This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk09: Quarter 2021 earnings call. Speaking on today's call from Biohaven are Dr. Vlad Chorich, our Chief Executive Officer, Jim Englehart, Chief Financial Officer, BJ Jones, Chief Commercial Officer, and Dr. Elise Stock, Chief Medical Officer. We also welcome Nick Ligonowitz, Global President, Pfizer Internal Medicine. Earlier this morning, we issued a press release announcing the third quarter 2021 highlights. A copy of this press release can be found on our website at biowaveandpharma.com, and we will file our Form 10-Q later today. Before we begin, let me remind everyone that today's discussion contains forward-looking statements based on the environment as we currently see it, and includes risks and uncertainties. A list and description of risks and uncertainties associated with an investment in Biohaven can be found in the company's filings with the U.S. Securities and Exchange Commission. Please be aware that you should not place undue reliance on any forward-looking statements we make today. For this call, we will focus on non-GAAP financial measures. Detailed descriptions of these non-GAAP measures and reconciliations to the most comparable GAAP measures can be found in our SEC filings. An archive of today's call will be posted to Biohaven's website in the investor relations section. With that, I will turn the call over to our CEO, Dr. Vlad Shorch.
spk10: Thank you, Caroline, and good morning. And thank you to our investors for joining the third quarter earnings call. This has been another exceptional quarter for Biohaven. Not only has NERTEC ODT become the number one migraine treatment in its class, allowing patients and doctors to customize a single migraine therapy to treat and prevent attacks, but we are also excited to announce an outstanding strategic commercialization collaboration with Pfizer for markets outside the United States. It is an ideal collaboration that combines our neuroscience R&D expertise with Pfizer's commercialization and marketing excellence to pave the way to bring Remedipant to as many patients as possible around the world. I want to thank the teams at Pfizer and Biohaven who worked tirelessly in the last few weeks and over last night to make this collaboration agreement a reality. Thanks to the teams. And I also want to thank Nick Lagunowitz, the global president of Pfizer Internal Medicine, who is on the line joining us today to speak about Pfizer's impressive global go-to-market commercial capabilities in just a few minutes. Our business performance this quarter continues to exceed all expectations across multiple fronts. NERTTEC ODT net revenue in the third quarter was $136 million, which brings a cumulative launch-to-date net revenue to approximately $336 million. We have a differentiated commercial product in NERTTEC ODT that continues to generate increasing and impressive revenue growth. To date, we have over 1 million prescriptions of NERTTEC ODT, and the demand in the oral CGRP market continues to show strong growth quarter over quarter. We're very pleased to see the continued strength in the NBRS metric after the prevention approval, as demonstrated by increasing to a 57% market share, reflecting robust demand for the dual indication. NERTEC ODT is providing fast and lasting relief to more and more migraine patients each day. The entire oral CGRP class is outperforming initial launch expectations and reflects the importance of these medications to individuals with migraine. Neurotech ODT is now the number one migraine treatment in its class. I want to thank our entire commercial, managed market, sales, and marketing teams for their determination and passion to continue to deliver our market-leading NBRX metric again this quarter. Today, Biohaven welcomes Pfizer as our global commercialization partner for Remedipant. As many know, that's known by Neurotech in the United States. Pfizer's commercialization reach and marketing expertise is unmatched in the pharmaceutical industry, making it the ideal collaborator to accelerate access of Remedipant to the more than 1 billion patients worldwide who suffer from migraines. We believe a collaboration between Pfizer and Biohaven brings together the winning combination of Biohaven's neuroscience R&D with Pfizer's brand strength and a vast global marketing network to deliver shareholder and patient value. Building upon the rapid success in the United States, our mutual goal is to gain approvals to deliver dual therapy NeurTech ODT rapidly to as many patients as possible around the world. With Pfizer's global clinical, regulatory, medical, patient advocacy, and commercial footprint, we can accelerate the access of Remedropant around the globe. Jim Englehart, our CFO, will discuss the finances of the global partnership in more detail in just a few minutes. But to summarize, this collaboration strengthens Biohaven's cash position with Pfizer's significant investment in Biohaven, $150 million in cash up front and $350 million in the purchase of Biohaven equity at a 25% premium, sales and development milestones, and the potential for long-term revenue on tiered double-digit royalties from net sales outside of the United States. Time and time again, we hear from patients and physicians that NeurTech ODT is changing the way migraine is treated and is improving the lives of patients with migraine. Partnering with Pfizer will allow us to ensure that we'll be able to more efficiently deliver Remedipant to the large patient population