Q3 2020 Biohaven Pharmaceutical Holding Company Ltd Earnings Call
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Greetings and welcome to Bio Haven Pharmaceuticals third quarter earnings call.
At this time, all participants are in listen only mode.
A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host <unk> Chief operating officer.
[music], Thank you and welcome to the buy we Havent third quarter 2020 earnings call.
Today's call are Dr. black charge, our chief Executive Officer.
Jim Hart, Chief Financial Officer BJ.
Hey, Dave Jones, our Chief commercial officer, and Dr. at least stock our Chief Medical Officer.
Earlier. This morning, we issued a press release announcing the third quarter 2020 highlights a copy of this press release can be found on our website at <unk> Dot com and.
And we will file our form 10-Q later today.
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Before we again, let me remind everyone that today's discussion contains forward looking statements based on the environment as we currently see it.
And include risks and uncertainties.
Less than a description of risks and uncertainties associated with an investment in power even can be found in the companys filings with the U.S. Securities and Exchange Commission.
Please be aware that you should not place undue reliance on forward looking statements we make today.
For this call we will focus on non-GAAP financial measures with detailed description of the GAAP and non-GAAP analysis in our filing.
An archive of today's call will be posted to the about having the website in the Investor Relations section.
And with that I will now turn the call over to our Chief Executive Officer, Dr. Black charge [laughter]. Thank you cliff.
Good morning to our investors and thank you for joining the call. This morning.
Before we get started with the earnings call I wanted to take a moment to acknowledge the exciting news about the COVID-19 vaccine efficacy data from Pfizer This morning.
This is an extremely important step in beating the COVID-19 virus and then what's sort of the impact that the pharmaceutical industry could have on solving some of the most difficult health care problems.
Hey Society, I would like to congratulate and thank the scientists and leaders at Pfizer, who put tremendous resources behind the science and designing such well run studies that resulted in a robust efficacy data that we are hearing about this morning, we are indebted to these scientists and others and the pharmaceutical industry and at the FDA.
Who are working on advancing the COVID-19 vaccine.
Now turning back to our earnings release.
This is our third quarter earnings call, representing our second full quarter earnings since the launch of Nortech OTI to these are extremely exciting times for bio even and again this quarter I am pleased to report the company continues to excel in achieving our goals across multiple areas.
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Third quarter commercial performance was impressive and exceeded our expectations. Despite the continued challenges in the global pandemic the progress of Nortech ODP and the highly competitive seed European marketplace has been exceptional with net revenues in the third quarter of $17.7 million, representing a greater than 80.
<unk> percent increase compared to our previous second quarter revenues.
Third quarter prescriptions Nortech ODP continue to be extremely strong with over 220000 prescriptions launch to date right.
Reflecting a fast growing market and our belief that nortech ODP as well on the trajectory to become a blockbuster drug.
Formulary access to Nortech ODP per patient that also considerably grown this last quarter. There are now over 200 million covered lives who have access to Nortech Ot team and we have attained almost 87% commercial coverage today.
In addition to another impressive quarter of neritic Ot team. The acute migraine, we are already looking to the future and planning for a potential launch for the prevention indication by mid year 2021, we were particularly pleased to announce that the FDA accepted our San Diego for Nortech ODP and prevention.
And I have a second quarter 2021 could do for a day.
I want to highlight the robust and linear growth that we are continuing to see what nortech Oh do you take although we were second to market by a couple of months, our differentiated profile continues to drive demand from patients and the new to brand Rx market share continues to be almost evenly split between the two oral.
P.J.P. antagonists.
As is clearly evident on this slide our commercial team continues to outperform and their efforts to overcoming the challenging circumstances of Cobiz is a testament to our commitment to serve our patients.
I like to thank our entire commercial organization for their dedication and delivering such strong market performance again this past quarter.
We continue to see positive momentum surrounding the Nordic ODP watch and are truly able to see the difference we are making and so many patient lives. We believe there remains a significant opportunity to expand the oral T.J.P. market.
This new mechanism represents a transformative solution for patients with migraine beyond the generic and beyond over the counter medications.
And within the growing multibillion dollar migraine market Nortech ODP is differentiated from our competitors characterized by notably high level of patient and physician satisfaction primary research and market studies and prescription data also suggests nortech Eau de <unk> is the brand of choice.
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Now that we are three quarters away through the year. It is evident that world Peter a piece have driven the lion's share of the overall seed European market growth and 2020.
We believe or a T.J.P. antagonist for acute treatment of migraine will grow into a $4 billion to $5 billion annual market in the U.S. alone.
Given the projected size of the overall market, we remain focused on investing in the long term success of Nortech OTI tea.
Our goal is to drive patient and physician trial of our product and has market share in this rapidly growing oral see GRP market.
We are already beginning to recognize a positive return on investment with increasing physician advocacy and attracting a greater pool of patients and expect this to continue throughout your read the strength of our commercial payer coverage is another leading indicator of the important impact that Nortech Boe D.T. will have on patients suffering from my way.
I would like to again, thank and acknowledge our managed markets team led by Chris Darden parts are probably our goal was to achieve 80% insurance coverage by the end of 2020, but we were able to exceed that in just six months post launch and three months ahead of our target.
With our long term goal in big vision in mind to build a blockbuster brand we expect to begin to see benefits from this year's launch investments although.
Although brought investments in growing market share will continue well into next year, we expect that Nortech ODP gross to net expenses will begin to improve in 2021 as patient affordability programs abate given the broad commercial access achieved this past year and wholesaler distribution service.
The agreement or D. S. Eight fees will begin to materially decreased as a result of the stance of volume growth.
2020 has certainly been a little bit year for bio Haven as we've seen the positive impact of world see GRP at the lives of patients for the acute treatment of migraine Nortech ODP has demonstrated best in class differentiation with key attributes, including its quit their job Ot team staffed on citadel.
Actually the ability for a patient to return to normal functioning and 60 minutes and sustained efficacy for two days after a single dose.
If the 2020 landscape for migraine treatment with about oral TRP isn't acute therapy, we hope that 2021 will be about oral therapies and prevention of migraine.
We announced just last month that our SMB application for Nortech ODP was accepted by the FDA for the preventative treatment of migraine Yep.
If approved in 2021 this will be a great advancement for millions of patients as we bring forward. The first dual acting oral CGP antagonist for both the acute and preventative management of migraine.
Patients deserve a unified treatment of migraine across its entire disease spectrum.
Finally, I'm pleased to report that the same R&D organization that delivered Nortech ODP to the market and completed our recent prevention SMB filing has also been working diligently on advancing multiple pipeline assets.
