Q3 2021 Biohaven Pharmaceutical Holding Company Ltd Earnings Call
Good morning, welcome to the Bio Haven Pharmaceuticals third quarter 2021 earnings conference call. 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. During the conference. Please press star zero on your telephone keypad. Please be advised that today's conference call may.
We recorded.
I'd now like to hand, the conference over to Caroline Dark from Bio Haven. Thank you. Please go ahead.
Thank you and welcome to filing in the third quarter 2021 earnings call.
Speaking on today's call from by the way then our Doctor of law charge, our Chief Executive Officer, Jim Engelhart, Chief Financial Officer P. J Jones, Chief Commercial Officer and Dr. Restock, Chief Medical Officer, We also welcome Nick Mcdonough with global President Pfizer.
Journal Medicine.
Earlier. This morning, we issued a press release announcing the third quarter 2021 highlights a copy of this press release can be found on our website at bio 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 detailed descriptions of these non-GAAP measures and reconciliations to the most comparable GAAP measures can be found in our SEC filings.
An archive of today's call will be posted to bio givens website in the Investor Relations section.
That I will turn the call over to our CEO Dr. Vlad charge. Thank you Caroline and good morning, and thank you to our investors for joining the third quarter earnings call.
This has been another exceptional quarter for bio Haven, not only has nortek ODT become the number one migraine treatment in its class, allowing patients and doctors to customize the single migraine therapy to treat and prevent attacks, but we are also excited to announce an outstanding strategic commercialization collaboration with Pfizer for <unk>.
<unk> outside the United States. It is an ideal collaboration that combines our neuroscience R&D expertise with pfizer's commercialization and marketing excellence to pave the way to bring <unk> to as many patients as possible around the world.
Want to thank the teams at Pfizer and bio even who work tirelessly in the last few weeks and over last night to make this collaboration agreement a reality thanks to the teams.
And I also wanted to take Nick Lugano West.
Mobile President of Pfizer internal medicine, who is on the line joining us today to speak about Pfizer's impressive global go to market commercial capabilities in just a few minutes.
Our business performance this quarter continues to exceed all expectations across multiple fronts <unk> ODT net revenue in the third quarter was $136 million, which brings our cumulative loss to date net revenue to approximately $336 million, we have a differentiated commercial product in nortek OTT that.
To generate increasing an impressive revenue growth.
To date, we have over 1 million prescriptions of Intertek ODT and the demand in the <unk> market continues to show strong growth quarter over quarter. We are very pleased to see the continued strength and the MD Rx metrics. After the prevention approval as demonstrated by increasing.
57% market share, reflecting robust demand for the dual indication.
<unk> ODT is providing fast and lasting relief to more and more migraine patients each day.
The entire or Ocs VIP classes outperforming initial launch expectations and reflects the importance of these medications to individuals with migraine <unk> ODT is now the number one migraine treatment in its class I want to thank our entire commercial managed market sales and marketing teams for their determination.
And passion to continue to deliver our market, leading <unk> metric again this quarter.
Today biodiesel welcomes Pfizer as our global commercialization partner for remote Japan as many know that's known by <unk> in the United States.
<unk> commercialization reach and marketing expertise is unmatched in the pharmaceutical industry, making it the ideal collaborator to accelerate access of our measure to add to the more than 1 billion patients worldwide, who suffer from migraine, we believe a collaboration between Pfizer and bio even brings together the winning combination of bio <unk>.
<unk> neuroscience, R&D with Pfizer's brand strength, and a vast global marketing network to deliver shareholder and patient value.
Building upon the rapid success in the United States. Our mutual goal is to gain approval to deliver dual therapy nortek ODT rapidly to as many patients as possible around the world.
With fiber advisors, a global clinical regulatory medical patient advocacy and commercial footprint, we can accelerate the access of <unk> around the globe, Jim Engelhart, our CFO will discuss the finances of the global partnership in more detail in just a few minutes, but to summarize this collaboration strengthens bio havens cash.
Mission with Pfizer is significant it investment in bio <unk> $150 million in cash upfront and $360 million in the purchase by an equity at a 25% premium.
Sales and development milestones and the potential for long term revenue on tier double digit royalties from net sales outside of the United States.
Time, and time again, we hear from patients and physicians that neuro Tech ODT is changing the way migraine is treated and is improving the lives of patients with migraine partnering with Pfizer will allow us to ensure that we'll be able to more efficiently deliver re-met, Japan to the large patient population across the globe.
We've been disabled and suffer from migraine.
As you know Pfizer has a strong history and vast experience and launching innovative products globally and drive market growth around the world. In addition to this strategic collaboration will allow bio haven to capitalize on Pfizer's deep PCP footprint as Pcp's are the key and the management of migraine and pain and the ex U S.
We are confident in the power of this collaboration given pfizer's long history of successfully launching and building partnered brands.
Yeah.
With this alliance there is an opportunity to bring this best in class migraine therapy, the patients outside the U S and potentially change the paradigm in the other regions of the world under the terms of the agreement five Haven would remain primarily responsible for further clinical development of <unk> and the parties will cooperate in red.
