Albireo Pharma, Inc. (ALBO) Q1 2021 Earnings Call Transcript

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Albireo Pharma, Inc. (ALBO)
Q1 2021 Earnings Call
May 7, 2021, 8:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day and welcome to the alboreto pharma first quarter 2021 earnings conference call. [Operator Instructions]

At this time, I would like to turn the conference over to Mr. Paul. Please go ahead, sir.

Paul S. Bavier -- Interim President, General Counsel And Secretary

Thank you, operator and good morning everyone. Thank you for joining today's call. This morning, Alberto issued a press release highlighting its recent business accomplishments and reporting its financial results for the first quarter ended March 31 2021. This press release is accessible via the company's website at www dot albireo pharma.com. Before proceeding, we would like to note that management's comments today may include bold looking statements regarding the company's plans and expectations. These statements are being made under the private securities litigation Reform Act of 1995. And they are subject to various risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the risk factors section of the company's most recent form 10k and the subsequent SEC filings. These filings can be accessed from the media and investors section of the company's website at www dot albireo pharma.com or on the SEC is website. Any forward looking statements represent management's views as of today, Thursday, May 6 2021, and should not be relied upon as representing their views as of any subsequent dates. The company undertakes no obligation to update these statements publicly.

Now, it is my pleasure to turn the call over to Ron Cooper Alvarez president and chief executive officer Ron. Right.

Ron Cooper -- President And Chief Executive Officer

Thank you, Paul. And thank you everyone for joining us this morning, Rob rails q1 2021 results and business update. With me today are Simon Harford, our Chief Financial Officer, Dr. Pat horn, our chief medical officer in Bama Stephenson, our chief Commercial Officer things for today our commercial readiness and corporate growth. At the start of the year, we laid out a plan of how we will expand to a global organization to reach the large 100,000 pediatric cola static patient opportunity around the world and realize our aspiration to exceed $1 billion in the second half of the decade. To deliver on the desperation, we must build a strong global commercial organization to successfully launch build a load of exhibits in defects. expand beyond people into other rare pediatric conditions and progress our pipeline in adult post static and viral liver diseases. What I'll do is I'll take you through the progress and achievements as we continue to deliver on our objectives and make plans in support of our ambitions. In the short term, our priorities remain. Number one, bring build a motivate Tibet over the line with product approvals in the US and Europe with the issuance of a priority review voucher and a fast start and approved markets. Number two, focus on the global opportunity in cholestatic liver disease progressing our market leading global commercialization approach in the top 25 markets to reach the 100,000 patients with rare cholestatic liver disease.

Three continue to enroll patients in our two gold standard global pivotal phase three studies in biliary atresia mold, and algae Ll syndrome, assert a number for advanced a 3907 through phase one, and interface to move a 2342 into the clinic and characterize our other novel bioacid modulators. Commercial residence, starting with our commercialization strategy and launch readiness, with priority with a Friday review and a producer date of July 20 in the US, and accelerate assessment in Europe, we've engaged in a good dialogue with regulatory authorities and anticipated in approval and launched in the second half of the year. plainly, we'd be ready to launch at any time and are encouraged by the ongoing discussions in progress with US and EU regulatory bodies on the path again, product approvals. Now part of launch readiness and making sure that you have a brand name that is simple and consistent around the world. We're very pleased to announce that build a is a brand name proto vixa that that has been accepted by the AMA and has been provisionally accepted by the FDA. Having one global name is important for brand recognition and it's just not easy to achieve. Today build a supports our brand positioning and it's tested well with physicians and patients on multiple parameters. So we're really excited to unveil it now. And then officially upon anticipated product approvals.

Day one, readiness is a core focus within our organization. And Pamela and her team are driving ahead in both the US new launches and the rest of world commercial partnerships. Having made great strides and significant progress in hiring, onboarding and training of people who are highly specialized in their respective geographies, functions in rare and liver disease markets. In the US, the sales team is onboarding and are surveying us ehcps on their current management of pefect paces in preparation for launch. At the same time, we're actively engaging with revere therapeutics to operationalize the planning for our combined efforts for the US launch. Also on track our customized in house Patient Support Services throughout rail assist. We have the entire care coordinator team in place, training alongside our commercial and medical teams, and working on perfecting the customized Patient Support Services to help families navigate their access to build a from the start and be with them when they grow. In Europe, Germany is an early launch country and it has the largest market potential. So we have prioritized and completed hiring of the full team in Germany, including commercial medical operations. We're also replicating our patient support services and localized for new country needs and regulations. So Alberto says Germany will soon be a reality providing support services to optimize patient outcomes and support long term adherence to build.

