Q2 2021 Albireo Pharma Inc Earnings Call
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Okay.
Good morning, and welcome to the Aparejo pharma second quarter 2021 earnings call.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation, depending on what should require operator assistance during the call. Please press star zero on your telephone keypad.
Please note that this conference is being recorded on.
Now I'll turn the call over to your house, Paul Arndt, managing director of lifestyle advisors. Thank you you may begin.
Thank you operator, and good morning, everyone. Thank you for joining today's call.
This morning, Albarino issued a press release, highlighting its recent business accomplishments and reporting its financial results for the second quarter ended June 30, 'twenty 'twenty..1. This press release is accessible via the company's website at Www Dot Albarino pharma dotcom.
Before proceeding we would like to note that managements comments today may include forward looking statements regarding the company's plans and expectations.
These statements are being made under the private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties.
The 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 Dot Albarino pharma dot com or on the S. E CS website.
Any forward looking statements represent our views as of today Thursday October 5th 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.
Now it is my pleasure to turn the call over to Ron Cooper of rails, President and Chief Executive Officer Ron.
Great. Thank you Paul and thank you everybody for joining US. This morning with me today are Simon Harford, our Chief Financial Officer, Pamela Stephenson and our Chief commercial officer and Dr. Christine Cleansing, Vice President and head of Medical Affairs Who's sitting in today for Dr. Pat Horn, who is on a well.
The certification this week.
We're very pleased to provide an update and an overview of our recent events. It's the only been a couple of weeks since we announced the unprecedented back to back U S and European approvals for Bill day, as well as our receipt of a priority review voucher.
It's exciting to begin the journey to bring Bill day to the approximately 100000 pediatric cholesteric patients around the world.
Since receiving approvals we've accomplished a great deal.
We're hearing from physicians about how pleased they are now able to treat children with the medical therapy versus putting them through invasive surgeries.
For example.
We've heard from a physician who put a child on Bell Bay, who prior to treatment had serum bile acids of 700 micro malls per liter. After only 1 week the physician reported of reduction to 100 micro malls per leader as well as the dramatic reduction in the in the child's pruritus.
We want to extend this type of benefit to as many patients as possible.
With Bill day, we have a competitive profile and oral once daily non systemic medicine with a favorable safety profile of low diarrhea rate of 9.5% versus 5% placebo demonstrated the positive effects on growth and the only approved drug to treat <unk>.
Brightest in PV patients across all subtypes.
So are we reaching patients the answer is yes, we're off to a fast start in the integrated launch system is working the field teams are meeting of the Hep's and payers prescriptions are being generated we are we are successfully working through patient cases throughout the rate of assist and we have commercial drug ready.
To put my hands of <unk> patients.
It's the only the first 2 weeks since approval of but we're pleased to see the integrated system working all the way from manufacturing to the ability to fulfill prescriptions.
So starting with manufacturing supply and distribution following our product approvals final goods have been package, we shipped to the distributors and the 3 specialty pharmacies have stock. So the good news is we're getting bill rate, where it needs to go and at the right time.
So then we focus on getting <unk> to the available patients we estimate that the global <unk> prevalent population is 15000 children, excluding China and India we.
We defined prevalent as anybody who has the disease and is alive. Our estimate for available patients is about 2500 globally.
These are patients who are ready to be treated.
This is a huge advantage for us versus other rare disease categories, where you have to work through diagnosis, and then find patients who could take years to diagnose but in this disease category. The patients have symptoms and are in the system ranging from the newly diagnosed to dose slated.
For potential transplant.
Our team's job is to reach the identified patients and we're working quickly with our specialized field teams to do that.
True of physician outreach standpoint, the Alberta Aon career teams are deployed and of hit the ground running we've already reached over 80% of the top 60 centers. Our first patients are enrolled and Alberto assist and the care corridors are working through reimbursement cases to ensure access to build <unk>.
Over the last 2 years Alvarez will work to ensure prescribed patients gaining coverage for <unk>.