Our neuro innovation pipeline is poised to deliver multiple pivotal trials over the next year.
The R&D team has been working tirelessly to bring new treatments to patients suffering from diseases like Alzheimer's spinal cerebellar taxi O C D multiple system atrophy and Ala.
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Unlike the early days of our company, we are no longer reliant upon the results of a single upcoming study right single modality for future value creation, we have a deep and robust pipeline consisting of multiple compounds modes of action and indications by.
Bio havens diverse pipeline contains both low risk opportunities in the <unk> lifecycle management of our seed ERP platform and higher risk high reward investments in our glutamate am I love products. The base inhibitor platform, we have multiple pipeline opportunity to deliver novel treatments for patients and create value for investors.
This slide highlights the exciting pipeline potential in multiple large market disease indication.
We have already spent time reviewing the progress and would never take though the team the acute and preventative management of migraine, but there is also significant potential in the lifecycle management of our broader C GRP platform.
We plan to initiate at least three proof of concept trials over the next year and on migraine indication and also planned studies in migraine or pain related adjacent fees. In addition, we are pleased to report that we initiate or a second pivotal trial of Intranasally that Japan pretty acute treatment of migraine in October as you.
Likely recall that that Japan is a third generation. She GRP antagonists that previously delivered positive results as an individual therapy in a phase two dose ranging trial for acute migraine.
We believe that this asset will be complementary to nortech ODP and provide patients with another tool to treat migraine with the potential for an ultra rapid onset of action.
In October we also began to one year long term safety trials that that Japan that keeps us on track for a potential NDS filing at the end of 2021, if the pivotal acute trial p. proves to be positive.
Finally, we are eagerly expecting topline results from our pivotal trial of troll really is all in mild to moderate Alzheimer's disease. The trial has been tracking ahead of schedule and we now anticipate results in either December or January.
The study enrolled 350 patients with Alzheimer's disease, who receive treatment with Trowbridge. Please all dose that 280 milligrams or placebo for one year. The co primary outcome measure is the Adas cog 11, and the CDR sum of boxes.
The change from baseline in EPS Campbell volume on MRI at week 48 is a key secondary outcome measure that assesses CRO really it's always potential for disease modification.
Important measures a function that did the AIDC EPS HDL scale and the nurse psychiatric inventory or Npis are also included in the key secondary outcomes.
In addition, biomarkers such as neuropathic, so in that light chain and Pete how 181, which have emerged over the past two to three years is validated measures of disease progression are also included in this trial.
As we all know there have not been novel treatments for Alzheimer's in decades, and currently there are no disease modifying therapies.
If the Alzheimer's disease trial would try it really is all is positive and we anticipate a bible five b to filing.
We are also on track to initiate our phase three trial for a really is all I know city by the end of this year.
As we look to the future and our novel assets I want to highlight the opportunity in our rare disease portfolio. We are advancing the repair therapies for a devastating rare diseases with high unmet need that I know a few a few prove treatment option.
Our rare disease portfolio has the potential for significant value creation, while bringing novel therapies to patients with severe neurodegenerative diseases.
As our CMO ALLETE stock will elaborate on shortly we are anticipating topline results in 2021, four at CA and that day and potentially kls given that these disorders represent rare diseases I havent had the internal expertise and scale to commercialize these rare diseases.
Globally.
We anticipate the potential for significant peak revenues as well as value creation upon positive results in our rare disease portfolio.
To summarize we have a strong portfolio of product opportunities in both common and rare diseases that we believe will deliver value for patient investors in the near term as well as for years to come. Our goal is to continue to work hard to improve the lives of patients suffering from neurologic and nursed psychiatric disorders and continue to deliver it.
Best in class therapies from our promising pipeline for patients.
I will now turn it over to Jim Hart, Our Chief Financial Officer to review the detailed results of <unk> financial performance and this last third quarter.
Thank you Brad.
Good morning, everyone and thank you for joining today.
[noise] third quarter up 20, Twond. He saw continued growth in net sales, increasing 82% to 17.7 million versus quarter two.
Driven by strong prescription volumes.
I am so pleased with our company's performance as it reinforces our commercial strategy and the impressive execution since our launch in March once again, despite headwinds of the ongoing pandemic Nortech ODP continues to demonstrate its differentiated label for the acute treatment of migraine to physicians and patients.
We continue to work in a nimble and agile way adapting to an evolving environment and overcoming the challenges of a virtual world to bring nortech ODP to patients suffering from migraine, while in parallel and advancing our clinical pipeline.
As we commented in quarter, two we will not be providing financial guidance regarding projected revenues spending we're earning as we are still.
Early in our first commercial launch and continued to be under an uncertain economic environment with the bad debt.
We will also be commenting on non-GAAP financial measures, while our filings contain the additional details on both a GAAP and non-GAAP financial basis.
For the three months ended September 30, we achieved net revenues of 17.7 million on robots script volumes driven by patient demand for Maritech ODP.
We are very pleased with our continued market penetration as it reinforces the differentiation of Nortech CODI tea and the unmet need that exists with patients for the acute treatment of migraine as evidenced by continued growth in patients and health care professionals choosing their tech odisi.
Continuing down the piano.
S DNA expense in the quarter on a non-GAAP basis was 110.2 million.
Paired to 22.4 million over the prior year quarter, an increase of 87.8 million.
Most of our Sta costs reflect our commercial investment and the increase to prior quarter represent investment behind our Nortech ODP launch.
This investment includes our commercial infrastructure consumer and health care professionals promotion and direct to consumer programs, including investment in digital platforms.
S. DNA also includes general and administrative costs, including finance legal as well as other administrative functions that saw a slight increase to support the operational needs of our new commercial business as well as efforts to complete our intra entity asset sale to our Irish subsidiary Siderar that was finalized this quarter.
R&D investment in the quarter on a non-GAAP basis was 51.8 million, which decreased 6.2 million over the prior year quarter, primarily due to 7.5 million in cost related to pre FDA approval process validation batches of vermette, Japan in quarter three 2019.
To wrap up the PML, we reported non-GAAP adjusted net loss for the three months ended September Thirtyth 2020 159.5 million.
Or $2 and 67.
Cents loss per share compared to 80.8 million or a $1.55 per share loss for the same period.
Turning to our balance sheet.
As a result of our remote Japan IP sale to our Irish subsidiary in August we recorded a deferred tax asset of $875 million.
We've established a full valuation allowance due to our current lack of net operating income history. The transfer Vermette, Japan intellectual property to our Irish subsidiary as part of our larger global operations expansion.
