Albireo Pharma, Inc.

Good morning, and welcome to the Albarrio Pharma Third 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'll now turn the conference over to your host, Paul Arndt, Managing Director. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining today's call. This morning, Albarrio issued a press release highlighting its recent business accomplishments and reporting its financial results for the third quarter ended September 30, 2021. This press release is accessible via the company's website at www.albarriopharma.com. Before proceeding, we would like to note that management's comments 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 investor section of our website at www.albariopharma.com or on the SEC's website. Any forward-looking statements represent our views as of today, Thursday, November 4th, 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?

Thank you, Paul, and thank you, everyone, for joining us this morning. With me today are Simon Harford, our Chief Financial Officer, Pamela Stevenson, our Chief Commercial Officer, and Dr. Pat Horn, our Chief Medical Officer. This is a historic quarter for Alvareo, as we achieved our first product approvals in the U.S. and Europe and successfully launched BuildAid. I'm proud of our organization's ability to deliver and execute as planned. If you go back in time, we committed to enrolling and reporting top-line data for the PEDFIC Phase III study in mid-2020. We committed to approvals and the launch of BILVE in the second half of 2021. We committed to starting two additional Phase III studies in algeal syndrome and biliary atresia in 2020. We committed to taking a next-generation ASBT inhibitor into the clinic in the first half of the year. We have delivered on all of these commitments and we expect the same going forward. Delivering commercial success with Bilve and advancing our pipeline as planned. In this quarter, we not only received product approvals in the US, EU and UK and launched Bilve globally, but we also shipped finished goods and generated the first partial quarter of sales for Bilve with revenue generation in the US and international which transformed us into a commercial company. The launch is going well, right to plan, and we're delivering on expectations. Bilve is fulfilling a clear market need for the first drug treatment auction. Doctors like it and payers are covering, and our team is delivering on fast launch uptake. We've generated Bilve sales, and we're just at the starting point for Alvareo and the journey to build a great liver company. We're looking forward to delivering BILVE launches in more countries, two BILVE fees, three clinical trials, and advancing two new next-generation compounds. Focusing on BILVE, the launch is going as planned, and Pamela will provide a clear picture of the launch status. The stories we hear and the lives we are impacting across geographies and PFIC types demonstrate the high unmet need and impact of BILVE. For example, We had two siblings, ages 16 and nine years of age, with the rare PFIX6 subtype. Both children have been on various off-label medications for many years that haven't been effective in providing relief from the pruritus. After living with these unrelieved symptoms for so long, they're excited to have Belvay as a new treatment option. The theme of getting better and better is one you will hear today, from launch to access, to our clinical programs and progressing pipeline. I am pleased to share that things keep getting better. We will share details on our progress by taking you through and covering, one, the Bill of A launch, two, key actions to penetrate the estimated 2,500 global PFIC patient opportunity, three, update on the progress of our exciting near-term pipeline, and four, financial progress. Starting with the launch of Bill of A, As this is the first quarterly call since the approval and launch, we surveyed several stakeholders to determine the most useful metrics to share with you on an ongoing basis. These stakeholders suggest that we provide the right balance of too few or too many metrics. Our plan would be to update our metrics every quarter going forward. In this quarter, we'll take time to explain each metric and provide an update. Note that this is the first quarter, This first quarter is a partial quarter, and given that approvals occurred at the end of July, let me turn it over to Pamela to explain the metrics. We'll be sharing with you and provide you an update. Pamela?

