Albireo Pharma, Inc. (NASDAQ:ALBO) Q3 2022 Results Conference Call November 8, 2022 4:30 PM ET
Company Participants
Hans Vitzthum – Managing Director, LifeSci Advisors
Ron Cooper – President and Chief Executive Officer
Jan Musin – Chief Scientific Officer, Head of R&D
Pamela Stephenson – Chief Commercial Officer
Simon Harford – Chief Financial Officer
Conference Call Participants
Miriam Nolan – Jefferies
Brian Skorney – Baird
Ritu Baral – Cowen
Seamus Fernandez – Guggenheim
Tim Lugo – William Blair
Andreas Argyrides – Wedbush Securities
Thomas Yip – H. C. Wainwright
Operator
Good afternoon. And welcome to the Albireo Pharma Third Quarter 2022 Earnings Call [Operator Instructions]. Please note that this conference is being recorded.
I will now turn the call over to your host, Hans Vitzthum, Managing Director of LifeSci Advisors. Thank you. You may begin.
Hans Vitzthum
Thank you, operator. This afternoon, Albireo issued a press release highlighting its recent business accomplishments and financial results for the third quarter ended September 30, 2022. This press release is accessible via the company’s Web site at 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 the company’s most recent Form 10-K and subsequent SEC filings. These filings can be accessed from the Investors section at albireopharma.com or on the SEC’s Web site. 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, Albireo’s President and Chief Executive Officer. Ron?
Ron Cooper
Thanks Hans, and thank you all for joining us this afternoon. With me today are Dr. Jan Musin, Chief Scientific Officer and Head of R&D; Pamela Stephenson, our Chief Commercial Officer; and Simon Harford, our Chief Financial Officer. It’s been another significant quarter for Albireo as we continue to develop our lead product Bylvay to reach its full potential. We’re moving fast to strengthen the value of Bylvay, 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 The Liver Meeting this past weekend.
Let me turn it over to Jan to give you an update on the data and our studies.
Jan Musin
Thanks, Ron. We had a very rich weekend at the AASLD 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 Bylvay 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 Bylvay improved native liver survival in patients with PFIC. Full data analysis showed at PFIC patients who responded to Bylvay remained liver transplant free for up to three years. Decrease in serum bile acids at six months of treatment was strongly associated with native 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 breaking oral presentation demonstrating that Bylvay restored biliary bile acid flow and was selected by AASLD for inclusion as a key presentation in the Best of Delivery Meeting in the pediatric hepatology category. This is just the first step in demonstrating native liver survival with Bylvay, and we anticipate providing additional data in the near future.
In addition, we presented data at the NASPGHAN 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 ASSERT. We announced top line data for ASSERT Phase 3 study in Alagille syndrome less than a month ago, and the R&D team has worked diligently to be able to submit the updated data set to AASLD in record time. As well, our regulatory team is working fast to file submissions in the US and Europe, trying to beat the record we set out with our PFIC submission. The ASSERT data was accepted by — 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 medical community has been interesting and very positive. For the first time, it has been demonstrated in a our Phase 3 study that an IBAT inhibitor can work across the two most prominent genetic sites in Alagille syndrome and in a wider age rate 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 PEDFIC studies with 5.9% in placebo and 11.4% in the Bylvay group.
Overall treatment-emergent diarrhea rate was also low with placebo being 5.9% and Bylvay group at 28.6%. With over 90% of patients being pruritus responders during the study as defined as at least a 1 point drop at any time point, we can provide relief to so many patients at the low therapeutic dose of Bylvay without having to cope with high diarrhea levels. Finally, I’m proud of our R&D organization for their hard work and their determination to fully enroll the BOLD Phase 3 study in biliary atresia according to our public guidance. We exceeded our target with 205 children versus 200 who are now enrolled into the largest global Phase 3 pediatric cholestatic trial ever conducted across 58 big sites around the world and during the COVID pandemic. We have had extensive discussions with regulatory bodies and decided to try to meet approval requirements. Biliary atresia is the most common pediatric liver disease and given our recent success as with our Bylvay Phase 3 studies in PFIC and Alagille 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 Bylvay can improve native liver survival in PFIC patients. It’s effective in Alagille patients, and I’m looking forward to supporting Bylvay data in biliary atresia patients. Ron?