Inventory activities to secure approval for the product.
Pfizer will commercialize <unk> upon approval in all regions outside the United States, While bio Haven continues to so we commercialized nortek ODT and the United States.
Additionally, part of the arrangement buyers there are gains rights outside of the U S is a desert Pan our third generation.
Generation highest any selected and structure unique Steve your IP receptor antagonists currently being studied in both an intranasal delivery in a softgel formulation in phase III trials.
We are all aware of Pfizer's track record of success global reach and execution outside of the U S. As Pfizer has accomplished numerous times before with big drugs such as <unk>.
We believe that our collaboration with Pfizer can transform remote Japan into a massive global brand and regions and markets that today, we just couldnt do alone success will be achieved by working together and unlocking access to the many patients with migraine worldwide I.
I am excited to be able to announce this global collaboration Pfizer is a world leader in global R&D and commercialization with impressive milestones that we highlight is the reason why they were the partner of choice to drive <unk> and its success around the globe.
We believe a collaboration between Pfizer and bio Avon will bring together a winning combination.
Next I will turn the call over to Nick Lugano Global President of Pfizer internal medicine to comment on our collaboration and I must say that next team is really unmatched in the pharmaceutical industry in terms of the commercialization and marketing expertise of multiple breakthrough medications neck.
Thank you Vlad I am very happy to be here. This morning on behalf of Pfizer. We're excited about the partnership with bio Hayes and even more excited to add <unk> to our global portfolio outside of the U S. We're looking forward to joining forces with BIOLASE to help patients around the world who are impacted with this debilitating.
Urologic whole disease.
When we look at the numbers.
They certainly tell a story I think but more important than the numbers is pfizer's purpose and that is to deliver breakthroughs that change patients' lives here at Pfizer, we apply science and our global resources to bring therapy to people that extend and significantly improve their lives through the discovery development and manufacturer of medicines and vaccines.
And for decades, we've been at the forefront of advancing world renowned breakthrough medicines and vaccines with global impact our portfolio includes more than 30 key medicine, and many more medicines beyond that several of which represent true breakthroughs such as commodity eloquent than the Max and <unk> to name a few and our expansive footprint stands over 100.
Third 25 countries around the world as of Q3, the Pfizer ex U S revenues were $35 4 billion, but more importantly, we're very very proud of the numbers of patients that we are impacted positively around the world. In fact during the first nine months of 2021, our innovative medicines and vaccines reached nearly 1 billion people.
Globally.
Excited about the opportunity to collaborate with bio <unk> to have an even greater impact on patients around the world who experienced debilitating migraine.
I want to congratulate blend and the <unk> team on their success in achieving the rapid uptake of <unk> in the U S. It certainly speaks to the unmet need and the value of the medicine, and we plan to build off that success to drive strong uptake in markets around the world.
We think.
About pillars for launch and what's required to launch successfully we begin with securing access and optimal value.
Which will achieve for focusing on the unmet need of the patients and appropriately engaging the right patient population to drive rapid uptake will leverage our go to market expertise and digital innovation to reach neurologists and specialists with information about this valuable treatment option.
And we will ensure long term success by leveraging our scale and capabilities along with our industry, leading customer facing colleagues to reach PCP specialists and health systems with the right information at the right time.
These three principles apply broadly and in coordination I'm confident that we'll be able to accelerate access and fuel uptake of remit, Japan and markets outside of the U S.
Thank you for the opportunity to join our call today and for your partnership I believe together, we can help patients suffering from this debilitating disease now it's my pleasure to turn it over to Jim Engelhart CFO Biohazard.
Thank you Nick good morning, everyone and thank you for joining today.
Before providing an update on our quarter three results I would like to Echo the words of our CEO of <unk>, George and Pfizer's, Nick Lugano, which on the exciting news of bio Haven advisor entering into a strategic commercial collaboration agreement for the treatment and prevention of migraine upon approval in markets outside the U S.
Some of the key financial terms of the agreement are as follows.
Pfizer will pay Bioherm and a total of 500 million at closing inclusive of $150 million in cash and $350 million in equity investment and common shares priced at approximately $173 per share a 25% premium to the 20 day the Wap on November eight.
2021 closing of the equity investment is contingent upon completion of a review of our review under.
Anti trust laws, including the Hart, Scott Rodino Antitrust improvement Act of $19 76 in the United States and is expected to close in December of 2021.
In addition, <unk> received from Pfizer are tiered double digit royalties and reimbursement for.
Poor related ex U S BMS and royalty pharma royalties.
<unk> is also eligible to receive up to $740 million in milestone payments and total bio Haven is eligible to receive up to approximately $124 billion in upfront payments and future milestones.
Our collaboration with Pfizer reduces bio Haven was ex U S investment to commercialize our merger Pan upon approval by leveraging Pfizer's vast global commercial organization.
<unk> will continue to oversee manufacturing responsibilities for ex U S markets, we look forward to our collaboration with Pfizer and the ability to serve more patients who suffer from the debilitating effects of migraine.