Tax deductions for amortization of the debt of the deferred tax asset will be recognized in the future. If any amortization is not deductible for tax purposes that will be carried forward indefinitely undertook Irish tax laws.
We expect the majority of our anticipated global taxable income to be generated from Irish subsidiary and be subject to the Irish statutory rate, which is currently 12.5%.
We estimate that our effective tax rate will be significantly less than the 12.5% as we utilize various tax benefits, including our inner well carry forwards.
As a result of the financings we completed in August our balance sheet remains strong with 550 million in cash and marketable securities as of September Thirtyth and immediate access to 100 million brought from our streets fixed rate financing, we are well capitalized and have the liquidity to support our ongoing commercial and development in there.
She didnt and our corporate infrastructure.
Our current cash position together with our projected nortech revenue and available funding from our recent royalty pharma in sixth Street transactions provide the funds to continue supporting the note Nortech ODP brand and our pipeline, while providing the company with an accelerated path to profitability.
To sum up I am very pleased on the performance we delivered in the third quarter with strong their tech ODP scripts and revenue.
Leasing up the successful non dilutive financing and our intra entity transfer ever met Japan intellectual property to our Irish subsidiary and our continued sound fiscal discipline to ensure a lean and agile organization.
Let me turn it over to BJ.
Yes.
Hey, Jim.
Good morning.
I'm pleased to update you on their tech OTI Tees progress launch date.
First and foremost we remain excited about the early performance of Nortech, Audi T. end market drill.
Driven by the most talented and passionate professionals I've had the pleasure to work with a quick note of thanks to the commercial founders bio either.
Let's keep our collective focus on the patients we serve and their loved ones.
In the third quarter, we grew volume with 155% growth over prior quarter, we continue to observe widespread adoption among clinicians with over 20% unique writers and our reach is rapidly approaching 140000 patients since launch.
We remain encouraged as Nortech OTI tea growth dynamics are fueled by the rapid expansion of the oral see GRP market.
There are two primary sources of volume.
One the patients with migraine.
Who may have failed or can't tolerate triptan and two patients who haven't been on a prescription within the past 12 months.
But had been managing their migraine attacks with over the counter meds or through other methods.
We expected the Rx naive patient segment of the migraine population to enter the class. It's later adopters, which remains a long term growth opportunity for the class, but we've been pleasantly surprised by these early entrants.
As for the former Triptan user segment of the patient base the steep growth curve witnessed by the oral CRP class an aggregate still only represent approximately 14% of the triptan market year to date.
With heavy branded class investment in awareness and education, among the physician community, both specialists and primary care as well as patients. We expect this growth trend to continue for the long term.
I'm thrilled to report there were trending green on all early launch metrics as our growth in breadth and depth of prescribing is healthy.
You starts in refills are strong and brand perception tracks more positively from quarter to quarter right.
Recent spherix syndicated data suggests that among neurologists oral siege Rps are rapidly gaining ground on triptan as the preferred acute therapy for patients with migraine.
As we're all aware Triptan had been the standard of care for decades enjoy the natural defenses of prescribing habits patient familiarity and a managed care infrastructure that incentivizes generic use.
So this early preference data amongst specialist is impressive given that we're still within a year of launching the class.
If we then double click on these data the news for Nortech Audi T. is even better as we continue to witness meaningful differentiation from you brought in.
In this case neurologists show a slight preference for Nortech, that's their agent of choice, 23% versus 20% and perceive it to be.
More significant advancement over triptan, 51% versus 42%.
In addition, the data reveal a growing perception of Nortech OTI Tees differentiated benefit.
Specifically when asked how does Nortech OTI T compared to you brought me I'm following metrics neuralgia.
Robert just identified consistent comparative advantages for net nortech across key clinical attributes as.
As well as perceptions of company and sales Representatives support were.
We're confident these early findings will continue to fuel Nortech booties leadership presence in markets.
And just to reinforce blast earlier comments, both sets of secondary prescription data Symphony and I.Q. via tell the same story first with two novel product launches. This year. The oral see GRP class is growing rapidly due to tremendous unmet need among patients with migraine.
And to Nortech Audi T. is competing favorably for market leadership, and what will ultimately become a very large primary care market.
We continue to make substantive progress on our strategic priorities as introduced in our Q2 discussion.
Number one is driving BCP awareness.
With greater penetration of our customer base and compelling messaging that highlights nortechs differentiated clinical profile. We have now achieved over 90% awareness of the Nortech OTI tea brand away.
Awareness these to trial trial to adoption and adoption to habit.
Therefore increased breadth of prescribing remain a critical success factor for us and thus far we have more than 20000 high volume prescribers on board and growing each week.
Number two is activating patients.
Our strategy to engage patients continues to fully leverage standard platforms of direct to consumer media well over indexing on digital social and word of mouth campaigns.
We remain in line with our competitors share of voice, while executing a highly targeted and efficient plant.
Of course, we look at share of voice engagement and conversion data, but nothing is more affirming about the potential of this brand been hearing the testimonials from literally thousands of patients who in many cases are having transformative life changing experiences because of Nortech OTI tea.
Here is just one example of thousands receipt.
After speaking with my Doctor in learning more about Nortech, OTI tea, I'm able to get quick pain relief and get back to normal function when a migraine attacks in just one day.
Moving forward, our consumer advertising will continue to feature actual nortech patients exclusively.
As we believe nothing is more compelling than the passionate expression of unprecedented relief genuine surprise and heartfelt gratitude from authentic patients.
And number three is ensuring access and affordability. We're pleased to report that contract negotiation and formulary decisions have largely been completed for the commercial channel with favorable nortech access for over 150 million people, representing approximately 87% of commercial lives. We're also.
So well ahead of plan for Medicaid and Medicare formulary as another 50 million or so lives have favorable nortech coverage.
In our mission to make nortech widely available to patients suffering from debilitating debilitating migraines this breadth of access exceed even our own high expectations.
In closing for all the reasons stated and more we're extremely optimistic about the full potential of Nortech OTI Ti to transform lives, but we're also realistic about the unprecedented and unpredictable headwinds of COVID-19.
The projections of increased infections, the winter months could continue to place downward pressure on access to physicians.
And patients.
And although this is certainly an industry challenge bio Haven is uniquely positioned and I believe uniquely committed to working with our customers to identify novel and innovative solutions to address their specific needs, where perhaps larger organizations can work.
We will continue to monitor these evolving market dynamics, and anticipate change where feasible, but always remain close to our customers and flex when and wherever necessary to address patient needs.
