Biohaven Ltd. Q1 FY2021 earnings call

• NURTEC ODT launched over a year ago, with over 600,000 prescriptions and >89% commercial coverage. First quarter net revenues were ~$44 million, post-launch net revenue total $107 million. • Robust pipeline across migraine and non-migraine indications, including over 10 CGRP antagonist clinical programs. Anticipated milestones in 2021-2022 include approval in migraine prevention Q2 2021, top line results for MPO inhibitor in MSA Q3 2021, enrollment completion in Phase III study for ALS in Q4 2021, and top line data for troriluzole in SCA by end of 2021/early 2022. • Commercial team focused on driving sales of NURTEC ODT, with confidence in continued growth and market penetration of oral CGRP agents.

NURTEC ODT achieved net sales of $43.8 million in Q1 2021, a 25% increase from Q4 2020. On a non-GAAP basis, SG&A expenses in the quarter were $130.9 million compared to $85 million in the prior year quarter, an increase of $45.9 million. R&D investment on a non-GAAP basis was $74.1 million compared to $49.8 million in the prior year quarter, an increase of $24.3 million. NURTEC ODT contributed significantly to revenue, with net sales of $43.8 million in Q1, representing a key segment performance.

• Anticipate approval in migraine prevention in Q2 2021. • Top line results for MPO inhibitor in MSA in Q3 2021. • Enrollment completion in Phase III study for ALS in Q4 2021. • Top line data for troriluzole in SCA by end of 2021 or early 2022. • Expect continued market expansion of NURTEC ODT and at least 4 pivotal trial readouts over the next year.

• External variables like COVID resurgence and weather can affect prescription volumes. • Variability in GPM numbers due to tweaking affordability programs and learning curves. • Challenges in payer negotiations and ensuring consistent GPM numbers as the year progresses.

Q: Ken Catacora asked about interactions with the agency regarding the prevention label and sampling support for launch.

A: Vlad Coric said they are at appropriate interactions with the agency and look forward to their decision. BJ Jones reinforced they will retain acute commercial access and pursue preventive access, with no major changes to sampling strategy.

Q: Ken Catacora also asked about degree of sampling support needed for prevention approval.

A: Vlad Coric mentioned prevention uses the same dose and APAC, streamlining launch, and BJ Jones added they believe in retaining acute access and have fruitful early discussions with payers.

Q: Kyuwon Choi asked about flat antibody growth and positioning of vazegepant.

A: Vlad Coric said flat growth may be due to acute therapy reducing need for mAbs, and vazegepant provides flexibility in prevention and non-migraine indications.

Q: Christopher Joseph asked about primary care vs specialist sales effort.

A: BJ Jones said they have transitioned to focus on primary care, building on initial specialty clinic focus.

Q: Marc Goodman asked about gross to net and spending.

A: Vlad Coric said there were variables like rule changes in affordability programs and external factors, and Jim Engelhart explained spending drivers including stock-based comp and timing of investments.

Q: Charles Duncan asked about vazegepant fit in CGRP franchise and pipeline assets.

A: Vlad Coric said vazegepant is complementary to NURTEC ODT, with intranasal for ultra rapid onset and oral for prevention and other diseases, and pipeline assets have improved chances of success due to Phase II data.

Q: Unidentified Analyst asked about productivity with market reopening and payer dynamics.

A: BJ Jones said they expect increased productivity as market reopens incrementally, and there is ongoing payer dialogue for prevention but no immediate landings.

Q: Vamil Divan asked about European partnership discussions and patient severity.

A: Vlad Coric said they are balancing partnerships and local groups, and most patients have less frequent migraines.

Q: Douglas Tsao asked about Script data dynamics.

A: Vlad Coric said they are focused on becoming market leader, with script numbers affected by affordability program changes.

Q: Esther Rajavelu asked about MPO inhibitor commercial environment and Nurtec patient proportion on mAbs.

A: Vlad Coric said MSA diagnosis is straightforward in specialty centers, and there's no specific quantifiable number on patients on mAbs also getting Nurtec scripts.