Now, let me turn to bio havens quarter three results.
<unk> ODT received achieved net sales of $135 7 million from quarter, three demonstrating another quarter of strong performance, increasing 46% versus quarter. Two of this year driven by continued sales volume.
And we are very pleased by the contribution that our expanded label is having on their tech ODT for performance.
Continuing down the P&L.
<unk> investment in the quarter on a non-GAAP basis was $68 9 million compared to $51 $8 million over the prior year quarter, an increase of $17 1 million.
The increase is primarily due to continued investment in our late stage product candidates and preclinical research, partially offset by a $10 million decrease in our R&D services obligation.
SG&A expense for the quarter on a non-GAAP basis was $149 6 million compared to $110 $2 million over the prior year quarter, an increase of $39 4 million.
Most of our SG&A costs continue to support commercial sales of North Nortek ODT as we invest behind our novel dual indication therapy. The increase was primarily due to increased promotional activity supporting OTT ODT in quarter, three as compared to quarter, three 2020, which was in earlier phases of launch.
We reported non-GAAP adjusted net loss for the three months ended September 30 of $125 1 million or $1 91 per share loss compared to $159 5 million or $2 67 per share loss for the same period in 2021.
Moving on to year to date September results.
R&D investments for the nine months of 2021 on a non-GAAP basis was $210 6 million compared to $137 $6 million over the prior year period, an increase of $73 million again. The increase is primarily due to our continued investment in our late stage product candidates and preclinical research, partially offset by the aforementioned.
The reduction in R&D service obligation.
SG&A expense for the nine months of 2021 on a non-GAAP basis was $434 2 million compared to $314 $7 million over the prior year quarter, an increase of $119 5 million. The increase was primarily due to increased promotional activity supporting the architect ODT during the full nine months.
Sure.
Of commercialized sales in 'twenty, one for the treatment and prevention of migraine as compared to the same period in 2020, where <unk> was launched in 2020.
We reported non-GAAP adjusted net loss for the nine months ended September 30 of $484 4 million or $7 55 per share loss compared to $444 2 million or $7 62 per share loss for the same period in 2021 2020 excuse me.
Turning to our balance sheet following the execution of our collaboration and subscription agreements with Pfizer, we will have access to more than $1 1 billion taking into account the impact investment advisor is making.
As of September 32021, we have $523 9 million in cash cash equivalents in marketable securities immediate access to $125 million from our debt facility with sixth Street, and anticipate $147 $2 million of additional capital proceeds from our series B preferred share agreement with royalty pharma.
Executed last year with that let me turn it over to BDA Jones, our Chief commercial officer Vijay. Thank.
Thank you Jim and good morning, everyone.
There's a lot to be excited about within bio Haven. This morning.
First I'm happy to report continued strong uptake of Nortek ODT five months end market post launch of our dual indication and second I'm thrilled with the announcement of our collaboration with Pfizer to create broad access to this life changing medications to those in need throughout the world. It's truly the fulfillment of our vision.
<unk> ODT to transform the lives of migraine patients all patients across the globe.
We're very pleased with third quarter sales of $136 million, an increase of 46% over prior quarter, which reflects enthusiasm and accelerated adoption within the broad clinician and patient communities. We are confident that nortek odt's unique profile as the first and only medication proven to treat them.
Migraine is well positioned to shift the paradigm in migraine treatment to dual therapy, which will drive demand for a more simple higher standard of care that produces better patient satisfaction and outcomes and therefore will dramatically expand the number of people with migraine seeking treatment.
Since the launch of <unk> differentiated dual therapy early this summer we have witnessed an acceleration in volume and share fueled by specialists and primary care physicians. Thanks to the passion commitment and exceptional execution of our high performing commercial team, we've steadily grown our new to brand market share by <unk> <unk>.
Nine points on top of a rapidly expanding branded oral market as Vlad shared earlier, we're all.
<unk> continued to drive incremental penetration of the Triptan market, along with new patients and market.
From a payer access perspective, we're also encouraged regarding 2022 formulary status for Nortek ODT, we have maintained our strong access for acute therapy and coverage for preventive therapy is progressing well.
As a result of the surge in demand for this one of a kind dual therapy medication Nortek ODT has become the number one migraine treatment and the oral CRP class since early August Nortek is the market leader in overall prescription due to brand prescriptions and prescribing among neurologists and this is <unk>.
Just the beginning because we believe nortek ODT is uniquely positioned to transcend the traditional categories of acute and preventive.
For patients with migraine, who want the simplicity of one medication. They can treat their migraine attacks and be adapted to prevent them when needed Nortek ODT is in a market of one.
Which brings us to this pivotal moment when we are prepared to build upon the exceptional foundation of <unk> U S launch by establishing a world class collaboration with the partner of choice Pfizer to bring dual therapy innovation to the many patients suffering from migraine around the world.
Who better to partner with if our objective is to create access to vertex life changing profile and impact as many people as possible as rapidly as possible needless to say five years second to none in there ex U S commercial reach and expertise with a proven track record of building massive global brands.