across the globe who have been disabled and suffer from migraines. As you know, Pfizer has a strong history and vast experience in launching innovative products globally and drive market growth around the world. In addition to this strategic collaboration, we'll allow Biohaven to capitalize on Pfizer's deep PCP footprint as PCPs are the key in the management of migraine and pain in the ex-U.S. markets. We are confident in the power of this collaboration given Pfizer's long history of successfully launching and building partnered brands. With this alliance, there's an opportunity to bring this best-in-class migraine therapy to patients outside the US and potentially change the paradigm in the other regions of the world. Under the terms of the agreement, Biohaven would remain primarily responsible for further clinical development of Remedipant, and the parties will cooperate in regulatory activities to secure approval for the product. Pfizer will commercialize Remedipant upon approval in all regions outside the United States, while Biohaven continues to solely commercialize Neurotech ODT in the United States. Additionally, per the arrangement, Pfizer gains rights outside of the U.S. to Zevegapan, our third-generation, high-affinity, selective, and structure-unique CGRP receptor antagonist currently being studied in both an intranasal delivery and a soft-shell formulation in stage 3 trials. We are all aware of Pfizer's track record of success. global reach and execution outside of the US. As Pfizer has accomplished numerous times before with big drugs such as Eliquis, we believe that our collaboration with Pfizer can transform Remedipant into a massive global brand in regions and markets that today we just couldn't do alone. Success will be achieved by working together and unlocking access to the many patients with migraine worldwide. I'm excited to be able to announce this global collaboration Pfizer is a world leader in global R&D and commercialization with impressive milestones that we highlighted as a reason why they were the partner of choice to drive Remedipant and its success around the globe. We believe a collaboration between Pfizer and BioAvent will bring together a winning combination. Next, I will turn the call over to Nick Lagunowicz, Global President of Pfizer Internal Medicine, to comment on our collaboration. And I must say that Nick's team is really unmatched in the pharmaceutical industry in terms of the commercialization and marketing expertise of multiple breakthrough medications. Nick?
spk13: Thank you, Vlad. I am very happy to be here this morning on behalf of Pfizer. We're excited about the partnership with Biohaven and even more excited to add Remedipant to our global portfolio outside of the U.S. We're looking forward to joining forces with Biohaven to help patients around the world who are impacted with this debilitating neurological disease. When we look at the numbers, they certainly tell a story, I think, but more important than the numbers is Pfizer's purpose, and that is to deliver breakthroughs that change patients' lives. Here at Pfizer, we apply science. and our global resources to bring therapy to people that extend and significantly improve their lives through the discovery, development, and manufacture of medicines and vaccines. And for decades, we've been at the forefront of advancing world-renowned breakthrough medicines and vaccines with global impact. Our portfolio includes more than 30 key medicines and many more medicines beyond that, several of which represent true breakthroughs, such as Comirnaty, Eloquist, Vindimax, and iBrants, to name a few. And our expansive footprint spans over 125 countries around the world. As of Q3, the Pfizer XUS revenues were $35.4 billion, but more importantly, we're very, very proud of the numbers of patients that we've impacted positively around the world. In fact, during the first nine months of 2021, our innovative medicines and vaccines reached nearly a billion people globally. We're excited about the opportunity to collaborate with Biohaven, to have an even greater impact on patients around the world who experience debilitating migraines. I want to congratulate Vlad and the BioHaven team on their success in achieving the rapid uptake of Remedipant in the US, which certainly speaks to the unmet need and the value of the medicine. And we plan to build off that success to drive strong uptake in markets around the world. We think about pillars for launch and what's required to launch successfully. We begin with securing access and optimal value. which we'll achieve through focusing on the unmet need of the patients and appropriately engaging the right patient populations. To drive rapid uptake, we'll leverage our go-to-market expertise and digital innovation to reach neurologists and specialists with information about this valuable treatment option. And we'll ensure long-term success by leveraging our scale and capabilities, along with our industry-leading customer base and colleagues, to reach PCPs, specialists, and health systems with the right information at the right time. With these three principles applied broadly and in coordination, I'm confident that we'll be able to accelerate access and fuel uptake of Remedjapan in markets outside of the U.S. Vlad, thank you for the opportunity to join your call today and for your partnership. I believe together we can help patients suffering from this debilitating disease. Now it's my pleasure to turn it over to Jim Englehart, CFO, Biohazard.