Ron Cooper
Great. Thanks, Jan for the scientific update. Developments clearly differentiate Bylvay as a best-in-class IBAT inhibitor. And Bylvay is the only IBAT inhibitor to show efficacy across all PFIC types, including PFIC 1 in long term studies. But unlike other IBATs, Bilbay has a low therapeutic dose, is given once a day and easy to administered capsules or sprinkles that could be combined with food or liquids. Bylvay has demonstrated a low drug related diarrhea rate that’s only a little above placebo in two placebo controlled trials, for evaluating Bylvay in Phase 3 studies in PFIC, Alagille syndrome and now a third one in Biliary atresia. With biliary atresia, the opportunity is roughly the size of PFIC and Alagille combined. We expect Bylvay to be first to market with a positive outcome of the BOLD study. What does all this means? 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 Alagille syndrome. We’re already seeing this in the Bylvay launch in PFIC with an excellent Q3. So let me turn it over to Pamela to provide more details on the quarter. Pamela?
Pamela Stephenson
Thanks, Ron and good afternoon, everyone. We are delighted with Bylvay’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 Bylvay 7.5 million net product sales in Q3 and what we’re seeing on the commercial front. We now have a total of 270 Bylvay 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 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 inline 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 Bylvay a global product, and the HCPs believe in this product and see that the real world use is inline or even better than what was seen in clinical trials. Furthermore, our speed and 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 Bylvay’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 Alagille syndrome and eventually in biliary atresia. Bylvay continues to receive high clinical ratings from European payer health technology assessment based on our Phase 3 trial results, demonstrating its unique approach, early rapid and sustained benefit, as well as favorable tolerability. HCPs in Europe believe in Bylvay 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 AASLD.
Let’s take a closer look at the US. We are seeing an increased demand in the US, 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 have had the most success in the accounts where HCPs understand how Bylvay 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 US sales force 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 US prescriber base. As our launch of PFIC continues to progress, the company is preparing for another Bylvay launch this time for Alagille syndrome, following the impressive Phase 3 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 Alagille syndrome and eventually in biliary atresia. In Europe, we have had ongoing meetings and dialog with all the major payer and reimbursement authorities, which gives us a leg up for what to anticipate in Alagille.
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 US, 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 Alagille indication.
Now I’ll hand the call over to Simon to cover our financial review. Simon?
Simon Harford
Thank you, Pamela. Let me summarize our financial results for the third quarter of 2022. Bylvay global net product revenue was $7.5 million in the quarter, up from $1.1 million in the same quarter last year. US 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 months repricing period in Germany. We are very pleased with the revenue in Q3, but for the time being and leaving 2022 Bylvay 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. Cost of product revenue was $0.6 million for the third quarter of 2022 compared with $0.4 million in the prior year quarter. Following approval of Bylvay certain manufacturing and quality headcount costs are now included in cost of 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 for 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 Bylvay, 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 ‘21 was due to the net proceeds from the 1 time sale of the priority review voucher for Bylvay. We entered in September into a royalty monetization agreement with Sagard Healthcare Partners for a total net amount of $111.6 million upfront in return for a mid single digit average royalty rate on Bylvay global annual net revenues if all three indications are approved. These additional resources provide us with the means to further develop Bylvay 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 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.
Ron Cooper
Thank you, Simon. With Bylvay, we have a product with a best-in-class profile and stellar clinical data. This puts the company in the strong place with total Bylvay patients increasing a strong third quarter sales, solid cash position, two successful Phase 3 studies in PFIC and Alagille syndrome and another ongoing Phase 3 in biliary atresia now fully enrolled, continue to be on a steady pace to drive our aspiration of making Bylvay a billion dollar drug in the second half of the decade, key for us to take Bylvay from a PFIC 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 2 and Phase 1 trials respectively. The strong portfolio and financial position we have a tremendous opportunity and will remain focused on our growth drivers. We thank everybody for joining us and pleased to open the call now for Q&A. Operator?
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Eun Yang of Jefferies.
Miriam Nolan
This is Nolan on for Eun, 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 Bylvay would be used to bridge the gap to liver transplant?
