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 Dircks 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 Coric, our Chief Executive Officer, Matthew Buten, Chief Financial Officer, BJ Jones, Chief Commercial Officer, and Dr. Elyse Stock, Chief Medical Officer. Also speaking on today's call are Dr. Michael Bozik and Dr. Steven Dworetzky, who will be joining Biohaven as President, Biohaven Labs, and Senior Vice President, Biohaven Labs, respectively. 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 Coric. 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. Nurtec 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-to-date sales 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 rimegepant. This partnership will serve as the catalyst for the creation of a world-class migraine business that will open the door to delivering rimegepant 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 rimegepant 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 in working closely with the CHMP to achieve this milestone. With the recent positive data for our pivotal trial of rimegepant in the acute treatment of migraine in China and South Korea, we are targeting a regulatory submission in the second half of 2022. 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 Nurtec ODT around the globe, our team is completing the NDA submission of zavegepant in the U.S., which we anticipate will be filed later this year. Zavegepant 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 zavegepant 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 their 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 pipeline. 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 taldefgrobep alfa 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 Nurtec 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%-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 CGRPs continue 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 triptans. 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 Nurtec 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 Nurtec ODT as the only medication that can provide acute and preventative treatment. Our world-class global commercialization partnership for rimegepant with Pfizer will allow us to bring what is the leading oral CGRP antagonist in the U.S. to patients worldwide suffering from migraine. Our mutual goal continues to be gaining approvals to deliver dual therapy Nurtec 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 release this morning regarding the positive CHMP opinion for rimegepant or VYDURA, 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 II 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 rimegepant is becoming a reality, and the expansion of Nurtec ODT beyond the U.S. 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 III data of zavegepant, 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, Elyse Stock, will update you on the progress in our regulatory efforts for zavegepant 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, BHV-7000, 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 Knopp Biosciences to Biohaven, and this includes their leaders, Dr. Michael Bozik and Steven Dworetzky, 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 taldefgrobep alfa from Bristol Myers Squibb. Taldefgrobep alfa is an anti-myostatin adnectin in a phase III-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 Bechtold, 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 Buten, our new Chief Financial Officer, who joined us in December. As a former Managing Director of Foresite Capital, Matt brings to Biohaven more than 20 years of experience in healthcare 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 Engelhart 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. Thank you, Vlad. First, let me say how thrilled I am to be here for today's call. As many of you have seen, I joined the Biohaven team in early December, right off the heels of the company announcing an incredible strategic collaboration with Pfizer, enabling us to gain access to their industry-leading expertise and global footprint to turbocharge global commercialization efforts for rimegepant. I've been following Biohaven's progress for many years while I was at Foresite, and I couldn't be more enthusiastic about the opportunity to join this incredible team, especially at a time like this as I look at the opportunities in front of us. Some of the guiding principles that I've incorporated in my role from learnings during the transition of my predecessor, Jim Engelhart, are threefold. Maximizing value for shareholders is top of mind, ensuring we're adequately capitalized, limiting dilution for shareholders whenever possible. This was and will continue to be a critical focus for us. This dovetails into the next key tenet of our strategy, which is ultimately getting to a place of profitability. This is critical for us, ensuring we are well-positioned to realize long-term revenue streams. We have obviously made tremendous inroads since the launch of our dual acute prevention label, and we see strong growth as we eventually pursue more of the extension opportunities for Nurtec in pediatric migraine, pain adjacencies, and other non-migraine indications. Finally, maintaining that steadfast financial discipline while continuing to ensure we are driving access and new patient starts. Investing wisely in a brand that is still relatively new in a market that only continues to grow rapidly. These are the critical components of our strategy, and I look forward to sharing more updates in the months ahead as we make progress. With that in mind, let me take you through some of the financial highlights from the past year. The press release we issued this morning contains details of our financial results for the fourth quarter of 2021, with further details in our 10-K, which should be filed shortly. Rather than read through all those details, my comments will focus on some key financial