Biohaven Ltd (BHVN) 2021 Q3 法說會逐字稿

Good morning. Welcome to the Biohaven Pharmaceuticals Third Quarter 2021 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference call may be recorded.

I would now like to hand the conference over to Caroline Dircks from Biohaven. Thank you. Please go ahead.

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

Earlier this morning, we issued a press release announcing the third quarter 2021 highlights. A copy of this press release can be found on our website at biohavenpharma.com, and we will file our Form 10-Q later today.

Before we begin, let me remind everyone that today's discussion contains forward-looking statements based on the environment as we currently see it, and includes risks and uncertainties. A list and description of risks and uncertainties associated with an investment in Biohaven can be found in the company's filings with the U.S. Securities and Exchange Commission. Please be aware that you should not place undue reliance on any forward-looking statements we make today.

For this call, we will focus on non-GAAP financial measures. Detailed descriptions of these non-GAAP measures and reconciliations to the most comparable GAAP measures can be found in our SEC filings. An archive of today's call will be posted to Biohaven's website in the Investor Relations section.

With that, I will turn the call over to our CEO, Dr. Vlad Coric. Thank you, Caroline, and good morning, and thank you to our investors for joining the third quarter earnings call. This has been another exceptional quarter for Biohaven. Not only has NURTEC ODT become the #1 migraine treatment in its class, allowing patients and doctors to customize a single migraine therapy to treat and prevent attacks, but we are also excited to announce an outstanding strategic commercialization, collaboration with Pfizer for markets outside the 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 rimegepant to as many patients as possible around the world.

I want to thank the teams at Pfizer and Biohaven who worked tirelessly in the last few weeks and over last night to make this collaboration agreement a reality, thanks to the teams. And I also want to thank Nick Lagunowich, the Global President of Pfizer Internal Medicine, who is on the line joining us today to speak about Pfizer's impressive global go-to-market commercial capabilities in just a few minutes.

Our business performance this quarter continues to exceed all expectations across multiple fronts. NURTEC ODT net revenue in the third quarter was $136 million, which brings the cumulative launch to date net revenue to approximately $336 million. We have a differentiated commercial product in NURTEC ODT that continues to generate increasing and impressive revenue growth.

To date, we have over 1 million prescriptions of NURTEC ODT, and the demand in the oral CGRP market continues to show strong growth quarter-over-quarter. We are very pleased to see the continued strength in the MDRX metric after the prevention approval, as demonstrated by increasing to a 57% market share, reflecting robust demand for the dual indication. NURTEC ODT is providing fast and lasting relief to more and more migraine patients each day.

The entire oral CGRP class is outperforming initial launch expectations and reflects the importance of these medications to individuals with migraine. NURTEC ODT is now the #1 migraine treatment in its class. I want to thank our entire commercial, managed market sales and marketing teams for their determination and passion to continue to deliver our market-leading NBRx metric again this quarter.

Today, Biohaven welcome Pfizer as our global commercialization partner for rimegepant. As many know, that's known by NURTEC 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 rimegepant to the more than 1 billion patients worldwide who suffer from migraine. We believe a collaboration between Pfizer and Biohaven brings together the winning combination of Biohaven's neuroscience R&D with Pfizer's brand strength in 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 NURTEC ODT rapidly to as many patients as possible around the world. With Pfizer's global clinical, regulatory, medical, patient advocacy, and commercial footprint, we can accelerate the access of rimegepant around the globe.

Jim Engelhart, our CFO, will discuss the finances of the global partnership in more detail in just a few minutes. But to summarize, this collaboration strengthens Biohaven's cash position, with Pfizer's significant investment 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 NURTEC 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 rimegepant to the large patient population across the globe who have been disabled and suffer from migraine. 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 will 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 is an opportunity to bring this best-in-class migraine therapy to patients outside the U.S. 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 rimegepant, and the parties will cooperate in regulatory activities to secure approval for the product. Pfizer will commercialize rimegepant, upon approval, in all regions outside the United States, while Biohaven continues to solely commercialize NURTEC ODT in the United States.

Additionally, per the arrangement, Pfizer gains rights outside of the U.S. to zavegepant, our third-generation, high-affinity, selective and structurally unique CGRP receptor antagonist, currently being studied in both an intranasal delivery and a soft gel formulation in Phase III trials.

We are all aware of Pfizer's track record of success, global reach, and execution outside of the U.S., as Pfizer has accomplished numerous times before with big drugs such as ELIQUIS. We believe that our collaboration with Pfizer can transform rimegepant into a massive global brand in regions and markets that, 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 the reason why they were the partner of choice to drive rimegepant and its success around the globe. We believe a collaboration between Pfizer and Biohaven will bring together a winning combination.

