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Good morning, ladies and gentlemen, and welcome to the Biohaven Pharmaceuticals Second Quarter 2020 Results Call. [Operator Instructions].
I would now like to hand the conference over to Biohaven's Chief Operating Officer, Clifford Bechtold. Thank you, and please go ahead.
Good morning. Thank you, and welcome to the Second Quarter 2020 Earnings Call. Speaking today are -- sorry, speaking this morning on today's call is Dr. Vlad Coric, our Chief Executive Officer; Jim Engelhart, Chief Financial Officer; BJ Jones, our Chief Commercial Officer; and Elyse Stock, our Clinical Medical Officer.
Earlier this morning, we issued a press release announcing our second quarter 2020 highlights. A copy of this press release can be found on our website at biohavenpharma.com. Before we begin today's presentation, I would like to remind you that various remarks that may be made on this call contain forward-looking statements, subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. All forward-looking statements made on this call are made based on the beliefs of Biohaven as of this date. Future events or simply the passage of time may cause these beliefs to change. During this call, presenters may make statements about our approved product, Nurtec ODT. Safety information and full prescribing information for Nurtec ODT can be found at nurtec.com.
For this call, we'll be focusing on non-GAAP financial measures with a detailed description to GAAP and non-GAAP analysis later in this presentation. For a more detailed description of the risks that impact these forward-looking statements, please refer to our most recent quarterly report on Form 10-Q and our annual report on Form 10-K. Please be aware, you should not place undue reliance on the forward-looking statements we make today.
With that, I'll turn the call over to Vlad Coric.
Thank you, Cliff. This is a particularly exciting day for Biohaven. This is our first earnings call and the company's first full quarter of revenues from the launch of Nurtec ODT. This has been an unprecedented quarter in so many different ways, but we are pleased to report the company is excelling in achieving our goals across multiple areas, including the following: the launch trajectory of Nurtec ODT is exceeding initial expectations; we continue to make progress in our clinical trials and have a robust pipeline with the potential to deliver multiple value-creating inflection points over the next year.
The strategic financing of up to $950 million that we announced on Friday leaves us with a strong balance sheet to execute on our long-term growth plans as we advance new treatments to patients. These are extremely exciting times for Biohaven and our investors. You will be hearing shortly from BJ Jones, our Chief Commercial Officer, about the details of the launch of Nurtec ODT, but I am happy to state that we had an impressive second quarter commercial performance. Despite launching in the midst of a global pandemic and multiple entrenched competitors in the marketplace, the launch of Nurtec ODT is going exceptionally well, and Nurtec ODT delivered net revenues in the second quarter of $9.7 million. Second quarter prescriptions of Nurtec ODT have been extremely strong with over 40,000 prescriptions.
Biohaven is now the market leader in new-to-brand prescriptions for oral CGRP therapies with 52.6% share in the NBRx metric. As the second-to-market oral CGRP, this is a tremendous accomplishment for our team and a testament to our best-in-class product profile to become the new-to-brand leader approximately one quarter after our launch. To also post such impressive metrics during the pandemic is a reflection of our company's unwavering commitment to the patients we serve and our investors. I am so proud of our commercial team's collective efforts in these challenging circumstances.
We now have widespread insurance coverage with our managed market teams achieving 141 million covered lives, representing approximately 83% of covered commercial lives. This level of coverage is often the goal that is set for a full year after launch, never mind after 1 quarter.
I would like to acknowledge and thank Chris Barrett, Paul Sbrilli and the entire Managed Markets team. I'd also like to thank Gil L'Italien, who runs our Global Health Outcomes Group; our CMO, Elyse Stock; our CSO, Charlie Conway; and of course, BJ's leadership for delivering this level of patient access to Nurtec ODT so early in our launch.
Migraine is a large market, affecting approximately 40 million Americans, and many patients are dissatisfied with the trade-off and efficacy and tolerability that they have to make with the older treatments in this class. This market is seeing new treatments for the first time in decades, and we believe that given the high level of patient and physician satisfaction with the efficacy and safety of Nurtec ODT that significant growth remains ahead. We are just at the very beginning of the paradigm shift that is occurring in the treatment of migraine with oral CGRP antagonists. The entire oral CGRP market combined currently accounts for only 12% of the market to date, underscoring the potential for tremendous growth ahead. We believe that Nurtec ODT is a best-in-class calcitonin gene-related peptide therapy and is highly differentiated from our competitors, including the following advantages: Nurtec ODT is a simple-to-use, oral, rapidly dissolving pill with fast onset of action that can return patients to normal functioning within 60 minutes and provide sustained effects out to 48 hours with a single dose. No other CGRP oral agent can make those label-based claims for the acute treatment of migraine. I believe that is why we now have the market leadership in the NBRx. With our sNDA submission for prevention, the company is also on track for the potential to be the first dual-action treatment for migraine for both acute and preventative properties in a single pill.
And moving on, as many of you know, I like to describe Biohaven as a modern-day pharmaceutical company, a company with a relatively small infrastructure that relies on a decentralized organization and fully utilizes the latest technology, including sophisticated sales analytics, virtual detailing, social media, telemedicine and online pharmacies to communicate and deliver Nurtec ODT to patients. We have to continue to innovate with modern media approaches to maximize our relevance, share of voice and impact in the market without overspending. For example, we have implemented industry-first campaigns with partners like Hulu, Twitter and IBM Watson, all with the social-first mentality, where we can encourage deeper engagement and sharing across patient networks. In everything we do, we are connecting with the health care providers and patients to drive home the message that there is an emerging new treatment paradigm for migraine.
