Biohaven Ltd. Q3 FY2020 earnings call

Vlad Coric's Statements - Highlighted Nurtec ODT's strong commercial performance with net revenues up 82% in Q3, over 220,000 prescriptions, and over 200 million covered lives with access. - Announced FDA accepted sNDA for Nurtec ODT in prevention with a 2021 PDUFA date. - Discussed pipeline progress including zavegepant's pivotal trial and Troriluzole's Alzheimer's trial. - Emphasized the company's diverse pipeline with multiple assets in various disease indications. ### Jim Engelhart's Statements - Reviewed financial results: net sales up 82% to $17.7M, SG&A expense $110.2M, R&D expense $51.8M, non-GAAP adjusted net loss $159.5M. - Talked about balance sheet strength with $550M in cash and marketable securities. ### BJ Jones' Statements - Updated on Nurtec ODT's market penetration, with 155% volume growth in Q3, over 20% unique writers, and positive brand perception. - Highlighted NURTEC ODT's differentiation from UBRELVY with neurologists showing a slight preference. - Mentioned over 90% awareness of the NURTEC ODT brand and progress on access and affordability. ### Elyse Stock's Statements - Highlighted R&D milestones, including sNDA acceptance for prevention, zavegepant's pivotal trial initiation, and Troriluzole's Alzheimer's trial progress. - Discussed global expansion of NURTEC ODT, including EU filing in Q1 2021 and Japan discussions. - Talked about upcoming key regulatory and trial milestones in rare diseases and other indications.

The key segment is Nurtec ODT. In the third quarter, net revenues from Nurtec ODT were $17.7 million, representing a greater than 80% increase compared to the second quarter. Nurtec ODT had over 220,000 prescriptions launched to-date, and there are now over 200 million covered lives with access to Nurtec ODT, attaining almost 87% commercial coverage to-date. Financially, net revenues for the three months ended September 30, 2020, were $17.7 million, SG&A expense on a non-GAAP basis was $110.2 million, R&D investment on a non-GAAP basis was $51.8 million, and non-GAAP adjusted net loss was $159.5 million.

- Expect continued market expansion of Nurtec ODT in migraine. ### - Anticipate at least four pivotal trial readouts over the next year. ### - Potential for multiple NDAs over the next couple of years as the company has important growth ahead.

- COVID-19 could place downward pressure on access to physicians and patients. ### - Uncertainty around regulatory approvals and market adoption of new products and indications.

Q: Comment on off-label prevention use and payer prior authorizations.

A: Vlad and BJ discussed early indicators of new patients and high approval rates in commercial space. Vlad mentioned seeing enthusiasm for the prevention sNDA but no significant off-label prescriptions yet, and BJ noted greater than 87% approval within the commercial space with few prior authorization denials.

Q: Top line results in Alzheimer's and 505(b)(2) filing.

A: Vlad discussed primary outcomes in the Alzheimer's trial (ADAS-Cog11 and CDR Sum of Boxes) and the 505(b)(2) filing process, stating the company is working on the submission package if results are positive.

Q: Gross-to-net, payer, and OTC market.

A: Vlad and BJ talked about gross-to-net trends, with Vlad noting gross-to-net will decrease in future years, and BJ mentioning high approval rates in payer space. They also discussed the potential OTC market expansion for Nurtec ODT.

Q: Pipeline probability and Alzheimer's readout.

A: Elyse and Vlad discussed pipeline probabilities, with Elyse stating it's hard to rank order but all trials are important. Vlad also discussed considerations for the Alzheimer's trial readout, including disease modification biomarkers.

Q: Prevention label impact and Troriluzole strategy.

A: BJ and Vlad discussed prevention label engagement, with BJ saying they will promote accordingly once approved. Vlad talked about Troriluzole's Alzheimer's filing plans, stating the company is working on the submission package for a positive Alzheimer's trial.

Q: Milestone confidence and Troriluzole effect size.

A: Jim and Vlad talked about milestone confidence, with Jim stating confidence in hitting milestones. Vlad discussed effect size in the Alzheimer's trial, noting it depends on symptomatic and disease-modifying effects.

Q: Volume, destocking, and Europe plan.

A: Jim, Vlad, and BJ discussed volume growth, with Vlad noting large increase in script volumes. Jim talked about no material destocking swings. Vlad discussed Europe filing plans, including EU filing in Q1 2021 and Japan discussions.

Q: Troriluzole filing and prescription migration.

A: Vlad and BJ discussed Troriluzole's filing priority, with Vlad stating Alzheimer's is the likely first indication if positive. BJ talked about prescription migration expectations, stating Nurtec ODT's unified treatment approach has potential to migrate prescriptions.

Q: SG&A, Europe plan, and prevention prescription.

A: Jim, Vlad, and BJ discussed SG&A, with Jim saying SG&A spending is driven by commercial investment. Vlad discussed Europe filing plans, and BJ talked about prevention prescription expectations, stating they will promote accordingly once approved.