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Dec 31, 2023
Biohaven Q4 2023 Earnings Report
Reported financial results and provided a review of recent accomplishments and anticipated upcoming developments.
Key Takeaways
Biohaven reported a net loss of $144.8 million, or $1.81 per share, for the three months ended December 31, 2023. The company is focused on advancing its clinical programs across five platforms and expects to deliver potentially groundbreaking data across three distinct programs.
Initiated first-in-human Phase 1 study with BHV-1300, with preliminary IgG lowering data expected in late 1Q 2024/early 2Q 2024.
Phase 3 database lock for interim efficacy analysis with troriluzole in OCD remains on schedule for 1Q 2024, with results expected in 2Q 2024.
Phase 3 topline data in ongoing fully enrolled SMA study with taldefgrobep expected 2H 2024.
Reported BHV-7000 Phase 1 study results, demonstrating it was well-tolerated at all doses studied without typical CNS adverse effects.
Biohaven
Biohaven
Forward Guidance
Biohaven anticipates achieving value-creating milestones in 2024 across multiple programs, including initiating Phase 2/3 trials, reporting topline results, and submitting IND applications.
Positive Outlook
- Initiate BHV-7000 Phase 2/3 program in focal epilepsy in 1Q 2024
- Initiate BHV-7000 Phase 2/3 study in generalized epilepsy in 2Q 2024
- Initiate BHV-7000 Phase 2/3 study in bipolar disorder in 1H 2024
- Initiate BHV-7000 Phase 2 study in major depressive disorder in 1H 2024
- Database lock in 1Q 2024 and report troriluzole Phase 3 interim efficacy analysis topline results in OCD in 2Q 2024
Challenges Ahead
- The expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials
- The timing of planned interactions and filings with the FDA
- The timing and outcome of expected regulatory filings
- Complying with applicable U.S. regulatory requirements
- The potential commercialization of Biohaven's product candidates