Biohaven Ltd. Q3 FY2021 Earnings Call

Good morning. Welcome to the Biohaven Pharmaceuticals, Third Quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Caroline Dircks from Biohaven. Thank you. Please go ahead.

Thank you and welcome to Biohaven Third Quarter 2021 Earnings Call. Speaking on today's call from Biohaven are Dr. Vlad Coric, our Chief Executive Officer, Jim Engelhart, Chief Financial Officer, Bj Jones, Chief Commercial Officer, and Dr. Elyse Stock, Chief Medical Officer. We also welcome Nick Lagunowich, 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 biohavenpharma.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 Coric.

Thank you Caroline, and good morning to our investors for joining the third quarter Earnings Call. This has been another exceptional quarter for Biohaven. Not only has NURTEC ODT become the number 1 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 U.S. 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 Rimegepant 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 the last night to make this collaboration agreement a reality. Thanks to the teams. I also want to thank Nick Lagunowich, 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. NURTEC ODT net revenue in the third quarter was $136 million, which brings cumulative launched to-date net revenue to approximately $336 million. We have a differentiated commercial product in NURTEC ODT that continues to generate increasing and impressive revenue growth. To date, we have over 1 million prescriptions of NURTEC ODT and the demand in the oral CGRP market continues to show strong growth quarter-over-quarter. We are very pleased to see the continued strength in the NBRx metric after the prevention approval, demonstrated by increasing to 57% market share, reflecting robust demand for the dual indication. NURTEC 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 migraines. NURTEC ODT is now the number 1 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 delivering our market-leading NBRx metric again this quarter. Today, Biohaven welcomes Pfizer as a global commercialization partner for Rimegepant, known as NURTEC in the U.S. Pfizer's commercialization reach and marketing expertise is unmatched in the pharmaceutical industry, making it the ideal collaborator to accelerate the access of Rimegepant to the more than 1 billion patients worldwide who suffer from migraines. We believe the collaboration between Pfizer and Biohaven brings together a winning combination of Biohaven's Neuroscience R&D with Pfizer's brand strength and vast global marketing network to deliver shareholder and patient value. Building upon the rapid success in the U.S, our mutual goal is to gain approvals to deliver dual therapy NURTEC 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 Rimegepant around the globe. Jim Engelhart, 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 of $150 million in cash upfront 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 U.S. Time and time again, we hear from patients and physicians that NURTEC ODT is changing the way migraines are treated and is improving the lives of patients with migraines. Partnering with Pfizer will allow us to ensure that we'll be able to more efficiently deliver Rimegepant 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 driving market growth around the world. In addition to the strategic collaboration, we'll allow Biohaven to capitalize on Pfizer's deep PCP footprint, as PCPs are the key in the management of migraines 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 U.S. and potentially change the paradigm in other regions of the world. Under the terms of the agreement, Biohaven would remain primarily responsible for further clinical development of Rimegepant and the parties will cooperate in regulatory activities to secure approval for the product. Pfizer will commercialize Rimegepant upon approval in all regions outside the U.S., while Biohaven continues to solely commercialize NURTEC ODT in the U.S. Additionally, per the arrangement, Pfizer gains rights outside of the U.S. to Rimegepant, our third-generation high-affinity selected and structurally unique CGRP receptor antagonists currently being studied in both an intranasal delivery and a soft gel formulation in Phase 3 trials. We are all aware of Pfizer's track record of success, global reach, and execution outside of the U.S., and Pfizer has accomplished this numerous times before with big drugs such as Eliquis. We believe that our collaboration with Pfizer can transform Rimegepant into a massive global brand in regions and markets that we couldn't do alone. Success will be achieved by working together and unlocking access to the many patients with migraines worldwide. I'm excited to announce this global collaboration. Pfizer is a world leader in global R&D and commercialization with impressive milestones that we highlighted as the reason they were the partner of choice to drive Rimegepant and its success around the globe. We believe the collaboration between Pfizer and Biohaven will bring together a winning combination. Next, I will turn the call over to Nick Lagunowich, Global President of Pfizer Internal Medicine, to comment on our collaboration, and I must say that Nick's team is unparalleled in the pharmaceutical industry in terms of commercialization and marketing expertise with multiple breakthrough medications.

