Albireo Pharma, Inc.

Good afternoon and welcome to the Albarrio Pharma third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star then zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to your host, Hans Witzem, Managing Director of LifeSci Advisors. Thank you, you may begin.

Thank you, operator. This afternoon, Albareo issued a press release highlighting its recent business accomplishments and financial results for the third quarter ended September 30th, 2022. This press release is accessible via the company's website at albareopharma.com. Before proceeding, we would like to note that the 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 investor section at albareofarma.com or on the SEC's website. Any forward-looking statements represent our views as of today, November 8, 2022, and should not be relied upon as representing our views as of any subsequent dates. We undertake no obligation to publicly update these statements. Now, it is my pleasure to turn the call over to Ron Cooper, Albareo's President and Chief Executive Officer. Ron?

Well, thanks, Hans. And thank you all for joining us this afternoon. With me today are Dr. Jan Motsen, Chief Scientific Officer and Head of R&D, Pamela Stevenson, our Chief Commercial Officer, and Simon Hartford, our Chief Financial Officer. It's been another significant quarter for Alvareo as we continue to develop our lead product, Bilvey, to reach its full potential. We're moving fast to strengthen the valuability both on the clinical evidence front and on the commercial front. Revenues have accelerated this quarter, which is exciting as we anticipate gaining access to more patients in additional diseases. We're also excited to present new top quality data at the AASLD deliver meeting this past weekend. Let me turn it over to Jan to give you an update on the data and our studies. Jan? Thanks, Ron.

We had a very rich weekend at the Yale team meeting with three oral presentations, including two late breakers and six posters. I would specifically like to draw your attention to three important clinical study achievements. Starting with disease modification and native liver survival, we have always believed that Bilvay would be a drug that would improve both the symptoms of cholestatic liver diseases as well as modify the natural course of the diseases. As you can appreciate, it takes a little bit of time to generate data for the latter, but we are moving with urgency, and the first data set is now available. In scientific sessions, we presented in an oral session data demonstrating that Bilvay improved native liver survival in patients with PFIC. Full data analysis showed that PFIC patients who responded to Bilvay remained liver transplant-free for up to three years. Decrease in serum bile acids at six months of treatment was strongly associated with negative liver survival for serum bile acid responders versus non-responders, with a p-value of 0.005. Responders also had mean improvements in liver function parameters. All PFIC bile acid responders and all pruritus responders remained transplant-free for up to three years. In addition, there was a late a breaking oral presentation demonstrating that Bilvay restored biliary bile acid flow and was selected by ASLD for inclusion as a key presentation in the best of the liver meeting in the pediatric hepatology category. This is just the first step in demonstrating native liver survival with Bilvay, and we anticipate providing additional data in the near future. In addition, we presented data at the NASP again annual meeting last month, which supports treating children as early in the disease as possible, even with mild pruritus, could result in greater efficacy and preserve the native liver. Another great clinical achievement is the CERT. We announced top-line data for the CERT phase 3 study in allergy syndrome less than a month ago, and the RNC team has worked diligently to be able to submit the updated data set to ASLD in record time. As well, our regulatory team is working fast to find submissions in the U.S. and Europe, trying to beat the record we set out with our PFIC submission. The assert data was accepted by ASLD as a late-breaking oral presentation and was selected as a key presentation in the best-of-the-liver meeting in the pediatric hepatology category. The response from the medical community has been enthusiastic and very positive. For the first time, it has been demonstrated in a phase 3 study that an iBET inhibitor can work across the two most prominent genetic types in Alladil syndrome and in a wider age range of patients to achieve the combination of improved pruritus, reduced bile acids, and improved sleep with a low drug-related diarrhea rate. Drug-related diarrhea was similar to what we saw with the PETFIX studies. with 5.9% in placebo and 11.4% in the Bilvey group. Overall treatment of urgent diarrhea rate was also low, with placebo being 5.9% and Bilvey group at 28.6%. With over 90% of patients being pruritus responders during this study, as defined as at least a one-point drop at any time point, we can provide relief to so many patients at the low therapeutic dose of Bilve without having to cope with high diarrhea levels. Finally, I'm proud of our R&D organization for their hard work and determination to fully enroll the Bold Phase III study in Bilartricia according to our public guidance. We exceeded our target with 205 children versus 200. who are now enrolled into the largest global phase III pediatric cholestatic trial ever conducted across 58 sites around the world and during the COVID pandemic. We have had extensive discussions with regulatory bodies and designed the trial to meet approval requirements. Filiartricia is the most common pediatric liver disease, and given our recent success with our Bill Bay phase III studies in PFIC and halideal syndrome, We feel confident of a positive outcome and look forward to a top-line data readout in 2024. So to conclude, I'm pleased to share with you new evidence that Bilvay can improve native liver survival in pediatric patients. It's effective in allogel patients, and I'm looking forward to supporting Bilvay data in benartricia patients. To you all.

