Q4 2020 Biohaven Pharmaceutical Holding Company Ltd Earnings Call
Good morning, welcome to the Bio Haven Pharmaceuticals fourth quarter journey of 'twenty and full year results call. At this time all participants lines are in a listen only mode.
After the Speakers' presentation there'll be a question and answer session if.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please be advised of todays conference call maybe recorded.
I would now like to hand, the conference over at the Bio Havens, Chief operating Officer Clifford Bechtold.
And you May now begin the.
Good morning, and thank you and welcome to the bio here in the fourth quarter 2020 earnings call.
Speaking on today's call are Dr. Vlad charge of our Chief Executive Officer, Jim Engelhart, Chief Financial Officer.
P J Jones, Chief commercial officer, and Dr. Lee stock, our Chief Medical Officer.
Earlier. This morning, we issued a press release announcing the fourth quarter 2020 highlights and the summary of our year end results.
A copy of this press release can be found on our website at <unk> dot com and will be on file with the 10-Q later filed today.
Before we begin let me remind everybody 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 the risks and uncertainties associated with an investment by way of these can be found in the company's filings with the U S of Securities and Exchange Commission.
Please be aware that you should not place undue reliance on the 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 filings.
An archive of today's call will be posted on the line of havens website in the investors section.
With that I'll turn the call over to our CEO Dr. Vlad <unk>. Thank.
Thank you cliff.
Good morning to our investors and thank you for joining the fourth quarter earnings call, representing our third full quarter of earnings since the launch of <unk> ODT.
Pleased to report the company continues to excel in delivering a paradigm shifting treatment for migraine and more broadly achieving our strategic goal of across multiple areas to grow value for patients on investors in years to come.
Our 2020 performance with <unk>, and we exceeded expectations across multiple fronts <unk> ODT was approved approximately one year ago today and despite facing what was perhaps the greatest challenge of any new drug launch with the emergence of the pandemic the bio <unk> team effectively and safely.
Our new migraine medication to patients.
To date, we have achieved over 450000 prescriptions of <unk> and access for patients as broad of with greater than 89% commercial coverage. The progress of neuro Tech has been exceptional with fourth quarter net revenues of approximately $35 million, representing an increase of over 98% from the third quarter.
Certainly a testament to our strong commercial team and the entire organization the fulfilled our responsibility to the patients to ensure the drug supply chain remains strong during the pandemic and together, we relieve suffering by delivering this novel migraine therapy for patients.
I'm also pleased to report this morning that our <unk> regulatory submission in Europe was recently accepted for review by the European Medicines Agency and is currently under review we are excited about the potential of bringing <unk> to patients around the globe and the European filing leverages, the acute and prevention data packages.
From our FDA filings. The EMEA package is the first the European filing for a dual acting migraine therapy for both acute and preventative treatment and one regulatory submission.
We believe the bio <unk> has the most broad and differentiated <unk> antagonist platform in the pharmaceutical industry. Our strategic goals are straightforward first maximize patient and shareholder value by continuing to execute on our Neurotechnology migraine is a common and disabling.
Disorder, we must efficiently deliver this new drug to patients and its differentiated profile to help them better treat their illness.
We believe that our of Windows efficacy returning patients to normal by 60 minutes and long lasting efficacy for two days after a single dose will ultimately win the <unk> class.
Third we will grow the market and acute but we will also expand this important drug to patients with other indications through a disciplined lifecycle management, including the pursuit of indications such as the prevention of migraine pediatric migraine, posttraumatic headache, and other pain related disorders.
Finally, we are leading the way by establishing new treatment paradigms and approach at.
This starts with our strategy to establish <unk> as the first and only dual acting migraine therapy for both acute and preventive therapy in one pill never before as migraine been treated with one medication across the spectrum of acute to prevention.
Additionally, we are following the science of seed European antagonism by expanding into several non migraine indications, including psoriasis and asthma.
<unk> is certainly the tip of the era of when it comes to the buyer Haven seizure of P franchise, and we wanted to update you regarding its market growth on this slide we continue to see robust and linear growth and the launch of <unk>. Although we were second to market by a couple of months, our differentiated profile continues to drive demand from pace.
<unk> and the new to brand Rx market share continues to almost be evenly split between the two approved oral <unk> antagonist I'd like to thank our entire commercial organization for their dedication and delivering such strong market performance in 2020.
For much of 2020, we heard directly from patients at their experience on <unk> was quite different than past experiences with other standard of care medications, we believe that neurotechnology the potential to become the first line standard of care therapy for migraine, given its efficacy and safety profile.
This slide shows that we have adjusted the very beginning of our market penetration compared to the Triptans.
Over the last year, there were approximately 16 million prescriptions for Triptans and this slide shows of the <unk> are steadily making progress by increasing market share compared to the Triptans and this is mainly due to our differentiated profile. This slide does not include the separate large population of patients who can't pay for it.
<unk> suite of Contra indications are of patients who fail trip plans. We believe that there is significant growth ahead for the royalty therapies as the.
Leading class of drugs for my time.
When we look at the <unk> targeting agents as a whole it remains evident that oral <unk> antagonists have driven the lion's share of the overall <unk> market growth in 2020 the.
This slide suggests that more of effective acute therapy, resulting in a diminished need for injectable preventative agents, we believe <unk> antagonist for the acute treatment of migraine will ultimately grow in two of $4 billion to $5 billion annual market in the U S alone and Thats for the acute indication on me.