Just a few weeks ago, you may have seen our innovative, patient-focused public relations and social media campaign called Take Back Today, featuring Khloé Kardashian. Khloé is a real migraine patient who is helped by Nurtec ODT as well as a powerhouse brand spokesperson through her social media presence. Khloé and other patients that are featured in our campaign provide a powerful voice to communicate the paradigm-shifting profile of Nurtec ODT.
We are seeing strong uptake from headache specialists, neurologists and high-prescribing primary care physicians with over 10,000 health care prescribers recommending Nurtec ODT to date. Our goal is to make Nurtec ODT more widely available to migraine patients around the world and through a disciplined approach to life cycle management expand the indications of our CGRP franchise. We've engaged health authorities across other major markets to address the varying regional regulatory requirements, as our Chief Medical Officer, Elyse Stock will discuss shortly. We have established distribution agreements to bring Nurtec ODT to Israel and the Middle East, and we have a wholly-owned subsidiary, BioShin that will bring Nurtec ODT to the 80 million migraine sufferers in China. We are committed to the global expansion of Nurtec ODT and expect future regulatory filings for Nurtec ODT in Europe, Japan and China.
Although we spend a considerable amount of time talking about the successful launch of Nurtec ODT and plans for life cycle development of the CGRP franchise, our R&D team that has delivered Nurtec ODT to the market is already working on multiple other pipeline assets in a similar fashion to bring new treatments to diseases like Alzheimer's disease, spinocerebellar ataxia, OCD, multiple system atrophy and ALS. We are not reliant upon a single upcoming study for our future value creation. We have a deep pipeline across several indications. Neuroscience is an area of great unmet need for patients, but also requires experienced R&D hands to navigate this traditionally challenging area. Biohaven's pipeline has both low-risk opportunities in life cycle management of our CGRP platform and higher-risk, high-reward investments in our glutamate and myeloperoxidase inhibitor platforms. We have multiple pipeline opportunities to deliver treatments for patients and create value for investors.
Biohaven has a strong portfolio of product opportunities, and, we believe, one of the most promising neuroscience pipelines. We believe that we will deliver best-in-class therapies for patients and strong growth for investors today and for years to come. We believe that our CGRP franchise is on schedule to become a blockbuster.
Lastly, we are in a strong financial position to grow the global value of our CGRP franchise and pipeline with a nonequity-based financings of up to $950 million that we announced last Friday. Royalty Pharma's investment of up to $450 million in the development of zavegepant, formerly known as vazegepant, and the restructuring of our current debt as well as up to $500 million in financing from Sixth Street will help meet our financial needs as we work towards reaching profitability with Nurtec ODT; exciting time for Biohaven.
I will now turn it over to Jim Engelhart, our Chief Financial Officer, to review the detailed results of our financial performance in the second quarter. Jim?
Thank you, Vlad. Good morning, everyone, and thank you for joining today. I first want to echo Vlad's comments on the importance of the two financial transactions we announced on Friday with Royalty Pharma and Sixth Street. We've been executing well on both our commercial launch and our robust R&D pipeline. Financing up to $950 million through these combined transactions strengthens our balance sheet and provides us with the capital continue to grow the company.
I will now provide an overview of our Q2 performance. This quarter was outstanding, both for the company's ability to drive a successful launch of our first commercial product, Nurtec ODT, and to have done so during the COVID pandemic. We are happy to report strong Q2 results, a testament to Nurtec's differentiated label as well as our launch preparation and sound execution of strategy. Our performance demonstrates our operational agility to adapt our plans and best serve patients and HCPs through the unprecedented challenges created by the pandemic.
During this call, we will not be providing financial guidance regarding projected revenues, spending or earnings, as we are still early in our first commercial launch and an uncertain economic environment with the pandemic. We will be commenting on non-GAAP financial measures, supporting schedules in this morning's presentation containing additional details on both the GAAP and non-GAAP financial basis. For the 3 months ended June 30, we achieved net revenues of $9.7 million on strong script volumes, driven by patient demand for Nurtec ODT. We are pleased with the growth trajectory that we saw during the quarter and continue to see in prescription trends.
Continuing down the P&L. For SG&A, SG&A expense in the quarter on a non-GAAP basis was $119.5 million, which increased $103.5 million over the prior year quarter. Our SG&A is primarily driven by commercial investment, including infrastructure, advertising and promotional spending, to support the launch of Nurtec ODT. SG&A also includes general and administrative costs, including finance, legal as well as other administrative functions, that have increased slightly to support the operational needs of a commercial organization. Our Q2 results include investment for launch activities as well as various corporate structure initiatives.
R&D. R&D investment in the quarter on a non-GAAP basis was $36 million, which decreased $5 million over the prior year quarter, primarily due to $7.6 million in regulatory filing fees in the second quarter of 2019, which did not occur in second quarter of 2020. This decrease was partially offset by an increase in spending for our MPO clinical development platforms. We also are at early stage in initiating early-stage development in nonmigraine CGRP indications. We continue to adhere to a disciplined small company mindset regarding infrastructure investment to ensure we utilize our spending in a value creation around our pipeline and commercial platform, while enabling a more agile organization. This strategy is proven to be highly effective during the pandemic.
