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spk04: Good morning, and welcome to the BioHaven Pharmaceuticals Q2 2021 earnings call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If anyone should require operator assistance, please press star zero on your telephone keypad. Please be advised that today's conference call may be recorded. I will now hand the conference over to Caroline Dirks from BioHaven. Thank you. Please go ahead.
spk08: Thank you, and welcome to the BioHaven second quarter 2021 earnings call. Speaking on today's call 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. Earlier this morning, we issued a press release announcing the second 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 Chorich.
spk05: Thank you, Caroline. Good morning to our investors, and thank you for joining our second quarter earnings call. This has been another transformational quarter for Biohaven. NERTEC ODT became the first oral CGRP targeting drug to be approved for the prevention of migraine and episodic patients and the first and only medication with a dual indication proven to treat acute migraine and prevent future attacks. How exciting. For the first time, patients and doctors can customize a single migraine therapy to treat and prevent migraines. I want to thank our R&D team, patients in our clinical trials, and the clinicians who helped attain the prevention approval. Together, we have changed the way migraine is being treated. Once again, our business performance this quarter has exceeded expectations on multiple fronts. NERTEC ODT net revenue in the second quarter was $93 million, which brings a cumulative launch-to-date net revenue to approximately $200 million. To date, we have achieved over 875,000 prescriptions of Neurotech ODT, and the oral CGRP market continues to show strong demand and quarter-over-quarter growth. Although much of our second quarter performance reflects the acute indication, we are very pleased to see robust growth in the new-to-brand Rx metric after the prevention approval. Our new-to-brand Rx market share as of this morning is now approximately 56%, reflecting robust demand from our dual indication. NeurTech ODT is providing fast and lasting relief to more and more migraine patients every day. The entire oral CGRP class is outperforming initial launch expectations and reflects the importance of these medications to individuals with migraines. The OROC GRP classes demonstrated strong and steady growth in RX volume. Neurotech ODT continues to drive demand, which is differentiated label and dual indications for acute and prevention. I want to thank our entire commercial team, managed markets, sales, and marketing groups for their determination and passion in delivering our market-leading new-to-brand RX metric this quarter. We believe that NeurTech ODT has the potential to become the first-line standard of care therapy given its efficacy and safety profile. Oral CGRPs are gaining market share compared to the older triptans, reflecting the limitations of prior therapies and the advantages of this new class. We believe there will be significant growth ahead as patients increasingly become informed about the fast and lasting benefits of NeurTech ODT. When we look at the CGRP targeting agents as a whole, it remains evident that oral CGRP antagonists continue to drive the growth of the overall CGRP targeting market. Injectable MABs are limited to prevention, and many patients may consider an injection less desirable compared to a simple oral pill. Given the projected size of the overall market, we remain focused and committed to investing in the long-term success of Neurotech ODT and growing the overall oral CGRP market. This morning, we are also very excited to share the news that the United States Patent and Trademark Office has awarded Biohaven a new patent covering our ODT formulation of Neurotech ODT. Innovation is at the core of our business and we have demonstrated the important differentiation of our ODT formulation with its fast onset of action and other attributes. It is so important to protect innovation and I would like to thank Warren Balls and our entire legal team for protecting our ideas in the marketplace. Without such IP protection, we cannot ensure the continued development of important new medications and formulations. This new patent, covers our API Remedipant as well as other CGRP inhibitors in an ODT formulation. The patent will extend until March 2039, not including potential patent term extensions. We believe that Biohaven has the most broad and differentiated CGRP antagonist platform in the pharmaceutical industry. At this time, we have over 10 CGRP clinical programs across both migraine and non-migraine indications that are currently running around the globe and aimed at areas of significant unmet medical need, including adolescent migraine, asthma, and psoriasis, just to name a few. We have also invested in numerous formulations and drug delivery options to optimize the PK and delivery to match each indication and each unmet need. This broad and diverse pipeline gives our CGRP franchise tremendous flexibility that can be optimized for various CGRP-mediated diseases outside of migraine. Our launch of NeurTech ODT and acute and preventative migraine is only the beginning of our franchise. We look forward to following the science of CGRP antagonism across neuroscience and immunoscience. In addition to our lifecycle management of NeurTech ODT, which includes the extension into pediatric migraine, we expect to have top-line data from intranasal Zavegapant soon, and if positive, we'll be ready to file Zavegapant as the first intranasal seizure P antagonist for the ultra-rapid treatment of migraine. An oral version of Zavegapant is also ongoing in clinical testing this year in migraine and non-migraine indications. There are approximately 1 billion individuals worldwide who suffer from migraine. Expansion of NERTEC-ODT beyond the United States has already begun with our two approvals for NERTEC-ODT in Israel and the UAE. We anticipate nine regulatory submissions across the globe by the end of this year. We have delivered great commercial success in the U.S., and we will continue to pursue that level of success with approvals in other regions of the world. NeurTech's significant paradigm shift will be able to improve the lives of many individuals living with