Biohaven .(US:BHVN)2025-08-11 20:19Financial Performance - Net loss for the three months ended June 30, 2025, was $198,147,000, compared to a net loss of $319,771,000 for the same period in 2024, indicating a reduction of approximately 38.0%[14] - The company reported a comprehensive loss of $198,223,000 for the three months ended June 30, 2025, compared to a comprehensive loss of $319,743,000 for the same period in 2024, a decrease of approximately 38.0%[14] - The segment net loss for the six months ended June 30, 2025, was $419,824,000, compared to $499,275,000 for the same period in 2024, indicating a decrease of about 16%[190] - The Company reported a total consolidated net loss of $198,147,000 for the three months ended June 30, 2025, compared to $319,771,000 for the same period in 2024, reflecting a decrease of approximately 38%[190] Assets and Liabilities - Total current assets decreased from $538,472,000 as of December 31, 2024, to $474,827,000 as of June 30, 2025, a decline of approximately 11.8%[12] - Total liabilities increased significantly from $191,671,000 as of December 31, 2024, to $415,828,000 as of June 30, 2025, representing an increase of approximately 117.5%[12] - The company has a significant accumulated deficit of $1,765,538,000 as of June 30, 2025, compared to $1,345,714,000 as of December 31, 2024, an increase of approximately 31.1%[12] - As of June 30, 2025, total assets measured at fair value amounted to $401,063,000, with cash equivalents of $88,944,000 and marketable securities totaling $149,050,000[65] Cash Flow and Investments - Cash and cash equivalents increased from $102,542,000 at the beginning of the period to $168,997,000 at the end of the period, reflecting a net increase of $66,455,000[19] - The company incurred a net cash used in operating activities of $333,060,000 for the six months ended June 30, 2025, compared to $270,435,000 for the same period in 2024, indicating an increase in cash outflow[19] - Cash and cash equivalents included $165,797 as of June 30, 2025, down from $239,147 in the prior year, reflecting a decrease of 30.7%[39] - The Company reported net investment income of $4,153 for the three months ended June 30, 2025, down from $5,100 in the same period of 2024, representing a decline of 18.5%[56] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $371,951,000, down from $470,791,000 for the same period in 2024, a decrease of approximately 21.0%[14] - Direct R&D program expenses for BHV-4157 (Troriluzole) were $14,245,000 for the three months ended June 30, 2025, down from $17,076,000 in 2024, a decline of approximately 17%[190] - R&D personnel expenses (excluding share-based compensation) for the six months ended June 30, 2025, were $41,627,000, compared to $37,202,000 in 2024, an increase of about 6%[190] - For the three months ended June 30, 2025, the Company recorded R&D expenses of $330,000, a decrease from $582,000 in the same period of 2024, representing a reduction of approximately 43%[185] Shareholder Equity and Stock Issuance - As of June 30, 2025, total shareholders' equity was $134,587, with a net loss of $198,147 for the quarter[98] - The Company issued 3,588,688 common shares as payment under license agreements, contributing $51,426 to equity[98] - 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[108] - The Company issued 1,872,874 common shares to Knopp, valued at approximately $65,981, as part of the Knopp Amendment in May 2024[102] Debt and Financing - The Company entered into a Note Purchase Agreement with a principal amount of $250,000, with an additional potential tranche of up to $150,000 contingent on FDA approval for troriluzole[40] - The Company entered into a Note Purchase Agreement on April 28, 2025, with an initial tranche of senior secured notes sold for an aggregate purchase price of $250,000[85] - A second tranche of up to $150,000 may be purchased, contingent upon FDA approval for troriluzole, with potential additional notes for $200,000 for permitted acquisitions[85] - The Company has granted a security interest in cash and equity interests related to troriluzole to secure obligations under the Note Purchase Agreement[93] Clinical Development and Regulatory Milestones - The NDA for Troriluzole in Spinocerebellar Ataxia has been accepted with priority review by the FDA, with a PDUFA date expected in Q4 2025[199] - The Company is advancing its innovative portfolio, including BHV-2000 (Taldefgrobep Alfa) for spinal muscular atrophy, with an FDA meeting scheduled in 1H 2025[198] - The pivotal Study BHV4157-206-RWE demonstrated a 50-70% slower rate of disease progression in SCA patients treated with troriluzole compared to untreated patients, translating to a delay of 1.5-2.2 years over the 3-year study period[205] - The study achieved its primary endpoint, showing statistically significant and sustained benefits on the f-SARA scale at years 1, 2, and 3 for patients treated with troriluzole[206] Legal Matters - A lawsuit was filed against the Company alleging federal securities law violations related to misstatements about BHV-7000's efficacy and clinical prospects[182]