Q4 2020 Albireo Pharma Inc Earnings Call
Good morning, and welcome to the envelope.
Farmers fourth quarter and year end 2020 financial results and business update presentation.
At this time all participants are in a listen only mode. A Q&A session will follow the formal presentation. If anyone should require operator assistance during the call. Please press star zero on your telephone keypad.
Please note that this conference is being recorded on.
Now I'll turn the call over to your host Paul Arndt, managing director of lifestyle and advisors. Thank you you may begin.
Thank you operator, and good morning, everyone. Thank you for joining today's call.
This morning, Albarino issued a press release, highlighting its recent business accomplishments and reporting its financial results for the fourth quarter and year ended December 31, 2020. This press release is accessible via the company's website at Www Dot Albarino pharma Dot com.
Before proceeding we would like to note that managements comments today may include forward looking statements regarding the company's plans and expectations.
These statements are being made under the private Securities Litigation Reform Act of 1995, and they are subject to various risks.
And uncertainties.
Actual results may differ materially due to various important factors, including those described and the risk factors section of the company's most recent form 10-K and its subsequent SEC filings. These filings can be accessed from the media and Investor Relations section of the company's website at Albarino pharma dot com or on the SEC's.
Website.
Any forward looking statements represent managements views as of today Thursday February 'twenty, five 'twenty 'twenty, one and should not be relied upon as representing their views as of any subsequent dates.
The company undertakes no obligation to update these public. These statements publicly now it is my pleasure to turn the call over to Ron Cooper, <unk>, President and Chief Executive Officer Ron.
Right.
Thank you Paul and thank you everyone for joining us this morning for Alba Rail's Q4, and year end 2020 results and business update.
With me today are Simon Harford, our Chief Financial Officer, Dr. Pat Horn, our Chief Medical Officer, and Pamela Stephenson and our Chief commercial officer.
And I'd like to begin today by giving you a short review of 'twenty and 'twenty, and then moving into 'twenty and 'twenty one.
2020 was a transformational year, where we delivered against all our stated milestones and commitments is flat.
And we're looking at another transformational year in 2021, where we plan to deliver against guidance, starting with becoming a fully commercialized organization with the planned launch the voter VIX about expansion beyond <unk> into other rare pediatric conditions and progressing our pipeline and adult cholestasis and viral.
Diseases.
Starting with 2020.
Story was overcoming unprecedented challenges Albert rail like many other companies worked under new conditions with the global COVID-19, pandemic, new constraints with remote working and unforeseen challenges conducting clinical trials and manufacturing around the world and are fully virtu.
And will matter.
Despite these headwinds our team persevered and overcame the challenges and ultimately delivered on a very successful 'twenty and 'twenty measured by our progress with a mix of both our pipeline and advancing the growth of the company.
First with all the victory, but we are committed to delivering the perfect. One phase III study results in Piecyk not only did we deliver those results, but they were strong hitting both primary endpoints with triple digit P values and a solid tolerability profile with low diarrhea rate.
<unk>.
On the back of that great data on our team worked in record time to submit for regulatory approvals and we're pleased to announce that both regulatory filings were accepted in the U S and Europe with the FDA granted priority review and the EMA and granting accelerated review.
It is estimated there are approximately 100000 patients with pediatric cholestasis liver disease around the world.
And we've always said or the VIX and bad as a pipeline and a product with a first indication and <unk> the analogy I'll syndrome and biliary atresia.
Knowing the potential or the Vicksburg could have and these three indications we decided to start on our first phase III study in <unk> do you know the nature of the disease.
We believe to be easier to validate the dose tolerability and our precision pruritus measurement tool, which we did and the results validated our decision.
We have the insights and great confidence from the pet Big one and two studies and.
And we're able to design and initiate two additional phase III studies and Cola static liver disease.
With the positive learnings from the <unk> program, we've increased our confidence and a positive outcome for our allergy L and biliary atresia programs.
We committed to starting in Belgrade, and treat the study and the first part of the year and we initiated the bold study, which is the world's first and largest prospective randomized placebo controlled study with and I bet inhibitor.
Julia trees, and its a largest pediatric <unk> liver disease with an estimated prevalence of approximately.
And 45000 patients around the world.
We also committed and starting a third pivotal program and I'll, let Jill syndrome and started the search for all and the fourth quarter of last year, fulfilling our development commitments and guidance for or the VIX about.