migraine across the globe. In addition to our CGRP franchise, we also have multiple significant near-term milestones outside of CGRP anticipated in 2021 and the early part of next year. starting with top-line results earlier than expected with our MPO inhibitor Verdepristat in multiple system atrophy in the third quarter of 2021, and then this will be followed by additional readouts at the end of the year and next year. We anticipate that enrollment in the Phase III study of Verdepristat in ALS will complete in the fourth quarter, and Trurelizol is anticipated to read out top-line data in spinocerebellar ataxia early next year. We are excited by the potential of our pipeline to bring value to patients suffering from devastating neurologic disorders. And you're gonna hear a lot more about the details of our portfolio strategy from our CMO, Elise Stock, in just a few minutes. So to summarize, NERTEC ODT has exceeded all expectations in its brief 15 months since our initial approval back in March of 2020. And now with the approval of prevention, NERTEC ODT's new indication we are able to unlock our ability to reach more people and improve lives and create a legacy of countless stories of personal transformation. It remains a testament to our determined R&D and commercial teams that have fulfilled our responsibility to patients to ensure that we relieve suffering by delivering our novel migraine therapy to patients. One medication to treat and prevent delivers unprecedented personal control for patients. We have differentiated this product and are increasing revenue growth quarter over quarter, and we have a strong portfolio of product opportunities that we believe will deliver value for patients and investors, not only in the near term, but for years to come. Our goal is to continue to deliver best-in-class therapies from our promising pipeline for patients. Before our Chief Commercial Officer, BJ Jones, tells you some more details about the success of our commercial launch with NeurTech ODT, I'm going to turn it over to Jim Englehart, our Chief Financial Officer, to review the detailed results of our financial performance in the second quarter of 2021. Jim?
spk02: Thank you, Vlad. Good morning, everyone, and thank you for joining today. NeurTech ODT achieved net sales of $93 million in quarter two, demonstrating another quarter of strong performance. increasing 112% versus Q1 of 2021, driven primarily by increased sales volume and favorability regarding gross to net price realization. If you recall, we have previously communicated that we expect improvements in our net realized price in 2021, and we are pleased to see that translate into our results this quarter. Continuing down the P&L, in R&D, Our investment in the quarter on a non-GAAP basis was $67.7 million compared to $36 million over the prior year quarter, an increase of $31.7 million. The increase is primarily due to continued investment in our late-stage product candidates and preclinical research, partially offset by a $10 million decrease in our obligation related to our two royalty pharma funding agreements. As G&A expands in the quarter, on a non-GAAP basis was $153.7 million compared to $119.5 million over the prior year quarter, an increase of $34.3 million. Most of our SG&A costs continue to support commercial sales of NERTEC ODT. The increase is primarily due to increased promotional activities supporting NERTEC ODT in Quarter 2-21 as compared to Quarter 2-2020, which was in the early phase of launch. which represented NERTEC's first full quarter reactor launch in the last few weeks of Q1 of 2020. On EPS, we reported non-GAAP adjusted net loss for the three months ended June 30, 2021, of $170.9 million, or $2.62 per share loss, compared to $150 million, or $2.55 per share loss, for the same period in 2020. Turning to six-month performance, R&D investment for the first six months of 2021 on a non-GAAP basis was $141.8 million, compared to $85.8 million over the prior year quarter, an increase of $56 million. Again, the increase is primarily due to our continued investment in our late-stage product candidates and preclinical research, partially off by the aforementioned reduction in the royalty pharma funding agreement obligations. SG&A expense for the first six months of 2021 on a non-GAAP basis was $284.6 million compared to $204.4 million over the prior year quarter, an increase of $80.2 million. The increase is primarily due to increased promotional activities supporting NERTEC ODT during the full six months of commercial sales in 2021 as compared to the same period in 2020 where NERTEC ODT was launched in March 2020. For EPS, we reported non-GAAP adjusted net loss for the six months ended June 30, 2021 of $359.3 million or $5.65 per share loss compared to $284.7 million or $4.94 per share loss for the same period in 2020. Turning to our balance sheet. We continue to be well capitalized with $368 million in cash, cash equivalents, and marketable securities as of June 30, 2021. In addition, we have immediate access to $225 million from our debt facility with Sixth Street and anticipate $164.8 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. As Vlad stated, we are very excited about our recent approval of NERTTEC ODT for the prevention of episodic migraine in addition to our prior indication for acute therapy. NERTTEC ODT is indeed the first and only medication proven to treat and prevent migraines, and we are encouraged by the enthusiastic reception we have received thus far from prescribers, patients, and payers since the launch of our dual indication. Fundamentally, we believe we're witnessing the early stages of a true paradigm shift in migraine treatment that will lead to demand for a more simple, higher standard of care that produces better patient satisfaction and outcomes. and consequently dramatically expands the number of people with migraine seeking treatment. In the nine weeks post-launch, we have witnessed an acceleration in volume and share driven by both increased acute and preventive therapy utilization. With NeurTech ODT's unique positioning as the first and only medicine proven to both treat and prevent migraine attacks, I'd like to share a perspective on this dynamic market. how we believe it will evolve over time, and the role that NeurTech ODT will play. The expanded market opportunity starts with the existence of extremely high