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 Rimegepant 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 by this debilitating neurological disease. When we look at the numbers, they certainly tell a story, but more important than the numbers are Pfizer's purpose, 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. For decades, we've been at the forefront of advancing world-renowned breakthrough medicines and vaccines with a global impact. Our portfolio includes more than 30 key medicines and many more beyond that, several of which represent true breakthroughs such as Comirnaty, Eliquis, Vyndamax, and Ibrance, to name a few. Our expansive footprint spans over 125 countries around the world. As of Q3, Pfizer’s ex-U.S. revenues were $35.4 billion. More importantly, we're very proud of the number of patients that we've positively impacted around the world. In fact, during the first 9 months of 2021, our innovative medicines and vaccines reached nearly 1 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 Rimegepant in the U.S., which certainly speaks to the unmet need and the value of the medicine, and we plan to build upon that success to drive strong uptake in markets around the world. When you think about the 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 needs of the patients and appropriately engaging the right patient populations. To drive rapid uptake, we'll leverage our go-to-market expertise and digital innovations to reach neurologists and specialists with information about this valuable treatment option and will ensure long-term success by leveraging our scale and capabilities along with our industry-leading customer-facing 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 we'll be able to accelerate access and fuel the uptake of Rimegepant in markets outside 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 Engelhart, CFO Biohaven.

Thank you, Nick. Good morning, everyone and thank you for joining today. Before providing an update on our third-quarter results, I would like to echo the words of our CEO, Vlad Coric, and Pfizer's Nick Lagunowich on the exciting news of Biohaven and Pfizer entering into a strategic commercial collaboration agreement for the treatment and prevention of migraines upon approval in markets outside the U.S. Some of the key financial terms of the agreement are as follows: Pfizer will pay Biohaven a total of $500 million at closing, inclusive of $150 million in cash and $350 million in equity investment in common shares priced at approximately $173 per share, a 25% premium to the 20-day Vivo app on November 8th, 2021. Closing of the equity investment is contingent upon completion of the review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvement Act of 1976 in the U.S. and is expected to close in December of 2021. In addition, Biohaven will receive from Pfizer tiered double-digit royalties and reimbursement for related ex-U.S. PMS and Royalty Pharma royalties. Biohaven is also eligible to receive up to $740 million in milestone payments. In total, Biohaven is eligible to receive approximately $1.24 billion in upfront payments and future milestones. Our collaboration with Pfizer reduces Biohaven's ex-U.S. investment to commercialize Rimegepant upon approval by leveraging Pfizer's extensive global commercial organization. Biohaven will continue to oversee manufacturing responsibilities for ex-U.S. markets. We look forward to our collaboration with Pfizer and the ability to serve more patients who suffer from the debilitating effects of migraines. Now, let me turn to Biohaven's third-quarter results. NURTEC ODT achieved net sales of $135.7 million from the third quarter, demonstrating another quarter of strong performance, increasing 46% versus the second quarter of this year, driven by continued sales volume. We are very pleased by the contribution that our expanded label is having on NURTEC ODT performance. Continuing down the P&L, R&D investment in the quarter on a non-GAAP basis was $68.9 million compared to $51.8 million over the prior year quarter, an increase of $17.1 million. The increase is primarily due to continued investment in our late-stage product candidates and pre-clinical research, partially offset by a $10 million decrease in our R&D services obligation. SG&A expense in the quarter on a non-GAAP basis was $149.6 million compared to $110.2 million over the prior year quarter, an increase of $39.4 million. Most of our SG&A costs continue to support commercial sales of NURTEC ODT as we invest behind our novel dual indication therapy. The increase is primarily due to increased promotional activities supporting ODT in the third quarter compared to the third quarter of 2020, which was in earlier phases of launch. We reported a non-GAAP adjusted net loss for the 3 months ended September 30th of $125.1 million or $1.91 per share loss compared to a $159.5 million or $2.67 per share loss for the same period in 2021. Moving onto year-to-date September results, R&D investment for the 9 months of 2021 on a non-GAAP basis was $210.6 million compared to $137.6 million over the prior year period, an increase of $73 million. Again, the increase is primarily due to our continued investment in our late-stage product candidates and pre-clinical research, partially offset by the aforementioned reduction in R&D service obligations. SG&A expense for the 9 months of 2021 on a non-GAAP basis was $434.2 million compared to $314.7 million over the prior year quarter, an increase of $119.5 million. The increase is primarily due to increased promotional activity supporting NURTEC ODT during the full 9 months of commercialized sales for the treatment and prevention of migraines, as compared to the same period in 2020, where NURTEC was launched in 2020. We reported a non-GAAP adjusted net loss for the 9 months ended September 30th of $484.4 million, or $7.55 per share loss, compared to $444.2 million, or $7.62 per share loss for the same period in 2020. Turning to our balance sheet, following the execution of our collaboration and subscription agreements with Pfizer, we will have access to more than $1.1 billion considering the investment that Pfizer is making. As of September 30th, 2021, we have $523.9 million in cash, cash equivalents, and marketable securities. Immediate access to $125 million from our debt facility was 63 million and we anticipate $147.2 million of additional capital proceeds from the Series B preferred share agreement with Royalty Pharma executed last year. With that, let me turn it over to Bj Jones, our Chief Commercial Officer.

