Q2 2021 Biohaven Pharmaceutical Holding Company Ltd Earnings Call
Good morning, and welcome to the Bio Haven Pharmaceuticals, Q2, 2021 earnings call and webcast at this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session. If anyone should require operator assistance. Please press star zero on your telephone keypad. Please be advised that today's conference call may be recorded I will now hand, the conference over to Caroline Dircks from Bio Haven. Thank you. Please go ahead.
Thank you and welcome to the Bio Haven second quarter 2021earnings call.
Speaking on today's call are Dr. Vlad Schwartz, our Chief Executive Officer, Jim Engelhart, Chief Financial Officer P. J Jones, Chief commercial officer, and Dr or at least stock Chief Medical Officer earlier. This morning, we issued a press release announcing the second quarter 2021 highlights a copy of this press release can.
Be found on our website at IR Hayden pharma Dot 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 bio Haven 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.
Descriptions of these non-GAAP measures and reconciliations to the most comparable GAAP measures can be found in our SEC filings and archive of today's call will be posted to <unk> website in the Investor Relations section.
With that I will turn the call over to our CEO Dr. Glad torch. Thank.
Thank you Caroline.
To our investors and thank you for joining our second quarter earnings call. This has been another transformational quarter for bio <unk>.
<unk> ODT became the first oral <unk> targeting drug to be approved for the prevention of <unk>.
Grain and episodic patients and the first and only medication with a dual indication proven to treat acute migraine and prevent future attacks. How excited for the first time patients and doctors can customize a single migraine therapy to treat and prevent migraine I wanted to thank our R&D team.
Agents in our clinical trials and the clinicians who help to attain the prevention approval together, we have changed the way migraine is being treated.
Yes.
Once again, our business performance this quarter has exceeded expectations on multiple fronts <unk> ODT net revenue on the second quarter was $93 million, which brings our cumulative launched to date net revenue to approximately $200 million.
To date, we have achieved over 875000 prescriptions of <unk> ODT and the <unk> market continues to show strong demand and quarter over quarter growth on.
Much of our second quarter performance reflects the acute indication we are very pleased to see robust growth in the new to brand Rx metric. After the prevention approval, our new to brand Rx market share as of this morning is now approximately 56%, reflecting robust demand from our dual indication.
<unk> ODT is providing fast and lasting relief to more and more on migraine patients every day.
The entire oral cgmp class is outperforming initial launch expectations and reflects the importance of these medications to individuals but migrate the <unk> classes demonstrated strong and steady growth in Rx volume Neurotechnology continues to drive demand, which is differentiated label.
<unk> and dual indications for acute and prevention.
Wanted to thank our entire commercial team managed market sales and marketing groups further determination and passion in delivering our market, leading new to brand Rx metric this quarter.
We believe that near Tech ODT has the potential to become the first line standard of care therapy, given its efficacy and safety profile or on <unk> are gaining market share compared to the older triptans, reflecting low limitations of prior therapies and the advantages of this new class we.
Believe there will be significant growth ahead as patients increasingly become informed about the SaaS and lasting benefits of <unk> ODT.
When we look at the <unk> targeting agents as a whole it remains evident that oral <unk> antagonist continued to drive the growth of the overall <unk> targeting market.
Injectable Nabs are limited to prevention and many patients may consider an injection less desirable compared to a simple oral pill.
Given the projected size of the overall market, we remain focused and committed to investing a long term success of neurotechnology.
And growing the overall oral <unk> market.
Yes.
This morning, we are also very excited to share the news that the United States patent and trademark office has awarded <unk>, a new patent covering our ODP formulation of <unk> ODT.
Innovation is at the core of our business and we have demonstrated the important differentiation of our ODP formulation with its fast onset of action and other attribute.
It is so important to protect innovation and I would like to think we're involved in our entire legal team for protecting our ideas in the marketplace without such IP protection, we cannot ensure the continued development of important new medications and formulations. This new patent covers our API <unk> as well as other.
<unk> inhibitors, and an ODT formulation the.
The patent will extend until March 2039, not including potential patent term extensions.
We believe that <unk> has the most broad and differentiated <unk> platform and the pharmaceutical industry. At this time, we have over 10 <unk> clinical programs.
Ross, both migraine and non migraine indications.
We are currently running around the globe and aimed at areas of significant unmet medical lead including adolescent migraine asthma and psoriasis just to name a few we have also invested in numerous formulation and drug delivery options to optimize the PK and delivery from match each indication and each unmet need.
This broad and diverse pipeline gives our cgmp franchised tremendous flexibility that can be optimized for various seed European mediated diseases outside of migraine.
Our launch of <unk>, ODT and acute and preventative migraine is only the beginning of our franchise. We look forward to following the science of <unk> antagonism across neuroscience and immuno science.
In addition to our lifecycle management of neurotic ODT, which includes the extension into pediatric migraine, we expect to have top line data from intranasal that Japan soon and if positive we were ready to file as a bed Japan as the first intranasal <unk> antagonist for the ultra rapid treatment of migraine.
An oral version of that.
