Albireo Pharma, Inc.

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

Thank you, Operator, and good morning, everyone. Thank you for joining today's call. This morning, Alvareo 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.alvareopharma.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 the company's most recent Form 10-K and subsequent SEC filings. These filings can be accessed from the Media and Investor Relations section on the company's website at alvareofarma.com or on the SEC's website. Any forward-looking statements represent management's views as of today, Thursday, February 25, 2021, and should not be relied upon as representing their views as of any subsequent dates. The company undertakes no obligation to update these statements publicly. Now, it is my pleasure to turn the call over to Ron Cooper, Alvareos President and Chief Executive Officer. Ron?

Thank you, Paul, and thank you, everyone, for joining us this morning for Alvareos 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 as planned. 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 launched to Votavix about expansion beyond PFIC into other rare pediatric conditions, and progressing our pipeline in adult cholestatic and viral diseases. Starting with 2020, the story was overcoming unprecedented challenges. Albareo, 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 Odovixibad, our pipeline, and advancing the growth of the company. First, with Odovixibad, we've committed to delivering the PEPFIC 1, Phase 3 study results in PEPFIC. 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 cholestatic liver disease around the world. And we've always said Odovixibab is a pipeline in a product with the first indication of PFIC, then allogel syndrome, and belly atresia. Knowing the potential Odovixibab could have in these three indications, we decided to start our first phase three study in PFIC. It is the nature of the disease. We believed it would 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 insight and great confidence from the PETBIC 1 and 2 studies, and we're able to design and initiate two additional phase 3 studies in cholestatic liver disease. With the positive learnings from the PEDVIC program, we've increased our confidence in a positive outcome for our allogel and bilirutresia programs. We committed to starting a bilirutresia 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-controlled study with an IVAD inhibitor. Bileatresia is the largest pediatric holostatic liver disease with an estimated prevalence of approximately around 45,000 patients around the world. We also committed to starting a third pivotal program in Allergy Ill Syndrome and started the ASSERT trial in the fourth quarter of last year, fulfilling our development commitments and guidance for Odovixibab. 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 doubled 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 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 put medical and access personnel on the ground, and they've been actively engaging 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 Odovixibet product growth to over $1 billion planned for the second half of the decade. First, we're planning for Odovixibet to be approved 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 in biliary atresia and the ASSERT study in allogilism. BOLD should be well on their way from an enrollment perspective. And third, we plan to characterize our pipeline further. Starting with Odovixibeth, with priority review and a PDUFA date of July 20th in the U.S. and accelerated assessment in Europe, we've engaged in a good dialogue with regulatory authorities and do anticipate 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 planned commercial formulation in the PEDFIC Phase III studies. We're also focusing on the supply chain. We've established agreements with 3PLs and specialty pharmacists while also building Albareo Assist, which is a customized in-house patient services program with dedicated care coordinators to help patients navigate their access to Otavix VAT from the start and be with them as they grow. With confidence in regulatory outcomes and drug supply in 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 PEDFIC study produced strong positive results from the largest randomized placebo-controlled Phase III study in PFIC. This provides us with compelling Class I evidence, but you also need a full access strategy. As part of the integrated access strategy, we have the natural history data from the NAPID study, which shows that a reduction of bile acids to 65 to 100, depending on the PFE type, by biliary diversion results in long-term NADA survival. Unfortunately, not all patients benefit from biliary diversion surgery and will require liver transplantation for refractory pruritus or end-stage disease. We believe Odovix VAT 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 about the comprehensive submission package that we've compiled to support the value of Odovix VAT and ensure patient access globally. The next priority is commercialization, and we are prepared. With our regional heads in the U.S. and Europe in place, they're focused on hiring a highly specialized sales team to call on healthcare 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 Travere Therapeutics. Travere is a leading rare disease company and marketer of Colbon capsules, which are used by pediatric hepatologists. So why is this important for our commercial strategy? The Travere representatives are highly experienced and have a long-standing relationship with our key HCP prescribers. So they'll be able to help us accelerate our launch and uptake in the U.S. With the Travere sales representatives and our own TAN representatives, will more than double our recent frequency coverage on day