Albireo Pharma, Inc.

Good morning and welcome to the Albarrio Pharma second quarter 2021 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 zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to your host, Paul Arndt, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining today's call. This morning, Albareo 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.albareopharma.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.alboreofarma.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, Alvarez President and Chief Executive Officer. Ron?

Great. Thank you, Paul, and thank you, everybody, for joining us this morning. With me today are Simon Harford, our Chief Financial Officer, Pamela Stevenson, 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's 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 Bilvay, as well as our receipt of a priority review voucher. It's exciting to begin the journey to bring Bilvay 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 Belvay 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 Bilve, we have a competitive profile. An oral, once-daily, non-systemic 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 Alvareo Assist, 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 packaged, we ship to the distributors, and the three specialty pharmacies have stock. So the good news is we're getting Bilvay where it needs to go and at the right time. So then we focus on getting bilby 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 those 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 Alvareo 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 Alvareo Assist, and the care coordinators are working through reimbursement cases to ensure access to Bilvay. Over the last two years, Alvareo has been working to ensure prescribed patients gain coverage for Bilvay, but it's important that we now lock in coverage and reimbursement. With BILVE, we have a clear benefit of the medicine defined with the strength of data, value proposition, evidence from the natural history study, and caregiver burden study. BILVE 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 prices for the individual bottles have not 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 patient will take a little more time to process, but we're confident in our ability to work through these cases through Alvareo Assist. Medicaid's 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 1st deadlines. This means that state Medicaid agencies have the options to start covering BILVE, 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 payoff response and feel that the early days of BILVE 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 timelines 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 authorizations 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 on the initial commercial launch, we are convinced now more than ever of the opportunity in PFIC. Bilve 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 three bilve clinical styles. Both the positive data from the PETFix study as well as US and EU approvals are a shot in the arm to our teams, increasing the already high level of confidence in bilve given the high level translatability of the data to biliary atresia and allogeal syndrome. For the bold phase three pivotal study of bilve and 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 Bilbane Allergy 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 Alvareo as we look at our aspiration of delivering 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 BILVE available to patients with biliary atresia and allogel syndrome. The completion of these programs is important, and we're optimistic based on the very positive results from the PETFIC 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 one trial of A3907 is proceeding as planned, and we anticipate sharing data later this year. In June, we presented early clinical data of easel that confirmed A3-nano7's 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 clinic with a phase one study in 2022. So in summary, we're excited to be up and going. with the launch of BILVE 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 Alpareo Assist. 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 BILVE, continued execution in the BOLD and the CERT trials to realize our $1 billion aspiration for BILVE, with the expansion to biliary atresia and allogel syndrome, our continued progress in our adult liver and viral disease compounds, A3907, A2342, and the planned monetization of the priority review voucher, which are currently worth about $100 million. We are at an exciting and meaningful period for Albarrio where we are seeing our strategic vision come to life as we bring BILVI 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?

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 Elabixabat 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 and program activities. The increase in program activities was mainly for bilve and biliary atresia and allergy syndrome, as well as A3907. These increased expenses were partially offset by lower bilve PFIC expenses and the fact that we are no longer developing elabixabat. General and administrative expenses were $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 Bilvay in PFIC. Net loss for the quarter ended June 30th, 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 30th, 2021, we had cash and cash equivalents of 186.3 million compared to 251.3 million as of December 31st, 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 and $135 million. With the launch of Bilvey 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 Bilvey 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.

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've entrusted us to successfully bring Bill Bay to market. With Bill Bay, 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 allogeal 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?

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. Our first questions come from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your questions.

Hi, team. Thank you so much for taking my question. Maybe the first one, Ron, you pointed out that you guys got more details on pricing for the two formulations. If you could just walk us through for both your 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 a third, how many of them are in the U.S. and Europe? And just sort of timeline on how enrollment is progressing in the geographies. And thank you so much for taking my question.

Yeah, so maybe, Yasmeen, I'll talk about a certain – I'll pass it over to – Pamela, to talk about the details and pricing. Thanks for the question. Look, we're really pleased with the progress that we've made with the CERT. We're looking for around about 35 sites, and 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?

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 as 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 30 capsules, as I mentioned. And it's a straight linear from there. So the 400-microgram swallow 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, you know, for patients, as mentioned, we have Alvareo Assist, and so we'll look at their insurance status and help them navigate the landscape and get on to Bill Bates. We're really excited about that.

Thanks for the question, Jasmine. You know, we've been really pleased with the response from payers thus far, so we're looking forward to bringing more and more patients through Alvareo Assist and getting access to Build Bay.

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 of color on sort of average weights or weights that, you know, maybe when they reach, you know, from 5 to 10 pounds, 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.

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, PENFIC-2, was 18 kilograms. And so that's 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. And that's how we've come up with the average calculation that we shared previously of $385,000 as a weighted average. So 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.