Japan is also ongoing in clinical testing this year in migraine and non migraine indications.
There are approximately 1 billion individuals worldwide, who suffer from migraine expansion of <unk> ODT beyond the United States has already begun with our 2 approvals for <unk> ODT in Israel and the UAE, we anticipate 9 regulatory submissions across the grow by the end of this year, we have delivered.
Great commercial success in the U S and we will continue to pursue that level of success with approvals in other regions of the world.
<unk> significant paradigm shift will be able to improve the lives of many individuals living with migraine across the globe.
In addition to our <unk> franchise. We also have multiple significant near term milestones outside of CIP anticipated in 2021 and the early part of next year, starting with top line results earlier than expected with our <unk> inhibitor of our debt for stat and multiple system atrophy in the third.
<unk> 2021, and then this will be followed by additional Readouts at the end of the year on next year, we anticipate that enrollment in the phase III study of <unk> and AOS will complete in the fourth quarter and for a really as always anticipated to read out top line data and Spinocerebellar ataxia early next year.
We are excited by the potential of our pipeline to bring value to patients suffering from devastating neurologic disorders, and youre going to hear a lot more about the details of our portfolio of strategy from our CMO ALLETE stock in just a few minutes.
Yes.
So to summarize <unk> ODT has exceeded all expectations in its brief 15 months since our initial approval back in March of 2020, and now with the approval of prevention Nortek Odt's, new indication, we are able to unlock our ability to reach more people and improve lives and create a legacy of countless stories of personnel at <unk>.
Information.
It remains a testament to our determined R&D and commercial teams that is fulfilled our responsibility to patients to ensure that we relieve suffering by delivering our novel migraine therapy to patients 1 medication to treat and prevent delivers unprecedented personal control for patients.
We have differentiated this product and are increasing our revenue growth quarter over quarter, and we have a strong portfolio of product opportunities that we believe will deliver value for patients and investors not only in the near term but for years to come our goal is to continue to deliver best in class therapies from our prime.
<unk> pipeline for patients.
Before our Chief commercial Officer B J Jones tells you some more details about the success of our commercial launch with <unk> ODT I'm going to turn it over to Jim <unk>, Our Chief Financial Officer to review the detailed results of our financial performance in the second quarter of 2021, Jim.
Thank you Brad.
Everyone and thank you for joining today.
<unk> achieved net sales of $93 million in quarter, 2 demonstrating another quarter of strong performance, increasing 112% versus Q1 of 2021, driven primarily by increased sales volume and favorability regarding gross to net price realization. If you recall, we have previously communicated.
<unk> that we expect improvements in our net realized price in 2021, and we are pleased to see that translate into our results this quarter.
Continuing down the P&L.
On R&D.
R&D investment in the quarter on a non-GAAP basis was $67.7 million compared to $36 million over the prior year quarter, an increase of $31.7 million.
The increase is primarily due to continued investment in our late stage product candidates and preclinical research, partially offset by a $10 million decrease on our obligation related to our 2 royalty pharma funding agreements.
SG&A expense in the quarter on a non-GAAP basis was $153.7 million compared to $119.5 million over the prior year quarter, an increase of $34.3 million most of our SG&A costs continue to support commercial sales of <unk> ODT.
The increase was primarily due to increased promotional activity supporting our tech ODT in quarter 221, as compared to quarter, 2.2020, which was in the early phase of launch which represented <unk> first full quarter. After launch in the last few weeks of Q1 of 2020.
On EPS, we reported non-GAAP adjusted net loss for the 3 months ended June 32021 of $170.979 million or $2.62.
Per share loss compared to $150 million or 2055 per share loss for the same period in 2020.
Turning to 6 months performance.
R&D investment for the first 6 months of 2021 on a non-GAAP basis was $141.8 million compared to $85.8 million over the prior year quarter, an increase of $56 million.
Again, the increase was primarily due to our continued investment in our late stage product candidates and preclinical research, partially offset by the aforementioned reduction in the royalty pharma funding agreement obligations.
G&A expense for the first 6 months of 2021 on a non-GAAP basis was $284.6 million compared to $204.4 million over the prior year quarter, an increase of 82 million. The increase was primarily due to increased promotional activities supporting <unk> ODT during the first during the fall.
6 months of commercial sales in 2021 as compared to the same period in 2020, we're <unk> ODT was launched in March 2020.
For EPS, we reported non-GAAP adjusted net loss for the 6 months ended June 32021 of $359.3 million or $5.65 per share loss compared to $284.7 million or $4.94 per share loss for the same period in 2012.
<unk>.
Turning to our balance sheet, we continue to be well capitalized with $368 million in cash cash equivalents in marketable securities as of June 32021. In addition, we have immediate access to $225 million from our debt facility with <unk> and anticipate $164.8 million of additional capital.
Proceeds from the series B preferred share agreement with royalty pharma executed last year with that let me turn it over to BJ Jones, our chief commercial officer, leading thank you Jim.
Good morning.
As Larry stated we are very excited about our recent approval of Intertek ODT for the prevention of episodic migraine. In addition to our prior indication for acute therapy <unk>.