spk02: Thank you, Nick. Good morning, everyone, and thank you for joining today. Before providing an update on our Q3 results, I would like to echo the words of our CEO, Vlad Chorch, 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 migraine upon approval in markets outside the US. 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 VWAP on November 8, 2021. Closing of the equity investment is contingent upon completion of a review under antitrust laws. including the Hart-Scott-Rodino Antitrust Improvement Act of 1976 in the United States and is expected to close in December 2021. In addition, Biohaven will receive from Pfizer tiered double-digit royalties and reimbursement for related ex-U.S. BMS and royalty pharma royalties. Biohaven is also eligible to receive up to $740 million in milestone payments. In total, Biohaven is eligible to receive up to approximately $1.24 billion in upfront payments and future milestones. Our collaboration with Pfizer reduces Biohaven's ex-US investment to commercialize Remedipant upon approval by leveraging Pfizer's vast global commercial organization. Biohaven will continue to oversee manufacturing responsibilities for ex-US markets. We look forward to our collaboration with Pfizer and the ability to serve more patients who suffer from the debilitating effects of migraine. Now let me turn to Biohaven's quarter three results. NERTEC ODT achieved net sales of 135.7 million in quarter three, demonstrating another quarter of strong performance, increasing 46% versus quarter two of this year, driven by continued sales volume and we are very pleased by the contribution that our expanded label is having on NeurTech 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 preclinical research, partially offset by a 10 million dollar 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 NERTEC ODT as we invest behind our novel dual indication therapy. The increase is primarily due to increased promotional activity supporting ODT in quarter three as compared to quarter three 2020, which was in earlier phases of launch. We reported non-GAAP adjusted net loss for the three months ended September 30th of $125.1 million or $1.91 per share loss compared to $159.5 million or $2.67 per share loss for the same period in 2021. Moving on to year-to-date September results, R&D investment for the nine 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 preclinical research, partially offset by the aforementioned reduction in R&D service obligations. SG&A expense for the nine 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 activities supporting NERCTEC ODT during the full nine months of commercialized sales in 2021 for the treatment and prevention of migraine as compared to the same period in 2020 where NERCTEC was launched in 2020. We reported non-GAAP adjusted net loss for the nine 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 taking into account 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 with 6th Street, and 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. BJ.
spk12: Thank you, Jim. 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 NERTEC ODT five months in market post-launch of our dual indication. And second, I'm thrilled with the announcement of our collaboration with Pfizer to create broad access to this life-changing medication to those in need throughout the world. It's truly the fulfillment of our vision for NERTEC ODT to transform the lives of migraine patients, all patients across the globe. We're very pleased with third quarter sales of 136 million, an increase of 46% over prior quarter, which reflects enthusiasm and accelerated adoption within the broad clinician and patient communities. We are confident that NeurTech 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 NeurTech'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, an exceptional execution of our high-performing commercial team, we have steadily grown our new-to-brand market share by nine points on top of a rapidly expanding branded oral market. As Vlad shared earlier, oral CGRPs continue to drive incremental penetration of the tryptan market along with new patients in market. From a payer access perspective, we are also encouraged regarding 2022 formulary status for NERTEC-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, NERTEC-ODT has become the number one migraine treatment in the oral CGRP class. Since early August, NERTEC is the market leader in overall prescriptions, due-to-brand prescriptions, and prescribing among neurologists. And this is just the beginning, because we believe NERTEC ODT is uniquely positioned to transcend the traditional categories of acute and preventive. For patients with migraine who want the simplicity of one medication that can both treat their migraine attacks and be adapted to prevent them when needed, NERTEC ODT is in a market of one. Which brings us to this pivotal moment when we are prepared to build upon the exceptional foundation of NERTEC'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 migraine around the world. Who better to partner with if our objective is to create access to NERTEC's life-changing profile and impact as many people as possible as rapidly as possible. Needless to say, Pfizer is second to none in their ex-US commercial reach and expertise, with a proven track record of building massive global brands in regions and markets that are dominated by generics. And I'll conclude as I began. There's a lot to be excited about this morning. NERTEC continues its successful trajectory driven by strong execution and growth in volume and share, delivering 136 million in third-quarter sales. In addition, 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, NeurTech 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. NeurTech ODT has helped me treat or prevent migraines. Being 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 migraine is around the corner. Biohaven's dedication and commitment to patients is also shared by Pfizer, and our collective teams are eager to begin the hard yet extremely rewarding work of putting neurotech and personal control in the hands of patients worldwide. Now I'd like to hand it over to my partner, Elise Stock, our Chief Medical Officer.
