Biohaven — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $129.3 million ($0.86 per share) for the three months ended September 30, 2026, compared to a net loss of $173.4 million ($1.64 per share) in the same period in 2025.
• Non-GAAP adjusted net loss was $110.7 million ($0.73 per share) for the quarter, compared to $155.9 million ($1.47 per share) in the prior year period.
• Research and development expenses were $101.9 million for the quarter, a decrease of $39.3 million (28%) from $141.2 million in the prior year period, driven by reduced direct program and preclinical spend following strategic reprioritization in Q4 2025.
• General and administrative expenses were $24.6 million for the quarter, a decrease of $3.6 million from $28.2 million in the prior year period, primarily due to decreased employee costs.
• Other expense, net, was $2.9 million for the quarter, compared to $3.8 million in the prior year period.
• Cash, cash equivalents, marketable securities, and restricted cash totaled approximately $164.0 million as of September 30, 2026.
• Total liabilities increased to $361.9 million as of September 30, 2026, from $399.4 million as of December 31, 2025, while total shareholders' equity turned negative to $(98.2) million from $52.1 million.
• Notes payable increased to $264.3 million as of September 30, 2026, from $238.9 million as of December 31, 2025.

Guidance and Future Outlook:

• The FDA user fee goal date for the Vyglxia (troriluzole) NDA resubmission in spinocerebellar ataxia (SCA) is set for the first quarter of 2027.
• Topline data for the RISE 3 pivotal Phase 3 trial of opakalim (BHV-7000) in epilepsy is expected in the second half of 2026.
• The pivotal Phase 3 trial for BHV-1400 in IgA nephropathy is targeted to initiate in the second half of 2026.
• Topline data for the Phase 2 obesity study of taldefgrobep alfa (monotherapy and combination with GLP-1) is anticipated in the second half of 2027.
• Biohaven plans to introduce additional innovative degraders from its MoDE and TRAP platforms in 2027.

Business Segments and Product Lines:

• Vyglxia (troriluzole): FDA accepted the NDA resubmission for SCA, considering it a complete response to the November 2025 action letter; an advisory committee meeting is anticipated.
• Opakalim (BHV-7000): Received an exclusive global license from SK Biopharmaceuticals for the Kv7 ion channel platform; SKBP assumes responsibility for future program costs. A partial clinical hold was issued on September 4, 2026, pausing new enrollment for BHV-7000 pending nonclinical data, though dosing for the >600 randomized patients in RISE 3 continues.
• MoDE Platform: Entered an exclusive license with Ono Pharmaceutical for the MoDE pan IgG degrader portfolio (led by BHV-1300) in Japan, South Korea, Taiwan, and ASEAN; Biohaven retains rights in the U.S., Europe, and China. BHV-1300 enrollment is ongoing in a Phase 3 trial for Graves' disease across >50 sites in the US and Canada.
• TRAP Platform: BHV-1400, a TRAP extracellular degrader targeting Gd-IgA1, is on track to initiate a pivotal Phase 3 trial in IgA nephropathy in 4Q 2026 across Japan, Asia-Pacific, US, Europe, and Latin America.
• Oncology: BHV-1530 (FGFR3-directed ADC) combination cohorts with LIBTAYO® are enrolling; early clinical activity shows confirmed partial responses in heavily pretreated patients. BHV-1510 endometrial expansion cohort enrollment is expected to complete in late 2026 to early 2027.
• Other Pipeline: Phase 2 obesity study for taldefgrobep alfa is ongoing; BHV-8000 (TYK2/JAK1 inhibitor) is in a global Phase 2/3 study for Parkinson's disease; BHV-8100 (PKM2 modulator) is in a first-in-human study.

Market and Competitive Landscape:

• The collaboration with Ono Pharmaceutical aims to strengthen Ono's late-stage pipeline in immunology and inflammation using Biohaven's clinically validated MoDE platform.
• The SK Biopharmaceuticals partnership positions opakalim with a leading epilepsy company for global commercialization.
• Biohaven is utilizing Bexorg's NeuroLens AI platform and BrainEx data to guide candidate selection and translational strategy for its neuroscience portfolio.

Risks and Challenges:

• A partial clinical hold on BHV-7000 (opakalim) requires completion of additional nonclinical studies to assess the risk of a specific metabolite observed in rodent testing; the significance of these findings to humans remains uncertain.
• Forward-looking statements regarding clinical trial outcomes, regulatory approvals, licensing closings, and payment receipts involve substantial risks and uncertainties.
• Post-trial motions have been filed regarding the $4 million trade secret misappropriation award against RA Capital and Avilar Therapeutics.

Management Commentary and Tone:

• Chairman and CEO Vlad Coric stated the quarter marked important progress in executing a strategy of building differentiated platforms and partnering them to create near-term and long-term value.
• Management highlighted the Ono and SK Biopharmaceuticals agreements as testament to the potential and versatility of the MoDE and TRAP platforms.
• Coric expressed confidence in the breadth of the pipeline, noting the company is well-positioned heading into a pivotal period.

Other Key Points:

• SK Biopharmaceuticals Agreement: Biohaven will receive $400 million in near-term cash consideration ($350 million at closing, $50 million one year later) plus up to $150 million in milestones and tiered royalties. The HSR waiting period expired on October 28, 2026.
• Ono Pharmaceutical Agreement: Biohaven received an $80 million upfront payment and is eligible for a $20 million milestone within a year, plus approximately 20% royalties on net sales in the licensed territory.
• Capital Position: Biohaven received $80 million from Ono on October 20, 2026, and expects to receive $350 million from SKBP upon closing.
• Legal Victory: The U.S. District Court confirmed a jury finding that RA Capital and Avilar Therapeutics willfully misappropriated a Yale trade secret, resulting in a $4 million award to Yale and Biohaven.
• Board Appointment: Technology investor John Yetimoglu was appointed to the Board of Directors in August 2026 to strengthen oversight of AI and computational methods.
• Share Count: Weighted average common shares outstanding were 151.0 million for the three months ended September 30, 2026, compared to 105.8 million in the prior year period.