<unk> ODT is indeed, the first and only medication proven to treat and prevent migraines and we are encouraged by the enthusiastic reception. We've received thus far from prescribers patients and payers since the launch of our dual indication fund.
Fundamentally we believe we are witnessing the early stages of a true paradigm shift in migraine treatment that will lead to demand for a more simple higher standard of care that produces better patient satisfaction and outcomes and consequently dramatically expands the number of people with migraine seeking treatment.
In the 9 weeks post launch we have witnessed an acceleration in volume and share driven by both increased acute and preventive therapy utilization with <unk> odt's unique positioning as the first and only medicine proven to both treat and prevent migraine attacks I'd like to share our perspective on this dynamic mark.
But how we believe it will evolve over time and the role that <unk> ODT will place.
The expanded market opportunity starts with the existence of extremely high unmet need in this category.
And what remains the second most disabling disease in the U S. There are many points to site, but I'll highlight some of the most compelling specific to migraine prevention.
There are too few people seeking preventive care only 15% second patients are very dissatisfied with 84% seeking better options and third the injection barrier among patients is real with 65% of people, who don't want to receive an injection.
These data speak to an immediate and compelling unmet need today, but we also see a longer term opportunity there is underdeveloped and waiting to be cultivated.
When you look at overall participation in the preventive market. It is striking how small the market is relative to the total population of people with migraine and.
In a market of approximately 40 million people with migraine fewer than 500000 are on some form of novel injectable therapy.
Approximately another million or so are on legacy for all therapies.
Most commonly to pyramid.
And why are so few people practicing preventive treatment research suggest that complexity burden and tolerability profile associated with existing therapies are the issue. While the previously mentioned barrier to injectable therapies is also substantially limited participation.
Nearly we see the immediate opportunity to convert many among the $1.6 million people who are dissatisfied with these other therapies. However, we also see a different much larger market below the surface that will steadily grow over time among people who have either left the preventive space or has been reluctant to.
Page based on the limitations of existing therapies.
We also see a market that isn't constrained by the traditional siloed categories of acute and preventive therapy of today. These rigid categories evolve not because physicians believed they were treating a differentiated underlying condition or because they wanted to add complexity, but rather the characteristics of traditional.
Migraine medications Ltd, the breadth of their utility.
<unk> ODT is well positioned to transcend these categories.
For patients with migraine, who want the simplicity of 1 medication. They can book treat their migraine attacks and be adapted to prevent them when needed <unk> ODT is in a market of 1.
Migraine is a complex disease and clearly other options are needed, but the unique ability to start and stay with Nortek ODT has the potential to make <unk>. The foundation in migraine treatment. This 1 of a kind profile encourages patients and prescribers to try and exhaust its full utility.
On treatment and prevention before adding additional therapies or progressing to injectables when they may not be needed.
This is a new market, we see before us and aimed to unlock and cultivate in the years ahead.
These are some of the insights clinicians have been sharing with us regarding their evolving utilization of <unk> ODT in this new landscape.
Most immediately acp's affirm that the indications are not merely additive but synergistic.
85% of customers say, the new preventive indication will increase their prescribing for acute use.
The mere possibility that patients could flex their use of <unk> to also prevent migraine attacks will drive greater initiation an acute therapy.
We're seeing this effect already emerge in the form of growing acute preference and <unk> share.
From a traditional prevention perspective, even before any promotion began more than 3 or 4 HCP surveyed stated that they were highly likely to prescribe <unk> ODT for prevention.
And win in.
In what we believe represents a large opportunity to expand the legacy preventive market, we see that 60% of targets said that they were also likely to adapt to use of <unk> ODT for intermittent or preemptive prevention to better manage predictable and unavoidable triggers like weather change hormonal changes.
In periods of stress.
Now from a payer access perspective, <unk> continues to perform very well and the critically important commercial channel. We're successful in establishing more than 89% coverage during the launch of 2020 and a sustain that level of coverage throughout 2021.
As it relates to all channel lives covered for <unk> Tec, we have increased access from 215 million lives exiting 2020 to 238 million covered lives currently.
Our access efforts for the new preventive indication are also progressing well the dosing flexibility that dual indications offer coupled with labeled safety data had been very well received by payers utilization management within the majority of payers is supported of the preventive indication to date prior author.
Nations and step edits have been similar to what we've experienced with acute largely generics only and utilization management criteria is consistent with that of the mass negotiations with the national Pbms and health plans for 2022 coverage for both acute and preventive indications are ongoing.
So in summary, these and other data reinforced the belief <unk> ODT is well positioned to uniquely address unmet needs in the migraine space and that this opportunity transcends traditional acute and preventive boundaries.
And then as big as it has become my custom I'd like to close with a focus on our patients.
We draw added confidence in knowing we landed on this market approach not because we were merely trying to stand out and differentiate ourselves in the market.
We executed this approach because of the personal experiences and insights gleaned from our patients and prescribers they.
They said the approach was intuitive to them. It is what they wanted.
And he gave many a level of personal control over their lives. They had never experienced since they were diagnosed with migraine.