spk03: 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 an even greater potential to bring multiple therapies to patients here in the US 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 will 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 review 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-US expansion. They bring global experience and a global footprint that will enhance our ability to win in migraine for patients around the world. With regard to our portfolio, we have an impressive CGRP franchise at Biohaven that is unparalleled. Neurotech ODT remains, of course, our cornerstone marketed product, now indicated for the acute treatment of migraine as well as for prevention. With our label expansion in late May, NERTEC ODT 75 mg has become the first and only ODT migraine medication approved to both 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 NeurTech 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 antagonists. Expansion beyond geographic regions, as already mentioned, and the dual acting indications is of critical importance to us. We have ongoing trials in pediatric migraine and trigeminal neuralgia. Investigator-initiated trials, Phase IV clinical trials, and studies in health economics will add to the important wealth of information that will ultimately be available for NeurTech and will help define the scope of important information for patients, providers, and payers, both within the U.S. as well as globally. The European evaluation of NERTEC'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 three clinical trial of NERTEC ODT for the acute treatment of migraine is ongoing in China and Korea. Studies to support filing in Japan will begin in 2022. Our Zevegipan program includes, as mentioned, both intranasal and oral formulations. An acute treatment phase three study with intranasals of Zevegipan began in October of last year, followed by a positive, following, excuse me, a positive phase two study. This second pivotal Zevegipan 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 Zevegipant for the acute treatment of migraine shortly after the results of this trial are available. Our oral formulation of Zevegipant was started in a phase three study in chronic migraine prevention this past March. Our next generation CGRP, 3100, has now advanced to the clinic and is in a phase one 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 our 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. Tririluzole, part of our glutamate-modulating has completed enrollment in its Phase III spinocerebellar ataxia study and will read out top-line results in the first half of 2022. A Phase III program in OCD started at the end of last year with the enrollment in the first study, and the second study was initiated in the first quarter of this year. Our myeloperoxidase inhibitor verdiprostats part of our MPO platform, was evaluated multiple system atrophy, a rare and rapidly progressive disease. And although we were disappointed not to have positive results, we continue to be hopeful about the Mass General Healy study that's testing this agent in ALS, and it will complete enrollment in the fourth quarter of this year. As you can see, we continue just to make great progress 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 one clinical trial in multiple myeloma. We expect our early pipeline to bring us exciting compounds in numerous areas over future years. 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 exciting, and we continue to drive performance. I'm really excited about our future at Biohaven. It is really a pleasure to be able to share all of this with you, and I will now turn the call back to Vlas.
spk10: Thank you, Elise, Nick, Jim, and DJ. In closing, Biohaven has demonstrated robust growth in terms of the commercialization of NERTEC ODT and 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 migrant sufferers around the globe has never been stronger, and our strategic collaboration with Pfizer will help ensure global access to NERTEC 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, 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 Neurotech ODP to patients. Let's open it up to questions. Operator?
spk04: Thank you. We will now be conducting our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is coming from the line of Ken Cacciatore with Cowan. Please proceed with your question.
spk17: Thanks so much. Vlad, you, Nick, Jim, DJ, you all sounded so natural and cohesive on the presentation. So wondering why we didn't just make it completely official and have Pfizer potentially buy the whole company. So just can you talk about the strategic process? Why not a complete exit? Is it price? Is it your belief in the pipeline? Um, obviously Pfizer's in vicious agreement about the opportunity with the, the quality, uh, agreement X U S you can just walk us through that. That would be helpful. First question. And then I'll save the second. Thanks.