But it's important that we know lock in coverage and reimbursement.
With <unk>, we have a clear benefit of the message of defined with the strength of data value proposition evidenced from the natural history study and care giver burden study.
Sales Bay is a weight based.
Oral medicine priced at $385000 per patient per year based on an average weight of 18 kilograms. The 40, and 120 microgram per kilogram capsules, a price linearly and the price of the individual bottles have now been listed in the compendium.
To date, we have meetings, either completed or scheduled with payers, who cover 95% of patients lives. So clearly we're focused on ensuring both commercial and public coverage with Medicaid.
We know that many insurers Medicaid included are working on medical eligibility criteria for prior authorizations.
Because of this we expect the first patient we will take a little more time to process, but we're confident our ability to work through these cases through alber Aosis Medicaid is a good example, with the late July FDA approval, we were able to submit our Medicaid national drug rebate agreement to CMS by the quarterly August 1st deadline.
This means the state Medicaid agencies of the auctions to start covering Bill day, and many will do so immediately with all states required to cover by October 1.
After that it will be much easier for new patients of flow through the system.
Overall, we're pleased with the payer response and feel that the early days of bill the availability in the U S are going well.
We're pleased to have Q2 to have 2 approvals in the week, which most companies experienced in a matter of months since debt. Therefore, our timelines and launches are compressed moving in a positive way.
Why is the significant we know based on other rare disease of analogs ex U S revenue can account for more than 50% of the global revenue. So we're driving as hard in Europe and the rest of the world as we are in the U S. Therefore, once we received marketing authorization in Europe, We began our launch activities first in Germany with <unk>.
Price listing planned for September.
Simultaneously, we're working on the remaining European markets, having submitted many reimbursement dossiers.
In the rest of the World, we continue to add commercial distributorships in regions and countries with high patient prevalence.
Now in parallel the European authorization allowed us to initiate a global managed access program that will enable access to patients through a variety of fruits, including named patient programs.
As we make progress on the initial commercial launch we are convinced now more than ever of the opportunity E&P fig build vapor fills a clear need in the market for a better treatment option for patients and given our already proven the ability to execute we have full confidence in our team to carry out.
Our launch plan successfully.
At the same time, we continue to execute on our 2 phase III build way clinical styles. Both the positive data from the <unk> study as well as U S and the EU approvals are a shot in the arm to our teams increasing the already high level of confidence and Bill day, given the high level of translate ability of the.
The data to biliary atresia analogy of syndrome.
For the bold phase III pivotal study of Bill of ambulatory Atresia, we have made tremendous progress.
Maria Teresa is the most common pediatric cholestasis liver disease bold is the only pivotal double blind randomized placebo controlled study and we've agreed with both the FDA and the EMA that this single trial will be sufficient for approval with a positive outcome.
<unk> remains on track for top line data in 2024.
The assert study is of phase III pivotal study of <unk>. Our <unk> syndrome. This study is also a double blind randomized placebo controlled study, which we have also agreed with both the FDA. The you made that this single trial will be sufficient for approval with the positive outcome of <unk>.
<unk> remains on track for top line data in 2022.
We will continue to drive enrollment for both of these studies, which is key for Alba rail as we look at our aspiration of delivery of $1 billion on revenue in the second half of the decade with expanded indications across 3 coal of static liver diseases. We estimate that there are 100000, cholesteric liver disease patients.
<unk> globally and <unk> is only the start as we work to meet <unk> available to patients with biliary atresia analogy of syndrome. The.
The completion of these programs is important and we're optimistic based on the very positive results from the <unk> study.
Now rounding out our development portfolio is our 2 adults liver disease product candidates <unk> 907, and $8.3 <unk> <unk> 907 is our oral systemic <unk> inhibitor, which is the first ASB inhibitor to have high bioavailability and the.
Systemic exposure the fee.
Phase 1 trial of <unk> 907 is proceeding as planned and we anticipate sharing data later this year.
