Albireo Pharma, inc (ALBO) Q3 2021 Earnings Call Transcript

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Albireo Pharma, inc (ALBO)
Q3 2021 Earnings Call
Nov 4, 2021, 10:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

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

I will now turn the conference over to your host, Paul Arndt, Managing Director. 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 third quarter ended September 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 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, November 4, 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

Thank you, Paul, and thank you, everyone, for joining us this morning. With me today are Simon Harford, our Chief Financial Officer; Pamela Stephenson, our Chief Commercial Officer; and Dr. Pat Horn, our Chief Medical Officer.

This is a historic quarter for Albireo as we achieved our first product approvals in the U.S. and Europe and successfully launched Bylvay. 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 three study in mid-2020. We committed to approvals and the launch of Bylvay in the second half of 2021. We committed to starting two additional Phase three studies in Alagille 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 Bylvay and advancing our pipeline as planned.

In this quarter we not only received product approvals in the U.S., EU and U.K. and launched Bylvay globally, but we also finished goods and generated the first partial quarter of sales for Bylvay with revenue generation in the U.S. and international which transformed us into a commercial company. The launch is going well right to plan and we're delivering on expectations. Bylvay is fulfilling a clear market need for the first drug treatment option. Doctors like it and impairs recovery and our team is delivering on fast launch uptick.

We generated Bylvay sales and we're just at the starting point for Albireo and the journey to build a great deliver company. We're looking forward to delivering Bylvay launches in more countries, to Bylvay Phase three clinical trials and advancing two new next-generation compounds.

Focusing on Bylvay, 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 the impact of Bylvay.

For example, we had two siblings, age is 16 and nine years of age with the rare PFIC-six subtype. Both children have been on various off label medications for many years. That hasn't been effective and providing relief from the pruritus after living with these unreleased symptoms for so long they're excited to have Bylvay 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 the things keep getting better. We will share details on our progress by taking you through and covering one, the Bylvay 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 Bylvay, 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 suggests that we provide the right balance of two fewer too many metrics. Our plan would be to update our metrics every quarter going forward. In this quarter will 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 the approvals occurred at the end of July.

Let me turn it over to Pamela to explain the metrics will be sharing with you and provide you an update. Pamela?

Pamela Stephenson -- Chief Commercial Officer

Thanks, Ron. Before jumping into the metrics, I would like to reiterate some of Ron's comments. I am delighted with response to Bylvay as there clearly is a significant unmet need and Bylvay is making a difference. To-date the launch is going as planned, and prescribers, patients and payers have reacted positively to the availability of Bylvay.

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 Bylvay, which has led to prescriptions being generated and patients starting treatments.

Our in-house AlbireoAssist 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 Bylvay these are patients where reimbursement has been achieved and Bylvay has been shipped. Number of potential rollover patients on Bylvay. These are number of patients that are in programs where they are on Bylvay and should convert to commercial sales in the future.

This includes patients in the PEDFIC two extension study, our early access program as well as patients in our managed access programs. This is a global number and these patients will rollover to commercial sales when we obtain country level pricing and reimbursement and for the patients in PEDFIC two 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 to Bylvay build a 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 Bylvay was 14 where reimbursement was achieved and product shipped. The number of patients with the potential to rollover to commercial drug is 100. Again, these patients are on Bylvay by way of their enrollment and 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., and 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 I'm confident and delivering our guidance of low single-digit sales for 2021.

In the U.S., we have 10 sales representatives and with this target 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 pruritis 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 their community and Pediatric GI's and adult hepatologist who treat the adolescent to adult patients. We are focused on calling on our top 100 physician targets, but also are extending our reach and partnership with true VR to the whole target universe of 700 physicians to reach as many patients as quickly as possible.

So we then focus on getting Bylvay 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 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 AlbireoAssist care coordinators are key to getting patients on Bylvay. 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 Bylvay. 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 Bylvay.

