Q3 2021 Albireo Pharma Inc Earnings Call
[music].
Good morning, and welcome to the album Rail Farm, a third quarter 2021 earnings call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the call. Please press stars zero on your telephone keypad.
Please note that this conference is being recorded.
Oh now turn the conference over to your host Paul aren't managing director 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 it's recent business accomplishments and reporting its financial results for the third quarter ended September 30th 2021.
This press release is accessible by the via the company's website at Www Dot Albarino pharma Dot 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 her subsequent SEC filings. These.
These filings can be accessed from the media and investors section of our website at Www Dot Albert Alpharma Dot Com [noise].
Or the SEC's website.
Any forward looking statements represent our views as of today Thursday November 4th 2021, and should not be relied upon as representing our views as of any subsequent dates.
We undertake no obligation to publicly update these statements now it is my pleasure to turn the call over to Ron Cooper, Alberto's, President and Chief Executive Officer run.
Yeah. Thank you Paul and thank you everyone for joining us this morning, and with me today are Simon Harford, Our Chief Financial Officer, Pamela Stephenson, our Chief commercial officer, and Doctor Pat form our Chief Medical Officer.
This is a historic quarter for Albarino as we achieved our first product approvals and the U S and Europe and successfully launched Bill Babe.
I'm proud of our organization ability to deliver and execute as planned.
If you go back in time, we committed to enrolling and reporting top line data for the pet Fig Phase three study in mid 2020, we committed to approvals and the launch of Bill's eight in the second half of 2021.
We committed to starting to additional fee three studies in the allergy will syndrome and Delorey atresia in 2020.
We committed to taking in next generation ASPD neighborhood you know.
[noise] 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 bill they and advancing our pipeline this plant.
In this quarter, we not only receive product approvals in the U S U in UK and launch build a globally, but we also ship finished goods in January the first partial quarter sales for built with revenue generation in the U S and international which transformed us into a commercial comes.
Body.
The launch is going well right to plan and we're delivering on expectations Bill vase fulfilling a clear market neat for the first drug treatment auction Dr.
Doctors like it compares recovery and our team is delivering on fast launch uptake.
We've generated bill Vey sales and we're just at the starting point for Albarino and the journey to build a great liver company.
We're looking forward to delivering go over he launches in in more countries to build a feast three clinical trials and advancing to new next generation compounds.
Focusing on bill by the locks is going as planned and Pamela will provide a clear picture of the launch status. The stories. We hear in the lies we are impacting across geographies and peek types demonstrates the high unmet need in the impact of building. For example, we had two siblings ages 16 and nine year.
As of age with the rare prefix six subtype bold children have been on various off believable medications for many years.
Haven't been effective in providing relief from the parade us after living with these unbelief symptoms for so long, they're excited <unk> as a new treatment option.
The theme of getting better and better as one you will hear today from launch to access to a clinical programs and progressing pipeline.
I'm pleased to share things keep getting better.
We will share details on our progress by taking you through and covering.
One the bill very launch two key actions to penetrate the estimated 2500 global Piecyk patient opportunity three update on the progress of our exciting near term pipeline and for financial progress.
Starting with the launch of build a as this is the first quarterly call since the approval and launch we surveyed several stakeholders determined the most useful metrics to share with you on an ongoing basis. These.
These stakeholders suggest that we provide the right balance of too few or too many metrics or 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 quarters of partial quarter and given that approvals occurred at the end of July let.
Let me turn it over to Pamela to explain the metrics will be sharing with you and provide you an update Pamela.
Thanks, Ron before jumping into the matrix I would like to reiterate some arrived comments.
Delighted with the response to build.
As there clearly is a significant unmet need and build a it making a difference today the largest going that plan.
And prescribers patients unheard have reacted positively to the availability of.
Our outlook continues to be very positive.
Especially as we deliver.
We are focused on executing against our global strategy to reach the 2500 available piecuch patients across the U S Europe and rest of world.