Now looking at our pipeline expansion activities, we completed IND, enabling studies with our novel ASB T inhibitor.
And three 907 for adult liver diseases, and we made progress with our first and T. C. P inhibitor 82342 for viral and cold static diseases.
Our company matured and many different ways in 'twenty and 'twenty from a financial perspective, we made excellent progress generating over $200 million of both equity and non dilutive capital.
Which will take us into 2023 and into the revenue generating period at the company.
In parallel the organization double its size and we built new capabilities and a lean infrastructure to drive successful commercialization.
Recent hires include our president of the Americas, and President of International both of whom are focus on hiring specialized teams as part of our launch readiness plans as well as driving our sales and market access strategies and execution and their respective regions.
We put medical and access personal on the ground and they've been actively engaging with health care professionals and payers to gain valuable feedback.
As we reflect on 2020 and the unprecedented challenges we were also fortunate to deliver on unprecedented success.
So now looking ahead in 2021, we're very clear on our goals and expectations for the year as we drive order VIX by product growth to over $1 billion plan for the second half of the decade.
First we're planning for road and VIX about to be proved and the U S and Europe with the issuance of a priority review voucher and deliberate commercial sales second we expect further progress in our pipeline with our pivotal phase III studies with the bolt study in biliary atresia and the search study and I'll, let Jill syndrome bolt should.
Be well on their way from an enrollment perspective, and third we plan to characterize our pipeline further.
Starting with OTA VIX about with priority review and up and <unk> date of July 20th and the U S and accelerated assessment and Europe, we engage and a good dialogue with regulatory authorities and Dubai and testing and approval and launch and the second half of the year.
And preparation, we're gearing up all critical launch activities and steps to ensure we have product to sell.
We've executed on the manufacturing plant and we agreed with the FDA and the fall of 2018 and.
And we feel confident about the commercial product having used the planned commercial formulation in the pet Big Phase III studies, we're also focusing on the supply chain, we've established agreements with three pls and specialty pharmacies, while also building albarino assist which is a customized in house.
Patient services program with dedicated care coordinators to help patients navigate their access to all the VIX about from the start and be with them as they grow.
And with confidence and regulatory outcomes and drug supply and place. Our next priority is access.
Regulatory approvals are important around the world, but having a compelling value story is equally important to ensure patients can access the drug.
Payers are looking for strong data and a good rationale.
The pet study produced strong positive results from the largest randomized placebo controlled phase III study and piece of it.
This provides us compelling class one evidence.
But you also need a full access strategy.
As part of the integrated access strategy, we have the natural history data from the Knapp and study, which shows that a reduction of bile acids to 65 to 100, depending on the P. P type by biliary diversion results and long term need of survival.
Unfortunately, not all patients benefit from bill rate diversion surgery, and will require liver transplantation for work factory pruritus or end stage disease.
We believe on the VIX about will be a much better option.
In addition, we initiated a burden of disease study to understand the cost and caregiver burden associated with <unk>.
And importantly, humanistic data that measures the burden on caregivers and families.
So overall, we feel really good at this time, both the comprehensive submission package that we've compiled to support the valuable to VIX about and ensure patient access globally.
The next priority is commercialization and we are prepared.
With our regional heads and the U S and Europe and place their focus on hiring a highly specialized sales team to call on health care providers.
In the U S. Our focus has been a fast start at launch so.
To deliver on that we're pleased that we have entered into a new co promotion agreement with Premier Therapeutics.
<unk> is a leading rare disease company and marketer of cobalt and capsules, which are used by pediatric herpetologist.
So why is this important for our commercial strategy.
The trivia representatives are highly experienced and have a long standing relationships with our key HCP prescribers, so they'll be able to help us accelerate our launch and uptake and the U S with.
And with the career sales representatives and our own 10 representatives will more than double our reach and frequency coverage on day, one of launch to give us a fast start.
Severe will also provide us with valuable insights and their sales representatives have been calling on pediatric hepatology and the related specialist for more than five years and they are the main call point for OTO VIX about.
The co promotion agreement is set for two years with Optionality for extending the relationship Alfredo and book all revenue and pay per view of certain fees to compensate and sales representatives for their efforts and selling older thinks about.
We believe this relationship with trivia and will ensure potential prescribers are aware of it would've Vicksburg and understand how to drive it for appropriate patients as quick as possible upon FDA approval.
Which will result in a faster start at lunch.
