Biohaven Ltd. Q4 FY2020 earnings call

• Nurtec ODT was launched approximately one year ago, navigating challenges from the pandemic, with over 450,000 prescriptions and greater than 89% commercial coverage.
• Regulatory progress: Nurtec's submission in Europe was accepted for review by the European Medicines Agency (EMA), leveraging acute and prevention data from FDA filings. The US sNDA for prevention is in a positive mid-cycle review.
• Pipeline updates: Intranasal zavegepant is expected to have top-line data by year-end, with an oral version set to begin clinical testing; myeloperoxidase inhibitor Verdiperstat and glutamate modulator Troriluzole have Phase 3 study readouts planned; BioShin subsidiary aims to file a public offering in Hong Kong or Shanghai Exchange by year-end.
• Commercial performance: Nurtec's differentiated profile drives demand, with new-to-brand Rx market share almost evenly split between approved oral CGRP antagonists; strong prescriber and patient trial growth is observed, with Nurtec prescribers showing higher productivity in writing prescriptions.

Nurtec ODT achieved fourth quarter net revenues of approximately $35 million, representing a 98% increase from the third quarter. This strong performance was driven by robust prescription volumes, with Nurtec ODT contributing significantly to the company's revenue.

• Management will not provide guidance regarding sales, spending, or earnings for 2021, but notes first quarter sales may be impacted by seasonality of patient deductibles and prescription re-authorizations.
• Expectations for multiple pivotal trial readouts over the next year and potential New Drug Applications (NDAs) in the coming years, including for prevention and other expanded indications.

• Impact of COVID-19 on access to physician offices, which affected RX volumes and could have influenced revenue.
• Regulatory review uncertainties for submissions in Europe and the US for various indications, including potential delays or questions from agencies.

Q: Charles Duncan asked about Nurtec's persistence and regulatory submissions for prevention and EMEA.

A: Vlad Coric responded that refill rates align with expectations based on migraine frequency, and the US sNDA for prevention is in a positive mid-cycle review. The European filing for dual-acting is based on US acute data.

Q: Paul Choi asked about regulatory review cycle and M&A filings.

A: Vlad Coric mentioned the EMA will review the European filing independently, with no specific timelines disclosed, and confidence in the package's independence from US reviews.

Q: Tyler Van Buren asked about Q1 trends and dual-acting messaging.

A: Vlad Coric and BJ Jones discussed seasonality impacts on Q1 sales and the disruptive messaging around unified migraine treatment with a single drug for both acute and prevention.

Q: Marc Goodman asked about spending and lifecycle extensions.

A: Jim Engelhart noted spending will continue to invest in the brand, and Vlad Coric discussed low-risk and high-risk lifecycle opportunities, including pediatric, post-traumatic headache, and non-migraine indications like psoriasis and asthma.

Q: Tim Lugo asked about European partners for Nurtec.

A: Vlad Coric mentioned considering regional and global partners for efficiency, balancing strengths of both types of partners to optimize market entry in Europe.