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Albireo Pharma, Inc. (ALBO) Q4 2020 Earnings Call Transcript

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ALBO earnings call for the period ending December 31, 2020.

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Albireo Pharma, Inc. (ALBO 3.24%)
Q4 2020 Earnings Call
Feb 25, 2021, 10:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to the Albireo Pharma's 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. [Operator Instructions] Please note that this conference is being recorded.

I'll now turn the call over to your host, Paul Arndt, Managing Director of LifeSci Advisors. Thank you. You may begin.

Paul Arndt -- Managing Director

Thank you, operator, and good morning, everyone. Thank you for joining today's call. This morning, Albireo 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.albireopharma.com.

Before proceeding, we would like to note that management's 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 in the Risk Factors section of our most recent Form 10-K and our subsequent SEC filings. These filings can be accessed from the Media and Investors section of our website at www.albireopharma.com or on the SEC's website.

Any forward-looking statements represent management's views as of today, Thursday, February 25, 2020, 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, Albireo's President and Chief Executive Officer. Ron?

Ron Cooper -- President and Chief Executive Officer

Thank you, Paul. And thank you everyone for joining us this morning for Albireo'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 Stevenson, our Chief Commercial Officer.

I'd like to begin today by giving a short review of 2020 and then moving into 2021. 2020 was a transformational year where we delivered against all our stated milestones and commitments and plan. 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 plan launch of odevixibat, expansion beyond PFIC into other rare pediatric conditions and progressing our pipeline in adult cholestatic & viral diseases.

Starting with 2020, the story was overcoming unprecedented challenges. Albireo, 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 in a fully virtual manner.

Despite these headwinds, our team persevered, overcame the challenges and ultimately delivered on a very successful 2020 measured by our progress with odevixibat, our pipeline and advancing the growth of the company.

First, with odevixibat. We've committed to delivering the PEDFIC one Phase III study results in PFIC. 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 rates.

On the back of that great data, our team worked in record time to submit for regulatory approvals. We're pleased to announce that both regulatory filings were accepted in the U.S. and Europe with the FDA granting priority review and the EMA granting accelerated review. It is estimated there are approximately 100,000 patients with pediatric cholestasis liver disease around the world.

And we have always said, odevixibat is a pipeline in a product with the first indication of PFIC then Alagille Syndrome and Biliary Atresia. Knowing the potential odevixibat that could have in these three indications, we decided to start our first Phase three study in PFIC nature of the disease. We believe it will be easier to validate the dose, tolerability and our precision pruritis measurement tool which we did and the result validated our decision.

We have the insight and great confidence in the PFIC one and two studies and we're able to design and initiate two additional Phase three studies in cholestatic liver disease. With the positive learnings from the PFIC program, we've increase our confidence in a positive outcome for our Alagille and Biliary Atresia program.

We committed to starting Albireo two year study in the first part of the year and we initiated the BOLD study which is the world's first and largest prospective randomized placebo control study with an IBAT inhibitor. Biliary Atresia is the largest pediatric cholestatic liver disease with an estimated prevalence of approximately around 45,000 patients around the world. We're also committed to starting a third pivotal program in Alagille Syndrome and started the trial in the fourth quarter of last year. So selling our development commitments and guidance for odevixibat.

Now looking at our pipeline expansion activities, we completed IND-enabling studies with our novel ASBT inhibitor, A3907 for adult liver diseases and we made progress with our first NTCP inhibitor, A2342 for viral and cholestatic diseases. Our company matured in many different ways in 2020. 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 of the company. In parallel, the organization double its size and we built new capabilities in a lean infrastructure to drive successful commercialization.

Recent hires include our President of the Americas and President of International, both of whom are focused on hiring specialized teams as part of our launch readiness plans, as well as driving our sales and market access strategies and execution in their respective regions. We've put medical and access personnel on the ground and they've been actively engaged with healthcare 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 expectation for the year as we drive odevixibat product growth to over $1 billion planned for the second half of the decade. First, we're planning for odevixibat to be proved in the U.S. and Europe with the issuance of a priority review voucher and deliver commercial sales.