Thanks, Ron. Before jumping into the metrics, I would like to reiterate some of Ron's comments. I am delighted with the response to BILVE, as there clearly is a significant unmet need, and BILVE is making a difference. To date, The launch is going as planned, and prescribers, patients, and payers have reacted positively to the availability of Bilvay. Our outlook continues to be very positive, especially as we deliver. We are focused on executing against our global strategy to reach the 2,500 available PFIC patients across the U.S., Europe, and rest of world. Our field teams have been meeting with HCPs and payers since launch, discussing the value and benefits of Bilvay, which have led to prescriptions being generated and patients starting treatment. Our in-house Alvareo Assist team continues to work with each family to help them navigate the reimbursement process, all of which have contributed to our success in driving prescriptions and getting patients on drug. So what are the key metrics that we will be sharing today and on an ongoing basis? Total net product revenue, for which we will split out U.S. and international revenue. Number of new prescriptions. These are total new prescriptions generated through the third quarter, some of which are still going through the reimbursement process. Number of patients on bill day. These are patients where reimbursement has been achieved and BILVE has been shipped. Number of potential rollover patients on BILVE. These are number of patients that are in programs where they are on BILVE and should convert to commercial sales in the future. This includes patients in the PEDFCT2 Extension Study, our Early Access Program, as well as patients in our managed access programs. This is a global number, and these patients will roll over to commercial sales when we obtain country-level pricing and reimbursement, and for the patients in PEDFIC-2 when they complete the 72-week study period. Number of discrete prescribers in the U.S. There are multiple tiers of potential prescribers in the U.S., but there are 100 key prescribers, and we will provide updates on how many unique physicians have prescribed Bilvay in the U.S. Again, I will remind you that this is our first quarter. It is a partial quarter, and it is the base for continued growth. I am proud that in Q3 we have achieved the following. Total net product revenue exceeded a million at $1.1 million globally. with the U.S. net revenue of $800,000 and international of $300,000. The number of new prescriptions was 28 patients worldwide. The number of patients on Bilvay was 14, where reimbursement was achieved and product shipped. The number of patients with the potential to roll over to commercial drug is 100. Again, these patients are on Bilvay by way of their enrollment in our clinical study or early access or managed access programs. So they will transition to commercial drug. The number of discrete prescribers in the U.S. is 19. We have 100 top tier HCPs whom we call on in the U.S. In Europe, we don't have the ability to track this at this time, but I will go into more detail on the mix and targeting of our HCPs in a minute. This is exactly where we expected to be at this early stage of a rare disease launch. I am pleased with our start and am confident in delivering our guidance of low single-digit sales for 2021. In the U.S., we have 10 sales representatives, and with this targeted approach and the revenue that we will be generating, this will allow us to leverage the P&L over time. With each day, we increase patient access and coverage worldwide. which means more physicians with the ability to prescribe, and in turn, more patients who now have access to a drug option to treat pruritus and PFIC. So given this very solid start, our key actions to penetrate the estimated 2,500 global PFIC patient opportunity are focused on HCP outreach and education, moving prescriptions through to reimbursement, gaining market access in new countries, and expanding our geographic footprint. Our team's job is to reach the identified patients, and we are working quickly with our specialized field teams to do that. Starting with the treaters, our field team is delivering with HCP outreach and education, which is resulting in prescriptions. We not only continue to reach the top 60 centers but the sales and medical teams are also reaching the physicians at the referring centers and in the community, and pediatric GIs and adult hepatologists who treat the adolescent to adult patients. We are focused on calling on our top 100 physician targets, but also are extending our reach in partnership with Travere to the whole target universe of 700 physicians to reach as many patients as quickly as possible. So we then focus on getting Bilvay to the estimated 2,500 patients globally. And how are we going to do that? Good news. These available patients are ready to be treated. This is a big advantage for us versus other rare disease categories where you have to work through diagnosis and then finding 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 patients to those slated for potential transplant. We are seeing a varying range of age and weight, going from as young as four months to 37 years old, and a weight range of six to 80 kilograms. In addition to the focus and hustle from our commercial and medical field teams, our Alvareo Assist care coordinators are key to getting patients on Bilvay. As each patient case is always a little different from the next, it requires a well-coordinated and high-touch approach. It has been imperative for our in-house team to lead the intensive process of follow-up with families, physician offices, payers, and specialty pharmacies to fulfill bill day. We are seeing some prescriptions receive reimbursement as quickly as one week after they are written, whereas others have been in progress for as long as two months. To pave the way for patient access in the U.S., our market access teams are working with private and public insurers to educate them on PFIC and BILVE. We are having success with getting BILVE to patients in a timely manner as medical eligibility criteria for prior authorizations are being defined. As predicted, the first patients took time to process but we learn with each case, and our care coordinators are doing an outstanding job at processing cases and providing support to families to reduce the burden of reimbursement. Because we finalized our Medicaid agreement by August 1st, we had a mandatory Medicaid coverage date of October for BILVE. For example, we are pleased to have a pathway to coverage for New York Medicaid patients. As expected, it still requires our team to work state to state to clear the way for approvals to allow new patients to flow through the system. Overall, we are pleased with the payer response and feel that the early days of getting Bill Day in the hands of families is on track. Now looking outside of the U.S., in Europe, where we are working on the remaining European markets, having submitted many reimbursement dossiers. We are actively pursuing pricing and reimbursement in 14 countries simultaneously and are well advanced in our discussions with authorities in many of these markets. We are seeking to accelerate reimbursement wherever possible by leveraging optimal pathways, notably the NICE highly specialized technologies or HST pathway in England and Wales, the SMC ultra orphan pathway in Scotland, and the Half Fast Track pathway in France. Our goal is to ensure patients have access to Bilvay while achieving reimbursement at a price that reflects the value of Bilvay. 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. The opportunity is that we can provide more patients access to Bill Day globally. Similarly, in the rest of the world, we will continue to add commercial distributorships in regions and countries with high patient prevalence. Another strategy we have continued to execute and deliver on is to enter into exclusive distribution and supply agreements with key rare disease companies in various markets to extend availability across all of Europe, parts of the Middle East, and eventually in LATAM and the APAC regions, as well as in China. We just completed a fifth deal with Swiss Biopharma in Central and Eastern Europe, adding to our existing partnering plans in Israel, Turkey, Saudi Arabia, and other Gulf countries. and Japan, which we announced with J. Dight Medicines, who will be responsible for clinical development, regulatory approval, and commercialization of Bilve, with Japan representing a significant market opportunity. Ron will expand on this shortly, but we are really excited about all five agreements to date as we continue to create pathways for global Bilve availability. Now, as we look at the larger cholestatic liver disease market, let me turn it back to Ron to provide an update on our pipeline.

