Workflow
Biohaven (BHVN) Earnings Call Presentation
Biohaven .Biohaven .(US:BHVN)2025-07-04 11:59

Pipeline Highlights - Troriluzole's NDA is under priority review for Spinocerebellar Ataxia (SCA), with a PDUFA date in 2H 2025[14, 118, 434], and if approved, commercial launch is expected in 2H 2025[434] The company estimates there are approximately 15,000 SCA patients in the US[441, 502] and troriluzole reduced SCA disease progression by 50% to 70% in RWE study[463, 468, 473, 501] - Kv7 activator BHV-7000 expects topline results for Major Depressive Disorder (MDD) in 2H 2025[14, 158, 161, 216] and Phase 3 focal epilepsy study topline results in 1H 2026[14, 158, 163] - Taldefgrobep Alfa has a planned FDA interaction in 1H 2025 regarding the Spinal Muscular Atrophy (SMA) registrational path[12, 396] and a Phase 2 obesity study is planned for 2H 2025[12, 342] - IgG Degrader BHV-1300 is expected to initiate a pivotal Graves' disease study in 2H 2025[10, 85, 90, 91, 40, 42] and Myasthenia Gravis study in 2026[10, 42, 93, 94] - Gd-IgA1 Degrader BHV-1400 completed Phase 1 and is expected to initiate a pivotal IgA Nephropathy (IgAN) study in 2026[10, 42, 47, 64] - β1AR AAb Degrader BHV-1600 expects to complete Phase 1 in 2H 2025 and initiate a pivotal Peripartum Cardiomyopathy (PPCM) study in 2026[10, 42, 114, 119] Immunology & Inflammation Platform - The company's MoDE and TRAP degraders have been dosed in 166 individuals[35] - BHV-1300 achieved median maximal reductions in total IgG of 83% by day 18[70, 73] - A single subcutaneous dose of BHV-1400 delivered rapid, selective, deep, and sustained reductions in Gd-IgA1 of up to 81% without suppression of healthy immunoglobulins[55] Oncology Platform - Trop2 ADC BHV-1510 is in Phase 1, with interim data expected in 2H 2025[12, 524, 581] Preliminary data shows tumor reduction in first 6 patients treated with BHV-1510 + cemiplimab combination[543, 546] - FGFR3 ADC BHV-1530 initiated Phase 1 in April 2025[12, 524, 576, 581] Financial Update - The company has approximately $518 million in cash[578, 579] - Potential royalties from Pfizer could reach up to $400 million per year, based on low- to mid-teens % of annual US net sales of rimegepant and zavegepant exceeding $525 billion[577, 578]