unmet need in this category. In what remains the second most disabling disease in the US, there are many points to cite, but I'll highlight some of the most compelling specific to migraine prevention. First, there are too few people seeking preventive care, only 15%. patients are very dissatisfied, with 84% seeking better options. And third, the injection barrier among patients is real, with 65% of people who don't want to receive an injection. These data speak to an immediate and compelling unmet need today, but we also see a longer-term opportunity that is underdeveloped and waiting to be cultivated. When you look at overall participation in the preventive market, it's striking how small the market is relative to the total population of people with migraine. In a market of approximately 40 million people with migraine, fewer than 500,000 are on some form of novel injectable therapy. Approximately another million or so are on legacy oral therapies, most commonly to Pyramace. And why are so few people practicing preventive treatment? Research suggests that complexity, burden, and tolerability profile associated with existing therapies are the issue, while the previously mentioned barrier to injectable therapies has also substantially limited participation. Clearly, we see the immediate opportunity to convert many among the 1.6 million people who are dissatisfied with these other therapies. However, we also see a different, much larger market below the surface that will steadily grow over time among people who have either left the preventive space or have been reluctant to engage based on the limitations of existing therapies. We also see a market that isn't constrained by the traditional siloed categories of acute and preventive therapy of today. These rigid categories evolved not because physicians believed they were treating a differentiated underlying condition, or because they wanted to add complexity, but rather the characteristics of traditional migraine medications limited the breadth of their utility. Neurotech ODT is well positioned to transcend these categories. For patients with migraine who want the simplicity of one medication, they can both treat their migraine attacks and be adapted to prevent them when needed. NERTTEC ODT is in the market of one. Migraine is a complex disease and clearly other options are needed. But the unique ability to start and stay with NERTTEC ODT has the potential to make NERTTEC the foundation in migraine treatment. This one of a kind profile encourages patients and prescribers to try and exhaust its full utility in treatment and prevention before adding additional therapies or progressing to injectables when they may not be needed. This is the new market we see before us and aim to unlock and cultivate in the years ahead. These are some of the insights clinicians have been sharing with us regarding their evolving utilization of NeurTech ODT in this new landscape. First, most immediately, HCPs affirm that the indications are not merely additive but synergistic. 85% of customers say the new preventive indication will increase their prescribing for acute use. The mere possibility that patients could flex their use of NeurTech to also prevent migraine attacks will drive greater initiation in acute therapy. We are seeing this effect already emerge in the form of growing acute preference and NBRX share. From a traditional prevention perspective, even before any promotion began, more than three of four HCPs surveyed stated that they were highly likely to prescribe NERTEC ODT for prevention. And in what we believe represents a large opportunity to expand the legacy preventive market, we see that 60% of targets said that they were also likely to adapt to use of NERTEC ODT for intermittent or preemptive prevention to better manage predictable and unavoidable triggers like weather change, hormonal changes, and periods of stress. Now, from a payer access perspective, NERTEC continues to perform very well. In the critically important commercial channel, we were successful in establishing more than 89% coverage during the launch of 2020 and have sustained that level of coverage throughout 2021. As it relates to all channel lives covered for NERTEC, we have increased access from 215 million lives exiting 2020 to 238 million covered lives currently. Our access efforts for the new preventive indication are also progressing well. The dosing flexibility that the dual indications offer, coupled with label safety data, have been very well received by payers. Utilization management within the majority of payers is supportive of the preventive indication. To date, prior authorizations and step edits have been similar to what we've experienced with acute largely generics only, and utilization management criteria is consistent with that of the MAS. Negotiations with the national PBMs and health plans for 2022 coverage for both acute and preventive indications are ongoing. So in summary, these and other data reinforce the belief NERTEC ODT is well positioned to uniquely address unmet needs in the migraine space and that this opportunity transcends traditional acute and preventive boundaries. And as it has become my custom, I'd like to close with a focus on our patients. We draw added confidence in knowing we landed on this market approach not because we were merely trying to stand out and differentiate ourselves in the market. We executed this approach because of the personal experiences and insights gleaned from our patients and prescribers. They said the approach was intuitive to them, it is what they wanted, and it gave many a level of personal control over their lives they had never experienced since they were diagnosed with migraine. It's life stories like Sabrina's and Melinda's on this slide that inspire us to work as hard as we do to innovate and deliver for customers. And it's experiences like Elena's that reinforce our strategy and approach to the market opportunity. She articulates the unique positioning of NERTEC perfectly. I think my neurologist picked NERTEC over uBrelvi because it's also approved as a preventive in case I need one in the future. NERTEC ODT, putting power back in the hands of patients. And that is why we remain incredibly bullish about the approach in the future of NERTEC ODT. And with that, I'd like to hand this over to my partner, Elise Stock, our Chief Medical Officer.
