Biohaven Ltd.

Quarter 2021 earnings call. Speaking on today's call from Biohaven 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. We also welcome Nick Ligonowitz, Global President, Pfizer Internal Medicine. Earlier this morning, we issued a press release announcing the third quarter 2021 highlights. A copy of this press release can be found on our website at biowaveandpharma.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 Shorch.

Thank you, Caroline, and good morning. And thank you to our investors for joining the third quarter earnings call. This has been another exceptional quarter for Biohaven. Not only has NERTEC ODT become the number one migraine treatment in its class, allowing patients and doctors to customize a single migraine therapy to treat and prevent attacks, but we are also excited to announce an outstanding strategic commercialization collaboration with Pfizer for markets outside the United States. It is an ideal collaboration that combines our neuroscience R&D expertise with Pfizer's commercialization and marketing excellence to pave the way to bring Remedipant to as many patients as possible around the world. I want to thank the teams at Pfizer and Biohaven who worked tirelessly in the last few weeks and over last night to make this collaboration agreement a reality. Thanks to the teams. And I also want to thank Nick Lagunowitz, the global president of Pfizer Internal Medicine, who is on the line joining us today to speak about Pfizer's impressive global go-to-market commercial capabilities in just a few minutes. Our business performance this quarter continues to exceed all expectations across multiple fronts. NERTTEC ODT net revenue in the third quarter was $136 million, which brings a cumulative launch-to-date net revenue to approximately $336 million. We have a differentiated commercial product in NERTTEC ODT that continues to generate increasing and impressive revenue growth. To date, we have over 1 million prescriptions of NERTTEC ODT, and the demand in the oral CGRP market continues to show strong growth quarter over quarter. We're very pleased to see the continued strength in the NBRS metric after the prevention approval, as demonstrated by increasing to a 57% market share, reflecting robust demand for the dual indication. NERTEC ODT is providing fast and lasting relief to more and more migraine patients each day. The entire oral CGRP class is outperforming initial launch expectations and reflects the importance of these medications to individuals with migraine. Neurotech ODT is now the number one migraine treatment in its class. I want to thank our entire commercial, managed market, sales, and marketing teams for their determination and passion to continue to deliver our market-leading NBRX metric again this quarter. Today, Biohaven welcomes Pfizer as our global commercialization partner for Remedipant. As many know, that's known by Neurotech in the United States. Pfizer's commercialization reach and marketing expertise is unmatched in the pharmaceutical industry, making it the ideal collaborator to accelerate access of Remedipant to the more than 1 billion patients worldwide who suffer from migraines. We believe a collaboration between Pfizer and Biohaven brings together the winning combination of Biohaven's neuroscience R&D with Pfizer's brand strength and a vast global marketing network to deliver shareholder and patient value. Building upon the rapid success in the United States, our mutual goal is to gain approvals to deliver dual therapy NeurTech ODT rapidly to as many patients as possible around the world. With Pfizer's global clinical, regulatory, medical, patient advocacy, and commercial footprint, we can accelerate the access of Remedropant around the globe. Jim Englehart, our CFO, will discuss the finances of the global partnership in more detail in just a few minutes. But to summarize, this collaboration strengthens Biohaven's cash position with Pfizer's significant investment in Biohaven, $150 million in cash up front and $350 million in the purchase of Biohaven equity at a 25% premium, sales and development milestones, and the potential for long-term revenue on tiered double-digit royalties from net sales outside of the United States. Time and time again, we hear from patients and physicians that NeurTech ODT is changing the way migraine is treated and is improving the lives of patients with migraine. Partnering with Pfizer will allow us to ensure that we'll be able to more efficiently deliver Remedipant to the large patient population across the globe who have been disabled and suffer from migraines. As you know, Pfizer has a strong history and vast experience in launching innovative products globally and drive market growth around the world. In addition to this strategic collaboration, we'll allow Biohaven to capitalize on Pfizer's deep PCP footprint as PCPs are the key in the management of migraine and pain in the ex-U.S. markets. We are confident in the power of this collaboration given Pfizer's long history of successfully launching and building partnered brands. With this alliance, there's an opportunity to bring this best-in-class migraine therapy to patients outside the US and potentially change the paradigm in the other regions of the world. Under the terms of the agreement, Biohaven would remain primarily responsible for further clinical development of Remedipant, and the parties will cooperate in regulatory activities to secure approval for the product. Pfizer will commercialize Remedipant upon approval in all regions outside the United States, while Biohaven continues to solely commercialize Neurotech ODT in the United States. Additionally, per the arrangement, Pfizer gains rights outside of the U.S. to Zevegapan, our third-generation, high-affinity, selective, and structure-unique CGRP receptor antagonist currently being studied in both an intranasal delivery and a soft-shell formulation in stage 3 trials. We are all aware of Pfizer's track record of success. global reach and execution outside of the US. As Pfizer has accomplished numerous times before with big drugs such as Eliquis, we believe that our collaboration with Pfizer can transform Remedipant into a massive global brand in regions and markets that today we just couldn't do alone. Success will be achieved by working together and unlocking access to the many patients with migraine worldwide. I'm excited to be able to announce this global collaboration Pfizer is a world leader in global R&D and commercialization with impressive milestones that we highlighted as a reason why they were the partner of choice to drive Remedipant and its success around the globe. We believe a collaboration between Pfizer and BioAvent will bring together a winning combination. Next, I will turn the call over to Nick Lagunowicz, Global President of Pfizer Internal Medicine, to comment on our collaboration. And I must say that Nick's team is really unmatched in the pharmaceutical industry in terms of the commercialization and marketing expertise of multiple breakthrough medications. Nick?