In June we presented early clinical data easel that confirmed <unk> 900, seven's effectiveness in Cola static liver disease with potential in PSC in PBC.
We are of high level of confidence in our new bile acid modulation technology and ability to provide new options for these patients.
Our second product candidate is <unk> 3 <unk>, the first potent oral <unk> inhibitor being developed for viral in colas static liver diseases.
We're generating important modeling data and completing IND, enabling studies with the intent to move into the clinic with the phase 1 study in 2022.
So in summary.
We're excited we're excited to be up and going with the launch of <unk> and starting our journey to provide a better treatment option for the estimates of 100000 pediatric liver disease patients in the world. We have already started and our teams are working diligently on outreach to educate physicians, while providing patient benefit support for families with the Alberto assist.
Beyond <unk>, we have tremendous opportunities with our ongoing clinical programs for our company with the first in class product with other strong candidates in the pipeline and look forward to a mile stone rich period, starting with <unk>.
Continued progress and update on our commercial launch of Bill day continue.
Continued execution in the bolt on the search trials to realize our $1 billion aspiration for Bill day with the expansion to bill rate of treasure analogy of <unk> syndrome.
Our continued progress in our adult liver and viral disease compounds <unk> hundred 97, 8% to $3.42.
And the planned monetization of the project review voucher, which are currently worth about $100 million.
We are at an exciting of meaningful period for Albarino, where we are seeing our strategic vision come to life as we bring <unk> 2 children with <unk> and look forward to the prospect of broadening our impact as we work to bring therapeutic relief to patients with other coal of static and.
Viral liver diseases.
So with that some of my pleasure to turn the call over to Simon for a financial update Simon.
Thanks, Ron Let me now review our financial results for the second quarter of 2021 revenues with $2.4 million for the second quarter compared to $1.9 million for the second quarter of 2020 the.
The higher revenue was due to the estimated royalty revenue to be received from EA pharma for <unk> of that for the treatment of chronic constipation in Japan. The royalty revenue as we've said previously is passed on to healthcare royalty partners.
Assets and development expenses were $20.9 million for the second quarter of this year compared to $18.4 million for the same quarter last year. The higher expenses were mainly due to personnel expenses as the company continues to increase our head count on program activities the increase in program.
Activities was mainly for Bill day in biliary atresia analogy of the syndrome as well as a 3.9 O..7 these increased expenses were partially offset by lower bill of AP FIC expenses and the fact that we are no longer developing <unk> Tibet.
General and administrative expenses was $16.9 million for the second quarter of 2021 compared to 8 in the half million dollars in the same quarter last year. The increase is attributable to personnel and related expenses as the company continued to increase head count on infrastructure to <unk>.
Support commercialization of Bill day in <unk>.
Net loss for the quarter ended June 30 of 2021 was $36.4 million or a loss of $1.90 per share compared to $26 million or a loss of $1.38 per share for the second quarter of 2020.
As of June 30 of 2021, we had cash and cash equivalents of $186.3 million compared to 251.3 million as of December 31st 2020, resulting in a cash burn of $65 million in the first 6 months of 2021.
We continue to anticipate the full year 2021 operating cash burn will be between 130 on a $135 million with the launch of bill them. The way. We continue to anticipate 2021 revenue from the product to be in the low single digit U S. Dollar.
Millions, we anticipate our cash runway, taking us into 2023, which includes revenue and expense needs from the launch of Bill day and expansion beyond the fake this cash runway excludes any proceeds from the planned sale of the priority review voucher in summary.
We are well positioned in terms of cash with $186.3 million in cash on cash equivalents access to non dilutive capital in the form of the priority review voucher that we plan to monetize at the optimal time and a clear go to market strategy with defined revenue generating launched steps.
With that let me turn the call back to Ron for closing remarks.
Thanks, Simon as we begin executing as a full fledged commercial organization with the burgeoning therapeutic pipeline.
I must again express my thanks to our patients families clinicians and the employees who have entrusted us to successfully bring bill of 8 to market with Bill day.