Our field team have been meeting with Htpc's entire since launch discussing the value and benefits of Dale de.
Which have led to prescriptions being generated and patient starting treatment.
Our in House Albert Rail exit poll continues to work with each family help them navigate the reimbursement process.
All of which have contributed to our success and 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 prescription. These are total new prescriptions generated through the third quarter.
Some of which are still going through the reimbursement process.
Number of patients on Bell day. These are patients were reimbursement has been achieved and build a has been shipped.
Number of potential rollover patients on Delta.
These are a number of patients that are in programs, where they are on bills and should convert to commercial sales in the future.
This includes patient and the pipes Acteal extension study or early access program as well as patients and are managed to access programs. This.
This is a global number Andy patients will rollover to commercial sales when we obtained country level pricing and reimbursement.
And for the patients and Patrick too 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 build a and the U S.
Again, I will remind you that this is our first quarter it as 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 1 million at.
At 1.1 million globally.
With the U S net revenue of 800000 and international of 300000.
The number of new prescriptions was 28 patients worldwide.
The number of patients on Bill's 814, where reimbursement was achieved and product shipped.
The number of patients with the potential to roll over to commercial drive is 100.
Again these patients are on bills by way of their enrollment in our clinical study or or early access or managed access programs. So they will transition to commercial drag.
The number of discrete prescribers in the U S is 19, we have 100 top tier hcp's, 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 https in a minute.
This is exactly where we expect it to be at this early stage of a rare disease launch I am pleased with our start and I'm confident in delivering our guidance of low single digit sales for 2021 and.
In the US we have 10 sales representatives and with this targeted approach and the revenue that we will be generating this will allow us to leverage the P&L overtime.
With each day, we increased patient access and coverage worldwide, which means more physicians with the ability to prescribed and in turn more patients who now have access to a drug option to treat pruritus in <unk>.
So given this very solid start are key actions to penetrate the estimated 2500 global piecuch patient opportunity are focused on HCP outreach and education moving prescriptions through to reimbursement gaming 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 specialist field teams to do that.
Parting with the traders are field team is delivering with HCP outreach and education, which is resulting in prescriptions we.
We not only continue to reach the top 60 centers, but the sales and medical teams are also reaching the physicians at the referring centers and in the community and pediatrics Gis in adults Hepatologists, who treat the adolescent too adult patients.
We are focused on calling on our top 105th physician targets, but.
But also are extending our reach in partnership with trivia to the whole target universe of 700 physicians to reach as many patients as quickly as possible.
So we've been focused on getting billed to the estimated 2500 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 eight kilograms.
In addition to the focus and hustle from our commercial and medical field teams or al derail assist her coordinators are key to getting patients on build egg.
As each patient case is always a little different from the next it requires a well coordinated and high touch approach.
It has been aperitive for our in house team to leave the intensive process of follow up with families physician offices, payors and specialty pharmacies to fulfill build a.
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. R market access teams are working with private and public insurers to educate them on <unk> and build a.
We are having success with getting billed eight to patients in a timely manner as medical eligibility criteria for prior authorizations are being defined.
As predicted the first patients took time to process, but we learn with each case and our care coordinators are doing an outstanding job at processing cases, and providing support to families to reduce the burden of reimbursement.
Because we finalized our Medicaid agreement by August 1st we had a mandatory Medicaid coverage date of October <unk>.
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 approval to allow new patients to flow through the system.
Overall, we are pleased with a payer response and fields at the early days of getting billed day in the hands of families is on track.
Now looking outside of the U S. In Europe, where we are working on the remaining European markets, having submitted many reimbursement dossiers.
We are actively pursuing pricing and reimbursement in 14 countries simultaneously and are well advanced in our discussions with authorities and many of these markets.
We are seeking to accelerate reimbursement wherever possible by leveraging optimal pathways, notably the nice highly specialized technologies are HST pathway in England and Wales.