It's life stories like Sabrina and Melendez on this line that inspire us to work as hard as we do to innovate and deliver for customers and it's experiences like Atlanta is that reinforce our strategy and approach to the market opportunity. She articulate the unique positioning of <unk> perfectly.
I think my neurologist picked <unk> because it's also approved as a preventive in case I need 1 in the future.
<unk> ODT, putting power back in the hands of patients and that is why we remain incredibly bullish about the approach in the future of <unk> ODT.
And with that I'd.
Like to hand, this over to my partner at least stock our Chief Medical Officer.
Thank you BJ this quarter I'm delighted to highlight the significant advances we continue to make across our R&D organization and I'm also happy to to look to the future and bio <unk> potential to bring multiple novel east to patients.
As Brad has mentioned we have an impressive <unk> franchisee piled Nathan that is unparalleled in our industry. Our focus on our lifecycle extension your tech OTT as well as the exploration of a wide variety of scientifically relevant indications outside of migraine is important too.
Hi.
And we're committed to following the science.
Expansion beyond geographic regions and the dual acting indication is of critical importance.
With ongoing trials in pediatric migraine, which is a large area of unmet need.
Additionally, we're studying trigeminal neuralgia and expect a steady nerve and several additional migraine adjacent areas, including costs dramatic headache, and at least 2 other undisclosed areas.
<unk> represents an important pathway in the Nexus between day immune and central nervous system and across a range of CJR P antagonist assets, we'll follow the science and conduct multiple proof of concept in Registrational studies additional non migraine studies are underway or planned and.
Includes psoriasis and asthma others remain undisclosed.
Investigator initiated trials and studies and health economics will add to the wealth of information that will ultimately be available for near term and will help define the scope of important information for patients payers and providers.
We continue to make great progress across our programs, including our <unk> franchise, our glutamate modulating agents on Myeloperoxidase inhibitor platform and the new opportunities we have across the common and rare diseases and our late stage portfolio as well as the early discovery work and bio even lapse.
We expect our early pipeline to bring us exciting compounds in numerous areas over the future years, but for today I will focus on our late stage programs that are in the clinic with many nearing topline readout.
<unk> ODT remains our cornerstone market product now indicated for the acute treatment of migraine as well as prevention with that label expansion in late May <unk> ODT 75 milligram has become the only migraine medication approved to both treat acute migraine attacks and help prevent.
Future migraine attacks.
Just imagine acute and prevent the ability to treat a large number of patients across the migraine continue on is a truly innovative approach to the treatment of migraine with the ability to use up to 18 doses per month, allowing from both acute and preventive treatment in the same patient I'm really proud of.
The team that's been able to make this a reality from your channel and those suffering from migraines.
In addition, the European evaluation from their tax dual acting filing is underway the filing in Europe took place in the first quarter of this year and we hope to secure approval in the first quarter of 2022.
Additionally, a phase III clinical trial of <unk> ODT from the 2 treatment of migraine is ongoing in China and Korea.
And our portfolio of small molecule <unk>.
<unk> us great flexibility and has the potential from multiple blockbusters important. Among these is the that Japan, which is already in phase III.
As you think Japan program includes both intranasal and oral formulations and acute treatment phase III study with intranasal <unk> began in October of last year. Following a positive phase 2 study and the second pivotal so that Japan study has the potential to confirm and even more rapid onset.
We anticipate a filing on this intranasal to vet, Japan for acute treatment of migraine in the fourth quarter of this year.
And our oral formulation of the vet, Japan began a phase III study in chronic migraine prevention in March.
Additionally, we're conducting into debt Japan's phase III trial in pulmonary complications of COVID-19 to assess whether <unk> receptor blockade can mitigate and excessive immune response and.
And will likewise follow where the <unk> science leads us into other non migraine areas later this year.
Also in our portfolio of CJR P antagonist small molecules or number of next generation <unk> antagonist and the first of these 3100 has now advanced to the clinic and it's in a phase 1 study.
These multiple <unk> antagonist opened numerous possibilities for us to expand our ctr platform and afford us the ability to really customize the unique attributes of each of these structurally unique compounds.
We have deep experience in this mechanism of action and multiple assets to optimize for different indications.
Our glutamate on Myeloperoxidase inhibitor platforms.
Likewise busy coordinating and most abundant excited Troy transmitter in the brain and we believe true really you saw has and will provide important advances in the neuroscience field across many areas.
So really it's all part of our glutamate modulating platform has completed enrollment in its phase III Spinocerebellar ataxia study and will read out top line results between the fourth quarter of this year and the first quarter of next year.
Our 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 just in this past first quarter of the year.
Both studies are based on critical signaling that emerge from earlier proof of concept OCD studies.
Debt we conducted.
On Myeloperoxidase inhibitor or defer stats pardon me about NPL platform is being evaluated in multiple system atrophy, a rare and rapidly progressive disease with FDA fast track designation.
The phase III study of <unk> in MSA will read out top line data in the third quarter of this year.
General here. We study this testing this agent in AOS is also on selling and will complete enrollment in the fourth quarter of this year.