Great. Thanks, Jan, for the scientific update. DEVELOPMENTS CLEARLY DIFFERENTIATE BILVE AS A BEST-IN-CLASS IBAT INHIBITOR. BILVE IS THE ONLY IBAT INHIBITOR TO SHOW EFFICACY ACROSS ALL PFIC TYPES, INCLUDING PFIC 1 IN LONG-TERM STUDIES. UNLIKE OTHER IBATS, BILVE HAS A LOW THERAPEUTIC DOSE, IS GIVEN ONCE A DAY IN EASY-TO-ADMINISTRATE CAPSULES OR SPRINKLES THAT CAN BE COMBINED WITH FOOD OR LIQUIDS. has demonstrated a low drug-related diarrhea rate that's only a little above placebo in two placebo-controlled trials. We're evaluating bilvate in phase three studies in PFIC, allongeal syndrome, and now a third one in biliary atresia. With biliary atresia, the opportunity is roughly the size of PFIC and allongeal combined. We expect bilvate to be first to market with a positive outcome of the BOLD study. What does all this mean? It means we have a product that is approved for PFIC, convenient for patients with excellent tolerability, addressing a broader patient population across many mutation types, and a stellar clinical data supporting its potential approval in allogeal syndrome. We're already seeing this in the bill they launch in PFIC with an excellent Q3. So let me turn it over to Pamela to provide more details on the quarter. Pamela?

Thanks, Ron, and good afternoon, everyone. We are delighted with Bilvay's ongoing global launch, the first and only FDA-approved medication for patients with PFIC, benefiting more patients around the world. Today, I'll share further color on Bilvay's 7.5 million net product sales in Q3 and what we're seeing on the commercial front. We now have a total of 270 Bilvay patients, which is 25 more patients compared to the previous quarter. We increased the number of reimbursed patients by more than 25%, with 27 new patients giving a total of 126. These patients account for the $7.5 million in revenue, and we have another 144 patients, 77 pending reimbursement, and 67 rollover patients who are on the drug who are on drugs that we expect to be revenue generated in the future. Revenues are continuing to trend up, and we are starting to see the annuity we mentioned last quarter. The weight variability is normalizing over time as expected. The discontinuation rate is in line with expectations and rates observed with comparable products in rare disease. Overall, prescribers see the benefits of our treatment, its efficacy, and its advantages with convenience for caregivers and families with the once daily easy administration of the drug and its favorable tolerability profile. Let's start with the international business, especially in Europe, where we are excelling on delivering on our promise to make Bilve a global product. And the HCPs believe in this product and see that the real world use is in line or even better than what was seen in clinical trials. Furthermore, Our speed in execution on pricing and reimbursement, demand generation, and scientific exchange has been optimal. And again, you see it translate into patient capture and revenue growth. We are continuing to grow in the European market with Bilvey's reimbursement confirmed in five European markets, Germany, the UK, Italy, Belgium, and recently in France. This strong platform will serve us well as we plan to launch our product in allogeal syndrome and eventually in biliary atresia. Bilvay continues to receive high clinical ratings from European payer health technology assessments based on our phase three trial results, demonstrating its unique approach, early rapid and sustained benefit, as well as favorable tolerability. HCPs in Europe believe in Bilvay as a liver drug and are understanding its potential to preserve native liver as demonstrated by our disease modification label in Europe and our long-term data just presented at AISLD. Let's take a closer look at the U.S. We are seeing an increased demand in the U.S., mostly because of our relentless work in the field. We continue to steadily increase the number of unique prescribers each quarter since launch, adding 13 new HCPs in Q3 to bring our total unique prescribers to 86. We've had the most success in the accounts where HTPs understand how well they can treat a symptom of the underlying liver disease and act with urgency to treat their PFIC patients. As a result, we are dialing up and deploying strong urgency to treat disease education programs and aligning our U.S. Salesforce and MSL resources to accounts where we need to help clinicians understand the importance of treating pruritus immediately, even in mild cases. This additional resource allocation should help continue to accelerate our expanding U.S. prescriber base. As our launch in PFIC continues to progress, the company is preparing for another bill they launch, this time for Allergy Syndrome, following the impressive Phase III data. We are excited to take learnings and opportunities from the PFIC launch. The treating physicians are the same in both indications. and the benefits they are seeing for PFIC patients should translate into prescriptions in allogeal syndrome and eventually in biliary atresia. In Europe, we have had ongoing meetings and dialogue with all the major payer and reimbursement authorities, which gives us a leg up for what to anticipate in allogeal. Furthermore, the total global market opportunity is larger than PFIC, and we believe that every 10 points of market share is worth somewhere between $50 million to $100 million. We expect to be launching in most European countries at a similar time as the other iBAT inhibitor, giving our already strong pricing reimbursement position, and in the U.S., even as a second entrant, we expect to capture a valuable market share. I will close by saying that the real-life experience for physicians and patients across many different types of PFIC patients has been overwhelmingly positive. and we are looking forward to being able to gain access to more patients with an allogeal indication. Now I'll hand the call over to Simon to cover a financial review. Simon?