The SMC ultra orphan halfway in Scotland, and the highest fast track pathway in France. Our goal is to ensure patients have access to build a while achieving reimbursement at a price that reflects the value of bills.
And parallel the European authorization allowed us to initiate a global managed to 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 build a globally.
Similarly in the rest of the World and we will continue to add commercial distributorship in regions.
Entrees with high patient prevalent.
Another strategy, we have continued to execute and deliver on is to enter into exclusive distribution and supply agreements with key rare disease companies and various markets to extend availability across all of Europe parts of the middle East and eventually at Latam in the APAC regions as well as in China.
We just completed a fifth deal with flicks 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.
<unk> and commercialization Upbuild Bay, with Japan, representing a significant market opportunity.
<unk> will expand on this shortly but we are really excited about all five agreements to date as we continue to create pathways for global build a availability.
Now as we look at the larger close tadic liver disease market, Let me turn it back to her on to provide an update on our pipeline.
Super Thanks, Pamela to.
The successful fees three pet fix WP fig regulatory approvals in the us and Europe and the ability to commercialize bill by around the world have a high level of translatability towards.
Reading value from our pipeline programs.
Starting with the pet fixed studies, we continue to do further analysis of the long term data we've generated based on the immensity of data and will share more results.
Upcoming bilbrey presentations at the so the announcer began meetings this year.
Data will show evidence of long term safety and efficacy, including improvements in hepatic hell growth and sleep.
<unk> the burden of disease sustained reductions in certain <unk> and improvements in parades symptoms across pubic types post surgery data as well as the presentation on the research study analogy will syndrome.
Are pivotal fees through your search study analogy will syndrome remains on track to report top line data in 2022, as we continue to successfully enrolled patients. It's a double blind randomized placebo controlled study, which we will also agree with both the FDA you make that the single trial will be sufficient for.
Approval with a positive outcome or.
Our second and largest ongoing <unk> study is the fee III bold study, a bill Bennett and Bill Murray Atresia bold as the only pivotal double Brian randomized placebo controlled study inbuilt <unk> atresia and we've agreed with both the FDA any you made 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 why do it in 2024.
Now beyond our pediatric programs to continue to advance our next generation Biowaste modulators with two adult liver disease product can be three amount of 78342.
With 839 O seven we have the world's first hi, bioavailability systemic <unk> inhibitor, which we believe will act differently than diabetic inhibitor.
We are presented preclinical data demonstrating.
E three nanoseconds ability to eliminate biowaste in the urine effectiveness in coal static liver disease, such as <unk> PVC and differential effects of mash now.
Now are awaiting results from the fees, one study, which we plan to share before year end.
Our second product candidate is 82342, the world's first potent oral mt's CPU inhibitor, which is being developed for borrowing cole static liver diseases.
We've been encouraged by their preclinical work in the optimistic about the probable leave success this compound wide.
<unk> is an approved and TCP temperature purchased bite Gilead for rebellion euros, but it is a peptide and must be given as as a daily subcu and oral agent in laws for a wider dosage range and better convenience, we'll be sharing more data at <unk> with 280 2342 poster presenters.
<unk> <unk> <unk> <unk> studies continue to progress with a phase one trial anticipate the start in 2022.
And finally as you look at the overall value of the company will continue to have strong financial footing, which only got stronger in Q3 with two financial agreements you'd Pamela mentioned the completion of a deal in Japan with Jadeite medicines, what was attractive about this partnership with the upfront payment of 50 million entitlement to the 120.
Million in milestone and double digit royalties and the <unk> team.
Jadeite has the right entrepreneurial spirit to navigate the Japanese or from market solid financial knowledge and the backing of the CBC group.
Then beyond the completion of the Jadeite deal. We also sold the prior to review voucher receded FDA approval for $105 million.