spk10: Hey, thanks a lot, Ken. Well, 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 US 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, right? You and I and others have had discussions about how is Biohaven going to commercialize around the globe? That's a very challenging situation where you have to have a commercial, pricing regulatory presence in so many different markets. And so, Ken, this really gives us the cash we need to run our business. There's equity that's been purchased today at a premium and is a really good long-term setup, all while still having all of the U.S. revenue come into the company and preserving future optionality for us and our investors.
spk17: Thanks a lot. Thanks, Ken.
spk04: Thank you. Our next question is coming from the line of Chris Raymond with Piper Sandler. Please proceed with your question.
spk05: Good morning. This is for Chris this morning. Thanks for taking our questions. So first, congrats on the Pfizer deal. Maybe just a clarifying question. I think Biohaven is eligible for up to 740 million in milestones. I guess how should we think about the split there between regulatory and commercial milestones and just the cadence of potential regulatory milestones with the EU? and other approval decisions expected next year.
spk10: Yeah, 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, with this type of partner, it's going to bring in those revenues much sooner than many anticipated, and also 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 XUS market because we really had not been able to demonstrate we'd be able to commercialize that. And so, you know, finally, we've said publicly, we're out there looking for the best partner, XUS. We found the best partner, and we think it's going to really set us up nicely for the long term.
spk05: Got it. And then maybe just one more on commercial. Now that there's another oral CGRP approved for prevention, just any color on how your messaging or text profile compared to QLIFTA, anything? color on maybe how you're comparing or contrasting the QLIPTA profile, both the safety and efficacy data on the label. It's a single indication and it's QD dosing. How is that resonating with docs maybe compared to NERTEC's profile?
spk10: We're continuing to enjoy the differentiated profile because there is no other product that has one therapy for acute and prevention and one pill. That is what is driving the our market share and why we are beating a much bigger company like AbbVie in the marketplace, right? And that message is resonating with payers, patients, and doctors that you can have one solution for migraine. And so we've set a new standard there, and a lot of the other treatments out there 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, so that's how we're going to continue to differentiate and grow the market. Next question, please.
spk04: Absolutely. Our next question is coming from the line of Paul Choi with Goldman Sachs. Please proceed with your question.
spk14: Hi. Thank you. Good morning, and thanks for taking our questions. First is a strategic question both for Vlad and Nick, if he's still available. Just as you think about the portfolio and NERTEC, can you maybe just speak to any strategic synergies that you consider either across the Biohaven and or Pfizer portfolio? Is there any sort of overlap in terms of the migraine footprint there? And then I had a follow-up question on the pipeline.
spk10: As Nick talked about earlier, this product profile, we believe, really fits their ex-U.S. global footprint really nicely with their strong presence with PCP and pain across the globe. Really, as we look to various parties to have discussions today, they were clearly at the top with regard to those capabilities. This is the right partner to bring a drug like NERTEC to patients. When you think about it, Paul, there's not many drugs that have the potential of reaching a billion people worldwide with how common of a disease migraine is. And as we know, the leading cause of disability in people less than 50, right? And so having that type of global infrastructure is really what brings the value to both companies here. And so 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.
spk14: Okay. Thanks for that, Vlad. And one question on the pipeline with regard to 1100 and the ARM program in myeloma. Can you maybe just guide us at a high level to how we might think about the cadence of data in that program in 2022, and just how you're thinking about where the ARM program might be fitting in the myeloma treatment paradigm, either for Elise or Charlie.
spk10: Yeah, so I'll hand it over to Charlie or Elise to chime in. You know, this represents a really important next stage of development of BioHaven and that with our BioHaven labs and the acquisition we made last year, we really have access to what is an exciting immuno-science you know, a platform that you're going to start to see, you know, INDs and clinical trials like this start in other indications like oncology, like neuroscience and others. And so this is the beginning of that. We are so excited to have the first patient enrolled in that multiple myeloma trial. And next year, you know, we hope to have some data from that trial. And this will be the first validation of of using this technology in humans to improve outcomes in immuno-oncology. Elise, want to add anything?
spk03: Yeah, no, I think that you said it all. We are really excited about having that first patient in and really being able to test the first of the assets that's coming out of that early pipeline. So 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.
spk15: Yeah, and Paul, what we saw pre-clinically is when we add, you know, BHB1100 to the CMNK cells, we were able to boost the efficacy in terms of myeloma cell killing. So we're really excited to be testing that hypothesis in the clinic and look forward to the upcoming data.
