Albireo Pharma, inc (ALBO) Q2 2021 Earnings Call Transcript

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Albireo Pharma, inc (ALBO)
Q2 2021 Earnings Call
Aug 6, 2021, 2:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to the Albireo Pharma Second Quarter 2021 Earnings Call. [Operator Instructions]

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

Paul Arndt -- Investor Relations and Corporate Communications Eexecutive

Thank you, operator, and good morning, everyone. Thank you for joining today's call. This morning, Albireo issued a press release highlighting its recent business accomplishments and reporting its financial results for the second quarter ended June 30, 2021. This press release is accessible via the company's website at www.albireopharma.com. Before proceeding, we would like to note that management's comments today may include forward-looking statements regarding the company's plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the Risk Factors section of our most recent Form 10-K and our subsequent SEC filings. These filings can be accessed from the Media and Investors section of our website at www.albireopharma.com or on the SEC's website. Any forward-looking statements represent our views as of today, Thursday, October 5, 2021, 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 -- President and Chief Executive Officer

Great. Thank you, Paul, and thank you, everybody, for joining us this morning. With me today are Simon Harford, our Chief Financial Officer; Pamela Stephenson, our Chief Commercial Officer; and Dr. Christine Clemson, Vice President and Head of Medical Affairs, who's sitting in today for Dr. Pat Horn, who is on a well-deserved vacation this week. We're very pleased to provide an update and an overview of our recent events. It's only been a couple of weeks since we announced the unprecedented back-to-back U.S. and European approvals for Bylvay as well as our receipt of a priority review voucher. It's exciting to begin the journey to bring Bylvay to the approximately 100,000 pediatric cholestatic patients around the world. Since receiving approvals, we've accomplished a great deal. We're hearing from physicians about how pleased that they are now able to treat children with a medical therapy versus putting them through invasive surgeries. For example, we've heard from a physician who put a child on Bylvay who prior to treatment had serum bile acids of 700 micromoles per liter. After only one week, the physician reported a reduction to 100 micromoles per liter as well as a dramatic reduction in the child's pruritus. We want to extend this type of benefit to as many patients as possible. With Bylvay, we have a competitive profile. An oral once-daily nonsystemic medicine with a favorable safety profile, a low diarrhea rate of 9.5% versus 5% placebo, demonstrated positive effects on growth and the only approved drug to treat pruritus in PFIC patients across all subtypes. So are we reaching patients? The answer is yes. We're off to a fast start, and the integrated launch system is working. The field teams are meeting with HCPs and payers. Prescriptions are being generated. We are successfully working through patient cases through AlbireoAssist. and we have commercial drug ready to put in the hands of PFIC patients.

It's only the first two weeks since approval, but we're pleased to see the integrated system working all the way from manufacturing to the ability to fulfill prescriptions. So starting with manufacturing, supply and distribution. Following our product approvals, final goods have been package, we shipped to the distributors and the three specialty pharmacies have stock. So the good news is we're getting Bylvay where it needs to go and at the right time. So then we focus on getting Bylvay to the available patients. We estimate that the global PFIC prevalent population is 15,000 children, excluding China and India. We define prevalent as anybody who has the disease and is alive. Our estimate for available patients is about 2,500 globally. These are patients who are ready to be treated. This is a huge advantage for us versus other rare disease categories where you have to work through diagnosis and then find patients who could take years to be diagnosed. But in this disease category, the patients have symptoms and are in the system ranging from the newly diagnosed to dose slated for potential transplant. Our team's job is to reach the identified patients, and we're working quickly with our specialized field teams to do that. From a physician outreach standpoint, the Albireo and Travere teams are deployed and have hit the ground running. We've already reached over 80% of the top 60 centers. Our first patients are enrolled in AlbireoAssist, and the care corridors are working through reimbursement cases to ensure access to Bylvay. Over the last two years, Albireo has been working to ensure prescribed patients gain coverage for Bylvay, but it's important that we now lock in coverage and reimbursement. With Bylvay, we have a clear benefit of the medicine defined with the strength of data, value proposition, evidence of the natural history study and caregiver burden study. Bylvay is a weight-based oral medicine priced at $385,000 per patient per year based on an average weight of 18 kilograms.