Second, we expect further progress in our pipeline with our pivotal Phase three studies with the BOLD study and Biliary Atresia and the assert study Alagille Syndrome. BOLD should be well under way in enrollment perspective. And third, we plan to characterize our pipeline further.

Starting with odevixibat, with priority review and a PDUFA date of July 20 in the US and accelerate assessment in Europe, we engage in a good dialogue with regulatory authorities and odevixibat an approval and launch in the second half of the year. In preparation, we're gearing up all critical launch activities and steps to ensure we have product to sell.

We've executed on the manufacturing plan. We agreed with the FDA in the fall of 2018. And we feel confident about the commercial product having used the plan commercial formulation in the PEDFIC Phase three studies. We're also focusing on the supply chain. We've established agreements with 3PLs in specialty pharmacists, while also building Albireo Assist, which is a customized in-house patient services program with dedicated care coordinators to help patients navigate their access to odevixibat from the start, and be with them as they grow.

With competence regulatory outcomes and drug supply in place our next priority is access. Regulatory approvals are important around the role, but having a compelling value story is equally important to ensure patients can access to drug. Payors are looking for strong data and a good rationale. The PEDFIC study produced strong positive results from the largest randomized, placebo-controlled Phase three study in PFIC, 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 NAPPED study, which shows that a reduction of bile acids to 65 to 100 depending on the PFIC type by biliary diversion results of long-term native survival. Unfortunately, not all patients benefit from biliary diversion surgery and will require liver transplantation for work factory pruritus or end stage disease, we believe odevixibat will be a much better option.

In addition, we initiated a burden of disease study to understand the cost and caregiver burden associated with PFIC, and importantly, humanistic data that measures the burden on caregivers and families. So overall, we feel really good at this time with the comprehensive submission package that we've compiled to support the valuable to odevixibat ensure patient access globally.

The next priority is commercialization, and we are prepared. With our regional heads in the US and Europe who place their focus on hiring a highly specialized sales team to colon healthcare providers. In the US, 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 Travere Therapeutics. Travere is a leading rare disease company and marketer of Cholbam capsules, which are used by pediatric hepatologists. So why is this important for our commercial strategy? Travere 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 in the US. With the Travere sales representatives and our own 10 representatives will more than double our reading frequency coverage on day one of launch to give us a fast start.

Travere will also provide us with valuable insights as their sales representatives have been calling on pediatric hepatologists and the related specialists for more than five years. And they are the mainly coupled with odevixibat.

The co-promotion agreement is set for two years with optionality for extending the relationship. Albireo will book all revenue and pay per view certain fees to compensate its sales representatives for their efforts in selling odevixibat.

We believe this relationship with Albireo ensure potential prescribers are aware of what would have expected and understand how to subscribe it for appropriate patients as quick as possible upon FDA approval, which will result in a faster start a bunch.

We're also planning on commercializing odevixibat another places around the world. In our recent commercial day we revealed the opportunity for odevixibat about this larger than our initial estimates with 100,000 pediatric liver disease patients around the world excluding Indian and China that could benefit from this therapy.

Now if you looked at the data from other rare disease therapies, many have them is created significant opportunity worldwide, with more than half of the brand's revenue for each of these coming outside the US, just two years after launch.

What this means is, we anticipate a larger patient population for odevixibat. Our aspiration is to reach $1 billion of sales for odevixibat within the second part of this decade through US and international sales.

With this in mind, we head into our first commercial distributor partnership for odevixibat with medicine, Pharma in Israel. This is the first a multiple plan ex-US Commercial distributorships, with a focus on countries with high prevalence rates, equally significant, commercial opportunities. So overall, it'll be a big year for odevixibat from an approval, reimbursement, commercialization, partnership perspective. And we are ready to go.

Moving on to our key development program is BOLD the first largest and the only global, Randomized, Placebo-controlled Phase three trail IBATi inhibitor in Biliary Atresia. As 42 sites activated and global enrollment continues to be on track. We anticipate having all the sites up and running the first half of 2021, but top line data available in 2024.

For ASSERT our pivotal Randomized, Placebo-controlled program in Alagille Syndrome we expect to have all the sites active in the first half of 2021 as well, with top line data available in 2022. With three pivotal programs for odevixibat we're planning a market leading global approach. Focusing on key regions like the US, Europe, the Turkey, Israel and Brazil.