Thank you, Jim. And good morning, everyone. There's a lot to be excited about within Biohaven this morning. First, I'm happy to report continued strong uptake of NURTEC ODT, 5 months in market post-launch of our dual indication. Second, I'm thrilled with the announcement of our collaboration with Pfizer to create broad access to this life-changing medication for those in need throughout the world. It's truly the fulfillment of our vision for NURTEC ODT to transform the lives of migraine patients globally. We're very pleased with third quarter sales of $136 million, an increase of 46% over the prior quarter, which reflects enthusiasm and accelerated adoption within the broad clinician and patient communities. We are 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, which will drive demand for a more simple, higher standard of care that produces better patient satisfaction and outcomes, and therefore will dramatically expand the number of people with migraines seeking treatment. Since the launch of NURTEC’s differentiated dual therapy early this summer, we have witnessed an acceleration in volume and share, fueled by specialists and primary care physicians. Thanks to the passion, commitment, and exceptional execution of our high-performing commercial team, we've steadily grown our new-to-brand market share by 9 points on top of a rapidly expanding branded oral market. As of last year, oral CGRP continued to drive incremental penetration of the Triptan market along with new patients and more. From a payer access perspective, we are also encouraged regarding 2022 formulary status for NURTEC ODT. We have maintained our strong access for acute therapy and coverage for preventive therapy is progressing well. As a result of the surge in demand for this one-of-a-kind dual therapy medication, NURTEC ODT has become the number 1 migraine treatment in the oral CGRP class. Since early August, NURTEC is the market leader in overall prescriptions due to brand prescriptions and prescribing among neurologists. And this is just the beginning because we believe NURTEC ODT is uniquely positioned to transcend the traditional category of acute and preventive care. For patients with migraines who wanted the simplicity of 1 medication that can both treat their migraine attacks and be adapted to prevent them when needed, NURTEC ODT is in a market of 1. This brings us to this pivotal moment. We're prepared to build upon the exceptional foundation of NURTEC’s U.S. launch by establishing a world-class collaboration with the partner of choice, Pfizer, to bring dual therapy innovation to the many patients suffering from migraines around the world. Who better to partner with if our objective is to create access to NURTEC's life-changing profile and impact as many people as possible, as rapidly as possible? Needless to say, Pfizer is second to none in its ex-U.S. commercial reach and expertise with a proven track record of building massive global brands in regions and markets that are dominated by generics. I'll conclude as I began—there's a lot to be excited about this morning. NURTEC continues its successful trajectory driven by strong execution and growth in volume and share, delivering $136 million in third quarter sales. Additionally, today we begin a critical collaboration with Pfizer to satisfy the tremendous unmet need in patients with migraines who reside outside the U.S. For many, NURTEC ODT's differentiated profile gives them a sense of personal control that provides renewed hope. I think Mary says it best in this testimonial: 'I have gone from handicapped and fearful to empowered and secure. NURTEC ODT has helped me treat or prevent migraines. As a single mom, I am now more productive and feel improvement in my parenting and relationships. I can go about my life now without fearing that migraines are around the corner.' Biohaven's dedication and commitment to patients is shared by Pfizer, and our collective teams are eager to begin the hard yet extremely rewarding work of placing NURTEC in the hands of patients worldwide. Now, I would like to hand it over to Elyse Stock, our Chief Medical Officer.

