Biohaven reports Q3 adjusted EPS ($1.44), consensus ($1.34)

Vlad Coric, M.D., Chairman and CEO of Biohaven, commented, “Our team at Biohaven continued to make tremendous progress this past quarter in advancing multiple development programs and innovating across our entire pipeline. Most recently, we shared important data from our molecular degrader of extracellular proteins (MoDE(TM)) program and demonstrated the potential for this technology in the field of immunology where targeting pathologic antibodies has been shown to have important therapeutic potential. We have demonstrated that BHV-1300, our lead IgG degrader, has great potential with a differentiated profile including: rapid onset of action, deeper reductions in IgG levels compared to FcRN targeting agents, lack of anticipated mechanistic effects on albumin or cholesterol, potential for self-administered subcutaneous dosing, and the compatibility to dose in combination with standard of care biologic therapeutic agents. BHV-1300 offers a highly competitive mechanism of action and potential for favorable differentiation from FcRn targeting agents. In addition, our technology can be readily modified to expand therapeutic targets past IgG to include other immunoglobulins and antigen specific autoantibodies. With multiple opportunities to address rare and common diseases alike, we continue to be impressed by the expansive potential of our degrader program. Beyond our extracellular degraders, we also shared key data from ongoing studies with BHV-7000, our highly selective Kv7.2/7.3 activator for epilepsy, mood disorders and pain. Consistent with results observed in clinical and non-clinical studies, EEG data reported last month confirmed CNS target engagement without showing waveform increases in frequencies typically associated with adverse events commonly associated with existing ASMs, such as somnolence and other CNS effects; we expect to present additional details and analyses from this EEG study at an upcoming scientific meeting soon. With target engagement now confirmed in EEG biomarker studies, a favorable safety profile demonstrated in Phase 1 studies, and development of a once-daily formulation of BHV-7000 complete, we look forward to initiating our Phase 3 program in focal epilepsy, which we expect to commence before the end of 2023 — a program poised to offer paradigm shifting potential in preventing seizures without burdensome CNS side effects. Separately, we completed enrollment in RESILIENT, our Phase 3 pivotal study of taldefgrobep alfa in SMA in record time, thanks to our partnership with the global SMA community and the remarkably efficient clinical trial expertise that we have in-house at Biohaven.” Dr. Coric continued, “With the closing of our recent public offering and achievement of several important milestones across our programs, we are in a strong position with access to approximately $495 million in capital following our public offering this month to continue to invest in accelerating and executing on our innovative pipeline. Our unwavering patient focus and methodical scientific approach drives every layer of our decision making, and we will progress and phase programs to balance our commitment with prudent resource allocation.”