Fourth piece that we anticipate being the first approved and first to market and the majority of the reasons for Alagille Syndrome we expect to be first in Europe and ex-US countries pending the results of our Phase three study and a fast follower with a best-in-class profile therapy in the US.

We also expect the first in the market for Biliary Atresia, because we have the only Phase three study up and running. The third thing to expect by the end of the year is greater insight into our pipeline beyond pediatric liver disease. We are making tremendous progress for our earlier stage compounds in adult, cholestatic and viral diseases.

We're advancing the development of A3907 Novel ASBT Inhibitor and A2342, which is a Novel NTCP Inhibitor. The unique properties of A3907 especially the high stomach availability holds great promise for solving adult high diarrhea challenges, observed with IBATi inhibitors in adult co-static liver diseases such as PBC and PSC.

For A3907 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 two in 2022. We believe A3907 has significant commercial potential in adult cholestatic diseases.

We're also excited about developing first NTCP inhibitor A2342 for viral and cholestatic diseases. NTCP is a key transporter for bile acids as well as Hepatitis B and D viruses.

A2342 also has unique properties as it is an all potent small molecule that blocks entry into the liver and it should have excellent combinability potential. There really is a good proof of concept A2342 with a peptide compound called Hepcludex, which is an NTCP inhibitor approved for Hepatitis D in Europe. But given the limitations of a peptide, the maximum dose can only be delivered as a daily SubQ injections. This product was recently purchased by Gilead for over 1 billion euros.

A2342 is currently an IND-enabling studies with a phase one trial anticipated to start in 2022 and phase two in 2023. We believe in A2342 could be a valuable treatment for hepatitis B and D and cholestatic diseases. Our research team continues to characterise other novel bile acid modulators.

So to conclude, we're coming off a tremendous year, and we have a great deal of confidence in our ability to deliver in 2021 and beyond. Why? Well because of our track record of Albireo. Starting with our commercial track record, not only do we have the building blocks in place, but we have leadership with a demonstrated record of launching.

Pamela leads our Commercial Organisations spent a decade at Pfizer and a decade with Vertex, commercialising products in competitive liver and rare disease market. Simon, our CFO has two decades of Lilly and a decade at GSK and I have over 20 years of BMS.

We believe our individual and combined successes is global product launches gives us a market leading commercialization approach and readiness. Collectively, we have dozens and dozens of successful launches under our belts. Development track, Albireo has successfully read out two phase three programmes. First, Elobixibat was the first IBAT inhibitor approved anywhere in the world with the approval in chronic constipation together with EA Pharma, our partner in Japan.

And then of course, the PEDFIC trial results for Odevixibat in PFIC. Odevixibat PFIC study was the first phase three study ever conducted in paediatric cholestasis where there is no precedent on endpoints, trial design and little natural history. We successfully enrolled and executed the Odevixibat phase three test study in PFIC. This gives us confidence in our chance for similar success with our BOLD study in biliary atresia, and our ASSERT study Alagille Syndrome.

Preclinical track records A3907 will be the third compound that the preclinical team has progressed into the clinic. This gives us confidence that A2342 will also advance this plan and there's potential in our other bile acids, modulator approaches, allowing for smart pipeline expansion from rare paediatric liver disease and now to adult and liver diseases.

So, overall, we feel very confident in our ability to deliver against our key objectives in 2021 as we plan to launch odevixibat, taking us toward our ambition to achieve $1 billion in sales, progressing our clinical progress analogy on biliary atresia, and further characterising our promising preclinical compounds.

So now with that, let me turn it over to Simon to give you quick financial update. Simon?

Simon Harford -- Chief Financial Officer

Thank you, Ron. Let me quickly summarize our financial results for Q4 and full year 2020. Revenues were $8.3 million for the year ended December 31, 2020, compared to 9.6 million for the year ended December 31, 2019.

Revenues were $2.7 million for the fourth quarter of 2020, compared to $6.4 million in the same period last year. The decrease in revenue for both the full year and fourth quarter primarily relates to a sales based milestone, achieved in 2019, offset by higher sales based royalties earned in 2020, from EA Pharma, which, as you know, are passed on to HealthCare Royalty Partners as part of an agreement to monetize the royalty stream.