In regions and markets that are dominated by generics.
And I'll conclude as I began theres a lot to be excited about this morning.
Nortek continues its successful trajectory driven by strong execution and growth in volume and share delivering $136 million in third quarter sales. In addition, today, we began a critical collaboration with Pfizer to satisfy the tremendous unmet need in patients with migraine, who reside outside the U S.
For many nortek odt's differentiated profile gives them a sense of personal control that provides renewed hope.
Moray said it best in this testimonial.
I have gone from handicap and fearful to empowered insecure Nortek ODT has helped me treat or prevent migraine being a single mom and now more productive and feel improvement in my parenting and relationships I can go about my life now without fearing that migraine is around the corner.
<unk> dedication and commitment to patients is also shared by Pfizer and our collective teams are eager to begin the hard yet extremely rewarding work of putting <unk> in personal control in the hands of patients worldwide.
Now I'd like to hand, it over to my partner at least stock our Chief Medical Officer.
Thank you P. J this quarter there is still much to be excited about we continue to make significant advances across our R&D organization and we have an even greater potential to bring multiple therapies to patients here in the U S as well as across the globe.
The collaboration we have formed with Pfizer now brings the best of all worlds to our <unk> antagonist platform.
With regard to R&D, we have demonstrated our ability to develop drugs that will meet the regulatory needs for filing and approval and innovators and expeditious fashion.
Finally, even has a large critical team with deep industry experience across relevant neuroscience areas.
Over 45 completed clinical trials with an approximately 40 additional trials ongoing and the data that we've generated has been published in leading peer reviewed journals such as the New England Journal in Lancet as BJ has mentioned we have been very successful in our U S commercialization.
We are now delighted to have Pfizer as a partner ex U S expansion, they bring global experience and a global footprint that will enhance our ability to win in migraine for patients around the world.
With regard to our portfolio, we have an impressive <unk> franchise with <unk>.
Unparalleled narrowcast OTT remains of course, our cornerstone market product now indicated for the acute treatment of migraine as well as for prevention.
With that label expansion in late late May Nortek, <unk> 75 milligrams has become the first and only ODT migraine medication approved to treat acute migraine attacks and to help prevent future migraine attacks.
The ability to treat a large number of patients across the migraine continuum is truly innovative and it's an approach to treatment that is amazing with the ability to use up to 18 doses per month, allowing for both acute and preventive treatment in the same patient.
We will continue to expand with lifecycle studies, Dr. Ptak ODT, both within neuroscience as well as explore a wide variety of scientifically relevant indications outside of migraine as we follow the science of the <unk> antagonist.
Expansion beyond geographic regions as already mentioned and the dual acting indications is of critical importance to us we have ongoing trials in pediatric migraine and trigeminal neuralgia.
Investigator initiated trials phase four clinical trials and studies and how the economics will add to the important wealth of information that will ultimately be available for near term and will help define the scope is important information for patients providers and payers both within the U S as well as globally.
The European evaluation near Teck's dual acting filing is underway the filing in Europe took place in the first quarter of this year and we hope to secure approval in the first half of 2022.
Additionally, our phase III clinical trial of <unk> ODT for the acute treatment of migraine is ongoing in China and Korea.
Studies to support filing in Japan.
We will begin in 2022.
And so that Japan program include as mentioned, both intranasal and oral formulations.
And acute treatment phase III study with intranasal <unk>, Japan began in October of last year, followed by a positive following excuse me a positive phase III study.
The second pivotal vegetarian trial will have a top line readouts this quarter and has the potential to confirm an even more rapid onset of effect.
We anticipate a filing of intranasal <unk> for the acute treatment of migraine. Shortly after the results of this trial are available.
Our oral formulation is that Japan with started in a phase III study in chronic migraine prevention. This past March.
Our next generation <unk>.
<unk> thousand 100, <unk> has now advanced to the clinic and it's in a phase one study.
These multiple <unk> antagonist opened numerous possibilities for us to expand our <unk> platform and afford us the ability to customize the unique attributes of each of these structurally unique compounds.
Across a range of <unk> antagonist assets, we will follow the signs and conduct multiple proof of concept and Registrational studies.
Additional non migraine studies are already underway or planned including pulmonary complications of COVID-19.
Yeah.
Psoriasis and asthma.
We continue to make great progress across other programs, including our glutamate modulating agents and our Myeloperoxidase inhibitor platform.
So it really is all part of our glutamate modulating platform has completed enrollment in phase III Spinocerebellar ataxia study and will read out top line results in the first half of 2022.
A phase III program in OCD started at the end of last year with the enrollment in our first study in the second study was initiated in the first quarter of this year.
Our myeloperoxidase inhibitor or defer staff part of our NPL platform was evaluated multiple system atrophy, a rare and rapidly progressive disease and although we were disappointed not to have positive results. We continue to be hopeful about the mass general Healey study.
Testing this agent in AOS and it will.
<unk> enrollment in the fourth quarter of this year.