Thank you, Pamela. Let me summarize our financial results for the third quarter of 2022. Bill Bay Global Net Product Revenue was $7.5 million in the quarter, up from $1.1 million in the same quarter last year. U.S. revenue was $4.1 million, and international revenue was $3.4 million. As we look forward to the end of the year, there will be an impact on Q4 international sales, as we are now outside of the 12-month free pricing period in Germany. We are very pleased with the revenue in Q3, but for the time being, are leaving 2022 bill their revenue guidance at $24 million. Royalty revenue was $2.3 million for the third quarter of 2022, compared with $2.6 million in the same period of 2021, resulting in a decrease of $0.3 million. The decrease relates to estimated royalty revenue, which is passed on to healthcare royalty partners. to product revenue was 0.6 million dollars for the third quarter of 2022 compared with 0.4 million in the prior year quarter following approval of build a certain manufacturing and quality headcount costs are now included in cost to product revenue there were no material costs as materials related to current products sold were expensed prior to approval Research and development expenses were $23.3 million for the three months ended September 30, 2022, compared with $21.1 million the same period in 2021, an increase of $2.2 million. The increase in research and development expenses was principally due to clinical program activities. Selling, general, and administrative expenses were $20.6 million for the third quarter compared to $17.6 million last year in Q3, an increase of $3 million. The increase is attributable to personnel and related expenses as we continue to increase our headcount and commercialization activities related to Bilvey, including our sales force and support for global expansion efforts. Net loss for the third quarter of 2022 was $37.8 million, or a loss of $1.92 per share, compared to net income of $57.1 million, or income of $2.90 per share, on a fully diluted basis for the third quarter of 2021. Net income in Q3 2021 was due to the net proceeds from the one-time sale of the priority review voucher for Bilvey. We entered in September into a royalty monetization agreement with Cigard Healthcare Partners, for a total net amount of $111.6 million up front in return for a mid-single-digit average royalty rate on BILVE global annual net revenues if all three indications are approved. These additional resources provide us with the means to further develop BILVE into a billion-dollar product for the treatment of additional rare cholestatic liver diseases. The agreement is treated as debt for financial reporting purposes. As a result, the net proceeds from the upfront fee are recorded on the balance sheet rather than the income statement. The only impact of the income statement is related to the revenue interest liability under interest expense. The company had cash, cash equivalents, and restricted cash of $272.5 million as of September 30, 2022. The company expects this total cash to be sufficient to extend our runway beyond at least the top line data readout of our bold study in biliary atresia in 2024 based on current revenue and expense projections. With that, let me turn it back to Ron for closing remarks.

Well, thank you, Simon. With Bilvey, we have a product with a best-in-class profile and stellar clinical data. This puts the company in a strong place. With total Bill Bay patients increasing, a strong third quarter sales, solid cash position, two successful phase three studies in PFIC and allogel syndrome, and another ongoing phase three in biliary atresia now fully enrolled. Continue to be on a steady pace to drive our aspiration of making Bill Bay a billion dollar drug in the second half of the decade. Key for us is to take Bilvay from epiphytic medicine to a leading pediatric cholestatic liver disease drug. We continue to progress our early assets in adult liver disease with A3907 and A2342, which will go into phase two and phase one trials, respectively. This strong portfolio and financial position, we have a tremendous opportunity and will remain focused on our growth drivers. We thank everybody for joining us. We're pleased to open the call now for Q&A. Operator?