We will continue to make strategic decisions across the portfolio as our data matures with both external partnerships and internal programs.
As you can see we're very busy and we remain focused on the important things.
Following the science, making streamlined and rational decisions based on well design studies and scientific day to day generate.
Rational an educated risk, taking while maintaining scientific integrity.
Is critical.
Optimization of drug design, and formulations, fostering innovative partnerships and collaborations nurturing and growing our internal talent.
And of course, keeping the patient at the center of all we do.
Our pipeline is really large and exciting and we continue to drive performance.
I can't wait to see what comes snacks, it's really a pleasure to be able to share all of you and I'll now turn the call back to flat.
Thank you Elyse, Jim and BJ and closing bioequivalence demonstrated a robust growth in terms of the commercialization of <unk> ODT and important maturation of our late stage innovative pipeline our strategy to develop <unk> as a dual acting theory for acute and prevention.
As well as launching with our unique and our patent protected <unk> ODT formulation demonstrates the key decision that we've made and ultimately this is what is differentiating our product in the marketplace. We expect continued market expansion of neurotic ODT in migraine anticipate multiple pip.
It'll trial Readouts over the next year, we have the potential from multiple NDA is over the next couple of years and significant growth lies ahead for our company.
Before opening up to Q1 day I would like to thank the entire <unk> team for their relentless commitment driving value accretion for patients on endeavors. I also want to thank all the patients and their family members and investigators to participate in our clinical trials that really helped to advance clinical care in the area of neuroscience, we must continue to.
Work hard to bring novel treatments for patients suffering from these devastating diseases. Finally, thank you again to our visionary investors are helped fund our studies of <unk> ODT to patients now we'll open it up to questions operator.
Thanks, Kunal conducting a question and answer session, if you'd like to be placed in the question queue. Please press star 1 on your telephone keypad, a confirmation tone will indicate your line is on the question queue. You May press star 2 if he'd like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick up per handset before pressing.
Star 1.1 moment, please what would you pull for questions. Our first question today is coming from Paul Choi from Goldman Sachs providers not alive.
Thank you and good morning, everyone and congratulations on the strong quarter.
A few commercial questions from marketplace, just first with regard to the prevention launch can you maybe just update us on how you are positioning and messaging nortek among potential prescribers and patients ahead of a competitive launch coming down the road and how would you characterize and quantify on a relative awareness of the of the different molecules at this point.
Great. Thanks, Paul I'm going to turn it over to P. J. The answer that question I did want to highlight though that because it prevents enlarge came late in the quarter were really the results. You saw today are still from the growing acute market.
And the early metrics book, so positive for the dual indication as reflected by the 56% <unk> today, but certainly I think youre going to see a lot more in the next quarter.
As we begin to realize more of those dual acting on prevention scripts. So Vijay.
Thanks for the question Paul.
Messaging has been it's been very clear we've been communicating to both commissions and patients. The fact that we are the first and only medication that can be utilized to treat and prevent migraine and once again as I mentioned it allows us to really set ourselves up as the.
Only medication in this space. So as you look at all the others that.
That may be coming right through it.
Pending <unk> dates and as well as the mab and and the rest of the market in the generic space like we are the only ones in that space and thus far as Vlad just mentioned.
We really have seen just tremendous receptivity to that messaging from clinicians and patients as well. So we feel very good about that from an awareness standpoint, it's very early on.
But we are excited because we don't have declined the hill of a brand new medications, we are well known or utilized the marketplace is well aware of neurotechnology. So we're able to use.
And that relative awareness really too to just launch us into what is a broad awareness around this dual indications. So thus far we like what we see every day.
I'll just add to that at least that.
So upon this and that's a paradigm shift with patients on their doctors rate debt.
They can customize the therapy, who doesn't want the only therapy that you can customize for acute and prevention as BJ talked about the 1 patient that provided us feedback about the reasons. She was put on aerotech was for that control that a patient lives and the ability to say I don't want to use it acutely now but maybe.
In the future I can then stay on the same medicine for prevention, if I need that or if you're somebody who needs. A preventative that you can have a simple medication that doesn't require a polypharmacy. So thanks, Paul for the question. Okay. Thanks a lot.
Operator next question. Thank you next question is coming from Ken Cacciatore from Cowen. Your line is now live.
Congratulations glad you're on the team really just fantastic performance I guess my question is around the value per Rx that youre securing currently in the acute just kind of give us a sense. If you could where that's going and then b J made a very nice commentary around about payer access around prevention I guess, just wanted to drill down a little bit more.
Here, obviously prevention is in essence, doubling the amount of pills and just wanted to understand how those payer discussions are going I think you mentioned debt at this point there is no real step through versus the Injectables, but maybe how that will shake out when you feel that we'll have this locked in and then maybe a sense.
Where the value per prescription on a blended basis, we will be going and then just back to you on ex U S. Obviously wonderful performance here in the U S. Maybe talk about how we're thinking about ex U S. P.
Pacing in decisions in terms of partnering thank you.
Thanks, a lot I can appreciate the comment on and then ill turn it over to Jim.
Jim to talk about value per hour accident BJ on the on the payer.