one of launch to give us a fast start. Travere will also provide us with valuable insights that their sales representatives have been calling on pediatric hepatologists and their related specialists for more than five years, and they are the main call point for Otavixabab. The co-promotional agreement is set for two years with optionality for extending the relationships. Alvareo will book all revenue and pay Trevier certain fees to compensate its sales representatives for their efforts in selling Odovixibab. We believe this relationship with Trevier will ensure potential prescribers are aware of Odovixibab and understand how to prescribe 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 Otavixibet in other places around the world. In our recent commercial day, we revealed the opportunity for Otavixibet is larger than our initial estimates with 100,000 pediatric liver disease patients around the world, excluding India and China, that could benefit from this therapy. Now, if you look at the data from other rare disease therapies, Many have demonstrated significant opportunity worldwide with more than half of the brand's revenue for each of these coming outside the U.S. just two years after launch. What this means is we anticipate a larger patient population for Odovixibab. Our aspiration is to reach $1 billion of sales for Odovixibab within the second part of this decade through U.S. and international sales. With this in mind, we enter into our first commercial distributor partnership for Otavixibet with Medicine Pharma in Israel. This is the first of multiple plan ex-U.S. commercial distributorships with a focus on countries with high prevalence rates equaling significant commercial opportunities. So overall, it'll be a big year for Otavixibet from an approval, reimbursement, commercialization, partnership perspective, and we are ready to go. Moving on to our key development programs, BOLD, the first, largest, and the only global randomized placebo-controlled Phase III trial of an IBAD inhibitor in biliatresia, has 42 sites activated, and global enrollment continues to be on track. We anticipate having all the sites up and running in the first half of 2021, with top-line data available in 2024. For ASSERT, our pivotal randomized placebo-controlled program in allogeal 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 Rotavix about, we're planning a market-leading global approach, focusing on key regions like the U.S., Europe, Turkey, Israel, and Brazil. For PPIC, we anticipate being the first approved and first to market in the majority of the regions. For allogel 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 the best-in-class profile therapy in the U.S. We also expect to be first in 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 is greater insight into our pipeline beyond pediatric liver disease. We are making tremendous progress with our earlier stage compounds in adult, cholestatic, and viral diseases. We're advancing the development of A3907, our novel ASBT inhibitor, and A2342, which is a novel NTCP inhibitor. The unique properties of A3907, especially the high systemic availability, holds great promise for solving the efficacy high diarrhea challenges observed with IBAD inhibitors in adult cholestatic liver diseases, such as PBC and PSC. For A3907, we're planning a first-in-human Phase I study by the end of first quarter, with top-line data anticipated later this year, and the initiation of Phase II in 2022. We believe A3907 has significant commercial potential in adult cholestatic diseases. We're also excited about developing the 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 oral, potent, small molecule that blocks entry into the liver and should have excellent combinability potential. There really is a good proof of concept for A2342 with a peptide compound called Hepcludex, which is an anti-CV inhibitor approved for hepatitis D in 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 a billion euros. A2342 is currently in IND-enabling studies with a Phase 1 trial anticipated to start in 2022 and Phase 3 in 23, so Phase 2 in 23. We believe that A2342 could be a valuable treatment for hepatitis B and D and cholestatic diseases. Our research team continues to characterize 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 at Alvareo, 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 organization, spent a decade at Pfizer and a decade with Vertex. commercializing products in competitive liver and rare disease markets. Simon, our CFO, has two decades at Lilly and a decade at GSK, and I have over 20 years at BMS. We believe our individual and combined successes at 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 projects. Alboredo has successfully read out two Phase III programs. First, Alabixa 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 PEPFIC trial results for Odovixibat and PFIC. Odovixibat-PFIC study was the first Phase III study ever conducted in pediatric cholestasis, where there was no precedent on endpoints, trial design, and little natural history. We successfully enrolled and executed the Odovixibab Phase III PETFix study in PFIC. This gives us confidence in our chance for similar success with our BOLD study in bilirutresia and our SIRT study in Allosil syndrome. Preclinical track record. 83907 will be the 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 acid modulator approaches, allowing for smart pipeline expansion from rare pediatric 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 Odovixibat, taking us towards our ambition to achieve a billion dollars in sales, progressing our clinical programs in allogel and valeriatresia, and further characterizing our promising preclinical compounds. So now with that, let me turn it over to Simon to give you a quick financial update.

