven reported a net loss of $186.8 million for Q4 2024, compared to a net loss of $144.8 million for the same period in 2023. The company's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $489 million as of December 31, 2024.
FDA accepted and granted Priority Review for troriluzole NDA for spinocerebellar ataxia, with a PDUFA date expected in 3Q 2025.
BHV-1300 achieved up to 84% reduction of total IgG in Phase 1 study with optimized subcutaneous administration.
First-in-human dosing with BHV-1400 achieved rapid, deep, and selective lowering of aberrant Gd-IgA1 in IgA nephropathy program.
Initiated first-in-human dosing with BHV-1600 in peripartum cardiomyopathy program, well-tolerated to date.
Biohaven
Biohaven
Forward Guidance
Biohaven anticipates several milestones in 2025 and 2026 across its various platforms, including clinical trial readouts, regulatory interactions, and the initiation of new studies.
Positive Outlook
- BHV-1300 Phase 1 completion with optimized subcutaneous formulation in 1H 2025.
- BHV-1310 FIH study initiation anticipated in 1H 2025.
- Phase 2 study in Graves' disease expected to initiate mid-2025.
- Phase 1 with BHV-1400 and BHV-1600 expected to be completed in 1H 2025.
- Pivotal major depressive disorder topline results expected in 2H 2025 for BHV-7000.
Challenges Ahead
- Focal epilepsy study topline results expected in 1H 2026 for BHV-7000.
- BHV-7000 did not statistically differentiate from the comparator arm on the primary efficacy endpoint of improvement from Baseline to Day 21 on the Young Mania Rating Scale in bipolar mania 3-week trial
- The company reported a net loss for the three months ended December 31, 2024 of $186.8 million, or $1.85 per share, compared to $144.8 million, or $1.81 per share, for the same period in 2023.
- The company reported a net loss attributable to common shareholders for the year ended December 31, 2024 of $846.4 million, or $9.28 per share, compared to $408.2 million, or $5.73 per share for the same period in 2023.
- The company is still awaiting results of critical Phase 3 data in each of their 2 identical ongoing studies in OCD.