The 40- and 120-microgram per kilogram capsules are priced linearly, and the price for the individual bottles have now been listed in compendia. To date, we have meetings either completed or scheduled with payers who cover 95% of patients' lives. So clearly, we're focused on ensuring both commercial and public coverage with Medicaid. We know that many insurers, Medicaid included, are working on medical eligibility criteria for prior authorizations. Because of this, we expect the first patients will take a little more time to process but we're confident in our ability to work through these cases through AlbireoAssist. Medicaid is a good example. With the late-July FDA approval, we were able to submit our Medicaid National Drug Rebate Agreement to CMS by the quarterly August one deadline. This means that state Medicaid agencies have the options to start covering Bylvay, and many will do so immediately, with all states required to cover by October 1. After that, it will be much easier for new patients to flow through the system. Overall, we're pleased with the payer response and feel that the early days of Bylvay availability in the U.S. are going well. We're pleased to have two approvals in a week, which most companies experience in a matter of months instead. Therefore, our time lines and launches are compressed, but in a positive way. Why is this significant? We know based on other rare disease analogs, ex U.S. revenue can account for more than 50% of the global revenue. So we're driving as hard in Europe and the rest of the world as we are in the U.S. Therefore, once we received marketing authorization in Europe, we began our launch activities first in Germany with price listing planned for September. Simultaneously, we're working on the remaining European markets having submitted many reimbursement dossiers. In the rest of the world, we continue to add commercial distributorships in regions and countries with high patient prevalence.

Now in parallel, the European authorization allowed us to initiate a global managed access program that will enable access to patients through a variety of routes, including named patient programs. As we make progress in the initial commercial launch, we are committed now, more than ever, of the opportunity in PFIC. Bylvay fulfills a clear need in the market for a better treatment option for patients. And given our already proven ability to execute, we have full confidence in our team to carry out our launch plan successfully. At the same time, we continue to execute on our two Phase III Bylvay clinical studies. Both the positive data from the PEDFIC study as well as U.S. and EU approvals are a shot in the arm to our teams, increasing the already high level of confidence in Bylvay, given the high-level translatability of the data to biliary atresia and Alagille syndrome. For the BOLD Phase III pivotal study of Bylvay in biliary atresia, we have made tremendous progress. Biliary atresia is the most common pediatric cholestatic liver disease. BOLD is the only pivotal double-blind, randomized, placebo-controlled study, and we've agreed with both the FDA and the EMA that this single trial will be sufficient for approval with a positive outcome. BOLD remains on track for top line data in 2024. The ASSERT study is a Phase III pivotal study of Bylvay in Alagille syndrome. This study is also a double-blind, randomized, placebo-controlled study, which we have also agreed with both the FDA and EMA that this single trial will be sufficient for approval with a positive outcome. ASSERT remains on track for top line data in 2022. We will continue to drive enrollment for both of these studies which is key for Albireo. As we look at our aspiration of delivering $1 billion in revenue in the second half of the decade with expanded indications across three cholestatic liver diseases. We estimate that there are 100,000 cholestatic liver disease patients globally, and PFIC is only the start as we work to make Bylvay available to patients with biliary atresia and Alagille syndrome.