On EPS, we reported non-GAAP adjusted net loss for the 3 months ended June 30, 2020, of $150 million or $2.55 per share compared to $59.6 million or $1.32 for the same period in 2019. Our balance sheet remains strong with $263.9 million in cash and restricted cash as of June 30. Our cash on hand at June 30, coupled with the $725 million in excess capital from our $950 million August 2020 financings, is well capitalized and provides with liquidity to support ongoing commercial and development initiatives and our corporate infrastructure into 2022. Our cash used in operations of $175.8 million includes onetime investments for the Nurtec ODT launch and development milestones. Our current cash position is sufficient to fund our commercial and development platforms and our corporate infrastructures into 2022. We are well positioned to continue to invest in the Nurtec ODT launch and grow our pipeline.
To sum up, we are delighted with how well the Nurtec ODT launch is going and how well our organization performed during a very challenging period. We remain well positioned with strong product momentum, a solid balance sheet and a robust pipeline.
With that, let me turn it over to BJ.
Thank you very much, Jim. I appreciate it. And it's a pleasure to be here with you this morning to discuss the progress of Nurtec ODT's launch to date as well as our commercial strategy going forward. Our Q2 launch was a culmination of Biohaven's team effort dedicated to building out a best-in-class commercial organization capability, while at the same time, creating the launch readiness plan for what we believe to be a transformative acute treatment for migraine. This preparation and our ability to adapt quickly as circumstances change allowed us to achieve strong, steady increases in prescriptions since launch despite the unexpected emergence of a pandemic and the expected competition from other recently launched acute therapies.
Let me provide some additional color. In mid-March, after only 2 days of end market promotion, we were compelled to make the difficult decision to have our field colleagues return to their homes for the shelter-in-place orders across the nation. It's in this context that we launched Nurtec ODT into the unexpected headwinds of COVID-19. Across our industry, we faced 2 critical issues: access to health care professionals was extremely challenging for our sales specialists, whether live or virtual, as clinicians and office staff struggled to adapt their capabilities in a new reality; and access to patients with migraine was restricted for physicians as well as unprecedented lockdowns led to patient requests for 30- to 90-day supplies of their existing meds instead of newly available products.
Through the commitment and partnership of our incredible employees, Biohaven's integrated team of commercial and medical professionals quickly reassessed our customer and patient needs to reprioritize our plans and reallocate our launch investment and execution accordingly. Our marketing strategy remains sound, but the team quickly shifted to adapt our tactical execution in light of evolving market dynamics. Within days of restrictions going into effect around the U.S., our sales specialists were redirecting their efforts to virtual meetings with key customers, while internally, we enhanced and accelerated our digital outreach to HCPs and patients. We utilized Zoom, FaceTime, phone calls and online media to engage with physicians, while also arranging for remote delivery of samples and co-pay cards. As for patients, we differentially invested in social media and DTC advertising to communicate with those seeking new therapies, while also entering into a collaboration with Cove, a pioneer in telemedicines, that provides specialized care and access to migraine sufferers.
We are pleased to report consistent week-over-week growth in prescription demand since launch, excluding 2 holiday weeks, resulting in CGRP market leadership in new-to-brand prescriptions of 52.6%. With rapid growth of both Nurtec ODT and the other currently available oral CGRP receptor agonist, we have observed significant uptake in what is ostensibly a very large market for acute oral therapies.
To reinforce the point, in other disease states, where several companies have competing products and DTC campaigns are prevalent, we tend to see an increase in diagnoses, treatment and overall class size. We believe Nurtec's differentiated profile of a simple-to-use oral, rapidly dissolving pill with a fast onset of action that can return patients to normal functioning within 60 minutes and provide sustained effects up to 48 hours after a single dose is well positioned to become the preferred acute treatment by both physicians and patients and, therefore, stand to benefit the most.
We have focused our launch strategy on 3 distinct components: one, driving health care practitioner awareness and trial; two, activating patients to request Nurtec ODT from their physicians; and three, ensuring access and affordability. I'll now walk through each of these areas in a little more detail. First, with respect to health care practitioners, we have successfully accelerated awareness and product trial among our targeted physicians. To date, over 10,000 unique prescribers that put pen to paper on behalf of their patients, and we are focused on expanding our base of prescribers week-in and week-out. This ever-changing physical access limitations associated with COVID-19 continue to hinder both our reach, which is breadth of HCPs we engage, and frequency, the number of times we engage each individual. Our sales professionals are committed to ongoing partnership and support of their customers. So the reduced number of live engagements has been offset by an increase in virtual interactions, including peer-to-peer programs and non-personal promotion. From what we have observed to date, the likelihood of Nurtec ODT prescribing and positive perceptions of the brand are highly correlated with a number of engagements between the HCPs and our sales specialists. Our ability to flex channels of engagement in real-time with our customers enables our field team to provide continuity of support to clinicians and their office staff.
Some investors had asked about our continued commercial resilience as the COVID-19 virus surges in various areas. We built a nimble infrastructure so that our decentralized teams can quickly react to customer dynamics in real time, which is critical to overcoming such challenges. For example, even though July brought a resurgent infection rate across the south and southeastern states, our local teams addressed customer needs and remain the fastest geographical areas of prescription growth for Nurtec ODT, and this demonstrates our ability to continue to deliver strong results even as the pandemic waxes and wanes across geographies. Importantly, among HCPs that have tried Nurtec ODT and other new oral therapies, perception tracking research suggests there's a preference for Nurtec ODT. And this advantage is validated through Spherix and other syndicated data, suggesting that: one, this preference is most evident among headache specialists, neurologists, who primary care physicians refer to; two, the speed of onset and mechanism delivery, which is the orally dissolving tablet, or ODT, appear to be the key factors driving these preferences; and finally, the positive reception by KOLs to our pivotal trial results for preventive treatment of migraine increases our confidence in the eventuality of market leadership.
