Biohaven .(US:BHVN)2024-11-12 21:16Financial Performance - The company reported a net loss of $160.3 million, or $1.70 per share, for Q3 2024, compared to a net loss of $102.6 million, or $1.50 per share, for the same period in 2023[12]. - Total operating expenses for Q3 2024 were $178,168,000, a 61.2% increase from $110,547,000 in Q3 2023[17]. - Non-GAAP adjusted net loss for Q3 2024 was $164,134,000, compared to $98,118,000 in Q3 2023, indicating a 67.1% increase[21]. - The company reported a non-GAAP adjusted net loss per share of $1.74 for Q3 2024, compared to $1.44 for Q3 2023[21]. - The net loss for Q3 2024 was $160,304,000, compared to a net loss of $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 $642 million[1]. - Cash and cash equivalents decreased to $84,390,000 as of September 30, 2024, down from $248,402,000 at the end of 2023[18]. - Total assets as of September 30, 2024, were $510,523,000, slightly down from $513,212,000 at the end of 2023[19]. - The accumulated deficit grew to $1,158,871,000 as of September 30, 2024, up from $499,292,000 at the end of 2023[20]. - Current liabilities increased significantly to $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 $62.1 million compared to $95.5 million in Q3 2023, driven by advancing clinical trials[9]. - Research and development expenses rose to $157,607,000 in Q3 2024, compared 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 $20.6 million, up from $15.0 million in Q3 2023, reflecting increased non-cash share-based compensation[10].