The completion of these programs is important, and we're optimistic based on the very positive results from the PEDFIC study. Now rounding out our development portfolio is our two adult liver disease product candidates, A3907 and A2342. A3907 is our oral systemic ASBT inhibitor, which is the first ASBT inhibitor to have high bioavailability and a significant systemic exposure. The Phase I trial of A3907 is proceeding as planned, and we anticipate sharing data later this year. In June, we presented early clinical at EASL that confirm A3907 effectiveness in cholestatic liver disease with potential in PSC and PBC. We have a high level of confidence in our new bile acid modulation technology and ability to provide new options for these patients. Our second product candidate is A2342. The first potent oral NTCP inhibitor being developed for viral and cholestatic liver diseases. We're generating important modeling data and completing IND-enabling studies with the intent to move into the client with a Phase I study in 2022. So in summary, we're excited to be up and going with the launch of Bylvay and starting our journey to provide a better treatment option for the estimated 100,000 pediatric liver disease patients in the world. We've already started, and our teams are working diligently on outreach to educate physicians while providing patient benefit support for families with AlbireoAssist. Beyond PFIC, we have tremendous opportunities with our ongoing clinical programs. We're a company with a first-in-class product with other strong candidates in the pipeline and look forward to a milestone-rich period starting with continued progress and updates on our commercial launch of Bylvay; continued execution in the BOLD and ASSERT trials to realize our $1 billion aspiration for Bylvay with the expansion to biliary atresia and Alagille syndrome; our continued progress in our adult liver and bile disease compounds, A3907 and A2342; and the planned monetization of the priority review voucher, which are currently worth about $100 million. We are in exciting and meaningful period for Albireo where we are seeing our strategic vision come to life as we bring Bylvay to children with PFIC and look forward to the prospect of broadening our impact as we work to bring therapeutic relief to patients with other cholestatic and viral liver diseases.

So with that, it's my pleasure to turn the call over to Simon for a financial update. Simon?

Simon Harford -- Chief Financial Officer

Thanks, Ron. Let me now review our financial results for the second quarter of 2021. Revenues were $2.4 million for the second quarter compared to $1.9 million for the second quarter of 2020. The higher revenue was due to the estimated royalty revenue to be received from EA Pharma for elobixibat for the treatment of chronic constipation in Japan. The royalty revenue, as we've said previously, is passed on to healthcare royalty partners. Research and development expenses were $20.9 million for the second quarter of this year compared to $18.4 million for the same quarter last year. The higher expenses were mainly due to personnel expenses as the company continues to increase our headcount on program activities. The increase in program activities was mainly for Bylvay and biliary atresia and Alagille syndrome as well as A3907. These increased expenses were partially offset by lower Bylvay PFIC expenses and the fact that we are no longer developing elobixibat. General and administrative expenses was $16.9 million for the second quarter of 2021 compared to $8.5 million in the same quarter last year.

The increase is attributable to personnel and related expenses as the company continued to increase headcount and infrastructure to support commercialization of Bylvay in PFIC. Net loss for the quarter ended June 30, 2021, was $36.4 million or a loss of $1.90 per share compared to $20.6 million or a loss of $1.38 per share for the second quarter of 2020. As of June 30, 2021, we had cash and cash equivalents of $186.3 million compared to $251.3 million as of December 31, 2020, resulting in a cash burn of $65 million in the first six months of 2021. We continue to anticipate the full year 2021 operating cash burn will be between $130 million and $135 million. With the launch of Bylvay underway, we continue to anticipate 2021 revenue from the product to be in the low single-digit U.S. dollar millions. We anticipate our cash runway taking us into 2023, which includes revenue and expense needs from the launch of Bylvay and expansion beyond PFIC. This cash runway excludes any proceeds from the planned sale of the priority review voucher. In summary, we are well positioned in terms of cash with $186.3 million in cash and cash equivalents, access to non-dilutive capital in the form of the priority review voucher that we plan to monetize at the optimal time and a clear go-to-market strategy with defined revenue-generating launch steps.

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

Ron Cooper -- President and Chief Executive Officer

Thanks, Simon. As we begin executing as a full-fledged commercial organization with a burgeoning therapeutic pipeline, I must again express my thanks to our patients, families, clinicians and employees who have entrusted us to successfully bring Bylvay to market. With Bylvay, we have the first and only drug option to treat pruritus in PFIC patients across all subtypes. Beyond PFIC, we have great confidence in our two Phase III clinical trials to expand into biliary atresia and Alagille syndrome. And finally, we will continue to diversify our portfolio in adult liver and viral diseases.

We thank everybody for joining us and are pleased to open the call now for Q&A. Operator?