All right I'll, just generally say that as you know, we don't guide towards that value per Rx, but I'll, let Jim comment just on the favorability that we've been seeing in pricing, but the good news is it's not just favorably on pricing, but continued growth that's driving this value jumped on that.
Yes, Thanks, a lot thanks, Kent, Ken for the question so.
As I mentioned, we don't we don't guide to our net price.
But I will say as I commented in my prepared script that we were pleased to see the improvement in the second quarter and we had provided in the past.
Some context that this would improve so we're really pleased about that.
1 of them.
Big drivers, obviously as we've talked about is these patient affordability programs that we have in place and over time, we will start to pull those back and certainly as we do that that will improve.
The price.
Just 1 thing we want to just keep people mindful of though as we've said in the past. This is we're still in launch phase and certainly now with the with the approval of prevention, we will see some volatility in.
In pricing in the future, but we are.
Competent and believe that we will continue to have success.
And strong performance.
Alright, and Ken Thanks for the question so as it relates to payer access in those discussions.
As you can imagine we're in constant dialogue at this point in time.
And really our ability to communicate what is <unk> clinical profile.
Unique dual indication dosing flexibility.
It continued safety.
Really been received extremely well and so we're excited about those discussions thus far.
Can't get ahead of ourselves in communicating exactly on what the outcome will be but we feel confident that within the next 60 days or so we will have some commitments for what will be 2022.
And that's what we're focusing on.
We have not thus far though run into situations. So our we believe our again our current pipe Ta criteria is consistent with that for the mats, which is best possible criteria.
And again these active negotiations are ongoing and we feel confident again about what is.
We believe will be an extension on the current U M. NPA criteria alright, Thanks, Jay I'll just add on that.
Criteria are the physician I'll say that this also reflects that even though there is debt through rate the high unmet need out there that we're seeing this type of growth.
There is a limitation of our current therapies and as we said prior to their lives sometimes those limitations don't get.
The realized by folks.
Until you have a drug in the market that you can contrast, it with it and so now what Youre seeing is patients haven't been satisfied with the true test, but it didn't have an option right now that there is a good oral option on both acute and prevention youre seeing the strong uptake and we think that's going to continue to just grow Ken on your question on global.
It's very infrequent that a drug like <unk>, along that could affect literally 1 billion people worldwide right. That's.
How many people suffer from migraine across the globe, we take that responsibility.
<unk>.
On a strongly because the impact we're seeing here in the U S and so the team is very hard at work at the regulatory filings. So that we could really bring <unk> to patients around the world.
As I've said previous during some of our public commentary that we are in decision, making mode about how we'll do the ex U S and global commercialization and those are all work still in progress and so we will have to stay tuned for future updates on region by region or.
Weather.
There would be other ways to globalize ex U S. So we'll leave it at that thanks, Kevin Operator next question.
Thank you. Our next question is coming from Chris Raymond from Piper Sandler Your line is not a lot.
Okay. Thanks.
Just on.
Quick question on the on the mix of prescribers. Some of our checks have indicated that you guys as seen on a lot of traction among pcp's I'm wondering if just generally you can talk about the mix there between primary care docs vs.
Headache specialists.
And also maybe circa.
Part of that question. If you can outline other access considerations at the PCP level versus specialists that you can talk to you.
Especially now with the prevention label.
Thanks, Chris.
Yes. Thanks for the question, Chris So as it relates to kind of specialists versus primary care.
1 would expect and we've seen in the data specialists are the ones that adopt more rapidly.
They see more patients obviously per per clinician.
But we do see a nice transit transition if you will.
Over time, where we're starting to see really strong pickup in primary care and we see that actually for <unk>, but certainly from a class as a whole we expect over time for primary care, just because theres. So many of them. They see so many page.
Patients with migraine is that that will be the bulk of.
This category in the <unk>.
Not too distant future and so we're excited again about what is.
Even a re energized excitement.
With our dual indication that we see even in this early stage from primary care as well as specialists as it relates to access issues I would say nothing.
Is really sticking out we do have strong access to primary care.
There is if you will kind of this overarching concern around not only the class, but but the broader industry as it relates to delta and the impact from an access standpoint, but thus far.
We're excited we're getting into see most important clinicians and communicating effectively with them.
Thanks, Chris operator.
Operator next question.
Thank you next question is coming from the meal demand from Mizuho. Your line is alive.
Hey, guys. This is a way for vogtle.
Just wondering first.
If you can talk a bit about let's say Japan.
I expect that you know the phase III readout on this year just wondering what your expectations are and how you would position the product.
And secondly, just.
Also wondering whether you have any more color with regards to <unk>.
Are you filing.
That's it thanks.
I'm going to turn it over to release I'll, just say that the ledge apparent we believe is going to be nicely complementary.
<unk> and <unk>.
Elyse.
Dress that at least.
Yeah. Thank you for the question.
We're very very excited about Japan right. It is in both the intranasal and oral formulations and what you're referring to of course is the intranasal formulation, which we're developing for ultra rapid use.