We have the first and only drug options to treat pruritus and perfect patients across all subtypes beyond <unk>, we are of great confidence in our 2 phase III clinical trials to expand into Billary atresia analogy of syndrome and.
And finally, we will continue to diversify our portfolio in adult liver and viral diseases.
We thank everybody for joining us and are pleased to open the call now for Q&A operator.
Thank you we will now be conducting a question and answer session. If you would like to ask the question. Please press star 1 on your telephone keypad.
A confirmation tone will indicate your line is and the question on queue.
The press star 2 to remove yourself from the queue.
So the participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, 1 moment. Please while we poll for your questions.
Our first questions come from the line of Yasmin Rahimi with Piper Sandler. Please proceed with your questions.
Hi team. Thank you so much for taking my question, maybe the first 1 Ron you pointed out that you guys caught more details on pricing.
For the 2 formulation. So if you could just walk us through for both of you sprinkle of small the cash sales and then for each of the doses and then the second 1 assets can you maybe help us understand out of the 30 total sites.
How many of them on the U S and Europe then.
Sort of timeline on how enrollment is progressing in the geographies and thank you so much for taking my question.
Yes.
I mean I'll talk.
Talk about the certain I'll pass it over to.
Pamela to talk about the details on pricing and thanks for the question look we're really pleased with the progress that we've made with the with the sort of looking for around about 35 sites and we've given guidance to <unk>.
<unk> data in 2022, which which we're on track for but we're really pleased actually is that we've had tremendous response in the U S and in fact in the U S of the sites that are up we have virtually all of the sites up in the U S. Only of 1 more to go most of our other sites on.
Our international which are coming on quickly and then I think what we're really pleased about in each of the sites that we have brought up our yield has been higher per site rates that gives us a lot of confidence to be able to fulfill our guidance of data in 2022 and on the 1 it should give you asked me a little more detail on on our pricing.
So our high ethane so I'll just start by saying that our models of linear based pricing approach and so as noted in the price income handy as listed we have 4.3 the capsule bottle strength of available. So for example of the 20 micrograms sprinkle capped per bottle is $6600.
For 1 bottle, which is the catheter and the capsules as I mentioned.
And it's the straight linear from there. So the 400 micrograms swallow is 13200 <unk>. The reason that we went with this pricing model is because its simple we talked extensively to payors and asked for input along the way and they told US they wanted simplicity and so thats right.
It's really important in this pricing model and for patients as mentioned, we have Alberto assessed and so we'll look at their insurance status.
And help them navigate the landscape and get on to developments are really excited about that.
So the questions. Yes, we've been really pleased with the response from payers. Thus far so we're looking forward to bringing more and more patients through alvarado assisting getting in getting access to build day.
Ken and Pam if I may ask when we think about sort of the weight of the PC.
Carl can you kind of give us a little bit color on sort of.
Average wait on that.
Maybe 1 day week from 5 to pass on what the average weighted with the or how much left there we'd would be compared to a normal child, just some color on the wage growth as the kids get older.
<unk> learned so much more as we get into the rail world and collect our data.
For now what we see as our clinical trial results and the average weight of patients in our clinical trial <unk> was 18 kilograms and so that's that's how we've looked at this at the start of.
Say, 90% of our patients will be on the 40 microgram dose and about 10% on the 120 and that's how we've come up with the average calculation that we shared previously of $385000 as and as at the weighted average so yes to answer your question. We will track these patients over time on scene.
How the weight change and on wind and early results are early patient and there are a variety of of agents and weight that we're seeing patients coming into the system.
Thank you Pam.
Thank you our next questions come from the line of Tim Lugo with William Blair. Please proceed with your questions.
Tim can you check if you're on mute please.
I was on mute thank you.
Congrats on all the progress on with Us.
Over the past few months and I. Thank you for taking the question.
I guess following up on <unk>.
Are the early patients being captured in that.
System mimicking the 18 kilograms, we saw on the clinical trials and how are you of handling any kind of area of.