Given the projected size of the overall market, we remain focused on investing in the long term success of Neurotechnology growing the overall <unk> market.
Yes.
As we look to the future of our cgmp franchise, one of the biggest limitations of migraine therapy to date has been the bifurcated treatment paradigm since no single migraine therapy could previously treat acute episodes and also prevent the next attack patients have had the historically use one medication to treat acute episodes in a <unk>.
Separate medication for.
Prevent migraines. This has resulted in polypharmacy, which of course is complicated by different side effect profiles of each additional therapy drug interactions and added costs for payers and patients and we hope to bring on hand to the treatment CASM.
As we look towards our upcoming NDA with prevention in the U S and our recently submitted dual therapy filing in Europe, we want to empower patients and doctors to treat migraine across the spectrum, we want to get rid of these two different categories of acute in prevention and think of what we believe the future state can be a singer.
The drug that treats acute episodes and that same drug at the same dose can simply be used more frequently to prevent migraines.
If approved for prevention in 2021, and Eurotech will represent a great advance advancement for millions of patients as we bring forward the first dual therapy or <unk> antagonist for both the acute and preventative management of migraine.
Patients deserve a unified treatment of migraine of course across its entire disease spectrum and bio haven hopes to deliver on that vision. This next year.
Think about the value proposition and simplicity that will bring to patients suffering from migraine the.
The one treatment that acts fast lasse and prevents future migraines, one drug one dose the patient and physician simply changed the frequency of use to meet each individual patient's need our vision is that <unk> will become the one treatment that can deliver relief across.
On the migraine spectrum from acute to prevention.
Now the <unk> is going to continue to be of key growth driver for our company. This next year and beyond but we have many other value inflection points for 2021 in future years.
While the commercial organization continues to focus on driving sales of Neurotechnology. The rest of the organization will be equally focused on driving new value inflection milestones in the future. This slide summarizes the breadth of our pipeline and lifecycle management opportunities of bio <unk>.
Outside of the U S. We expect to see global approvals of Neuro Tech beginning in 2021 and have already established distributor agreements in certain geographic regions.
While we await our EMA approval for dual acting we will advance the discussions regarding ex U S. Partnering of <unk> Europe and other major markets. In addition to our lifecycle management of <unk>, we expect to have topline data from interest Nathan for the bed, Japan by the end of the year end of positive will be ready to file the VAT, Japan as the first interim.
<unk> antagonist for the ultra rapid treatment of migraine.
An oral version of that Japan is also set the begin clinical testing shortly in both migraine and non migraine indications.
Outside of the <unk> antagonist franchise. We also have important phase III study readouts on our Myeloperoxidase inhibitor and glutamate modulator platform for depth of stat of drug thought the decreased bringing inflammatory pathways is expected to have top line results in both MSA and AOS later this year for really is all on.
We remain modulators with respect to have top line data and FCA by the end of the year or early next year.
We are also excited that our wholly owned Asia Pacific subsidiary, Biogen is driving to file of public offering and ease of the Hong Kong Shanghai exchange by the end of the year neurotoxin will be an important new treatment for the over 80 million Chinese suffering from migraine.
The <unk> robust pipeline is poised for continued to deliver value for patients and investors for the long term. Our R&D team has delivered on past milestone and has an exciting late stage portfolio that we believe will continue to create value over the next year and beyond.
To summarize we have a strong portfolio of product opportunities that will deliver value for patients.
Our goal is to continue to work hard to improve the lives of patients suffering from neurological and neuropsychiatric disorders and continue to deliver best in class therapies from a promising pipeline for patients with the establishment of the new bi specific platform and bio even labs, you will hear a lot more about our antibody enhancers and extra seller of Degraders and future.
Here's the will enable us to branch out further beyond neuroscience build additional partnerships and deliver more medicines across multiple areas of serious unmet need.
I will now turn it over to Jim angle, our CFO to review the detailed results of our financial performance in the fourth quarter and the year and Jim.
Thank you Brad good morning, everyone and thank you all for joining today.
The <unk> ODT sales achieved sales of 35 million demonstrated another strong performance versus prior quarter, increasing 98%.
The $35 million versus Q3, 2020, driven by strong prescription volumes as we previously communicated these results were not impacted by changes in inventory levels.
Looking ahead to 2021, while we will not be providing guidance regarding the sales spending or earnings. We do expect our first quarter sales to be impacted by the seasonality of patient deductibles and prescription re authorizations typically experienced in our business.
Continuing down the P&L breast.
For SG&A SG&A expense in the quarter on a non-GAAP basis was $114 million compared to $66 8 million over the prior year quarter, an increase of $47 2 million most of our SG&A costs reflect our commercial investment in <unk> ODT and the increase represents the investment in the launch it from there.
Tech this year.
SG&A also includes general and administrative costs, including finance and legal as well as other administrative functions.
R&D investment in the quarter on a non-GAAP basis was $57 8 million, which was flat to the prior year quarter.
On EPS, we reported non-GAAP adjusted net loss for the three months ended December 31, 2020 of $161 7 million or $2 69 per share loss compared to a $124 4 million for $2 38.
Per share loss for the same period in 2019.
Turning to our balance sheet, we continue to be well capitalized with $357 4 million in cash marketable securities and restricted cash as of December 31, 2020. In addition, we have immediate access to $225 million from our debt facility at sixth Street agreed to eliminate the.
The minimum sales threshold clause in our prior agreement as the result of our strong fourth quarter of 2020 sales performance. Finally, we anticipate $300 million of additional capital from our series B preferred and the vet, Japan development funding financing with royalty pharma last year.