We're also planning on commercializing on our books about another places around the world and our recent commercial day, we revealed the opportunity for one and VIX about is larger than our initial estimates with a 100000 pediatric liver disease patients around the world and excluding India and China that could benefit from this therapy.
Look at the data from other rare disease therapies, many of demonstrating the significant opportunity worldwide with more than half of the brand's revenue for each of these coming outside of the U S. Just two years after launch.
What this means as we anticipate a larger patient population for OTO VIX about.
Our aspiration is to reach $1 billion of sales from other banks that within the second part of this decade through U S and international sales.
With this in mind, we entered into our first commercial distributor partnership road and VIX out with Medicine pharma and Israel. This is the first of multiple planned ex U S commercial distributorships and with a focus on countries with high prevalence rates equaling significant commercial opportunities.
So overall it will be a big year for OTA VIX about it from an approval reimbursement commercialization partnership perspective and.
And we are ready to go.
Moving on from our key development programs and Bowl.
First largest and the only global randomized placebo controlled phase III trial of them and I bet inhibitor and biliary Atresia has 42 sites activated and global enrollment continues to be on track, we anticipate having all the sites up and running and the first half of 2021 with top line data available in 2024.
Third our pivotal randomized placebo control program analogy L syndrome, we expect to have all of the sites active and the first half of 'twenty, one as well with top line data available in 2022.
With three pivotal programs flow to VIX about we're planning a market leading global approach focusing on key regions like the U S. Europe.
But Turkey, Israel and Brazil.
For <unk>, we anticipate being the first approved and first to market and the majority of the regions for Ala Jill syndrome, we expect to be first in Europe, and ex U S countries pending the results of our phase III study and a fast follower with a best in class profile therapy and the U S. We also expect to be first and the market for biliary atresia because.
We have the only phase III study up and running.
The third thing to expect by the end of the year as greater insight into our pipeline beyond pediatric liver disease, we are making tremendous progress on earlier stage compounds and adult <unk> and viral diseases.
We are advancing the development of 80, 397, and our novel <unk> inhibitor and <unk> to $3 42, which is a novel <unk> inhibitor and the unique properties of 18 on especially at a three nine to seven, especially the high systemic availability holds great promise for solving the efficacy high diarrhea challenges observed with the.
I bet inhibitors and at our core static liver diseases, such as PBC and PSC.
For <unk> nine seven and we're planning a first in human phase one study by the end of first quarter with top line data anticipated later this year.
And the initiation of phase III in 2022, we believe 83, nine and seven has significant commercial potential and adult cholesteric diseases.
We're also excited about developing our first and TCP inhibitor eight to $3 42 for viral and colas static diseases.
And T. C. P is a key transporter for bile acids, as well as hepatitis B and D viruses.
<unk> three <unk>. Two also has unique properties as it is an oral potent small molecule that blocks entry into the liver and should have excellent combinability potential.
So it really is a good proof of concept for eight to $3 42, with the peptide compound called <unk>, which is and Mtc P inhibitor approved for hepatitis D and Europe, but.
Given the limitations of a peptide the maximum dose can only be delivered as a daily sub Q injection.
This product was recently purchased by Gilead for over 1 billion euros.
<unk> is currently in IND, enabling studies with a phase one trial anticipated to start in 2022 and phase III and 'twenty three.
Phase two and 'twenty three.
We believe and <unk> could be a valuable treatment for hepatitis B and D and cold static diseases.
Our research team continues to characterize other novel bile acid modulators.
So to conclude.
And we're coming off a tremendous year and we have a great deal of confidence and our ability to deliver in 'twenty 'twenty, one and beyond.
Why.
Well because of our track record and Alba rail starting with our commercial track record.
Not only do we have the building blocks and place, but we have leadership with a demonstrated record of launching.
Pamela leads our commercial organization and spent a decade at Pfizer and the decade with vertex commercializing products and competitive liver and rare disease markets. Simon our CFO has two decades at Lilly and a decade of GSK and I have over 20 years at BMS.
We believe our individual and combined success as a global product launches gives us a market leading commercialization approach and readiness.
Collectively we have dozens and dozens of successful launches under our belt.
Development track record Alberto has successfully read of two phase III programs First Olympics up was the first I bet inhibitor approved anywhere in the world with the approval and chronic constipation together with E pharma our partner in Japan, and then of course, the pet Vic trial results for O to VIX about and P.
Thanks.