R&D expenses were $76.8 million for 2020, up from $45.6 million for the same period in 2019. R&D expenses were $20.1 million for the fourth quarter of 2020 compared to $14.2 million to Q4 of last year. The increases for both the full year and fourth quarter were mainly the result of headcount and program expenses related to odevixibat.

The main drivers of the increase in expenses for our lead asset were related to the PEDFIC regulatory submissions, as well as clinical trials for biliary atresia and Alagille syndrome, as we continue to progress our 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 2020, compared to $23 million for the previous year. For the fourth quarter of 2020, G&A expenses were $14.2 million, compared to $6.2 million for the same quarter in 2019.

For both the full year and fourth quarter, the increases were primarily attributable to headcount and expenses related to commercial readiness, as discussed during our recent commercial day.

Net loss for the year ended December 31, 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 31, 2019. For the fourth quarter of 2020, the net loss was $24.8 million, or a loss of $1.30 per share, compared to a net loss of $7.5 million or a loss of $0.57 per share in the fourth quarter of 2019.

As of December the 31, 2020, we have cash or cash equivalents of $251.3 million, which compared to $278.7 million in September 30, 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 PFIC launches for odevixibat. We also anticipate 2021 revenue for odevixibat to be in the low single digit millions, assuming timely approval, and then ramping up over time as access is achieved, approvals in other countries have gained and new potential indications are launched.

With that, let me turn the call back over to run for closing remarks. Ron?

Ron Cooper -- President and Chief Executive Officer

Great. Thanks, Simon. So to recap, we have a number of significant milestones that we expect to drive our growth and we feel good about the milestones to come in 2021, and to deliver against guidance. We're confident or a path to a billion because the tremendous global opportunity, a robust value proposition and our high level of readiness and our action to expand beyond PFIC to other diseases.

The Albireo opportunity is not about odevixibat and PFIC in the US. Rather, it's about building odevixibat into a leading global product on the back of multiple indications and geographies, and taking out promising new compounds into larger adult patient populations.

We thank everybody for joining us. We're pleased to open the call now for Q&A. Over to you, operator.

Questions and Answers:

Operator

Thank you. At this time, we'll be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Hi, Tammy, thank you so much for taking my questions. I may have -- you may have stated that, but if you could remind us again, what is the number of the -- how big is the sales team of Travere that they have? And what is the outreach just to their pediatric hepatologists across regarding regardless whether they're transplanters centrist or not. So you could just give a little bit color of the depths of Salesforce and expertise that they have would be helpful. And then I have a follow up question.

Pamela Stephenson -- Chief Commercial Officer

Hi, Yasmeen. It's Pamela here. Just answering your question on how big their sales team is. They have a team of 12 representatives in the US who are highly experienced and have long standing relationships with the pediatric hepatologist. They also call on some other related specialties as well, but their primary focus is the pediatric hepatologist. So we're really excited about this and how it will help accelerate our launch and uptake at launch.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Thank you. And then another question I have is, can you provide a little bit color on now as one-third has begun enrollment, how it's progressing? Maybe also remind us what percentage of the sizer here in the US versus ex US? Can you give us a little bit more of that granularity and also whether you're planning to turn on more sites across those studies as third and bold, given the pandemics to just kind of give us a little bit numbers around the progress that you're making on both fronts would be very helpful for us?

Ron Cooper -- President and Chief Executive Officer

Yeah, absolutely. Look, we're absolutely really pleased that where we are with ASSERT, it's actually going exactly according to plan. So we have our first site up and going, we anticipate having all of the sites up and going. In the first half of this year, we've accounted for the challenges, the global pandemic, and that's why we have 35 sites around the world. And we'll try and use -- the global aspect of the study as an advantage, to go to places where things open up. But as I said at the beginning, we're up and going, and we feel pretty good about our guidance for the Alagille ASSERT study.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Thank you so much. And I'll jump back into the queue.

Ron Cooper -- President and Chief Executive Officer

Thank you. Yasmeen.