Moving on to the second key tenet of our strategy, activating patients. Our marketing programs have proven to be very successful in reaching patients, as Nurtec ODT patient awareness remains in line with that of the competing oral CGRP launched 8 weeks prior to Nurtec ODT and into an open market prior to shelter-in-place constraints. Direct-to-consumer media will continue to play a critical role in expanding our trial among patients with migraine. We believe through more modern and innovative approaches, similar to customer engagement strategies leveraged outside of our industry, Biohaven can maintain a competitive share of voice with less capital investment. For example, Nurtec has been able to achieve the share of voice in the migraine category that is significantly higher than our share of actual spend. Broad advertising on TV will serve to complement more efficient and targeted digital, social and word-of-mouth campaigns.
Patient engagement has been a powerful component of our marketing strategy, and many Nurtec patients have actively utilized social media to describe the transformative life-changing effects from their experiences with Nurtec ODT. We call this organic demand. And as experience increases, this ripple effect will continue. Obviously, Nurtec will not work for everyone. But if the early response is any indication, we believe there are potentially millions of other patients who stand to benefit like Khloé Kardashian, as Vlad mentioned in his opening comments, and the cadre of other patients who have openly shared their life-changing experiences as a result of Nurtec ODT.
The third and final component of our strategy has been ensuring access and affordability. We have made strong inroads with major payers, and the majority of formulary decisions have been finalized with favorable access for Nurtec. We have approximately 141 million covered lives to date and significant formulary wins, including CVS, Aetna, Express Scripts, Cigna and Prime Therapeutics. In addition, we've been able to achieve this broad access with rebate levels in line with our launch forecast. Patient access to Nurtec ODT is extremely important to us. And we are dedicated to making Nurtec ODT widely available to all patients suffering with debilitating migraines.
In closing, we are very pleased with the launch to date, and I join Vlad in being extremely proud of our team, their collective resilience in the face of COVID and their relentless commitment to improving patients' lives. Five months into launch, and it's clear that our commercial leaders have driven strong and focused execution of our launch strategy, which has led to Nurtec ODT's early success. We drive HCP awareness and trial by meeting physicians where they are, live or remote, whatever it takes to educate HCPs on the differential benefit and safety profile for Nurtec ODT. We activate patients by driving awareness through effective, yet efficient DTC, in both traditional and social channels, while facilitating organic demand by sharing the powerful testimonials of our patients who have had life-changing experiences with Nurtec ODT. And finally, we ensure patient access and affordability by leveraging Nurtec's compelling data to achieve broad formulary coverage. These fundamentals are strong, and our belief is, as COVID recedes, patient and physician access will open to what appears to be over 85% of an expansive and untapped oral CGRP market, fueling broad trial and adoption of Nurtec ODT as the acute therapy of choice for patients not satisfied with current options.
And with that, I'll turn it over to Elyse to provide an update on Biohaven's broader pipeline. Elyse?
Thank you, BJ. I am pleased to be here this morning to provide some clinical updates regarding Nurtec ODT, our commercial product as well as what's coming next in the Biohaven pipeline, which I'm really excited about.
Starting with our CGRP antagonist franchise, and I use the term franchise because rimegepant, zavegepant and the other CGRP antagonists that we have rights to represent a potential for important expansion, both in terms of disease indications and geographical locations. Based on the initial development success of Nurtec ODT for the acute treatment of migraine in the U.S., we've been busy expanding on several market fronts. Many of the ex U.S. regions rely on the U.S. data package, and we've already submitted an application for the acute treatment of migraine in Israel and plan on having submissions across other countries in the Middle East later this year. Approvals in these countries are expected to start at the end of this year through 2021. We're also moving forward with our development program in China and Korea with the study starting to supplement that submission later this year. With regard to Europe, we will rely on our data from both the acute and preventive treatment of migraine and plan on a submission in early 2021. With regard to regulatory filings in Japan, we plan to meet with the PMDA in the second half of this year and plan to file for dual treatment, including both acute and prevention, after performing a bridging study.
In addition to disciplined market expansion, we're moving quickly to advance life cycle activities. We recently announced positive results of our Phase III rimegepant trial for the prevention of migraine and expect a submission in the U.S. within this year for label expansion. If successful, we will be the only company with a strategy for an oral and dual-acting CGRP therapy delivering both acute and preventive benefits in a single pill. Currently, our competitors offer separate drugs for acute and preventive treatment and the use of 2 drugs rather than a single drug across the continuum results in an increased health care burden. We believe patients want simple, streamlined and easy-to-use approaches to treat their migraine. I personally as a physician would prefer the simplicity of using 1 drug that could potentially treat both your acute episode and help prevent the next migraine.