With that let me turn it over the BJ Jones, our Chief commercial officer.
Yes.
Thank you Jim.
Hey, good morning, all.
2020 has been a defining year for bio Haven in many ways as we completed the build out of our commercial organization in Q1 last year, we quickly and effectively launched <unk> ODT upon approval.
We're fully aware of the market forces of rate against us, but sort of confident in our ability to succeed because of the <unk> differentiated profile of unique set of benefits for patients with high unmet need.
As you look back at 2020 full year results, which reflects approximately nine months of market. We're in.
Static with the success of <unk> ODT to date and the significant impact we've had in the lives of so many patients with migraine and their loved ones. We anticipated that <unk> was going to launch in a highly competitive market battling against large and well established pharma companies with long histories neuroscience and migraine.
What we didn't anticipate of course was executing the Companys first launch on the global pandemic at.
At the end of our Q for milestone the <unk> story continues to strengthen in the marketplace. The.
The <unk> class is growing rapidly do tremendous unmet need among patients with migraine fueled by two successful oral <unk> launches in 2020, <unk> ODT is poised for differential growth and market leadership in what will become a very large market.
Our fourth quarter results were strong as <unk> net sales increased by 98% over prior quarter with week over week volume growth through year end discounting how the variability we continue to perform well across all launch metrics at the prescriber and patient trial and advocacy steadily growth.
We are encouraged by growth trends and launched two new research the signal the significant potential of this market, which is aligned to our stated objective to win the <unk> class and grow the acute market.
This slide reflects results from the latest Sferics syndicated market research study in migraine, we chose increasing trends for neurologists self reported and projected oral CRP share overtime with corresponding declines <unk> share we.
We intend to invest wisely to capture the lion's share of impending growth as we anticipate <unk> will become the preferred acute migraine therapy in the mid to long term.
Another cut of these data suggests approximately 96% of neurologists preceding <unk> ODT to be in advance of the Triptans and importantly, close to half of the specialists anticipate using <unk> as their preferred acute migraine therapy versus other oral agents.
Although these data reflect specialist feedback, we expect <unk> preferential share to translate directly to the broad primary care audience as well.
Analogues of this specialists the PCP cascade dynamic are plentiful and varying disease states.
From CV metabolic and anti coagulation to neuroscience and major depressive disorder.
We credit our success and <unk> differential perception to a revolutionary product profile, yes, but also to excellence and execution.
As an emerging company launching our first approved product we place a high premium on working smarter and harder than the other guys.
Constant reinforcement of our clear and compelling strategy leads to efficient brand promotion for an optimal blend of both innovative and traditional channels.
We've been prudent with our resources to ensure we're investing not only where the greatest volume is today, we would clinical influencers that will shape the larger primary care market of tomorrow the.
The concept is novel, but requires extraordinary discipline during a global pandemic, where face to face engagements have been at a premium.
Since may when physician offices began to open the <unk> has been effective in matching abbvie share of voice with these customer cut.
Customers and with far fewer sales representatives less than 60% of our competitors' field force.
And one share of promotional activity is critical critical to success, but impact as a result of engaging the right customers. The right number of times with the right message.
In a challenging year for physician access our sales specialists partners with over 27000 prescribers.
Experience of <unk> ODT with over 450000 prescriptions to date.
We are slowly, but surely closing the gap and total prescribers per our competitors two months non COVID-19 has started launch.
You'll also notice the <unk> prescribers are more productive writing more <unk> per doctor and do you grow the prescribers.
We do to fully execute against the similar strategy with our DTC investments is our highly targeted and efficient media plan has yielded beating competitive share of voice, while spending close to half of the budget of our competitor.
With continuous monitoring of closed loop consumer engagement and feedback, we refine and optimize the evolving engagement platforms to activate and enroll patients.
And perhaps the most compelling metric is that of the voice of people with migraine.
With greater brand exposure and trial since launch we've witnessed a growing variance in patient satisfaction between <unk> and <unk>.
The substantive trend not dissimilar from neurologists growing preference over time is a compelling reason to believe the <unk> will achieve market leadership in this rapidly evolving growth market.
Trying to eventually on Ctrip Tan as the standard of care for the acute therapy of migraine.
Our collective passion and commitment are rooted in our patients in.
In the very real unmet need.
Plus social mentions <unk> ODT received per week and the powerful testimonial shared never get all.
We're also blown away that approximately 80% of Murtech social mentions are categorized as a positive emotional response and where else does that happen on line.
So what's next.
Vlad mentioned upfront the wary, we anticipate an FDA decision on approval of our preventative indication by the end of Q2.
And now filed our dual therapy regulatory package in Europe.
As part of our eye for the globalization of our <unk> antagonist franchise as such we're preparing to transform the treatment of migraine, where the first in class paradigm shifting solution that addresses the patient's needs across the migraine continue with a single pill and seen dose proven safe and effective.
For both acute and preventive migraine therapy.
So in closing we remain enthusiastic about the short and long term opportunity for <unk> ODT in this rapidly expanding oral CERP market.
We're hopeful that as COVID-19 infection rates hospitalization and deaths continue to decrease physician access will return and stabilize in the summer months significantly improving patient access to innovative medicines. If we can put up numbers like we did in the fourth quarter in the midst of the pandemic imagine what we can.
Do an unconstrained environment in.
In the meantime, we remain committed to invest in novel partnerships with our customers to identify innovative solutions to satisfy their patients moving in.