We are having success with getting Bylvay 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 1, we had a mandatory Medicaid coverage date of October for Bylvay.

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 a payer response and feel that the early days of getting Bylvay 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 and 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 highest Fast Track pathway in France.

Our goal is to ensure patients who had access to Bylvay while achieving reimbursement at a price that reflects the value of Bylvay. 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 Bylvay globally.

Similarly in the rest of the world, we will continue to add commercial distributive ships 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 the LATAM and the APAC regions as well as in China.

We just completed a fifth deal with Swixx 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 Jadeite Medicines who will be responsible for clinical development, regulatory approval and commercialization of Bylvay 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 Bylvay 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.

Ron Cooper -- President and Chief Executive Officer

Super and thanks Pamela. The successful Phase three PEDFIC and PFIC regulatory approvals in the U.S. and Europe and the ability to commercialize Bylvay around the world have a high level of translatability toward generating value from our pipeline programs. Starting with the PEDFIC 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 Bylvay presentations at the AASLD and NASPGHAN NASA 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 Pacific types. Post-surgery data, as well as a presentation on the ASSERT study in Alagille syndrome.

Our pivotal Phase three ASSERT study in Alagille 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 the single trial will be sufficient for approval with a positive outcome.

Our second and largest ongoing Bylvay study is the Phase three BOLD study, of Bylvay and biliary atresia BOLD is the only pivotal double-blind, randomized, placebo controlled study in biliary atresia, and we've agreed with both the FDA and EMA that the single trial would be sufficient for approval with a positive outcome. We've made tremendous progress with BOLD which remains on track to deliver top line data in 2024.

Now beyond our pediatric programs to continue to advance our next generation Bile Acid modulators with to adult liver disease product candidates A3907 and A2342 with A3907 we have the world's first high bioavailability systemic ASBT inhibitor, which we believe will act differently than n I bet inhibitor. We have presented preclinical data demonstrating A3907 ability to eliminate bile acid in the urine effectiveness and cola static liver disease such as PSC and PBC, and differential effects at NASH and now are waiting results from the Phase one study, which we plan to share before year end.

Our second product candidate is A2342 the world's first potent oral NTCP inhibitor, which has been 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 EUR1 billion. But it is a peptide and must be given as a as a daily subcu.

An oral agent allows for a wider dosage range and better convenience. We'll be sharing more data at AASLD with A2342 poster presentations. A2342 IND enabling studies continue to progress with a Phase one trial anticipate 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. Pamela mentioned the completion of a deal in Japan with Jadeite medicines.

What was attractive about this partnership was the upfront payment of $15 million entitlement to the $120 million in milestones and double-digit royalties, and the Jadeite team. Jadeite has the right entrepreneurial spirit to navigate the Japanese orphaned market, solid financial knowledge and the backing of the CBC Group.

Then beyond the completion of the Jadeite deal, we also sold a Priority Review Voucher received FDA approval for $105 million. The non-dilutive capital from both deals give us a strong financial position as we continue to expand availability of Bylvay 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 Bylvay and PFIC and availability worldwide across cholestatic liver diseases with our BOLD and ASSERT trials that allow us to realize our $1 billion aspiration for Bylvay, in parallel or advancing our next generation bile acid modulators with the potential of A3907 and A2342 adult liver and viral diseases.

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

Simon Harford -- Chief Financial Officer

Thank you, Ron. Let me now review our financial results for the third quarter of 2021. Bylvay 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 elobixibat 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 Bylvay approval were included in expenses.

However, since approval, a portion of these costs are now recorded in cost of product revenue. As Bylvay 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 one one study and the completion of the elobixibat Phase two trial in NASH in Q3 2020. Offset by increases this year in the Bylvay 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 Bylvay.

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 30, 2021, we had cash and cash equivalents of $262.6 million, compared to $186.3 million on June 30, 2021.