Thank you, BJ. This quarter there is so much to be excited about. We continue to make significant advances across our R&D organization, and we have even greater potential to bring multiple therapies to patients here in the U.S. as well as across the globe. The collaboration we have formed with Pfizer now brings the best of all worlds to our CGRP antagonist platform. With regard to R&D, we have demonstrated our ability to develop drugs that meet the regulatory needs for filing and approval in an innovative and expeditious fashion. Biohaven has a large clinical team with deep industry experience across relevant neuroscience areas. We have over 45 completed clinical trials with approximately 40 additional trials ongoing. The data that we've generated has been published in leading peer-reviewed journals such as The New England Journal and Lancet. As BJ has mentioned, we have been very successful in our U.S. commercialization. We are now delighted to have Pfizer as a partner in our ex-U.S. expansion. They bring global experience and a global footprint that will enhance our ability to win in migraine for patients around the world. Regarding our portfolio, we have an impressive CGRP franchise at Biohaven that is unparalleled. NURTEC ODT remains our cornerstone market product now indicated for the acute treatment of migraines as well as for prevention. With our label expansion in late May, NURTEC ODT 75 milligrams has become the first and only ODT migraine medication approved to treat acute migraine attacks and help prevent future migraine attacks. The ability to treat a large number of patients across the migraine continuum is truly innovative and is an approach to treatment that is amazing with the ability to use up to 18 doses per month allowing for both acute and preventive treatment in the same patient. We will continue to expand with lifecycle studies of NURTEC ODT both within neuroscience as well as explore a wide variety of scientifically relevant indications outside of migraines as we follow the science of the CGRP antagonists. Expansion beyond geographic regions, as already mentioned, and the dual-acting indication is of critical importance to us. We have ongoing trials in pediatric migraines and trigeminal neuralgia. Investigator-initiated trials, Phase 4 clinical trials, and studies in health economics will add to the important wealth of information that will ultimately be available for NURTEC and help define the scope of important information for patients, providers, and payers both within the U.S. and globally. The European evaluation of NURTEC's dual acting filing is underway. The filing in Europe took place in the first quarter of this year, and we hope to secure approval in the first half of 2022. Additionally, a Phase 3 clinical trial of NURTEC ODT for the acute treatment of migraines is ongoing in China and Korea. Studies to support filing in Japan will begin in 2022. The Zavegepant program includes both intranasal and oral formulations. An acute treatment Phase 3 study with intranasal Zavegepant began in October of last year, following a positive Phase 2 study. This second pivotal Rimegepant trial will have a top-line readout this quarter and has the potential to confirm an even more rapid onset of effect. We anticipate a filing of intranasal Rimegepant for the acute treatment of migraines shortly after the results of this trial are available. Our oral formulation of Rimegepant started in a Phase 3 study for chronic migraine prevention this past March. Our next-generation CGRP 3100 has now advanced to the clinic and is in a Phase 1 study. These multiple CGRP antagonists open numerous possibilities for us to expand our CGRP platform and afford us the ability to customize the unique attributes of each of these structurally unique compounds. Across a range of CGRP antagonist assets, we will follow the science and conduct multiple proof-of-concept and registrational studies. Additional non-migraine studies are already underway or planned, including pulmonary complications of COVID-19, psoriasis, and asthma. We continue to make great progress across other programs, including our glutamate modulating agents and our myeloperoxidase inhibitor platform. Troriluzole, part of our glutamate modulating platform, has completed enrollment in its Phase 3 Spinocerebellar Ataxia study, and we will read out top-line results in the first half of 2022. A Phase 3 program in OCD started at the end of last year with enrollment in the first study and the second study initiated in the first quarter of this year. Our myeloperoxidase inhibitor Verdiperstat, part of our MPL platform, was evaluated in multiple system atrophy, a rare and rapidly progressive disease. Although we were disappointed not to have positive results, we continue to be hopeful about the Mass General Healey study that's testing this agent in ALS, which will complete enrollment in the fourth quarter of this year. As you can see, we continue to make great strides across all of our late-stage assets and are excited about all of the opportunities we have across both common and rare diseases. Our Biohaven Laboratory also remains busy with its early discovery work. Earlier this quarter, we advanced one of these compounds, an antibody recruiting molecule, into a Phase 1 clinical trial in multiple myeloma. We expect our early pipeline to bring us exciting compounds in numerous areas over the coming years. We will continue to make strategic decisions across the portfolio as our data mature with both external partnerships and internal programs. Our pipeline is large and exciting and we continue to drive performance. I'm really excited about our future at Biohaven. It is a pleasure to share all of this with you and I will now turn the call back to Vlad.