Change of our allogeneic <unk> patients and physicians that might be reaching out the albarino.
Side of the clinical trials.
Yeah.
Yes, so Tim thanks, Thanks for the questions like look we'd like to have as many patients come through Alvarado assist as possible because that provides support for the clinicians and support for the patients as well.
And to the earlier to the earlier question and we can only report the day that we kind of know right now the data that we have is 18 kilograms of the average and we're going to learn a lot more with the real real world evidence over time.
As it relates to patients that do not fit in our label.
Eligible for Alberto assist stripe, but we provide support through our medical Affairs organization, where we're able to provide information that if RASK.
From from clinicians. So we have a fully functioning medical affairs organization that is working really diligently during this timeframe.
Okay understood and with the Medicaid plants coming on in October 1 is that when we'll kind of start to see of the first lien.
The full bump up or is there.
Already into August can you just maybe talk a bit about how the patchy.
Past few weeks has been trending.
Yes, I can speak to the just certainly add to the Medicaid piece of debt the.
The deadline that we mentioned is the October 1st because we were making on we made the August 1st deadline, so that means on Allstate.
Our required to cover of Bill day by October 1st, but many states have the option and we will do so ahead of time, So we'll see patient coverage now and we'll see patient coverage than on any.
With the commercial plans. This is the process on and what we're going to take every patient and work them through and to ensure that they cant get coverage as soon as possible.
Understood well congratulations on the SaaS cart.
Thanks, Tim.
Thank you our next questions come from the line of <unk> <unk> with Cowen. Please proceed with your questions.
Hi, guys. Thanks for.
Taking the questions just to just a few more questions on.
Coverage on logistics will help us with our model.
On the.
Yeah.
How do you think about.
Timeline wise, turning over into commercial U S patients of that.
It will happen by the end.
On the here.
Okay.
Now the types of claims can you give us any color on on debt pay.
The numbers on the loss on.
The expanded access program and then how should we be thinking about.
Now out of at least early on and I do understand that certain of these will become more mature launch, but as we think about how albarino assessed works.
All of it helps.
Doctors officers going on.
Shipments of et cetera.
How should we be thinking about that strength.
End of the year.
Sure. Let me start first with the question on the EAP, which I'll expand to talk about some of the Patrick to rollover patients on drug instead of globally in Patrick to an EAP and Westwood I can say is that these patients will be rolling over at different time on.
And again in the U S with Albert <unk>, what we have is.
The team of care coordinators, who can work now with the patients to ensure that they have access for the rollout of our <unk>..1 thing we are very committed to ensure that they have access to bill day as they go through that transition. So the timeframe will vary but they are coming up over the coming months.
And then on your second question on time to fill again, it's fareed right in my experience in doing this on with rare disease drags of some some will go through very quickly and some will take a longer time. So I think at this point, it's too early to mention what we think the time to sales will be but that's certainly a metric that we're tracking and looking to shorten.
Over time without the wireless test, yes, sorry.
So the <unk>, where we're.
We're pleased that the bill of <unk> as a global opportunity the large global opportunity, but that sort of relates to pamela's answer on both the Patrick 2 studies in the EAP we of patients all over the world that are in those programs right and so they will be subject to subject reimbursement in those countries as well as panelists indicated.
In the U S. As we get them to the <unk> announced were able to get them insurance, but they will rollover.
Great. Thank you.
Thank you. Our next question comes from the line of <unk> Yang with Jefferies. Please proceed with your questions.
Hi, This is not a line on for Yoon on I have 2 questions. Please number 1 on for Bill.
So the dosage adjustment and the use of the criteria and to increase the recommended daily dosage to the higher dose would be.
Based on there being no improvement in pruritus in 3 months.
On an ex U S.
Is that the same criterion used to just finding adequate clinical response or is it based on improvements in fall of at this level.
So I just wanted to make sure because it's a little bit hard to hear you right. So and you feed it off a little bit of I think your question was that after there is if there is a inadequate response after 3 months what is the criteria to move up the dose.