Thank you. We will now begin the question and answer session. To join the question queue, you may press star, then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, then 2. We will pause for a moment as callers join the queue. Our first question comes from Yun Yang of Jefferies.

Please go ahead. Hi, this is Nalin on for you, and thank you very much for taking our question. We have one on biliary atresia, please. So we've heard that most pediatric patients get liver transplant as an only curative option. Is it reasonable to assume that bilve would be used to bridge the gap to liver transplant? Thank you.

Thanks, now.

First, we're pretty excited about getting the BOLD trial fully enrolled. You know, this is the largest study in pediatric cholestasis. And right now, when you think about these children with biliary atresia, you know, it really is, it's really terrible for these families, right, because they have their baby, they have this Casai procedure, and then, you know, the parents will ask, well, what treatments are available? And there are no treatments available. And so the only thing that can really look look towards is sometime in the future a liver transplant and so what we're hoping with with bilbao is that we bring hope to those families and those children by changing that course right so either delaying a transplant so the child is even healthier or potentially even preventing that that transplant so we're looking forward to getting that data in 2024. thank you

Our next question comes from Brian Scorny of Baird.

Please go ahead.

Hey, good afternoon, guys. Thanks for taking the question. Just want to kind of look at the numbers that you have in your corporate back in terms of bill day patients, reimbursed patients. I'm just wondering if I kind of like look at the end, coming out of each of the last quarters, just sort of do a back of the envelope calculation against the reimbursed patients. at sort of the expected net launch price, it sort of matches up with the next quarter. So I guess, you know, if I kind of stepwise look at it, you know, five and a half, seven and a half, it would kind of imply like nine and a half for fourth quarter based on the 126 rolling out of this quarter. Can you help us understand, is that sort of the right way to think about what those reimbursed patients represent in terms of projecting revenue?

So what I would say to you, Brian, is obviously there's not a direct correlation. It is more an indicator of direction of travel and trends for future revenue on the basis that, as we've discussed many times, you have everything from six-month-old children all the way up to sort of teenagers, which have quite a widespread in terms of um individual revenue particularly at this point still in in the launch so there will be some variability from um time to time but certainly the trend is there to help you understand that we're going in an upward direction over time great and then maybe just a follow-up to your point on sort of that that variability is you get more patients sort of under uh reimbursement

do you sort of see more consistent net pricing per patient than sort of that choppy mass that we saw over the first couple of quarters? Do you think we're at a point where it's sort of a more reliable average?

So I think it's becoming more reliable because ultimately you're right, sort of the critical mass over time should sort of average things out to a greater extent. But that's not to say there couldn't still be some bumps along the road from a little bumpiness is the way I should maybe put it in terms of revenue for a few quarters to go.

Got it. Thanks. That's helpful. I'll hop back in the queue.

Thank you for the questions, Brett. Implicitly, if you look at the value between a child versus a teenager and adult, it's really 10 times the difference, right? So When Hyman is speaking about that, that's what kind of reflects to that potential variability quarter to quarter.

Our next question comes from Rito Baral of Cohen.

Please go ahead.

Good afternoon, guys. Thanks for taking the question. And it was good to see you at the conference this past weekend. I wanted to ask about your data that you collected. presented on the partial serum bile acid responders. It was pretty intriguing as to what it might mean for potential liver survival across the cholestatic conditions. Can you talk to what that might mean for clinicians and especially the US physicians and their perspective a pruritus drug versus Bilvay as a drug that could prolong liver survival.

Well, hi, Ritu. Yeah, pleasure to see you as well. You were chopping in and out a little bit, but I think what you were saying is in the data that we presented on native liver survival with Bilvay and TIFIC, what does that kind of mean to U.S. prescribers, and how do you think they will do it, right?

Especially given the partial responder class as part of that data set.

So, I think what's interesting is it's the same types of patients around the world. It's the same phase three data. There is some different utility in different geographies. And what we find is when physicians really understand that building has the potential not only to improve their symptoms, right, but also to help with preserving livers over time. That's where they get really compelled to do things. So I think what we were excited about the data that was presented this past weekend, particularly if you look at the PFIC2 patients, there's really no difference between the full responders and partial responders, right? And remember, these responders and responder definitions is what we've created with the partial responder definition. It's a pretty strict definition. The partial responder definition expands that definition. The net of that is it doesn't really matter if you're a partial responder or a full responder. You seem to do pretty well in PFIC with your native liver survival based on the data presented this past weekend.