Questions and Answers:

Operator

[Operator Instructions] Our first questions come from the line of Yasmeen Rahimi with Piper Sandler.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Maybe the first one, Ron, you pointed out that you guys got more details on pricing so -- for the two formulations. So if you could just walk us through for both the sprinkle as well as the capsules and then for each of the doses. And then the second one is, can you maybe help us understand out of the 30 total sites for ASSERT, how many of them are in the U.S. and Europe and just sort of time line on how enrollment is progressing in the geographies.

Ron Cooper -- President and Chief Executive Officer

Yes. So maybe, Yasmeen, I'll talk about ASSERT and I'll pass it over to Pamela to talk about the details on pricing. And thanks for the question. Look, we're really pleased with the progress that we've made with ASSERT. We're looking for around about 35 sites. We've given guidance to have data in 2022, which we're on track for. What we're really pleased actually is that we've had tremendous response in the U.S. And in fact, in the U.S., of the sites that are up, we have virtually all the sites up in the U.S. We only have one more to go. Most of our other sites are international, which are coming on quickly. And then I think what we're really pleased about in each of the sites that we have brought up, our yield has been higher per site, right? So that gives us a lot of confidence to be able to fulfill our guidance of data in 2022. Pamela, why don't you give Yasmeen a little more detail on our pricing.

Pamela Stephenson -- Chief Commercial Officer

Sure. Hi, Yasmeen. So I'll just start by saying that our model is a linear-based pricing approach. And so as noted in the pricing compendia listed, we have four 30-capsule bottle strengths available. So for example, the 20-microgram sprinkle capsule bottle is $6,600 for one bottle, which is a -- 30-capsules, as I mentioned. And it's a straight linear from there. So the 400-microgram swallowed is $13,200. The reason that we went with this pricing model is because it's simple. We talked extensively to payers and asked for input along the way, and they told us they wanted simplicity. And so that's what's really important in this pricing model. And for patients, as mentioned, we have AlbireoAssist. And so we'll look at their insurance status and help them navigate the landscape and get on to Bylvay. So really excited about that.

Ron Cooper -- President and Chief Executive Officer

Thanks for the questions, Yasmeen. I mean, we've been really pleased with the response from payers thus far. So we're looking forward to bringing more and more patients through AlbireoAssist in getting access to Bylvay.

Yasmeen Rahimi -- Piper Sandler -- Analyst

And Pam, if I may ask, when we think about sort of the weight of a PFIC child, can you kind of give us a little bit color on sort of average weights or weights that maybe when they reach from five to 10 what an average weight would be or how much less their weight would be compared to a normal child. Just some coloring on the weight growth as the kids get older.

Pamela Stephenson -- Chief Commercial Officer

Sure. We'll learn so much more as we get into the real world and collect our data. But for now, what we see is our clinical trial results, and the average weight of patients in our clinical trial, PEDFIC 2, was 18 kilograms. And so that's how we've looked at this is to sort of say, 90% of our patients will be on the 40-microgram dose and about 10% on the 120 micrograms. That's how we've come up with the average calculation that we shared previously of $385,000 as a weighted average. So we'll -- to answer your question, we'll track these patients over time and see how the weights change. And early results or early patients in, there are a variety of ages and weights that we're seeing patients coming into the system.

Operator

Our next questions come from the line of Tim Lugo with William Blair.

Tim Lugo -- William Blair -- Analyst

Congrats on all the progress over the past few months. I guess following up on AlbireoAssist, are the early patients being captured in that system mimicking the 18 kilograms we saw in the clinical trials? And how are you handling any biliary atresia or Alagille patient and physicians that might be reaching out to Albireo outside of the clinical trials?

Ron Cooper -- President and Chief Executive Officer

Yes. So Tim, thanks for the questions. Look, we'd like to have as many patients come through AlbireoAssist as possible because that provides support for the clinicians and support for the patients as well. And to the earlier question, we can only report the data we kind of know right now, right? And the data that we have is 18 kilograms is the average, and we're going to learn a lot more with real-world evidence over time. As it relates to patients that do not fit in our label, they're not eligible for AlbireoAssist, right? But we provide support through our medical affairs organization where we're able to provide information that, if we're asked, from clinicians. So we have a fully functioning medical affairs organization that is working really diligently during this time frame.