Well the VIX about perfect study was the first phase III study ever conducted and pediatric cholestasis, where there was no precedent on endpoints trial design and little natural history.
We successfully enrolled and executed the yard and VIX about phase III <unk> study in <unk>.
This gives us confidence and our chance for similar success with our bold study and biliary atresia and our search study and Alex Youll syndrome.
Pre clinical track record.
<unk> three nine and seven will be the third compound that the preclinical team has progressed and into the clinic. This gives us confidence at eight three and <unk> will also advance as plan and there is potential in our other bile acid modulator approaches, allowing for smart pop pipeline expansion from rare.
Pediatric liver disease, and now to adults and liver diseases.
So overall, we feel very confident of our ability to deliver against our key objectives in 2021, as we plan to launch order VIX about taking us towards our ambition to achieve $1 billion in sales progressing our clinical programs and allergy all in biliary atresia and further characterizing our per.
Thomas and preclinical compounds.
So now with that let me turn it over and assignment to give you a quick financial update and Simon.
Thank you Ross, let me quickly summarize our financial results for Q4 and full year 2020.
Revenues were $8 3 million for the year ended December 31st 2020, compared to $9 6 million for the year ended December 31st 2019 Rev.
Revenues with $2 7 million for the fourth quarter of 2020 compared to $6 4 million and the same period last year.
The decrease in revenue from both the full year and fourth quarter, primarily relates to a sales based milestone achieved in 2019 offset by higher sales based royalties and in 2020 from EA pharma, which as you know are passed on to healthcare royalty partners as part of and agree.
And to monetize the royalty stream.
R&D expenses were $76 8 million for 2020 up from $45 6 million from the same period and 2019 R&D expenses were $20 1 million for the fourth quarter of 2020 compared to $14 2 million for Q4 on.
And last year.
The increases from both the food yet and fourth quarter were mainly the result of headcount and program expenses related to <unk>. So that the main drivers of the increase in expenses for our lead assets were related to the <unk> regulatory submissions as well as clinical trials for biliary atresia and.
And the allergy and will syndrome as we continue to progress on development programs. In addition for the full year R&D expenses increased due to preclinical programs.
General and administrative expenses were $42 4 million for 'twenty, and 'twenty compared to $23 million for the previous yet for.
And for the fourth quarter 2020, G&A expenses were $14 2 million compared to $6 2 million for the same quarter in 2019.
Both the food, yet and fourth quarter. The increases were primarily attributable to head count and expenses related to commercial readiness as discussed during our recent commercial day.
Net loss for the year ended December 31st 2020 was 107 $6 million.
Or a loss of $6 73 per share compared to a net loss of $62 7 million or a loss of $5.04 per share for the year ended December 31st 2019.
For the fourth quarter 2020, the net loss was $24 8 million or a loss of $1 30 per share compared to a net loss of seven and a half million or a loss of 57 per share in the fourth quarter of 2019.
As of December 31st 2020, we had cash and cash equivalents of 251 3 million, which compares to $278 7 million in September.
30th 2020.
Given significant financings during 2020, using both equity and non dilutive capital. We currently anticipate our cash to last into 2023.
Additionally, we are eligible for a priority review voucher, assuming approval and we would plan to monetize it at the appropriate time.
For 2021, we are providing guidance for operating cash burn.
To be in the range of $120 million to $130 million as we advance our development programs and prepare for the anticipated perfect launches of OTA VIX about.
We also anticipate 2021 revenue per <unk> is about to be in the low single digit millions assuming timely approval and.
And then ramping up over time as access is achieved approvals in other countries are gained and new potential indications and launched with that let me turn the call back over to Ron for closing remarks Ron.
Thanks, Simon so to recap we have a number of significant milestones that we expect to drive our growth growth and we feel.
Good about the milestones to come in 2021 and to deliver against guidance. We're confident on our path to 1 billion because of the tremendous global opportunity a robust value proposition and our high level of readiness and our actions to expand beyond <unk> into other diseases.
And the Albury opportunities just not about OTA mix bad and PC in the U S. Rather it's about building on the Vicksburg into a leading global product on the back of multiple indications and geographies and taking a promising new compounds into larger adult patient populations.
We thank everybody for joining us and we're pleased to open the call now for Q&A over to you operator.
Thank you at this time and I'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is and the question queue.
And you May press star two if you'd like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Our first question comes from the line of Yasmin Rahimi with Piper Sandler. Please proceed with your question.