As you know right with patients who have migraine frequently they have nausea, and although an ODT is a big advance versus something that must be swallowed investment disintegrate wallet now.
Intranasal may be something that is appealing to those of course, who may have more severe nausea, but also is extremely fast. So it will be something that can be used for for for patients.
Who are suffering with migraine, who need something immediately.
And can't even wait as long.
As they do for our disintegrating tablet, which is also very clear.
Yes, as you said that phase III readout.
We will take place and we certainly expect a filing by the end of the year on are really excited about that and so stay tuned for that with regard to our European filing.
You know that's been filed and we are expecting.
Or hoping for an approval I should say at the beginning of next year and that process.
As with the FTA long process of approximately a year and it is going exactly as we would've expected at.
At this point, so I can't give you more details we don't usually give details on the specifics around the regulatory process Thats ongoing.
But suffice it to say that it's going exactly as we would've protect predicted at this point in time.
Yes.
Great. Thanks, Amit.
Next question operator.
Your next question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.
Yes, good morning, Gladden team very nice quarter. Congratulations thanks for taking our questions had a commercial question on 1 M..1 R&D or pipeline question.
Regarding the commercial question I guess I'm wondering if BJ you could provide a little bit more color on that.
The new prescriptions are they coming from new prescribers or are they coming from from.
Our deeper prescribing within a practice.
Great question, Charles and thanks for that and as you can imagine where we're looking at that every day to make that determination and the quick answer is both.
Is exactly what we would hope for and expect we certainly see.
Depth of prescribing for those who already believe and have had success and so they're extending that utilization rate into preventive and then as it relates to we've also seen what has been an acceleration in new prescribers as well and so again, it's we're 9 weeks and so on.
I want to be careful and certainly on predicting going forward, but so far we see acceleration in both those categories, which is good news for us.
And Charles.
Yes, yes.
Perhaps for lease.
On the sedan, Japan, again getting back to how to position relative to remit, Japan I guess I'm wondering is that primarily going to be focused and intranasal delivery and as such how do you compare the potential profile relative to other drugs such as DHT.
Yeah. So.
Japan will actually as being developed into different formulations right the intranasal.
And the.
Thank God.
As I mentioned it is being positioned as something that is extremely rapid and given the.
Relatively benign side effect profile, which is.
Which is we've seen with <unk> and we expect that Japan to have and we've seen.
Really comparable safety profile, we expect that patients will be really pleased compared to many of the other drugs that are that are on on the market.
And so that's the intranasal formulation, but in addition, we also.
Have an oral formulation, which is being developed in prevention and we do have a study that started.
In or starting in prevention and that oral formulation will be able to be utilized in prevention or patients who really need in every day dose.
And so those are for patients who have much more frequent migraines and really need something.
Net.
Is even more robust in terms of the every day dosing. So we are going to be coming forward we hope.
<unk> programs and approvals filings and approvals proposal intranasal and oral.
Flat yes.
I appreciate it I would just add Charles on you know.
I think from various surveys of patients that have been done in clinician that 1 of the most welcome parts of the classic Z jerky as has been the Tolerability profile patients want their migraine to go away and they don't want new problems and baggage associated with some of the older Med. So I think what youre going to see was the Virgin.
And is this mechanism, which clinicians have now are turning increasingly towards.
With a great efficacy and side effect profile I, just bring that to the intranasal, what the ultra rapid onset of action rather than kind of re treaded old mechanisms and.
So we think that it's going to differentiate nicely from other older drugs that have known limitations on dissatisfied front. Thanks Dara.
Got it.
Thank you. Our next question is coming from Laura Chico from Wedbush Securities. Your line is now live.
Good morning, Congrats on the quarter on thanks, very much for taking my question.
Got a commercial 1 I'm wondering if you can talk to the proportion of patients that are continuing on therapy with <unk>.
I believe some of the Symphony data shows, perhaps a higher percentage of patients staying on your browser versus <unk> at this point, but I'm wondering if you could just comment on where the figure is relative to your expectations and how do you expect that to shift over time, thanks very much.
Okay.
Or happy to address that for you I don't have explicit that I can actually get back to you on that but what I can suggest as it relates to the kind of the.
The relative proportion of folks staying on <unk>.
<unk> versus the competitor.
There are multiple doses with the competitor.
As I think we've all seen there's been and this utilization at a starting dose and then rapidly progressing to what would be the <unk>.
Higher dose because they perhaps did not see the efficacy they were searching for it. So again, we have to be careful as it relates to how we.
<unk>.
Determine exactly what that means we feel very confident again because of the feedback we get from patients and clinicians alike is that there's a high degree of satisfaction with <unk> OTT. The specific data that we can point to that shows a strong delta between satisfaction is.
It relates to <unk>, and <unk> and <unk> and so that's that's the basis on kind of our belief again that we have a unique and.
Highly beneficial product yes.
And last profile. It speaks for itself, we think it's a more efficient way of treating migraine, where people don't need to take multiple different doses multiple different drugs for different indications and so.
I would echo what BJ said don't misinterpret that with other approaches have patients out there.
Take a second dose there's multiple doses and so <unk>.