Tim Lugo -- William Blair -- Analyst

Okay. Understood. And with the Medicaid plans coming on in October 1, is that when we'll kind of start to see the first meaningful bump up? Or is there -- we're already into August, can you just maybe talk a bit about how the past few weeks has been trending?

Pamela Stephenson -- Chief Commercial Officer

Yes, I can speak to the -- certainly, to the Medicaid piece of this. The deadline that we mentioned is October one because we were -- we made the August one deadline. So that means that all states are required to cover Bylvay by October 1, but many states have the option and will do so ahead of time. So we'll see patient coverage now, and we'll see patient coverage then. And same with commercial plans. This is a process, and we're going to take every patient and work them through and to ensure that they get coverage as soon as possible.

Tim Lugo -- William Blair -- Analyst

Understood. Well, congratulations on the fast start.

Ron Cooper -- President and Chief Executive Officer

Thanks, Tim.

Operator

Our next questions come from the line of Ritu Baral with Cowen.

Ritu Baral -- Cowen -- Analyst

Just a few more questions on coverage logistics to help us with our model. The EAP -- U.S. EAP patients, how do you think about them time line-wise turning over into commercial U.S. patients? Is that something that you would expect to happen by end of year? And now that it's approved, can you give us any color on the patient numbers in the U.S. expanded access program? And then how should we be thinking about time to fill out of the gates, at least early on. I do understand that it shortens obviously with a more mature launch. But as we think about how AlbireoAssist works, how it helps the doctors' offices in the shipments, etc. How should we be thinking about that, at least through the end of the year?

Pamela Stephenson -- Chief Commercial Officer

Sure. Let me start first with your question on EAP, which I'll expand to talk about sort of the PEDFIC two rollovers, patients on drug globally in PEDFIC two and EAP. What I can say is that these patients will be rolling over at different times. And again, in the U.S. with AlbireoAssist, what we have is a team of care coordinators who can work now with the patients to ensure that they have access for the rollover. And one thing, we are very committed to ensure that they have access to Bylvay as they go through that transition. So the time frames will vary. But they're coming up over the coming months. And your second question on time to fill, again, it's varied, right? In my experience in doing this with rare disease drugs, some will go through very quickly and some will take a longer time. So at this point, it's too early to mention what we think the time to fill will be, but that's certainly metrics that we're tracking and looking to shorten over time with AlbireoAssist.

Ron Cooper -- President and Chief Executive Officer

Yes. So Ritu, I think we're pleased that Bylvay is a global opportunity, a large global opportunity, but that sort of relates to Pamela's answer on both the PEDFIC two studies and the EAP. We have patients all over the world that are in those programs, right? And so they will be subject to reimbursement in those countries as well as Pamela has indicated, in the U.S., as we get them through AlbireoAssist, we're able to get them insurance. But they will roll over.

Operator

Our next questions come from the line of Eun Yang with Jefferies.

Na Lin -- Jefferies -- Analyst

This is Na Lin on for Eun. I have two questions, please. Number one, for Bylvay dosage adjustment in the U.S., the criterion to increase the recommended daily dosage to a higher dose would be based on there being no improvement in pruritus in three months. And ex U.S., is that the same criterion used to determine adequate clinical response? Or is it based on improvements in bile acid levels?

Ron Cooper -- President and Chief Executive Officer

So I just want to make sure -- because it's a little bit hard to hear you, right? So -- and you faded off a little bit. I think your question was that after there's -- if there is an inadequate response after three months, what is the criteria to move up the dose? Was that correct?

Na Lin -- Jefferies -- Analyst

Yes, the criterion in ex U.S. I believe in the U.S. is pruritus. In ex U.S., is that the same criterion?

Dr. Christine Clemson -- Vice President and Head of Medical Affairs

This is Christine. And -- outside of the U.S., the SmPC has similar language, but it's not specific to pruritus. So if an adequate clinical response has not been achieved after three months of continuous therapy, the dose may be increased.

Na Lin -- Jefferies -- Analyst

So would that be bile acid?