Super. Thanks, Pamela. The successful Phase III PEPFIG study in PFIG, regulatory approvals in the U.S. and Europe, and the ability to commercialize bilve around the world have a high level of translatability towards generating value from our pipeline programs. Starting with the PedFix studies, we continue to do further analysis of the long-term data we've generated based on the immensity of data, and we'll share more results with 10 upcoming bill-based presentations at the ASLD and NASPGAM meetings this year. Data will show evidence of long-term safety and efficacy, including improvements in hepatic health, growth, and sleep that reduce the burden of disease. sustained reductions in serum bile acids, and improvements in pruritus symptoms across PFIC types, post-surgery data, as well as a presentation on the ASSERT study in allogel syndrome. Our pivotal Phase III ASSERT study in allogel syndrome remains on track to report top-line data in 2022 as we continue to successfully enroll patients. It's a double-blind, randomized, placebo-controlled study which we've also agreed with both the FDA and EMA that this single trial will be sufficient for approval with a positive outcome. Our second and largest ongoing BILVE study is the Phase III BOLD study of BILVE and biliary atresia. BOLD is the only pivotal double-brined randomized placebo-controlled study in biliary atresia, and we've agreed with both the FDA and EMA that this single trial would be sufficient for approval with a positive outcome. We've made tremendous progress with BOL, which remains on track to deliver top-line data in 2024. Now, beyond our pediatric programs, we continue to advance our next-generation bile acid modulators with two adult liver disease product candidates, A3907 and A2342. With A3907, we have the world's first high bioavailability systemic ASVT inhibitor, which we believe will act differently than an IVAT inhibitor. we have presented preclinical data demonstrating A3-907's ability to eliminate bile acid in the urine, effectiveness in cholestatic liver disease, such as PSC and PBC, and differential effects in NASH, and now are awaiting results from the Phase I study, which we plan to share before year-end. Our second product candidate is A2342, the world's first potent oral NTCP inhibitor, which is being developed for viral and cholestatic liver diseases. We've been encouraged by their preclinical work and optimistic about the probability of success with this compound. Why? Hepcludex is an approved NTCP inhibitor purchased by Gilead for over a billion euros, but it is a peptide and must be given as a daily sub-Q. An oral agent allows for a wider dosage range and better convenience. We'll be sharing more data at ASLD with two A2342 poster presentations. A2342 IND enabling studies continue to progress with a phase one trial anticipated to start in 2022. And finally, as we look at the overall value of the company, we continue to have strong financial footing, which only got stronger in Q3 with two financial agreements. You heard Pamela mention the completion of a deal in Japan with J-Diode Metasys. What was attractive about this partnership with the upfront payment of $15 million, entitlement to the $120 million in milestones and double-digit royalties, and the J-DITE team. J-DITE has the right entrepreneurial spirit to navigate the Japanese orphan market, solid financial knowledge, and the backing of the CBC Group. Then beyond the completion of the J-DITE deal, we also sold the prior to review voucher, received an FDA approval for $105 million. The non-dilutive capital from both deals gives us a strong financial position as we continue to expand availability of Bilvay worldwide. We are a company with a first-in-class and first-to-market product with other strong candidates in the pipeline. Our focus is on our global commercial launch of Bilvay and PFIC and availability worldwide across cholestatic liver diseases with our BOLD and the SIRT trials that will allow us to realize the our $1 billion aspiration for Bilbao. In parallel, we're advancing our next generation bile acid modulators with the potential of A3907 and A2342 adult liver and viral diseases. So with that, it's my pleasure to turn the call over to Simon for a financial update.

