Biohaven Ltd.

Good morning and welcome to the Biohaven Pharmaceuticals fourth quarter and full year 2021 earnings call. 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 will be recorded. I would now like to hand the conference over to Caroline Dirks from Biohaven. Thank you, Caroline. Please go ahead.

Thank you, and welcome to the BioHaven fourth quarter and full year 2021 earnings call. Speaking on today's call are Dr. Vlad Chorich, our Chief Executive Officer, Matthew Butin, Chief Financial Officer, BJ Jones, Chief Commercial Officer, and Dr. Elise Stock, Chief Medical Officer. Also speaking on today's call are Dr. Michael Bozic and Dr. Stephen Dworski, who will be joining BioHaven as President, Biohaven Labs, and Senior Vice President, Biohaven Labs, respectively, and Cliff Bechtold, President and General Manager, Biohaven Ireland. We are also pleased to announce the addition of Jennifer Porcelli to Biohaven Pharmaceuticals as Vice President, Investor Relations. Earlier this morning, we issued a press release announcing the fourth quarter 2021 highlights and a summary of year-end results. A copy of this press release can be found on our website at biohavenpharma.com, and we will file our Form 10-K 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 Chorch.

Thank you, Caroline. Good morning, and thank you to our investors for joining the year-end fourth quarter earnings call. Fourth quarter 2021 has been another standout quarter in what was simply an exceptional year for Biohaven. NERTEC ODT has become the number one prescribed migraine treatment in its class, allowing patients and doctors the ability to customize a single therapy to treat and prevent migraines. Business performance continues to exceed all expectations with 2021 year-end date sale revenues of $463 million in net revenue and over 1.6 million prescriptions since our launch. Our strong revenue growth highlights the value that our differentiated product brings to patients and physicians. The only simple-to-use oral migraine medication with dual indications to stop your migraine attack now and prevent your next one. Our global strategic collaboration with Pfizer for markets outside the U.S. is well underway, and our teams are working lockstep to prepare for an expanding global launch of Remedipant. This partnership will serve as a catalyst for the creation of a world-class migraine business that will open the door to delivering Remedipant to millions of patients around the globe. Imagine what our global commercialization with Pfizer will achieve for patients. We are extremely pleased to announce this morning the CHMP positive opinion for Remedipant in the EU, recommending the granting of a marketing authorization for the prophylaxis and acute treatment of migraine. I want to congratulate the Biohaven and Pfizer teams for this exceptional outcome and working closely with the CHMP to achieve this milestone. With recent positive data for our Our pivotal trial for MedJapan and acute treatment migraine in China and South Korea. We are targeting a regulatory submission in the second half of 2022. And if approved, this will unlock a market of greater than 120 million acute migraine patients in China who may benefit from the relief provided by the number one migraine treatment in its class. In addition to the market growth and anticipated expansion of NeurTech ODD around the globe, our team is completing the NDA submission of Zavegipant in the U.S., which we anticipate will be filed later this year. Zavegipant is the only intranasal CGRP receptor antagonist in late-stage development and has demonstrated an ultra-rapid onset of action within 15 minutes of administration. If ultimately approved, we believe that Zavegipant will provide an important treatment option to enhance speed to migraine relief, and a non-oral formulation for patients with prominent nausea or vomiting at the time of the migraine attack. While we are very proud of our robust CGRP franchise and the positive impact that it's having on patients, we continue to focus on advancing other novel and potentially best-in-class therapies for patients suffering from neurologic and neuropsychiatric disorders. We are excited to announce this morning the acquisition of two new platforms to our pipelines, We acquired what we believe is a potentially best-in-class KV7 ion channel activator for epilepsy and other neurologic indications that we will discuss in further detail later in this presentation. We are also pleased to report that we have licensed a late-stage myostatin targeting asset from Bristol-Myers Squibb that is expected to enter Phase III clinical trials in spinal muscular atrophy, or SMA, later this year. The license of Taldefgravet, will become the third drug candidate to enter the clinic that we have licensed from BMS. With the two additions to our portfolio announced this morning and the discovery engine of Biohaven Labs, our clinical pipeline is robust, and we believe will fuel the development of new, innovative drugs for patients. In the U.S., we have raced ahead of the competition, and Neurotech continues to be the number one migraine treatment in its class. Our commitment to innovation in the treatment of migraine is strong as we continue to strive for excellence and look forward to bringing this leading therapy to patients around the world. The new CGRP oral medications are just beginning to scratch the surface of the migraine market in the U.S. The oral CGRP class is showing strong growth and continues to gain momentum into 2022. To put the progress in perspective, oral CGRPs as a class recorded a remarkable net sales of approximately $1 billion in 2021, while only representing a small fraction, about 5% to 6% of the overall migraine