Biohaven Ltd.

Good morning, and welcome to the BioHaven Pharmaceuticals Q2 2021 earnings call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If anyone should require operator assistance, please press star zero on your telephone keypad. Please be advised that today's conference call may be recorded. I will now hand the conference over to Caroline Dirks from BioHaven. Thank you. Please go ahead.

Thank you, and welcome to the BioHaven second quarter 2021 earnings call. Speaking on today's call are Dr. Vlad Chorich, our Chief Executive Officer, Jim Englehart, Chief Financial Officer, BJ Jones, Chief Commercial Officer, and Dr. Elise Stock, Chief Medical Officer. Earlier this morning, we issued a press release announcing the second quarter 2021 highlights. A copy of this press release can be found on our website at biohavenpharma.com and we will file our Form 10-Q later today. Before we begin, let me remind everyone that today's discussion contains forward-looking statements based on the environment as we currently see it, and includes risks and uncertainties. A list and description of risks and uncertainties associated with an investment in Biohaven can be found in the company's filings with the U.S. Securities and Exchange Commission. Please be aware that you should not place undue reliance on any forward-looking statements we make today. For this call, we will focus on non-GAAP financial measures. Detailed descriptions of these non-GAAP measures and reconciliations to the most comparable GAAP measures can be found in our SEC filings. An archive of today's call will be posted to Biohaven's website in the Investor Relations section. With that, I will turn the call over to our CEO, Dr. Vlad Chorich.

Thank you, Caroline. Good morning to our investors, and thank you for joining our second quarter earnings call. This has been another transformational quarter for Biohaven. NERTEC ODT became the first oral CGRP targeting drug to be approved for the prevention of migraine and episodic patients and the first and only medication with a dual indication proven to treat acute migraine and prevent future attacks. How exciting. For the first time, patients and doctors can customize a single migraine therapy to treat and prevent migraines. I want to thank our R&D team, patients in our clinical trials, and the clinicians who helped attain the prevention approval. Together, we have changed the way migraine is being treated. Once again, our business performance this quarter has exceeded expectations on multiple fronts. NERTEC ODT net revenue in the second quarter was $93 million, which brings a cumulative launch-to-date net revenue to approximately $200 million. To date, we have achieved over 875,000 prescriptions of Neurotech ODT, and the oral CGRP market continues to show strong demand and quarter-over-quarter growth. Although much of our second quarter performance reflects the acute indication, we are very pleased to see robust growth in the new-to-brand Rx metric after the prevention approval. Our new-to-brand Rx market share as of this morning is now approximately 56%, reflecting robust demand from our dual indication. NeurTech ODT is providing fast and lasting relief to more and more migraine patients every day. The entire oral CGRP class is outperforming initial launch expectations and reflects the importance of these medications to individuals with migraines. The OROC GRP classes demonstrated strong and steady growth in RX volume. Neurotech ODT continues to drive demand, which is differentiated label and dual indications for acute and prevention. I want to thank our entire commercial team, managed markets, sales, and marketing groups for their determination and passion in delivering our market-leading new-to-brand RX metric this quarter. We believe that NeurTech ODT has the potential to become the first-line standard of care therapy given its efficacy and safety profile. Oral CGRPs are gaining market share compared to the older triptans, reflecting the limitations of prior therapies and the advantages of this new class. We believe there will be significant growth ahead as patients increasingly become informed about the fast and lasting benefits of NeurTech ODT. When we look at the CGRP targeting agents as a whole, it remains evident that oral CGRP antagonists continue to drive the growth of the overall CGRP targeting market. Injectable MABs are limited to prevention, and many patients may consider an injection less desirable compared to a simple oral pill. Given the projected size of the overall market, we remain focused and committed to investing in the long-term success of Neurotech ODT and growing the overall oral CGRP market. This morning, we are also very excited to share the news that the United States Patent and Trademark Office has awarded Biohaven a new patent covering our ODT formulation of Neurotech ODT. Innovation is at the core of our business and we have demonstrated the important differentiation of our ODT formulation with its fast onset of action and other attributes. It is so important to protect innovation and I would like to thank Warren Balls and our entire legal team for protecting our ideas in the marketplace. Without such IP protection, we cannot ensure the continued development of important new medications and formulations. This new patent, covers our API Remedipant as well as other CGRP inhibitors in an ODT formulation. The patent will extend until March 2039, not including potential patent term extensions. We believe that Biohaven has the most broad and differentiated CGRP antagonist platform in the pharmaceutical industry. At this time, we have over 10 CGRP clinical programs across both migraine and non-migraine indications that are currently running around the globe and aimed at areas of significant unmet medical need, including adolescent migraine, asthma, and psoriasis, just to name a few. We have also invested in numerous formulations and drug delivery options to optimize the PK and delivery to match each indication and each unmet need. This broad and diverse pipeline gives our CGRP franchise tremendous flexibility that can be optimized for various CGRP-mediated diseases outside of migraine. Our launch of NeurTech ODT and acute and preventative migraine is only the beginning of our franchise. We look forward to following the science of CGRP antagonism across neuroscience and immunoscience. In addition to our lifecycle management of NeurTech ODT, which includes the extension into pediatric migraine, we expect to have top-line data from intranasal Zavegapant soon, and if positive, we'll be ready to file Zavegapant as the first intranasal seizure P antagonist for the ultra-rapid treatment of migraine. An oral version of Zavegapant is also ongoing in clinical testing this year in migraine and non-migraine indications. There are approximately 1 billion individuals worldwide who suffer from migraine. Expansion of NERTEC-ODT beyond the United States has already begun with our two approvals for NERTEC-ODT in Israel and the UAE. We anticipate nine regulatory submissions across the globe by the end of this year. We have delivered great commercial success in the U.S., and we will continue to pursue that level of success with approvals in other regions of the world. NeurTech's significant paradigm shift will be able to improve the lives of many individuals living with migraine across the globe. In addition to our CGRP franchise, we also have multiple significant near-term milestones outside of CGRP anticipated in 2021 and the early part of next year. starting with top-line results earlier than expected with our MPO inhibitor Verdepristat in multiple system atrophy in the third quarter of 2021, and then this will be followed by additional readouts at the end of the year and next year. We anticipate that enrollment in the Phase III study of Verdepristat in ALS will complete in the fourth quarter, and Trurelizol is anticipated to read out top-line data in spinocerebellar ataxia early next year. We are excited by the potential of our pipeline to bring value to patients suffering from devastating neurologic disorders. And you're gonna hear a lot more about the details of our portfolio strategy from our CMO, Elise Stock, in just a few minutes. So to summarize, NERTEC ODT has exceeded all expectations in its brief 15 months since our initial approval back in March of 2020. And now with the approval of prevention, NERTEC ODT's new indication we are able to unlock our ability to reach more people and improve lives and create a legacy of countless stories of personal transformation. It remains a testament to our determined R&D and commercial teams that have fulfilled our responsibility to patients to ensure that we relieve suffering by delivering our novel migraine therapy to patients. One medication to treat and prevent delivers unprecedented personal control for patients. We have differentiated this product and are increasing revenue growth quarter over quarter, and we have a strong portfolio of product opportunities that we believe will deliver value for patients and investors, not only in the near term, but for years to come. Our goal is to continue to deliver best-in-class therapies from our promising pipeline for patients. Before our Chief Commercial Officer, BJ Jones, tells you some more details about the success of our commercial launch with NeurTech ODT, I'm going to turn it over to Jim Englehart, our Chief Financial Officer, to review the detailed results of our financial performance in the second quarter of 2021. Jim?