The 2021 operating cash burn guidance has previously been for $130 million 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 Bylvay and the next stages of the early asset portfolio. In order to be more specific and ensure clear expectations, 2021 revenue from Bylvay is anticipated to be USD3 million to USD4 million, 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.

Ron Cooper -- President and Chief Executive Officer

Thank you, Simon. We're proud of what we've accomplished in the first two months of Bylvay launch and the opportunities we continue to work toward. Ultimately, our goal remains bring Bylvay to the approximately 100,000 pediatric cholestatic patients around the world. Starting as the first and only approved drug option for keeping 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?

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Ritu Baral with Cowen. You may proceed with your question.

Ritu Baral -- Cowen -- Analyst

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

Pamela Stephenson -- Chief Commercial Officer

Hi, it's Pamela. Thanks. Many thanks for the question. Yes, we with a 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 pruritis 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 they really have not been a barrier, the prior authorizations, not a barrier to getting patients through the system and on to Bylvay.

And I believe your second question is about sort of, our expectation around the percentage of covered lives. And again, we're very positive on we've gotten out to all the payers, that represents the majority 95% of lives across the U.S. And they understand or recognize the value of Bylvay

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 Albireo 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.

Ron Cooper -- President and Chief Executive Officer

Yes, thank you Ritu for the question. I think the [Indecipherable] 3907 pretty excited about it, you know, because we believe being the first highly bioavailable ASPD inhibitor with systemic exposure that we can probably do some different things with that compared to the I bet 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 then we'll chart the path for but it's in the range of, 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.

Operator

Our next question comes from the line of Eun Yang with Jefferies. You may proceed with your question.

Eun Yang -- Jefferies -- Analyst

So in terms of pricing, I know that ex-U.S. pricing could have 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 differentiator between the U.S. and ex-U.S. pricing?

Pamela Stephenson -- Chief Commercial Officer

What we're looking at is European list of prices for Bylvay that are within the 20% to 30% quarter of our U.S. whack which is right in line with our-the rare disease analogues that we've seen and analyzed today. So we're feeling very confident about our pricing strategy both in the U.S. and in Europe.

Eun Yang -- Jefferies -- Analyst

And in Europe or outside the U.S. the PPPD surgery that's a lot cheaper. So do you-have you seen any kind of some sort of pushback from payers outside the U.S. based on the pricing differential between the surgery and Bylvay?

Pamela Stephenson -- Chief Commercial Officer

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

Eun Yang -- Jefferies -- Analyst

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

Ron Cooper -- President and Chief Executive Officer

Thanks for the question, Eun. We are just really pleased to be up and going with the assert trial, 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 expecting data in 2022.

Operator

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

Yasmeen Rahimi -- Piper Sandler -- Analyst

I have two quick questions for you. Simon thank you for providing guidance for 2022. But can you maybe help us understand how much the contribution would be coming from the U.S. 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 be looking also at some matrix in the European launch? And thank you again for taking my question.

Simon Harford -- Chief Financial Officer

The guidance was actually for 2021 for $3 million to $4 million of revenue this year. As you can see from the split in Q3 yes, 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 till 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.

Pamela Stephenson -- Chief Commercial Officer

And then for your second question, Yasmeen, regarding the cadence in Europe. You know, what we're seeing as, 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 U.K., 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.

Yasmeen Rahimi -- Piper Sandler -- Analyst

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?

Ron Cooper -- President and Chief Executive Officer

Yes, I think Yasmeen, the way we think about the launch, think about this year is kind of working through the logistics in the U.S., right. As you know, there's about 1000 different payers within in 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, you were looking at some specialized pathways, we're really pleased with the early dialogue, particularly in the clinical assessments, right. So we were pretty confident that through next year, we'll sort through those European countries.