The non dilutive capital from both deals gives us a strong financial position as we continued to expand availability of build a worldwide.
We are accompany with the first in class and first to market products with other strong candidates in the pipeline. Our focus is on our global commercial launch a build ANP fig and availability worldwide across cholesteric liver diseases with our bold in the search trials that will allow us to realize.
Or $1 billion aspiration for Bilbo.
In parallel were advancing our next generation ball us modulators with the potential will be 3978342, adult liver and borrow diseases.
So with that's my pleasure to turn the call over to Simon for a financial update.
Thank you wrong, let me now review all financial results for the third quarter of 2021.
Build their revenue was one 1 million for the third quarter in line with analysts consensus following the launches in the US in July and an international in September U S. Revenue was 800000 and X U S revenue or international was 300000.
Loyalty revenue was two 6 million for the third quarter compared to $2.1 million to the third quarter of 2020, an increase of 500000. The increase relates to estimated royalty revenue to be received from Eas farmer <unk> about to the treatment of chronic constipation.
Which as you know is passed on to healthcare royalty partners.
Cost of product revenue was 400000 for the third quarter of 2021, due to manufacturing and quality headcount costs manufacturing and quality headcount costs. Prior to build the approval were included in expenses. However, since approval a portion of these costs and now recorded.
And cost of product revenue.
As Bilbo ramps up these head count costs will become a much lower percent of product revenue that were no material costs. During the third quarter of 2021 as materials related to current product revenue where expense prior to approval.
Research and development expenses with 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, where principally due to the completion of the pet.
One study and the completion of the <unk> about phase two trial and Nash in Q3 2020.
Offset by increases this year in the build a as a bold trials and investments in early assets.
Selling general and administrative expenses was $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 saw headcount and commercial expenses to launch build bay.
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 $37 million for the third quarter of 2020.
Earnings per share for the third quarter of this year with $2.90 on a fully diluted basis compared to a loss of $1.96 for the third quarter of 2020.
As of September 30th 2021, we had cash and cash equivalents of $262.6 million compared to $186 $3 million on June 30th 2021.
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 will received after two two fees from the recently completed.
All of the Pov.
In addition.
We are due to receive an additional 15 million dollar 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 build bay and the next stages at the early asset portfolio.
In order to be more specific and ensure clear expectations 2021 revenue from bill pay is anticipated to be three to 4 million U S dollars consistent with all previous guidance with low single digit U S dollar Amelia.
With that let me turn the call back over to Rome for closing remarks. Thank you Simon.
We're proud of what we accomplished in the first two months of build a launch and the opportunities. We continue to work toward ultimately our goal remains Springfield Bay to the approximately 100000 pediatrics cholesteric patients around the world starting is the first and only approved drug option for patients across all types.
Worldwide, and finally will continue to advance our portfolio, an adult liver and viral diseases. We thank everybody for joining us and we're pleased to open the call now for Q&A operator.
Thank you at this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Confirmation tonal indicate that your line is in the question Q U.
You May press Star two if you would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the sarkies one moment, please while we pull for questions.
Our first question comes from the line of Reto Brawl with Cowan you May proceed with your question.
Good morning, guys. Thanks for taking the question I wanted to focus on the launch pad.
Pier discussion.
That's the most common prior authorization requirement to be.
I guess going forward steady state.
E.
Is it just like diagnosis.
Any plans asking for like.
See room pile acid level or each added station.
And then can you tell us like.
Right now how you're looking at percent covered lives or most of the reimbursement is through exception, thanks, and I've got a quick call.
Hi, Pamela thanks, many thanks for the questions, Yes, we with a prior authorization requirements on what we see is that they they vary plan to plan and we're seeing the whole range from everything that you mentioned it could be looking at baselines here on bile levels confirming <unk>.
President confirmation of specialist prescribing.
All of all of these factors that you would expect with the initial prior authorization on a new new product.