Thank you, Elyse, Nick, Jim, and BJ. In closing, Biohaven has demonstrated robust growth in terms of the commercialization of NURTEC ODT and an important maturation of our late-stage innovative pipeline. We have the potential for multiple NDAs over the next couple of years and significant growth ahead as a company. Our commitment to migraine sufferers around the globe has never been stronger, and our strategic collaboration with Pfizer will help ensure global access to NURTEC ODT, and we're excited to see the benefits to patients that will come through this partnership. Before opening the Q&A, I'd like to thank the entire Biohaven team for their relentless commitment to drive and value creation for patients and investors. I want to thank patients and their family members and investigators who regularly participate in our clinical trials to advance clinical care in neuroscience. We must continue to work hard to bring novel therapies to patients suffering from devastating diseases. Finally, thank you to our visionary investors who have helped fund our studies and bring NURTEC ODT to patients. Let's open it up to questions.

Thank you. We will now be conducting our question-and-answer session. The confirmation tone will indicate your line is in the question queue. Our first question is coming from the line of Ken Cacciatore with Cowen. Please proceed with your question.

Thanks so much. Vlad, you, Nick, Jim, and BJ, you all sounded so natural and cohesive on the presentation. I’m wondering why we didn't just make it completely official and have Pfizer potentially buy the whole company? Can you talk about the strategic process? Why not a complete exit? Is it prices that your beliefs in the pipeline? Obviously, Pfizer's in a strong agreement about the opportunity with the quality agreement ex-U.S. Could you just walk us through that? That would be helpful. First question and then I’ll ask the second.

Thanks a lot, Ken. From our perspective, we think this is a much better long-term setup for Biohaven. When you think about it, we preserve all optionality in the U.S. and we partnered with a leading pharmaceutical company to increase not only the size of future revenue from this asset but also get us there sooner. You and I and others have had discussions about how Biohaven was going to commercialize around the globe. That's a challenging situation where you have to have a commercial, pricing, and regulatory presence in so many different markets. Ken, this really gives us the cash we need to run our business. There's equity that has been purchased today at a premium and it's a really good long-term setup while still having all of the U.S. revenue come into the company and preserving future optionality for us and our investors.

Thanks a lot.

Thank you. Our next question is coming from the line of Chris Raymond with Piper Sandler. Please proceed with your question.

Good morning. This is Alley Bratzel on for Chris this morning. Thanks for taking our questions. First, congrats on the Pfizer deal. Maybe just a clarifying question. I think Biohaven is eligible for up to $740 million in milestones. How should we think about the split between regulatory and commercial milestones and just the cadence of potential regulatory milestones with the EU and other approval decisions expected next year?

Yes. We'll have some more details in our filing. We don't go into that level of detail of the split. What I would say again is that this type of partner is going to bring in those revenues much sooner than many anticipated. The size of those... when you think about the position we were in and a lot of individuals weren't able to give us credit for the ex-U.S. market because we had really not been able to demonstrate we could commercialize that. We've said publicly, we're out there looking for the best partner ex-U.S. and we found the best partner. We think it's going to really set us up nicely for the long term.

Got it. And then maybe just one more on commercial. Now that there's another oral CGRP approved for prevention, could you provide any color on how your mustering NURTEC profile compares to Eliipta? Any color on maybe higher comparing or contrasting the Qlik the profile, both the safety and efficacy data on the label. How is that resonating with docs maybe compared to NURTEC?

You know, we are continuing to enjoy the competitive profile because there is no other product that has one therapy for acute and prevention in one pill. That is what is driving our market share and why we are beating a much bigger company like AbbVie in the marketplace. This message is resonating with payers, patients, and doctors that you can have one solution for migraines. We've set a new standard there and a lot of the other treatments are living in the past of multiple different medications. We're the only migraine therapy that has that one pill solution for both acute and prevention. That's how we're going to continue to differentiate and grow the market. BJ, do you want to add to that?

Yeah. Well said, Vlad.

Next question, please. Our next question is coming from the line of Paul Choi with Goldman Sachs. Please proceed with your question.

Hi. Thank you. Good morning. And thanks for taking my questions. First is a strategic question, both for Vlad and Nick, if you're still available. Just as you think about the portfolio and NURTEC, can you maybe just speak to any strategic synergies that you consider across the Biohaven and/or Pfizer portfolio? Is there any overlap in terms of the migraine footprint there? And then I have a follow-up question on the pipeline.