scripts. We believe that the Oral-CGRP class will show growth for many years and ultimately will become first-line therapy for migraine. Looking specifically at fourth quarter market share versus Triptan, the Oral-CGRP has continued to gain market share. This reflects the limitations of these older therapies and the advantages offered by the new oral CGRP class. The oral CGRPs have shown quarterly increases in both TRX and NBRX volume compared to the tryptans. As you can see, there is a significant growth opportunity ahead of us, and we are already seeing the increased penetration of oral CGRPs as patients increasingly become more informed about the fast and lasting benefits of dual-acting NERTEC ODT. We continue to update this slide regarding the oral CGRP class penetration compared to the injectable monoclonal antibodies. Oral CGRP antagonists continue to drive the growth of the overall CGRP market. Injectable MABs are limited to prevention, and many patients consider an injection less desirable compared to a single dissolving pill. Given the projected size of the overall market, We remain focused and committed to investing in the long-term success of NERTEC ODT as the only medication that can provide acute and preventative treatment. Our world-class global commercialization partnership for Medjapant with Pfizer will allow us to bring what is the leading oral CGRP antagonist in the U.S. to patients worldwide suffering from migraines. Our mutual goal continues to be gaining approvals to deliver dual therapy neurotic ODT rapidly to as many patients as possible around the world. There are approximately 1 billion patients who suffer from migraine across the globe. The news released this morning regarding the positive CHMP opinion for Remedipant or Vidura, as it will be marketed in Europe, to treat acute and prevent episodic migraine is exciting. In addition to the regulatory progress in the EU, we also recently received positive phase-through data in our China-South Korea study for the treatment of migraine. We anticipate filing an NDA in China later this year. The global market opportunity for Mirage Japan is becoming a reality, and the expansion of neurotic ODT beyond the US continues to be robust. With multiple approvals in migraine for both acute and prevention, double-digit submissions across the globe, and multiple pivotal trials ongoing, we are seeing the results of our differentiated product. We are confident in the power of our collaboration with Pfizer and their long history of successfully launching and building partnered brands around the world. With the positive phase three data of Zavegapan, which is another cornerstone of our unparalleled CGRP franchise, Biohaven has the only intranasal CGRP antagonist with ultra-rapid migraine relief and the potential to usher in a new era of non-oral CGRP-targeting migraine therapies. Our CMO, Lee Stock, will update you on the progress in our regulatory efforts for Zevegipant later during the presentation. Now, moving from one cutting-edge development platform to the next, we are excited this morning to announce the acquisition of Channel Biosciences, a subsidiary of Knopp Biosciences and their KV7 platform. an innovative potassium channel platform that is expected to move into the clinic by the end of this year. Later in the presentation, you will hear directly from the clinicians and scientists who developed this platform. We believe the lead molecule, BHV7000, has the potential to be a best-in-class potassium channel modulator for epilepsy and represents a validated mechanism of action with other broad therapeutic applications. We are especially excited to welcome the entire KV7 team from channel biosciences or not biosciences to Biohaven. And this includes their leaders, Dr. Mike Bozic and Steven Duretsky, who will be joining our company to ensure that the lead assets are efficiently advanced to patients. Mike and Steven will be discussing the exciting program with you in more detail shortly. In what has been a morning filled with new announcements, we are pleased to announce more breaking news with the acquisition of Taldef Gravep from Bristol Myers Squibb. Taldef Gravep is an anti-myostatin adenectin and a phase three ready asset that already had a sizable human safety database in pediatric populations. Given the recent proof of concept data, Of other myostatin-targeting agents, our intention is to initiate a Phase III study in the first half of 2022 for the treatment of spinal muscular atrophy. Importantly, this acquisition further extends the neuroscience R&D collaboration between BioHaven and BMS. This is our third late-stage asset licensed from BMS to enter the clinic, and Cliff Bechthold, who previously was the development lead for this asset at BMS, will speak in more detail about this differentiated product in just a few minutes. To summarize, we have a strong portfolio of product opportunities that we believe will deliver value for patients and investors in the near term and for years to come. Our goal is to continue to deliver best-in-class therapies from our promising pipeline for patients across the globe. I'd like to now introduce Matthew Beaton, our new Chief Financial Officer who joined us in December. As a former Managing Director of Foresight Capital, Matt brings to Biohaven more than 20 years of experience in healthcare investment, investment banking, and strategic structuring deals for both large and small cap companies. We are thrilled to have him. I would also like to thank Jim Englehart for his long service and dedication to Biohaven. We wish Jim well in his much deserved retirement. Matt will now review the details and results of our financial performance in the fourth quarter and year-end of 2021.