Hi, Tim and thank you so much for taking my questions and me.
You may have stayed on it but if you could remind us again.
What is the number of the how big is the sales team.
They are on them that they have and what is that is there outreach gesture that pediatric herpetologist across regardless of whether their transplant.
Interest earned on so if you could just give a little bit color of the death of sales force and expertise that they have would be helpful. And then I have a follow up question.
Hi, yes.
Pamela here I just answering your question on how big their sales team and they have a team of 12 representatives in the U S who are highly experienced and have long standing relationships with the pediatric herpetologist.
And they also call on on some others.
It related specialties as well, but their primary focus is the pediatric herpetologist. So we're really excited about this and how it will help accelerate R. R.
Launch and uptake at launch.
Thank you and then another question I have is can you provide a little bit color on now and as Terry has begun enrollment how it's progressing and maybe.
And maybe also remind us what percentage of the sidecar here and the U S versus ex U S. Can you give us a little bit more of that granularity and also whether you're planning to turn on more sites across both studies, a third and adult and.
Given the pandemic, so just kind of give us a little bit numbers around the progress that you're making and bulk friendship and be very helpful for us.
Yeah, absolutely as you know look we're absolutely really pleased at where we are with with this surge it's actually going exactly according to plan and so we have our first sites up and up and going we anticipate having all of the sites up and going.
And the first half of this year, we've accounted for the challenges the global pandemic and Thats why we have 35 sites around the world and we'll try and use the the global aspect of this study is an advantage.
To go to places where things open up but.
And as I said at the beginning we're up and going and and we feel pretty good about our guidance for the allergy yellow search study.
And thank you so much and I'll jump back into the queue. Thank.
Thank you guys.
Thank you. Our next question comes from the line of Liana <unk> with Wedbush Securities. Please proceed with your question.
And congratulations on your progress and it was an excellent commercial day I have two questions. So say two years from now and what would be the parameters for you to decide to extend your collaboration with trivia and my second question has to do with a 39 seven.
And the phase one trial and <unk>.
Oh marker data and there what kind of data are we going to see this year.
Alright that Lee and thanks, very much those questions Sam I'll take the first one on the impact and maybe comment on that on a three 907.
Luckily you how do we go on and get ahead of ourselves here right and we're just starting that.
And this partnership together, but I think the thing to talk about this partnership as well.
Time, and Pamela and myself and others. We've been involved in many global launches many global launches right and if we reflect back on those launches. The one thing we might have regretted is not going hard enough at the beginning right.
And so and our experienced and we always say hmm now that we're doing well, we can add some resource and maybe at the end of a product lifecycle, we probably leave on too much resource system.
We have a real opportunity here, we said, let's use our experienced are really go out it's hard to really flood the zone and that was our thinking with you know.
Working with our relationship with Premier and then we looked at a bunch of other different companies and different potential partners, but absolutely to revere is right at the very top because why they have five years of history with our with our key customers. So we think this is going to be a wonderful relationship you know ive spoken to there.
Leadership, they're very excited to be part of and exciting launch and other VIX about we're excited to work with them and together I think we're going to we're really going to accelerate the uptake of out of expense. So let us do that first and then we'll figure out how the rest of the rest of it goes from Pat do you want to talk about 8907.
Yes so.
<unk> 907, and he is he is really the first systemic <unk> inhibitor. So this is a traditional phase one study it's going to be a combined single and multiple dose study and we will be looking predominantly at pharmacokinetics and safety tolerability and and typical dose escalation and fashion, but it's the same.
And time, we will be major and biomarker on biomarkers related to bile acid bile acid production and bile acids and elimination.
Alright, Thank you very much.
Thanks Liana.
Thank you. Our next question comes from the line every two per hour with Cowen and company. Please proceed with your question.
Hi, guys. This is on with that line sorry wait till this morning. Thank you for taking our questions and congrats on the quarter. So two questions from us actually.
Firstly, what data will you have and.
And before.
And beyond and not natural.
History study data to support the.
On the call economics behind the pricing of the time on from cooler and then following up on you're asking the question from on Yeah could.
Could you give us some color on the estimated number of treating physicians you lead.
You will get asset access to the actions here and what do you have any plans to do additional similar agreements and the U S and you. Thanks.
Hi, it's Pamela.
So the first question you asked around what data, we will have and hand beyond the Knapp and data.