Was that correct criterion and ex U S. I believe in the U S is pruritus and ex U S is that the same criterion.
Hi, This is Christine.
Outside of the U asked the S&P has similar language, but it is not specific to alright. So of an adequate clinical response has not been achieved after 3 months of continue on therapy. The dose may be increased.
So with that the bile acid.
I think the way the label right.
Up to the judgment of the clinician to decide what the adequate response.
Got it Okay and the second question is could you. Please maybe comment on what percentage of the patients you would expect it to be on maintenance dose of 40 versus 80 versus 120 micrograms per kilogram.
Per day, thank you.
So hi, it's Pamela.
4 our assumptions for our launch here, what we're assuming is that the vast majority 90% will be on the <unk> dose and 10% on the on 'twenty again, we will see in the real world how the how this works out over time, that's our initial assumption.
Thank you.
Thanks very much.
Thank you our next questions come from the line of Joseph Stringer with Needham <unk> Company. Please proceed with your questions.
Hi, good morning, everyone. Thanks for taking our questions just to follow up on an earlier question on the time, that's I realize it's early and can't give any.
May not be able to give metrics, but is there the optimal sort of time to fill.
As things progress here and then second question is.
On <unk> and biliary atresia, just get your thoughts on any potential.
Enrolment headwinds or issues with.
Related to Covid.
Thanks for taking our questions.
Well thanks for all the optimal time is very fast actually right.
But the reality of it is we have everything in place to go very quickly right. So our operator representative of trivia representatives or out of the field generating prescriptions.
The enrollment form goes to the Alberto assess so the the.
The speed issue is how quickly the regenerate prescriptions how quickly can we get the sites to work with us to fill of the El Dorado assist form and then very quickly our care coordinators are in contact with the families and in contact with the insurers right. That's the variable part right. As you know there are about 1000.
Different plans within within the U S right and so we're getting experience law with all of the first ones are going to be a little bit of little bit longer because they've got to get their criteria in place what theyre going to do from prior authorizations new to them, but then I think after that it's just Google faster and faster so.
Of the optimal is almost instantly it's going to take us a little bit at the beginning of it will get faster over time.
I think then Joey is real estate as it relates to our other 2 phase III studies.
Pleased with the execution of further when you think about the bolt on as the global study, we're looking for in the near 17 sites around the world and.
I'm, just really proud of our organization because we are on track for data.
Into the data in 2024, Similarly, I made comments about the of certain study earlier, we expect data in 2022.
Now, it's not easy at the best of time doing clinical trials of our difficult challenge, particularly the global clinical trials. However, given our experience with the <unk> program, where we've done that successfully I'm pretty confident that we'll be able to combat any headwinds and deliver on the data for those 2 phase 3 studies.
Great. Thanks for taking my question.
Thank you.
Thank you. Our next question comes from the line of Brian <unk> with Baird. Please proceed with your questions.
Alright, Thank you for taking the question good morning.
Just trying to see if there's any way to push to get some sort of.
The quantification of.
Of anything so I just wanted to see about insight into do you guys get sort of granularity on why non prescription is written or oral only granularity on on.
On when it gets filled and I'm just trying to understand how albarino assessed.
Works across of our down at like like are all enrollment forms through all of our assets coming after on on our actions written or some enrollment forms coming ahead of the non Rx and are these occurring completely in parallel or specific sequence just any any insight you can provide better Sheila.
So hi, Brian Yeah, so on.
And we're on that form is the prescription so what we see is we.
We know from our field teams at prescriptions are getting written but the prescription or the enrollment form comes right into out of the rail assets and that is a prescription form that we can then start working with the payers and to understand the insurance benefits of that particular patient while also on triaging that form right over to the special.
The pharmacy, and so with the well coordinated activity, where we have eyes on on every step of the lag.
Okay.
Great and if I can just ask a question to kind of move a little bit off about the commercial side of things, but I was wondering if you kind of walk through a little bit of the rationale.