Additionally, we will be starting programs in pediatrics and at least 1 other migraine adjacent indication, which is as of yet undisclosed. And in addition to geographical and life cycle management within migraine and its adjacencies, we are also leading the way for CGRP antagonism in nonmigraine indications. You've gotten a glimpse into this with our trial of intranasal zavegepant to potentially treat pulmonary inflammation associated with COVID-19. I'm proud of how quickly the Biohaven team move forward to initiate a new study with zavegepant for hospitalized COVID-19 patients requiring oxygen therapy. That study remains underway, and we are hopeful that zavegepant will help in mitigating a severe inflammatory response, which can be life-threatening for some COVID patients. This COVID study with zavegepant is in addition to our study of intranasal zavegepant in the acute treatment of migraine, which will have a Phase III start by the end of the year. This study follows a positive Phase II study and has a potential to demonstrate even more rapid onset of effect.
CGRP represents a very important pathway in the nexus between immune and central nervous system. And we will follow the science into at least 3 other nonmigraine indications for this franchise over the next year. Our funding collaboration with Royalty Pharma and Sixth Street is providing important access to resources to bring forward our CGRP antagonist to patients with unmet medical need in nonmigraine indications. And I've only just gotten started as we have other drug candidates in our portfolio that we hope will become just as successful as Nurtec ODT.
Let's first talk about our glutamate-modulating platform. Glutamate is the most abundant excitatory transmitter in the brain, and we believe troriluzole will provide important advances in the field across many indications. We've delivered important proof-of-concept results in both spinocerebellar ataxia and obsessive-compulsive disorder, or OCD. Our follow-on Phase III studies in these areas are utilizing important signals from our Phase II proof-of-concept studies, which we are hopeful will yield positive results. We'll be meeting with the FDA for our end of Phase II meeting regarding OCD in the next quarter. Earlier this year, we discontinued our generalized anxiety disorder program, GAD program, due to a lack of signal, demonstrating really our commitment to continued development of indications and assets only when we believe there's a signal.
Earlier this year, we passed an interim analysis in our Alzheimer's disease study and look forward to completing the trial by the end of this year. We expect top line data by next year for both Alzheimer's disease in the first quarter of 2021 and spinocerebellar ataxia by the fourth quarter of 2021.
Next, I'd like to turn to our myeloperoxidase or MPO platform and other novel targets. We licensed verdiperstat from AstraZeneca, who established themselves as the leader in MPO inhibition technology. Our myeloperoxidase inhibitor trial in multiple system atrophy, a rare and rapidly progressive disease, received Fast-Track Designation by the FDA earlier this year. This study is ahead of time lines, and we expect top line data next year. We also recently enrolled the first patient in the Mass General HEALEY study that is testing this agent in amyotrophic lateral sclerosis, or ALS. This platform study selected verdiperstat to be one of the potentially promising new drug candidates to be studied.
Lastly, I want to highlight some of our preclinical candidates. We continue to progress our work on developing a potential first-in-class inhibitor of metallothionein, which is associated with a host of chronic inflammatory diseases. We'll focus on neuroinflammatory diseases, but will also be open to exploring other areas. We're likewise working in our DEGRADER platform with development of assets that may help to harness the body's own machinery to eliminate certain circulating protein pathogens that are implicated in a variety of diseases.
So as you can see, we have been really busy with our exciting and robust pipeline. It's a real pleasure to be able to share all of this with you. And I will now turn the call back to Vlad.
Thank you, Elyse, Jim and BJ. In closing, it's only been 3 years since our IPO, and Biohaven has advanced our lead asset to approval and commercialization. With strong uptake of Nurtec ODT, we are turning to life cycle indications and global expansion of our CGRP franchise. We have a robust pipeline, including glutamate-modulating and myeloperoxidase inhibitor platforms with 3 pivotal trial readouts in Alzheimer's disease, spinocerebellar ataxia and multiple system atrophy in the next 6 to 18 months. The company is in a strong financial position with the recent strategic financing of up to $950 million and the trajectory of our Nurtec ODT sales. We believe that we are well positioned to deliver on our future long-term growth plans from both a commercial and pipeline perspective.
Before opening up to Q&A, I would like to end by thanking and commending the entire Biohaven team for their relentless commitment to patients and safety and advancing our innovative pipeline to patients during this unprecedented pandemic. I would also like to thank all the patients, their family members and investigators who participated in our clinical trials to help advance clinical care in the area of neuroscience. We must continue to work hard to bring novel treatments to patients suffering from diseases that affect the CNS. Finally, thank you to our visionary investors, who have helped fund our studies and bring Nurtec ODT to patients.
We'd now like to open up the call to take your questions. Operator?
[Operator Instructions]. Our first question comes from the line of Paul Choi from Goldman Sachs.
Congratulations on all the progress. Vlad and team, I was wondering if we can maybe just start with a discussion of the payer dynamics. And specifically, given that we're coming into late summer, early fall, can you maybe just discuss what the status of your 2021 payer negotiations are? And also, has any contracting come up for your 2021 discussions? And then I have a follow-up.
Yes, Paul, I'll have BJ speak to that. But again, I just want to highlight how successful the team has been, and over 83% commercial coverage after quarter's worth of a launch, quite remarkable metrics, and in fact, in many cases, unprecedented. That's usually the goal after 1 year. And you're right, we're already looking towards the future years. So BJ, do you want to give some more granularity around future payer interactions?
Absolutely. Paul, thank you very much for the question. It's a good one. And clearly, we're very confident in terms of what we've been able to achieve thus far. And I will say that many of those contracts actually do extend beyond '20 into '21 and some even beyond that. So there are some who have differential contracts, and we're starting to begin those -- that dialogue now and negotiations. But once again, it's predicated upon the same great profile that we have. And so those conversations are going very well also.