With that I'd like to pass the mic on.
For my partner for the stock.
Thank you BJ.
Again this quarter I'm happy to highlight the significant advances made across our research and development organization to bring multiple novel therapies to patients.
We continue to make impressive progress across our programs, including our <unk> franchise, our growing myeloperoxidase inhibitor platform, including the modulating agents and continued work on other novel targets that will one day bring treatments to show many who suffer from debilitating neurologic disorders.
<unk>.
We're delighted to have been able to further expand our <unk> platform in 2020.
No Jack ODT remains our cornerstone marketed product indicated for the acute treatment of migraine with the prevention indication being evaluated by the FDA.
Was that Japan is following closely behind with the intranasal formulation in the clinic.
For all formulation about to go into clinical studies.
We've expanded this portfolio with additional new next generation <unk> antagonist of molecules brought in by our collaboration with Justin you had Paris.
This morning I'll be.
Highlighting some of the most important progress to date.
Yes.
Our portfolio of yellow of small molecule <unk>.
Towards the us great flexibility and has the potential for multiple blockbusters.
The impressive commercial success of nurse, Jackie United States has been touched upon by both flat and B J.
The R&D team completed our NDA filing of <unk> ODT for the prevention of migraine and recently completed a regulatory filing for dual acting indication in Europe.
The simplicity of using one medicinal product to treat migraine is poised to simplify the treatment paradigm and improve the lives of many living with migraine.
We've been actively engaged in a disciplined approach to the lifecycle management to expand further on your tech indications and bring this important drug to other regions as the world.
Lifecycle expansion beyond geographic region and the dual acting indication is also of critical importance to bio Haven as it will help define the scope of important information for patients providers and payers.
We expect to study in your tech and several migraine adjacent areas with regard to non migraine indications. We've begun the preliminary study in plaque psoriasis and have a study in asthma planned for this year.
We will continue to advance other previously undisclosed indications. This next year and look to expand our trials across multiple of our <unk> antagonists.
As soon as the Pant program include both the intranasal.
And the oral formulations on it.
<unk> treatment phase III study with intranasal da Vinci Pantheon in October of last year and follows a positive phase III study.
Does that Japan has the potential for an even more rapid onset of effect.
Oral formulation has been developed and will be poised to be weighted in the phase III study to start in the first half of this year.
We also plan to studies of the Japan, and a variety of Mike migraine and non migraine areas, what's your yet undisclosed.
Newest in our portfolio of seizure ERP antagonist small molecules are those assets brought in by our recent Li announced collaboration with association of tariffs.
These new molecules for many more possibilities for us to expand on <unk> platform and of Florida, the ability to customize the unique attributes of each of the structurally unique compounds.
We have deep experience in the mechanism of action and now have multiple assets to optimize.
Optimized for different indications.
<unk> represents an important pathway in the nexus between the immune and central nervous system. As you can see we're quite busy with the <unk> franchise.
We'll follow the science into multiple non grain of indications for this franchise over the next year and years to come.
Hi, Lievens pipeline has both low risk opportunities in the lifecycle management of our <unk> platform.
And higher risk high reward investments and our glutamate on Myeloperoxidase inhibitor platforms.
Including the modulating platform is just one of those high risk high reward areas.
So it really is our recently completed enrollment in a phase III study and Spinocerebellar ataxia and will read out top line results between the fourth quarter of 2021, and the first quarter on the next year.
The phase III program in OCD started at the end of last year with enrollment in the first of two planned studies on the second study began earlier this quarter.
As previously mentioned flow.
Studies are based on critical signaling that emerged from earlier proof of concept OCD studies, we conducted.
<unk> is the most of the backend excitatory transmitter in the brain and we believe true really itself and will provide important advances in the field across many of these areas, which means and the expansion.
With regard to our NPL platform.
And Myeloperoxidase inhibitor trial in multiple system atrophy of rare and rapidly progressing disease with FDA fast track designation will readout top line data at the end of this year.
On the mass General Healy study that is testing the agent in AOS is also on selling unexpected to readout by years end.
Finally, the efforts across our glutamate and Myeloperoxidase platforms allows us to target three rare and devastating diseases.
Multiple system atrophy, amyotrophic lateral sclerosis, and Spinocerebellar ataxia.
We anticipate Q phase III readouts by the end of this year and the potential for three global orphan drug approvals by 2023.
So really the earlier this year, we acquired the series of novel assets informed bio Hayden labs to advance our translational discovery platform.
Our early pipeline is extremely robust and now includes antibody recruiter molecules.
Multimodal antibody therapy, Enhancers also known as mace and the molecular day craters of extra cellular for gene.
How'd, you greater platform harnesses, the body's own machinery to eliminate certain circulating protein pathogens that are implicated in a variety of diseases.
We plan on advancing two of our lead assets from Bio Haven labs.
Later this year.
I'll highlight just one of the numerous near to clinic opportunities, we have in bio Haven labs.
Our COVID-19 program is an exciting program that was accelerated in the development with funding from Bill and Melinda Gates Foundation the.
The main technology uses of peptide the covalently bind to <unk> and targets. The COVID-19, spike protein to do three things one neutralize the virus.
To induce immune cell mediated viral clearance and three provide long term vaccination effect.
Our preclinical studies have already demonstrated that in vitro.
<unk> is able to find the viral material.
The two antibody induced cellular clearance of viral material similar to call the lessons Sierra and <unk>.
Has the ability to produce viral inhibition.