Operator

Thank you. Our next question comes from a line of Liana Moussatos with Wedbush Securities. Please proceed with your question.

Liana Moussatos -- Wedbush Securities -- Analyst

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 Travere?

And my second question has to do with A3907, the Phase one trial, any biomarker data in there, what kind of data are we going to see this year?

Ron Cooper -- President and Chief Executive Officer

All right, Liana thanks very much for those questions. I'll take the first one, and then Pat maybe comment on A3907. Look Liana, we go on and get ahead of ourselves here, right. We're just starting this partnership together. But I think the thing to talk about this partnership is, you know, Simon, 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 in our experience, we always say, now 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. So since we have a real opportunity here, we said, let's use our experience and really go at it hard to really flood the zone.

And that was our thinking with, you know, working with our relationship with Travere. And then we looked at a bunch of other different companies, and different potential partners, but absolutely Travere is right at the very top, because why, they have five years of history with our key customers.

So we think this is going to be a wonderful relationship. I've spoken to their leadership, they're very excited to be part of an exciting launch of odevixibat, we're excited to work with them and together, I think we're going to -- we're really going to accelerate the uptake a lot of expense. So, let us do that first. And then we'll figure out how the rest of it goes.

But Pat, do you want to talk about A3907?

Patrick Horn, M.D., Ph.D. -- Chief Medical Officer

Yeah. So, you know, A3907 is really the first systemic IBAT inhibitor. So this is a traditional Phase one study, it's going to be a combined single and multiple dose study. And we'll be looking predominantly at pharmacokinetics and safety tolerability in a typical dose escalation fashion. But at the same time, there will be major environmental biomarkers related to bile acids, bile acid production and bile acids elimination.

Liana Moussatos -- Wedbush Securities -- Analyst

Thank you very much.

Ron Cooper -- President and Chief Executive Officer

Thanks Liana.

Operator

Thank you. Our next question comes from line of Ritu Baral with Cowen and Company. Please proceed with your question.

Amita -- Cowen and Company -- Analyst

Good question. Hi, guys, this is Amita [Phonetic] on for Ritu 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 in hand before beyond the NAPPED natural history data to support the pharmaco economics behind the pricing at the time of approval? And then following-up on Yasmeen's question from earlier, did you give us some color on the estimated number of treating physicians you will get access to via Travere? And would you have any plans to do additional similar agreements in the US and EU? Thanks.

Pamela Stephenson -- Chief Commercial Officer

Hi. It's Pamela. So the first question you asked around, what data we'll have in hand beyond the NAPPED data. You know, of course, we have our open-label study going on now, which gives us great long term data to add into the dossier submissions with payers. And then secondly, I call out our PEDFIC study, which is our burden of illness and caregiver study that we are currently working on and fielding and that is collecting data on the burden that this disease takes on caregivers and their families and the cost to these families and to society. This will be very important, as we know, as we talk to payers to really be 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 has to do with the treating physician, the beauty of this relationship with Travere is they are calling on the exact same 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 is the 100 pediatric hepatologist, who are the specialists, but there is the broader universe of about 1,100 potential prescribers. 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, really, really pleased with the synergies of the two teams here.

Amita -- Cowen and Company -- Analyst

And do you have -- yeah.

Ron Cooper -- President and Chief Executive Officer

Just to sort of loop around that a little bit. From an access perspective, I think that, we're very confident our ability to gain access to some the fact that the access strategy indeed impact that we have between PFIC and PEDFIC studies, the two studies between the NAPPED data and the caregiver burden. So that is a good package. And we're already in dialogue with payers. So we feel really good about that. And as it relates to the Travere relationship, that's a US only relationship. And we'll focus just on the US for that. We're not planning on any other geographies to go into partnership, at this time.

Amita -- Cowen and Company -- Analyst

Okay. Okay. Great. Thank you.

Ron Cooper -- President and Chief Executive Officer

Thanks very much for the questions.

Operator

Thank you. Our next question comes from line of Brian Skorney with Baird. Please proceed with your question.