Next, I will turn the call over to Nick Lagunowich, Global President of Pfizer Internal Medicine, to comment on our collaboration. And I must say that Nick's team is really unmatched in the pharmaceutical industry in terms of the commercialization and marketing expertise of multiple breakthrough medications. Nick?

Thank you, Vlad. I am very happy to be here this morning on behalf of Pfizer. We're excited about the partnership with Biohaven and even more excited to add rimegepant to our global portfolio outside of the U.S. We're looking forward to joining forces with Biohaven to help patients around the world who are impacted 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, ELIQUIS, VYNDAMAX and IBRANCE, to name a few. And our expansive footprint spans over 125 countries around the world.

As of Q3, the Pfizer ex-U.S. 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 9 months of 2021, our innovative medicines and vaccines reached nearly 1 billion people globally. We're excited about the opportunity to collaborate with Biohaven to have an even greater impact on patients around the world who experience debilitating migraine.

I want to congratulate Vlad and the Biohaven team on their success in achieving the rapid uptake of rimegepant in the U.S., which certainly speaks to the unmet need and the value of the medicine, and we plan to build off that success to drive strong uptake in markets around the world. When 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 capability, along with our industry-leading customer-facing colleagues to reach PCPs, specialists, and health systems with the right information at the right time. With these 3 principles applied broadly and in coordination, I'm confident that we'll be able to accelerate access and fuel uptake of rimegepant 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 Engelhart, CFO, Biohaven.

Thank you, Nick. Good morning, everyone, and thank you for joining today. Before providing an update on our quarter 3 results, I would like to echo the words of our CEO, Vlad Coric Pfizer's Nick Lagunowich on the exciting news at Biohaven and Pfizer entering into a strategic commercial collaboration agreement for the treatment and prevention of migraine, upon approval, in markets outside the U.S.

Some of the key financial terms of the agreement are as follows. Pfizer will pay Biohaven a total of $500 million at closing, inclusive of $150 million in cash and $350 million in equity investment in common shares priced at approximately $173 per share, a 25% premium to the 20-day 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 of 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-U.S. investment to commercialize rimegepant, upon approval, by leveraging Pfizer's vast global commercial organization. Biohaven will continue to oversee manufacturing responsibilities for ex-U.S. markets. We look forward to our collaboration with Pfizer and the ability to serve more patients who suffer from the debilitating effects of migraine.

Now let me turn to Biohaven's quarter 3 results. NURTEC ODT received -- achieved net sales of $135.7 million in quarter 3, demonstrating another quarter of strong performance, increasing 46% versus quarter 2 of this year, driven by continued sales volume. And we are very pleased by the contribution that our expanded label is having on NURTEC ODT performance.

Continuing down the P&L, R&D investment in the quarter on a non-GAAP basis was $68.9 million, compared to $51.8 million over the prior-year quarter, an increase of $17.1 million. The increase is primarily due to continued investment in our late-stage product candidates in preclinical research, partially offset by a $10 million decrease in our R&D services obligation.

SG&A expense in the quarter on a non-GAAP basis was $149.6 million, compared to $110.2 million over the prior-year quarter, an increase of $39.4 million. Most of our SG&A costs continue to support commercial sales of NURTEC ODT as we invest behind our novel dual-indication therapy. The increase is primarily due to increased promotional activity supporting ODT in quarter 3, as compared to quarter 3 2020, which was in earlier phases of launch.

We reported non-GAAP adjusted net loss for the 3 months ended September 30 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 9 months of 2021 on a non-GAAP basis was $210.6 million, compared to $137.6 million over the prior-year period, an increase of $73 million. Again, the increase is primarily due to our continued investment in our late-stage product candidates and preclinical research, partially offset by the aforementioned reduction in R&D service obligations.

SG&A expense for the 9 months of 2021 on a non-GAAP basis was $434.2 million, compared to $314.7 million over the prior-year quarter, an increase of $119.5 million. The increase is primarily due to increased promotional activity supporting NURTEC ODT during the full 9 months of commercialized sales in '21 for the treatment and prevention of migraine, as compared to the same period in 2020, where NURTEC was launched in 2020.

We reported non-GAAP adjusted net loss for the 9 months ended September 30 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 2021 -- 2020, excuse me.

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 30, 2021, we have $523.9 million in cash, cash equivalents, and marketable securities, immediate access to $125 million from our debt facility with Sixth 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?