The ability of the area of trees on studying and how the specifically think about the sort of high low baseline bile acids and the predictability of that might have on that.
Your line, especially how to think about sort of the.
Of the intervention and the they're using here post kasai.
Overall <unk>, even as an adjunct took us all right. Thanks.
Well when we think of Billary atresia right. This the cole of static liver disease right. So this is the disease of interest of <unk>.
<unk> flow and remember we're only treating children that are post kasai, if the children will get because they generally will die it's a life saving.
The treatment.
But what's interesting is when you look at the natural history of the largest natural history database and you look at patients.
Post ESI and when you look at their outcomes right. If you look at the children after that kasai, which restore some intra paddick circulation, but sometimes it's not perfect right those children, who have low bile acid in 2 years the.
Most of them keep their native liver or ally those flow through of high bio assets they lose their need of liver.
Or they die right over 50% of the right. So that's where bill that comes in the coal aesthetic disease of children with elevated bile acids, we demonstrated in the pet fixed study at the doses of.
Of 40, and 120 that we can reduce bile acids, we're pretty confident that we can reduce bile acids in these children and change their outcomes and if you think of the unmet need. This is the number 1 pediatric cholesteric liver disease. This is the number 1 reason for pediatric liver transplant.
And right now the pediatric hepatology and the surgeon after they do that Kasai surgery. They know that half of those children are going to need the new deliver of the 2 years, they just sort of put their hands up and weighted.
<unk> can make a big difference in the showroom, that's where we're looking for of the results from the bill of the.
Bold study, which we plan to deliver in 2024.
Great. Thanks, Ron.
Thank you.
Thank you our next questions come from the line of Ed Arce with H C. Wainwright. Please proceed with your questions.
Great. Thank you for taking my questions.
So 3 for me.
Yes.
I realize it's only been 2 weeks now, but just qualitatively thinking about.
Your first.
Reimbursements.
Do you think those first view on reimbursement could come in.
And just the general cadence of payer coverage between now and through the end of the year.
If you if you can give us a sense for.
The number of prescriptions that you've received so far to date.
I'm, just trying to get a sense for.
In relation to the.
The speed of reimbursements, whether you think there is any.
Expectations for an initial peripheral of of commercial revenue in the third quarter.
Or is it more likely to be on the fourth quarter.
And then lastly, just wondering about the global managed access program. If you could just give us a little more detail around that and your expectations. There. Thanks so much.
Alright, thanks, very much free of for the question.
Similar themes to your colleagues.
I'd say its the process right prescriptions are coming out of there are a lot of different insurers to work through.
We've given guidance of sales of Bill day for this year in the low single digits why is that right because we've got to work our way through these insurance companies and getting reimbursement, we're absolutely confident we're going to get there as indicators of what we've given you information regards to mitigate but the reality is some states.
From from the Medicaid perspective, we'll wait till October right.
Others, others will not.
We will watch these through and we're pretty confident that as we get through to the end of the year. We will have very good assets per build day. The move was able to really continue to generate the sales of <unk>. We expect so we're executing on what's going to happen right just bear with us a little bit and we will update.
Sue.
The balance you want to talk a little bit about the rest of the world on the managed access approach that we're taking the absolutely. So our managed access program. We're really excited is now live and what the program does is really the health.
With patients who are in countries that don't yet have reimbursement for available. So as mentioned, we're starting the first in Germany price lease listing in September of <unk>.
And other many of the other European countries, we've already submitted reimbursement dossier as we worked through that reimbursement process. We want to ensure that patients have access to bill day, and then the markets or countries outside of the.
The country that also we want to have access to.
We have named patient programs et cetera, and we have a very comprehensive far reaching the managed access program that we've launched and.
The overall on heavy.
Okay.
Great. That's helpful. Thank you.
Yes.
Thank you our next questions come from the line of Andreas <unk> with Wedbush. Please proceed with your questions.
Good morning, and thank you for taking our questions.