And with that let me hand off to my partner at least.
[noise]. Thank you BJ.
Again this quarter I'm happy to highlight the significant contributions made across our R&D organization to advance novel therapies.
We continue to make impressive progress on multiple fronts, including a robust TRP franchise.
Growing glutamine platform.
Continued work and diligence on our Milo Twox Ace inhibitor and other novel targets that will one gay brink treatments just shown many who suffer from debilitating neurologic disorders.
Well, we're providing this quarter's update.
I wanted to highlight how important R&D cheap Vince.
She GRP receptor antagonist program.
First and as stated earlier by flat slightly even at San Diego for Nortech, Oh, GTN migraine prevention was accepted for filing by the EPS yet.
It actually went into the second quarter 2000.
21 to just Ajay.
Yes, I shouldn't be an exception marks a really critical milestone and I Havent heard you develop your check cookie cheap as you unique jumbles Cathy for both the preventive and acute treatment of migraine.
Yes, that's driving a successful nortech highly differentiated and robust product profile will provide one prescription still has the potential to treat migraine crossed a complete my green continue on.
Baskin Triple action in treating acute attacks.
<unk> really return to function with excellent tolerability.
Additional indication for prevention will allow for a single prescription to finally provide a unified treatment of migraine.
Its oral route of administration provides a low pill burden with every other day dosing without the need for painful injection.
That's your question.
Approach, coupled with a shorter half life and injectable allows for convenience and the ability for individuals to more quickly altered their medication regimen should they need or choose to do so.
[noise] approved in prevention, Nortech, Oh, Gee will be the first and only feed your p. targeting drug indicated for both.
Preventive treatment of migraine.
In this last quarter. We also made significant progress in the development third generation GRP antagonist that you can't.
So that you can have the dairy high affinity for the sea GRP receptor and unique characteristics, including being highly water soluble.
No we have the luxury of being able to do.
They never right formulation.
I'm pleased to report that.
Our second pivotal trial.
You said that you do have to October and if the trial is positive.
Right on track for a potential NDS filing by the end of 2021.
Im sure in April so that you can't have the potential to have a very rapid onset and first teaching our few receptor antagonist.
It's for nasal formulation.
We're also advancing oral formulation, just the veggie patch and recently, reaching target exposures in humans.
We're excited to be moving our oral formulation into a phase three migraine prevention trial early next year as well as planning for three not migraine proof of concept trial 2021.
Finally, even has numerous upcoming key regulatory and trial milestones.
As we focus across the R&D pipeline.
We have made progress on many fronts and this slide highlights some of our most important milestone events.
We already discussed few important developments check out <unk> and is it that you can't migraine indication.
<unk> science driven approach to lifecycle management, we will continue to expand the indications for C. GRP franchise.
In addition to our efforts in the U.S.
Answering your text <unk> across the globe to make nurse Jackie O.G. more widely available green patients around the world.
Last quarter, we engaged and they are on schedule for filing in Europe in the first quarter of 2021.
In August we also had initial discussions summer and that just yet.
Japanese regulatory authority P M D.
Well I'll start portfolio, including our Glutamates churches and mile a proxy based assets were looking for which topline result in at least four indications both rare and common diseases over the next year.
Hi, Alzheimer's disease study, which are really is all expected to read out in the coming weeks and has the potential to serve as the basis of an N D filing 2021.
Additionally, we anticipate the potential for top line results in treat rare disease by the end of next year.
A rare disease portfolio.
And has the potential for bringing novel therapies to patients.
The air Neuro degenerative diseases.
Let's look a little more closely at the upcoming opportunities in rare disease lift for superstar and for really at all.
We have to really rare disease programs that are progressing with enormous potential each of these studies opportunities.
The first of these potential pivotal trials to readout be alburger superstar multiple system atrophy trial in a latter part.
With a potential filing 2020 two.
And that's generally trial I forget burst out in L.S. is progressing well with enrollment and we anticipate top line data as you heard from Black Friday, and just 2021 or early 2022.
By a regulatory filing by 2023.
Sure we use all program for EPS yeas on track.
At the top line at the end of 2021 with an opportunity to file.
He too.
We're very proud of our robust and differentiated rare disease portfolio and the opportunity to serve those underserved patients with the ability and often fatal rare neurological diseases.
I've mentioned.
It's highlighted a number of accomplishments and upcoming milestones and now like if you look at the rest of our pipeline opportunities as I mentioned, we continue traditionally focused on making sure check Oh Gee widely available to migraine patients around the world.
Through a disciplined approach to lifecycle management expand the indications other CRP franchise.
As previously communicated we are committed to the global expansion of Jacek, Oh, Gee and expect future regulatory filings for your check ODC in Europe, Japan, and China as well as meeting.
Excuse me to support our established distribution agreements to bring your check Oh, GTT, Israel and the Middle East.
We remain on target for E filing.
First quarter up 21.
And prevention treatment of migraines.
Already been in discussions with <unk>.
Patient this filing.
Early in Japan, we discussed our filings approach with the P.M.D.I.
I plan to come to agreement with them over the next few months or bridging strategy for both acute and preventive treatment migraine.
That's contained in our last earnings call we like.
Likewise progressed <unk> filings city acute treatment of migraine in China across the Middle East.
Our programs supporting a filing in China, and Korea is underway with the phase three supplemental local trial, having commenced justice October.
And we've already filed for the acute treatment migrate in both Israel and the United Arab Emirates.
Filings other middle Eastern countries are expected this year with approvals except for some of these countries in the coming months.
Through 2021.
Further lifecycle extension beyond to prevention indication is also on track for the start of our pediatric program by the end of this year.
We expect to begin at least one study and the migraine adjacent seat in 2021.
As I mentioned I saw that you can't program is on full throttle that studies Intranasally says that you can't cheat Paul.
Pulmonary inflammation associated with cooking gene.
So that you can't acute treatment of migraine study.
An oral formulation is being progressed.
TRP represents a very important pathway and the nexus between immune and central nervous system, and we will follow the sites at least dreamed on migraine indications fitness franchise over the next year.
R&D is also working on multiple other pipeline assets in a similar fashion to bring forward new treatments in areas of unmet need.
I Lievens pipeline has high risk high reward investments now coordinate and my Lippert oxidase inhibitor platforms.
Oh Gee program is progressing with trial slated to begin this year.
Well you've heard about many others.
Other tour release, all and MTO programs and we're excited about what the next year will bring with it at least for topline readout.