results. Nurtec ODT achieved net sales of $190 million in Q4, demonstrating another quarter of strong performance, increasing 40% versus Q3, and increasing 440% year-over-year, driven largely by increased sales volume in Nurtec ODT and expanded and improved managed care reimbursement. The oral CGRP market continues to grow at an exceptional pace, carving out a small but expanding market share for migraine drugs, while generating almost While generating over $1 billion in revenues last year. In total, oral CGRP market revenues grew greater than 400% for the full 2021 year, while Biohaven grew revenues over 600%. As the market continues to grow, we expect to see higher-than-market rates of growth for the oral class of CGRPs, as well as for Biohaven. In the fourth quarter, we benefited from a large and growing market, which supported higher volume. In addition, we had some favorable seasonality, which impacted us in a few ways. Higher volume and net price, as payer constraints on patients such as deductibles and coinsurance were largely satisfied, resulting in reduced co-pay assistance for Biohaven. This is in addition to direct efforts we made to encourage refills. We also experienced favorable payer mix with lower rebate payers. We discussed the influence of positive seasonal factors as well as market growth in our Q4 results during webcast presentations and investor meetings, as well as last year on our year-end earnings call. Many of these favorable contributors we experienced in Q4 are typical and expected with patient-supported pharma programs, and may pull back along with the typical seasonal changes anticipated in Q1, and it could have an impact on volume as well as sequential revenues. Now as we go down the P&L, R&D investment in the quarter on a non-GAAP basis was $76.4 million, compared to $57.8 million in the prior quarter, an increase of $18.6 million or 32%. The increase is primarily due to continued funding of post-approval international and pipeline expansion spending for rimegepant as well as our late-stage product candidates, including zavegepant, troriluzole, and Verdiperstat, which combine with the vast majority of our spend. SG&A expense in the quarter on non-GAAP basis was $189.3 million, compared to $114 million in the prior quarter. An increase of $75.3 million or 66%. Most of our SG&A costs continue to support commercial sales of Nurtec ODT as we invest behind our novel dual indication therapy with less than 50% of spend on personnel costs and the rest supporting our promotional spend. Now moving on to the full year 2021 results. Nurtec ODT achieved net sales of $462.5 million for 2021, growing $399 million or 627%, demonstrating very strong performance. This is driven by increased volume in Nurtec ODT, which benefited from a partial year of sales associated with the expanded label to include prevention, compared to a partial year of sales in 2020 with only the acute label. Net revenues were also benefited by improvements in net price realization. R&D investment for the year ended 2021 on a non-GAAP basis was $287.1 million, compared to $195.4 million in the prior year period, an increase of $91.7 million or 47%. Again, the increase was primarily due to our continued investment in our post-approval international and product expansion opportunities from rimegepant as well as other late-stage product candidates in preclinical research. The late-stage products I mentioned earlier also comprise the vast majority of our spend for the year. SG&A expense for 2021 on a non-GAAP basis was $623.6 million, compared to $428.6 million in the prior year, an increase of $195 million, or 45%. The increase was primarily due to increased promotional activity supporting Nurtec ODT commercial sales in 2021 for the treatment and prevention of migraine, which got its dual indication approval on May 21. Compare that to the same period in 2020, which reflects pre-commercial and promotional Nurtec ODT spend, which was launched in March 2020. Now turning to our balance sheet. Pro forma for the closing of our collaboration and subscription agreements with Pfizer in early January, we have access to approximately $1 billion in liquidity. As of December 2021, we have $ 367 million in cash and cash equivalents and marketable securities, immediate access to $125 million from our debt facility with Sixth Street, and an additional $500 million of cash we received on January 4th from Pfizer. Let me echo what Vlad said about our excitement over our recently announced acquisition of Channel Biosciences, adding a valuable Kv7 program for epilepsy and potentially other indications to our pipeline. The terms of the deal are as follows. Upfront consideration comprises $65 million of Biohaven stock and $35 million in cash. Success-based milestone payments broken down as follows: BHV-7000 regulatory milestones of up to $325 million for U.S., EMA, and Japan approvals for epilepsy, and $250 million for additional geographies and additional indications for Kv7. BHV-7000 sales-based commercial milestones of up to $562.5 million, with the full amount achievable upon reaching $3 billion in annual sales. We'll pay scaled royalties for BHV-7000 of high single digits to low teens. For additional programs, we'll pay starting royalties in the mid single digits. With that, let me turn it over to BJ Jones, our Chief Commercial Officer. BJ? Thank you, Matt, and good morning, all. 2021 has been a transformational year for Biohaven and Nurtec ODT. We remain enthusiastic about the brand's success to date and the significant impact we've had in the lives of so many patients with migraine and their loved ones. Looking back at the year, Nurtec ODT experienced strong and steady growth in market as healthcare professionals and patients became more familiar with the brand's unique and what we believe to be best-in-class profile. We began the year singularly focused on promotion in acute therapy, which produced a healthy growth curve through the spring. Once