Ron Cooper
First, we are pretty excited about getting the BOLD trial fully enrolled. This is the largest study in pediatric cholestasis. And right now, when you think about these children with biliary atresia, it’s really terrible for these families, right, because they have their baby, they have this procedure. And then the parents will ask what treatments are available, and there are no treatments available. And so the only thing they can really look towards is sometime in the future a liver transplant. And so what we are hoping with Bylvay is that we bring hope to those families and those children by changing that course, right? So either delaying a transplant for the child who’s even healthier or potentially even preventing that transplant. So we are looking forward to getting that data in 2024.
Operator
Our next question comes from Brian Skorney of Baird.
Brian Skorney
Just want to kind of look at the numbers that you have in your corporate deck in terms Bylvay patients, reimbursed patients. So I’m just wondering if I kind of like look at the end — coming out of each of the last quarter 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 if I kind of stepwise look at it 5.5, 7.5 would kind of imply like 9.5 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?
Simon Harford
What I would say to you, Brian, is obviously, it is not a direct correlation, it is more an indicator of direction of travel and trends for future revenue, on the basis that as we have 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 individual revenue, particularly at this point still in the launch. So there will be some variability from time-to-time. But certainly, the trend is there to help you understand that we are going in an upward direction overtime.
Brian Skorney
And then maybe just a follow-up to your point on sort of that variability. As you get more patients sort of under reimbursed, do you sort of see more consistent net pricing per patient and sort of that choppiness that we saw over the first couple of quarters? Do you think we are at a point where it’s sort of a more reliable average?
Simon Harford
So I think it’s becoming more reliable, because ultimately you are right sort of the critical mass overtime 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 little bumpy mix, is the way I should maybe put it in terms of revenue for a few quarters to go.
Ron Cooper
Thank you for the questions, Brian. 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 Simon is speaking about that, that’s what kind of reflects to that tenfold variability quarter-to-quarter.
Operator
Our next question comes from Ritu Baral of Cowen.
Ritu Baral
Thanks for taking the question. And it was good to see you at the conferences this last weekend. I wanted to ask about your data that you 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 condition. Can you talk to what that might be — what it might mean for clinicians and their — especially the US physicians and their perspective [Technical Difficulty] pruritis drug versus Bylvay as a drug that could prolong liver survival?
Ron Cooper
Ritu, pleasure to see you as well. You were chopping in and out a little bit, but I think what you were saying is on the data that we presented on native liver survival with building PFIC, what does that kind of mean to US prescribers and how do you think that they will — how they will do it, right? Is that what you’re saying?
Ritu Baral
Yes, especially given the partial responder class as part of that dataset.
Ron Cooper
So I think what’s interesting is it’s the same types of patients around the world, it’s the same Phase 3 data. There is some different utility in different geographies. And what we find is when physicians really understand that Bylvay has the potential not only to improve their symptoms, but also to help with preserving livers over time that’s where they get really compelled to do things. And I think what we were excited about the data that was presented this past weekend, particularly if you look at the PFIC 2 patients, there’s really no difference between the full responders and partial responders, right? And remember these responder definitions is what we’ve created when the partial responders often did, it’s a pretty smart 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 we presented this past weekend.
Ritu Baral
And is that something that you can take to FDA to change label language? I mean, it was a pretty compelling presentation.
Ron Cooper
Yes, it was. Thank you for the complement. It was a compelling presentation. 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. So as these data sets mature, I think, there’d be a time where we’ll get into a dialog with regulatory authorities, given their reactions to the data and we’ll take it from there.
Operator
Our next question comes from Seamus Fernandez of Guggenheim.
Seamus Fernandez
So Ron, one question for you is, just how you see the opportunity in Europe, in particular, as you bring on the Alagille indication? It seems like there is an opportunity with established reimbursement to capitalize on that market and potentially secure reimbursement prior to the competitor who maybe 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 are likely to see data and what you are most excited about in the earlier stage pipeline?
Ron Cooper
Actually, maybe on 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?
Pamela Stephenson
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 have been given, and just have experience and we sort of know the questions that they’ll be asking. So as we head into Alagille, 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 need 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.