Operator

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

Tim Lugo -- William Blair -- Analyst

There's a lot going on for Tim, thanks for taking the questions. I was wondering, as it comes to the sort of stressing you about the launch cadence and adoption, that-what are the sort of bottleneck for major gating factors to kind of getting patients on drug, is that patient identification or doctors just waiting until that patient comes in for that x routine visit for prescribed, is that insurance scenario or situation there? What are the sort of main gating factors and 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 going to be sort of coming online over the course of the year and really taking a big effect in 2023?

Pamela Stephenson -- Chief Commercial Officer

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've mentioned, coverage, as of October, and so we've been very pleased in terms of getting being able to get patients on to Medicaid. And, of course, there are some states that drag a little bit, but we're getting into their cycles. And so we should, 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 Bylvay added to formulary. So we're working through patient by patient, and I don't think that will be any type of 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, what are the sort of the steps in the process and 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 Bylvay, once they get prescribed to Bylvay then we take them throughout the rail assist and it's just a process of working them through either a prior authorization or a new, any type of requirements that the plan has.

And then thirdly, getting the product shipped out to Bylvay. So it's just a couple of factors that can be-can take a short time or can take a longer time.

Operator

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

Brian Skorney -- Baird -- Analyst

I'm just trying to think about the flow of nRx here. Are you kind of seeing it as a steady state or there any sort of differences within the quarter like, like an early build up? And how we should kind of think about this going forward? Do you anticipate anything that could lead to an acceleration and 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 vote? Thanks.

Pamela Stephenson -- Chief Commercial Officer

Yes, to your first question on the sort of the cadence for the nRx. We are seeing patients come on and, and come through the system. And it's sort of patient by patient. So I was-I would expect that to continue to grow, especially as more payers become familiar with Bylvay that, 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 patient's through.

Ron Cooper -- President and Chief Executive Officer

And I think the other thing to think about from a new Rx perspective, Brian is 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 PEDFIC two period, these people would convert to commercial as well, right.

So 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 had other geographies on board that's going to help and that's your question about you have we had no-have we had nRX rejected, it's still early, 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.

Operator

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

Joseph Stringer -- Needham and Company -- Analyst

Thanks for taking my question. Just to follow-up on sort of the cadence and the transition of patients onto commercial drug. Ron, you mentioned the PEDFIC two, and just wanted to get your thoughts on whether we can expect sort of a Bylvay of patients in 2022, that are either transitioning, from PEDFIC two or any EAP program or would it be sort of, a little bit slower transition, specifically on to commercial drug. Thank you.

Pamela Stephenson -- Chief Commercial Officer

Let me start by just talking a little bit through sort of these potential rollover patients and that we had mentioned, so we have 100 potential rollover patients worldwide. And these are patients as a reminder by way of, they're either enrolled in our clinical study, or they're in one of our early access or manage access programs.

And so we have a lot of programs and a lot of different countries, and we have patients rolling off to 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 on an on to commercial drive over the next year or so.

Operator

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

Andreas Argyrides -- Wedbush Securities -- Analyst

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

Pamela Stephenson -- Chief Commercial Officer

So let me start with your first couple of questions here. So, 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 rant, you know, rare disease.

There is a number of patients as 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 Bylvay on a case-by-case basis.

So it's not too hard to get them through, they asked for specific information, the physician's office, submit that information, and we're able to get patients through and claims paid for Bylvay.

Ron Cooper -- President and Chief Executive Officer

And I think one of the things to think about Andreas is, when you think about your primary care products, where you have a lot of patients you have, you know, large insurance companies, a lot of prescribers, you know, a metric like coverage lives is an important metric. But in this case, this is a rare disease, right. And this is a rare disease with a massive unmet medical leave.

These are children that are suffering, right. 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-we're pretty confident in our ability to continue to gain reimbursement for the prescriptions that are generated.

Andreas Argyrides -- Wedbush Securities -- Analyst

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

Pamela Stephenson -- Chief Commercial Officer

Yes, of course. So in terms of identifying patients are Albireo 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 transplant. So we continue to get to engage with HCPs was ongoing in-person and virtual meetings and educational sessions as we have the upcoming opportunities virtually at AASLD & NASPGHAN.