Nurtec received agency approval for preventive therapy, we witnessed dramatic acceleration in our growth rate with early traction among established prescribers, as well as those new-to-brand. We remain confident that Nurtec ODT's unique profile, as the first and only medication proven to treat and prevent migraines, is well-positioned to shift the paradigm in migraine treatment to dual therapy. We're very pleased with fourth quarter sales of $190 million, an increase of 40% over prior quarter, which totaled $463 million in our first full year of commercialization. With Nurtec ODT only now approaching its second anniversary in market, we have achieved $526 million in revenue since launch. We're certainly proud of our commercial team and what it's accomplished with passionate support from every member of the Biohaven family, because we realize that every prescription filled is a potential life-changing moment for patients and those they love. The new year brings with it tremendous opportunity as the oral CGRP class continues to penetrate what is a highly dissatisfied market. As Vlad mentioned earlier, we're witnessing significant penetration of the generic triptan market, as well as significant growth from patients who haven't filled a prescription in years and have made do with over-the-counter meds and other means to address their migraine attacks. With the tremendous clinical advance of oral CGRPs, we see old habits changing. In the most recent Spherix data, evidence suggests physicians are optimistic about gepants and expect their adoption to accelerate in the months ahead. Not surprisingly, we see a similar dynamic among preventive therapies. Physicians predict strong uptake of oral CGRPs, specifically Nurtec, while generic therapies continue to erode over time. Although changing physician prescribing behavior doesn't happen overnight, these data are a leading indicator of the evolution taking place across the migraine market that will come to fruition in the months and years to come. Another leading indicator is physician satisfaction with migraine therapies, and as you can see by this graph, oral CGRPs dominate. Even among these impressive class data, a consistent theme shows Nurtec is the brand of choice among physicians. Highlighted here, we see Nurtec chosen as the brand with the highest level of satisfaction. As the market leader, Nurtec is poised to benefit differentially by the growth dynamic among the oral CGRPs. We're also encouraged by the class volume growth within the last few weeks. In early Q1, we anticipated slower uptake for all the seasonal factors that are endemic to our industry, i.e., new year insurance plan changes, deductible annual resets, prescription acceleration in year-end refills in Q4, et cetera. We are seeing earlier return to growth trends than in years past. In closing, 2021 has been an amazing year. We're pleased with our position as market leader in a rapidly growing market with high unmet needs. We continue to perform well across all launch measures as prescriber and patient trial and advocacy steadily grow. In addition, I'm pleased to report we've maintained Nurtec's extremely strong formulary access for both acute and preventive indications. With that, I'd like to introduce you to another Nurtec patient, Greg, with a great testimony to share. "I'm a retired Green Beret from the Army. 21 years, seven combat tours. I have a TBI and bad migraine headaches. I started to take Nurtec ODT, and I think it has changed my life. I used to live in my closet. Between migraine headaches and all my other problems after seven combat tours, I had lost hope. Nurtec has made my life so much better. I've now started Blue Ridge Safehouse. It's a nonprofit to help active duty guys like me. Patients like Greg and so many others make what we do every day so incredibly worthwhile. At this point, I'd like to hand it over to my partner, Elyse Stock, our Chief Medical Officer. Thank you, BJ. Oh my goodness, so much has happened in this last quarter, and I'm really delighted to share it with you. Before I start, I really want to thank the fantastic people that I work with at Biohaven, because they are really the ones who are delivering the milestones that I'll be sharing with you this morning. With these talented individuals, we will be able to unleash the potential of our multiple assets and bring multiple therapies to patients here in the U.S., as well as with our Pfizer colleagues across the globe. So far this year, and I'll remind you, we're only in February, we're delivering on important milestones. Just yesterday, we received news of a positive opinion from the CHMP on our filing of Nurtec for both acute and preventive treatment of migraine. This quarter, we also had positive top-line results from our Nurtec acute treatment of migraine study in Asia. At the end of last year, we delivered positive results on our second registrational intranasal zavegepant trial. We're expecting further milestones to be achieved over the course of the year, but I'll delve into each of our most recent achievements just a bit more. Our impressive CGRP franchise at Biohaven is just unparalleled in our industry. Nurtec ODT remains our cornerstone marketed product and the only oral migraine product indicated for the acute treatment of migraine, as well as for prevention. Yesterday, we got news from the CHMP that we've been given a positive opinion on our Nurtec submission for this dual treatment. For those of you following closely, we were not required to attend an oral explanation. We were quickly able to address all of the issues raised and really appreciate the speed and collaborative nature of the European regulators. The ability to treat a large number of patients across the migraine continuum is a truly innovative approach to the treatment of migraine, and we look forward to an approval over the coming weeks. Earlier this month, we also announced positive results from our fourth positive phase III study of