Dr. Christine Clemson -- Vice President and Head of Medical Affairs

I think the way the label is written is it's up to the judgment of the clinician to decide what that adequate response would be.

Na Lin -- Jefferies -- Analyst

Got it. Okay. And the second question is, could you please maybe comment on what percent of the patients you would expect to be on maintenance dose of 40 micrograms versus 80 micrograms versus 120 micrograms per kilogram per day?

Pamela Stephenson -- Chief Commercial Officer

Hi, it's Pamela. For our assumptions for our launch year, what we're assuming is the vast majority, 90%, will be on the 40 microgram dose and 10% on the 120 microgram. Again, we'll see in the real world how this works out over time. That's our initial assumption.

Operator

Our next questions come from the line of Joseph Stringer with Needham & Company.

Joseph Stringer -- Needham & Company -- Analyst

Just to follow up on an earlier question on the time to fill. I realize it's early, you can't give any -- you may not be able to give metrics. But is there an optimal sort of time to fill as things progress here? And then second question is on Alagille and biliary atresia just want to get your thoughts on any potential enrollment headwinds or issues with -- related to COVID.

Ron Cooper -- President and Chief Executive Officer

Thanks for -- well, the optimal time is very fast, actually, right? But yes, the reality of it is we have everything in place to go very quickly, right? So our Albireo representatives, Travere representatives are out in the field generating prescriptions as an enrollment form goes to AlbireoAssist. So the speed issue is how quickly do we generate prescriptions, how quickly can we get the sites to work with us to fill up the AlbireoAssist form. And then very quickly, our care coordinators are in contact with the families and in contact with the insurers, right? That's the variable part, right? As you know, there are about 1,000 different plans within the U.S., right? And so we're getting experience with all of them. The first ones are going to be a little bit longer because they've got to get their criteria in place, what they're going to do from prior authorization is new to them. But then I think after that, it's just going to go faster and faster. So the optimal is almost instantly. It's going to take us a little bit at the beginning, it will get faster over time. I think then, Joey, as it relates to our other two Phase III studies, we're really pleased with the execution that's occurring there. You think about the BOLD trial, this is a global study where we're looking for near 70 sites around the world. And I'm just really proud of our organization because we're on track for data into -- data in 2024. Similarly, I made comments about the ASSERT study earlier, we expect data into 2022. Now it's not easy at the best of times. Doing clinical trials are a difficult challenge, particularly global clinical trials. However, given our experience with the PEDFIC program where we've done that successfully, I'm pretty confident that we'll be able to come by at any headwinds and deliver on the data for those two Phase III studies.

Operator

Our next questions come from the line of Brian Skorney with Baird.

Brian Skorney -- Baird -- Analyst

Just trying to see if there's any way to push to get some sort of quantification of anything. So I just wanted to see about insight into, do you guys, like, get sort of granularity on when a prescription is written or only granularity on when it is filled? And I'm just trying to understand how AlbireoAssist works across those gamut. Like, are all enrollment forms through AlbireoAssist coming after an nRx is written or some enrollment forms coming ahead of an nRx? And are these occurring completely in parallel or a specific sequence? Just any insight you can provide there.

Pamela Stephenson -- Chief Commercial Officer

Sure. Sure. Brian, yes. So the enrollment form is the prescription. So what we see is we know from our field teams as prescriptions are getting written, but the prescription or the enrollment form comes right into AlbireoAssist, and that is a prescription form that we can then start working with the payers and to understand the insurance benefits of that particular patient, while also triaging that form right over to the specialty pharmacies. And so it's a well-coordinated activity where we have eyes on every step of the way.

Brian Skorney -- Baird -- Analyst

Great. And if I could just ask a question to kind of move a little bit off of the commercial side of things. But I was wondering if you can kind of walk through a little bit of the rationale in the biliary atresia study? And how do you specifically think about the sort of high, low baseline bile acids and the predictability that might have for high bile inhibition and especially how to think about sort of the intervention that they're using here post-Kasai versus overall pre-Kasai or even as an adjunct to Kasai.