Paul, you had a follow-up as well?
Yes. And then just on some of the international filings and commercializations that you are talking about, can you maybe just sort of discuss how you're thinking, Vlad, about either in terms of business development strategy with respect to partnering? And just sort of what you're looking for in terms of potential partners in these international markets and when you might be able to announce developments there? Congratulations on all the success.
Thanks, Paul. And Paul, as you know, I've often talked about, you have to be ready to run your business on your own. That's your #1 priority. And then if you do that in the right way, there'll be a lot of optionality on partnership opportunities. And certainly, that's something that we will be looking at for other regions where other potential partners might already have an established commercial footprint. We're not reliant on having to do a deal. We are going to run this business on our own. But obviously, in markets like Europe and Japan and China, they are going to likely be the possibility of partnership in those regions.
Our next question comes from Charles Duncan from Cantor Fitzgerald.
Vlad and team, congratulations on a very good launch quarter. First question is on Nurtec and the commercial setting. And then I had a follow-up on the pipeline. Regarding Nurtec, I'm wondering if you could provide some additional color on prescriber engagement, both not only in terms of numbers but also the percentage of target? And how has this evolved in the third quarter? And what will you do if there is a second wave of COVID?
I'm going to turn it over to BJ to give you details on that. What I will say is, look, we've demonstrated the ability to deliver Nurtec to patients in what was a very difficult and challenging time of a full quarantine lockdown. And I think given that we're confident moving forward that we'll be able to work through future challenges. It's not going to be easy. And as BJ commented, we've already seen where there's been resurgences, we've been able to continue that commercial growth. And so I'll turn it over to BJ for some additional details.
Thank you, and good question, Charles. Thanks for that. As it relates to kind of our target group of physicians, and again, it's -- we're focused on neuros, on headache specialists and on primary care physicians and high prescribers. And we've been able -- we're very confident we've been able to achieve reach -- right contact with those -- over 80% of those folks, even in what has been kind of this COVID environment. And so there -- obviously, there's some challenges in terms of frequency against those clinicians. But we feel confident we'll be able to continue to engage them in a meaningful way. The good news is, they're also looking for how do they operate in what is kind of this new environment. And so again, I think where we have a bit of an advantage is we're small and nimble, and we can flex to the needs of our customer base. And so we expect that to continue and get them better in time.
Okay. That's helpful. On the pipeline, just had a question regarding the prevention claim sNDA for Nurtec. I'm not sure it's clear to me whether or not an actual filing has been made and if not, you anticipate that by the end of the year. And then with regard to zavegepant, if you could outline kind of news flow over the course of the next 12 months, that would be helpful.
Sure. No, absolutely. So on the sNDA, we are on our time lines for a filing by the end of the year. So really excited about that. We don't view there being any barriers to achieving that. With regard to zavegepant, now that our funding has been secured with the partnership with Royalty Pharma and Sixth Street, we very quickly be moving to institute the remaining pivotal trials. Our goal is to have top line data by next year and then to very quickly be able to move for filing for what we believe will be the first CGRP intranasal agent out there. So thanks, Charles. Appreciate the question.
Our next question comes from the line of Ken Cacciatore from Cowen and Company.
Congrats on all the progress. Just wondering on pricing and contracting as we move forward. We obviously can calculate the value per prescription from this quarter. But Vlad, wondering what our expectation should be as we move forward? Can you give us a sense of where this may eventually shake out as we try to think about a net value per prescription?
Ken, thanks. Great question. So as we've talked about year 1 of a new-to-brand launch with the competitor that we have is a very expensive endeavor. We believe that the high gross to net the first 1 to 2 years will stabilize and normalize to what we think will be more of a typical peer group gross to net for an oral small molecule. This year and next year, it really is all about market share, right? And then we will focus on profitability thereafter. It's so important in a new-to-brand launch to get patients on your treatment, get physicians familiar with your medication, and that will pay future dividends as we hit towards the later years. So thanks for that question, Ken.
Our next question comes from the line of Laura Chico with Wedbush Securities.
So one quick question, Vlad. You mentioned the covered lives, 83% covered lives on commercial. Pretty fast pace so far. I'm wondering if you could also update us on where the progress is with regards to the Medicaid state formulary adoption. I think you've already had a couple of wins there so far, but just how should we think about the pace over the remainder of the year? And then 1 pipeline question. I just want to make sure I'm understanding for troriluzole in T2 PROTECT, it sounds like we should be expecting top line data in the first quarter, but can you just remind us kind of what is the regulatory path forward should the data show an improvement in cognition? And lastly, how are you thinking about the magnitude of improvement that's clinically meaningful?
Sure. Thanks, Laura. And BJ, I'll let you start.
Absolutely. So thank you, Laura, and good question. And we actually have done extremely well with Medicaid thus far. We're very happy with how quickly we've been able to get on contract with many of the states. And we're tracking actually ahead of what our expectations were and again at a rate, if you will, right, that is in line with our expectations for launch. Medicaid -- Medicare, it takes more time, right? And we're in negotiations right now. Again, we're not behind the time line in any way, shape or form. And so we feel very confident about our ability to be able to negotiate and get on those formularies in due time as well.