We have our open label study going on now which gives US great long term data to on add into that the dossier submissions with Payors and then secondly, I call out our picture study, which is our burden of illness and caregivers study that we are currently.
Working on and fielding and that is collecting data on the bird and that this disease takes on caregivers and their families and the and the costs.
And two to these families and society.
This will be very important as we know as we talk to payers to really on.
And being able to show them the value and they're looking for this type of evidence and value.
As to the impact of the burden of disease. Your second question, which had to do with the treating physicians and.
The beauty of this relationship with trivia as they are calling on the exact same.
And for potential prescribers that we will be calling on and so it's the same universe that we've talked about before which at the top of the 100.
On pediatric Hepatology is who are the specialists, but there is the broader universe of about 1100 and potential prescribers and.
And as Ron has outlined having two teams work on this right from day, one allows us to get out to all of these potential prescribers that much faster. So again I'm really really pleased with.
Synergies of the two teams here.
And your interest you have yeah.
And just sort of loop around that a little bit from and access perspective, I think that we're very confident on our ability to gain access just on the fact that the ex the strategy and need a pack that we have between pet FIC as the pet fixed studies the two studies.
And the Knapp and data and the caregiver burden and so that is a good package and were already and dialogue with payers. So we feel really good about that and as it relates to the revere a relationship that's a U S. Only relationship and we will focus just on the U S for that we're not planning on any other geographies to go into partnership.
No.
At this time okay.
Okay, great. Thank you.
Thanks, very much the questions.
Thank you. Our next question comes from the line of Brian score and he with Baird. Please proceed with your question.
Hey, good morning, everyone and thank you for taking my question I'm. Just wondering if you had any recent dialogue with the FDA on the potential for an advisory Committee.
And and you say you are prepared for a second half 'twenty. One launch voted index about I guess, what sort of position would be and should approval come early and does the trivia deal and I'll provide some buffer to help you do that should you got an approval how does the Purdue pharma.
Thank you for the question, Brian wouldn't it be great to have an approval on early.
Look it's hard for me to comment on the regulatory gosh, it's only the bag.
And we're engaging in a very good dialogue with them and in the event that we get and Advisory Committee.
B, we are going to be we're going to be ready.
So we're pleased with the dialogue, thus far and you and you're absolutely correct one of the other considerations.
Working their relationship with severe is they are already out there. They are already calling on pediatric herpetologist. They already know how to navigate those special hospitals and so in the in the event that we were lucky enough to have and approval earlier.
We are we will be ready to go with the <unk>, but frankly will also be ready from Albemarle perspective.
Well, so let's cross our fingers for for both scenarios.
Alright, Thanks, Brian.
Yeah.
Yes.
Thank you. Our next question comes from the line of Joseph Stringer with Needham and company. Please proceed with your question.
Hi, and good morning, Thanks for taking my questions.
For the allergy all trial.
Can you describe a little bit more detail around.
So the genetic identification process of of the patients in terms of percentage of patients who could potentially be excluded.
From the trial and maybe just more generally for the allergy on those.
The biliary Atresia trial can you maybe talk about.
Yes, and potential screening failure rates assumptions.
Assumptions, there relative to what you observed and Patrick Thanks.
Okay.
Yeah. This is Pat so in allergy yields our study is open to.
Patients with mutations in both notch, two and Jaguar and gene and that is almost all of the allergy on patients. So from a genetic point of view that almost all of the eligible patients will be eligible in terms of screen failures.
And so we have assumed roughly for allied deals at similar screen failure rate.
We had in the pediatric population.
In order to enter they need to have and elevated bile acids, and and an elevated price score.
Biliary atresia is a bit different so these infants.
Yeah.
Ours.
Eligible right after Kasai and it really is an all comer.
Ah study. So there are very very few exclusion criteria and we expect the majority of patients who are on.
Identified and whose family are willing to participate and will be eligible.
Thank you.
Thanks very much.
Thank you. Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Thanks for taking my question and congratulations on the partnership I know the <unk> team, while not large in size and outstanding and quality and experience and I'm sure there'll be very focused on the new product.
And that kind of leads a question or will they be distributing and go to VIX about through their specialty channel as well and I'm, just wondering kind of how integrated the back and we'll be between the two companies around distribution and msos or maybe even if there is that need from a payer hub.
And thanks very much for the question Tim and.
And you're absolutely right, we're excited to be working with the <unk> team and I know that they're excited about being part of it.