spk14: Great. Thank you.
spk04: Thank you. Our next question is coming from the line of Jeff Hung with Morgan Stanley. Please proceed with your question.
spk16: Thanks for taking the questions and congratulations on the XUS partnership. You mentioned that Pfizer was the partner of choice. Can you talk about the process for the ex-U.S. partnership? You know, was it a competitive process, and if so, how many other parties were involved? And then I have a follow-up.
spk10: Yeah, thanks, Justin. As you know, 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, and we'll leave it at that.
spk16: All right, thanks. And then... How are conversations with payers going around the preventive treatment for 2022? Any feedback that you're able to share?
spk10: Really exciting feedback that I'm going to let BJ update you on.
spk12: Yes, great question, Jeff. And I would say that, you know, the discussions with payers are actually going extremely well. Once again, we feel very confident in regards to our ability to maintain what is the coverage that we have for acute therapy. And thus far, things are progressing extremely well as it relates to what is preventive therapy for 2022. And we'll be excited to announce some good news on that in near term as well.
spk16: Thank you.
spk04: Thank you.
spk12: Next question operator.
spk04: Absolutely. Our next question is coming from the line of Emile Devon with Mizuho. Please proceed with your question.
spk00: Hi, 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 just curious if there's any sort of standstills or other sort of clauses in there that could prevent an expansion of the agreement or something else happening in the future. And then the second, just if you could, Just looking at slide six, you've obviously done very well with gaining new-to-brand share, but in the last few weeks, UBrelvy sort of made a little bit of headway there. I'm just curious if you can sort of comment on what you're seeing on the new-to-brand side, specifically related to UBrelvy's sort of recent gains here.
spk10: Thank you. Great. Thanks for the questions. No, there is not a standstill in the contractual agreements. That is not in there, so there's no standstill. And then, look, I think on regard to quarter-over-quarter growth, we continue to see strong growth there. Of course, there's always some back and forth. Being at 57% of MDRX continues to be exceptionally strong when you look at who our competitor is. And I think, again, it's resonating with the message of the one treatment for both acute and prevention. BJ?
spk12: The only thing I'd add, thanks, Vlad, is that, you know, again, we're very pleased with our NBRX share gains, especially since our dual launch in June. As you know, clearly, we're the category leader. We're now sitting at approximately, you know, 14-point NBRX share advantage over UGROV, and NBRX trends over time is very important. We watch that clearly. But as many of you know, it's, you know, fairly volatile as well. In addition to monitoring what is long-term NBRX trends, we closely watch all the other early indicators to drive long-term MBRX share trends, such as perceived product differentiation, stated brand preference, and intent to prescribe, as well as relative competitive access. And on all these measures, it favors NERTEC ODT and supports our hypothesis in the long-term health, really, of the brand and our leadership. Thanks. Next question, Operator.
spk04: Our next question comes from the line of Laura Chico with Wedbush Securities. Please proceed with your question.
spk08: Hey, good morning, guys. Thanks very much for taking the question. I might ask this question a little bit differently than has been asked already, but I'm wondering, you know, you've mentioned a couple times now Pfizer's legacy in the primary care market. Was establishing a collaborative relationship in the U.S. territory a consideration kind of given their PCP presence?
spk10: So, Laura, I think what I've always said publicly for some time now is our focus was on the ex-US revenue streams. The US 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, right? And so we did that with this collaboration today. This collaboration gets us the cash we need to run and grow. The company brings in the potential for revenue streams that we couldn't do on our own. and allows us to maintain our full optionality, and we continue 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. And so we're very happy with the collaboration, and we'll leave it at that.
spk08: That's super helpful. If I could just sneak in one follow-up. European law is probably going to start on different footings. than in the U.S. with potentially two indications, acute and prevention. And you just mentioned kind of the 22 dynamics really boding well in the U.S. Wondering if you could just take a moment, talk a little bit on how there might be likely differences in pricing access in the European markets versus the U.S. Thank you.
spk10: Thanks, Laura. Just like our pre-launch activities 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. And, of course, we can't comment on that because it's all an ongoing interaction that's going on right now. We are preparing for a launch. Before, 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. And so, we're preparing for a launch in 22, and that's what I was getting at earlier, the importance of this deal, right? We get approval in Europe, you're going to have revenue streams coming in much quicker and at higher amounts than we would ever be able to do. And so that's why this partnership is particularly important for patients and violated.