Thank you, Pam.

Thank you. Our next question has come from the line of Tim Lugo with William Blair. Please proceed with your questions. Tim, can you check if you're on mute, please?

I was on mute. Thank you. Congrats on all the progress over the past few months, and thank you for taking the question. I guess following up on Alvareo Assist, 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 allogeal patients and physicians that might be reaching out to Alvareo outside of the clinical trials.

Yes, so Tim, thanks for the questions. Look, we'd like to have as many patients come through Alvareo with Cysta 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 Alvareo's cyst, right? But we provide support through our medical affairs organization where we're able to provide information that if we're asked, you know, from clinicians. So we have a fully functioning medical affairs organization that is working really diligently during this time frame.

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

Yes, I can speak certainly to the Medicaid piece of this. The deadline that we mentioned is October 1st because we made the August 1st deadline. So that means that all states are required to cover bill day by October 1st, 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 are going to take every patient and work them through and to ensure that they get coverage as soon as possible.

Understood. Well, congratulations on the fast start.

Thanks, Tim.

Thank you. Our next questions come from the line of Ritu Baral with Cowan. Please proceed with your questions.

Hi, guys. Thanks for taking the questions. Just a few more questions on coverage logistics to help us with our model. The U.S. EAP patients, how do you think about them timeline-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 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 Alvareo Assist works, how it helps the doctor's offices and then shipments, et cetera, how should we be thinking about that, at least through the end of the year?

Sure. Let me start first with your question on the EAP, which I'll expand to talk about sort of the PEDFIC2 rollovers, patients on drug sort of globally in PEDFIC2 and EAP. What I can say is that these patients will be rolling over at different times. And again, in the U.S. with Alvareo Assist, 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, you know, we are very committed to ensure that they have access to Bill Day as they go through that transition. So the timeframes 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 I think at this point it's too early to mention what we think the time to fill will be, but that's certainly a metric that we're tracking and looking to shorten over time with Alvareo Assist.

Yeah, so, Ritu, I think we're pleased that, you know, that Bill Bay is a global opportunity, a large global opportunity, but that sort of relates to Pamela's answer on both the PETFIC-2 studies and the EAP. We have patients all over the world that are in those programs, right? And so they will be subject to... Subject. the investment in those countries, you know, as well as Pamela's indicated in the U.S., you know, as we get them through valvulosis and as we're able to get them insurance. But they will roll over.

Great. Thank you.

Thank you. Our next question has come from the line of Boon Yang with Jefferies. Please proceed with your questions.

Hi. This is Nalin on for Yoon. I have two questions, please. Number one, for bill of aid 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 in ex-U.S., is that the same criterion used to define an adequate clinical response, or is it based on improvements in bile acid levels?

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, you know, after there's an, if there is a inadequate response after three months, what is the criteria to move up the dose? Was that correct?

The criterion in XUS, I believe in the U.S. is paritis. In XUS, is that the same criterion?

Hi, this is Christine. Outside of the U.S., the SMTC 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. So would that be bile acid? You know, 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.

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 versus 80 versus 120 micrograms per kilograms per day? Thank you.

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

Thank you.

Thanks very much. Thank you. Our next questions come from the line of Joseph Stringer with Needham & Company. Please proceed with your questions.

Hi, good morning, everyone. Thanks for taking our questions. Just to follow up on an earlier question on time to fill, I realize it's early, can't give any, may not be able to give metrics, but is there an optimal sort of time to fill, you know, as things progress here? And then second question is on allogeal and biliary atresia, just want to get your thoughts on any potential enrollment headwinds or issues with related to COVID. Thanks for taking our questions.

Well, thanks for tuning in. Well, the optimal time is very fast, actually, right? But yeah, the reality of it is we have everything in place to go very quickly, right? So our Alvareo representatives, Revere representatives are out in the field generating prescriptions. And an enrollment form goes to Alvareo Assist. So the The speed issue is how quickly do we generate prescriptions? How quickly can we get the site to work with us to fill out the Alvareo Assist 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 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 a little bit at the beginning. It'll 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. When you think about the Voltron, it's a global study, and 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 in 2024. Similarly, I made comments about the ACERT study earlier. We expect data into 2022. Now, it's not easy. At the best of time, you know, 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 combat any headwinds and deliver on the data for those two phase three studies.

Great. Thanks for taking our question. Thank you.

Thank you. Our next questions come from the line of Brian Sporny with Baird. Please proceed with your questions.

Hey, thank you for taking the question. Good morning. Just trying to, you know, see if there's any way to push to get some sort of quantification of anything. So, you know, I just want to see about insight into do you guys 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 Alvareo Assist works across that gamut. Like, are all enrollment forms through Alvareo Assist coming after an NRX is written? Are 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. Sure.

