Biohaven Ltd.

Good morning. Welcome to BioHaven Pharmaceuticals' fourth quarter 2020 and full year results call. At this time, all participants' lines are in listen-only mode. After the speaker's presentation, there will be a question and answer session. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's conference call may be recorded. I would now like to hand the conference over to BioHaven's Chief Operating Officer, Clifford Bechtold. Thank you, and you may now begin.

Good morning, and thank you. And welcome to the Biohaven's fourth quarter 2020 earnings call. Speaking on today's call are Dr. Vlad Torch, our Chief Executive Officer, Jim Englehart, Chief Financial Officer, Vijay Jones, Chief Commercial Officer, and Dr. Elise Stock, our Chief Medical Officer. Earlier this morning, we issued a press release announcing the fourth quarter 2020 highlights and a summary of our year-end results. A copy of this press release can be found on our website at biohavenfarmer.com and will be on file with the 10Q later filed today. Before we begin, let me remind everybody that today's discussion contains forward-looking statements based on the environment as we currently see it. It includes risks and uncertainties. A list and description of the 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 the forward-looking statements we make today. For this call, we will focus on non-GAAP financial measures with detailed descriptions of GAAP and non-GAAP analysis in our filings. An archive of today's call will be posted on the Live Havens website in the Investors section. With that, I'll turn the call over to our CEO, Dr. Vlad Charch.

