Biohaven .(US:BHVN)2022-11-09 21:19Financial Performance - For the three months ended September 30, 2022, total operating expenses were $67,637,000, an increase of 21.8% from $55,492,000 in the same period of 2021[9]. - The net loss attributable to common shareholders for the three months ended September 30, 2022, was $68,853,000, compared to a net loss of $54,365,000 for the same period in 2021, representing a 26.6% increase[9]. - The net loss per share attributable to common shareholders for the three months ended September 30, 2022, was $(1.75), compared to $(1.38) for the same period in 2021[9]. - For the nine months ended September 30, 2022, total operating expenses were $354.5 million, an increase of $186.5 million from $168.0 million in the same period of 2021[176]. - The company recorded a net loss of $68.9 million for the three months ended September 30, 2022, compared to a net loss of $54.4 million for the same period in 2021, an increase of $14.5 million[170]. - The provision for income taxes for the nine months ended September 30, 2022, was $14,581,000, compared to a benefit of $(1,091,000) in the same period of 2021[9]. Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2022, were $300,028,000, compared to $139,668,000 for the same period in 2021, reflecting a 114.4% increase[9]. - Research and development expenses for the three months ended September 30, 2022, were $52.8 million, up from $47.0 million in the same period of 2021, reflecting an increase of $5.9 million[172]. - The Company recorded $25,000 thousand to R&D expense during the nine months ended September 30, 2022, for a regulatory milestone payment due to Knopp[52]. - Research and development expenses for the three months ended September 30, 2022, were $23,048,000, up from $17,396,000 in 2021, reflecting a year-over-year increase of 32.1%[97]. - Research and development expenses for the three months ended September 30, 2022, were $9,722, down from $10,187 in 2021, indicating a decrease of 4.6%[61]. Cash and Financing Activities - Cash and restricted cash at the end of the period on September 30, 2022, was $51,418,000, down from $362,690,000 at the end of the same period in 2021[14]. - As of October 3, 2022, the Company had a cash balance of approximately $257,799 following a cash contribution from the Former Parent[32]. - The Company completed a public offering on October 25, 2022, resulting in net proceeds of approximately $282,763[32]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $222,282,000, compared to $112,784,000 for the same period in 2021, showing an increase of 97%[14]. - The company completed a public offering of 28,750,000 common shares at a price of $10.50 per share, raising approximately $282.8 million in net proceeds[184]. Company Structure and Spin-Off - Biohaven Ltd. became an independent, publicly traded company following the spin-off from its former parent on October 3, 2022, with 35,832,557 common shares issued[19]. - Following the Spin-Off on October 3, 2022, the Company issued an aggregate of 35,832,557 common shares to holders of Former Parent common shares[119]. - The Transition Services Agreement with the Former Parent includes provisions for finance, IT, clinical study support, and other services to ensure an orderly transition post Spin-Off[107]. Future Outlook and Risks - The Company faces risks typical of early-stage biotechnology firms, including the need for significant additional capital for research and development efforts[21]. - The Company’s future viability depends on its ability to raise additional capital to finance operations[33]. - The Company has incurred recurring losses since its inception and anticipates ongoing operating losses for the foreseeable future[31]. - The company anticipates needing to raise additional capital until it becomes profitable[191]. Clinical Trials and Product Development - The Company is focused on developing therapies for neurological and neuropsychiatric diseases, including epilepsy and mood disorders, with a broad pipeline of drug candidates[16]. - BHV-7000, the lead asset from the Kv7 platform, is currently in Phase 1 clinical trials, with expected results by the first half of 2023[132]. - The company aims to initiate at least one pivotal trial for BHV-7000 in epilepsy patients in the second half of 2023 if the Phase 1 study is successful[135]. - Taldefgrobep alfa (BHV-2000) is a Phase 3-ready anti-myostatin adnectin licensed from BMS, targeting neuromuscular diseases[144]. - The company commenced enrollment in a Phase 3 clinical trial of BHV-2000 for Spinal Muscular Atrophy, expecting to enroll approximately 180 patients[145].