In both the US and Europe, we know we have a compelling build a value story, including the pet big one randomized placebo controlled trial testing to open label data with patients on drug beyond two years, Napa Natural History data and the caregiver disease burden study. This compelling packet of evidence should be an advantage in our mission to gain broad access ability across a wide range of patients. We have confidence in our comprehensive submission package in country level plans that we have compiled to support the value of build a and ensure patient access globally. outside the US and Europe, a key component of our commercialization strategy is a solid partnership network with leading Rare Disease companies. This is particularly important to regions such as turkey in the Middle East, that have an increased prevalence of Piecyk, making them top 10 markets for commercial opportunities. So we're thrilled to share that completion of 2x US Commercial partnerships for building the first with getting a lash or getting a leading specialty pharmaceutical company in Turkey with more than 20 years of experience partnering with global pharmaceutical companies to bring innovative therapies and rare solutions to the community. Yen will be responsible for regulatory filings, reimbursement submissions, medical and commercial support for building.

The second partnership is with Jen farmer Jen farm services a privately held regional pharmaceutical company focused on rare diseases specifically in Saudi Arabia and the Gulf. Unlike other countries, the number one reason for pediatric liver transplants in Saudi Arabia is making the region important for helping patients and commercial opportunities that will serve similar gyrations of again, Gen five will be responsible for regulatory filings reimbursement submissions, medical and commercial support for building. As part of both agreements albireo net sales we recognize on sales to each party, adding again and Jen farmer agreements to the one sign of the first quarter with medicine, we now have three solid commercial distributions in place. Each company's a rare disease market leader in his respective regions in each of the regions have some of the highest prevalence rates. These agreements are a demonstration of advancement of our well laid plans as part of our global strategy for the commercial commercialization of building. Now he's looking ahead to the longer term commercialization readiness and expanding beyond pefect. We continue to progress are pediatric development programs that will enable additional indications for current unmet cola static liver disease patient is a global pivotal phase three study of build a analogy Olson drum for search study continues to enroll, and those patients tracking of all sites active in the first half of 2021 with topline data available next year.

The full study, which is the first and only pivotal phase three trial of an IV inhibitor in biliary atresia continues to be the track and we're meeting our patient enrollment goals with 48 Global site activations, including 18 in the US, and 30 sites x us bellary. Three is a largest pediatric homeostatic liver disease with an estimated prevalence of approximately 45,000 patients around the world. We anticipate topline data in 2024. A positive data readout will lead to a major global expansion opportunity and a potential treatment that could make an impact on many families. Corporate growth, r&d. Looking at early stage in preclinical work, our focus remains on smart pipeline expansion efforts, most recently solidifying progress in rare pediatric liver disease to adult and viral liver diseases. In March, we announced the initiation of our Phase One study with a three nano seven, the first highly bioavailable aspd inhibitor to enter the clinic, which we're planning to develop for adekola static liver diseases such as primary sclerosing cholangitis PSC, and primary biller Ray colon Jaiden PVC. This is significant. We dosed the first patient in the first inhuman study to investigate the safety tolerability pharmacokinetics from COVID dying dynamics of the oral formulation. The unique properties of a 3907 especially the high systemic availability holds great promise for increasing for increasing dose to gain additional efficacy, while minimizing the diarrhea dose limiting effects observe as I bet inhibitors in this patient population. Now that we have the base one study of progress, we're looking at the top line data later this year and the initiation of phase two in 2022.

We're also pleased with the issuance of a US composition of matter and method of use pattern, which provides exclusivity into 2014, not including a patent term extension. We believe that a three Nanos seven has significant commercial potential and added called a static liver disease. We're also excited about ongoing preclinical studies and modeling for a 234 to the first all in TCP and amateur for viral and cold static diseases in TCP is key transport for bile acids as well as Hepatitis B in the viruses. A 2342 also has unique product properties as it is an oral, potent small molecule that blocks entry into the liver and should have really excellent combine ability potential. Absolute x, ideally sub two ntcp inhibitor purchase by gilia. For over a billion euros provides both good scientific and financial proof of financial value proof of concept at 342 is currently an ind enabling studies for the phase one trial anticipate the starting in 2022. Overall, we continue to expand our pipeline delivering on the promise of scientific leadership. For context. A three nanosecond is the third compound that the principal and local team has progressed into the clinic, which which continues to give us great confidence that 82 342 will also advance this plan. There's also potential in our other bile acid or bile acid modular approaches the research team continues to work on enterprise strength. Beyond the outstanding hiring we've completed in the US Europe and most specifically Germany, UK and Italy.