As you can see we continue just to make great progress across all of our late stage assets and are excited about all of the opportunities we have across both common and rare diseases.
Our bio Haven Laboratory also remains busy with its early discovery work earlier this quarter, we advanced one of these compounds and antibody recruiting molecule into a phase one clinical trial in multiple myeloma.
We expect our early pipeline to bring us exciting compounds in numerous areas over future years.
We will continue to make strategic decisions across the portfolio as our data matures with the external partnerships and internal programs are.
Our pipeline is large and exciting and we continue to drive performance.
I'm really excited about our future <unk>. It is really a pleasure to be able to share all of this with you and I will now turn the call back to flat. Thank you Elyse, Nick Jim and BJ and clothing Bio Haven has demonstrated robust growth in terms of the commercialization of <unk> ODT and imported maturation of our late stage innovative.
Pipeline, we have the potential for multiple NDA is over the next couple of years and significant growth ahead as a company our commitment to migraine sufferers around the globe has never been stronger and our strategic collaboration with Pfizer will help ensure a global assets and nurse ex ODP and we're excited to see the benefits to patients that will come through this.
Partnership before opening to Q&A I'd like to thank the entire <unk> team for their relentless commitment to driving value creation for patients and investors I want to thank patients and their family members investigators who regularly participate in our clinical trials to advance clinical care in neuroscience, we must continue to work hard to bring novel.
Therapies to patients suffering from devastating diseases. Finally, thank you to our visionary investors, who have helped fund our studies and bring Nortek ODT to patients, let's open it up to questions operator.
Thank you we will now be conducting a question and answer session. 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 he would like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing the star keys.
Our first question is coming from the line of Ken Cacciatore with Cowen. Please proceed with your question.
Thanks, So much glad you Nick Jim DJ you all sounded so natural and cohesive on the presentation. So wondering why we didn't just make it completely official and.
At Pfizer potentially buy the whole company. So just can you talk about the strategic process.
Why not a complete exit is it is it price is it your belief in the pipeline.
Obviously, pfizer ambitious agreement about the opportunity with the quality agreement ex U S. You can just walk us through that that would be helpful. First question and then I'll say the second thanks.
Thanks, a lot I can well from our perspective, we think this is a much better long term center for <unk> and when you think about it we preserve all optionality in the U S and we partnered with a leading pharmaceutical company to increase not only the size of future revenue from this asset, but also get us there sooner right.
You and I and others have had discussions about how is <unk> going to commercialize around the globe Thats, a very challenging situation, where you have to have a commercial pricing regulatory presence in so many different markets and so can this really gives us the cash we need to run our business. There is equity that's been purchased today at a premium.
And as a really good long term setup all while still.
Having all of the U S revenue come into the company and preserving future optionality for us and our investors.
Thanks, a lot.
Thanks, guys.
Our next question is coming from the line of Chris Raymond with Piper Sandler. Please proceed with your question.
Good morning. This is allie, perhaps along for a Christmas morning. Thanks.
Thanks for taking our questions.
So first congrats on the Pfizer deal maybe just a clarifying question I think five haven is eligible for up to 740 <unk> milestones I guess, how should we think about the split there between regulatory and commercial milestones and just the cadence of a potential regulatory milestones with the EU and other approval decisions.
Next year.
Yes, we'll have some more details on our in our filing.
Go into that level of detail the split what I would say again with this type of partner, it's going to bring in those revenues much sooner than many anticipated and also the size of those when you think about.
The position, we were in and a lot of individuals' weren't able to give us credit for the ex U S market because we really.
It had not been able to demonstrate we'd be able to commercialize that and so finally, we've said publicly we are out there looking for the best partner ex U S. We found the best partner and we think it's going to really.
Set us up nicely for the long term.
Got it and then maybe just one more on that on commercial.
Now that there is another oral <unk> approved for prevention, just any color on how your messaging our tax profile compared to lock you left.
Any color on maybe how you're comparing or contrasting the queue up the profile.
The safety and efficacy data on the label.
A single indication on it it's QD dosing like how is that resonating with docs may be compared to your tax.
While we.
We're continuing to enjoy the differentiated profile because there is no other product that has one therapy for acute and preventive and one pill that is what is driving our market share and why we are beating a much bigger company like abbvie in the marketplace right and that message is resonating with payers with.
Payers patients and doctors that you can have one solution for migraine and so we've set a new standard there and a lot of the other treatments out there are living in the past of multiple different medications, where the only migraine therapy that has that one pill solution for both acute and prevention. So that's how we're going to.
To differentiate and grow the market.
Thank you everyone.
Yeah.
Well said.
Yes.
Next question. Please absolutely. Our next question is coming from the line of Paul Choi with Goldman Sachs. Please proceed with your question.
Hi, Thank you good morning, and thanks for taking our questions.
First a strategic question, both for Vlad and Nick if you're still available as.
As you think about the portfolio and <unk> and can you maybe just speak to any.
Strategic synergies that you consider either across the bio Haven <unk> Pfizer portfolio.