Brian Skorney -- Baird -- Analyst

Hey, good morning, everyone. Thank you for taking my question. Just wondering, if you had any recent dialogue with the FDA on the potential for an advisory committee? And you say, you're prepared for a second half 2021 Launch Road events about I guess, what sort of position would be in should approval come early, end of the Travere deal at all, provide some buffer to help you do that? Should you get an approval ahead of PDUFA?

Ron Cooper -- President and Chief Executive Officer

Thank you for the question, Brian, wouldn't it be great to have an approval early. Look it's hard for me to comment on the regulatory discussion, only -- or engaging in a very good dialogue with them in the event that we did advisory committee -- we are going to be -- we're going to be ready. So we're pleased with the dialogue thus far. And you're absolutely correct. One of the other considerations of working their relationship with Travere is they are already out there. They are already calling on pediatric hepatologist. They already know how to navigate those special hospitals. And so in the event that we were lucky enough to have an approval earlier. We will be ready to go with Travere team but frankly, we'll also be ready from perspective, as well. So, let's cross our fingers for both scenarios.

Brian Skorney -- Baird -- Analyst

Right. Thanks, Ron.

Operator

Thank you. Our next question comes from line of Joseph Stringer with Needham & Company. Please proceed with your question.

Joseph Stringer -- Needham & Company -- Analyst

Hi, good morning. Thanks for taking our questions. For the Alagille trial, can you describe a little bit more detail around sort of the genetic identification process of the patients in terms of percent of patients who could potentially be excluded from the trial?

And maybe just more generated for the Alagille and the biliary atresia trial, can you may be talk about potential screening failure rates assumptions there relative to what you observe in PFIC? Thanks.

Patrick Horn, M.D., Ph.D. -- Chief Medical Officer

Yes, this is Pat. So, in Alagille, our study is open to patients with mutations in both NOTCH2 and JAG1 genes and that is almost all of the Alagille patients. So, from a genetic point of view, almost all of the Alagille patients will be eligible. In terms of screen failures, so we have assumed roughly for Alagille a similar screen failure rate that we had in the PFIC population because in order to intervene elevated bile acids and an elevated pruritus score.

Biliary atresia is a bit different. So, these infants are eligible right after Kasai and it really is an all-comer study. So, there are very, very few exclusion criteria, and we expect the majority of patients who are identified and whose family are willing to participate will be eligible.

Joseph Stringer -- Needham & Company -- Analyst

Okay.

Patrick Horn, M.D., Ph.D. -- Chief Medical Officer

Thanks very much.

Operator

Thank you. Our next question comes from line of Tim Lugo with William Blair. Please proceed with your question.

Tim Lugo -- William Blair -- Analyst

Thanks for taking the question and congratulations on the partnership. I know Travere team, while not large and size, is outstanding and quality and experience. I'm sure they'll be very focused on the new product. And that kind of leads to the question will they be distributing events about atresia specialty channels? Well, I'm just wondering kind of how integrated the back end will be between the two companies around distribution, MSLs, or maybe even if there was a need for a pair hub?

Ron Cooper -- President and Chief Executive Officer

Thanks very much for the question, Tim. You're absolutely right. We're excited to be working with the Travere team and I know that they're excited about being part of a big launch. But we try to keep this as simple as possible, right?

So, think about it this way. Albireo is responsible for all the distribution. We book all the revenue. This is just a simple arrangement where we pay Travere certain fees to compensate sales representatives for their efforts for selling out of expense during the lifecycle promotion, and that's it, right. So it's very much focused on their sales team, the rest of it we will take care of.

Tim Lugo -- William Blair -- Analyst

Okay. And maybe Simon, can you help us on how that will flow through the P&L as we kind of worked the partnership into our model?

Simon Harford -- Chief Financial Officer

Yeah. I mean, it's very simple. 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 that we paid to Travere will be booked.

Tim Lugo -- William Blair -- Analyst

Okay. So we'll just work it into the SG&A kind of...

Simon Harford -- Chief Financial Officer

Reps.

Tim Lugo -- William Blair -- Analyst

Through up to their reps. Okay, fantastic. And I guess one last question, are you looking at any partnerships for other regions?