Which will be uncovering information in Alzheimer's disease finer cerebellar in taxi, a multiple system atrophy and unless.
We continue to progress our work on the Delhi developing a potential first in class inhibitor up to tell us I mean, which was associated with a host of chronic inflammatory diseases.
Well focus on your on inflammatory diseases, well also be open to exploring other areas.
Likewise, working on RG greater platform.
Looking at assets that might help to harness the body's oh machinery.
Eliminate certain circulating protein pathogens that are implicated.
Implicated in a variety of diseases.
Our pipeline is really exciting.
Continued to drive each robust platforms and programs forward, we are very busy.
We remain committed to follow the science.
Keeping the patient.
I'm sure all we do it.
It is really a pleasure to be able to share all this review.
I will now turn the call back to flat.
Thank you Elise, Jim and BJ and clothing buyer Haven continues to demonstrate robust growth in terms of the commercialization of Nortech ODP and impart important maturation of our late stage Noora innovation pipeline. We expect continued market expansion of Nortech ODP at migraine and antenna.
The pay at least for a pivotal trial readouts over the next year, we have the potential for multiple end da's over the next couple of years and have important growth ahead of us as a company.
Before opening up the queue and I'd like to end by thanking the entire bio even team for their relentless commitment to commercializing nortech ODP and advancing our innovative pipeline. During this unprecedented pandemic I would also like to thank all the patients their family members and investigators who participated in our clinical trials and 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 central nervous system.
Finally, thank you to our visionary investors, who have helped fund our studies and bring Nortech ODP to patients.
We'd now like to open it up to questions operator.
Thank you at this time, we'll be conducting a question and answer session if.
If you would like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the Q.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Our first question today comes from Paul Choice of Goldman Sachs. Please proceed with your question.
Hi, Thanks, Good morning, everyone and thank you for taking our questions.
A couple from me. Please maybe just starting on the commercial side can you maybe comment on if you are seeing any off label.
Prevention use I'm, just kind of what what sort of utilization is being seen there I had a few art your formal indication next year and then just with regard to the payer side can you maybe just comment also on just what the <unk> yeah right.
Eight of rejections for prior authorizations, and so forth. It's been like interest has has there been sort of a decrease on that right and then I had a clinical question on all fibers.
Thanks.
Well I really appreciate that you know with regards to the prescriptions were seeing it is mainly in the triptan experienced patients, but as BJ noted we are seeing a very nice early indicator a patient who haven't been on prescriptions over the last year also coming new into the space, which gets us extremely excited.
The future growth ahead of us.
We hear a lot of enthusiasm about what we're going to call. This dual acting approach with our prevention Sndk, but we don't believe there is significant.
Uptake in the prescriptions right now for prevention certainly all the docs are talking about it. They are very enthusiastic about and we think thats going to contribute to future growth.
Turn it over to BJ for your payer question.
Yes, well, thank you for that and as it relates to the peer question in terms of rate or prior authorizations denial.
With you know again greater than 87%.
Prove all within the commercial space, we actually don't see much them out at all.
We're very happy we've received actually very strong feedback even from our customers from clinicians as well as patients that they see a relatively seamless process by which you know is shifting as written and then they can pull that at pharmacy. So we're we're very pleased thus far yeah, and I would say the only challenge at Covance brought up with regard to that.
As getting the doctors to fill out the prior art forms and so once they fell a we're seeing high rates of approvals and we're not seeing those denies the insurance companies.
Kobe presented some challenges and having the doctors in a timely fashion fill those out.
And so you know I think that contributed someday the challenges of Coven and then Paul I think you had a question on Alzheimer's, which you know were coming up the data. So excited to hear about what you want to know about 80, yeah, just with regard to that to the topline results. You know just how much will you disclose it initially versus first the first is.
Medical meeting that down the road and then just you know assuming the trial is positive what will you have to do in terms of maxed out what the regulators you mentioned the five of IP to approach could you maybe just elaborate on that as well. Please thank you very much.
Okay. Thanks, Paul appreciate it so with regard to the Alzheimer's data, which is up for coming shortly we expect to release our primary outcome measure is that the co primaries, Adas cog and see there are some of the boxes. We also at this point whats rate limiting to the top line as we do want to wait for a very important.
Morning, biomarker, which is a volume metric M.R.I.N. and that is done by an external group and that's going to be rate limiting to that top line. We think it's important to have both of those at the same time. So we can comment not just on clinical improvement, but also is there evidence of disease modification and as I mentioned.
I mentioned earlier, there is a number of other exciting biomarkers those probably won't be ready at that top line.
But you know at least we'll have a view on the volume metric MRI apply to the CIO and the final if I may be to look.
Because we now have experience with Trevor resolve for over three years now with our assay a trial or LCD patients as well as the patients we have a very robust safety package.
Our active metabolite is really is all ends 'em. We have received confirmation from the FDA that really truly is a would be considered a five or five be too. We have received waivers on CCAR and others. So if we were in a fortunate position to have positive results, we will very quickly be ready to move forward with it.
Filing there thanks, Paul next question.
The next question is from Tyler Van Buren of Piper Jaffray. Please proceed with your question.
Hey, guys. Good morning, Thanks for taking my questions. So.
So on the lunch I. Appreciate you know that you guys are doing the exact right thing to ensure that you drive the most volume for the long term and gross to net is clearly variable early on in the launch if you just do the simple math him take you know quarterly Nortech revenue divided by prescriptions. It looked like it looks like the gross to net.
Might have gone down a little bit quarter over quarter of course, there could have been stocking in Q2 or something like that that could have impacted so could you just give a little more color. There you know that jumped down is it or is it maybe more flat what should we expect it to look like moving forward and then an old timers just.
Maybe any thoughts you have on the recent at Academy.
The committee outcome and what do you think you need to show in the Alzheimer's trial.
I have a more.
I guess supportive review.
The committee so thank you.
Thanks, Thanks, Tyler this year as we've said multiple times is all about building the brand and getting physician and patient trial Nortech has its BJ went over once they experience the positive efficacy and the profile of this drug we had a very differentiated preference compared to our competitors.
And so this year is all about script volume and number of scripts were not overly focused on the investments required. This year, because we know building a large blockbuster brand requires that type of investment year. One you know today for the first time, we did guide towards that in 2021, we will begin to see decreases and.
And as we've said all along rights this year year, one launches about script volume year, two and beyond will be focused on maximizing profitability with regard to the recent AD Com look I think we're very excited to hear at last week's AD com and to here.
FDA perspective on how much of an unmet need Alzheimer's is and their acknowledgment that.