Simon? Thank you, Ron. Let me now review our financial results for the third quarter of 2021. Bilvey revenue was $1.1 million for the third quarter, in line with analyst consensus, following the launches in the U.S. in July and in international in September. U.S. revenue was $800,000, and ex-U.S. revenue, or international, was $300,000. Royalty revenue was $2.6 million for the third quarter, compared to $2.1 million for the third quarter of 2020. an increase of $500,000. The increase relates to estimated royalty revenue to be received from EA Pharma for Elabixabat for the treatment of chronic constipation, which, as you know, is passed on to healthcare royalty partners. Cost of product revenue was $400,000 for the third quarter of 2021 due to manufacturing and quality headcount costs. Manufacturing and quality headcount costs prior to BILVE approval were included in expenses. However, since approval, a portion of these costs are now recorded in cost of product revenue. As BILVE ramps up, these headcount costs will become a much lower percent of product revenue. There were no material costs during the third quarter of 2021 as materials related to current product revenue were expensed prior to approval. Research and development expenses were $21.1 million for the third quarter, compared to $22.2 million for the third quarter of last year, a decrease of $1.1 million. The decrease in research and development expenses for the 2021 period were principally due to the completion of the PEDFIC-1 study and the completion of the ELOBIXABAT phase two trial in NASH, in Q3 2020, offset by increases this year in the BILVE, ASSERT, and BOLD trials and investments in early assets. Selling general and administrative expenses were $17.6 million for the third quarter of 2021, compared with $11.7 million for the same quarter last year, an increase of $5.9 million. The increase is attributable to personnel and related expenses as we continue to increase our headcount and commercial expenses to launch BuildA. Net income for the third quarter of 2021 was $57.1 million, driven by the one-time sale of the priority review voucher, compared to a net loss of $30.7 million for the third quarter of 2020. Earnings per share for the third quarter of this year were $2.90 on a fully diluted basis compared to a loss of $1.96 for the third quarter of 2020. As of September the 30th, 2021, we had cash and cash equivalents of $262.6 million compared to $186.3 million on June the 30th, 2021. the 2021 operating cash burn guidance has previously been for $130 to $135 million and is now expected to be closer to $130 million. During the third quarter of 2021, an additional $103.4 million of net proceeds were received after deducting fees from the recently completed sale of the PRV. In addition, we are due to receive an additional $15 million upfront fee from the recently announced Japan licensing agreement in the fourth quarter of 2021. As a result, cash and cash equivalents are anticipated to be sufficient to fully fund the launches of Bilvey and the next stages of the early asset portfolio. In order to be more specific and ensure clear expectations, 2021 revenue from Bilvey is anticipated to be 3 to 4 million U.S. dollars, consistent with our previous guidance of low single-digit U.S. dollar millions. With that, let me turn the call back over to Ron for closing remarks.

Thank you, Simon. We're proud of what we've accomplished in the first two months of Bilvey launch and the opportunities we continue to work toward. Ultimately, our goal remains to bring Velvete to the approximately 100,000 pediatric cholestatic patients around the world, starting as the first and only approved drug option for PFIC patients across all types worldwide. And finally, we'll continue to advance our portfolio in adult liver and viral diseases. We thank everybody for joining us, and we're pleased to open the call now for Q&A. Operator?

Thank you. At this time, we will 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 that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from the line of Ritu Baral with Cowen. You may proceed with your question.