And we look forward to progressing this program in detail.
You are going to hear a lot about these next generation bi specific platforms in the coming years, and we expect our early pipeline to bring us exciting compounds in numerous areas for future years.
We're excited by the immense opportunity across these platforms and we will continue to make strategic decisions across the portfolio with the external partnerships and internal programs.
Our pipeline is really exciting and we continue to drive these robust platforms and programs for worse, we're very busy and we remain committed to follow the science and to keeping the patient at the center of all we do.
It is really a pleasure to be able to share all of this with you.
And I'll now turn the call back to the last thank you.
Thank you Elyse, BJ and Jen and clothing bio haven't has demonstrated robust growth in terms of the commercialization of <unk> and important maturation of our late stage neuro innovation pipeline. We expect continued market expansion of <unk> in migraine and an anticipated at least for a pivotal trial readouts over the next year.
Of the potential for multiple NDA is over the next couple of years and important growth as the company ahead before opening up to Q&A I'd like to end by thanking the entire <unk> team for the relentless commitment and value creation for patients and investors I'd also like to thank all of the patients. They are 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 for patients suffering from diseases for.
Finally, thank you to our visionary of investors, who have helped fund our studies and bringing their attack the patients we now like to open it up to questions operator.
Thank you we will now be conducting a question and answer session.
If you'd like to ask a question. Please press star one from your telephone keypad and the confirmation tone will indicate your line is on the question queue you.
You May press star two of it relates to move of your question from the queue for.
Participants using speaker equipment may be necessary to pick up the handset before pressing the star keys.
One moment. Please so the poll for questions.
Thank you on our first question is from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Okay. Thank you for taking my question Vlad and team congratulations on a very good year execution.
I had a quick question regarding the current.
Situation with Barrick Tech in terms of persistence on slide 25 of the share some data on.
On patient satisfaction, and I guess I'm wondering if.
If you can provide any color on the current persistent C that you see in terms of patients and perhaps provide a little bit more information on what that slide tells us.
Yes, Thanks, Charles I. Appreciate the question you know if you recall back to that.
Open label one.
We did an 800 patients that looked at frequency of use and it is exactly what we expect the that was a very large study and it basically showed that their use of neurotechnology the <unk>.
<unk> of my range, you had per month up to a certain point that if we had more than 14 you didn't need.
<unk> more than every other day and that was the Genesis of our prevention strategy as well as our apacs rates that we know that <unk> will cover the vast majority of patients acute needs and that's exactly what we're seeing in our refill rates reflect that so if you have for migraines per month you typically.
Need for both on in APAC last year more than a month. If you have the eight you typically need eight and thats the month supply and so without getting into the particulars because we don't disclose the exact the refill rate is right in line with what we thought Charles.
Okay. That's helpful on them regarding the SMB for prevention and recent filing to the EMEA I guess I'm wondering is there any color you can provide on the interactions with the agency regarding that S NDA or any new observations or trigger points that.
Cause you to file the EMEA for the dual dual filing on our two of us recently.
Yes, what I can say is just like we were in a similar spot.
Last year with their acute where do the same kind of spot and prevention. We're past our mid cycle review and have not received any comments.
The comments past mid cycle, so we'll take that as a very encouraging sign.
And the U S package really for them the whole basis of the European dual acting in Europe, We wanted of new special indication and we are waiting for the prevention data in the U S filing to be complete.
And then submitted that in Europe, where we think the dual acting thats going to be very important of differentiation. So right off the bat there we'd like to come out with the first dual acting in Europe.
And by then hopefully we will have that indication in the U S as well.
Okay very good final cut.
Thank you. Thanks, Thanks for the chase it right.
The next question is from the line of Paul Choi with Goldman Sachs. Please proceed with your questions.
Hi, Thank you good morning, everyone on let me also off for my congratulations not all beyond the quarter back on.
<unk> 2020 as well.
I wanted to maybe start with one commercial question and just can you maybe just comment on recent trends on what the sales force is hearing on the appeals are out of it.
The field is the reopening of increasing the level of engagements for.
Or is the.
Originations.
The co pay is still off.
Deductible spill.
Sort of normal frontier.
Yeah, Thanks, Brian I'm going to turn it over to Vijay to answer that question yes.
Yes, Paul Thank you for the question and answer the good one obviously, we know there's been kind of this impact from what was the Covid surge there the general Q on seasonality, but at this point because of the decline frankly in numbers offices are opening up on <unk>.
<unk> are starting to see certainly more patients and we're actually very bullish about that is the hope obviously is the accelerated.
That's what we're pushing to see but what we like the trend. We're seeing currently and don't expect to really see anything go sideways in the coming weeks, yes, I just wanted to add to that that when you look at last year's performance, which really was remarkable for any launch here that was done in this very difficult environment and so.
The team has demonstrated that we can launch and do well on the most difficult environments. BJ said, we're seeing things finally start to open up with rates decreasing with Covid and we think that's going to only increase our our outlook. When we were back in early fall I think we actually expected even the higher.
The net revenues by fourth quarter, but we really the country got hit hard by a surge in Covid late fall early winter and that did decrease access to.
<unk>, obviously is despite the fact, we did very well we think we would have done better if it wasn't for COVID-19.
Now as we are loosing up from Covid, we're seeing the increase in access again. So I think those are all really exciting and optimistic signs that we should continue to do well as COVID-19 related.
Okay great.
Income from color and then as my follow up I wanted to ask a regulatory question on the MAA filing.