Is there is there any sort of overlap in terms of the migraine footprint there.
And then I had a follow up question on the pipeline.
Yes.
Nick talked about earlier in this product profile, we believe really fits their ex U S global footprint really nicely with their strong presence with PCP and pain across the globe really as we look to the various parties to have discussions they were clearly at the top with rigs.
To those capabilities. This is the right partner to bring a drug like <unk> patients. When you think about it Paul there is not many drugs that have the potential of reaching 1 billion people worldwide with how common.
The disease migraine is and as we know the leading cause of disability in people less than 50, right and so having that type of global infrastructure is really what brings the value to both companies here.
So not only are we going to benefit such a large number of patients, but this is going to be an important.
Drug for both companies with regard to revenue generation outside the U S.
Okay. Thanks for that flat and one question on the pipeline with regard to 1100 and the arm program in myeloma can you maybe just guide us at a high level, how we might think about the cadence of data in that program in 2022, and just how youre thinking about where the arm program might be fitting in myeloma treatment.
Either for a lease or Charlie.
Yes, so I'll hand, it over to Charlie or at least.
Chime in.
This represents really important next stage of development of a bio haven and that with our bio <unk> labs and the acquisition. We made last year, we really have access to what is an exciting immuno science.
On.
Our platform that youre going to start to see.
<unk> and clinical trials like this start.
Other indications like oncology like neuroscience.
And in others and so this is the beginning of that and we are so excited to have the first patient enrolled in that multiple myeloma trial and next year. We hope to have some data from that trial and this will be the first validation of using this technology in humans.
Prove outcomes in immuno oncology.
Yeah, No I think that you said it all we are really excited about having that first patient in and really being able to test. The first of the assets. It's coming out of that early pipeline. So we're very excited more than anything it's really going to as Vlad said validate the mechanism for us and give us an early read.
On safety as well.
And Paul what we saw pre clinically is when we add PHP 1100 to DCM.
NK cells, we were able to boost the efficacy in terms of myeloma cell, killing so we're really excited to be testing that hypothesis in the clinic and look forward to our coming data.
Yes.
Great. Thank you.
Thank you. Our next question is coming from the line of Jeff Hung with Morgan Stanley. Please proceed with your question. Thanks.
Thanks for taking the questions and congratulations on the ex U S. Partnership you mentioned that Pfizer was the partner of choice can you talk about the process for the ex U S partnership with.
The competitive process and if so how many other partners parties were evolved.
And then I have a follow up.
Yes, Thanks, Jeff and as you know those discussions occur under a confidentiality agreement. So we cant get into the details of that other than to say there were more.
Multiple parties and we'll leave it at that.
Alright, Thanks, and then.
Our conversations with payers going around the preventive treatment for 2022 any feedback that you are able to share.
Really exciting feedback then I'll, let BJ update you on.
Yes, Great question, Jeff and I would say that.
The discussions with payers are actually going extremely well once again, we feel very confident in regards to our ability to maintain what is the coverage that we have for Q therapy.
And thus far things are progressing extremely well as it relates to what is preventive therapy for 2022 and <unk>.
We're excited to announce.
So good news on that in near term as well.
Thank you.
Thanks next question operator, absolutely. Our next question is coming from the line of MLT ban with Mizuho. Please proceed with your question.
Hi, great. Thanks for taking the questions.
So maybe one on the agreement and one on the quarter just in terms of the agreement I'm, just curious if theres any sort of standstill or other sort of clauses in there that could prevent and expansion of the agreement or or something else happening in the future and then the second just if you could.
Just looking at your slide six you've obviously done very well with gaining new to brand share, but the last few weeks.
<unk> sort of made a little bit of headway. There I'm. Just curious if you can sort of comment on what youre seeing on the brand side.
Especially as particularly related to <unk> sort of recent gains here. Thank you.
Thanks for the questions.
No there is not a standstill in the contractual agreements.
That is not in there so there's no standstill and then.
Well I think Ryan in regard to quarter over quarter growth. We continue to see strong growth. There of course, there's always some back and forth being at 57% of the MD Rx continues to be exceptionally strong when you look at who our competitors.
And I think again, it's resonating with the message of the one treatment for both acute and prevention Lisa.
The only thing I'd add thanks, Brad is that we're again, we're very pleased with our <unk> share gains, especially since our dual launch in June.
As you know clearly we're the category leader, we're now sitting at approximately 14 point <unk> share advantage over <unk> and <unk> Rx trends over time, it's very important we watch that clearly, but as many of you know.
Fairly volatile as well in addition to monitoring what is long term MBS Rx trends, we closely watch all of the other early indicators to drive long term MBS Rx share trends, such as Percy product differentiation stated brand preference and intend to prescribe as well as relative competitive access on all.
These measures.
It favors nortek ODT and supports our hypothesis and the long term health really of corporate brand and our leadership.
Thanks.
Next question operator, our next question comes from the line of Laura Chico with Wedbush Securities. Please proceed with your question.