We are adding top level leadership strength as part of the enterprise team recently appointed john Connolly as Chief Technology Officer during the organization to oversee drug substance and product development, clinical supply distribution commercial supply chain in quality, Jones career spans manufacturing management, regulatory filings, CMC, and product commercialization as well as supply chain logistics sourcing and procurement. Most recently, john led technical operations at deadline therapeutics where she was responsible for taking their lead product from the ind stage through to commercialization. And before that, john has held senior roles and neutral systems in Bristol Myers Squibb. So we're fortunate to add John's expertise that spans early drug development through product launches, which is As we prepare for launch, while progress here clinical and preclinical programs in pediatric and adult liver diseases do deep expertise and experience in Indian drug development and commercialization only strengthens our capabilities as we continue to progress our pipeline and prepare for the market. So in summary, we feel very confident as we plan to launch build a taking us toward our ambition to achieve a billion dollars in build a sales in the second part of the decade. progressing our clinical programs, nella Gielan builder atresia, and further characterizing our promising preclinical compounds, the right vision, strategy approach and people as we continue to deliver on our corporate objectives, and build our barrell into a fully commercialized organization that will deliver on a successful product launch.

Now, let me turn it over to Simon to give you a quick financial update Simon.

Simon Harford -- Chief Financial Officer

Thank you, Ron. Let me quickly summarize our financial results for q1 2021. revenues were two million for the first quarter of this year compared to one and a half million for the first quarter of 2020. The higher revenue was due to the estimated royalty revenue received from EA pharma for Olympics to that for the treatment of chronic constipation. The royalty revenue as always is passed on to healthcare royalty partners. r&d expenses were 19 point 9 million for the first quarter of 2021 compared to 16 point 1 million for the first quarter of last year. The higher expenses were principally due to personnel expenses as we continue to increase our headcount and program activities. The increase in program activities was primarily due to build a for the regulatory submission in p fic. And the additional indications for biliary atresia and allergen syndrome as we continue to drive our development programs. In addition, we increased spending for a free 907. As the drug progress is in phase one, these increased expenses were partially offset by the fact that we are no longer developing Ella because of that, and due to lower spend in preclinical programs. general and administrative expenses were 15 point thee million for the first quarter of the year, compared to 8.2 million for the same quarter last year. The increase is due to headcount and activities in a number of areas, such as marketing field force preparations in the US and Europe, and infrastructure to support commercialization and P fic.

Once anticipated approval is received. net loss for the first quarter of 2021 was $43.7 million, or a loss of $2.29 per share, compared to a net loss of $31.5 million, or a net loss of $2.23 per share for the first quarter of 2020. As of March the 31st 2021. We had cash and cash equivalents of 217 point 1 million, which compares to 251 point three million at December 31 2020. The company has sufficient cash runway to fund the plan launch of other bits of that in p Vic, and its development programs into 2023. Additionally, we plan to monetize the priority review batch at an appropriate time if received upon approval. We have revised guidance for the 2021 operating cash burn, which is now anticipated to be in the range of 130 to $135 million. The increase is primarily due to acceleration of the pipeline. For example, a pre 907 phase one started earlier than originally planned. And to further bolster the Fast Start build a launch efforts. 2021 revenue from Bill Bay is anticipated to be in the low single digit US dollar millions.

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

Ron Cooper -- President And Chief Executive Officer

Super Thank you, Simon. He started the year strong and marching toward the potential launch of Bilbo while progressing our pipeline proving our ability to deliver against guidance. We need to bring Billy over the line in the US and Europe with the issuance of primary voucher to fast start in the approved markets. That are recap our top priorities. Number one, we're focused on the global cholestatic liver disease opportunities in the top 25 markets starting with P pick regulatory approvals, patient access and commercial distributed the distribution agreements. Do we will continue to enroll patients in Are to global phase three studies that are atresia now jail syndrome, as well as expand beyond pefect. Three, r&d will advance with a three nine no seven phase one under way while moving at 340 in the clinic and characterize our other novel biologic modulators. Overall, our global commercial strategy is solid with buildbase robust value proposition, our high level of readiness and our action to expand beyond p 50. to other diseases. In the coming months, we look forward to now the approval to build a in both the US and Europe in updating you on our launch efforts. So more to come on that.