Ron Cooper -- President and Chief Executive Officer

Well, when we think of biliary atresia, right, this is a cholestatic liver disease, right? So this is a disease of intrahep function of bile flow. And remember, we're only treating children that are post-Kasai. If the children will get Kasai, they generally will die. So it's a life-saving treatment. But what's interesting is when you look at the natural history -- the largest natural history database and you look at patients post-Kasai, when you look at their outcomes, right. If you look at the children after that Kasai, which restores some intrahepatic circulation, but sometimes it's not perfect, right? Those children who have low bile acids, in two years, most of them keep their native liver alive. Those ones who have high bile acids, they lose their native liver or they die, right, over 50% of them, right? So that's where Bylvay comes in, a cholestatic disease, these are children with elevated bile acids. We've demonstrated in the PEDFIC study at the doses of 40 micrograms and 120 micrograms that we can reduce bile acids. We're pretty confident that we can reduce bile acids in these children and change their outcomes. And if you think of the unmet need, this is the number one pediatric cholestatic liver disease. This is the number one reason for pediatric liver transplant. And right now, the pediatric hepatologists and the surgeon after they do that Kasai surgery, they know that half of those children are going to need a new liver within two years. So they just sort of put their hands up and wait. Bylvay can make a big difference in these children. That's where we're looking forward to the results from the BOLD study, which we plan to deliver in 2024.

Operator

Our next questions come from the line of Ed Arce with H.C. Wainwright.

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

So three for me. First, I realize it's only been two weeks now. But just qualitatively, thinking about your first reimbursements when you think those first few reimbursements could come in and just the general cadence of payer coverage between now and through the end of the year. If you can, give us a sense for a number of prescriptions that you've received so far to date? I'm just trying to get a sense for -- in relation to that speed of reimbursements, whether you think there's any expectations for an initial trickle of commercial revenue in the third quarter? Or is it more likely to be all in the fourth quarter? And then lastly, just wondering about the global managed access program. If you could just give us a little more detail around that and your expectations there.

Ron Cooper -- President and Chief Executive Officer

All right, Ed. Thanks very much for the questions. And similar themes to your colleagues. I'd say it's a process, right? Prescriptions are coming in. There are a lot of different insurers to work through. We've given guidance of sales of Bylvay for this year is a low single digit. Why is that, right? Because we've got to work our way through these insurance companies and getting reimbursement. We're absolutely confident we're going to get there. As indicated as we've given you information in regards to Medicaid, but the reality is some states from a Medicaid perspective will wait until October, right? Others will not. We will watch these through, and we're pretty confident that as we get through to the end of the year, we'll have very good access for Bylvay and we'll be able to really continue to generate the sales that we expect. So we're executing. It's going to happen, right? Just bear with us a little bit, and we'll update you. Pamela, do you want to talk a little bit about the rest of the world on the managed access approach we're taking?

Pamela Stephenson -- Chief Commercial Officer

Yes, absolutely. So our managed access program, really excited, is now live. And what this program does is really to help with patients who are in countries that don't yet have reimbursement for Bylvay. So as mentioned, we're starting first in Germany. We expect price listing in September full speed ahead. In other -- many of the other European countries, we've already submitted reimbursement dossiers. As we work through that reimbursement process, we want to ensure that patients have access to Bylvay. And then there's markets or countries outside of the European countries that, also, we want to have access to -- we have many patients programs, etc. So we have a very comprehensive far-reaching managed access program that we've launched and with the full goal of having patients have access to Bylvay.

Operator

Our next questions come from the line of Andreas Argyrides with Wedbush.

Andreas Argyrides -- Wedbush -- Analyst

In your prepared remarks, you mentioned that Albireo and Travere sales reps have reached 80% of the HCPs at the top 60 centers. How should we think about how rep interactions ultimately gradually translate to revenues? Do the 60 centers cover all of the 60 -- sorry, the 600 estimated available patients in the U.S.? And then I have a follow-up.

Pamela Stephenson -- Chief Commercial Officer

What I would say there is that absolutely the top 60 centers includes the majority of the 100 pediatric hepatologists across the country. And many of the patients identified are in those centers. However, we're also finding that there are patients out in the community as well, in the community pediatric -- hepatology and pediatric gastro environment. And so this is the great thing about working with Travere is that we have double the number of reps in the field covering not only the 60 centers but also the additional potential prescribers outside of those 60 centers.