Specifically with how you guys are thinking about sort of bookend of the stop and start and just what sort of the review cycle of life might be with the EMA and then.
If they have questions on one of the indications one of the U S indications vs versus the other.
Does that cause I put the other one at risk.
Potentially even if it's clean.
Yes, great question for you I appreciate it so we had previous discussions with EMA before submission. So we had added ability to assess the dual acting in.
The indication and that's where we landed on so we're confident that that package is independent of the U S. If I understand your question correctly, so they'll view at our current debt of regulatory guidance on our interactions with them independent of what happens in the U S.
And timelines, we're not going to go into specifics, obviously for competitive nature to others, knowing exactly when we might launch in Europe I think today, we disclosed for the first time that we have been through the validation process are finally, it's been accepted.
We can't give specific guidance on approval dates just yet the thanks.
Okay.
Thank you Paul.
Thank you for the next question is from the line of Tyler Van Buren with Piper Sandler. Please proceed with your questions.
Hey, guys. Good morning, congratulations on all of the progress just wanted to ask about a couple of topics. The first one is just a follow up on Jim's comments with respect to patient deductibles and prescription reauthorization in Q1, which could potentially affect the gross to net quarter over quarter is that the pretty.
Pretty standard impacts that you see with other drugs or is there anything specific to <unk>, maybe perhaps with respect to the reauthorization and then the the second topic is on once prevention becomes available hopefully with an approval here relatively soon how does the sales message change.
Does winning contracts become that much easier now that you guys sort of approved for two indications relative to you broadly.
Thanks, Tyler and I'm going to turn it over to Jim for the first part of the question then I'll handle the second Tim.
Yes, good morning, Tyler and thanks for the question so.
As it relates to the.
The gross to net in the.
First quarter. So as we said it's it really is just the nature of it.
All of our of our business and these are.
Like deductibles patient deductibles.
Prior authorizations is really a reset when you start out the new year deductibles start over and the prior offs have to be have to be collected again, and thats really whats driving that.
The impact this quarter and for.
Tyler you know on them.
The messaging around the dual acting in prevention I think you saw the first glimpse of that in some of the slides today look at we're trying to be disruptive here and we have for years with this strategy and having this in mind, we don't want to talk about acute and prevention of post prevention approval, we want to talk about the finally, the treatment of migraine period right.
That's what the disruptive that's what that's where nobody else has on their strategy and even if others pivot to that strategy, which I think in future years theyre going to try to do that we're going to have a significant lead in that area and Tyler look you've written about your own migraine in your own experience with.
And I think he'll from of payment perspective, the simplicity of one pill that can treat your migraine that you can be in control of the frequency of use do you need it for acute therapy. If you have of infrequent migraine you'd only needed a couple of times of few times a month. If you have very frequent migraine than you just increase the frequency, but as you think about.
The simplicity for patients and the empowerment of one drug that does both in the significant payer advantages there too you're not paying for multiple.
Drugs, and that's going to be our focus.
With regard.
To the payer and the managed markets landscape. We do think there is an advantage to already being approved in acute and.
Look at we showed that in the slide with the Mab as rate more effective acute treatment. We believe decreases quantification of migraine. So we think an important part of an approval on prevention.
It's making sure of people first appropriate treat the acute episodes and only those who really need it more frequently.
It should be using it in the every other day paradigm. So we're excited about disrupting the current status quo.
Both on how you think of the treatment of migraine across the spectrum, but also how do we make this first line therapy and it should be when you talk the patients listen to their experience on trip and listen to their experience on <unk>. It's night and day of these patients don't talk about there being a slight difference the.
Social media Communications, we receive every single week now these talk about changes in patient lives not subtle differences. This is a paradigm shift and I think people are finally, realizing thanks Tyler.
Our next question comes from the line of Laura Chico with Wedbush. Please proceed with your questions.
Good morning, and thank you for taking the question.
We have one question, we keep getting is with respect to the <unk> trends and just out of curiosity could you talk a little bit about perhaps your current sampling efforts and I know you've mentioned a couple of.
The broader dynamics that could be potentially impacting gross to net in the first quarter, but kind of curious how you might have been shifted you're shifting your strategy in recent weeks and then a second clarification question just on the term loan with sixth Street.
You mentioned the revenue provision was dropped any additional color you can provide there I think you mentioned the for acute trends, but curious if there was anything about the first quarter, that's being observed that contributed there. Thanks.
Thanks, So much Laura just on that second piece right off the bat due to the strong fourth quarter performance Sixth Street believe we were already on our trajectory to hit the revenue requirement and so it was a pretty straightforward of discussion to get removed and so we'd like to thank <unk> for being proactive in working with us.
To remove that so.
That was accomplished pretty easily Jim do you want to add anything to the.
I think you summed it up.
They saw it as we did in Derisking the.
The situation and we move forward with them on the yeah. So look at the the first quarter as we.
Kind of told folks previously you look you can expect some turbulence around these GTS, but overall, you're going to see improvement over time, right and first quarter is no stranger to headwinds.
Headwinds of every single launch in every single company talks about this right. The first quarter projections are always.
Take a little bit of a hit because of the need to start the calendar year over with new deductibles, new prior offs and there are programs that we institute to make sure of access continues despite those headwinds and then that typically lets up the rest of the year. There is nothing more than the normal dynamic around that that we expect for the share BJ.
Anything else out.