Thank you, Jim, and good morning, everyone. There's a lot to be excited about within Biohaven this morning. First, I'm happy to report continued strong uptake of NURTEC ODT 5 months in market, post-launch of our dual indication. 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 NURTEC ODT to transform the lives of migraine patients, all patients across the globe.

We're very pleased with the 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 NURTEC ODT's unique profile as the first and only medication proven to treat and prevent migraines is well positioned to shift the paradigm in migraine treatment to dual therapy, which will drive demand for a more simple, higher standard of care that produces better patient satisfaction and outcomes, and therefore, will dramatically expand the number of people with migraine seeking treatment.

Since the launch of NURTEC's differentiated dual therapy early this summer, we have witnessed an acceleration in volume and share, fueled by specialists and primary care physicians. Thanks to the passion, commitment, and exceptional execution of our high-performing commercial team, we have steadily grown our new-to-brand market share by 9 points, on top of a rapidly expanding branded oral market. As Vlad shared earlier, oral CGRPs continue to drive incremental penetration of the triptan market, along with new patients in market.

From a payer access perspective, we are also encouraged regarding 2022 formulary status for NURTEC ODT. We have maintained our strong access for acute therapy, and coverage for preventive therapy is progressing well. As a result of the surge in demand for this one-of-a-kind dual therapy medication, NURTEC ODT has become the #1 migraine treatment in the oral CGRP class. Since early August, NURTEC is the market leader in overall prescriptions, new-to-brand prescriptions, and prescribing among neurologists. And this is just the beginning because we believe NURTEC ODT is uniquely positioned to transcend the traditional 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, NURTEC 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 NURTEC's U.S. launch by establishing a world-class collaboration with the partner of choice, Pfizer, to bring dual-therapy innovation to the many patients suffering from migraine around the world. Who better to partner with, if our objective is to create access to NURTEC's life-changing profile and impact as many people as possible, as rapidly as possible? Needless to say, Pfizer is second to none in their ex-U.S. commercial reach and expertise, with a proven track record of building massive global brands in regions and markets that are dominated by generics.

And I'll conclude as I began. There's a lot to be excited about this morning. NURTEC continues its successful trajectory, driven by strong execution and growth in volume and share, delivering $136 million in third-quarter sales. In addition, today we began a critical collaboration with Pfizer to satisfy the tremendous unmet need in patients with migraine who reside outside the U.S. For many, NURTEC ODT's differentiated profile gives them a sense of personal control that provides renewed hope. I think Mary says it best in this testimonial. I have gone from handicapped and fearful to empowered and secure. NURTEC ODT has helped me treat or prevent migraines. 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 NURTEC and personal control in the hands of patients worldwide.

Now I'd like to hand it over to my partner, Elyse Stock, our Chief Medical Officer.

Thank you, BJ. This quarter, there is so much to be excited about. We continue to make significant advances across our R&D organization, and we have an even greater potential to bring multiple therapies to patients here in the U.S., as well as across the globe. The collaboration we have formed with Pfizer now brings the best of all worlds to our CGRP antagonist platform.

With regard to R&D, we have demonstrated our ability to develop drugs that 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 an approximately 40 additional trials ongoing. The data that we've generated has been published in leading peer-reviewed journals, such as the New England Journal and Lancet. As BJ has mentioned, we have been very successful in our U.S. commercialization. We are now delighted to have Pfizer as a partner in our ex-U.S. expansion. They bring global experience and a global footprint that will enhance our ability to win in migraine for patients around the world.

With regard to our portfolio, we have an impressive CGRP franchise at Biohaven that is unparalleled. NURTEC 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, NURTEC ODT 75 milligrams 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 NURTEC ODT, both within neuroscience, as well as explore a wide variety of scientifically relevant indications outside of migraine, as we follow the science of the CGRP antagonist.

Expansion beyond geographic regions, as already mentioned, and the dual-acting indication 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 NURTEC 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 NURTEC's dual acting filing is underway. The filing in Europe took place in the first quarter of this year, and we hope to secure approval in the first half of 2022. Additionally, a Phase III clinical trial of NURTEC ODT for the acute treatment of migraine is ongoing in China and Korea. Studies to support filing in Japan will begin in 2022.

Our zavegepant program includes, as mentioned, both intranasal and oral formulations. An acute treatment Phase III study with intranasal zavegepant began in October of last year, followed by a positive -- following, excusing me, a positive Phase II study. This second pivotal zavegepant 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 intranasals zavegepant for the acute treatment of migraine shortly after the results of this trial are available. Our oral formulation of zavegepant was started in a Phase III study in chronic migraine prevention this past March.