Andreas Argyrides -- Wedbush -- Analyst

Okay. And then so how -- again, I don't know, my first question was about the 80% of those prescribers. How do we I mean, if it gets to 100, I mean, do we eventually -- how do we kind of try to quantify that or model that going forward?

Ron Cooper -- President and Chief Executive Officer

I think the way to -- let's back up a little bit here. So we have, I think, a really great go-to-market model, right? So the nice thing about it, most of the business is concentrated. There's about 60 key centers. There's more centers out there, 60 key centers. There's 100 key docs. There's more doctors than that. They will represent the vast majority of the prescriptions. Now as Pamela has said, now that we're actually out there and that people see that Bylvay is a once a day, it's oral, it has a good safety profile, there's interest in using Bylvay in some of the other centers. And so what we're learning is some of those centers close to those main centers are interested in using Bylvay. And so having both our representatives at Albireo, plus the Travere representatives out there, we have tremendous coverage. And so even in the first couple of weeks, we've covered 80% of it. In another couple of weeks, we'll be well on our way to covering most of our customers. And so that's, I think, really great execution and should bode well for prescription generation.

Andreas Argyrides -- Wedbush -- Analyst

Looking forward to the updates. As far as pricing, does that take into account discounts?

Pamela Stephenson -- Chief Commercial Officer

So the numbers that I've shared are before the mandatory government discounts.

Operator

[Operator Instructions] Our next questions come from the line of Ritu Baral with Cowen.

Ritu Baral -- Cowen -- Analyst

So this was the first orphan drug launch that has occurred, at least in my universe, right into the teeth of COVID. And I'm wondering, as you guys think of launch activities rather than ongoing commercial activities, what specific launch activities have been tailored to a more -- a much, much more virtual environment -- commercial environment than in any time in the past? And how should we be thinking about presence at medical meetings for data or boots, etc., going forward?

Pamela Stephenson -- Chief Commercial Officer

A couple of points I would make on that one. The first is that we've hired experienced representatives who have been selling through the COVID world. And so they're very nimble at flipping back and forth between virtual visits with physicians and in-person live. So we see that they are already in the fields able and quite frankly, doing both types of visits. The second would be our speaker program. And again, we were able to do a lot more now virtually with getting out, training doctors quickly, doing -- training them in their off hours when they're not in clinic and getting the news out about Bylvay. And then third, on the medical meetings, we're seeing that, again, a hybrid approach. So AASLD, as an example, is taking an approach with having some portions of the program live and some virtually. And again, I think the experience that our collective team has in terms of being able to access and work with physicians, both virtually and in person, is going to give us a great uptake.

Operator

Thank you. We have reached the end of our Q&A session. I will now turn the call back over to Ron Cooper for any closing remarks.

Ron Cooper -- President and Chief Executive Officer

Thank you, operator. Thank you all for attending today's conference call. We'll continue to keep you updated on progress with our global Bylvay launch as well as our clinical programs in biliary atresia and Alagille syndrome and our adult liver and viral disease as we continue to advance Albireo's vision to provide hope to families of patients with liver disease and the entire liver community. Thanks to all for your continued support.

Operator

[Operator Closing Remarks]

Duration: 48 minutes

Call participants:

Paul Arndt -- Investor Relations and Corporate Communications Eexecutive

Ron Cooper -- President and Chief Executive Officer

Simon Harford -- Chief Financial Officer

Pamela Stephenson -- Chief Commercial Officer

Dr. Christine Clemson -- Vice President and Head of Medical Affairs

Yasmeen Rahimi -- Piper Sandler -- Analyst

Tim Lugo -- William Blair -- Analyst

Ritu Baral -- Cowen -- Analyst

Na Lin -- Jefferies -- Analyst

Joseph Stringer -- Needham & Company -- Analyst

Brian Skorney -- Baird -- Analyst

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

Andreas Argyrides -- Wedbush -- Analyst

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