Hey, good morning, guys. Thanks, very much for taking the question I might ask this question a little bit differently than has been asked already but I'm wondering you've mentioned a couple of times now pfizer's legacy in the primary care market.
Establishing a collaborative relationship in the U S territory of consideration kind of given their PCP presence.
So Laura I think what Ive always said publicly for some time now is our focus was on the ex U S revenue streams. The U S launch is going so well the team is outperforming.
Very large competitor what we wanted to solve for in this first step is revenue outside right and so we did that with this collaboration today.
This collaboration gives us the cash we need to run and grow the company brings in the potential for revenue streams that we couldnt do on her own and.
Allows us to maintain our full optionality and we continue to own full U S rights, it's a win for patients because our two companies together are going to bring.
We think is the best in class therapy to patients around the globe.
And so we're very happy with the collaboration and we'll leave it at that.
That's super helpful. If I could just sneak in one follow up.
European launch probably going to start on different footing than in the U S with potentially two indications acute intervention and you just mentioned kind of the 'twenty two dynamics really boding well in the U S. Wondering if you could just take a moment to talk a little bit on how there might be likely differences in pricing access in the European market versus the U S. Thank you.
Thanks, Laura.
Just like our prelaunch activities in the U S. Our teams have been fast at work here preparing.
The completion of the regulatory process as well as the pricing process and of course, we can't comment on that because thats all on ongoing interaction thats going on right now we are preparing for a launch.
Before we were preparing for getting the approval because that was our regulatory and R&D footprint now we have a commercial partner that's going to be ready to bring this to so many patients in Europe and so we're preparing for a launch in 'twenty two and that's what I was getting at earlier the importance of this deal right. We get approve on Europe, you're going to have revenue streams coming in.
In much quicker and at a higher amount than we would ever be able to do.
And so thats why this partnership is particularly important for patients and violator.
Thank you.
Thanks.
Thank you. Our next question is coming from the line of Tim Lugo with William Blair. Please proceed with your question.
We saw improvements in <unk> in Q3, I guess, what the prevention launch previously signaled that that could hurt GCN.
Just directionally can you talk about where you expect to go over the next few quarters. You know, we don't need hard numbers, but directionally, well GTE and still be negative from prevention, but maybe that's improved with a more mature product users or should we expect volatility scale.
Hey, Tim Thanks, and I'll have Jim comment.
Yes, thanks for the question Tim.
As you know, we don't give guidance, but what we can say is we're certainly pleased by the performance.
Not only volume, but even in the last quarter, where we demonstrated an inflection point of improved pricing, which.
Which we which we had predicted would happen in 2021.
The prevention launches as BJ mentioned earlier the key there is all about getting access and we're making really good progress there and certainly as we as we navigate through that that could put some pressure on gross to net but overall, we're very pleased with the long term strategy that we have in place.
Alright, thank you.
Thank you. Our next question is coming from the line of Marc Goodman with SVP Leerink. Please proceed with your question.
Hi, Thank you this is Monday.
Sorry, Mike.
I have two questions. The first is do you have any data on your answer patients staying on that you would be able to share with us.
And then the second is could you elaborate a little more.
How do you view the mechanism and opportunity as we get their start in AOS. After the negatives MSA study. Thank you.
Yeah sure. So what we can tell you the migraine durability is very strong patients who respond and we know from our data you see about two thirds or so patients responding.
It tends to take <unk> as it reflects the monthly migraine frequency, it's mirroring that it's just as we saw in a real world trial. So we're seeing very nice durability and refill rates. There of course, we don't reveal the exact numbers around those.
We're very pleased.
So it was how well the drug is working for <unk> ALS right. So we know with this drug we are hitting the target and we are decreasing neuro inflammation. It's all about what stage of the illness and disease pathology is the right one to target with the Myeloperoxidase.
<unk> inhibitor.
No from our previous MSA study it may be that the later stage in that disease and the pathology is different than other neurodegenerative disorders. That's why we have this very important strategy of assessing drugs that hit the target of important mechanisms in different diseases that are unrelated by the underlying pathology.
Allergy. So there is no cross readout in these different indications and Mechanistically we.
We believe that there is significant evidence in AOS and its driven by neuro inflammation and we will find out soon enough on whether we hit our topline numbers. There at least you want add anything no I mean I think.
But again you said it all I think that we do not believe at this point that we can predict in any way what will happen with AOS, if there isn't clear.
Read through at all and the mechanisms are different.
We are collaborating in that mass general Healey study.
As Brad mentioned, we're going to complete enrollment this quarter and so we should have that data out.
Sometime after that.
Thanks, Please thank you.
Thank you. Our next question comes from Jeff Hung with Morgan Stanley. Please proceed with your question.
Thanks for taking the follow up I had a question for Nick if you're still on the line can you talk about pfizer's interest in an aerospace in general I was under the impression that you might have left the space. Thanks.
Yeah, Hey, Jeff sorry, Niclas had to drop off so he's.
No problem. Thank you.
Thanks.
Thank you. The next question is coming from <unk> <unk> with Mizuho. Please proceed with your question.