Simon? 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 for 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 Odovixabat. the main drivers of the increase in expenses for our lead asset were related to the PFIC regulatory submissions, as well as clinical trials for biliary atresia and allergen 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 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 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 31, 2020, we had cash and cash equivalents of $251.3 million, which compares 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 to $130 million as we advance our development programs and prepare for the anticipated PFIC launches of Odovixibat. We also anticipate 2021 revenue for Odovixibat 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 are gained, and new potential indications are launched. With that, let me turn the call back over to Ron for closing remarks. Ron?

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 in our path to a billion because of the tremendous global opportunity, our robust value proposition, and our high level of readiness and our action to expand beyond PFIC into other diseases. You know, the Alvarez opportunity is just not about Odovixibab and PFIC in the U.S. Rather, it's about building Odovixibab into a leading global product on the back of multiple indications and geographies and taking our 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.

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Hi, team. Thank you so much for taking my questions. You may have stated it, but if you could remind us again. What is the number of the ñ how big is the sales team of Travera that they have, and what is their outreach just to the pediatric hepatologists across, regardless whether they're transplants or centers or not? So if you could just give a little bit color of the depth of Salesforce and expertise that they have would be helpful. And then I have a follow-up question.

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 U.S. who are highly experienced and have longstanding relationships with the pediatric hepatologists. 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.

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

Absolutely. Look, we're absolutely really pleased at where we are with the surge. It's actually going exactly according to plan. So we have our first sites 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 of the global pandemic, and that's why we have 35 sites around the world. We'll try and use, you know, the global aspect of the study as an advantage, you know, to go to places where things open up. But, you know, as I said at the beginning, we're up and going, and we feel pretty good about our guidance for the Allergy Illicit Study.

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

Thank you, Yasmeen.

Thank you. Our next question comes from the line of Liana Muppet. with Woodbridge Securities. Please proceed with your question.

Congratulations on your progress and it was an excellent commercial day. I have two questions. So say it's 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?

All right, Leanna, thanks very much for those questions. I'll take the first one and then Pat can maybe comment on A3907. Look, Leanna, we don't want to get ahead of ourselves here, right? We're just starting, you know, 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, 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. So since we have a real opportunity here, we said, let's use our experience to really go at it hard, to really flood the zone. And that was, you know, 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. You know, I've spoken to You know, their leadership, they're very excited to be part of, you know, an exciting launch in Odovixibet. We're excited to work with them and together I think we're going to, you know, we're really going to accelerate the uptake of Odovixibet. So, let us do that first and then we'll figure out, you know, how the rest of it goes. But Pat, do you want to talk about A3907?

Yes. So, you know, A3907 is really the first systemic IVAD inhibitor. 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, we will be measuring biomarkers related to bile acids, bile acid production, and bile acid elimination.

All right. Thank you very much.

Thanks, Leanna.

Thank you. Our next question comes from Ryan of Ritu Baral with Cowan & Company. Please proceed with your question.

Hi, guys. This is Anvitao 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 NAAP, National History Study data to support the pharmacoeconomics behind the pricing at the time of approval? And then following up on Yasmin's question from earlier, could 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 U.S. and EU? Thanks.

Hi, it's Pamela. So the first question you asked around, you know, what data we'll have in hand beyond the NAFID 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 picture 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 costs. 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 had to do with the treating physicians, you know, the beauty of this relationship with Travere is they are calling on the exact same 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 hepatologists who are the specialists, but there is the broader universe of about 1100 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. And do you have – yeah.

Just to sort of loop around that a little bit, you know, from an access perspective, I think that we're very confident in our ability to gain access just on the fact that PETFIC as the PETFIC studies, the two studies between the NAPA data and the caregiver burden. So that is a good package. And we're already in dialogue with PEAR, so we feel really good about that. And as it relates to the Travere relationship, that's a U.S.-only relationship. And we'll focus just on the U.S. for that. We're not planning on any other geographies to go into partnership at this time.

Okay. Okay, great. Thank you.

Thanks very much for the questions.

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

Hey, good morning, everyone. 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 you say you're prepared for second half 21 launch of what it's about. I guess what sort of position would be in should approval come early? And does the Travier deal at all provide some buffer to help you do that should you get an approval ahead of the PDUFA?