spk06: Thank you, BJ. This quarter, I'm delighted to highlight the significant advances we continue to make across our R&D organization, and I'm also happy to look to the future and Biohaven's potential to bring multiple novel therapies to patients. As Vlad has mentioned, we have an impressive CGRP franchise at Biohaven that is unparalleled in our industry. Our focus on the lifecycle expansion of NeurTech ODT as well as the exploration of a wide variety of scientifically relevant indications outside of migraine is important to us, and we're committed to following the science. Expansion beyond geographic regions and the dual acting indications is of critical importance. We have ongoing trials in pediatric migraine, which is a large area of unmet need. Additionally, we're studying trigeminal neuralgia, and expect to study NeurTech in several additional migraine-adjacent areas, including post-traumatic headache and at least two other undisclosed areas. CGRP represents an important pathway in the nexus between the immune and central nervous system, and across a range of CGRP antagonist assets, we'll follow the science and conduct multiple proof-of-concept and registrational studies. Additional non-migraine studies are underway or planned, and include psoriasis and asthma. Others remain undisclosed. Investigator-initiated trials and studies in health economics will add to the wealth of information that will ultimately be available for NeurTech and will help define the scope of important information for patients, payers, and providers. We continue to make great progress across our programs, including our CGRP franchise, our glutamate modulating agents, our myeloperoxidase inhibitor platform, and the new opportunities we have across both common and rare diseases in our late-stage portfolio, as well as the early discovery work in BioHaven Labs. We expect our early pipeline to bring us exciting compounds in numerous areas over the future years. But for today, I'll focus on our late-stage programs that are in the clinic with many nearing top-line readouts. NERTEC ODT remains our cornerstone marketed product now indicated for the acute treatment of migraine as well as prevention. With our label expansion in late May, NERTEC ODT 75 milligrams has become the only migraine medication approved to both treat acute migraine attacks and help prevent future migraine attacks. Just imagine acute and prevent. The ability to treat a large number of patients across the migraine continuum is is a truly innovative approach to the treatment of migraine with the ability to use up to 18 doses per month, allowing for both acute and preventive treatment in the same patient. I'm really proud of the team that's been able to make this a reality for NeurTech and those suffering from migraines. In addition, the European evaluation of NeurTech'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 quarter of 2022. Additionally, a Phase III clinical trial of NERTEC-ODT for the acute treatment of migraine is ongoing in China and Korea. And our portfolio of small molecule CGRPs affords us great flexibility and has the potential for multiple blockbusters. Important among these is the Vegapant, which is already in Phase III. Our Zovegapan program includes both intranasal and oral formulations. An acute treatment phase three study with intranasal Zovegapan began in October of last year following a positive phase two study. And this second pivotal Zovegapan study has the potential to confirm an even more rapid onset of effect. We anticipate a filing of this intranasal Zovegapan for acute treatment of migraine in the fourth quarter of this year. And our oral formulations formulation of the VEGPANT began a phase 3 study in chronic migraine prevention in March. Additionally, we're conducting a VEGPANT phase 3 trial in pulmonary complications of COVID-19 to assess whether CGRP receptor blockade can mitigate an excessive immune response and will likewise follow where the CGRP science leads us into other non-migraine areas later this year. Also in our portfolio of CGRP antagonist small molecules are a number of next-generation CGRP antagonists, and the first of these, 3100, has now advanced to the clinic and is in a Phase I study. These multiple CGRP antagonists open numerous possibilities for us to expand our CGRP platform and afford us the ability to really customize the unique attributes of each of these structurally unique compounds. We have deep experience in this mechanism of action and have multiple assets to optimize for different indications. Our glutamate and myeloperoxidase inhibitor platforms are really likewise busy. Glutamate is the most abundant excitatory transmitter in the brain, and we believe tririluzole has and will provide important advances in the neuroscience field across many areas. Tririluzole, part of our glutamate modulating platform, has completed enrollment in its phase three spinocerebellar ataxia study and will read out top line results between the fourth quarter of this year and the first quarter of next year. A phase three program in OCD started at the end of last year with the enrollment in the first study, and the second study was initiated just in this past first quarter of the year. Both studies are based on critical signaling that emerged from earlier proof-of-concept OCD studies that we conducted. Our myeloperoxidase inhibitor, Verdiprostat, part of our MTO platform, is being evaluated in multiple system atrophy, a rare and rapidly progressive disease with FDA's fast-track designation. The Phase III study of Verdiprostat in MSA will read out top-line data in the third quarter of this year. The Mass General Healy study that's testing this agent in ALS is also ongoing and will complete enrollment in the fourth quarter of this year. We will continue to make strategic decisions across the portfolio as our data matures with both external partnerships and internal programs. As you can see, we're very busy, and we remain focused on the important things. Following the science, making streamlined and rational decisions based on well-designed studies and the scientific data they generate. Rational and educated risk-taking while maintaining scientific integrity is critical. Optimization of drug design and formulation, fostering innovative partnerships and collaborations, nurturing and growing our internal talent, and of course, keeping the patient at the center of all we do. Our pipeline is really large and exciting, and we continue to drive performance. I can't wait to see what comes next. It's really a pleasure to be able to share all with you, and I'll now turn the call back to Vlad.