rimegepant for the acute treatment of migraine, which was conducted in China and Korea. The study met its co-primary endpoints of freedom from pain and freedom from the most bothersome migraine-associated symptom, also known as MBS, which includes nausea, phonophobia, and photophobia at two hours following a single oral dose of rimegepant. As seen in the graph, a single oral dose of rimegepant 75 milligrams provides statistically significant relief of migraine symptoms and return to normal function at two hours and delivered sustained efficacy that lasted up to 48 hours for many patients. Rimegepant showed broad efficacy across multiple clinically meaningful endpoints at a favorable safety and tolerability profile that was consistent with prior clinical trial results in the United States. Our work with Pfizer has brought us great collaborative colleagues, and I'm confident that they will be able to take these tremendous accomplishments and expand our global footprint, bringing relief to patients suffering with migraine across the globe. As I've said before, we will continue to expand our program with life cycle studies of Nurtec ODT, both within neuroscience as well as explore a wide variety of scientifically relevant indications outside of migraine as we follow the science of the CGRP antagonist. Earlier this month, we enrolled our first patient in a Nurtec study of rhinosinusitis. This is just one of the Nurtec studies we intend to begin this year. Investigator-initiated trials, phase IV clinical trials, and studies in health economics will add to the wealth of information that will ultimately be available for Nurtec and will help define the scope of important information for patients, providers, and payers, both within the U.S. as well as globally. We recently announced positive results from our intranasal zavegepant phase III study. Its co-primary endpoints of pain freedom and freedom from MBS at two hours were statistically significant and replicated the results seen in our positive phase II study. As we hoped, it confirmed an ultra-rapid speed of onset with pain relief differentiating from placebo as early as 15 minutes with a single dose. After the zavegepant treatment, patients who previously experienced moderate to severe pain achieved reductions to mild or no pain. We anticipate a filing of intranasal zavegepant for the acute treatment of migraine in the first half of this year, 2022. Our oral formulation of zavegepant is being evaluated now in a phase III study in chronic migraine. We continue to just make great progress across all of our late-stage assets, including our glutamate modulating agents and our myeloperoxidase inhibitor platform. Over the coming months, we will see top-line readouts and are excited about all of the opportunities that we've got across both common and rare diseases. Our Biohaven Labs also remain busy with its early discovery work, and it continues just to grow. We have more than 10 pre-clinical programs that include both novel small and large molecule approaches. These currently target over 12 indications with high unmet medical needs. Our pipeline is not only advancing, but it's growing. We're delighted to have just announced the acquisition of Channel Biosciences, and we are really delighted to welcome their team into the Biohaven family. Their innovative potassium channel modulation platform is exciting, and we believe that the unique and differentiated pharmacology of their lead compound will allow us to effectively study pediatric and adult seizure disorders. I'll let Mike and Steven tell you about it in just a moment. Additionally, we've added taldefgrobep, Crobac, and anti-myostatin assets to our portfolio, and you will hear more about that as well. We will continue to make strategic decisions across the portfolio as our data matures with both external partnerships and internal programs. Our pipeline is large and growing, and I'm really excited about Biohaven's future. It's a real pleasure to be able to turn the call over to Mike Bozik and Steven Dworetzky to speak about Biohaven's newest innovative platform technology, Kv7. Thank you, Elyse. We couldn't be more delighted to be joining Biohaven Labs at such an exciting time for the business, and we're pleased to be delivering our Kv7 platform to the capable and efficient hands of Biohaven Pharmaceuticals. We founded the Kv7 platform at Channel Biosciences to address an ancient disease and also one of the most prevalent. In the United States alone, 3.5 million people suffer from epilepsy, a disease that can take over and disrupt your life because of seizures that can strike at any moment, and comorbidities like depression and migraine headaches. Focal epilepsy is the most common form of the disease, affecting both children and adults, and for many patients, it's not easily treated. In fact, focal epilepsy is refractory in one in three adults and one in four children, often requiring two or more medications in highly individualized treatment regimens. Epilepsy is not only difficult to treat, but tragically, it can also be lethal. Each year, more than one in 1,000 people with epilepsy die from SUDEP, or sudden unexpected death in epilepsy, in a person who was otherwise healthy. Clearly, there's a missing piece in epilepsy treatment, and from the start, we targeted a critical regulator of neuronal excitability called Kv7, a voltage-gated potassium channel present in the brain. The field discovered Kv7 about three decades ago, but unlocking the pharmacology has proven difficult. Although targeting Kv7 has been clinically validated as a mechanism for seizure treatment, existing Kv7 activators carry tolerability risks. We believe our in-house team of biologists and medicinal chemists have cracked the Kv7 code. We have a library of small molecules in the platform with different pharmacology profiles and that have the potential for development in adjacent indications beyond epilepsy. We believe our lead molecule, BHV7000, shows