Got it. And is that something that you can take to FDA to, you know, change label language? I mean, it was a pretty compelling presentation.

Yeah, it was. Thank you for the compliment. It was a compelling presentation. You know, I think as Jan has said in the prepared comments, this is just the first of other datasets that we're creating and working on. You know, as these data sets mature, you know, I think there'll be a time where we'll get into a dialogue, you know, with regulatory authorities, you know, give their reactions to the data, and we'll take it from there.

Got it. Thanks for taking the question.

Thank you, Ritu.

Our next question comes from Seamus Fernandez of Guggenheim. Please go ahead.

Great. Thanks for the question. So, Ron, one quick one question for you is just how you see the opportunity in Europe in particular as you, you know, bring on the allogeal indication. You know, it seems like there's an opportunity with established reimbursement to capitalize on that market and potentially, you know, secure reimbursement prior to the competitor who maybe, you know, is going to be in the market a little bit earlier with the indication but not necessarily reimbursement. And the second question is just in terms of the pipeline and the earlier stage pipeline, can you guys update us on how you're planning to kind of progress products in those markets in particular and when we're likely to see data and what you're most excited about in the earlier stage pipeline?

Thanks.

All right.

Thank you, Seamus. Actually, maybe the first question in regards to Europe, I'll let Pamela comment first, and then I'll talk a little bit about how we see the pipeline evolving. So, Pamela?

Sure. Hi, Seamus. The first thing I would say is we have a lot of experience with payers in Europe and are pleased with the high assessments, clinical assessments that we've been given, and just have experience, and we sort of know the questions that they'll be asking. So, As we head into AllerGeal, we think this certainly gives us a good advantage in terms of being able to quickly submit the reimbursement dossiers to get the type of high clinical ratings that's needed to secure favorable pricing and reimbursement. And we already have the contracts in place with many of these large payers. And so we expect that process to go quite well and quite smoothly.

And I would just add, Seamus if you kind of think about you know these European countries place-by-place You were going there with phase three data with the assert data, which looks which looks really well We receive as panelists at great indications and good ratings with the PFIC data We already have contracts in place by that time in most countries. We have a we have a Sales force in place. We should be able to go pretty quickly there so we look forward to that and as it relates to the to the early stage pipeline and I think what we're excited about, these are real drugs, right? A3907 is the world's first and only systemic ASPT inhibitor. A2342 is the world's first and only oral NTCP inhibitor. A397 will be going into a Phase II study. A2342 will be going into a Phase I study. And we anticipate having some data next year. What we're pretty excited about is these drugs not long ago were just ideas, but Jan and his team have done a great job in advancing these products. We're coming into some studies that are really going to tell us an awful lot about the potential for these important new medicines.

Our next question comes from Tim Lugo of William Blair.

Please go ahead.

Thank you for taking this question. And I guess just expanding on the liver survival data, I believe the presenter mentioned that, I guess the quote was, only time will tell before we know that, you know, this is truly a disease-modifying therapy. And it sounds like Jan is kind of working on more data around this. Can you just maybe expand upon that timeframe? I agree with the presenter. Everything's pointing in that direction, but maybe what's kind of the timeframe before the community comes around to seeing Belvay as this truly disease-modifying therapy versus maybe some of the community just viewing as a symptomatic therapy? Can you just maybe give us, is this a one-year, is this a two-year timeframe? What do you believe?

Yeah, I think thanks for the question, Tim. You know, I think this is always this classic question when you're at these scientific meetings. Longer is always better. But I think in this case, I think the question, you know, the real question is like, you know, will you reverse liver disease, right? Which is a very high bar, right? And, you know, I don't know if we or anybody will be able to show that over a long timeframe. So, that's sort of the ultimate, right? I think now that we have data that goes three years and we'll have more data over time, I think many of the community members believe that this is really important data that we are, in fact, we should be giving data to show that we improve native liver survival. And I know that the presenter in this case is a strong believer in that as well. So, we believe we're modifying the disease, right? And that's what's most important. To be able to say you're reversing the disease, I don't know if anybody's going to be doing that. It's going to be a bar that's very high.

