Financial Performance - The company reported a net loss of 1.70 per share, for Q3 2024, compared to a net loss of 1.50 per share, for the same period in 2023[12]. - Total operating expenses for Q3 2024 were 110,547,000 in Q3 2023[17]. - Non-GAAP adjusted net loss for Q3 2024 was 98,118,000 in Q3 2023, indicating a 67.1% increase[21]. - The company reported a non-GAAP adjusted net loss per share of 1.44 for Q3 2023[21]. - The net loss for Q3 2024 was 102,574,000 in Q3 2023, representing a 56.3% increase in losses[17]. Cash and Assets - As of October 2, 2024, the company reported cash, cash equivalents, marketable securities, and restricted cash totaling approximately 84,390,000 as of September 30, 2024, down from 510,523,000, slightly down from 1,158,871,000 as of September 30, 2024, up from 152,294,000 in Q3 2024, compared to 55,423,000 at the end of 2023[19]. - The number of outstanding shares increased to 1,381,699 as of September 30, 2024, from 887,528 at the end of 2023[20]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were 157.6 million, an increase of 95.5 million in Q3 2023, driven by advancing clinical trials[9]. - Research and development expenses rose to 95,517,000 in Q3 2023, reflecting a 65% increase[17]. - The company anticipates submitting a total of 4 Investigational New Drug (IND) applications in 2024 as part of its MoDE™ platform[8]. - The pivotal trial for troriluzole in spinocerebellar ataxia (SCA) achieved positive topline results, demonstrating a 50-70% slowing of disease progression, equating to a delay of 1.5-2.2 years over the 3-year study period[4]. - The company plans to submit a New Drug Application (NDA) for troriluzole to the FDA in 4Q 2024, following the positive trial results[4]. - The company initiated a Phase 2 trial for BHV-2100 in the acute treatment of migraine, with an expected enrollment of approximately 575 patients across 60 sites in the U.S.[5]. - Upcoming milestones include topline data from the Phase 3 trial of taldefgrobep alfa in spinal muscular atrophy (SMA) expected in 4Q 2024[7]. Expenses - General and Administrative (G&A) expenses for Q3 2024 were 15.0 million in Q3 2023, reflecting increased non-cash share-based compensation[10].
Biohaven .(BHVN) - 2024 Q3 - Quarterly Results