potential to be a best-in-class Kv7 activator. BHV7000, the lead candidate to emerge from our platform, was rationally designed to target Kv7. Importantly, it's structurally distinct from two other Kv7 activators, ezogabine and XEN1101, with patent life to at least 2039. Its profile is also highly differentiated because we dialed out the GABAergic activity intrinsic to these competing molecules. We expect BHV7000 to be in the clinic this year, an important next step in delivering what we hope will be a key missing piece for the treatment of epilepsy. The molecule also benefits from rare pediatric disease designation from the FDA. All in all, we're coming to Biohaven with a potential best-in-class treatment for epilepsy and with follow-on compounds from our Kv7 platform with the potential to treat other types of epilepsy as well as pain disorders and affective disorders. With that, I'll turn it over to my friend and colleague of 30 years, Dr. Steven Dworetzky. Thanks, Mike. Let me reinforce being excited about the opportunity to be joining Biohaven Labs and working with the team to deliver BHV-7000 for rapid and efficient development by this organization. As Mike mentioned, we see BHV-7000 as highly differentiated from the existing Kv7 modulators, ezogabine and XEN1101. Those first- and second-generation drugs clinically validated Kv7 as a compelling target in epilepsy, but with attributes we have worked hard to overcome. For example, on the left panel, ezogabine is chemically unstable to light, and its label cites the risk of blue skin discoloration, as well as a boxed warning for potential retinal effects and vision loss. In contrast, BHV-7000 is stable to photooxidation. Shown in the middle panel, XEN1101, like ezogabine, has significant activity at the GABA A receptor, which may account for the off-target activities responsible for somnolence, dizziness, fatigue, and other tolerability issues that have been reported. In comparison, as you can see, BHV-7000 has negligible activity for GABA A receptors. Our aim from the start was to avoid these liabilities while also maintaining potent anti-seizure efficacy in vivo. Put another way, we want to maximize the therapeutic index by putting as much distance as possible between efficacy and intolerability. As shown on the right panel, BHV-7000 attains that goal as both a potent activator of the Kv7 channel and was effective in preclinical seizure assays and was well-tolerated. Allow me to share more detailed evidence in the following slide. Epilepsy happens to be a disease where the preclinical assays have excellent predictive validity in humans. What we're showing here on the left graph in the green circles is the number of animals protected from seizures with increasing dose. We demonstrate excellent potency with an ED50 of 0.5 mg/kg. Now take a look at the open red circles along the bottom of the graph. That is the measure of tolerability according to a neurological deficit, with zero reflecting normal animal behavior. As you can see, these animals are normal. The shaded area between the green and red results calculates a therapeutic index greater than 40-fold. On the right, you can see the similar experiment for ezogabine. The green triangles represent the anti-seizure efficacy, which you see has an ED50 of about 20 mg/kg, so the potency is much lower than for BHV-7000. Let me turn your attention to the red triangles, which you can see shows the neurological deficit increasing with increasing dose and is close to the efficacy dose. Thus, the therapeutic index is approximately three fold compared to more than 40-fold for BHV-7000. This approximates the clinical experience with ezogabine as the drug was poorly tolerated. We do not have the same experimental results for XEN1101, but based on Xenon reported data, we estimate its therapeutic index at approximately six fold, somewhat better than ezogabine, but dramatically different than the greater than 40-fold therapeutic index of BHV-7000. Our aim is to develop and deliver the third-generation best-in-class Kv7 modulator, and we hope this will give people with refractory epilepsy better control of their diseases and their lives. In closing, we believe BHV-7000 significantly differentiates from other molecules in this class of Kv7 activation. The graphic shows where we believe the superiority of our lead asset will provide the potential best-in-class for the treatment of refractory epilepsy and other neurological hyperexcitability disorders. Thanks for the chance to share a bit of the BHV-7000 story. Now back to you, Elyse. Thanks so much. I would also like to introduce Cliff Bechtold, who will provide a brief update on the recently licensed anti-myostatin inhibitor. Thanks, Elyse. We're very excited to add taldefgrobep alfa to the Biohaven portfolio. Myostatin is a well-characterized negative regulator of muscle growth. Based on a number of disease models and clinical studies, we believe a molecule that can target the signaling pathway of myostatin has potential in many different disease areas that could lead to improved strength and function in patients with muscular dystrophies and other neuromuscular diseases as an adjuvant to their current therapies. Taldefgrobep alfa is an advanced development program that has extensive human data, especially in the pediatric population. With this robust package, we will be able to rapidly enter phase III in neuromuscular diseases, including SMA. I know this asset very well. I led the program while I was at BMS and oversaw its development from the lab into phase III. This program will synergize with Biohaven's experience in ataxia and other rare diseases, and we are looking forward to partnering with the SMA community of patients, physicians, and advocacy organizations to find novel combination therapies. With that background, I'm gonna hand it back to Vlad. Thank you, Matt, BJ, Elyse, Mike, Steven, and Cliff. Once again, welcome to the entire Channel Biosciences team. We're