Hi, Thanks for taking my follow ups here. So just a couple quick ones. One I'm wondering if you can share the split of sort of treatment versus prevention sales in the quarter.
And then the second one is just runs of a Japan and.
I guess sort of a couple of parts here the expectations you have on that data before we give them and then could that be something that also gets added into this agreement if the data are positive.
Yes, so we're seeing growth in both acute and prevention, we don't break down those numbers.
Lot of the script data that Youre seeing just shows you script. It doesn't tell you whether it's one or two apacs, we're very pleased with the growth we're seeing in both segments. There and remember we're trying to get rid of the notion of two different segments right and so it really depends on how many migraine attacks per month, and how long that eight or 16 pack last year. So yes.
Japan, if I understand your question Pfizer.
Has the rights that Japan as well.
Data coming very soon that studies are going to read out shortly with intranasal adjuvant and thats going to be the first intranasal <unk> that could give you an ultra rapid onset of action. So that we believe is an important drug not just here in the U S. But it's part of this deal and obviously, we believe it can be very important.
Drug outside of the U S. So we're excited about that did I answer your question on Avondale.
Clarify so thank you all.
Alright last question please.
Our final question is coming from the line of <unk> <unk> with UBS. Please proceed with your question.
Hi, Thanks for squeezing me in congrats on the deal I guess, a clarifying question with Pfizer will be responsible for the Asian markets as well or will bias and be the lead in Asia and then I have a quick question for Chad.
Yes, Pfizer I wanted all ex U S markets and we have secured all ex U S markets. So they will be responsible for the Asian markets I will remind you that.
80 million Chinese with migraine very substantial market and we're excited to be working with Pfizer China team.
And as you know our studies ending up there and we'll be reading out again shortly.
And then we will be proceeding to filing.
And then operator I think there was one more question on the line but.
Do you have a question for Jim as well, yes, yes, just a quick one Jim given the cash infusion with the CLO can you give us an understanding for the use of funds over the next 12 to 18 months.
Between R&D and SG&A.
Yes, yes. Thanks for the question, yes, so I guess really the key.
Strategy for US here is really and the importance of getting that infusion as part of this transaction is really getting us to profitability.
So we're really pleased with not only the position or the cash that we have on hand and access to but also the funds that we're closing on in this transaction.
Yes.
We've always said like we wanted to be able to get to self funding of other programs without having to go.
Back to the equity capital markets.
Many times right and Thats been important and we've demonstrated our ability to fund the company in other ways.
Make sure we limit dilution to our shareholders. This is a really important cash infusion purchase of our stock at a premium.
Puts us in a strong position.
For longer term revenue stream, so just really excited about that alright.
Alright last question operator.
Absolutely. Our last question is coming from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Super Thanks for fitting me in juggling calls this morning, <unk> and team congratulations on this transaction and really great quarter had a quick question regarding how do you think about the European market and maybe even even the Asia markets as you think about Pharmacopeia economic.
<unk>.
Key contributors to pricing not really asking you about pricing, but how do the European speak about migraine versus say the United States priest.
Prescribers.
Yeah, Great question Charles and.
What I can say there is just like in the U S. We've made the value proposition to payers and I'll remind you.
We did get favorable reviews with regard to our pricing because our demonstrating on the reduction of disability right.
About the Churros and people are less than 50. This is the leading cause of disability rights and so thats important in our <unk>.
<unk> impact analysis to the payers both in the U S and outside of the U S and again the ICR and their review is included we were cost effective for patients with migraine.
Who didn't either respond or didn't have a full response or couldn't take a trip Tanner didn't respond. So we're going to have that same value proposition outside the U S.
And the payer constraints there are different but also we have a very large global market that we're going out here. So we're really excited about the prospects.
Excellent last quick question regarding <unk>.
This transaction ungodly, you won't be able to answer it but I guess I'm wondering if at any time Pfizer expressed interest in the U S markets as well and I apologize. If this has already been asked.
Yeah.
Okay.
What I can say there again Charles is that our focus was first priority was making sure. We can globalize <unk> and we said publicly previously that's what our priority was to find a global partner. That's what we went after and we've maintained all of our Optionality and flexibility.
In the U S market. We so we have that right here and we're doing exceptionally well with BJ and team. So this to US was an ideal partnership puts us on a real sound financial footing and creates a very significant future revenues, we believe for our shareholders.
<unk> brings important drug to patients. So we think it was the right deal and we'll leave it at that.
Excellent thanks for taking the questions congratulations Mike.
Alright.
Thank you well have reached the end of our question and answer session I'll pass the floor to management for closing remarks.
Yes. Thank you so thank you everyone for.
Joining us today, we really appreciate the support of our employees investors and our global partner now Pfizer and working together to deliver life changing therapies and for those suffering from migraine. This is a really important day to day, because we have a path forward to bring them the best in class <unk> agent in something.
We think it's going to have the potential to change the treatment paradigm outside the U S and improve patient lives. So thank you all.
Yes.
Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation and you may disconnect your lines at this time.
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