spk05: Thank you, Elise, Jim, and BJ. In closing, Biohaven has demonstrated robust growth in terms of the commercialization of Neurotech ODT and important maturation of our late-stage innovative pipelines. Our strategy to develop Neurotech ODT as a dual-acting therapy for acute and prevention, as well as launching with our unique and now patent-protected Zytus ODT formulation, demonstrates the key decision that we have made, and ultimately, this is what is differentiating our product in the marketplace. We expect continued market expansion of Neurotech ODT in migraine and anticipate multiple pivotal trial readouts over the next year. We have the potential for multiple NDAs over the next couple of years and significant growth lies ahead for our company. Before opening up to Q&A, I would like to thank the entire Biohaven team for their relentless commitment, drive, and value creation for patients and investors. I also want to thank all the patients, their family members, and investigators who participate in our clinical trials that really help to advance clinical care in the area of neuroscience. We must continue to work hard to bring novel treatments to patients suffering from these devastating diseases. Finally, thank you again to our visionary investors who have helped fund our studies and bring Neurotech ODP to patients. Now we'll open it up to questions. Operator?
spk04: Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from Paul Choi from Goldman Sachs, your line is now live.
spk10: Thank you, and good morning, everyone, and congratulations on the strong quarter. A few commercial questions from us, please. Just first, with regard to the prevention launch, Can you maybe just, you know, update us on how you're positioning and messaging NERTEC among potential prescribers and patients ahead of a competitive launch coming down the road? And, you know, how would you characterize and quantify relative awareness of the different molecules at this point?
spk05: Great. Thanks, Paul. I'm going to turn it over to PJ to answer that question. I did want to highlight, though, that because the prevention launch came late in the quarter, we really, the results you saw today are still from the growing acute market, and the early metrics look so positive for the dual indication as reflected by the 56% NBRX today. But certainly, I think you're going to see a lot more in the next quarter as we begin to realize more of those dual acting and prevention scripts. So, BJ?
spk12: Thanks for the question, Paul. You know, messaging has been very clear. We've been communicating to both clinicians and patients the fact that we are the first and only medication that can be utilized to treat and prevent migraine. And once again, as I mentioned, it allows us to really set ourselves up as the only medication in this space. So as you look at all the others, those that may be coming through impending PDUFA dates and as well as the MABs and the rest of the market in generic space, we are the only ones in that space. And thus far, as Vlad just mentioned, we really have seen just tremendous receptivity to that messaging from clinicians and patients as well. So we feel very good about that. From an awareness standpoint, it's very early, but we are excited because we don't have to climb the hill of a brand new medication. We are well known, we're utilized, the marketplace is well aware of Neurotech, and so we're able to use that relative awareness really to just launch us into what is a broad awareness around this dual indication. So thus far, we like what we see.
spk05: And BJ, I'll just add to that. Elisa, you know, touched upon this, and that's the paradigm shift with patients and their doctors, right, that they can customize this therapy. Now, like, who doesn't want the only therapy that you can customize for acute and prevention? And as BJ talked about, the one patient that provided us feedback about the reasons she was put on Neurotech was for that therapy, control that a patient wants and the ability to say, I want to use it acutely now, but maybe in the future I can then stay on the same medicine for prevention if I need that. Or if you're somebody who needs a preventative, that you can have a simple medication that doesn't require polypharmacy. So thanks, Paul, for the question.
spk10: Okay. Thanks, Paul.
spk04: Operator, next question. Thank you. Next question is coming from Ken Cacciatore from Cal, and your line is now live.
spk03: Congratulations, Vlad, to you and the team. Really just fantastic performance. I guess my question is around the value per Rx that you're securing currently in the acute. Just kind of give us a sense, if you could, where that's going. And then BJ made a very nice commentary about payer access around prevention. I guess just wanted to drill down a little bit more here. Obviously, prevention is, in essence, doubling the amount of pills and just wanted to understand how those payer discussions are going. I think you mentioned that at this point there's no real step through versus the injectables, but maybe how that will shake out when you feel that we'll have this locked in and then maybe a sense of where the value per prescription on a blended basis will be going. And then, Vlad, just back to you on XUS, obviously wonderful performance here in the U.S. Maybe talk about how we're thinking about XUS and pacing and decisions in terms of partnering. Thank you.
spk05: Thanks a lot, Ken. Appreciate the comments. I'm going to turn it over to Jim to talk about value per Rx and then BJ on the payer front. I'll just generally say that, as you know, we don't guide towards that value per Rx, but I'll let Jim comment just on the favorability that we've been seeing in pricing. But the good news is it's not just favorability in pricing, but continued growth that's driving this value. Jim, do you want to?
spk02: Yeah, thanks, Vlad, and thanks again, Ken, for the question. As I mentioned, we don't guide to our net price, but I will say, as I commented in my prepared script, that we were pleased to see the improvement in the second quarter, and we had provided in the past some context that this would improve, so we were really pleased about that. One of the big drivers, obviously, as we've talked about, is these patient affordability programs that we have in place, and over time, we will start to pull those back. And certainly as we do that, that will improve the price. Just one thing we want to just keep people mindful of, though, as we've said in the past, this is We're still in a launch phase, and certainly now with the approval of prevention, we will see some volatility in pricing in the future, but we are confident and believe that we'll continue to have success and strong performance. Turn it over to you, Daniel.