so excited to have you part of Biohaven. Also on behalf of the whole team at Biohaven, we just wanted to say how excited we are to be working with Mike and Steven again. Many might not know this, but they were both important leaders at the BMS Neuroscience Group that many of us were all part of years back. It's somewhat of a homecoming to have them in the company and working with us again. In closing, Biohaven has demonstrated robust growth in our commercialization of Nurtec ODT, an important maturation of our late-stage innovative pipeline. We continue to expand our clinical pipeline as well as our early-stage portfolio with the goal of increasing value and growth year- over- year. Our commitment to people with migraine around the globe has never been stronger, and our global expansion with Pfizer will open the door to the 1 billion people worldwide who suffer from this debilitating disease. Before opening up to Q&A, I would like to thank the entire Biohaven team for their relentless commitment, drive, and value creation for patients and investors. I also wanna take the opportunity to thank all the patients who've enrolled in our clinical trials, their family members and investigators who participated in advancing our pipeline. We will continue to work hard to bring novel treatments to patients living with the burden of devastating neurologic and neuropsychiatric diseases. Finally, thank you again to our visionary investors who have helped fund our studies and bring Nurtec ODT to patients. Operator, we'd now like to open up the call and take some questions. Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment please while we poll for questions. Our first question today is coming from Ken Cacciatore from Cowen and Company. Your line is now live. Hey, good morning, and congratulations on all the progress. I was wondering, with no formal guidance, could you give us a sense of comfort maybe around the street's Nurtec specific revenues for this year around $850 million? And then maybe, Matt, can you speak a little bit to the thoughts on spending this year? Is a Q4 run rate good? And then a general question for you, Vlad. Obviously, really exciting new pipeline additions, but some investors do worry that increasing the pipeline investment, which you further enhanced today, could detract from Nurtec value. It's just hard to value the pipeline versus easier to value Nurtec. Can you talk about the balance of really huge spending to support Nurtec, need to invest in pipeline versus potentially an exit or maybe even a split of the business? Are all options still on the table? Can you talk us through that? Thanks so much. All right. I'll have, Matt start off, and then I'll jump in. Yeah, Ken, as you know, we don't provide guidance, so can't really comment on the $850. As it relates to sort of the Q4 run rate for expense, we do expect modest increases on the expense side, and we, you know, just have added a few really promising assets, which would be part of that calculation. Ken, we're excited about Nurtec. As you know from prior discussions, when you look at where we are in our net revenue generation and where we and others believe we'll be in future years, there are very few drugs that have this type of potential, both for patients and net revenue generation for companies. I don't think we have a large spend to support that. I think it's an appropriate infrastructure size and spend to what we believe ultimately will be multi-billion-dollar net revenues at peak sales, and give you a little bit of a glimpse as to how early we are and how much growth, you know, is ahead of us. In addition to the revenue from Nurtec, we do want to make sure we have other assets that can mature into the commercialization infrastructure that we have. I think what you saw today is an addition of what I would view as two de-risk mechanisms of actions that are very much fast follower approaches. When you look at some of the external data that's been generated in Kv7 and epilepsy and the predictability of assays to how those assets will perform in the clinic, we think these are high probability or higher probability wins in neuroscience. That's why we're so excited to be incorporating them into the pipeline. Your question about M&A and other activity, as you know, we can't comment too much on that, you know, other than say that, look, acquisitions like today in broadening the pipeline just strengthens our company and strengthens, I think, our ability to organically generate increased revenue in future years or for something that would be of interest to other parties, right? To put together a pipeline like this. We're gonna continue to run our business, maximize investor returns, and grow value, and we're gonna continue to do that until there's a reason not to. Thanks for the question, Ken, and appreciate it. Thank you. Operator, next question. Our next question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live. Good morning. Thanks for taking the question. Congrats, Vlad and team, on continued good commercial execution as well as the news flow this morning. Wanted to ask a commercial question for BJ, and that is that, BJ, you mentioned in your prepared remarks that you've seen earlier returns to growth in the first quarter than perhaps you would've expected, given your experience in previous years. I'm just wondering if you could provide some more color on that. Relative to the current, I'll call it adoption rate of the oral CGRPs, and specifically Nurtec ODT, what message would you like prescribers to hear that could drive further adoption of the class and the drug specifically? Charles, thank you for the question. Appreciate that. I would say, just to provide a little context around the comment around the earlier growth is that, you know, it is a little bit slow in regards to what the uptake is in Q1, normally. Again, that's not just either a Nurtec or a migraine, you know, issue in some sense, right? It's just more broad across