Biohaven Ltd.

Good morning. Welcome to the BioHaven Pharmaceuticals Q1 2021 earnings call. At this time, all participant lines are in a 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 Clifford Bechtold from Biohaven. Biohaven, thank you, and please go ahead.

Thank you, and good morning to everybody. And welcome to the Biohaven first quarter 2021 earnings call. Speaking on today's call are Dr. Vlad Torch, our chief executive officer, Jim Englehart, chief financial officer, BJ Jones, chief commercial officer, and Dr. Elise Stock, our chief medical officer. Earlier this morning, we issued a press release announcing the first quarter of 2021 highlights. A copy of this press release can be found on our website at biohavenfarmer.com, and we will file our Form 10-Q later 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, and 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 filing 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 to the Biohaven's website in the investor relations section. With that, I will turn the call over to our CEO, Dr. Vlad Chorch.

Thank you, Cliff. Good morning to our investors, and thank you for joining the first quarter earnings call, representing our first full year of earnings since the launch of NERTEC ODT. The company continues to excel in our launch of NERTEC ODT and, more broadly, advancing our strategic goals across the pipeline to grow value for patients and investors in years to come. Our first quarter 2021 performance continues to exceed expectations across multiple fronts. NeurTech ODT was approved a little more than a year ago, 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've achieved over 600,000 prescriptions of NeurTech ODT, and access for patients is broad with greater than 89% commercial coverage. While we had expected first quarter sales to be impacted by the seasonality of patient deductibles and prescription reauthorizations typically experienced in our business, NERTEC and our strong commercial team broke the mold and demonstrated exceptional delivery with first quarter net revenues of approximately $44 million for a year one post-launch net revenue total of $107 million. And climbing, I have to say. A testament to our determined commercial team and the entire organization that fulfills our responsibility to patients to ensure the drug supply chain remains strong during the pandemic. Together, we relieve suffering by delivering this novel migraine therapy to patients. In addition to NERTEC ODT, I'm also pleased to report that our internal robust pipeline continues to grow across both migraine and non-migraine indications in common and rare diseases. We believe that BioAvent has the most broad and differentiated CGRP antagonist platform in the pharmaceutical industry. At this time, we have over 10 CGRP antagonist clinical programs across both migraine and non-migraine indications running around the globe aimed at areas of significant unmet needs. In addition to our growing and robust CGRP platform, we continue to grow and expand the pipeline into areas including multiple system atrophy, ALS, spinal cerebellar ataxia, OCD, and others. These programs will bring treatment options to millions of patients suffering from rare and common diseases that are untreated or undertreated. Elise Stock, our CMO, will shortly speak in more detail regarding these programs, and I'm pleased to share that as we build our pipeline, our goal is to bring value to patients and shareholders for many years to come. We have multiple significant near-term milestones anticipated in 2021 and the early part of 2022, starting with anticipated approval in migraine prevention in the second quarter of 2021, and then followed closely by top-line results earlier than expected with our MPO inhibitor for defrostat in MSA in the third quarter. We anticipate the enrollment in our phase three study for defrostat in ALS being performed at Mass General, will now complete in the fourth quarter. Trobilizol is also anticipated to read out top line data in SCA at the end of the year or early in 2022. We are excited about the potential of our pipeline to bring value to patients suffering from devastating neurologic disorders and bring long-term value to our shareholders. Neurotech ODT continues to hold strong in the market as their differentiated product profile continues to drive demand. During this quarter, we have taken steps and have made appropriate and rigorous decisions to ensure our continued growth and future success with minimal impact to our share and NVRX. These decisions will allow us to see further improvement in GTN in the latter half of 2021. I'd like to thank our entire commercial organization and managed markets team for their dedication and continuing to deliver strong market performance in the first quarter of 2021. For much of 2020, we heard directly from patients that their experience on NeurTech ODT was quite different than past experiences with other standard of care medications. We believe that NeurTech ODT has the potential to become the first-line standard of care therapy, given its efficacy and safety profile. This slide shows that we are at the very beginning of our market penetration compared to the triptans, and a lot more growth is ahead of us. also shows that oral seizure P's are making steady progress in increasing market share specifically compared to the triptans due to this profile. I want to note that this slide does not include the separate large population of patients who can't take triptans due to contraindications or patients who have failed or don't show a full response to triptans. This type of growth early against the standard care medications is certainly boding well for the entire oral CGRP class and shows that we are changing the paradigm by which migraine is treated. When we look at CGRP targeting agents as a whole and refresh this slide, it remains evident that oral CGRP antagonists continue to drive the lion's share of the overall CGRP market. The slide also suggests that effective acute therapy results in a diminished need for patients to go on to injectable preventative agents. We believe oral CGRP antagonists for the acute treatment of migraine will ultimately grow into a $4 to $5 billion a year annual market in the U.S. alone. Given the projected size of the overall market, we remain focused on investing in the long-term success of Neurotech ODT and growing the overall oral CGRP market. Neurotech ODT is going to continue to be a key growth driver for our company this next year, but we have many other value effects and points for 2021 and beyond. While the commercial organization continues to focus on driving sales of Neurotech ODT, the rest of the organization will be equally focused on driving new value inflection milestones. This slide summarizes the breadth of our pipeline and lifecycle management opportunity at BioAven. Outside of the U.S., we have seen global approvals of Neurotech ODT begin in early 2021 and have already established distributor agreements in certain geographic regions. While we await our EMA approval for dual-acting therapy, we continue to advance discussions regarding ex-U.S. partnering of Neurotech in Europe and other major markets. In addition to our lifecycle management of Neurotech ODT, we expect to have top-line data from intranasals of Vegepant by year-end, and if positive, we will be ready to file the Vegepant as the first intranasal CGRP antagonist for the ultra-rapid treatment of migraines. An oral version of the VEGPAN is also set to begin clinical testing this year in migraine and non-migraine indications, giving our CGRP franchise flexibility in multiple formulations and different drugs that can be optimized for various CGRP-mediated diseases outside of migraine. Beyond the CGRP antagonist franchise, we also have important Phase III readouts in our myeloperoxase inhibitor and glutamate modulating platforms. For Depristat, a drug thought to decrease brain inflammatory pathways is expected to have top-line results in both MSA and ALS. Torrelizol, a glutamate modulator, is also expected to have top-line data by the end of the year or early next year. In addition, we have multiple assets moving through our Biohaven Labs discovery engine, bringing diversity to our portfolio and long-term value to Biohaven, and we anticipate some robust clinical candidates coming to to IND in the next year or so and enabling us to branch out further beyond neuroscience, build additional partnerships, and deliver more medicines across multiple areas of serious unmet need. 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. To summarize, we have a differentiated commercial product in NeurTech ODT that is generating increasing and impressive revenue growth, and we have a strong portfolio of product opportunities that we believe will deliver value for patients and investors in the near term, as well as for years to come. 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 pipelines for patients. I will now turn it over to Jim Englard, our Chief Financial Officer, to review the detailed results of our financial performance in the first quarter of 2021.