Be cautious on how you interpret that type of script data versus the efficiency.
It's coming across loud and clear with with no tech so.
Thank you next.
Next question operator.
Thank you. Our next question is coming from Marc Goodman from SVP Leerink. Your line is now live.
Yes, good morning.
You've been true is it.
Portability play obviously this quarter this past quarter there was a major.
Benefit.
Okay.
On your thinking about it.
You're on.
And into next year, just you know last time, you had said.
These programs to really.
The benefit until later in the obviously it had 1 much much earlier, so I'm just kind of curious about your overall just kind of big share.
Guidance for all of us to understand how that is going on behind the scenes and then as you're having these 2020.
'twenty 2.
Okay.
1 of the big successes this past.
Year since its launch.
Yeah.
Okay.
Thanks Margaret.
I think we got the gist of the question, although there was some choppiness there, but yeah I think we got.
And there are no problem and not your fault the internet.
You know look at generally speaking its what we had said last year that priority number 1 is building the market on a launch year.
And then Jim Vijay on myself, getting together and assessing data coming in and tweaking. Those programs, then they'll always be some back and forth and some changes that get done so we did get.
Some are.
Favorable.
<unk>, a little bit quicker than <unk>.
Expected, but as Jim said earlier, we're in a lion's share is still now for our dual indications so.
I wouldn't just assume that things are going to be steady. We've always said wait until the end of this year. When you get into next year I think you'll see more stable assessment of where we land with affordability. So.
I think we can all expect there'd be some modifications to the programs.
And we'll watch it carefully and over time, we think you'll you'll see the favorability, but there could be some volatility. Thanks Mark next question.
Okay.
Thank you. Your next question today is coming from <unk> from UBS. Your line is alive.
Hey, Thanks for taking my question and congrats on the quarter.
I have a couple for BK and then 1 on bad debt with that I can.
So on on.
Boy the PCP prescribing can you give us some color on whether that specifically headache specialists.
Generally PCT broadly.
And then can you also talk a little bit about how you're thinking about the EU market dynamics. What are some of the push is on call that you expect.
You would expect that Youre planning for a potential commercial launch.
We're happy to respond faster and I'll hand, it over to a lease in a moment to talk about the EU, but as it relates to <unk>.
There are a very small segment that are actually headache specialists, but the vast majority of them of them and the vast majority of those primary care writers or just your general practitioners and and again they are folks who see a lot of patients. Therefore.
A lot of patients with migraine.
And so we do again expect this area to be the 1 where there is.
Tremendous adoption over time, just because they see so many patients.
And at least.
Yeah with regard to.
Europe again, you know the filing took place at the end of last year.
We're in the midst of discussions.
With regulators in the in the normal process that you would expect and the physicians that we've spoken to in the field.
Been as excited about.
About being able to hopefully at some point right.
Approved in and have it on their marketplaces. So.
They've just been very excited and I think the dynamics once we're out there will be comparable.
What we see in the U S.
Yeah, and I would just add look look at the ROE miratec in other oral <unk> therapies are playing in the U S rate again, highlighting the limitations past therapies and when you have that contrast, you see the difference it makes in People's lives and their disability and I think the overall.
Health economic benefits.
From a therapy like this and so we would expect that over time to play out in Europe.
Next probably last question operator.
Certainly our final question today is coming from Tim Lugo from William Blair. Your line is now live.
Thanks for the question. Thanks for sneaking me in can you just comment on your cash position.
368 down from 200 last quarter and I know you have access to the fixed rate on our series B financing that still seems to be maybe a bit thin, giving how much investments going on in aerotech and all of the clinical programs and potentially Europe.
Can you just talk about maybe some areas where.
You might want to partner or or maybe bioshock could produce from capital.
Execute in Asia.
Yeah, no great growth.
And Tim and I think as you know, we've always demonstrated ability to appropriately from the company and these are things we watch very closely.
And we're also very.
Cognizant of wanting to avoid.
Dilution to our shareholders, especially when 1 understands the magnitude of this asset and then obviously, we want to work as quickly as possible to profitability. So we could self fund rather than having to go to the markets.
There is not a lot we can say at this point on.
Some of the plans ex U S again, youre going to have to do.
Just be low patient so we can.
Come up with the best strategy, there and communicate that but.
Jim and team and myself.
Make sure that company is always well funded Jim anything you want to add to that.
I think there's some debt up well blood work.
Barry dilution sensitive obviously for our investors, but I believe we are well capitalized.
Set up for success not only on when do you.
Look at our current.
Cash on hand, and access to capital there isn't any eminent need for us to go out and have to do something from a rate perspective.
BJ team keeps on hitting their numbers it makes that even even easier to deal with so thanks Tim.
Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.
Great well. Thank you again for joining us today and we deeply appreciate the support of our employees and investors as we move forward to delivering these life changing therapies to patients.
And we're excited about continuing to meet with you quarterly and giving you updates on what has been a paradigm shifting treatment and Eurotech ODT, but then also a lot of excitement in the rest of the portfolio in the quarters ahead, and so look forward to future calls with everyone. Thank you very much.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.