Thank you, Cliff. Good morning to our investors, and thank you for joining the fourth quarter earnings call, representing our third full quarter of earnings since the launch of Nerdtech ODT. I'm pleased to report the company continues to excel in delivering a paradigm-shifting treatment for migraine, and more broadly, achieving our strategic goals across multiple areas to grow value for patients and investors in years to come. Our 2020 performance was simply stellar, and we exceeded expectations across multiple fronts. NERTEC ODT was approved approximately one year ago today, and despite facing what was perhaps the greatest challenge of any new drug launch with the emergence of the pandemic, the BioHaven team effectively and safely delivered our new migraine medication to patients. To date, we have achieved over 450,000 prescriptions of NERTEC, and access for patients is broad with greater than 89% commercial coverage. The progress of NERTEC has been exceptional, with fourth quarter net revenues of approximately $35 million, representing an increase of over 98% from the third quarter. Certainly a testament to our strong commercial team and the entire organization that fulfilled our responsibility to impatience, to ensure the drug supply chain remains strong during the pandemic. And together, we relieve suffering by delivering this novel migraine therapy to patients. I'm also pleased to report this morning that our NERTEC regulatory submission in Europe was recently accepted for review by the European Medicines Agency and is currently under review. We are excited about the potential of bringing NERTEC to patients around the globe and the European filing leverages the acute and prevention data packages from our FDA filings. The EMA package is the first European filing for a dual-acting migraine therapy for both acute and preventative treatment in one regulatory submission. We believe that Biohaven has the most broad and differentiated C-GRP antagonist platform in the pharmaceutical industry. Our strategic goals are straightforward. First, maximize patient and shareholder value by continuing to execute on our Neurotech launch. Migraine is a common and disabling disorder. We must efficiently deliver this new drug to patients and its differentiated profile to help them better treat their illness. We believe that our one-dose efficacy, returning patients to normal by 60 minutes, and long-lasting efficacy for two days after a single dose will ultimately win the oral CGRP class. Third, we will grow the market in acute, but we will also expand this important drug to patients with other indications through a disciplined lifecycle management, including the pursuit of indications such as prevention of migraine, pediatric migraine, post-traumatic headache, and other pain-related disorders. Finally, we are leading the way by establishing new treatment paradigms and approaches. This starts with our strategy to establish NERTTEC as the first and only dual-acting migraine therapy for both acute and preventive therapy in one pill. Never before has migraine been treated with one medication across its spectrum of acute to prevention. Additionally, we're following the science of CGRP antagonism by expanding it to several non-migraine indications, including psoriasis and asthma. NERTTEC is certainly the tip of the arrow when it comes to the Biohaven CGRP franchise. and we wanted to update you regarding its market growth on this slide. We continue to see robust and linear growth in the launch of NERTEC. Although we were second to market by a couple of months, our differentiated profile continues to drive demand from patients, and the new-to-brand Rx market share continues to almost be evenly split between the two approved oral CGRP antagonists. I'd like to thank our entire commercial organization for their dedication and delivering such strong market performance in 2020. For much of 2020, we heard directly from patients that their experience on NeurTech was quite different than past experiences with other standard of care medications. We believe that NeurTech has the potential to become the first line standard of care therapy for migraine given its efficacy and safe profile. This slide shows that we are just at the very beginning of our market penetration compared to the triptans. Over the last year, there were approximately 16 million prescriptions for triptans, and this slide shows that the oral TGRPs are steadily making progress by increasing market share compared to the triptans, and this is mainly due to our differentiated profile. This slide does not include the separate large population of patients who can't take triptans due to contraindications or patients who fail triptans. We believe that there is significant growth ahead for the oral CGRPs as the leading class of drugs for migraine. When we look at the CGRP targeting agents as a whole, it remains evident that oral CGRP antagonists have driven the lion's share of the overall CGRP market growth in 2020. This slide suggests that more effective acute therapy results in a diminished need for injectable preventative agents. We believe oral CGRP antagonists for the acute treatment of migraine will ultimately grow into a $4 to $5 billion annual market in the U.S. alone, and that's for the acute indication only. Given the projected size of the overall market, we remain focused on investing in the long-term success of NeurTech and growing the overall CGRP market. As we look to the future of our CGRP franchise, one of the biggest limitations of migraine therapy to date has been the bifurcated treatment paradigm. Since no single migraine therapy could previously treat acute episodes and also prevent the next attacks, patients have had to historically use one medication to treat acute episodes and a separate medication to prevent migraines. This has resulted in polypharmacy, which of course is complicated by different side effect profiles of each additional therapy, drug interactions, and added costs for payers and patients. We hope to bring an end to this treatment chasm. As we look towards our upcoming SNDA with prevention in the US and our recently submitted dual therapy filing in Europe, we want to empower patients and doctors to treat migraine across its spectrum. We want to get rid of these two different categories of acute and prevention and think of one. We believe the future state can be a single drug that treats acute episodes And that same drug at that same dose can simply be used more frequently to prevent migraines. If approved for prevention in 2021, NeurTech will represent a great advancement for millions of patients as we bring forward the first dual therapy oral CGRP antagonist for both the acute and preventative management of migraine. Patients deserve a unified treatment of migraine across its entire disease spectrum. and Biohaven hopes to deliver on that vision this next year. Think about the value proposition and simplicity that this will bring to patients suffering from migraines. The one treatment that acts fast, lasts, and prevents future migraines. One drug, one dose, The patient and physician simply change the frequency of use to meet each individual patient's need. Our vision is that NeurTech will become the one treatment that can deliver relief across the migraine spectrum from acute to prevention. Now, NeurTech is going to continue to be a key growth driver for our company this next year and beyond, but we have many other value inflection points for 2021 and future years. While the commercial organization continues to focus on driving sales of NeurTech, the rest of the organization will be equally focused on driving new value inflection milestones in the future. This slide summarizes the breadth of our pipeline and lifecycle management opportunities at Biohaven. Outside of the U.S., we expect to see global approvals of NeurTech beginning in 2021 and have already established distributor agreements in certain geographic regions. While we await our EMA approval for dual acting, we will advance discussions regarding ex-US partnering of NeurTech in Europe and other major markets. In addition to our lifecycle management in NeurTech, we expect to have top-line data from intranasal Zevegipant by the end of the year, and if positive, we'll be ready to file Zevegipant as the first intranasal CGRP antagonist for the ultra-rapid treatment of migraine. An oral version of Zovegapant is also set to begin clinical testing shortly in both migraine and non-migraine indications. Outside of the CGRP antagonist franchise, we also have important phase 3 study readouts in our myeloperoxase inhibitor and glutamate modulating platforms. For Depostat, a drug thought to decrease brain inflammatory pathways is expected to have top-line results in both MSA and and ALS later this year. Tririlazole, our glutamate modulator, is expected to have top-line data in SCA by the end of the year or early next year. We are also excited that our wholly-owned Asia-Pacific subsidiary, BioShin, is driving to file a public offering in either the Hong Kong or Shanghai exchange by the end of the year. NERTEC will be an important new treatment for the over 80 million Chinese suffering from migraines. Biohaven's robust pipeline is poised to continue to deliver value for patients and investors for the long term. Our R&D team has delivered on past milestones and has an exciting late-stage portfolio that we believe will continue to create value over the next year and beyond. To summarize, we have a strong portfolio of product opportunities that will deliver value for patients. Our goal is to continue to work hard to improve the lives of patients suffering from neurologic and neuropsychiatric disorders and continue to deliver best-in-class therapies from our promising pipeline for patients. With the establishment of the new bispecific platform in Biohaven Labs, you will hear a lot more about our antibody enhancers and extracellular degraders in future years that will enable us to branch out further beyond neuroscience, build additional partnerships, and deliver more medicines across multiple areas of serious unmet need. I will now turn it over to Jim Englehart, our CFO, to review the detailed results of our financial performance in the fourth quarter and the year end. Jim?