And we have been able to get these through the system. What I can say is that they really have not been a barrier the prior authorization not a barrier to.
Getting patients through the system and on to build a.
On your own.
Go ahead sorry.
And I believe your second question is about.
Our expectation around the percentage of covered lives and again, we're very positive when we've gotten out to all the players that represents the majority 95% of lives across the U S and they understand and recognize the value of bills and to date has been covering an approving on.
On.
As with any new product going through the exception process, but that's why we have alvarado assessed.
Take the cases, and we understand the plan requirements and we are able to work that patients through the system and get the claim is paid for.
Great. Thanks, and a very quick question on 39 O seven when might we expect direction on targeted indication Ron like how are you thinking about.
The unmet need and.
C versus the established pattern PVC then.
Nash.
Yes. Thank you reached for the question I think free 307 pretty excited about it because we believe being the first.
Highly by available <unk> inhibitor with systemic.
Exposure that we can probably do some different things without compared to the iPad inhibitors I think to answer your question, we really need to get through the phase one day, the first which we anticipate sure review by the end of the year. Once we have a chance to digest that data.
Will 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 of the ability to take <unk> out of the body not only through the.
The area, but also to take them out through the kidney could be very interesting.
Got it I'll hop back into Hugh Thanks for taking the question.
Thank you you too.
Our next question comes from the line of you with Jeffries you May proceed with your question. Thank you.
So in terms of pricing I know that.
You as the pricing could didn't quite get from my country.
Country basis, but at the same time.
From your experience in your discussions and so far do you know what.
Potentially the differential between the U S and ACSF pricing.
Hi, and thank you for the question what we're looking at is European list prices for build a that are within the 20% to 30% quarter of our U S. Whack, which is right in line with are the rare disease.
Analogues that we've seen and analyze to date. So we're feeling very confident about our pricing strategy both in the us and in Europe.
And in in neural or outside the U S.
The PBT surgery that sound a lot cheaper so do you.
Have you seen any kind of of some sort of a push it back from.
<unk> outside the U S.
Based on the pricing differential between the surgery and.
We have not seen that pushed back to date, I think payers really see the value of having a non surgical option for these patients.
Alright, and then lastly question Myalgia syndrome. So data is on track for 2000 Tony team.
The first the patient was I think it does seem March.
So maybe a little bit tardy to comment that.
Can you kind of a give us.
Some guidance of when you might expect to complete the patient enrollment. Thank you.
Thanks for the question.
We're just really pleased to be up and going with the assert trial across the globe.
We're just really pleased to be up and going with the assert trial across the globe.
And we're pleased with the enrollment thus far will provide you an update once we have the study fully enrolled but we reiterate our guidance of expecting data even 2022.
Thank you.
Our next question comes from the line of you guys mean rahimi with parts of Sandler you May proceed with your question.
Hi team. Thank you so much for all the great updates Uhm two quick questions for you.
And thank you for providing guidance for 2022, but.
Can you maybe help us understand how much into contribution would be coming from the U S.
Part one and then the second question answers can you give us a little bit color. How you guys can be thinking about sort of the cadence of dose.
See that are going to be filed in Europe, and and sort of which geographies could be easier to gain market acceptance and approval versus others. Just just to kind of help us oriented as we'd be looking also at some matrix and European launch and thank you again for taking my question.
Hi, Thanks, Yes mean.
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 us and Europe at this stage.
It is premature to give 2022 guidance currently because frankly, we want to wait to any way 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 the.
The split between the U S.
And the EU and the rest of the world will be fairly balanced.
And then for your second question the as named.
Regarding the cadence in Europe, and what we're seeing as mentioned we are actively pursuing the reimbursement in 14 countries with the submission of the dossier and so the way. We think about this is of course, we've launched in Germany, where are actively and in discussions with UK, France and Italy. The next.
Largest markets in Europe, and then at the same time the remaining on markets in Europe, where there's also a lot of opportunity were simultaneously submitting those dossiers as well.