the industry. I will say that again, in recent weeks, basically starting in February, we start to see what is kind of that return to growth again, and I'd say across the class, which is, you know, positive news for us. Again, there are good reasons for that. I think a lot of it is the incremental promotion that's happening because of different products actually entering the market as well, which actually benefits everyone, especially patients. That's a good news story overall. That points to, you know, greater growth. We're pleased about what that means for coming weeks. As it relates to, you know, the adoption rate that's happening and what I'd like to say to prescribers, and this is essentially what we communicate on a day-to-day basis, right, with all of our customers out there, is that, essentially now they have an opportunity to utilize, right, a product for patients who've been suffering in this space for so long with really very little risk, but tremendous upside for those individuals, and they can use it in this convenient platform, which again is one product obviously, right, that can treat and prevent. It's one dose, and again, does not have the same kind of baggage, if you will, that, you know, the older medications have had in the past. You know, I will say again, I think it's part of what is the fire that's lit kind of under this marketplace is that clinicians perceive that. They see it, they actually give trial and get tremendous feedback from patients. That is what we believe really will fuel this market going forward. Thanks, Charles. Operator, next question. Thank you. Next question is coming from Chris Raymond from Piper Sandler. Your line is now live. Yeah, thanks. Just a couple of questions on some of these new assets, if you don't mind. So I guess the anti-myostatin, just did some digging on this molecule. Looks like it's been studied already in DMD, and failed to show, you know, impact on ambulatory measures. And I know DMD and SMA are different in a lot of ways, but just kinda what are you guys seeing in the data that sort of gives confidence, you know, in this indication? And then just thinking about phase III design, is it contemplated this will be looked at in combo with a disease modifier like Spinraza? Any details on that sort of plan would be great. You know, I guess on the Kv7 asset, you know, it looks like this is on the Knopp website anyway, it is in development for epileptic encephalopathy. You know, can you maybe. Is that still on the table as an indication that you're targeting as maybe sort of a quick path to market. Just maybe talk about that a little bit. Sure. Maybe if I can put one more question to you guys, maybe more strategic, just on how you're thinking about guidance. Are there some elements around the business that you're looking for before guiding, or is there maybe sort of some, you know, philosophical reason to not guide? Thanks. Great. Thanks, Chris. Just I'll turn over to Mike in a minute to talk about Kv7 response to that comment. On myostatin, I'll also have Cliff chime in here. The mechanism of action in it has not been demonstrated in DMD to establish efficacy. However, we have a very sizable safety database from that experience. As you know, the Scholar Rock data in SMA with a similar myostatin targeting did suggest efficacy. That's really the clinical proof of concept that is you know advancing our interest in this area. We also note that there's other competitors you know Roche who have a myostatin targeting agent as well. Roche and Scholar Rock are both heading into SMA given the recent clinical POC there. We believe that this has the potential to be a best-in-class myostatin targeting agent, and excited to quickly advance into SMA given the emerging data. Cliff, do you wanna add anything? Yeah, just really quickly. I think, you know, what we learned in the Duchenne area is that the molecule is very safe. It was well tolerated in pediatric population. But we also learned that it's, as a monotherapy, it didn't hit the significance to see a clinical benefit. What's different in SMA is the presence of the SMN upregulating therapies that are approved in the market, which we think, and demonstrated by preclinical models, will show a synergistic effect. That's why we're targeting SMA to begin with. Great. Yes, the study would be in combination with standard of care. Yeah ... gene therapy and others. Great. Mike, do you wanna comment on Kv7? Sure. The indication. We are really excited to be joining the Biohaven team and their commitment to advancing BHV-7000 in for the treatment of epilepsy. In answer to your question, the drug has c linical proof of concept as a treatment for adult refractory focal epilepsy. We'll clearly be advancing the drug along that path. It's an established clinical development pathway. You're following footprints in the snow. That is a strong commitment. We're equally committed to exploring the potential of the drug as a pediatric epilepsy treatment, including the opportunity to treat patients with KCNQ2 epileptic encephalopathy. We'll be advancing the molecule in clinical development. As you know, there are steps that you need to take before you can treat children and certainly young children. We'll be taking the steps that we need to to be able to walk down that path. Okay. Matt, you wanna guide? Yeah, I mean, from a guidance perspective, I think we're gonna be more comfortable getting to a place where we're guiding next year. At this point, we have a lot of variables, a lot of moving parts, including Pfizer and sort of how they're looking at this in EU from a contribution. We have prevention, which, you know, is still kind of early-ish in the launch phase. We have, you know, a highly competitive environment. There are variables there as well. As we get more comfortable with all those, you know, we'll start to provide guidance. Great. Thank you. Operator, next question. Certainly. Our next question is coming from Paul Choi from