spk12: All right. Ken, thanks for the question. As it relates to payer access and those discussions, You know, as you can imagine, we're in constant dialogue at this point in time. And really our ability to communicate what is NERTEC's clinical profile, this unique dual indication, dosing flexibility, where continued safety, you know, has really been received extremely well. And so we're excited about those discussions thus far. I can't get ahead of ourselves and communicate exactly what the outcome will be, but we feel confident that within, say, the next 60 days or so, we will have some commitments for what will be 2022. And that's what we're focusing on. We have not thus far, though, run into situations. So we believe, again, our current PIPA criteria is consistent with that for the MAPs, which is best possible criteria. And again, these active negotiations are ongoing, and we feel confident, again, about what we believe will be an extension of the current UMN and PA criteria. Great. Thanks.
spk05: I'll just add on the PA, you know, criteria. As a physician, I'll say that this also reflects that even though there's step-through, right, the high-end men need out there, that we're seeing this type of growth because there's a limitation of our current therapies. And as we said prior to the launch, sometimes those limitations don't get completely realized by folks necessarily. until you have a drug in the market that you can contrast it with. And so now what you're seeing is patients haven't been satisfied with triptans, but they didn't have an option, right? Now that there's a good oral option on both acute and prevention, you're seeing the strong uptake. And we think that's going to continue to just grow. Ken, your question on global. It's very infrequent that a drug like Neurotech comes along that could affect literally a billion people worldwide, right? That's how many people suffer from migraine across the globe. We take that responsibility very strongly because the impact we're seeing here in the U.S. And so the team is very hard at work at the regulatory filing so that we could, you know, really bring NERTEC to patients around the world. And as I've said previous during some of our public commentary that, you know, we are in a decision kind of making mode about how we'll do the ex-U.S. and global commercialization and Those are all works still in progress, and so we'll have to stay tuned for future updates on region by region or whether there be other ways to globalize XUS. So we'll leave it at that. Thanks, Ken, and operator, next question.
spk04: Thank you. Our next question is coming from Chris Raymond from Piper Sandler. Your line is now live.
spk13: Hey, thanks. Just a question on the mix of prescribers. Some of our checks have indicated that you guys have seen a lot of traction amongst I'm wondering if just generally you can talk about the mix there between primary care docs versus, you know, headache specialists. And also maybe a second part of that question, if you can outline, are there any access considerations at the PCP level versus specialists that you can talk to, you know, especially now with the prevention label? Thanks, Chris.
spk12: Yes, thanks for the question, Chris. So as it relates to kind of specialist versus primary care, as one would expect, and we've seen in the data, you know, specialists are the ones that adopt more rapidly. They see more patients, obviously, you know, per clinician. But we do see a nice transition, if you will, over time where we're starting to see really strong pickup in primary care. And we see that actually for NERTEC, but certainly for the class as a whole. We expect over time for primary care, just because there's so many of them, they see so many patients with migraine, is that that will be the bulk of this category in the not too distant future. And so we're excited again about what is even a re-energized excitement with our dual indication that we see even in this early stage from primary care as well as specialists. As it relates to access issues, I would say that nothing is really sticking out. We do have strong access to primary care. So there is, if you will, kind of this overarching concern around not only the class but the broader industry as it relates to Delta and the impact from an access standpoint. But thus far, we're excited. We're getting in to see our most important clinicians and communicating effectively with them.
spk04: Thanks. Thanks, Chris. Operator, next question. Thank you. Next question is coming from Vamil Devon from Azul. Your line is now live.
spk00: Hey, guys. This is a way for Vamo. Yeah, just wondering, first, if you can talk a bit about Vasei Japan that expected, you know, Phase 3 readout this year. Just wondering what your expectations are and how you would position the product. And secondly, just also wondering whether you have any more color with regards to the EU filing. That's it. Thanks.
spk05: Thanks. I'm going to turn it over to Elyse. I'll just say that Zevegipant is going to be nicely complementary to Neurotech ODT, and we'll have Elyse address that. Elyse?
spk06: Yeah. Thank you for the question. You know, we're very, very excited about Zevegipant, right? It is in both the intranasal and oral formulations, and what you're referring to, of course, is the intranasal formulation, which we're developing for ultra-rapid use. As you know, with patients who have migraines, frequently they have nausea. And although an ODT is a big advance versus something that must be swallowed and doesn't disintegrate while in the mouth, Intranasal may be something that is appealing to those, of course, who may have more severe nausea, but also is extremely fast. So it will be something that can be used for patients who are suffering with migraine who need something immediately and can't even wait as long as they do for our disintegrating tablet, which is also very quick. Yes, as you said, that Phase 3 readout will take place, and we certainly expect a filing by the end of the year and are really excited about that, and so stay tuned for that. With regard to our European filing, as you know, that's been filed, and we are expecting or hoping for an approval, I should say, at the beginning of next year, and that process is as with the FDA, a long process of approximately a year, and it is going exactly as we would have expected at this point. So I can't give you more details. We don't usually give details on the specifics around the regulatory process that's ongoing, but suffice it to say that it's going exactly as we would have predicted at this point in time.