And maybe just a quick follow up is there.
Timeline that you have in mind.
Able to complete the next condos T. Like have you have you have you given yourself certified.
As time fine on by when to complete how many that you feel comfortable wanting to share with that.
Yes, I think he has been.
The way, we think about the launch think about this year's kind of working through the logistics in the U S. Right. As you, though is about 1000 different payers with in the US. This is the logistics of the U S. And then from a European perspective perspective speak about next year.
40 through European access and is Pamela stages in the early comments you were looking at some specialized pathways. We're really pleased with the early dialogue, particularly human clinical assessments road. So we've been pretty confident that through next year, we'll sort through those European countries.
Thank you so much for taking my question.
Q as me.
Our next question comes from the line of Tim Lugo with William Blair. You May proceed with your question.
Hey, guys. This is laughlin onto Tim Thanks for taking my questions.
I was wondering.
As it comes to this sort of.
About the mulch cadence.
<unk>.
What are the sort of bottleneck will major gating factors.
Getting patients on drug as a patient identification.
A doctor's just waiting until the patient comes in genetics routine visit polak describes it.
Insurance scenarios all situations.
Sort of made.
Getting caught and getting more patients on drug.
And on the topic of of insurance coverage.
I know the timing was probably talk to get into the 2022 negotiating cycle you expecting.
Yes significant formulary improvements starting in 2022 or.
Re sort of coming online over the course of the year and really.
Taken to be effective in 2023.
Let me start with your second question and then look 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 in so.
On the Medicaid side, we've had as I mentioned.
Coverage as of October and so we.
We've been very pleased in terms of get being able to get patients onto Medicaid.
And of course, there are some states that drag a little bit, but we're getting into their cycles until we should we are in good standing there with Medicaid and then for the commercial peace again, we are able to get patients through without necessarily having bill they added to formulary. So we're working through patient.
Hi, patient and I don't think that that will be any type of gating factor in 2022 in terms of waiting for a cycle because we were able to actually get them through case by case at this point in time.
And then back to your first question on one.
What are those sort of the steps in the process in terms of getting on patients in in and treated.
As we've mentioned the patients are identified in in the system and so the first step is to make sure they get into the Doctor's office and get prescribed build a.
Once they get prescribed to build a then we take them throughout the rail assessed and that's just the process of working them through on either a prior authorization or a new.
Any any type of requirement that the plan has and then thirdly.
Getting the product shipped out to build a so it's just a couple of factors that can be it can take a short time or can take a longer time.
Great. Thanks.
Mclachlan.
Our next question.
Question comes from the line of Brian's Gorney with Bird you May proceed with your question.
Okay. Good morning team. Thanks for taking my question just trying to think about the flow of anorexia are you kind of seen it as a steady state or of any sort of differences within the quarter like like an early.
Build up.
And how we should kind of think about this going forward.
I anticipate anything that could lead to an acceleration on anorexia and then are you seeing any examples where an rx isn't converting to a patient on on treatment like is their actual attrition here, where a patient doesn't pursue authorization to ultimately CRX spelled thanks.
Yes.
To your first question on that sort of the cadence of the N R X.
We are seeing patients come on in and come through the system and that sort of patient by patient. So I would expect that to continue to grow, especially as more hires become familiar with bill value in the beginning it takes a little bit of time for them to work out their process, but as we get go.
And here will work into a faster cadence in terms of pulling the patient throw.
And I think the other thing to think about renew Rx perspective, Brian is we.
We talked about countries coming on board and we also talked about 100 patients that we that we have in the wrong drug that will convert tribes. So as we get access in different countries and ask patients come out of the 72, we had two period. These people would convert to commercial as well so.
Yeah, I think we're really pleased with the first two months of what we're gonna have we're going to continue to we're going to continue to grow.
<unk>.
