Biohaven .(BHVN) - 2025 Q2 - Quarterly Results

Biohaven Second Quarter 2025 Business and Financial Update Q2 2025 Key Highlights Biohaven ended Q2 2025 with $408.2 million cash, awaiting FDA decision for VYGLXIA, and reported significant clinical progress Financial Position as of June 30, 2025 | Metric | Value (USD) | | :--- | :--- | | Cash, cash equivalents, marketable securities and restricted cash | ~$408.2 million | - The New Drug Application (NDA) for VYGLXIA in spinocerebellar ataxia (SCA) is under review, with a PDUFA date set for Q4 2025[4] - MoDE degrader BHV-1300 demonstrated IgG reductions up to 87% in Phase 1, while TRAP degrader BHV-1400 showed sustained Gd-IgA1 reductions over 80%, highlighting potential in immune-mediated diseases[4] - The next-generation Trop2 ADC, BHV-1510, showed early clinical activity, with tumor reduction observed in the first 6 patients treated in combination with cemiplimab[4] - A pivotal Phase 2/3 study was initiated for BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor, in patients with Parkinson's disease[4] CEO Commentary CEO expressed optimism for VYGLXIA's decision and highlighted progress across I&I, Ion Channel, and Oncology platforms - The company is preparing for a potential commercial launch of VYGLXIA for spinocerebellar ataxia (SCA), pending FDA approval, to address a high unmet need[3][5] - Progress in the Inflammation and Immunology (I&I) platform is highlighted by compelling data from MoDE/TRAP degraders (BHV-1300, BHV-1400) and the initiation of a pivotal study for the brain-penetrant TYK2/JAK1 inhibitor (BHV-8000) in Parkinson's disease[3] - The Ion Channel platform (Kv7) continues to advance, with promising early observations from the compassionate use of opakalim in a pediatric epilepsy patient[3] - The Oncology platform is generating promising early clinical data, with BHV-1510 showing tumor reduction in the first six patients treated with cemiplimab, and BHV-1530 (FGFR3-directed ADC) advancing into clinical testing[3] Recent Business Highlights Biohaven reported positive degrader data, advanced oncology, initiated Parkinson's study, and discontinued troriluzole for OCD - The MoDE program's BHV-1300 achieved IgG reductions up to 87% in a Phase 1 multiple-dose study, suggesting potential for treating diseases like Graves' and rheumatoid arthritis[6] - The TRAP degrader BHV-1400 achieved rapid, deep, and sustained reductions in Gd-IgA1 of up to 81% after a single dose in a Phase 1 study, targeting IgA Nephropathy[6] - The Trop2-directed ADC, BHV-1510, demonstrated early clinical activity, with tumor reduction in all six of the first patients treated in combination with cemiplimab[6] - A pivotal Phase 2/3 study of the brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, was initiated for the treatment of early Parkinson's disease[6] - The Phase 3 trial of troriluzole in Obsessive-Compulsive Disorder (OCD) was completed with no efficacy signal detected, leading to the termination of the OCD development program[7] Expected Upcoming Milestones Biohaven anticipates key milestones through 2026, including VYGLXIA PDUFA, registrational degrader studies, and BHV-7000 results - VYGLXIA (Glutamate Modulator): A PDUFA date for the SCA NDA is expected in Q4 2025, with the company preparing for a potential commercial launch[8] - MoDE/TRAP Platforms: A Phase 1b study for BHV-1300 in Graves' disease is set to begin in 2H 2025, with a potentially registrational study also expected in 2H 2025. A potentially registrational study for BHV-1400 (IgA nephropathy) is expected to start in 2026[11] - BHV-7000 (Kv7 Activator): Pivotal topline results are anticipated in 2H 2025 for major depressive disorder and in 1H 2026 for focal epilepsy[11] - Taldefgrobep alfa (Myostatin): A Phase 2 study in obesity is expected to be initiated in 2H 2025[11] - ADC Platform: Phase 1/2 studies with BHV-1510 and a Phase 1 study with BHV-1530 will continue to advance through 2025[11] Financial Performance This section details Biohaven's Q2 2025 financial position, operating expenses, net loss, and balance sheet Capital Position Biohaven maintained a strong capital position with approximately $408.2 million in cash and marketable securities as of June 30, 2025 Cash Position | Date | Metric | Value (USD) | | :--- | :--- | :--- | | June 30, 2025 | Cash, cash equivalents, marketable securities and restricted cash | ~$408.2 million | Second Quarter 2025 Financial Highlights Biohaven's Q2 2025 net loss narrowed to $198.1 million due to decreased R&D expenses, despite increased G&A Q2 Financial Performance (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $184.4 | $314.8 | ($130.5) | | G&A Expenses | $27.3 | $19.0 | $8.4 | | Net Loss | ($198.1) | ($319.8) | $121.7 | | Net Loss Per Share | ($1.94) | ($3.64) | $1.70 | | Non-GAAP Adj. Net Loss | ($166.4) | ($308.6) | $142.2 | - The $130.5 million decrease in R&D expenses was primarily due to a one-time non-cash expense in Q2 2024 for a milestone and royalty buyback related to the BHV-7000 platform, partially offset by increased direct program costs in 2025[10][12] - The $8.4 million increase in G&A expenses was mainly driven by higher non-cash share-based compensation and fees related to a Note Purchase Agreement entered into during Q2 2025[13] Consolidated Statements of Operations Biohaven reported Q2 2025 total operating expenses of $211.7 million and a net loss of $198.1 million, a significant improvement Consolidated Statements of Operations Highlights (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $184,367 | $314,819 | | General and administrative | $27,334 | $18,953 | | Total operating expenses | $211,701 | $333,772 | | Loss from operations | ($211,701) | ($333,772) | | Net loss | ($198,147) | ($319,771) | | Net loss per share | ($1.94) | ($3.64) | Consolidated Balance Sheets Biohaven's total assets decreased to $550.4 million as of June 30, 2025, with liabilities increasing to $415.8 million, reducing equity Consolidated Balance Sheet Highlights (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $165,797 | $99,134 | | Marketable securities | $239,183 | $386,857 | | Total current assets | $474,827 | $538,472 | | Total assets | $550,415 | $615,107 | | Total current liabilities | $124,324 | $154,226 | | Notes payable | $257,070 | $— | | Total liabilities | $415,828 | $191,671 | | Total shareholders' equity | $134,587 | $423,436 | Reconciliation of GAAP to Non-GAAP Financial Measures Biohaven reconciled Q2 2025 GAAP net loss of $198.1 million to a non-GAAP adjusted net loss of $166.4 million GAAP to Non-GAAP Net Loss Reconciliation (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP net loss | ($198,147) | ($319,771) | | Add: non-cash share-based compensation | $20,812 | $12,232 | | Add: loss from change in fair value of derivatives | $10,970 | ($1,040) | | Non-GAAP adjusted net loss | ($166,365) | ($308,579) | GAAP to Non-GAAP Net Loss Per Share Reconciliation (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP net loss per share | ($1.94) | ($3.64) | | Non-cash share-based compensation per share | $0.20 | $0.14 | | Loss from change in fair value of derivatives per share | $0.11 | ($0.01) | | Non-GAAP adjusted net loss per share | ($1.63) | ($3.52) |