Great. And with regards to the Alzheimer's program, we're very excited for the upcoming top line of a T2 PROTECT trial. As you know, we passed an interim futility analysis, which, obviously, we derived a lot of encouragement from that. However, we all know this is a tough disease. And the last patient will be treated this year with top line being in the first quarter. To answer your question about regulatory path forward, really depends on the robustness of that data. I will remind you that although this is an NCE, and we have full patent protection for 19 years on these compounds, the safety, package and otherwise will be a 505(b)(2), which does allow us for some acceleration of filing processes because of that. And so we will have to wait and see that top line data, Laura, before I can tell you whether additional studies would be needed or not with Alzheimer's. So thanks, Laura.
Our next question comes from Tim Lugo with William Blair.
Congratulations on a fantastic drug launch to date. You mentioned the 10,000 unique prescribers for Nurtec. Can you give us a sense of how deep that penetration is as of now? And are majority of those prescribers also prescribing the other oral CGRP? And maybe talk a bit about some of the early experience between those who've prescribed both?
Yes, absolutely, Tim. Thanks for the question. And yes, we're just north of 10,000 or so unique prescribers. And I would say it's a good 25% or so of what the priority target universe is, right, for the highest prescribers kind of in the space. Obviously, there's a very long tail as we look at the primary care universe. But we are actually encouraged by initial prescribing in that space as well and that relative growth. And we are seeing, again, what is a strong pace of incremental new writers on a week-by-week basis. And so we're encouraged by what is the expansion of that prescriber base. The color around that, again, is that what we would expect is actually playing out in which the neuros and the headache specialists are primarily the writers, they have about 75% or so of prescriptions to date. And yes, indeed, there's -- the majority of those writers actually do write both from oral CGRPs at this point in time. As I mentioned in my earlier remarks, there is some data that tends to show that when folks actually write both that we see a bit of an advantage for Nurtec ODT. We are very early, I'll say, but so far so good in what we see.
That's great to hear. And maybe can you also expand a bit upon the European and Japanese markets. You're obviously looking at filing to both of those. Can you just give us kind of broadly how meaningful these are in terms of dollar opportunities?
Yes, they do represent significant markets, and we believe an important part of our global growth expansion of the asset. So we'll be meeting with the PMDA this year for Japan and then plan our filing with the EMA early next year. And then, of course, our efforts in China represent another emerging and important growth market for us with our own efforts through BioShin to bring Nurtec to the 80 million Chinese who suffer from migraine. Thanks, Tim.
The next question comes from Marc Goodman with SVB Leerink.
First on the prevention filing. Can you talk about what the gating issue is to filing? Just given when the data was and when you're filing, it just seems like a long period of time, and I just don't remember what the issues were that you had to get accomplished over the course of the year. And second, you talked about gross to net a little bit. Given your accomplishments with the payers, which seem to -- a lot of it has happened kind of just in the past 3 or 4 months. I would think that the gross to net would improve a little bit in the second half of the year. If you could talk about that? What type of step down do you expect next year? And you mentioned after 2 years, you'd expect them to normalize at a level that's normal for orals. Can you just talk about what that level is? Is that something in the 40s, is that something in the 50s?
Yes, sure. I'll let BJ talk on the gross to net first?
Absolutely. Yes. So thanks for the question. Again, we've been able to negotiate and basically now to get on these formularies as we mentioned. But just a reminder for everyone is that those things actually happen -- the majority of them happen as of like July 1 and as of August 1. And so there's still some time. We're just coming into what would be kind of that better coverage scenario, if you will. And I'll actually turn it over to Jim to address the change in GTN.
Yes. Marc, and great question. And you're right, as our patients get onto formulary, there is a shift from the co-pay programs, which bear the burden currently over to those payer programs. So naturally, we can see some near-term improvement. I wouldn't describe those as significant. And then as Vlad had mentioned earlier, the plan right now is really all about scripts and getting patients on Nurtec. And as we get out of the launch phase is when we'll see more meaningful improvements over time. But I can't disclose or we won't really guide to what those percentages look like, I think, as you said, in the 50s or 60s, we just don't guide to those numbers.
And Marc, on the sNDA filing for prevention, we are absolutely on our time lines. We don't view there being any barriers to that. We've always guided kind of before the end of the year, and we think it will -- folks will be happy with the news that we have before at the end of the year. For competitive reasons, we don't release the exact dates. Thank you.
The next question comes from the line of Vamil Divan from Mizuho Securities.
So first, just want to get a sense in terms of the market share as you think about the specialist segment of the market versus more of the primary care. I'm assuming over time this will turn into more of a primary care-type market. So I'm just trying to get a sense of if you're seeing a difference in terms of uptake so far or any sort of feedback that you're getting from the specialist community relative to what you might be hearing sort of these early months around the primary care side? And then my second question, again, going back to the Europe, I mean, this international opportunity, I'm just trying to understand better, maybe if you can sort of bring the acute opportunity versus the prevention opportunity. I think there's clearly a preventative market in Europe, and we're seeing the injectables going there. But I'm just curious how much of a real commercial opportunity there is in terms of reimbursement and those kind of things for acute migraine treatments at this point.
Vamil, I'll turn it over to BJ for the first half of your question. But just on our strategy ex U.S., and this is why we were waiting for our prevention filing. As you pointed out, there being a much more robust payer environment for that prevention indication ex U.S., but we have a more novel strategy now that we have the top line data from prevention. Our strategy is for dual acting in all geographic regions outside the U.S. So to go for a filing, that's very novel that includes the treatment of migraine of both acute and preventative. We believe that novelty will be viewed as being cost-effective for payers ex U.S., and we believe we can get prevention level reimbursement for that -- the only dual-acting agent. And I'll turn it over to BJ for the first half of the question.