spk04: Well, congrats, guys. Thank you.
spk10: Thanks.
spk04: Thank you. Our next question is coming from the line of Tim Lugo with William Blair. Please proceed with your question.
spk11: Thanks. We saw improvements in GTN in Q3. I guess with the prevention launch, you previously signaled that this could hurt GTN. Just directionally, can you talk about where you expect to go over the next few quarters? You know, we don't need hard numbers, but directionally, will GTN still be negative from prevention, but maybe that's improved with the more mature product users, or should we expect volatility still?
spk10: Tim, thanks, and I'll have Jim comment.
spk02: Yeah, thanks for the question, Tim. So, as you know, we don't give guidance. But what we can say is, you know, we're certainly pleased by the performance, not only of 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 launch, as BJ mentioned earlier, the key there is all about getting access, and we're making really good progress there. And certainly, as we navigate through that, that could put some pressure on gross to net, but overall, we're very pleased with the long-term strategy that we have in place.
spk11: All right, thank you.
spk04: Thank you. Our next question is coming from the line of Mark Goodman with SVB Learing. Pleased to see with your question.
spk06: Hi, thank you. This is on for Mark. I have two questions. The first, do you have any data on adherence or patients staying on NIRTEC that you would be able to share with us? And then the second is, could you elaborate a little more on how you view the mechanism and opportunity of radiprostat and ALS after the negative MSA study? Thank you.
spk10: Yes, sure. So, you know, what we can tell you, the migraine durability is very strong. You know, patients who respond, and we know from our data, you see about two-thirds or so of patients responding. They tend to take NERTEC as it reflects their monthly migraine frequency. It's mirroring that. It's just as we saw in a real-world trial. We're seeing very nice durability and refo rates there. Of course, we don't reveal the exact numbers around those, but we're very pleased and it shows how well the drug is working. Verdepristat and ALS, right? So we know with this drug we are hitting the target and we are decreasing neuroinflammation. It's all about what stage of illness and which disease pathology is the right one to target with the myeloperoxidase inhibitor drug. And I know from our previous MSA study, it may be that the later stage in that disease and the pathology is different than other neurodegenerative disorders. That's why we have this very important strategy of assessing drugs that hit the target of important mechanisms in different diseases that are unrelated by the underlying pathology, so there's no cross-readout in these different indications, and mechanistically, we believe that there is significant evidence in ALS that it's driven by neuroinflammation, and we will find out soon enough on whether we hit our top-line numbers there. Elise, do you want to add anything?
spk03: No, I mean, I think that, again, you said it all. I think that we do not believe at this point that we can predict in any way what will happen with ALS if there isn't clear read-through at all, and the mechanisms are different. You know, we are, you know, collaborating in that Mass General Healy study, and as Vlad mentioned, we're going to complete enrollment this quarter, and so we should have that data out sometime after that. Thank you.
spk04: Thank you. Our next question comes from Jeff Hung with Morgan Stanley. Please proceed with your question.
spk16: 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 neurospace in general? I was under the impression that you might have left the space. Thanks.
spk10: Hey, Jeff, sorry. Nick just had to drop off, so he's not able to answer that.
spk16: Thank you.
spk00: Thanks. Thanks.
spk04: Thank you. The next question is coming from Vamil Devon with Mizuho. Please proceed with your question.
spk00: Hi. Thanks for taking my follow-ups, too. So just a couple quick ones. One, I'm wondering if you can share the split of sort of treatment versus prevention sales in the quarter. And then the second one is just around Zavei Japan, and I guess sort of a couple parts here, the expectations you have on that data before we get that And then could that be something that also gets added into this agreement if the data are positive?
spk10: Yeah, so we're seeing growth in both acute and prevention. We don't break down those numbers. A lot of the script data that you're seeing just shows you a script. It doesn't tell you whether it's one or two 8-packs. We're very pleased with the growth we're seeing in both segments there. And, you know, remember, we're trying to get rid of the notion of two different segments, right? And so it really depends on how many migraine attacks you have per month and how long that 8- or 16-pack lasts you. So, yes, on Zevegipan, if I understand your question, Pfizer has the rights on Zevegipan as well. We have data coming very soon. That study is going to read out shortly with intranasal Zevegipan, and that's going to be the first intranasal CGRP that could give you an ultra-rapid onset of action, right? And so that, we believe, is an important drug, not just here in the U.S., but It's part of this deal, and obviously we believe it's going to be a very important drug outside the U.S., so we're excited about that. Did I answer your question on that, Vamil?