On the big launch, but we tried to keep this as simple as possible right. So you know.
Think about it this way.
<unk> is responsible for all the distribution.
And we book all of the revenue. This is just a simple a simple arrangement.
And where are.
Well, where we pay tribute of certain fees to compensate and sales representatives for the reference for selling on the VIX, but during the life of the co promotion and that's that's it right. So it's very much focused on their sales team. The rest of it will be we will take care of.
Okay, and maybe Simon can you can you help us on how that will flow through the P&L as we kind of work the partnership into our model.
Yeah, I mean, it's very simple line, we'll book all of the revenue related to that and in the operating expense line.
On the commercial you would expect to see the costs related to the fee for service.
We pay to trip that will be booked at.
Okay, and we'll just work it into the SG&A.
Or a true up to their reps, okay fantastic and I guess one last question are you looking at any partnerships for other regions.
And not in this type of structure right, so and so when I talk about this type of from the premiere.
Arrangement is a is a relationship to actually boost from a promotional perspective and other parts of the world Our plans and Europe will have our dedicated Alba Rayos team and then and other countries such as we announced medicine and Israel, Israel, but other countries like the middle East parts of <unk>.
Southern Europe, and Latin America, and we plan on.
Engaging and our relationships with top quality companies in those regions and we're well advanced and our discussions with those companies and hope to announce some more of that.
As the year progresses.
Great. Thank you for the questions.
Thank you Tim.
Thank you, ladies and gentlemen, and I as a reminder, if you'd like to join the question queue. Please press star one on your telephone keypad. Our next question comes from the line of Ed Arce with H C. Wainwright. Please proceed with your question.
Hi, great. Thanks for taking my questions just a few from me.
Firstly on.
On your commercial outlook.
Is there well first of all day.
If you could.
Share with us.
Given your your data on what you're seeing in terms of the breakdown of.
Of targeted physicians between sort of transplant centers and other sort of academic centers other other sorts of sites.
And if theres any sort of meaningful.
Differences and the way that you approach.
On the the targeting of those physicians that that's question one second is.
If you could remind us the breakdown that you see at this point between sort of commercial lives and and other Medicare and Medicaid.
Split.
And then lastly.
And with the ex.
Ex U S.
<unk> and some of the reasons I think.
Clearly certain countries like Turkey, and Israel are of interest due to the higher prevalence of patients with.
And that are due to can sanguinous.
Disease are there, perhaps other specific countries or regions.
And that would fit that sort of profile that you're also targeting thanks. So much.
Alright, and thanks for the question. So I think your three questions were sort of a breakdown of of kind of where are the targets or the second one on sort of the mix.
Between payers and and what it looks like and some of these high prevalence countries. Let me just take the first one and I'll leave you at the other two I'll, let I'll, let Pamela addressed because that's the first one is pretty simple right. So as Pamela said and there are about 100 key individuals in the U S and they are in about 60 centers right.
And then if you go down a little bit deeper theres, probably another 400, keeping leaders prescribers and then another 600 hospital folks. So it was very concentrated approach and between.
On the Alberto team and the <unk> team will be able to cover them and then a very intense way from day, one to try and maximize the number of patients that we will get on or the VIX about and.
And then you know Pamela can talk a little bit about the the on the.
Mix and what we expect and then what other countries have.
On a higher prevalence and maybe Pamela.
Hi.
Sure.
For us to know and advance how and what percentage of our patients will be.
Medicaid Medicare and that based on looking at.
Other analogs and my own experience with other.
Populations, we and we think it's likely between a quarter and a third of the U S patients will be Medicaid patients and so.
That's the second question you had asked and on the third question.
Around other countries, where we sort of see a little bit of a higher prevalence rate certainly in the and Saudi Arabia, Turkey are two important countries that come to mind that have higher rates.
Great. Thanks, so much that's helpful.
Thank you Ed.
Thank you ladies and gentlemen, this concludes our question and answer session and I'll turn the floor back to Mr. Cooper for any final comments.
Great. Thank you operator, and thank you all for attending today's conference call you know as we enter it.
And into a new stage of the company will continue to update you on our commercial planning and our overall growth and our ambition two 1 billion per.
The attention of day, we are a lot of exciting near term milestones ahead of us our financial position is strong and this will enable us to continue to advance <unk> mission to provide hope to families with liver diseases and the entire liver community. Thanks again for your continued support.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.