Completely understood. And I guess just more commercially talking, it sounds like 77 patients are pending reimbursement. I know we're still early into the launch, but has there been any leakage of those patients kind of since the beginning of the launch, or should we just assume that those 77 patients will eventually go on to reimburse therapy over, you know, a certain number of months?

You know, you can assume that those patients will go on to therapy. There's been no leakage. Those patients are literally in countries where we don't yet, you know, have final reimbursement, and our history to date has been that those patients in the countries when we get reimbursement have transitioned.

Understood. Thank you for the clarity.

Thank you, Tim.

Our next question comes from Andreas Argarides of Wedbush Securities. Please go ahead.

Good afternoon, and congrats on the progress during the quarter. So for building in PFIC, you mentioned patient weight is normalizing. Are you still seeing that? Is it being prescribed more in younger patients? Where do you see the biggest impact of recent growth coming from?

And then I have a follow-up.

So what we're seeing is, you know, with the patient weights, if I understand your question correctly, is we're seeing younger patients and older patients. So we're seeing a good variability of patients coming on to Bilvay. And, you know, because the overall number of Bilvay patients is increasing, you know, the sort of the impact of the individual fluctuations will sort of subside over time. And overall, the number of patients of revenue will increase.

Okay, great.

With a strong gold standard data, as Ron likes to say, and not an algea syndrome, when you see building differentiating from a competitor when launched in the U.S. and EU, is it in the under one-year-old population or would meaningful safety difference on diarrhea encourage switching?

Well, I think, first of all, you know, Andreas, you know, this is the first time that you see phase three data, randomized placebo-controlled data, and if I take, you know, the reaction of both the U.S. and the international community at the ASLD liver meeting this past week, and they're pretty excited to have that. So, it's not one thing. It's a range of things. It's the fact that, you know, there are both mutation types in this database. It's the fact that it is... wider range of patients it's the fact that the effects were seen very early and that they were sustained across over time and then to your point on the tolerability you know we're just absolutely delighted about the diarrhea rates you know being you know 5.9 in the placebo group, and 11.4 in the bilbaic group. And that was consistent with what we saw with the PFIC patients as well, right? So, you know, if you look at that totality of the database, I don't think it's one thing. It's multiple things that are tried. Then you throw on top of that just the drug itself. Andres, you know, when we talk to the physicians, the fact that it's once a day, always once a day, it's a low dose. It's a capsule that can be taken as a capsule or mixed with food or mixed with water. You put that package together. I think that's what's exciting, both the U.S. physicians and the international physicians.

Okay, great. Yeah, exciting indeed. Congrats again on the progress.

Thank you, Andreas.

Our next question comes from Ed Arce of H.C. Wainwright. Please go ahead.

Thomas Yip Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. There are a couple from us. Assuming Bell Bay's approval for GEO and US and EU, what would you highlight as the most important aspects in a potential commercial launch in those two areas?

It's a little bit like what I said before previously, Thomas. I think it's phase three data, unequivocal data, and just the breadth and depth of that data across different patient types, different mutations, wide range of patients, great sleep, great sustained effect. So I think that's what we'll speak about. And then just the implicit qualities of the drug itself, always once a day, always low dose. easy to give with food or in the capsule or in the liquid, and a very reasonable tolerability profile. We think that is a best-in-class profile, and that's what's going to be attractive.

Understood.

And perhaps one question for Billy or Trisha with both studies, as you pointed out completely, and Rhodes. How should investors look at the market opportunity? As you mentioned, it's a much larger market compared to PFIG and Algeo even combined. Can you outline some major differences that you anticipate in commercial strategy in Hillary and Tricia versus the other two indications?

Well, that's the beauty of our business model. Thomas, when you really think about it, it's the same doctors that prescribe for PFIC, for Allergil, and for bilirutresia. We built out a commercial structure in the US and Europe that covers that audience and covers it very well. So we're not going to require much incremental resources to get at these customers. And so as we get to bilirutresia, which, as you said, is the biggest opportunity, You know, we think that that really becomes a game changer for us, right, that can really accelerate our business.

Got it. Thank you again for taking our questions and looking forward to progress in LSU.

We have reached the end of our Q&A session.

I will now turn the call over to Ron for closing remarks.

Great. Thank you, operator. Thank you all for attending today's conference call. I'm really proud of our organization's ability to deliver and execute this plan, and I thank each and every one of our employees for their commitment, drive, and innovation. Continue to keep you updated as we advance Alvareo's mission to provide hope to patients and families impacted by these devastating liver diseases. Thank you all for your continued support.

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.