Thank you for the question, Brian. Wouldn't it be great to have an approval early? You know, look, it's hard for me to comment on the regulatory discussion only for engaging in a very good dialogue with them. And in the event that we get an advisory committee, you know, we are 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 in a relationship with Travere is they are already out there. They are already calling on pediatric hepatologists. They already know how to navigate those special hospitals. And so in the event that we were lucky enough to have an approval earlier, you know, we'll be ready to go with the Revere team, but frankly, we'll also be ready from an Alba Rail perspective as well. So let's cross our fingers for both scenarios.

Great. Thanks, Ron.

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

Hi. Good morning. Thanks for taking our questions. For the allogeal 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 generally for the allogeal and the biliary atresia trial, can you maybe talk about the you know, potential screening failure rates, assumptions there relative to what you observed in PSIC. Thanks.

Yeah, this is Pat. So, in allogeals, our study is open to patients with mutations in both NOTCH2 and JAG1 genes, and that is almost all of the allogeal patients. So, from a genetic point of view, almost all of the allogeal patients will be eligible. In terms of screen failures, so we have assumed roughly for allogeals a similar screen failure rate that we had in the PFIC population because in order to enter, they need to have an elevated bile acid and an elevated pruritus score. Biliary atresia is a bit different, you know, so these infants, are eligible right after CASAI, 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.

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 the question and congratulations on the partnership. I know Travere team, while not large in size, is outstanding in quality and experience. I'm sure they'll be very focused on the new product. And that kind of leads to the question of will they be, distributing Otavix about through their specialty channel as well. And 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 payer hub.

And thanks very much for the question, Tim. And you're absolutely right. We're excited to be working with the Trevira team. And I know that they're excited about being part of a So, you know, think about it this way. Alvareo is responsible for all the distribution. You know, we book all the revenue. You know, this is just a simple arrangement, you know, where we pay Trivier certain fees to compensate sales representatives for their efforts for selling Oda Vixbet during the life of the co-promotion. And that's it, right? So it's very much focused on their sales team. we will take care of.

Okay, and maybe Simon, 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. We will book all of the revenue related to that. And in the operating expense line, under commercial, you would expect to see the costs related to the fee for service that we pay to Trivia will be booked there.

Okay. So we'll just work it into the SG&A, kind of the true up to their reps. Okay. Fantastic. And I guess one last question. Are you looking at any partnerships for other regions?

Not in this type of structure, right? So when I talk about this type of structure, the Trivia 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 Alvareo team, and then in other countries, such as we announced medicine in Israel, but other countries like the Middle East, parts of Southern Europe, and Latin America, we plan on engaging in relationships with you know, top quality companies in those regions. And we're well advanced in our discussions with those companies and hope to announce some more of that, you know, as the year progresses.

Great. Thank you for the question.

Thank you, Tim.

Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes from Ed Arcee with AC Wainwright. Please proceed with your question.

Hi, great. Thanks for taking my questions. Just a few for me. Firstly, on your commercial outlook, is there, well, first of all, 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 centers and other sort of academic centers, other sorts of sites. And, you know, 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 commercial lives and other Medicare, Medicaid split. And then lastly, with the ex-US markets in 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.

All right, Ed, thanks for the question. So I think your 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-prevalent countries. Let me just take the first one, and then the other two I'll let Pamela address, because this first one is pretty simple, right? So as Pamela said, there are about 100 key individuals in the U.S., right? And they're in about 60 centers, right? Then if you go down a little bit deeper, there's probably another 400 key pain leaders, prescribers, and then another 600 hospital folks. So this is a very concentrated approach. And between the Alvareo team and the Travere team, we'll be able to cover them in a very intense way from day one to try and maximize the number of patients you know, that we will get on Otavix about. And then, you know, Pamela can talk a little bit about the, you know, the mix of what we expect and then what other countries have, you know, a higher prevalence. So, maybe over to Pamela.

Hi. Sure. It's difficult for us to know in advance how, you know, what percentage of our patients will be, you know, primarily, you know, Medicaid, Medicare, But based on looking at other analogs and my own experience with other populations, you know, we think it's likely between a quarter and a third of the U.S. patients will be Medicaid patients. 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 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. I'll turn the floor back to Mr. Cooper for any final comments.

Great. Thank you, Operator. Well, thank you all for attending today's conference call. As we enter a into the new stage of the company. We'll continue to update you on our commercial planning and our overall growth and our ambition to a billion. Appreciate the attention today. We have lots of exciting near-term milestones ahead of us. Our financial position is strong, and this will enable us to continue to advance Alvarejo's 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.