Good morning, guys. Thanks for taking the question. I wanted to focus on the launch payer discussion. What do you expect the most common prior authorization requirement to be, I guess, going forward, steady state? Is it just, like, diagnosis? Are any plans asking for, like, a certain serum bile acid level or itch attestation? And then can you tell us, like, right now how you're looking at percent covered lives or if most of the reimbursement is through exception? Thanks. And I've got a quick follow-up, I promise.

Hi, it's Pamela. Many thanks for the questions. Yes, with the prior authorization requirements, what we see is that they vary plan to plan, and we're seeing the whole range. From everything that you mentioned, it could be looking at baseline serum bile levels, confirming pruritus is present, confirmation of specialist prescribing. All of these factors that you would expect with an initial prior authorization on a new product And we've been able to get these through the system. You know, what I can say is that they really have not been a barrier, the prior authorizations, not a barrier to getting patients through the system and on to Bill Bay.

Go ahead, sorry.

And I believe your second question is about sort of, you know, our expectation around the percentage of covered lives. And, again, we're very positive. We've gotten out to all the payers. that represents the majority, 95% of lives across the U.S., and they understand and recognize the value of Bilve, and to date have been covering and approving on, as with any new product, going through the exception process. But that's why we have Alvareo Assist. We take the cases in, we understand the plan requirements, and we are able to work the patients through the system and get the claims paid for.

Great, thanks. And a very quick question on 3907. When might we expect direction on a targeted indication, Ron? Like, how are you thinking about, you know, the unmet need in PSC versus the established path in PBC and then, you know, NASH?

Yeah, thank you, Reese, too, for the question. I think, you know, for 8397, we're pretty excited about it, you know, because we believe being the first highly bioavailable ASBT inhibitor with systemic exposure that we can probably do some different things with that compared to the IPAT inhibitors. I think to answer your question, we really need to get through the phase one data first, which we anticipate sharing with you by the end of the year once we have a chance to digest that data. you know, then we'll chart the path forward. But it is in the range of, you know, right now we continue to think about adult liver diseases because we believe the profile, the ability to take bile acids out of the body, not only through the ileum, but also to take them out through the kidney could be very interesting.

Got it. I'll hop back in the queue. Thanks for taking the questions.

Thank you, Rita. Thank you.

Our next question comes from the line of Yoon Young with Jefferies. You may proceed with your question.

Thank you. So in terms of pricing, I know that, you know, ex-U.S. pricing could be quite different by country on the country basis. But at the same time, from your experience and your discussions so far, do you know what could be potentially the differential between the U.S. and ex-U.S. pricing?

Hi, Yoon. Thank you for the question. What we're looking at is European list prices for BuildA that are within the 20% to 30% corridor of our U.S. WAC, which is right in line with the rare disease analogs that we've seen and analyzed to date. So we're feeling very confident about our pricing strategy both in the U.S. and in Europe.

And in Europe or outside the U.S., The PVD surgery, that's a lot cheaper. So have you seen any kind of some sort of a pushback from payers outside the US based on the pricing differential between the surgery and Belvay?

We have not seen that pushback to date. I think payers really see the value of having a non-surgical option for these patients.

Great. And then last question on allergy syndrome. So data is on track for 2022. You know, the first patient was, I think, a dose in March this year. So maybe it's a little bit too early to comment. But can you kind of give us some guidance when you might expect to complete the patient enrollment? Thank you.

Thanks for the question. We're just really pleased to be up and going with the ASSERT trial program. you know, across the globe. And we're pleased with the enrollment thus far. We'll provide you an update once we have the study fully enrolled, but we reiterate our guidance of expecting data in 2022. Thank you.

Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. You may proceed with your question.

Hi, team. Thank you so much for all the great updates. I have two quick questions for you. Simon, thank you for providing guidance for 2022. But can you maybe help us understand how much of the contribution would be coming from the US versus Europe? That's part one. And then the second question is just kind of give us a little bit of color how you guys are thinking about sort of the cadence of dossiers that are going to be filed in Europe and and sort of which geographies could be easier to gain market access and approval versus others, just to kind of help us orient as we'd be looking also at some matrix in the European launch. And thank you again for taking my question.