Thank you, everyone, for joining us. And we're pleased on the call now for q&a. Operator over to you.

Questions and Answers:

Operator

[Operator Instructions] And we'll take our first question from Eun K. Yang with Jeffries. Please go ahead.

Eun K. Yang -- Jeffries -- Analyst

Thank you. So much for questions. So I think for Pete's sake in the past, you've mentioned that about, you know, 500 to 700 addressable patients in the US. Most of them have been identified. So, in the US, the question is, what would be the kind of gating factors to reach the patients and get them on the block? And second question is on the European pricing side. So in the US, eu, you know, your commercial day, you talked about pricing range, but in EU I just say Germany would have the highest pricing, but overall, what do you think a pricing band would be?

Pamela Stephenson -- Chief Commercial Officer

Thank you. Hi, To answer your question, you asked first, around the gating factors in the US with the estimated pefect prevalence, you had mentioned that we shared our commercial day, the 500 to 700 addressable patients. In the US, the gating factors to reach this market potential are twofold, you know, one is ensuring that patients have access to therapy. And what we're doing there is with with the payers and showing that they are educated around pefect. And secondly, with Alba rail assist our customized Patient Support Program, which will help individual patients navigate through reimbursement. And so to answer your questions, those we will be working as quickly as possible. And we know that payers it takes it takes time to move through that process right through the through the reimbursement process for each individual payer. So we'll be moving moving quickly, to ensure me the are addressing that gating factor. On your second question around European pricing, we've done a lot of work. And as you know, in in Europe, the reimbursement process, including Germany, is dependent on your ability to show the value of the product and be able to demonstrate efficacy through your clinical data, especially robust clinical data. And as we look across Europe, we're confident in in the in the pricing band that other rare disease analogs have been able to secure art. So it's, if you look across these analogues, it's quite, you know, well, within the range, typically, we see a list prices that are within you know, 20 to 30%, of what you're going to see in the US and that, that's the, that's the analogs that we're looking at. So just closing, you know, we're excited, we're ready to go. And, you know, both in Europe and in the US. Thank you.

Ron Cooper -- President And Chief Executive Officer

Thanks for the question. You know, just to add, you know, Pamela said, probably the biggest issues for uptake is access and as Hamlin said, we're working actively here in the US, but also right around the world with our submissions. So what we would like to do as quickly as possible is get to the 20 estimated between 20 320 800 available patients, right? So that's where our focus is, but as Pamela says, Is access here in the us and access Europe as well.

Eun K. Yang -- Jeffries -- Analyst

Thanks for the questions you.

Operator

Will take our next question from the Ritu Baral with Cowen and Company, please go ahead.

Ritu Baral -- Cowen and Company -- Analyst

Good morning, guys. Thanks for taking the questions. And I'm gonna beg your forgiveness as a as a jaded analyst who has been dealing with the FDA requests. Given your upcoming produce a date in July, has there Have there been any new questions or submissions to the agency submitted that you could drive a three month extension of the putting for like we have, like we've seen all around. And then right now, as far as we know, without disclosing anything you can our labeling discussions plan to start on a relatively timely basis per usual schedules.

Ron Cooper -- President And Chief Executive Officer

Thanks for the questions I'm sure that that's been a challenge for you on multiple fronts. Appreciate I can't really get into the specifics as our depth on our dialogue with the FDA. Suffice to say that the pefect has high unmet medical need, there's no approved drug, you know, our, our data and the epic one and pesic two studies, so great advocacy and great tolerability. And thus far, I think we've enjoyed a good dialogue with the agency. You know, they've been engaged in and timely, so we feel pretty confident about our July 20 Paducah date and the subsequent launch for Bill Bay in the US.

Ritu Baral -- Cowen and Company -- Analyst

Got it. Thanks for thanks for addressing that. And then I guess as you think about your hires, as you mentioned, algorithm assist seems to be hired up in your field forces in place. Can you talk about what can you just reiterate sort of the headcount in both of those, and then who are the hires that you have made in in those positions? What's their experience? Where are they from? And do they have pre existing relationships with pediatric hematologist or those specialist centers?