Thank you, Vlad. I am very happy to be here this morning on behalf of Pfizer. We're excited about the partnership with Biohaven and even more excited to add Remedipant to our global portfolio outside of the U.S. We're looking forward to joining forces with Biohaven to help patients around the world who are impacted with this debilitating neurological disease. When we look at the numbers, they certainly tell a story, I think, but more important than the numbers is Pfizer's purpose, and that is to deliver breakthroughs that change patients' lives. Here at Pfizer, we apply science. and our global resources to bring therapy to people that extend and significantly improve their lives through the discovery, development, and manufacture of medicines and vaccines. And for decades, we've been at the forefront of advancing world-renowned breakthrough medicines and vaccines with global impact. Our portfolio includes more than 30 key medicines and many more medicines beyond that, several of which represent true breakthroughs, such as Comirnaty, Eloquist, Vindimax, and iBrants, to name a few. And our expansive footprint spans over 125 countries around the world. As of Q3, the Pfizer XUS revenues were $35.4 billion, but more importantly, we're very, very proud of the numbers of patients that we've impacted positively around the world. In fact, during the first nine months of 2021, our innovative medicines and vaccines reached nearly a billion people globally. We're excited about the opportunity to collaborate with Biohaven, to have an even greater impact on patients around the world who experience debilitating migraines. I want to congratulate Vlad and the BioHaven team on their success in achieving the rapid uptake of Remedipant in the US, which certainly speaks to the unmet need and the value of the medicine. And we plan to build off that success to drive strong uptake in markets around the world. We think about pillars for launch and what's required to launch successfully. We begin with securing access and optimal value. which we'll achieve through focusing on the unmet need of the patients and appropriately engaging the right patient populations. To drive rapid uptake, we'll leverage our go-to-market expertise and digital innovation to reach neurologists and specialists with information about this valuable treatment option. And we'll ensure long-term success by leveraging our scale and capabilities, along with our industry-leading customer base and colleagues, to reach PCPs, specialists, and health systems with the right information at the right time. With these three principles applied broadly and in coordination, I'm confident that we'll be able to accelerate access and fuel uptake of Remedjapan in markets outside of the U.S. Vlad, thank you for the opportunity to join your call today and for your partnership. I believe together we can help patients suffering from this debilitating disease. Now it's my pleasure to turn it over to Jim Englehart, CFO, Biohazard.