spk05: Okay. Thanks, Amal. And next question, Operator.
spk04: Thank you. Next question is coming from Charles Duncan from Cancer Fitzgerald. Your line is now live.
spk01: Yeah, good morning, Vlad and team. Very nice quarter. Congratulations. Thanks for taking our questions. Had a commercial question and one M1 R&D or pipeline question. Regarding the commercial question, I guess I'm wondering if, BJ, you could provide a little bit more color on you know, the new prescriptions, are they coming from new prescribers or are they coming from deeper prescribing within a practice?
spk12: Great question, Charles, and thanks for that. As you can imagine, we're looking at that every day to make that determination, and the quick answer is both, which is exactly what we would hope for and expect. We certainly see... depth of prescribing for those who already believe and have had success. And so they're extending that utilization, right, into preventive. And then as it relates to we've also seen what has been acceleration in new prescribers as well. And so, you know, again, we're nine weeks in, so I want to be careful and certainly not predicting going forward. But so far we see, you know, acceleration in both those categories, which is good news for us.
spk05: And Charles, a second question.
spk12: Go ahead.
spk01: Yep. Quickly, perhaps for Elise. On Zyvad Japan, again, getting back to how to position relative to RIMID Japan, I guess I'm wondering, is that primarily going to be focused at intranasal delivery? And as such, how do you compare the potential profile relative to other drugs such as DHE?
spk06: Yeah, so the VegePant actually is being developed in two different formulations, right, the intranasal. And, you know, I think that, as I mentioned, it is being positioned as something that is extremely rapid. And given the relatively benign side effect profile, which we've seen with NERTEC and we expect the VegePant to have and we've seen, really comparable safety profile, we expect that patients will be really pleased compared to many of the other drugs that are on the market. And so that's the intranasal formulation. But in addition, we also have an oral formulation, which is being developed in prevention. And we do have a study that started in or starting in prevention. And that oral formulation will be able to be utilized in prevention for patients who really need an everyday dose. And so those are for patients who have much more frequent migraines and really need something that is even more robust in terms of the everyday dosing. So we are going to be coming forward, we hope, with programs and approvals, filings and approvals for both the intranasal and oral. I think that we...
spk05: Appreciate it. I would just add, Charles, and you know, I think from various surveys of patients that have been done and clinicians, that one of the most welcome parts of this class of CGRPs has been their tolerability profile. You know, patients want their migraine to go away and they don't want new problems and baggage associated with some of the older meds. So I think what you're going to see with the Vegapan is this mechanism, which clinicians have now are turning increasingly towards with a great efficacy and side effect profile, just bring that to the intranasal with the ultra-rapid onset of action rather than kind of retreaded old mechanisms. And, you know, so we think that it's going to differentiate nicely from, you know, other older drugs that have known limitations on the side effect front. Thanks, Gerald. Got it.
spk04: Thanks. Our next question is coming from Laura Chico from Red Bush Securities. Your line is now live.
spk09: Good morning. Congrats on the quarter, and thanks very much for taking the question. I've got a commercial one. I'm wondering if you can talk to the proportion of patients that are continuing on therapy with NERTEC I believe some of the symphony data shows perhaps a higher percentage of patients staying on Ubrella versus Neurotech at this point, but wondering if you could just comment on where the figure is relative to your expectations and how do you expect that to shift over time? Thanks very much.
spk12: Laura, happy to address that for you. I don't have explicit data. I can actually get back to you on that, but what I can suggest as it relates to the kind of the relative proportion of folks staying on NeurTech versus the competitor. Remember, there are multiple doses with the competitor. As I think we've all seen, there's been kind of this utilization of starting dose and then rapidly progressing to what would be the higher dose because they perhaps did not see the efficacy they were searching for. So again, we have to be careful as it relates to how we you know, determine exactly what that means. We feel very confident, again, because of the feedback we get from patients and clinicians alike is that there's a high degree of satisfaction with Neurotech ODT. There's specific data that we can point to that shows a strong delta between satisfaction as it relates to Neurotech and Urelvi. And so that's the basis of kind of our belief, again, that we have a unique and highly beneficial product.
spk05: Yeah, just to add, you know, our fast and last profile speaks for itself. We think it's a more efficient way of treating migraine where people don't need to take multiple different doses, multiple different drugs for different indications. And so I would echo what PJ said. Don't misinterpret that with other approaches. you know, half patients have to take a second dose. There's multiple doses. And so, you know, be cautious in how you interpret that type of script data versus the efficiency. I think it's coming across loud and clear with NERTEC. So thank you. Next question, operator.
spk04: Thank you. Our next question is coming from Mark Goodman from SVB Lyric. Your line is now live.