Hi, thanks, Yasmeen. The guidance was actually for 2021, the $3 million to $4 million of revenue this year. As you can see from the split in Q3, Yeah, it was a partial quarter, but it was sort of relatively balanced between the U.S. and Europe at this stage. It's premature to give 2022 guidance currently because, frankly, we want to wait anyway until the end of the year when we have a better visibility of sort of final numbers for this year. But I think it's reasonable to assume that the split between the U.S., and the EU and the rest of the world will be fairly balanced.

And then for your second question, Yasmine, regarding the cadence in Europe, what we're seeing, as mentioned, we're actively pursuing the reimbursement in 14 countries with the submission of the dossiers. And so the way we think about this is, of course, we've launched in Germany We're actively in discussions with UK, France, and Italy, the next largest markets in Europe. And then at the same time, the remaining markets in Europe where there's also a lot of opportunity, we're simultaneously submitting those dossiers as well.

And maybe just a quick follow-up. Is there a sort of timeline that you have in mind by being able to complete the next 10 dossiers? Like, have you... given yourself sort of like a timeline on by when to complete, how many that you feel comfortable wanting to share with us.

Yeah, I think, Yasmeen, you know, the way we think about the launch, you know, think about this year as kind of working through the logistics in the U.S., right? As you know, there's about 1,000 different players within the U.S., so this is the logistics of the U.S. And then from a European perspective, think about next year as us working through, European access. And as Pamela stated in the early comments, we're looking at some specialized pathways. We're really pleased with the early dialogue, particularly in the clinical assessments, right? So we remain pretty confident that through next year we'll sort through those European countries.

Thank you so much for taking my questions.

Thank you, Yasmeen.

Our next question comes from the line of Tim Lugo with William Blair. You may proceed with your questions.

Hey guys, this is Lachlan on for Tim. Thanks for taking the questions. I was wondering, you know, as it comes to the sort of, especially about the launch cadence and the adoption there, what are the sort of bottlenecks or major gating factors to kind of getting patients on drug? Is it patient identification? Doctors just waiting until that patient comes in for their next routine visit before they're prescribed? Is it, you know, the insurances? scenario or situation there? What are the sort of main gating factors in getting more patients on drug? And then on the topic of insurance coverage, I know the timing was probably tight to get into the 2022 negotiating cycle. So are you expecting, I guess, significant formulary improvements starting in 2022 or they're going to be sort of coming online over the course of the year and really taking a big effect in 2023.

Let me start with your second question and then loop around to your first. In terms of the cycle for the U.S., the payers, as we go through this, what we're finding is that this is really a case-to-case by case approach to reimbursement. And so On the Medicaid side, we've had, as I mentioned, coverage as of October. And so we've been very pleased in terms of being able to get patients onto Medicaid. And, of course, there are some states that drag a little bit, but we're getting into their cycles. And so we are in good standing there with Medicaid. And then for the commercial piece, again, we are able to get patients through without necessarily having Bill of A added to formulary. So we're working through patient by patient, and I don't think that that will be any type of, you know, gating factor in 2022 in terms of waiting for a cycle because we're able to actually get them through case by case at this point in time. And then back to your first question on, you know, what are the sort of steps in the process in terms of getting patients in and treated? As we've mentioned, the patients are identified and in the system. And so the first step is to make sure they get into the doctor's office and get prescribed Bilvay. Once they get prescribed Bilvay, then we take them through Alvareo Assist, and it's just a process of working them through either a prior authorization or any type of requirement that the plan has. And then thirdly, getting the product shipped out to BuildA. So it's just a couple of factors that can take a short time or can take a longer time.

Great, thanks. Thanks, Lachlan.

Our next question comes from the line of Brian Scorney with Baird. You may proceed with your question.

Okay, good morning, team. Thanks for taking the question. I'm just trying to think about the flow of NRX here. Are you kind of seeing it as a steady state, or are there any sort of differences within the quarter, like an early buildup, and how we should kind of think about this going forward? Do you anticipate anything that could lead to an acceleration in NRX? And then are you seeing any examples where an NRX isn't converting to a patient on treatment? Like is there actual attrition here where a patient doesn't pursue authorization to ultimately get the TRX filled? Thanks.