Quarter by quarter, and certainly as we have other geographies on board is going to Hell and then to your question about you will have we had no.
Have we had an Rx rejected.
Phil early for slowing the process with many of them. So we will continue to Russell phone the move taking longer but we're pretty confident will get their overtime.
Great. Thank you.
Thanks, Brian.
Our next question comes from the line of Joseph Stringer with Needham Inco. You May proceed with your question.
Hi, Good morning number one thanks for taking my question just to follow up on.
Sort of.
The cadence and the transition of.
Patients onto a commercial drug.
Ron you mentioned, the perfect too and just wanted to.
Good good.
Yeah.
Your thoughts on whether we can expect sort of a.
Bold list of patients in 2022 that are either transitioning.
From public two or any.
Program or or would it be sort of.
A little bit slower transition.
Specifically onto commercial drug thank you.
Let me start by just.
Talking a little bit through some of these potential rollover patients.
That we had mentioned so we have 100 potential rollover patients worldwide and these are patients as a reminder.
By way of.
They are either enrolled in a clinical study or are there in one of our early access or managed access programs.
And so we have a lot of programs on a lot of different countries and we have patients rolling off the 72 weeks at different time periods. So what I can say is that will 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 this sort of steady state of patients coming through and then on to commercial drive over the next year or so.
Great. Thanks for taking my question.
Our next question comes from the line of Andreas are there really are agrees with Wedbush Securities. You May proceed with your question.
Good morning, and thanks for taking a question.
A small apology for a kind of harping on what the reimbursement status.
But just what what are the.
The postal service.
Nobody's profiles pretty.
And and compelling and so.
What does it really take.
From the payer perspective to get.
Or to convince them too.
Put this on their formularies and maybe what are the expectations.
That you have internally as to want to go to a certain number of covered lives and when you do so do you plan on press release from that.
So let me start.
With your first couple of questions here so into the profile is very compelling prepared they see the value they understand the unmet need and they want to pay for this.
And they don't want to manage it too closely because this is like any rare disease.
There's.
The 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 put in place because most of these plans will just be covering.
Covering build a on a on a case by case basis.
Yes.
So it's not too hard to get them through they ask for specific information the physician's office submit that information and we were able to get patients through and claimed paid for for built.
And I think one of the things to think about it Andrew is when you think about primary care products for you have a lot of patience you have large insurance companies a lot of prescribers met.
Metric like coverage lives as an important as an important metric but in this case. This is a rare disease and.
This is a rare disease massive unmet medical leave user choke room that are that are suffering and so forth.
An individual pay there. This is a handful of patients and is Pamela said the compelling data that we have plus the value pack that we put together has worked out thus far us we super pretty confident in our ability to continue to gain reimbursement for the prescriptions that are generated.
Okay, Great and then as far as.
Ongoing too Dennis.
<unk>.
A new patients could you kind of walk us through that process.
Yeah of course, so in terms of identifying patients are al derail and trivia airfield team have reached 100% of the cost 60 centers and 90% of the top 100 prescribers. So in doing that we've really been able to quickly identify hcp's with patient in the system.
Patients can can range of course from either being newly diagnosed or those slated for potential transplant. So we continue to engage with https with ongoing and cursing and virtual meetings and educational sessions and we have the upcoming opportunities virtually at Asl D and.
<unk> began and we also engaged with the patient advocates who who have been working to ensure that their communities are aware of bills and a new treatment option. So through all of these efforts were.
Absolutely able to identify new patients and bring them into the system and bringing them into older in the system bring them in for treatment with Bell bag.
Great. Thanks for taking our questions and congrats on on all the progress in queue.
Okay. Thank you address.
Our next question comes from the line of Ed Arse with HC Wainwright May proceed with your question.
Hi, Thanks for taking my questions and.
And thank you for all of the.
The launch metrics upfront here, it's very helpful.
I wanted to start our first question on that you mentioned 28 28.
New prescriptions.