Ron Cooper
And I would just add, Seamus, if you kind of think about these European countries place-by-place, we’re going there with Phase 3, with the ASSERT data, which looks really well. We received, as Pamela said, great indications and good ratings with the PFIC data. We already have contracts in place by that time in most countries. We have a sales force in place. We should be able to go pretty quickly there. So we look forward to that. Then as it relates to the early stage pipeline, I think what we are excited about, these are real drugs, right? A3907 is the world’s first and only systemic ASBT inhibitor. A2342 is the world’s first and only oral NTCP inhibitor. A3097, we’ll be going into a Phase 2 study. A2342, we’ll be going into a Phase 1 study. And we anticipate having some data next year. And so what we’re pretty excited about is these drugs don’t long go, were just ideas, but Jan and the team have done a great job in advancing these products. We are coming into some studies that are really going to tell us an awful lot about the potential for these important new medicines.
Operator
Our next question comes from Tim Lugo of William Blair.
Tim Lugo
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 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 is pointing in that direction. But maybe what’s kind of the time frame before the community comes around to see Bylvay as is truly disease modifying therapy versus maybe some in the communities 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?
Ron Cooper
I think, this is always this classic question when you’re at these scientific meetings, the longer is always better. But I think in this case, I think, the real question is like will you reverse liver disease, right, which is a very high bar, right? And I don’t know if we or anybody will be able to show that over a long time frame. 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 given 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.
Tim Lugo
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 a certain number of months?
Pamela Stephenson
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 have final reimbursement. And our history to date has been that those patients in the countries when we get reimbursement have transitioned.
Operator
Our next question comes from Andreas Argyrides of Wedbush Securities.
Andreas Argyrides
So for Bylvay and PFIC, you mentioned patient weight is normalizing. Are you still seeing that as being prescribed more in younger patients? And where do we see the biggest impact and recent growth coming from? And then I have a follow up.
Pamela Stephenson
So what we’re seeing is with a patient weight, so 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 Bylvay. And because the overall number of Bylvay patients is increasing, 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.
Andreas Argyrides
And with the strong gold standard data, as Ron likes to say, in Alagille syndrome. When we Bylvay differentiating from those competitors when launched the US and EU? Is it in the under one year old population, or would the meaningful safety difference on diarrhea encourage switching?
Ron Cooper
Well, I think first of all, Andreas, this is the first time that you see Phase 3 data, randomized placebo controlled data. And if I take the reaction of the both the US and the international community at the AASLD 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 there are both mutation types in this database. It’s the fact that it is a wider range of patients. It’s the fact that the effects were seen very early and that they were sustained across overtime. And then to your point on the tolerability, we are just absolutely delighted about the diarrhea, being 5.9% in the placebo group and 11.4% in the Bylvay group. And that was consistent with what we saw with the PFIC patients as well, right? So if you look at that totality of the database, I don’t think it’s one thing, it’s multiple things that are driving. Then you throw on top of that just the drug itself, Andreas. When we talk to the physicians, the fact that it’s once-a-day, always once, 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 and I think that’s what’s exciting both the US physicians and the international physicians.
Operator
Our next question comes from Ed Arce of H. C. Wainwright.
Thomas Yip
This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. Perhaps a couple from us. Assuming Bylvay’s approval for US and EU, what would you highlight as the most important aspects and a potential commercial launch in those two areas?
Ron Cooper
A little bit of what I said before previously, Thomas. I think it’s Phase 3 data, unequivocal data and just the breadth and depth of that data across different patient types. There are sort of different mutations, wide range of patients, rate 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.
Thomas Yip
And then perhaps one question for biliary atresia with both [indiscernible] [completely] enrolled. How should investors look at the market opportunity as you mentioned there’s a much larger market compared to PFIC and Alagille even combined? Can you outline some major differences that you anticipate in commercial strategy in biliary atresia versus the other two indications?
Ron Cooper
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 Alagille and for biliary atresia. We built out a commercial structure in the US and Europe that covers that audience and covers it very well. So we are not going to require much incremental resources to get at these customers. And so as we get to biliary atresia, which as you said is the biggest opportunity, we take that, that’s really becomes a game changer for us, right? It can really accelerate our business.
Thomas Yip
Got it. Thank you again for taking our questions, and looking forward to progress in Alagille regulatory filing.
Operator
We have reached the end of our Q&A session. I will now turn the call over to Ron for closing remarks.
Ron Cooper
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 as planned. And I thank each and every one of our employees for their commitment, drive and innovation. Continue to keep you updated as we advance Albireo’s mission to provide hope to patients and families impacted by these devastating liver diseases. Thank you all for your continued support.
Operator
This concludes today’s conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.
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