Goldman Sachs. Your line is now live. Thank you. Good morning, everyone, and congrats. Let me add my congrats on all the progress as well. My first question is for Vlad and BJ as well maybe. As you're thinking about the commercial execution strategy here in 2022, you launch in a pandemic environment, you know, which involved a lot of virtual selling. You know, how are you thinking maybe about, you know, pivoting to more feet on the street to grow the Nurtec franchise over the course of this year, next year as we exit the pandemic? Then second on the pipeline, maybe for Elyse. As you think about the clinical strategy for SMA, is there gonna be a particular focus on a subpopulation, whether it's type one where you see the highest probability or type two and so forth? Just, you know, maybe any specifics you can provide on, you know, just sort of your high-level thoughts on clinical trial design here would be great. Thank you. Thanks, Paul. You know, with regard to this year, you know, the pandemic, we demonstrated the success of Nurtec despite the pandemic. I think it reflects how debilitating this illness is, and that people will go out and get a novel treatment because they're so disabled by migraine when it strikes. We've demonstrated the ability to do this well in a very harsh environment. What we see from the data is that as patient traffic and volume at physicians' offices increases, we do better. We believe as the pandemic gets behind us, there will be a greater opportunity to increase volume. We are not planning anything other than modest changes to our sales force. There'll be some, like always, some optimization to ensure we're remaining highly competitive and maximizing, you know, share. You're gonna see a continued emphasis on digital and virtual in addition to the in-person, of course. The things that made us successful during the pandemic, we're gonna continue to optimize as that alleviates. BJ, you wanna add anything to that? The only thing I'll add is very well said, Vlad. Thank you. I'd say is that, you know, we are absolutely committed to what is kind of our digital-first approach. Again, that is in the full light of day, hopefully, as this pandemic passes. The beauty is what we can and will do is build this capability so that we can actually integrate that with what are our feet on the street. As Vlad mentioned, we'll do kind of what is kind of a modest incremental investment in feet on the street. We are focused on increasing impact, right, of each one of our folks out there. We look forward to the full year. I'll invite Cliff and Elyse to maybe make a comment. Yeah. On the design of the SMA, I mean, one thing the field has changed significantly. We've been partnering with thought leaders and experts in the area to understand that with the advances in the marketed products that are operating on SMA, we're seeing it move away from the classification of SMA two and three because they are performing differently. Partnering with the experts in the field, with patient advocacy, we're still coming up with the right design to move forward. Great. All right. Operator, last question. Thank you. Our final question today is coming from Laura Chico from Wedbush. Your line is now live. Hey, thanks guys for squeezing me in. Just two on the pipeline. First, BHV-7000. Could you talk a little bit more on how you see clinical points of differentiation manifesting it? It sounds like you're highlighting GABA activation. I'm just curious how this plays out. Is this more on the adverse event side? I guess how would you elaborate or could you elaborate on how you would tease that out from a trial design perspective? Just with respect to verdiperstat, I know we're getting results in around the middle of the year. Could you talk a little bit more about the communication strategy around those top line results? This is obviously a unique design evaluating a couple different therapies in the study. I just wanna make sure I understand perhaps how the degree of disclosure might work or who will be leading that effort. Thanks. Sure. We'll invite Mike and Steven to comment and reply on the Kv7. Mike, you wanna start? Sure. As you probably know, the first and second generation KV7 activators are not specific for KV7. They have a GABA activation component to their pharmacology. We specifically dialed out the GABA activity because we're very confident, and we have the preclinical data to show that KV7 activation alone is sufficient for efficacy and potent efficacy at that. Then what has really limited KV7 activators to date is the fact that as you know, you become effective, you bump up against side effects, somnolence, vertigo, diplopia. When you hit those side effects, you can't go further. You have efficacy limitations, and you also have compliance limitations. We have preclinical evidence that we don't see this. We will be looking for differentiation in terms of side effect profiles. There are other liabilities that the first and second generation activators have had, including events of urinary retention. We think we'll be differentiated both as a more potent activator of the target, which we hope will translate into very good efficacy, as well as a compound that will be very well tolerated and patients will stay on the drug. Great. Thank you. Just to wrap up on the question about the HEALEY and the ALS trial. Although that's a platform trial with multiple different assets, they share a placebo arm. As an asset reads out, we will get the top-line on that asset. We're not waiting for other assets to read out. Once we get to that top-line data, it will be revealed, and we're thinking somewhere around mid-year. I know we have to wrap up now as we're out of time. Thank you everyone for joining us today. We deeply appreciate the support of our employees and investors as we move forward to delivering life-changing therapies to patients, and talk to everyone very soon. Thank you. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.