We as a field and as a regulatory agency need to move things forward now summer. So we took that very positively and we like everyone else will be waiting to see whether the approval comes.
I've been researching a need for many many years and I think everyone in the field would welcome a first disease modifier. So I wish them. Good luck and hope this positive news there.
Next question. Thank you.
The next question is from Kevin I can category of Cowen and company. Please proceed with your question.
Hey, good morning, everyone I just want to follow up on on Tyler's question. It's because we get a lot of asked a lot about this gross to net or net value per prescription. So you, Brazil the seem to be up quarter over quarter. So just wanted to know if you can help nuance a little bit of a difference maybe it's occurring between them and you all is it distribution fees or is it.
At an earlier start on launch and therefore managed care is working its way to the planned level.
Asked or maybe you can talk mechanistically about when you give the 87% covered just mechanistically what does it mean to start hearing you get a more value out of having that level of Brett. That's the first question second question, which I think you're going to pass on is can you give us a sense of where do you think that pricing will start to land in 2000.
21, or later in 2021, just give us a sense if youd.
Provide a range and then last question.
There is obviously and you talk about drawing prescriptions and from over the counter and obviously, we can track the prescriptions of Triptans are the total amount of Triptan prescriptions that are out there to try to size that kind of unknown over the counter or maybe opioid and said market that pool that maybe you're also going to be going after thank you.
Thanks, Dan So you know you're right I think on the net sale per script number what we have said there is that look we're going to be in line with our peers and when we're at that stable point.
Growth in EPS will be considerably lower in future years, as we've said and you've highlighted some of the reasons why.
Theres been hi, Gtlds, and some turbulence around them quarter to quarter. This first year because of the level of investment, but there's a number of things as you know, it's very complex with regard to it we say, 87% insurance coverage remember that just doesn't turn out overnight right. There's a cadence to our insurance coverage coming on in the interim that's where all.
Our affordability programs right you have a choice you can pay for affordability programs and get patients and doctors to experience Nortech ODP and then beyond that over the course of their entire life from their illness right. That's an important investment versus saying, we're going to try to manage logix generate a year, one and lose the the overall.
Battle on market share that wouldn't make any sense and so I think the cadence of insurance companies coming on is an important part of it and yes. There is a big Delta and distribution fees were a brand new company, we get the highest fees until you get volume, but again, we were able to guide today. We already know for example, we had very market and substantial.
Productions.
Projected for next year given.
Some of the idea say fees that we've negotiated so we're going to see that markedly change and.
Next year, and then also don't underestimate the Medicare Medicaid mix as well again being a new company.
There has been a delay for us to get coverage in those areas and although they only represent about 15% of the acute migraine that delta between you know.
Medicare Medicaid because we are new to the system this year.
Well at the DSE fees coming on to insurance all of that really accounts for the Delta Yeah, I would say for the rest of this year expect there to be a high GTN is and then you know as we've said for the first time today, we believe there will be reductions beginning in 2021, but we will continue to invest in and building the market share and then.
Beyond you're going to see EPS right in line with our peers at steady state.
Okay, all right and that's.
Next question.
The next question is from Charles I'm sorry.
There is an over the counter question you know, we do think it I will turn it over to BJ, there's very substantial market.
Market sizing being front line and migraine, we believe ultimately with this profile not only is it going to be a frontline, but is going to be primary care. We you know we see there is being a very large market expansion. Peter you want to add anything to that yes. The only thing I'd add to that and is that you know we at this point in time you were approximately.
25% or so right of of our business is in that kind of Rx naive you know market and and obviously the overall size of that market is very very large how rapidly, though they were able to penetrate that and get that conversion.
We're we're still investing right, but but what we see is we actually see that coming into this market much faster than we thought so.
I can't give you a number in terms of the relative size of that but we expect that to grow over time. So that's.
Great next question operator.
The next question is from Charles Duncan of Cantor. Please proceed with your question.
Yes, thanks for taking the question and congrats glad and team on a great quarter of progress had a couple of commercial questions and then and then and then one for at least for the up pipeline relative to the commercial questions want to step back from gross to net debate and.
And think more bigger picture I guess I'm glad as you consider revenue potential for Nortech over the next 12 months wonder that kinda nuanced operational metrics that you'll be looking at that will be most important to you to gauge the efforts in in that franchise.
Great. Thanks.
And then after you answer that will go back to you for the question with the lease book. This next year I think it's really important to see you know our primary care penetration I think that really is going to represent important market growth here as a class also beat again gave the update on the percent of the.
Triptan scripts that we are already seeing convert over I'd want to see that continue quarter over quarter to the increase and then obviously the new patients and the space and BJ I Miss I think I'll turn it over to you or other.
Operational metrics no. It's that I mean, that's ideal essentially there there were two primary metrics that we're looking at one of which is like is the the class growing as rapidly as we believe it can and in the second really is in what is our share of a backlash right. Those those two primary things many many different metrics underneath those but those are two.
Yes, I think as you know look to see new company like Bio Haven, basically splitting market share there and then a new to brand are actually with a large established company like Abbvie has been a big success for us that's.
Thus far we want to continue to demonstrate we can do that we believe we have the differentiated profile and ultimately patients and doctors are going to you know determined that my market share. So we look forward to expanding our profile from acute into the first dual acting as well and you had a question for at least.
Yeah, absolutely. Thank you and for on the pipeline and <unk> and thinking about trying to release all strategy I know this can be difficult but.
I'm wondering if you could rank order or call. It probability of success for Alzheimer's disease signers spinal cerebellar at taxi and LCD and kind of what the basis is and then.
Nuance in the Alzheimer's disease read out if you could if you saw kind of interesting, but not not compelling if you will.
Clinical benefit, but changes in hippocampus volume that pointed to greater benefit overtime would you continue to proceed.
Thanks.
Turnover, so two ways to answer, but I did want to just preface it to say I can't resist your question because it's just very reason why were doing multiple TRO really you saw studies I think in neuroscience.
Everyone's notoriously been bad at predicting which had several indications is going to be the one that wins and so we took this more big agnostic approach rank ordered disorders, where glutamate played an important role and that said, let's run the experiments, let's let the data to determine where the winds are going to be rather than our prognosticating around that so.
With that I'll, let a lease prognosticate and tell you what she thanks.
Oh.
I got to tell you, it's a very tough one and we.
<unk>.
Room sometime Oh, you know thinking about which one we would rank first I'm I'm going to echo that with flat you know gloomy just a principal excited trade transmitter and its really ubiquitous in the brain.