No. The other thing I'd say just the support that is the sampling strategy is the same we continue to make samples available to our of our primary customers and we also see a bit right, especially in the last couple of weeks a bit of the hit to overall prescriptions not just.
Within our own area, but across the industry as a whole because of the holiday and severe weather right Theres just an impact there.
We expect that the bounce back frankly is coming in and so that's a good point that whether it's COVID-19 or of severe weather in Texas closing that big markets.
Access will always impact.
On your Rx is in and we see that across therapeutic.
Areas.
I think looking forward to the coming weeks and quarters.
As those things for lens, we should see a nice.
Spike up.
In scripts so thanks Laura.
Our next question comes from the line of Marc Goodman with SBB Leerink. Please proceed with your questions.
Jim I know you don't want to give the spending guidance, but can you just give us a sense of.
How we should be thinking about spending this year just any comments you can make and then flat line.
Lifecycle extension indications for nerve check I was curious if you could help us understand a few of these and how big they are like the like pediatrics, which I would think would be pretty interesting just given there's no pediatric with triptans at least I don't think there is.
But also a couple of of the others just help size them and how fast do these ramp up and are we seeing off label on them now or or are they really that much.
Additive. Thank you thanks.
Thanks, Mark Tim Yeah. Thanks, Mark Yeah, so as it relates to spending Youre right as we don't give guidance I can't I can't go into any type of detail here, but I think as we've said before our commercial organization that we have in place.
Is fully staffed and as far as our overall commercial spending we will continue to invest in the brand as we move through 2021, you've seen the success that we've had and the success of the program that we've been running so we will continue to invest but we can't go into details on.
On the level.
And Mark yes.
Really excited about the lifecycle management of <unk> and we have an amazing team here at the bio Haven, that's done this with other large brands in.
What's really important in this life cycle management as you have some very low risk ventures that should quickly lead to SMB as an approval of an expansion and then some higher risks, which gives you even further upside.
And that's important as an organization because as you know that most analysts and investors have focused just on the acute in the U S that you know that.
On a total of four to 5 billion in projected sales just on the acute does not even layer in these other indications right and so you can vary substantially.
Increase your upside revenue by just expanding your label and in a very disciplined way. We've started with the low risk ventures that are kind of migraine related and then go into some non migraine indications that provide even more significant upside some might say it could be even bigger upside the migraine itself right and none of that's been.
<unk> factored in I think our valuation.
So prevention is one aspect of lifecycle management and unifying the treatment of migraine.
<unk> already begun and well underway and enrollment is the PGM pediatric effort, we get called by so many individuals in the pediatric age range of one access and as you pointed out there of the Triptans haven't been successful in this area and the side effects and the profile for adolescence sewer school age really <unk>.
Ported that they're not burdened by that so that's another major priority and a very important lifecycle expansion for patient need but also future.
And then just an idea of some of the the pain related disorders, I mean things like post traumatic headache, and when you think of a mild concussions in this country and the number of individuals who suffer headache in the ensuing weeks and time period that will be of very large and important indication to pursue theres other pain.
Disorders, including things like T J pain.
Theres cluster headache discharge of eminent around yet there is a whole host of them in <unk>.
Many of them have either begun are about to begin and we think will substantially increase the upside of <unk> and then outside of.
The migraine following the science of Cgmp very robust science about this mechanism.
On the crosses over into the non migraine indications, where the immune system and the nervous system interact with one another in psoriasis as one example of that and I think everyone. On this mine is familiar with how large of an indication that could represent and we've already started our proof of concept with the leading psoriasis researchers for now.
And the study is on.
Underway.
This year, we're looking at in the study in.
Asthma and other large market indication and there is others that we're not going to disclose I think were comfortable disclosing those two because we're well underway in their initial studies and.
And so we already have a competitive lead there and being in those indications, but there are several others that I think likewise people will be happy with the size of the market. So when you look at that lifecycle management, we're gonna delivers of BJ and team can call on all of these other indications and really grow the size of this market. So thanks Mark.
Our next question is from the line of the amount of on with Mizuho. Please proceed with your questions.
Yes. Thanks, so much for taking the questions following up on a couple of those.
The one question for again is just around the prevention approval here in the.
The U S. I mean is there any sort of off label use of you sense from that or I guess, maybe on the other.
On a sign of the potential approval do you see of big sort of catalyst the prescription trends based on that approval or is it something that's kind of take a little bit more time to kind of really come through in the prescription data and then on the spending side and Jim I. Appreciate you can't get into too much detail I'm, just trying to maybe better understand just how this past year wind because of Covid.
And not having as much of the in person interactions.
Was there a lot of the you sort of stayed.
In 2020 that we should not assume you're going to be spending as you go into more of in person sort of activities. In 2021. When did you pretty much spend where you thought you would have spent so you've kind of already on the normal sort of.
We should forecast going forward.
Thanks, so much.
Really appreciate the questions.
So on the.
Prevention front I think.
Positions they are appropriately conservative, saying that look at many of them are saying that they're waiting for the formal indication we don't see a lot of off label use.
And any off label use we think is pretty minimal at this point.
From the slides of the Triptans.
This is a huge common disease market in the acute youre just seeing the very beginning of the acute story here and no. We don't think there's much in prevention right now so upon approval. There's two dynamics that I think as we get rid of these two cash.
We'd like to see acute grow in prevention, because people with more effective acute treatments should have less need for preventative agents in the knows who need to increase the frequency or those that we already know has such a high frequency. They need of every other day, obviously in the label, we'll be able to compete for those patients. So we think there'll be two fold increase post.