Sure. Hi, 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 Alvareo Assist, 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.

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 could kind of walk through a little bit of the rationale in the biliary atresia study and how to specifically think about the sort of high-low baseline bile acids and the predictability that might have for IVAT inhibition, and especially how to think about sort of the intervention that you're using here post-casai versus a role pre-casai or even as an adjunct to casai? Thanks.

Well, when we think of biliary atresia, right, this is a cholestatic liver disease, right? So this is a disease that interrupts a bile flow. And remember, we're only treating children that are post-casai. If the children don't get casai, they generally will die. So it's a life-saving disease. treatment but what's interesting is when you look at the natural history the largest natural history database you look at patients post Casai and you look at their outcomes right if you look at the children after that Casai which restore some intrahepatic circulation but sometimes it's not perfect right those children who have low bile acid in two years Most of them keep their native liver or are 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 bilbao comes in. The cholestatic disease, these are children with elevated bile acids. demonstrated in the PEDFix study at the doses of 40 and 120 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 hepatologist and the surgeon are After they do that CASAI surgery, they know that half of those children are going to need a new liver within two years, and they just sort of put their hands up and wait. Bilvay can make a big difference in these children, and that's where we're looking for the results from the BOLD study, which we plan to deliver in 2024. Great. Thanks, Ron.

Thank you. Our next questions come from the line of Ed Arce with HC Wainwright. Please proceed with your questions.

Great. Thank you for taking my questions. 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 the number of prescriptions that you've received so far to date. And 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, you know, 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. Thanks so much.

All right, Ed. Thanks very much for the questions. And it's similar to each of 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 Build Bay for this year at the low single digits. Why is that? 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, we've given you information in regards to Medicaid, but the reality is some states, from a Medicaid perspective, will wait until October. Others will not. We will wash 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 BuildA, and we'll be able to really continue to generate the sales that we expect. So we're executing. It's going to happen. 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 and the managed access approach we're taking?

Yeah, absolutely. So our managed access program, we're 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 Bill Day. So as mentioned, we're starting first in Germany. We expect price listing in September, full speed ahead. In many of the other European countries, we've already submitted reimbursement dockets. As we work through that reimbursement process, we want to ensure that patients have access to Bill Day. And then there's markets or countries outside of the European countries countries that also we want to have access to. We can have named patient programs, et cetera. So we have a very comprehensive, far-reaching managed access program that we've launched with the sole goal of having patients have access the whole day.

Great. That's helpful. Thank you.

Thank you, Ed. Thank you. Our next questions come from the line of Andreas with Wedbush. Please proceed with your questions.

Good morning, and thank you for taking our questions. In your prepared remarks, you mentioned that Albarrio and Travere sales reps have reached 80% of the HCPs at the top 60 centers. How should we think about how rep interactions ultimately and gradually translate to revenues? Do the 60 centers cover all of the 600 estimated available patients in the U.S., and then I'll have a follow-up. Thanks.

What I would say there is that absolutely the top 60 centers include 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.

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

I think the way this is, let's back up a little bit here. So You know, we have, I think, a really great go-to-market model, right? So the nice thing about it is most of the business is concentrated. There's about 60 key centers. There's more centers now, but there's 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 said, now that we're actually out there and that people see that Bilve is a once-a-day, it's oral, It has a good safety profile. You know, there's interest in using Bill Bay in some of the other centers. And so what we're learning is some of those centers close to those meeting centers are interested in using Bill Bay. And so, you know, having both our representatives at Alvareo, plus the Trevira representatives out there, we have tremendous coverage. And so even in the first couple of weeks, we've covered 80% of this. 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.

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

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

Okay, much appreciated. I'll have another one, but I'll jump in the queue. Thank you so much.

Thank you, Andres.

As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next questions come from the line of Ritu Baral with Cowan. Please proceed with your questions.

Hey, guys. Thanks for taking the follow-up. So this is 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 are have been tailored to 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 booths, et cetera, going forward? Thanks.

A couple. a couple points i would make on that on that one and the first is that we've hired experienced representatives who have been selling through the covid world and so they're very nimble at at flipping back and forth between uh virtual visits with physicians and in-person lives so we see that they are already in the field able and 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, training them in their off hours when they're not in clinic and getting the news out about Bill's day. And then third, on the medical meetings, we're seeing that, again, a hybrid approach. So ASLD, 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.

Great. Thanks for taking the follow-up.

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.

Thank you, Operator. Thank you all for attending today's conference call. We'll continue to keep you updated on progress with our global Build Bay launch, as well as our clinical programs in biliatresia and allogeal syndrome, and our adult liver and viral disease. As we continue to advance Alvareo's mission to provide hope to families of patients with liver disease and the entire liver community, thanks to all for your continued support.

Thank you. That does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time. Have a great day.