Yes. To your first question on sort of the cadence of the NRX, we are seeing patients come on and come through the system, and it's sort of patient by patient. I would expect that to continue to grow, especially as more payers become familiar with Bill Bay. In the beginning, it takes a little bit of time for them to work out their process, but as we get going here, we'll work into a faster cadence in terms of pulling the patients through.

I think the other thing to think about from a New York's perspective, Brian, is You know, we talked about countries coming on board, and we also talked about the 100 patients that we have that are on drug that will convert, right? So as we get access in different countries and as patients come out of the 72-week PedFix2 period, these people would convert to commercial as well, right? So, yeah, I think we're really pleased with the first two months of what we're going to have. We're going to continue to grow, I think, quarter by quarter, and certainly as we get other geographies on board, that's going to help. And then to your question about have we had an RX rejected, I think we're still in the process with many of them, so we'll continue to wrestle some of them of taking longer, but we're pretty confident we'll get there over time. Great. Thank you. Thanks, Brian.

Our next question comes from the line of Joseph Stringer with Needham & Co. You may proceed with your question.

Hi, good morning, everyone. Thanks for taking my question. Just a follow-up on sort of the cadence and the transition of patients onto commercial drug. Ron, you mentioned the PETFIT2, and just wanted to get your thoughts on whether we can expect sort of a a bolus of patients in 2022 that are either transitioning, you know, from PEDVIC2 or any EIT program, or would it be sort of, you know, a little bit slower transition specifically onto commercial drug? Thank you.

Let me start by just, you know, talking a little bit through sort of these potential rollover patients that we had mentioned. So we have 100 potential rollover patients worldwide. And these are patients, as a reminder, by way of, you know, they're either enrolled in our clinical study or they're in one of our early access or managed access programs. And so we have a lot of programs in a lot of different countries, and we have patients rolling off the 72 weeks at different time periods. So what I can say is that we'll have patients rolling off as they hit the 72 weeks. At the same time, we have new patients coming on through our managed access programs. So I think we'll see this sort of steady state of patients coming through and on to commercial drug over the next year or so.

Great. Thanks for taking our question.

Our next question comes from the line of Andres Argariz with Wedbush Securities. You may proceed with your question.

Good morning, and thanks for taking our question. And I guess a small apology for kind of harping on the reimbursement status. But just what are the, you know, the profile is pretty obvious and compelling. And so, in essence, what does it really take from the payer perspective to get or to convince them to, you know, put this on their formularies? And maybe what are the expectations, you know, that you have internally as to when to get to a certain number of covered lives? And when you do so, do you plan on press releasing that?

So, let me start. with your first couple of questions here. So, you know, the profile is very compelling for payers. They see the value, they understand the unmet need, and they want to pay for this. And they don't want to manage it too closely because this is like any rare disease. The number of patients is such it's not really worth it for them to manage it closely. So we don't even expect a lot of coverage policies to put in place because Most of these plans will just be covering Bill Day on a case-by-case basis. So it's not too hard to get them through. They ask for specific information. The physician's office submits that information, and we're able to get patients through and claim paid for for Bill Day.

And I think one of the things to think about, Andreas, is when you think about primary care products where you have a lot of patients, you have large insurance companies, a lot of prescribers, a metric like coverage lives is an important metric. But in this case, this is a rare disease. And this is a rare disease with a massive unmet medical need. These are children that are suffering. And so for an individual payer, this is a handful of patients. And as Pamela said, the compelling data that we have plus the value pack that we put together has worked out thus far. So we're pretty confident in our ability to continue to gain reimbursement for the prescriptions that are generated.

Okay, great. And then as far as efforts ongoing to identify new patients, could you kind of walk us through that process?

Yes, of course. So in terms of identifying patients, our Alvareo and Travere field teams have reached 100% of the top 60 centers and 90% of the top 100 prescribers. So in doing this, we've really been able to quickly identify HCPs with patients in the system. And these patients can range, of course, from either being newly diagnosed or those slated for potential transplants. So we continue to engage with HCPs with ongoing in-person and virtual meetings and educational sessions. We have the upcoming opportunities virtually at ASLD and NASP again. We also engage with the patient advocates who have been working to ensure that their communities are aware of building a new treatment option. So through all these efforts, we were absolutely able to identify new patients and bring them into the system and bring them into, or they're in the system, bring them in for treatment with BuildA.

Great. Thanks for taking our questions and congrats on all the progress. Thank you.

Thank you, Andres.

