Biohaven Ltd. Q4 FY2021 earnings call

• NURTEC ODT is the number one prescribed migraine treatment, with over 1.6 million prescriptions since launch and $463 million in net revenue for the year-end 2021.
• Global collaboration with Pfizer for rimegepant's global launch is underway, and the CHMP gave a positive opinion for rimegepant in the EU.
• Zavegepant's NDA submission for the U.S. is anticipated later in 2022.
• Acquired a Kv7 Ion Channel Activator for epilepsy and other neurologic indications and licensed Taldefgrobep from Bristol-Myers Squibb for spinal muscular atrophy.
• R&D investment in Q4 2021 was $76.4 million, up 32% from the prior quarter, driven by pipeline expansion. SG&A expense in Q4 2021 was $189.3 million, up 66% from the prior quarter, supporting NURTEC ODT commercial sales.

In the fourth quarter of 2021, NURTEC ODT achieved net sales of $190 million, demonstrating a 40% increase versus the prior quarter and a 440% year-over-year increase. For the full year 2021, NURTEC ODT net sales totaled $462.5 million, growing by $399 million or 627%. NURTEC ODT is the primary revenue contributor, with its strong performance driven by increased volume and improved net price realization.

• No formal guidance provided, but mentioned ongoing growth in NURTEC ODT sales and pipeline investments.
• Anticipated continued growth in the oral CGRP market and progress in regulatory submissions for rimegepant and zavegepant.

• Forward-looking statements based on current environment carry risks and uncertainties, detailed in the company's SEC filings.
• Risks associated with clinical trial outcomes, regulatory approvals, and market competition for pipeline assets.

Q: Could you give a sense of comfort around the Street’s NURTEC-specific revenues for this year around $850 million?

A: We don’t provide guidance. We expect modest increases on the expense side and have added promising assets.

Q: With new pipeline additions, how to balance spending on NURTEC and pipeline?

A: NURTEC has significant potential for multibillion-dollar net revenues. Acquisitions broaden the pipeline and strengthen the company.

Q: Earlier returns to growth in Q1, any color?

A: Somewhat slow in Q1 historically, but recent weeks show return to growth. Prescribers should use NURTEC for its convenience and minimal risk with great upside.

Q: Thoughts on anti-myostatin asset for SMA?

A: Scholar Rock data in SMA suggests efficacy. The asset is safe and well-tolerated in pediatric populations, and will be studied in combination with standard of care.

Q: Clinical differentiation for BHV-7000?

A: BHV-7000 is differentiated by dialing out GABA activity, reducing side effects, and has a better therapeutic index compared to existing Kv7 activators.

Q: Communication strategy for verdiperstat top line results?

A: Once top line data is available for verdiperstat, it will be revealed, with the top line expected around mid-year.