Our next-generation CGRP, 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 customize the unique attributes of each of these structurally unique compounds. Across a range of CGRP antagonist assets, we will follow the science and conduct multiple proof-of-concept and registrational studies. Additional non-migraine studies are already underway or planned, including pulmonary complications of COVID-19, psoriasis, and asthma.

We continue to make great progress across other programs, including our glutamate modulating agents and our myeloperoxidase inhibitor platform. Troriluzole, part of our glutamate modulating platform, has completed enrollment in its Phase III spinal cerebellar 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, verdiperstat, 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 HEALEY 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 I 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 Vlad.

Thank you, Elyse, Nick, Tim, and DJ. In closing, Biohaven has demonstrated robust growth in terms of the commercialization of NURTEC ODT, an important maturation of our late-stage innovative pipeline. We have the potential for multiple NDAs over the next couple of years and significant growth ahead of the company. Our commitment to migraine sufferers around the globe has never been stronger, and our strategic collaboration with Pfizer will help ensure global access to NURTEC ODT, and we're excited to see the benefits to patients that will come through this partnership.

Before opening to 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 and 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 OBT to patients.

Let's open it up to questions. Operator?

(Operator Instructions) Our first question is coming from the line of Ken Cacciatore with Cowen.

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? Obviously, Pfizer's ambitious agreement about the opportunity with the quality agreement ex-U.S., so can you just walk us through that? That would be helpful. First question, and then I'll save the second.

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 U.S., and we've 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.

Our next question is coming from the line of Chris Raymond with Piper Sandler.

This is Ally Bratzel on for Chris this morning. 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?

Yes. We'll have some more details in our filing. We don't go into that level of detail of the split. What I would say, again, with this type of partner, is 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 ex-U.S. market because we really had not been able to demonstrate we'd be able to commercialize that. And so, finally, we've said publicly, we're out there looking for the best partner ex-U.S. We found the best partner, and we think it's going to really set us up nicely for the long term.

Got it. And then, maybe just one more on commercial. Now that there's another oral CGRP approved for prevention, just any color on how you're messaging NURTEC's profile compared to QULIPTA? Any color on maybe how you're comparing or contrasting the QULIPTA profile, both the safety and efficacy data on the label? It's a single indication and it's QD dosing. Like, how is that resonating with docs, maybe, compared to NURTEC's profile?

We're continuing to enjoy the differentiated profile because there is no other product that has one therapy for acute and prevention in one pill. That is what is driving our market share and why we are beating a much bigger company like AbbVie in the marketplace, 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.

BJ, you want to add anything?

Well said.

Next question, please.

Our next question is coming from the line of Paul Choi with Goldman Sachs.

First is a strategic question, both for Vlad and Nick, if he's still available, just as you think about the portfolio and NURTEC, and 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.

Yes. As Nick talked about earlier, in 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 looked to various parties to have discussions, they were clearly at the top with regard to those capabilities.

This is the right partner to bring a drug like NURTEC to patients. When you think about it, Paul, there's not many drugs that have the potential of reaching 1 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.

Okay. 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 Elyse or Charlie?

Yes. So I'll hand it over to Charlie or Elyse to chime in. This represents a really important next stage of development of Biohaven, in that, with our Biohaven Labs and the acquisition we made last year, we really have access to what is an exciting immunoscience platform that you're going to start to see 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, we hope to have some data from that trial. And this will be the first validation of using this technology in humans to improve outcomes in immuno-oncology.

Elyse, do you want to add anything?

Yes. 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.

Yes, and Paul, what we saw preclinically is, when we add BHV-1100 to the CIML NK cells, we were able to boost the efficacy in terms of myeloma cell killing. So we're really excited to be testing the hypothesis in the clinic and look forward to outcoming data.

Our next question is coming from the line of Jeff Hung with Morgan Stanley.

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

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

All right. And then, how are conversations with payers going around the preventive treatment for 2022? Any feedback that you're able to share?

Really exciting feedback there I'm going to let BJ update you on.

Yes, great question, Jeff. And I would say that 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.

Next question, operator.

Our next question is coming from the line of Vamil Divan with Mizuho.

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 sort of Slide 6, you've obviously done very well with gaining new-to-brand share. But the last few weeks, you rally 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?

Yes. Thanks for the question. And 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 in 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 NBRx 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?

The only thing I'd add -- thanks, Vlad -- is that we're -- again, we're very pleased with our NBRx share gain, especially since our dual launch in June. As you know, clearly, we're the category leader. We're now sitting at approximately 14-point NBRx share advantage over UBRELVY. And NBRx trends over time is very important. We watch that, clearly. But as many of you know, it's fairly volatile as well.