Our next question comes from the line of Ed Ars with HC Wainwright. You may proceed with your question.

Hi, thanks for taking my questions. And thank you for all of the launch metrics up front here. It's very helpful. I wanted to start first question on that. You mentioned 28 new prescriptions and 14 patients currently on Bilvay. So, you know, in just the first two months representing, you know, 50% conversion. which I view as a testament not only to the strong value proposition of Bilve itself, but also success with the high-touch approach of Alvareo Assist. But I'm wondering, is that conversion timeline something you expect to remain stable or perhaps accelerate, given that you're going through the very first of these prescriptions and over time that could... That's the first question. The second one is on the 19 prescribers, discrete prescribers in the U.S. that you mentioned as well. Wondering if there's any different dynamics you could discuss with, it would appear, a few docs that have already written multiple prescriptions. And then thirdly, if you could remind us what you're seeing right now what you project in terms of the proportion between commercial pay, Medicare, and Medicaid. Thanks so much.

Great. Let me start with the first question on conversion. You know, what I would say here is that, you know, 28 new prescriptions, 14 patients on BuildA. Very pleased with that result. You keep in mind some of those some of those patients, those prescriptions would have come in late in Q3, right? And so the conversion rate of 50%, I may not use that going forward just because the numbers are small and the patients are coming in over the course of the quarter, right? So I think we can expect to see a higher conversion rate going forward over a longer time period with more patients coming. So that's one thing to keep in mind. The second question on the 19 prescribers and the dynamics there, what we see here is, you know, really that we're really pleased with the breadth of prescribers, right, if you think about the top 100 that we have in the U.S. And, you know, we're looking here more at sort of breadth of prescribers necessarily, you know, rather than a number of prescriptions coming from like a small number of prescribers. So there we're really pleased to see the breadth of prescribing. And then your final question on the split. Too early for us to comment on this, but what I will say is the payer mix is right in line with what we expect for rare disease drugs.

Great. Thanks so much.

Our next question comes from the line of Ritu Baral with Cowen. You may proceed with your question.

Hi, guys. Thanks for taking the follow-up. I'm just curious, do you have any free drug or bridging program in place early on while patients are navigating reimbursement and exception? And then also, of the new prescribers, the 19, can you talk to what percentage of them are already bilve experienced from the clinical trials? Thanks.

Okay, let me talk to the first question around the assistance programs. So we do, through Alvareo Assist, offer a wide range of financial and patient support assistance programs. So when a patient comes in, we screen them right away for our free drug program called our patient assistance program. And then we have a series of other programs, including a temporary access program that can, as you say, help patients get onto drug while we are navigating through a particularly lengthy prior authorization process, for example. So yes, we do offer a range of different assistance programs to help ensure that patients have access to Bilvay as quickly as possible. Then on your second question, on the 19th... Experience with Bilvay. Oh, yes, experience with Bilvay. Yes, we can't really comment on the exact percentage of those patients who...of those prescribers who are in their clinical trials. But what we can say is that we are seeing a mix of prescribers from our top tier who would have experience with BILVE as well as new prescribers as well.

Yeah, I think we're really pleased about that part, actually, Ritu, because obviously a lot of the high-level awareness of BILVE, given that we have three Phase III clinical trials either ongoing or completed, So there's a lot of individuals who are aware, so high-level awareness that we expect prescriptions from those people that are aware. But we're actually pleased that there's a number of people that are sort of new to us that are prescribed as well. So as Pamela said, we'll continue to expand that over time.

Really helpful. Thanks.

At this time, we have reached the end of the question and answer session. I will now turn the call back over to Ron Cooper for closing remarks.

All right, great. Thank you, operator. Well, thank you all for attending today's conference call. We'll continue to keep you updated on the BILVE global launch progress, enrollment in the two BILVE V3 studies, as well as our progress with our two next-gen bile acid modulators for adult cholestatic and viral liver disease. The next opportunity for an update will be our post-AAS elite conference call on November 16th, where Dr. Pat Warren, our chief medical officer, will join me again, as well as our chief scientific officer and co-founder, Dr. Jan Mattson. So please confirm on your calendars. Until then, we'll continue to advance Albreo's mission to provide hope to families of patients with liver disease and the entire liver community. Thanks to all of you for your continued support.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation and have a great day.