As Nick talked about earlier, this product profile, we believe really fits their ex-U.S. global footprint nicely with their strong presence with PCPs and pain across the globe. As we look to various parties to have discussions, they were clearly at the top regarding those capabilities. This is the right partner to bring a drug like NURTEC to patients. When you think about it, Paul, there are not many drugs that have the potential to reach one billion people worldwide with how common migraines are, as they are the leading cause of disability in people less than 50. Having that type of global infrastructure is really what brings the value to both companies here. Not only are we going to benefit such a large number of patients, but this is going to be an important drug for both companies with regard to revenue generation outside the U.S.

Okay. Thanks for that, Vlad. And one question on the pipeline with regard to BHV-1100 and the arm program in myeloma. Could you maybe just guide us at a high level to how we might think about the cadence of data in that program in 2022? How are you thinking about where the program might fit into the myeloma treatment paradigm, either for Elyse or Charlie?

I'll hand it over to Charlie or Elyse to chime in. This represents a really important next stage of development for Biohaven, and with our Biohaven lab and the acquisition we made last year, we have access to what is an exciting immunoscience platform that you're going to start to see INDs and clinical trials like this begin. In other indications like oncology, neuroscience, and in others. This is the beginning of that. We are so excited to have the first patient enrolled in that multiple myeloma trial, and next year we hope to have some data from that trial. This will be the first validation of using this technology in humans to improve outcomes in immune-oncology. Elyse, do you want to add anything?

Yeah. You said it all. We're really excited about having that first patient and being able to test the first of the assets that's coming out of that early pipeline. We're very excited. More than anything, it's really going to, as Vlad said, validate the mechanism for us and give us an early read on safety as well.

Paul, what we saw pre-clinically is that when we added BHV-1100 to the NK cells, we were able to boost the efficacy in terms of myeloma cell killing. So, we're really excited to be testing the hypothesis in the clinic and look forward to our coming data.

Thank you. Our next question is coming from the line of Jeff Hung, with Morgan Stanley. Please proceed with your question.

Thanks for taking the questions and congratulations on the ex-U.S. partnership. You mentioned that Pfizer was the partner of choice. Can you talk about the process for that U.S. partnership? Was it a competitive process? If so, how many other parties were involved? And then I have a follow-up.

Thanks, Jeff. As you know, those discussions occur under a confidentiality agreement, so we can't get into the details of that other than to say there were multiple parties. We'll leave it at that.

Great, thanks. How are conversations with payers going around preventative treatment for 2022? Any feedback that you're able to share?

We have really exciting feedback that I’ll let BJ update you on.

Yes, great question, Jeff. I would say that the discussions with payers are actually going extremely well. Once again, we feel very confident regarding our ability to maintain what is the coverage that we have for acute therapy. Thus far, we think they are progressing extremely well as it relates to what is presented for 2022, and we're excited to announce some good news on that as well.

Thanks. Next question, operator.

Absolutely. Our next question is coming from the line of Vamil Divan with Mizuho. Please proceed with your question.

Great. Thanks for taking the questions. So, maybe one on the agreement and one on the quarter. Just in terms of the agreement, I’m curious if there are any sort of standstill or other clauses that could prevent an expansion of the agreement or something else happening in the future. And then the second, just looking at slide 6, you’ve obviously done very well with gaining new-to-brand share. But the last few weeks, you’ve probably sort of made a little bit of headwind there. I’m curious if you can comment on what you’re seeing on the new-to-brand side, specifically related to your recent gains.

Thanks for the questions. There is not a standstill in the contractual agreements, so that's not in there. Regarding the quarter-over-quarter growth, we continue to see strong growth. Of course, there is always some back and forth. Being at 57% of NBRx continues to be exceptionally strong when you consider who our competitor is. I think again, it’s resonating with the message of the one treatment for both acute and prevention.

The only thing I’d add is that we’re very pleased with our NBRx share gains, especially since our dual launch in June. We’re now sitting approximately 14-point NBRx shared advantage over Ubrelvy. NBRx trends over time are very important. We watch that clearly, but as many of you know, it’s fairly volatile as well. In addition to monitoring long-term NBRx trends, we closely watch all other early indicators to drive long-term NBRx share trends such as product differentiation, stated brand preference, intent to prescribe, and relative competitive access. On all of these measures, it favors NURTEC ODT, supporting our hypothesis of the long-term health of the brand and our leadership.

Thanks. Next question, operator.

Our next question comes from the line of Laura Chico with Wedbush Securities. Please proceed with your question.

Good morning, guys. Thanks very much for taking my question. I might ask this question to help me differently than it has been asked already. But wondering, you've mentioned a couple of times now Pfizer's legacy in the primary care market was establishing a collaborative relationship in the U.S. territory—a consideration given their PCP presence.