In addition to monitoring what is long-term NBRx trends, we closely watch all the other early indicators that drive long-term NBRx share trends and -- such as perceived product differentiation, stated brand preference in intent to prescribe, as well as relative competitive access. And on all these measures, it favors NURTEC ODT and supports our hypothesis in the long-term health, really, of the brand and our leadership.

Next question, operator.

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

I might ask this question a little bit differently than has been asked already. But wondering, you've mentioned a couple of times now Pfizer's legacy in the primary care markets. Was establishing a collaborative relationship in the U.S. territory a consideration, kind of given their PCP presence?

So, Laura, I think what I've always said publicly for some time now is our focus was on the ex-U.S. revenue streams. The U.S. launch is going so well. The team is outperforming a very large competitor. What we wanted to solve for in this first step is revenue outside, 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 2 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.

That's super helpful. If I could just sneak in one follow-up: the European launch is probably going to start on different footing than in the U.S. with potentially 2 indications, acute and prevention. And you just mentioned kind of the '22 dynamic really boding well in the U.S. I'm 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 market versus the U.S.

Just like our prelaunch 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 a 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 Biohaven.

Our next question is coming from the line of Tim Lugo with William Blair.

We saw improvements in GTN in Q3. I guess, with the prevention launch, you previously signaled that that could hurt GTN. Just directionally, can you talk about where you expect to go over the next few quarters? We don't need hard numbers, but directionally, will GTN still be negative from prevention, but maybe that's improved with the more mature product users? Or should we expect volatility still?

Tim, thanks, and I'll have Jim comment.

Yes, thanks for the question, Tim. So as you know, we don't give guidance. But what we can say is 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.

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

This is Madhu Yennawar on for Marc. I have 2 questions. The first, do you have any data on adherence or patients staying on NURTEC that you would be able to share with us? And then the second is, could you elaborate a little bit on how you view the mechanism and opportunity of verdiperstat in ALS after the negative MSA study?

Yes, sure. So what we can tell you, the migraine durability is very strong. Patients who respond -- and we know from our data, you see about 2/3 or so patients responding -- they tend to take NURTEC as it reflects their monthly migraine frequency. It's mirroring that. It's just as we saw in a real-world trial, so we're seeing very nice durability and [refill] rates there. Of course, we don't reveal the exact numbers around those, but we're very pleased and shows how well the drug is working.

Verdiperstat in 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. 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.

Elyse, do you want to add anything?

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, as there isn't clear read-through at all, and the mechanisms are different. We are collaborating in that Mass General HEALEY study, and as Vlad mentioned, we're going to complete enrollment this quarter, and so we should have that data out sometime after that.

Our next question comes from Jeff Hung with Morgan Stanley.

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

Yes, Jeff, sorry. Nick just had to drop off, so he's not here to answer that.

Okay, no problem.

The next question is coming from Vamil Divan with Mizuho.

So just a couple of 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 zavegepant and I guess sort of a couple of 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 -- obviously, if the data are positive?

Yes. 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 1 or 2 8-packs. We're very pleased with the growth we're seeing in both segments there. And remember, we're trying to get rid of the notion of 2 different segments, right? 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 zavegepant, if I understand your question, Pfizer has the rights on zavegepant as well. We have data coming very soon. That study is going to read out shortly with intranasal zavegepant, 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?

Yes, that clarifies it.

All right, last question, please.

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

Vlad, congrats on the deal. I guess a clarifying question. Will Pfizer be responsible for the Asian markets as well, or will BioShin be the lead in Asia? And then I have a quick question for Jim.

Yes. 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, a 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.

Yes, 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 US SG&A?

Yes. Yes, thanks for the question, Esther. Yes, 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.

Yes. Esther, we've always said, like, 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 cash infusion, purchase of our stock at a premium, that puts us in a strong position for longer-term revenue stream, so just really excited about that.

All right, last question, operator.

Absolutely. Our last question is coming from the line of Charles Duncan with Cantor Fitzgerald.

Super. Juggling calls this morning. Vlad and team, congratulations on this transaction and really great quarter. I 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?

Great question, Charles. And what I can say there is, just like in the U.S., we've made the value proposition to payers. And I'll remind you that we did get favorable reviews with regard to our pricing because we'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 reviews included we were cost-effective for patients with migraines 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.

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.

What I can say there, again, Charles, is that our focus was -- for a priority was making sure we can globalize NURTEC. 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, so we 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 footing, and creates very significant future revenues, we believe, for our shareholders and brings an important drug to patients. So we think it was the right deal, and we'll leave it at that.

Excellent. Congratulations, Vlad.

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

Yes. 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.

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