Simon Harford -- Chief Financial Officer

Not in this type of structure, right. So when I talk about this type for the Travere arrangement is a relationship to actually boost from a promotional perspective. In other parts of the world, our plans in Europe, we'll have our dedicated Albireo team. And then in other countries, such as we announced medicine in Israel, Israel, but other countries like the Middle East, parts of southern Europe and Latin America, we plan on engaging in relationships with top quality companies in those regions. And we're well advanced in our discussions with those companies note to announce some more of that as the year progresses.

Tim Lugo -- William Blair -- Analyst

Great. Thank you for the question.

Simon Harford -- Chief Financial Officer

Thanks, Tim.

Operator

Thank you. [Operator Instruction] Our next question comes from line of Ed Arce with H.C. Wainwright. Please proceed with your question.

Ed Arce -- H.C. Wainwright -- Analyst

Hi, great. Thanks for taking my question. Just a few for me. Firstly, on your commercial outlook, is there -- well, first of all the -- if you could share with us, given your data what you're seeing in terms of the breakdown of targeted physicians between sort of transplant centres and other sort of academic centres or other sorts of sites? And if there's any sort of meaningful differences in the way that you approach the targeting of those physicians, that's question one.

Second is, if you could remind us the breakdown that you see at this point between sort of commercialized and other medicare medicaid split. And then lastly, with the ex US markets, and some of the regions I think clearly, certain countries like Turkey and Israel are of interest due to the higher prevalence of patients with -- that are due to consanguineous disease, are there perhaps other specific countries or regions that would fit that sort of profile that you're also targeting? Thanks so much.

Ron Cooper -- President and Chief Executive Officer

Thanks for the question. So I think the three questions were sort of a breakdown of kind of where the targets are, the second one on sort of the mix between payers and what it looks like in some of these high prevalence countries. Let me just take the first one. And then the other two, I'll let all that Pamela address because this first one is pretty simple, right? So as Pamela said, there are about 100 key individuals in the US, and they are in about 60 centres, right.

Then if you go down a little bit deeper, there's probably another 400 key pinion leaders prescribers, and then another 600 hospital folks. So there's a very concentrated approach in between the Albireo team and the trivia team will be able to cover them and in a very intense way from day one, to try and maximize the number of patients that we will get on odevixibat. And then, you know, Pamela, can talk a little bit about the mix of what we expect, and then what other countries have a higher prevalence. So maybe over to Pamela?

Pamela Stephenson -- Chief Commercial Officer

Hi, sure. It's difficult for us to know in advance how -- what percentage of our patients will be, you know, primarily Medicaid, Medicare, but based on looking at other analogues and my own experience with other populations. We you know, we saved likely between a quarter and a third of the US patients will be Medicaid patients. So that's your -- 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 Saudi Arabia, Turkey are two important countries that come to mind that have higher rates.

Ed Arce -- H.C. Wainwright -- Analyst

Great, thanks so much. That's helpful.

Ron Cooper -- President and Chief Executive Officer

Thank you, Ed.

Operator

Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I'll turn the floor back to Mr. Cooper for any final comments.

Ron Cooper -- President and Chief Executive Officer

Great. Thank you, operator. Well, thank you all for attending today's conference call. You know, as we enter into a new stage of the company, we will continue to update you on our commercial planning and our overall growth in our ambition to Albireo.

Appreciate the attend today. We have a lot of exciting near term milestones ahead of us. Our financial position is strong, and this will enable us to continue to advance Albireo mission to provide hope to families, liver diseases and the entire liver community. Thanks again for your continued support.

Operator

[Operator Closing Remarks]

Duration: 25 minutes

Call participants:

Paul Arndt -- Managing Director

Ron Cooper -- President and Chief Executive Officer

Simon Harford -- Chief Financial Officer

Pamela Stephenson -- Chief Commercial Officer

Patrick Horn, M.D., Ph.D. -- Chief Medical Officer

Yasmeen Rahimi -- Piper Sandler -- Analyst

Liana Moussatos -- Wedbush Securities -- Analyst

Amita -- Cowen and Company -- Analyst

Brian Skorney -- Baird -- Analyst

Joseph Stringer -- Needham & Company -- Analyst

Tim Lugo -- William Blair -- Analyst

Ed Arce -- H.C. Wainwright -- Analyst

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