Yes. Thank you. And thus far, as it relates to kind of share, is there any differential, I think what the question was between what would be specialists and primary care. And at this juncture, what we've seen essentially is very strong, again, share in new to brand, and then even in Ts, where we're actually now approaching what would be the mid-40s in terms of our share there. So that's very strong growth. In primary care side, if you look at the total primary care market, our share would be a bit less. But of those primary care doctors that we're targeting, we actually see a very similar share. So again, we like to say, and we believe it's true, unexemplified is that where we play, we win. And so we're making sure that we're getting to those priority physician groups and primary care specifically. And so we can -- we'll and expect to continue to see relative growth in both sets of positions.
Our next question comes from the line of Umer Raffat with Evercore.
I had three, if I may. First, perhaps maybe just building up further on the launch progress. I was curious if you could speak to the vintage cohort of April starts and how many blister packs have they taken to date? I'm just trying to understand what the average duration is looking like, especially from people that started early?
Secondly, on atogepant Phase III from recently, would just love to hear your thoughts on how you looked at their data, especially hyper-responders? And if you could speak to Nurtec data as well? And then finally, on vazegepant, I always understood this as an intranasal offering, but based on some recent disclosures, it looks like you're developing it as an oral as well. So I'm just trying to understand the positioning relative to Nurtec, especially given Nurtec will have on demand and prophy indications?
Thanks, Umer. Great questions. On the competitive front in prevention, I think you talked to our competitors at a recent release of atogepant. Of course, everyone has to be careful of cross-trial comparisons. What we'll say there is if you just plot out the efficacy of all the oral as well as the mAB agents in prevention, I think you're going to see somewhat of a similar story and magnitude of effect. And what you see changes is placebo rates, right? So when you're hitting the target, what this teaches us is that you get robust efficacy. And if you look at the magnitude of our effect, we had one of the largest magnitude of effects in the prevention space. And so we're quite encouraged by that. But then some differentiation there, it's a very different profile on some safety measures, such as constipation.
As you recall, we did not have any signal for constipation with regards to Nurtec ODT, and that was very different than at least two of our competitors where that's a signal that's being picked up. I really believe that's the benefit from our intermittent dosing and giving a differentiated profile there. And then also highlight, we are the only company with this dual-acting strategy. If we're successful with our prevention, we will be the only one that says 1 pill, same dose, acute and prevention, big differentiation point in the marketplace, big win for patients in the simplicity as well as payers, right? You don't have to then pay for 2 different segments here. It's going to give us a lot of opportunity to work with payers to make sure that this approach is accessible to patients and cost-effective.
Finally, zavegepant intranasal is our lead. But yes, we're now, for the first time kind of talking more about our total program with zavegepant, including an oral version. Actually, we have 2 different oral versions, and we're excited to take that into a number of nonmigraine indications, and you'll be hearing more about that. We won't be giving more details today for competitive reasons. But the zavegepant program, you're going to see branch out in different directions, not just in migraine and pain. And so that's why as Elyse said earlier, we talk about our CGRP antagonist as a franchise. We have so many multiple indications in migraine adjacencies as well as multiple compounds. And I'll turn it over to BJ for the first half of the question.
Yes. So Umer, thank you for the question. And as it relates to refill rates, essentially, what I'll say is from a compliance and persistency standpoint, it's -- obviously, it's too early to assess how a long-term compliance and persistency trends. But we don't see any early signs, even of those, as you mentioned, kind of the cohort that started in April, any signs of patients trying Nurtec and then abandoning its use. I can't -- and I'm uncomfortable sharing exactly what that percentage is in April because at the end it was so small, as you can imagine. But we see certainly refill rates in line with launch projections. And our expectations is that we will see over the course of time, if we kind of reach what would be a "steady-state pacing" within a given year, we expect the number of prescription to exceed that of what you currently see with generics just because of the product profile and the type of really passionate feedback we're hearing from patients as well.
Our final question comes from Tara Bancroft with Piper Sandler.
So you recently mentioned that unlike the mAB market, Biohaven and Allergan-AbbVie are not competing on price in terms of positioning and rebates, but rather on volume. So I was wondering if you could elaborate on that a little bit.
Sure. I think what we're describing is that we both appear to be parity on most formularies. And so that allows us actually to compete on the product. And obviously, each of us have a different commercial view of our product and the advantages of it. What we are going to stay focused on our things, our competitor can't say because we have label-based claims that they do not have, right? So we have the oral dissolving tablet. We have return to normal by 1 hour. Our competitor does not have return to normal in their label. We have sustained effect to 48 hours.
Our competitor does not have that. So they can't say that. So we're going to continue, BJ and his team, to really messaging that differentiated label, and we think that's going to cause a growth. I also have to acknowledge it's really good for patients to have choice, right? And by having our competitor in a pharmaceutical company like AbbVie in the market, both of us are working hard to educate physicians and patients about the benefits of oral CGRPs. I think the whole class is going to grow and there's a paradigm shift that's going to occur there. So we're very excited about that, and we're very excited to be working with our competitor to raise awareness here in this space.
Good. So I wanted to just end by thanking you all for joining us today. We deeply appreciate the support of our employees and investors as we move forward to deliver life-changing therapies to patients. We look forward to speaking with you again soon. Thank you all very much.
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