Laura, I think what I've always said publicly is our focus was on the ex-U.S. revenue streams. The U.S. launch is going so well. The team is outperforming a very large competitor. What we wanted to solve for in this first step is revenue outside, and so we did that with this collaboration today. This collaboration gets us the cash we need to run and grow the company, bringing in potential revenue streams that we couldn't do on our own and allowing us to maintain our full optionality while continuing to own full U.S. rights. It's a win for patients because our two companies together are going to bring what we think is the best-in-class therapy to patients around the globe. We’re very happy with the collaboration.

That's super helpful. If I could just sneak in one follow-up, the European launch is probably going to start on a different footing than in the U.S. with potentially two indications, acute and prevention. I’m wondering if you could talk a little about how there might be likely differences in pricing access in the European markets versus the U.S.?

Thanks, Laura. Just like in the U.S., our teams have been fast at work here preparing for the completion of the regulatory process as well as the pricing process. Of course, we can't comment on that because that's all an ongoing interaction, but we are preparing for a launch. Prior to this, we were preparing for getting the approval because that was our regulatory and R&D footprint. Now we have a commercial partner that's going to be ready to bring this to so many patients in Europe. We're preparing for a launch in '22. The importance of this deal is clear: getting approved in Europe means revenue streams will come in much quicker and at higher amounts than we would ever be able to do alone. This partnership is particularly important for patients.

Thanks.

Thank you. Our next question is coming from Tim Lugo with William Blair. Please proceed with your question.

Thanks. We saw improvements in GTN in Q3. With the prevention launch, you'd previously signaled that could hurt GTN. Directionally, can you talk about where you expect to go over the next few quarters? We don't need hard numbers, but directionally, will GTN still be negative from prevention but maybe that's improved if they've been more mature product users, or should we expect volatility still?

As you know, we don't give guidance, but we can say we're certainly pleased by the performance, not only in volume but even in the last quarter where we demonstrated an inflection point of improved pricing, which we had predicted would happen in 2021. The prevention launches, as BJ mentioned earlier, are key to getting access. We're making really good progress there.

All right. Thank you.

Our next question is coming from the line of Marc Goodman with SVB Leerink. Please proceed with your question.

Hi, thank you. This is (inaudible) and I’m for Marc. I have two questions. First, do you have any data on patients staying on NURTEC that you would be able to share with us? Second, could you elaborate a little on how you view the mechanism and opportunity of (inaudible) in ALS after the negative MSA study?

Yes, sure. Regarding migraine durability, it is very strong. Patients respond, and we know from our data that you see about two-thirds of patients responding; they tend to take NURTEC as it reflects their monthly migraine frequency. It mirrors that. We saw similar outcomes in our real-world trials. So, we're seeing a very nice durability and repo rates there. Of course, we don't reveal the exact numbers, but we're very pleased as it shows how well the drug works. Regarding Verdiperstat and ALS, we know with this drug that we are hitting the target and decreasing neuroinflammation. It's all about the stage of illness and which disease pathology is the right target to go after with the myeloperoxidase inhibitor. From our previous MSA study, it may be that targeting later stages in that disease and the pathology differs for other neurodegenerative disorders. We have an important strategy for assessing drugs that effectively hit the mechanisms in different diseases unrelated to each other. Therefore, there are no cross-readouts in these different indications; mechanistically, we believe that significant evidence in ALS is driven by neuroinflammation. We will find out soon enough whether we hit our top-line numbers there. Elyse, do you want to add anything?

No, I think you’ve said it all. We do not believe at this point that we can predict in any way what will happen with ALS, as there isn't any clear read-through at all; the mechanisms there are different. We are collaborating on the Mass General HEALEY study, and as Vlad mentioned, we’ll complete enrollment this quarter and should have that data out in due course.

Next, please.

Thank you. Our next question comes from Jeff Hung with Morgan Stanley. Please proceed with your question.

Thanks for taking the follow-up. I had a question for Nick, if he's still on the line. Can you talk about Pfizer's interest in the neuro space in general? I was under the impression that you might have left the space.

Jeff, sorry. Nick just drove off, so he’s not here.

All right. No problem with that. Thank you.

Thank you. The next question is coming from Vamil Divan with Mizuho. Please proceed with your question.