spk00: Yeah, that clarifies it. Thank you. Thanks.
spk10: All right, last question, please.
spk04: Thank you. Our final question is coming from the line of Esther Rajavillou with UBS. Please proceed with your question.
spk07: Hi. Thanks for squeezing me in. Lad, congrats on the deal. I guess a clarifying question. Will Pfizer be responsible for the Asian markets as well, or will Biogen be the lead in Asia? And then I have a quick question for Jim.
spk10: 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 80 million Chinese with migraine, very substantial market, and we're excited to be working with the Pfizer China team And as you know, our study is ending up there, and we'll be reading out again shortly, and then we'll be proceeding to filing. And then, operator, I think there was one more question on the line, but Esther, do you have a question for Jim as well?
spk07: Yeah, just a quick one. Jim, given the cash infusion with this deal, can you give us an understanding for the use of funds over the next 12 to 18 months between R&D and USSG&A?
spk02: Yeah, thanks for the question, Esther. Yeah, so I guess really the key strategy for us here is really, and the importance of getting that infusion as part of this transaction is really getting us to profitability. So we're really pleased with not only the position of the cash that we have on hand and access to, but also the funds that we are closing on in this transaction.
spk10: Yeah, you know, 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, right? And that's been important. We've demonstrated our ability to fund the company in other ways to make sure we limit dilution to our shareholders. This is a really important issue. cash infusion, purchase of our stock at a premium that puts us in a strong position for a longer-term revenue stream. So just really excited about that. All right, last question, operator.
spk04: Absolutely. Our last question is coming from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
spk01: Super. Thanks for fitting me in, juggling calls this morning, Vlad and team. Congratulations on this transaction and really great quarter. Had a quick question regarding how to think about the European market and maybe even the Asian markets. As you think about pharmacoeconomic contributors to pricing, not really asking you about pricing, but how do the Europeans think about migraine versus, say, the United States prescribers?
spk10: Yeah, great question, Charles. And what I can say there is just like in the US, we've made the value proposition to payers. And I remind you that we did get favorable reviews with regard to our pricing because they're demonstrating on the reduction of disability, right? Think about this, Charles. In people less than 50, this is the leading cause of disability, right? And so that's important in our health impact analysis to the payers, both in the U.S. and outside of the U.S. And again, ICER, in their review, concluded we were cost-effective for patients with migraines, you know, who didn't either respond or didn't have a full response or couldn't take a triptan or didn't respond. So we're going to have that same value proposition outside the U.S., and the pair constraints there are different, but also we have a very large global market that we're going at here. So we're really excited about the prospects.
spk01: 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. And I apologize if this has already been asked.
spk10: What I can say there, again, Charles, is that Our focus was, for a priority, was making sure we can globalize NERTEC, and we said publicly previously that's what our priority was, to find a global partner. That's what we went after, and we've maintained all of our optionality and flexibility. In the U.S. market, we solely have that rights here, and we're doing exceptionally well with BJ and team. So this, to us, was an ideal partnership, puts us on real sound financial footing, and creates very significant future revenues, we believe, for our shareholders and brings important drug to patients. So we think it was the right deal, and we'll leave it at that. Okay.
spk01: Excellent. Thanks for taking the questions. Congratulations, Len. Thanks. All right.
spk04: Thank you. Thank you. We have reached the end of our question and answer session. I'll pass the floor to management for closing remarks.
spk10: Yeah, thank you. So thank you, everyone, for joining us today. We really appreciate the support of all our employees and investors and our global partner now, Pfizer, in working together to deliver life-changing therapies. And for those suffering from migraine, this is a really important day-to-day because we have a path forward to bring them the best-in-class oral CGRP agent and something that we think is going to have the potential to change the treatment paradigm outside the U.S., and improve patient lives. So thank you all.
spk04: Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation, and you may disconnect your lines at this time.
Disclaimer