Pamela Stephenson -- Chief Commercial Officer

Thanks for the question, ritu, and I'll let Pamela talk about a little bit of the background. But in terms of numbers, what we said is we typically have about 10 representatives in the US, in addition to the dozen representatives, trigger therapeutics as a partner we haven't really given given the details in terms of the care coordinators, but suffice to say the care coordinators, there'll be enough individuals there to deal with any patients all all the prescriptions to help those patients navigate through the the process of getting access to build and when maybe you can talk a little bit about the background of our teams.

Yeah, so on our sales team, we've had the good fortune of just being able to recruit and attract type, really high caliber, experienced sales professionals who have been working in detail, I'd say there's two different things we're looking for that we've been able to achieve. The first is experience in hepatology spades, So to your point, they they know ologists have great experience, really understand and have existing relationships. And then the second would be the rare disease. So being able to understand how, you know, in an environment, we're going into sort of the targeted 60 centers, understanding and knowing how to put up sell through the entire center. And so those two attributes, I would say, are the are the most important things. And we've been successful in being able to have those attributes on our team. And then, as Ron mentioned, that bolstered by our partnership with true VR, because they have those existing relationships as well. And they're very experienced. And then the final thing is recency of experience.

So we're taking people right out of the field right now who've been selling through the COVID environment. And so they have the virtual selling skills. So that's, that's the makeup of our sales team. And then on the care coordinator side, again, we are we have hired care coordinators who have been doing this their entire career they have been working from the highly experienced companies that have their own in house patient support programs, who are who are very skilled at speaking with patients and families. As well as understanding how to navigate the complex reimbursement environment in the US. So really pleased and excited by the caliber of people we've been able to, to attract care coordinators who have had rare disease, that sort of rare disease. So we're on his retargeted Rare Disease companies.

Ritu Baral -- Cowen and Company -- Analyst

Yep. Super and sorry, last question that I want to speak sleep. Again, any last allowances for the COVID roll off period that you're going to be launching into? We've heard from other companies that patient doctor interactions have been down across a number of disease states, and just wondering how much of that is applicable for pediatric prostatic diseases? And do you see any trends in that sort of patient clinician interaction?

Ron Cooper -- President And Chief Executive Officer

That's fine the first half we find that in this serious rare diseases like this, that the interactions with the between the patients and the physicians has has remained quite strong, either through in person visits and or virtual visits. So we don't anticipate an impact in terms of patients being able to see their providers primarily because of the severity of this disease. Got it? Thanks for Thanks for letting me sleep that one and put the rest.

Ritu Baral -- Cowen and Company -- Analyst

Thanks for you too.

Operator

And we'll take our next question from Liana Moussatos with Wedbush Securities, Inc.. Please go ahead.

Liana Moussatos -- Wedbush Securities, Inc. -- Analyst

Thank you for taking my questions, and congratulations on your project progress. For the label, are there any, do you expect a broad label? Or are there any bogeys that that could happen for likely?

Pamela Stephenson -- Chief Commercial Officer

Well, Liana, as you can appreciate it, I really can't comment on it directly on our regulatory interactions. Suffice to say that we as we've submitted all five modules, both to the FDA and the AMA, we submitted the peptic tastic data, which you know, was what hit both primary endpoints and showed good tolerability, we also submitted the best pick to open label data as well as interim cut. And within that, we have had to pick one, two and three patients. So they have all the information or an active dialogue with them. And we're looking forward to sharing with you more more details as we get past the due for date of July 20.

Ritu Baral -- Cowen and Company -- Analyst

Thank you.

Operator

Thanks. And we'll take the next question. from Brian Skorney With Robert W. Baird & Co, please go ahead.

Brian Skorney -- Robert W. Baird & Co -- Analyst

Hey, good morning, everyone. Thank you for taking my question. I just want to kind of give a little help and trying to think through the the near term guidance on build a sales and just kind of how to think about it a little bit on a medium term. And so for the near term, you know, how do we kind of think about that in terms of sort of new, entirely new starts for stations on the expanded access program? And can you discuss it all the size of the expanded access program sample right now and the sort of timeline we can think about, we're converting those from the program to commercial form. And then on the medium term side of things, when you think about that 600 patient available US market? You know, how many patients are there really ideal and under care? And if I look at something like the launch of a kaleidoscope, a product, this we had 90% of the patients on treatment about a year end? There's a bit of an outlier, but what do we how should we be thinking about feedback in that context and the differences you see in the markets that would would sort of anticipate sort of a longer road to higher penetration?

