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Mar 31, 2024
Biohaven Q1 2024 Earnings Report
Biohaven reported first quarter 2024 financial results and recent business developments.
Key Takeaways
Biohaven reported a net loss of $179.5 million, or $2.20 per share, for the first quarter ended March 31, 2024. The company's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $287.6 million as of March 31, 2024, excluding net proceeds from a public offering completed in April 2024. Biohaven is advancing its pipeline with multiple clinical trials underway and INDs planned for its MoDE platform.
Reported preliminary safety and IgG lowering data from ongoing SAD study with BHV-1300.
Initiated Phase 2/3 program with BHV-7000 underway in epilepsy and also initiated a Phase 2 study in MDD and Phase 2/3 studies in Bipolar Disorder and Generalized Epilepsy with BHV-7000.
Taldefgrobep alfa awarded "rare pediatric disease" designation by the FDA.
Delivered oral and poster presentations at AAN showcasing breadth of development work across the platform.
Biohaven
Biohaven
Forward Guidance
Biohaven is positioned to achieve value-creating milestones in 2024 across numerous programs. The company plans to continue advancing Phase 2/3 programs in epilepsy, MDD and bipolar disorder, advance Phase 3 trials with troriluzole in OCD, initiate taldefgrobep Phase 2 study in obesity, report taldefgrobep Phase 3 topline results in SMA, initiate BHV-2100 Phase 2 study in acute migraine, conduct BHV-2100 proof of concept study for neuropathic pain, complete SAD/MAD studies with BHV-8000 and advance to Phase 2, and advance Phase 1 TROP2 directed ADC program with BHV-1510 in multiple tumor types.
Positive Outlook
- Continue to advance Phase 2/3 programs in focal epilepsy, idiopathic generalized epilepsy, MDD and bipolar disorder
- Continue two Phase 3 trials with troriluzole in OCD
- Initiate taldefgrobep Phase 2 study in obesity in 2H 2024
- Report taldefgrobep Phase 3 topline results in SMA in 2H 2024
- Initiate BHV-2100 Phase 2 study in acute migraine in 2H 2024
Challenges Ahead
- Conduct BHV-2100 proof of concept (POC) study for neuropathic pain in 2H 2024
- Complete SAD/MAD studies with BHV-8000 and advance to Phase 2 in 2H 2024
- A total of 4 Investigational New Drug Applications (INDs) are expected for the degrader program in 2024
- Provide progress updates regarding ongoing Phase 1 SAD study with BHV-1300 at annual R&D Day on May 29, 2024 followed up with a MAD update in 2H24
- Advance Phase 1 TROP2 directed ADC program with BHV-1510 in multiple tumor types