In your prepared remarks, you mentioned that all barrera to your sales reps of reached 80% of the Hcp's at the <unk>.
Top 60 centers, how should we think about how rep interactions ultimately gradually translate to revenues through the 60 centers cover all of the 60 I'm sorry of the 600 estimated available patient the patients in the U S.
Then I'll have the follow up thanks.
But I would say there is that absolutely. The top 60 centers include the majority of the 100 pediatric herpetologist across the country and the met and many of the patients identified are in the center. However, there were also finding that there are.
Patients out in the community as well on the community pediatric.
Metrology in pediatrics gastro environment and so this is the great thing about working with <unk> is that we have doubled the number of reps in the field covering not only the 60 centers.
But also the additional potential subscribers outside of the 60 centers.
Okay, and then so again I don't know if Thats. My first question was about the the 80%.
Of those prescribers.
How do we.
Gets to 103 eventually.
How do we kind of tried to quantify that or model that going forward. Thanks.
I think the weighted let's back up a little bit here. So we haven't I think of really great go to market model right of the nice thing about it and most of the business is concentrated there's about 60 key centers theres more centers of their 60 key centers is the 100 key docs theres more doctors on that.
They will represent the vast majority of the prescriptions now as Pamela said now that now that we're actually out there and that people see that Bill day as the once a day oral.
He has a good good safety profile.
Interest in using build in some of the other centers and so what we're learning is some of those centers close to those those means sensors are interested in using bill day and so.
Having both are representatives of the Alba rail plus the trivia of representatives of <unk>, we have tremendous coverage and so even in the first couple of weeks, we've covered 80% of it on.
Other couple of weeks, we'll be well on our way.
You have to covering most of our customers and select assets.
I think really great execution that should bode well for prescription generation.
Hi, Thanks, so on looking forward to the updates as far as pricing does that take into account.
Discounts.
So the numbers that I've shared our before the mandatory government discounts.
Okay much appreciate it.
I have another 1 but I'll jump in the queue. Thank you so much.
Thank you Indra.
As a reminder, if you would like to ask the question. Please press star 1 on your telephone keypad.
Our next questions come from the line of Ritu <unk> with Cowen. Please proceed with your questions.
Hey, guys. Thanks for taking the follow up.
So the the.
First on.
Orphan drug launch that has occurred at least in my universe.
Right into the key to per zone.
And I'm wondering of you guys think of launch of <unk>, rather than ongoing commercial activity.
Specific launch activities.
Have been tailored to a more on a much much more virtual environment commercial environments.
And any time in the past on how should we be thinking about.
Present at medical meetings for day.
Data or boots et cetera going forward. Thanks.
A couple.
Couple of points I would make on the on that line in the first is that we've hired experience representatives, who have been selling through the COVID-19 world and so they're very nimble at flipping back and forth between virtual visits with physicians and in personal line. So we see that they are already in the field April.
And quite frankly doing both types of the visit the second with the our Speaker program and again, we were able to do a lot more now virtually with getting out training doctors quickly doing the training them on their off hours. When they are not in clinic and getting the news out about Bill day, and then the third on the medical.
Meetings, we're seeing that again, a hybrid approach the OAS LTE as an example has taken on approach of having some portions of the program life and some virtually and again I think the experience at our collective team has in terms of being able to access and work with physician both virtually and in percentage.
And again give us a great uptake.
Great. Thanks for taking the follow up.
Thank you we have reached the end of our Q&A session I will now turn the call back over to Ron Cooper for any closing remarks.
Thank you operator, thank you all for attending today's conference call. We'll continue to keep you updated on progress with our global Bill of a launch as well as our clinical programs in biliary atresia analogy of syndrome.
<unk> liver and viral disease.
As we continue to advance of Royals machine to provide hope to families of patients with liver disease and the entire Liberty community.
Thanks to all for your continued support.
Thank you that does conclude today's teleconference. Thank you for your participation you may disconnect your lines at this time.
Have a great day.
Okay.