The prevention one in acute.
Market share and then one in going head to head for the prevention of patient.
Patients so really excited about that that approval, that's coming up and Jim I'll, let you comment on the second half, yes sure yes, the way I would answer that is.
Yes.
For the Covid impact did not result in us cutting back on the program spending it's just really a reallocation of programs.
We didn't have the in person as we had hoped but we reinvested those funds and other programs that gave us gave us visibility of excess thanks, alright take care.
The next question is from the line of Tim Lugo with William Blair. Please proceed with your questions.
Thanks for the question you mentioned the potential European partner for <unk>, and obviously with your filing on players. It seems like you would want to sign one this year is that of Gulf of the team what is the ideal partner look like and is there a chance you do launch in the region yourself.
Yeah no. Thanks, so look the reason ourselves.
Other than areas, where we of distributors that can easily do that it would be more ideal type of partner, we don't want to have the increased infrastructure spend globally. We think it's better suited in the efficiency of that with the right partner.
We can't disclose too much about that other than the two sets of partners that we have seen one is strong people in a particular region and others are global multinationals that you would have one partner with look we have to do what's best for our investors there and so we will appropriately assess.
Those two types of partnerships.
Partnerships, obviously for efficiencies, having one global partner.
We'd have some advantages, but there are some regional partners that are very strong in Europe and other areas. So we will balance those two things Tim I appreciate it.
Our next question comes from the line of cement Kulkarni with Canaccord. Please proceed with your questions.
Thanks for taking my questions on nice to see all of the progress of the company I have a couple of questions first as the company prepares to blur the lines between prevention of acute treatment of migraine, how should we think about the potential of the sales for prescription metric the stabilized at what point the discretionary contribution to the gross to net difference, Mike Colby and second conceptually what does the company.
Thinking about the potential to use <unk> antibody treatment strategies have applications in setting monoclonal antibodies across the blood brain barrier than the more efficiently I'm asking this because of what the opportunity then valuation potentially might get unlocked, especially relative to the neuro degenerative diseases.
Thanks, so much.
Really appreciate the beta if you want to.
Jim I don't know if either one of our.
So I'll start.
So we're again, we're very excited as it relates to the opportunity with what will be the preventive indication and this dual strategy that we talked about and.
Ill start with generally kind of of coverage perspective, and then maybe Jim can speak to the gross to net side, but.
We're confident that that dual therapy strategy will facilitate the broad access for patients.
With the indication and we expect to continue to maintain what is the excellent coverage that we secured for acute.
And our strategy will make sure that we're aligned from a gross to net is kind of.
The goal standpoint, if you will the message is proprietary at this time, but.
But we will certainly execute against that and I think on <unk>, we expect them to improve throughout the year. We are not going to provide additional granularity of that bio Haven labs extremely excited about this platform and <unk>, it's not just about getting it into the brain and yes. There are certain ways. You can do that we're also the signifies our appetite for other.
The indications that are not CNS based and so theres a number of ways you can buy an engineer of antibodies across therapeutic indications to optimize them. So when you think of Biosimilars think of this as a buyer of superior approach you could take existing antibodies bioengineer them make them better right.
The remaining more efficacious or less of the side effects and then the greater technology.
The timing of an extra cellular protein, that's causing disease as technology in the very unique way gets your body to use delivered to the grade those proteins and there are a number of the greater technologies out there that are interest cellular this is an extra seller that could be complementary. So thank you and I think we have one last question and then we will have the end.
Hey, instead of the next last question is coming from Douglas Tsao with H C. Wainwright.
Hi, good morning, Thanks for taking the questions and I appreciate you sneaking me in.
Just flat on the C. G. R. P program obviously.
You know you have a lot of sort of lifecycle management for our programs in development I'm. Just curious in terms of the profile of that Youre looking to get with the oral formulation.
The formulation of the badge of patch do you think that could be faster than the intranasal or what would sort of be the targeted for that and then also with the hectares program I'm. Just curious if you could provide us any color in terms of what youre looking to do with with that program as well just obviously a lot of you know it's of great.
Secret piece of great target that you're kind of lot of sort of irons on the fire.
Thanks, a lot of it I really appreciate the question. So the whole CGP franchise represents multiple assets with different PK profiles that could suit these different disorders. So the <unk>.
The Japan will be important for a lot of the non migraine indications because there where you're not treating it like when you think about acute migraine speed of onset is important but you'd want a different perhaps profile for.
Sure.
Other indications so think of asthma, that's more of a chronically treated where even psoriasis rates of your profile would be different and so there. It would allow us to have a separate <unk> for those indications of optimized for those versus people of migraine. We're gonna want the ODT. The quick onset the durability of those aspects and so that edge of advantages gives.
US maximum flexibility and then the hectares.
Assets that we brought in and partner with of terrorists on look we know this mechanism really well and there are certain indications that we haven't disclosed yet we're gonna want alternate formulations and the <unk> molecule is unique and has some attributes that the that Japan and Nortek don't have so without disclosing those this morning.
Of our eyes set on some other indications for that compound and what youre going to see is following the science across all of these different disorders and we're one of the few companies that has so many of these late stage CGP assets that we could use different ones for different organization of different indications and optimize its use there. So thank you Doug.
Thank you everyone for joining us today, we deeply appreciate the support of our employees and investors as we move forward to deliver life changing therapies to patients and I can't wait to speak to you soon on the next quarterly report of a good day everyone.
This concludes today's conference. Thank you for your participation.