And they're really distinct deficits and different brain disorders and.
Hypothesis for a true real use all is really disease specific and independent for each of these whether it's an eight.
A b or C.
He day <unk> and even <unk> you saw the G.H. and so I think it's impossible to rank order them because the neural circuits that are dysfunctional are really not the same in each of these disorders. So I'm going to take a pass on it because if we went around the <unk>.
I think we would all we would all take different Flyers on it I think there there are distinct and any of them are really could could have positive outcomes and so we're just excited right. If we knew the answers suites. We certainly wouldn't run. This study. So we're running them, we're going to let them play out and I'm not a betting person so I can't.
That's on that.
With regard to.
To your question about Alzheimer's disease, and be a read out on that and and what happens if we have interesting, but not compelling results in our primary endpoints, but the volume metric MRI Oh. It looks positive look I think it really will depend on how closely are just statistical significance on the.
And the point that we have Oh, Adas cog as well as our summer boxes.
So I think it really will be a discussion that we have with the FDA and but as Brad said earlier, that's why we really want to wait for the MRI result, as well because we think together those three measures will really be able to inform us and and inform the.
FDIC as to whether we think this it's really going to have to legs and the potential to be a game changer for Alzheimer's.
Perfect. Thanks for the added color.
Thanks.
Expression.
Next question is from Tim Lugo of William Blair. Please proceed with your question.
Thanks for taking the question graduation, and all the progress is prevention of that Alonso label next year does that trigger any new managed care efforts and should we still expect GTN to continue to improve next year or does that.
Maybe change your GTM kind of discussions that Youve just given this say about improvement and then maybe clinically.
Can you talk about the experience from Tarenas all in the Sci patients given the prior phase two and if any of those patients who have undergone MRI and if there's anything they paid claims from those patients.
Thank you, yes, no one yeah prevention outlet.
Ill, let BJ talked about how it might affect you know GTN next year, yes.
Thanks, Tim and so as it relates to two preventive and if that comes through for US absolutely, we would need to and we'll certainly engage proactively with all the payers and we have not done that as of yet we're still obviously anxiously waiting for.
Feedback from the FDA.
But if we do get that approval our expectation would be that we would have to re engage and revisit right frankly some of the contracts that we currently have as it relates to will there be a variance in terms of the GTN based upon what we've seen thus far with acute and what Weve suggested.
We don't know quite yet there is a lot of work that still needs to be done and again, we have not actively engaged payers on this front, but that will start very quickly axiom re anchoring in Q1 will start to have that preliminary discussion pit grade.
Great and on EBITDA you know, we're really excited by you know every few months, we take a look at the long standing patients treated in the trial.
You know, we're seeing what we think is pretty impressive.
Stability of disease that we think is consistent with a disease modifying effect. You know we did have a cohort large cohort of patients who and from the initial ended the trial to when we started the extension.
Had come off of therapy, while we were getting the extension up and running and we saw a worsening of symptoms. When people came off that then rebounded a improved and stabilized after getting back on therapy. So I do think from what we are seeing in the sch round out three years out a with a level.
I Love just people many patients disease being quite stable over that time, where you would expect.
Within Urgen disorder, where we tested folks should actually that they should have a larger worsening and in the recent LCD results I think those two point towards we have an active drug here and were excited about the upcoming Alzheimer's you know I've always viewed it.
I say this is one of the most important exciting story neurotransmitters that were modulating. These are the type of things that one would expect to have an effect. So we're encouraged by what we're seeing an EPS CA.
And we'll see the I won't comment on biomarker changes.
Thanks appreciate it.
No problem. Thanks.
The next question is from Laura Chico of Wedbush Securities. Please proceed with your question.
Hey, good morning, guys. Thanks for taking my question I got two.
Q4, you want to nurture and one on sure really it's all so first on Nortech I believe about 125 million of the term loan facility through six street was contingent on hitting that $45 million milestone net sales by the first or second quarter of 2021. So I'm wondering if you could just talk a little bit to your confidence and.
Being able to achieve that milestone then I've got one follow up on a troubling so yes.
Turning to Jim for that.
Yes, good morning, Laura.
Yes, so we're confident in our ability to hit that milestone we have either the first or second quarter to hit it but we're confident achieving that.
Okay.
Maybe I'd sure really is on my apologies if I missed this but it's actually a two parter. So first can you actually confirm if the last patient visit has already happened and then I know you were asked with regards to <unk> panels kind of what you saw the read through here, but you know at the panel there was a ton of debate around what constitutes a clinically meaningful.
In fact, I don't think Ive actually heard you kind of clarify what you see that as here today, which are really at all so I'm wondering if you could help us kind of understand in the specific contracts have a mild moderate 80 population what do you see as a clinically meaningful change on eight EPS CAGR CDR sum abaxis. Thank you.
Yeah. Thanks, So you know we don't specifically comment.
Where are you know every last data point isn't that trial as I said earlier the rate limiting is getting all the MRI data and and analyzed the biometric device. It is being done by the Dcs and so with that a little outside of our control there.
Mild to moderate.
In our expectations.
It depends on whether you know if you have evidence of disease modification, you might actually expect a smaller effect size because.
Because if you are looking at stabilization not improvement so I think a lot of what you know.
We'll be deemed a success here is a are you seeing a symptomatic effect. If so then that's a win right and you'd like to see a disease modifying but if.
If you have a symptomatic, but not disease modifying I think thats a clear path forward if you have a.
Smaller improvement and more stabilization, but a robust disease modifying effect then that's exciting because.
You have the potential to treat even earlier and Brent Brent the progression of the on this.
So I think in either case would be a big win and then of course you know it's easy if you had both a symptomatic and disease modifying I think thats a.
Obviously, something we could all fantasize for and hope for would be the most robust outcome. So your question about the effect size. It really hinges on effects on the biomarkers of disease modification and we look forward to seeing them shortly.
Thanks Budd.
Thanks, Laura please it.
The next question is from from 11 of Mizuho Securities. Please proceed with your question.
Great. Thanks for taking my questions.
So how did you get a lot of question on the pricing side just in a couple of maybe more on the volume side. So one you mentioned that 220000 prescriptions I believe to date I was just trying to clarify that is to date or is that through the end of third quarter ending backlog yes.
Yes, thats much today.
Can you give us the third quarter number like you did in the second quarter. How many scripts you got to you you saw in turn.
I don't think we are sharing those were focused on launch to date numbers as you know there's been some discrepancies between the two reporting systems. We obviously have our internal numbers, but given the discrepancy were not revealing the you know internal numbers.