spk14: Yes, good morning. You've been tweeting. The affordability plan, obviously, this quarter, this past quarter, there was a major benefit in the growth of that line. I guess if you could comment on how you're thinking about it for the rest of the year and into next year. Just, you know, last time you had said these programs to really have a major benefit until later in the year. Obviously, it had one much earlier. So I'm just kind of curious about your Overall, just kind of big, you know, guidance to all of us to understand how that is going on behind the scenes. And then as you're having these 2022, I know one of the big benefits this past year or so since launch has been that they really haven't had.
spk05: Thanks, Mark. I think we got the gist of the question, although there was some choppiness there. But, you know, I think we got it. No, no problem. And not your fault, the Internet. You know, look, generally speaking, it's what we had said last year, that, you know, priority number one is building, you know, the market in a launch year. And then, you know, Jim, BJ, and myself getting together and assessing data coming in and tweaking those programs. And there will always be some back and forth and some, changes that get done. So we did get some, you know, favorable improvements a little bit quicker than expected. As Jim said earlier, we're in a launch year still now for our dual indication, so I wouldn't just assume that things are going to be steady. We've always said, wait until the end of this year. When you get into next year, I think you'll see more stable assessments of where we land with affordability, so I think we can all expect there to be some modifications to the programs, and we'll watch it carefully, and over time, we think you'll see the favorability, but there could be some volatility. Thanks, Mark. Next question.
spk04: Thank you. Our next question today is coming from Esther Rajelvu from UBS. Your line is now live.
spk07: Hey, thanks for taking my question, and congrats on the quarter. I just have a couple for BJ, and then one on the different stats, if I can. So on... North Tech, for the PCPs that are prescribing, can you give us some color on whether they're specifically headache specialists or just generally PCPs broadly? And then can you also talk a little bit about how you're thinking about the EU market dynamics? What are some of the pushes and pulls you would expect as you're planning for a potential commercial launch?
spk12: I'm happy to respond, Esther, and I'll hand it actually over to Elise in a moment to talk about the EU. But as it relates to PCPs, there are a very small segment that are actually headache specialists, but the vast majority of them and the vast majority of those primary care riders are just general practitioners. And again, they are folks who see a lot of patients, therefore they see a lot of patients with migraines. And so we do, again, expect, you know, this area to be the one where there is tremendous adoption over time just because they see so many patients. Annalise?
spk06: Yeah, with regard to Europe, again, you know, the filing took place at the end of last year. We're in the midst of discussions with regulators in the normal process that you would expect. And the physicians that we've spoken to in the field have been as excited about being able to hopefully at some point be approved and have it on their marketplaces. So they've just been very excited. And I think the dynamics, once we're out there, will be comparable. to what we see in the U.S.
spk05: Yeah, and I would just add, look at the role NERTEC and other oral CGRPs are playing in the U.S., right? Again, highlighting the limitations of past therapies, and when you have that contrast, you see the difference it makes in people's lives and their disability, and I think the overall health economic benefits, you know, of a therapy like this, and so we would expect that over time to play out in Europe. Next, probably last question, operator.
spk04: Certainly. Our final question today is coming from Tim Lugo from William Blair. Your line is now live.
spk11: Thanks for the question. Thanks for sneaking me in. Can you just comment on your cash position? You know, you hold 368 down from 200 last quarter, and I know you have access to the 6th Street and a Series B financing, but it still seems to be maybe a bit thin given how much investment is going into NeurTech and all of the clinical programs and potentially Europe. Can you just talk about maybe some areas where you might want to partner or maybe BioShin could produce some capital if that executes in Asia?
spk05: Yeah, no, great question, Tim. And I think, as you know, we've always demonstrated ability to appropriately fund the company, and these are things we watch very closely. And we're also very cognizant of wanting to avoid dilution to our shareholders, especially when one understands the magnitude of this asset. And obviously, we want to work as quickly as possible to profitability so we could self-fund rather than having to go to the markets. You know, there's not a lot we can say at this point on, you know, some of the plans ex-US. Again, you're going to have to, you know, just be a little patient so we can, you know, come up with the best strategy there and communicate that. But, you know, Jim and team and myself will, you know, make sure the company is always well-funded. Jim, anything you want to add to that?
spk02: I think you summed that up well, Vlad. We're very dilution-sensitive, obviously, for our investors, but I believe we're well-capitalized and set up for success.
spk05: Yeah, when you look at our current cash on hand and access to capital, there isn't any imminent need for us to go out and have to do something from a raised perspective anymore. And BJ and team keeps on hitting their numbers. It makes that even easier to deal with. So thanks, Tim.
spk04: Thank you. We have reached the end of our question and answer session. I'd like to turn the floor back over for any further closing comments.
spk05: Great. Well, thank you again for joining us today. And we deeply appreciate the support of our employees and investors as we move forward to delivering these life-changing therapies to patients. and we're excited about continuing to meet with you quarterly and giving you updates on what has been a paradigm-shifting treatment in Neurotech ODT, but then also a lot of excitement in the rest of the portfolio in the quarters ahead, and so look forward to future calls with everyone. Thank you very much.
spk04: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.
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