Hi, thanks for taking my follow-ups. Just a couple quick ones. One, I’m wondering if you can share the split of treatment versus prevention sales in the quarter. The second one is regarding Zavegepant. Could you specify your expectations on the data from that before we get them, and could that be something that also gets added into this agreement if the data are positive?

We're seeing growth in both acute and prevention. We don’t break down those numbers. A lot of the script data you’re seeing just shows you a script; it doesn't tell you whether it's one or two packs. We’re very pleased with the growth we’re seeing in both segments as we try to eliminate the notion of two different segments. It would really depend on how many migraine attacks you have per month and how long that pack lasts you. We believe Pfizer has the rights on Zavegepant as well. We have data coming very soon; that study will read out shortly with intranasal Zavegepant, which could provide an ultra-rapid onset of action. We believe this will not only be an important drug here in the U.S. but it's part of this deal and we expect it to have a very significant presence outside of the U.S. so we’re excited about that. Did I answer your question on that, Vamil?

Yeah, that clarifies it. Thank you.

All right, last question please.

Our final question is coming from the line of Esther Rajavelu with UBS. Please proceed with your question.

Hi, thanks for squeezing me in. Vlad, congrats on the deal. A clarifying question: Will Pfizer be responsible for the Asian market as well or will Biohaven be the lead in Asia? Then I have a quick question for Jim.

Yep. Pfizer wanted all ex-U.S. markets and we have secured all ex-U.S. markets, so they will be responsible for the Asian markets. I will remind you that there are 80 million people in China with migraines; that’s a very substantial market. We’re excited to be working with Pfizer’s China team. Our study is wrapping up there, and we will be proceeding to filing shortly.

Just a quick one, Jim: Given the cash infusion with this deal, could you provide an understanding of the use of funds over the next 12 to 18 months between R&D and U.S. SG&A?

Yes. The key strategy for us here is really—and the importance of that infusion as part of this transaction is to get us to profitability. We are pleased with the cash position we have on hand and access to funds associated with this transaction.

Yes. As we've always said, we want to be able to get to self-funding of other programs without having to go back to the equity capital markets too many times and that's been important. We've demonstrated our ability to fund the company in other ways to limit dilution to our shareholders. This is a really important cash infusion, and the purchase of our stock at a premium puts us in a strong position for longer-term revenue streams. We are really excited about that.

Absolutely. Our last question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Super thanks for fitting me in while juggling calls this morning, Vlad and team, congratulations on this transaction and really great quarter. I had a quick question regarding how you think about the European market and potentially even the Asian markets, as you think about pharmacoeconomic contributors to pricing. Not really asking you about pricing, but how do the Europeans consider migraines versus, say, U.S. prescribers?

Great question, Charles. What I can say is that, just like in the U.S., we've made the value proposition clear to the payers. We did receive favorable reviews regarding our pricing because we demonstrated a reduction in disability. In people less than 50, migraines are the leading cause of disability, so that's important to our health impact analysis for the payers, both in the U.S. and outside the U.S. Again, Pfizer’s reviews concluded that we were cost-effective for patients with migraines who didn't respond or didn't have a full response or can take a triptan and didn't respond. We're going to have that same value proposition outside the U.S. Payer constraints there differ, but we have a very large global market we are targeting here. We're genuinely excited about the prospects.

Excellent. Last quick question regarding this transaction. Undoubtedly you won't be able to answer it, but I guess I'm wondering if at any time Pfizer expressed interest in the U.S. markets as well. I apologize if this has already been asked.

What I can say is that our focus was always for priority on making sure we can globalize NURTEC. We said publicly before that this would be our priority—to find a global partner. We maintained all of our optionality and flexibility in the U.S. market, and we're doing exceptionally well with BJ and the team. So this, to us, was an ideal partnership that places us on sound financial footing and creates significant future revenues, we believe, for our shareholders. It also brings an important drug to patients. We think we have the right deal, and we'll leave it at that.

Excellent. Thanks for taking the questions. Congratulations, Vlad.

Thanks. Operator.

Thank you. We have reached the end of our question-and-answer session. I'll pass the floor to management for closing remarks.

Thank you, everyone for joining us today. We appreciate the support of our employees, investors, and our global partner, Pfizer, in working together to deliver life-changing therapies. For those suffering from migraines, this is a significant day because we have a path forward to bring them the best-in-class oral CGRP agent and something that has the potential to change the treatment paradigm outside the U.S. and improve patient lives. Thank you all.

Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation and you may disconnect your lines at this time.