And 14 patients currently on Bill.
So.
And just the first two months representing 50% conversion.
Which.
I view as a customer not only to the strong value proposition of building itself, but also.
Success and please heidstra approach.
Albarino assist.
But I'm wondering.
That conversion timeline.
You expect to remain stable.
Or perhaps accelerate given that you are going through the very first of these prescriptions and.
Overtime that pig.
<unk>. That's the first question. The second one is on the 19 prescribers discrete prescribers in the U S that you mentioned as well wondering if there's any different dynamics you could discuss with it.
Appear a few dogs.
Already.
Multiple prescriptions.
And then thirdly.
Could remind us.
What you're seeing right now.
Your project in terms of the proportion between commercial pay Medicare and Medicaid. Thanks, so much.
Great. Let me, let me start with the first question on conversion what I would say here is that 28, new prescriptions 14 patients on bill.
Gary pleased with that result, you keep in mind some of those.
Some of those patients this prescriptions would've come in late in Q3, right and so this is a.
The conversion rate of 50 per cent.
I may not use that going forward just because of the numbers are small and the patients are coming in over the course of the of the quarter right. So.
I think what we can expect to see a a higher conversion rate going forward over a longer time of year time period, no more patients.
So that's that's one thing to keep in mind the.
The second question on the 19th per subscriber then the dynamics. They are what we see here is really that we're really pleased with the breath of prescribers right. If you think about the top 100 that we have in the U S and.
Yeah, we're looking here more it sort of breath of prescribers.
Necessarily rather than a number of prescribed prescriptions coming from like a small number of.
Prescribers. So they were really pleased to see the breath of prescribing.
And then your final question.
Mitigate.
On the on the slip.
Too early for us to comment on that but what I will say is the payer mix.
Right in line with what we expect for rare disease drivers.
Great. Thanks, so much.
Our next question comes from the line of <unk> with Cowan you May proceed with your question.
Oh, Hi, guys. Thanks for taking take thanks for taking the follow up I'm.
I am just curious do you have any free drug we're bringing program in place.
Early on while patients are now.
Navigating reimbursement an exception and then also off the new prescribers.
The 19.
Q what percentage of them are already build a experienced from the from the clinical trial. Thanks.
Okay. Let me talk to the first question around the assistance programs. So we do through Alvarado assessed 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 and.
Ensure that patients have access to build a as quickly as possible.
Then on your second question.
On the 19th.
Oh, yes, and experience with bill they.
Yes, we.
Can't really comment on.
The exact percentage of those patients who have those prescriber to her in a clinical trial, but what we can say is that yes. We are we are seeing.
It makes sense of prescribers from our from our top tier would have could have <unk>.
Experience with bill of a as well as new prescribers as well I.
I think we're really pleased about that part actually read too because.
Obviously, a lot of a high level of awareness to build a given that we have three phase three clinical trials either.
Ongoing or completed so there's a lot of individuals who are aware so high level of awareness that we expect prescriptions from those people that are aware, but.
Please have the number of people are new to us prescribed as well.
Is boundless that will continue to expand that over time.
Really helpful. Thank.
At this time, we have reached the end of the question and answer session I will now turn call back over to Ronkonkoma frozen.
Great Great. Thank you operated well. Thank you all for attending today's conference call will continue to keep you updated on the Billboard Global launch progress enrollment in the to build a feast three studies as well as our progress referred to next Gen. <unk> module leaders for adult cold aesthetic and bar.
Bold emergencies.
The next opportunity for an update will be our post aes will be conference call on November 16th where Dr. <unk>, Our Chief Medical Officer will join me again as well as our Chief Scientific Officer and co founder Dr. John Motson. So.
Please confirm on your calendars until then we'll continue to advance our Brailles mission to provide hope to families of patients who deliver disease and the entire Livered community. Thanks to all of you for your continued support.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation and have a great day.
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Okay.
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