Ron Cooper -- President And Chief Executive Officer

Thanks. All right, great. Brian, let me try to characterize how we see how we see this year going, I think the way to think about this year is there's still a lot of variables that, you know, that aren't quite clear yet. And so that's why we've given guidance for sales, you know, in the low single digit millions. So what's not that we don't know exactly the date of approval, right? And remember that that's approval for both the US, right, the producer date of July 20, but also Europe. And remember, you know, what we're trying to do is access the 2300 to 2800 patients, right? from a global perspective that are available that are you know, and these are people that are eligible for treatment right now. So what so one of the things that we have to add, first of all, we have to have the Pro Bowl so both the US and Europe are pretty important and we're still working on the our European approval, so we're we don't always Acting, that's gonna cripple you feel confident that's going to occur the second half of the year. The second thing is the sequencing of access, right? As Pamela has spoken about. We've got a we've been in dialogue with insurance companies in Europe in the US, but it does take time for them to process as well, you know, we're in an active dialogue with payers within Europe as well. And that will take some time as well. So we've got to work our way through that.

So think of this year as the year of where we sort of sort through the access part of these resorts to the regulatory process. Right. And then your question about about EAP patients and open label patients. Part of that is if people are in different countries, right? So think about those patients as sort of correlating with that time of when we get approval. And, and we get access. So as we think about this year, the patients that we were talking about here, the 2300 to 2800 not available patients, these are patients that are available for therapy, they are in various stages of early diagnosis or or waiting for treatment, and we'll try and access them as quickly as possible, get access for them, get them into Alberto assists, put put nice white gloves around them and take care of them and help them grow into being stronger and healthier children.

Brian Skorney -- Robert W. Baird & Co -- Analyst

Thanks, Ron

Operator

And take our next question from Ed Arce with Wainright & Co.. Please go ahead.

Ed Arce -- Wainright & Co. -- Analyst

Hey, thanks for taking my questions. And congrats on the continued progress across the pipeline. couple questions for me. Probably first for for Pamela. We're just a little over two months away from the Paducah date now. And of course, you've mentioned that your reps are on boarded and doing the appropriate outreach, as well as you know, the team at revere as well as your abuela assist. Seems like everything is in place. I'm wondering what is the focus between now and produce, as you know, the last few weeks in terms of know what still may need to get done for that day one readiness.

Ron Cooper -- President And Chief Executive Officer

Thanks for the question. Yeah, we're two months away from the Paducah date, but we're ready to go now. So as mentioned, you know, we hired we've trained for onboarding, onboarding. And so we are ready to go from an operational perspective, from a from a team perspective. And the one outstanding, you know, item is, is the is the final FDA approved label. So between now and then as we get more insight on that label, we keep training and training and training, in fine tuning. But we're ready to go. There's really nothing left. We could you know, we could launch tomorrow, we've gone through all of the critical tasks that needed to get done. So yeah, from a commercial perspective, we're ready to go. We've just been waiting for the approval.

Pamela Stephenson -- Chief Commercial Officer

Yeah, I think that is the team has been practicing, right and practicing what it looks like you how we generate prescriptions, how we deliver drug, right, and now we made sure that throughout the roses, that the patients have a really great experience. So you know, there's just some things you just can't do until you get the final label, right. It's supposed to be the final label, we'll be moving very quickly. Of course. Right. So just one follow up for me on these commercial partnerships, as you mentioned, he just recently signed your second and third, I know there's 25 markets that you're focused on globally. wondering if you could help us understand which of those are most likely amenable to partnerships, either on a regional basis or a country by country basis as you continue to march forward. High emphasis Simon set so as we've looked at regional partnerships, our approach has really been to say let's focus first and foremost on those major markets, where we will be able to launch relatively quickly following US and European anticipated approval. So if you look at top 10 market overall, several countries come in to the top here. And outside of Europe in the US, and those include Turkey, Saudi Arabia, and part parts of the Gulf region, as well as Brazil, in Latin America.

So we've really tried to focus on some of those key top markets, because they typically allow for fairly early access in and of themselves as markets as well as being a good opportunity. And as we discussed our commercial day. Yeah, more than 50% of revenue, typically in similar analogues in rare diseases, comes from markets outside of the US, then we have have for the longer term, we also have sort of looking at the opportunity to China. As we said, on commercial day, that's not in our top 25 markets currently of what we sort of projected going forward. That that is a good opportunity, particularly for biliary atresia, longer term. But to go to a market such as DAC, we would want to make sure that we have the right milestones in place and that we are getting appropriate value from an opportunity such as that but near term focus, Turkey, Saudi, to have the the top 10 markets. And then Brazil's another important one.