Okay.
Let me now speak why don't you comment I may have missed it just.
Are there any de stocking or destocking dynamics, either this quarter or last quarter that we should be aware of.
They think about their yeah. Good morning, good morning good.
Good morning, the mill.
We don't report out on an actual OD channel inventory, but what I can say is there is nothing unusual or no material swings.
From and the levels that we've been managing.
Okay and again my last company when do you see the large increase in script volumes. This quarter over last obviously, it's quite impressive and we've always said two years about script numbers and we're way exceeding our script numbers.
Last thing if I could just on the four to 5 billion peak sales that you mentioned in the press release. Furthermore, I guess the class as a whole can you talk about sort of what peak share on the Triptan market, you think you'd be able to obtain to get that love. I think you said your 14% now just trying to get a sense again to kind of volume expectations longer term.
Well as a clinician I'm not sure you know why why folks with.
Triptan in the future state given a cardiovascular risk factors and other tolerability them that gives you never use had a rebound headaches.
It is interesting when you do look at some other generic markets, sometimes what happens is you.
You see some erosion of the generic but then it's really the growth of the novel treatment and the market is where.
You see most of the uptake so if you go and look at.
The novel Anti quietly went for example versus Warfront. There still is a very robust prescription of war friend Thats out in the market but.
The novel Anti consultants are you know probably going to be 10 billion dollar plus right you know a market.
Annually and so we see that often where generic still will get prescribed. However, you know the novel therapeutic becomes the dominant market share before anyone else.
There's not much I can add that was really answer well Brian I agree is that you know what we don't know and we're going to see over time is what that relative ratio is between if you will kind of ex trip to end users and in Rx naive. We expect again that latter group to continue to grow exponentially.
The data doesn't show that there is any.
Yeah define it out we are quarter over quarter. It is really nice robust I mean, it's for I don't know launches. The seat is continued growth not just for us for our competitor I think speaks towards where this class is going.
Okay. Thank you.
The next question is from Sumant Kulkarni Canaccord. Please proceed with your question.
Good morning, Thanks for taking my questions I have a couple so first on shortened it so I'm not going to sort of thing, but indication a priority, but if everything goes to plan clinically what indication do you expect to be in a position to find first and my second question is on Mexico do you see what specifically can be done to make the seats a prescription numbers in north Dakota migrate upwards or is it just.
That you might have to wait until you get approval book Prevention and then it becomes that's simply the competitor having two products that acute intervention. What's is one for you which means one plus one equals two comes from a payer perspective, what your competitor, which is maybe one for you that.
Thanks.
Seamless so.
With regard to what's the potential if everything went.
As expected and we had positive data whats the the first for was that an indication that we would file an NDA for that clearly would be Alzheimer's at Alzheimer's ends up being positive so.
The teams already working on putting together the package at risk and having it ready to be submitted if we're fortunate enough to have positive data and as I said earlier that will hinge on the type of robustness of the data as well as whether there's disease modifying effects, but we're already working on the submission package there and.
I'll turn it over to BJ.
As it relates to the second question. So I guess I want to be clear is that once again as I mentioned, a moment ago. Our expectation is that will be essentially kind of changing evolving. The paradigm. Currently of how migraine is actually treated our belief is that there is certainly greater growth opportunity as it relates to.
A single product that will be used for both acute and prevention versus potentially having two compounds think to address each and and our expectation again is that it will be.
Much more convenient it'll be a you know and much more simple frankly for physicians as well as where patients right to especially against that different approach. So our belief is that we definitely have more robust strategy and that will lead to overall leadership in March.
All right last question operator.
The last question is from Marc Goodman of SVB Leerink. Please proceed with your question.
Yes morning few questions first Jim can you talk about just SGN AE and.
Is this quarterly level kind of what we should be expecting going forward into next year would that be another step up.
Secondly.
Flat can you talk about your plan for Europe.
Is this something that you can.
Considered in a different way previously I mean, I know some of these other countries.
In Asia, you know will be still be partners and stuff, but how are you thinking about.
But Europe and then.
And then thirdly, just on prevention when that comes how should we be expecting.
The prescription for prevention to be different from the prescription for Q. How are you thinking about that right now thanks.
Thanks Mark.
Good morning, Mark This is Jim I'll take the first question on SGN, a as you know we don't guide.
To our projected spending but as we've said before we have the.
The majority of our spending in EPS DNA is driven by the commercial.
Investment and we have our full.
Commercial organization in place the variable variable component is obviously the level of spending and.
And so that that can ebb and flow based on the programs that we have in any given period. So that's good I like in the coming there and Mark we're very excited about global expansion of North Dakota. The we are on schedule for our EMEA filings.
In the first quarter, and so thats going to get out the door a pretty rapidly.
And what like always you know we've always had an approach if you needed to do it alone you when should do that but our efforts there are focused in on the U.S. and certainly ex us in all markets. We do look for the right.
Partners and so after the filing we will I'm, probably early next year EPS and better guidance about you know our plans visa the potential partnerships ex us.
And also of course, we're excited about China and buyer shed and there you saw recent raise.
So that we could build the right infrastructure there without it coming off of the buyer Haven.
Proper books, so BJ if ever do.
More so it's an interesting question, obviously, we have to be careful in regards to our projections.
What the FDA has not yet approved.
So obviously, we have to wait for approval, we have to wait for the clarity in the label.
But our expectation is clearly we will promote weve accordingly within that label and.
And our thought is that a physician, we either right for acute therapy or they would write for preventive therapy and again, we will promote accordingly to what we're seeing with yeah. That's is that as a clinician I do think that there will be a halo effect on acute meaning that I think clinicians will say well why wouldn't I.
Start with the acute therapy that could have prevented effects and so I think people will have the flexibility. This unified treatment start on acute and then if you need to move to that prevented you can do so with the same agent by just changing the frequency of use and not the dose I mean think about how streamlining and convenient for patients and physicians.
I think patients really deserved finally that unified treatment for migraine wide you got two different drugs pay produce different drugs take you have two different side effects. So.
Think is going to be a halo effect in acute.
So what should we be expecting that the prescription for prevention would be yeah.
You know 15 pills at the same price obviously is it's priced right now.
You know I think we.
We are going to be working with some creative options with payers and we're going to leave it at that until the drugs approved and then.
I see those discussions with payers, who after more granularity on next year. Thanks Mark.
So thank you everyone for joining us today, and we really appreciate the support of our employers and investors as we move forward to delivering these life changing therapies to patients. We look forward to speaking they get right.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
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