Biohaven .(BHVN) - 2024 Q3 - Quarterly Report

Financial Performance - Total operating expenses for Q3 2024 were $178.168 million, a 61.3$110.547 million in Q3 2023[11]. - Research and development expenses increased to $157.607 million in Q3 2024, compared to$95.517 million in Q3 2023, reflecting a 65% rise[11]. - Net loss for Q3 2024 was $160.304 million, compared to a net loss of$102.574 million in Q3 2023, representing a 56.3% increase[11]. - Cash used in operating activities for the nine months ended September 30, 2024, was $411.711 million, compared to$216.844 million for the same period in 2023, a 90% increase[14]. - The company expects to continue generating operating losses for the foreseeable future, indicating ongoing financial challenges[22]. Shareholder Equity and Shares - The weighted average common shares outstanding increased to 94,372,159 in Q3 2024 from 68,320,125 in Q3 2023, indicating a 38.2% increase[11]. - As of September 30, 2024, total shareholders' equity was $316,006, a decrease from$427,975 as of December 31, 2023, reflecting a net loss of $179,504 for the three months ended September 30, 2024[75]. - The company raised approximately$247,830 from a public offering of 6,451,220 common shares at $41.00 per share on April 22, 2024, and approximately$269,935 from another offering of 6,052,631 shares at $47.50 per share on October 2, 2024[82][83]. - The company issued 1,872,874 shares to Knopp, valued at approximately$65,981, as part of the Knopp Amendment in May 2024[79]. - As of September 30, 2024, the company had issued 4,248,588 common shares under the amended Equity Distribution Agreement, generating total net proceeds of approximately $146,250[85]. Cash and Investments - Cash, cash equivalents, and restricted cash at the end of Q3 2024 were$88.019 million, down from $125.990 million at the end of Q3 2023, a decrease of 30$294,211 in U.S. treasury bills with a fair value of $294,426 as of September 30, 2024, reflecting a gross unrealized gain of$215[44]. - The company’s total cash and cash equivalents decreased by 24.5% from $111,697 as of September 30, 2023[32]. - The company reported no proceeds from the sale of available-for-sale debt securities for the nine months ended September 30, 2024, compared to$4,920,000 in 2023[52]. Research and Development - Biohaven is focused on developing therapeutics in key areas such as immunology, neuroscience, and oncology, leveraging proprietary drug development platforms[16]. - The company is advancing its innovative portfolio in key therapeutic areas, including immunology, neuroscience, and oncology, with multiple proprietary drug development platforms[152]. - Troriluzole, the most advanced product candidate, is in two Phase 3 trials for OCD and plans to submit an NDA for Spinocerebellar Ataxia (SCA) to the FDA[156]. - The pivotal Study BHV4157-206-RWE demonstrated a 50-70% slower rate of decline in SCA patients treated with troriluzole compared to untreated patients, translating to a 1.5-2.2 years delay in disease progression over three years[163]. - The company announced a worldwide license agreement with BMS for taldefgrobep alfa (BHV-2000), a Phase 3-ready anti-myostatin adnectin, to enhance muscle mass and strength in neuromuscular conditions[174]. Future Plans and Milestones - The company plans to submit an NDA to the FDA in Q4 2024 for troriluzole, with potential commercialization in the U.S. in 2025 if approved[167]. - The Phase 3 program for OCD has an estimated total enrollment of up to 700 participants, with topline data expected in the first half of 2025[171]. - A Phase 2 clinical trial for taldefgrobep in metabolic disease is planned for Q4 2024 or early 2025[183]. - The company has potential future milestone payments under its licensing agreements of up to approximately $140,650,000,$641,975,000, and $2,150,450,000 for developmental, regulatory, and commercial milestones, respectively[100]. Accounting and Financial Reporting - The company is currently evaluating the impact of recently issued accounting standards on its consolidated financial statements[42]. - The company’s assessment of its ability to continue as a going concern involves estimating future cash inflows and outflows[28]. - The fair value of forward contract liabilities is determined based on significant inputs not observable in the market, representing a Level 3 measurement within the fair value hierarchy[41]. Non-Cash Expenses - The company recorded a non-cash share-based compensation expense of$34,877 for the three months ended September 30, 2024[75]. - The company reported total non-cash share-based compensation expense of $12,160,000 for the three months ended September 30, 2024, compared to$4,456,000 in 2023[91]. - The total unrecognized compensation cost related to unvested share options was $78,570,000, expected to be recognized over a weighted average period of 2.13 years[94].