Ed Arce -- Wainright & Co. -- Analyst

That's very helpful. laying out the timeline. I appreciate it. Congrats again. Thank you.

Operator

We'll take our next question from Tim Lugo with William Blair. Please go ahead.

Tim Lugo -- William Blair -- Analyst

Thanks for the question. And I know, everyone's probably excited about another regulatory question. But just following up on some of the, I guess, anxiety from the, from the analyst community. Last year, the agency had difficulty in kind of executing manufacturing inspections because of the pandemic. But you know, hopefully, that's not as much of an issue now, with the US opening back up, can you update us on your manufacturing status? And how confident you are from a regulatory perspective?

Ron Cooper -- President And Chief Executive Officer

I know there's anxiety out there. But to be honest, I'm not anxious. Right. I think we feel that with confidence, right. From a manufacturing perspective. As I said, we submitted the full module, the full CMC module. In our phase three study, we use the plan commercial formulation, in that we spoke to we had a good dialogue with the FDA a couple years ago when we're executing on that plan. Right, and that seems to be on track. So we feel pretty confident, again, about our approval around our producer date of July 20. And as Pamela said, you know, we're ready to go from from all fronts. That's, that's great to hear them, you know, let's kind of look forward into 2022, when hopefully, well less anxious, you know, given the patient dynamics in the US, with your partner to severe, but also, you know, what should be a European approval, you know, knock on wood, hopefully by then. Do you expect a significant portion of revenues in 2022 could be coming from Europe and maybe even a larger portion, then what would be we will be seeing from the US.

Now, again, added, you know, as I said in my earlier response, there are there are just some there, there are multiple unknowns in this case, right, so the exact date of our US approval, we think it's going to be the date of the 20th of July, we're in good dialogue with Europe, so the exact date of that, and then also, how these regional partnerships kick in, and I'll access coincidence. So some of those ones we're gonna, we'll see. But, you know, frankly, we're focused on the global opportunity for fraud. Excellent. We're building a pediatric cholestatic liver disease drug, we want to get at the end around 100,000 individuals around the world and when it comes to pefect, you know, that range of 2300 to two to 2800 page guide individuals, we're going to try and get to them as quickly as possible. And given that there are more patients outside the US. It's quite possible that we'll be seeing a a higher than anticipated contribution from Europe, but it's really too early to say.

Tim Lugo -- William Blair -- Analyst

Alright, great. Thank you for all the color Thanks.

Operator

Let's take our next question from Yasmeen Rahimi, Piper Sandler & Co., please go ahead.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Hi, Pam, thank you so much for sharing all the updates a couple questions for you. Maybe the first one would be, Can you shed light into what to expect to, you know, continuing to enroll and have patience on? Have you been able to collect event rates, event rates, meaning, you know, coming off of confrontation with or late events? Is there a potential that regulators could ask for those types of data points, and it may even require a separate, you know, study to be conducted. So I would love to hear your thoughts on that. And then maybe the second one is on the prv. So, you know, what is in your view, the likelihood of being granted the prv at the approval, and then I have a follow up.

Pamela Stephenson -- Chief Commercial Officer

This is Pamela, and I can take the one on the pet stick to study. So that is our ongoing studies looking at the long term safety and efficacy of Olympic sebagian patients with all types of pieces. And there, we are really collecting those long term outcomes, we're looking at time to biliary diversion surgery time for liver transplant, whether patients can cover surgery with either from the biliary diversion surgery or liver transplant patient. So that is that is an ongoing study as continuing as planned. The plans for that study are well known to both of the regulatory agency in terms of post marketing commitment, you know, certainly those will be part of the discussion with ongoing regulatory agency. And then I guess to add to that, yes, we did answer your question about about the PRB. And when we are in dialogue with, with both regulatory agencies, the FDA and the AMA, we have confirmed at that time that pennsic. One, on its own, was all that we needed to do with submission perspective. for approval, much like the single study of gold, the single study of assert is needed for approval. So additional data that we yay for pethick to give additional color, the interview cards. And so those are the types of things we'll continue to talk through in terms of post approval commitment, as Pat indicated.