And we also engage with patient advocates who, you know, who have been working to ensure that their communities are aware of building new treatment options. So through all these efforts, we're absolutely able to identify new patients and bring them into the system and bring them into order in the system, bring them in for treatment with Bylvay.

Operator

Our next question comes from the line of Ed Arce with H.C. Wainwright. You may proceed with your question.

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

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 Bylvay. So you know, in just the first two months representing you know, 50% conversion, which I view is a testament not only to the strong value proposition of Bylvay itself, but also success with the high touch approach of AlbireoAssist?

But I'm wondering, is that conversion timeline, something you expect to remain stable, or perhaps accelerate, given that, you know, you're going through the very first of these prescriptions and over time that could accelerate that's first question? Second one is on the 19 prescribers-discreet 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 doc's that have already written you know 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.

Pamela Stephenson -- Chief Commercial Officer

Right, let me start with the first question on conversion. What I would say here is that, 28 new prescriptions, 14 patients on Bylvay very pleased with that result. You keep in mind some of those patients, you know, those prescriptions would have come in, late in Q3, right. And so they, there's a conversion rate of 50%. I mean, 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-we can expect to see a higher conversion rate going forward over a longer time-period with more patients.

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, 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 the-we're looking here more at sort of breadth of prescribers necessarily, rather than a number of-prescriptions coming from like a small number of prescribers. So they were really pleased to see the breadth of prescribing and then your final question?

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

Medicaid was it?

Pamela Stephenson -- Chief Commercial Officer

Honestly, 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.

Operator

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

Ritu Baral -- Cowen -- Analyst

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 Bylvay experienced from the clinical trials? Thanks.

Pamela Stephenson -- Chief Commercial Officer

Okay. Let me talk to the first question around the assistance program. So we do through AlbireoAssist 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 particular 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 build as quickly as possible. Then on your second question on the 19...

Ron Cooper -- President and Chief Executive Officer

Experience with Bylvay.

Pamela Stephenson -- Chief Commercial Officer

Oh, yes, experience with Bylvay. Yes, we can't really comment on the exact percentage of those-prescribers who are in their clinical trials. But what we can say is that, yes we are seeing you know, a mix of prescribers, from our top tier, who would have experience with Bylvay as well as new prescribers as well.

Ron Cooper -- President and Chief Executive Officer

Yes, I think we're really pleased about that part, actually, Ritu. Because obviously a lot of this is a high level of awareness of Bylvay, given that we have three phase three clinical trials, either ongoing or completed. So there is a lot of individuals who are aware, so high level awareness so we expect prescriptions for 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 prescribed as well. So as Pamela said, we'll continue to expand that over time.

Ritu Baral -- Cowen -- Analyst

Really helpful thanks.

Operator

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.

Ron Cooper -- President and Chief Executive Officer

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 Bylvay global launch progress enrollment in the two Bylvay Phase three 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-AASLD conference call on November 16, where Dr. Pat Horn our Chief Medical Officer will join me again as well as our Chief Scientific Officer and co-Founder Dr. Jan Mattsson.

So please confirm on your calendars. Until then, we'll continue to advance all Albireo'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.

Operator

[Operator Closing Remarks]

Duration: 56 minutes

Call participants:

Paul Arndt -- Investor Relations and Corporate Communications Eexecutive

Ron Cooper -- President and Chief Executive Officer

Pamela Stephenson -- Chief Commercial Officer

Simon Harford -- Chief Financial Officer

Ritu Baral -- Cowen -- Analyst

Eun Yang -- Jefferies -- Analyst

Yasmeen Rahimi -- Piper Sandler -- Analyst

Tim Lugo -- William Blair -- Analyst

Brian Skorney -- Baird -- Analyst

Joseph Stringer -- Needham and Company -- Analyst

Andreas Argyrides -- Wedbush Securities -- Analyst

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

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