Now, as it relates to the prv, we'd announced a couple of years ago that, in fact, the FDA has has deemed Oda vixa, that as being prv eligible, so we are prv. Eligible. And I think the way you need to think about that is that approval, pretty much yet equals prv being granted, right? So we have to fulfill the requirements, the prv, which is doing the TED fix, study and submitting the drug, there are some administrative pieces that that that have to occur do on approval, but we feel pretty confident that the prv will be issued on approval. And as you know, those are quite valuable. We sit in a very good cash position. So we have the luxury of I mean, we need the prv so that we plan to monetize them, or monetize at the right time.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Thank you, Ron and think your path to color. Maybe a follow up, are you you know, Germany may be one of the you know, largest market opportunity there. And also, you can go in with, you know, no pricing, being able to get market access faster. Can you help us understand sort of how many patients have been identified in Germany, just just to kind of help us understand more granularly on some of the larger opportunities, like how many patients that are placed in Germany alone, that could be available for therapy.

Ron Cooper -- President And Chief Executive Officer

Yeah, thanks for that question. Yes, we were pretty excited about Germany because as you said, it's in areas a fair amount of people then immigrate into Germany with the disease. So I think we has pretty good, pretty good level of disease, we really are keeping leader support. And, and as you said, it has good pricing at this time. We're not giving country by country detail in terms in terms of numbers, but suffice to say that, you know, in terms of patients that are available for treatment, you know, x us we anticipate somewhere between 17 120 100 patients, so pretty significant opportunity there as well. Kill on putting in my question.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Thank you

Operator

And we'll take our next question from Joseph stringer with Needham & Company, LLC. Please go ahead.

Joey Stringer -- Needham & Company -- Analyst

Everyone. Good morning, thanks for taking our question. Just one on the kind of like competitive side of things to quickly be first to market in us for Pacific and in, in Europe, you know, things go well, likely first to market but to be a competitor coming to market in the first part of 2022. In Europe, and just wanted to get your thoughts on how you see that affecting your current, you know, commercial crap and discussions with around reimbursement of things in Europe? And maybe, would there be any sort of, you know, read through to, to your us, and launch discussions? Thank you.

Ron Cooper -- President And Chief Executive Officer

Yeah, I think what we're really excited about Joe, is that, you know, we're taking a leadership approach with build a, with all diseases right around the globe, right. So, you know, when you think about that, the pethick study, the bold study, the asserts study, these are all gold standard, or double blind, placebo controlled studies, right. And so they should help us gain approval, you know, if the latter two are successful in multiple regions around the world, right. So we feel really good about our leadership approach. But that's not only about regulatory approval, that also is from an access perspective, right. And so that will actually, you know, that is level one class one type information. Now, we're going to supplement that with the Napa Natural History database, and the burden of care study, and we put together a pretty compelling access package. And when you consider in the in the in the pethick data, we have both typic, one, two and three patients. So there's a lot of really interesting, interesting data there. So as a result, we believe that we will have a leadership approach, you know, for both regulatory approvals and access across multiple indications for building and building buildings and what we will believe we believe will be a billion dollar product the the second part of the decade.

Pamela Stephenson -- Chief Commercial Officer

Thanks for the question.

Ron Cooper -- President And Chief Executive Officer

Thanks, Joey.

Operator

Appear there are no further questions. At this time. I'd like to turn the conference back to CEO Ron Cooper for any additional or closing remarks.

Ron Cooper -- President And Chief Executive Officer

Great, thanks, operator. Well, first of all, thank you all for it for attending today's conference call. You as we continue to ready for approval, we'll update you on our regulatory filings and launch planning as well as the advancement of our clinical programs. As part of our growth strategy, really appreciate your attention today. We have a lot of exciting year through milestones ahead of us and our strong financial position will enable us to continue to advance operators mission, which is to provide hope to families of patients with liver disease and the entire liver community. Thanks again to all of you for your continued support. Have a great day.

Operator

[Operator Closing Remarks]

Duration: 54 minutes

Call participants:

Paul S. Bavier -- Interim President, General Counsel And Secretary

Ron Cooper -- President And Chief Executive Officer

Simon Harford -- Chief Financial Officer

Pamela Stephenson -- Chief Commercial Officer

Eun K. Yang -- Jeffries -- Analyst

Ritu Baral -- Cowen and Company -- Analyst

Liana Moussatos -- Wedbush Securities, Inc. -- Analyst

Brian Skorney -- Robert W. Baird & Co -- Analyst

Ed Arce -- Wainright & Co. -- Analyst

Tim Lugo -- William Blair -- Analyst

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Joey Stringer -- Needham & Company -- Analyst

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