Q2 2022 Albireo Pharma Inc Earnings Call
Good afternoon, and welcome to the Albury Pharma second quarter 2022 earnings call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call. Please press star zero on your telephone keypad.
Please note that this conference is being recorded.
I'll now turn the call over to your house, hence vets too.
Managing director of lifestyle advisors. Thank you you may begin.
Thank you operator, and good afternoon, everyone. Thank you for joining today's call. This afternoon <unk> issued a press release highlighting its recent business accomplishments and financial results for the first quarter ended June 32022.
This press release is accessible via the company's website at Www <unk> com.
Before proceeding we'd 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 are subject to various risks and uncertainties actual results may differ materially due to various important factors.
<unk>, including those described in the risk factors section of our most recent Form 10-K, and our subsequent SEC filings. These.
These filings can be accessed from the Investor section of our website at Www, Aparejo pharma dot com or on the SEC website.
Any forward looking statements represent our views as of today August 15th 2022, and should not be relied upon as representing our views as of any subsequent date, we undertake no obligation to update these statements publicly.
Now it is my pleasure to turn the call over to Ron Cooper, Albert <unk>, President and Chief Executive Officer Ron.
Thanks, Hans and thank you everyone for joining us this afternoon.
With me today are Simon Harford, our Chief Financial Officer, Pamela Stephenson, our Chief commercial officer and Dr. Jan Madsen, our Chief Scientific officer and head of R&D.
We estimate that there are about 100000 cola static liver disease patients around the world that could benefit from bill based therapy.
And in Q2, we had another strong quarter.
Assessing these patients through excellent execution of both our commercial and clinical development plans.
All standard phase III studies like ours provide the highest quality.
Selling data for payers regulators and prescribers.
Our approach resulted in build a U S new approvals in pizza and we expect the same for eligible syndrome and Bill are you Tricia.
If a country commercialization rollout continues as planned.
Looking forward to a major phase III readouts that al Jill syndrome around the corner.
The bold biliary atresia study to be fully enrolled this year.
We're building short term and long term corporate value at a steady pace to drive our aspiration of making building a billion dollar drugs in the second half of the decade.
On top of built they are promising earlier stage assets 83, nine or seven 8% to 342 are progressing exactly according to planning and will become valuable growth drivers.
Strong financial footing in the teen years of expertise in bile acid modulators.
Poised to deliver our plan to create additional value.
As we shared with you in the first half of 2021, we have a global launch strategy for building.
Keeping global net product revenues of $5 9 billion in the quarter.
While sales are important.
The more important metric is patient capture which relates to the long term value of our drug.
I'm pleased that we now have 245 total bill b patients either on drug or in process.
On a quarter to quarter basis, we've had.
<unk> new patient capture.
We continue to make excellent progress with global will be launched and gained important market insights along the way.
This quarter, we had a larger change in the mix of babies versus adults on therapy.
We're also finding that in the U S patients are a bit more dispersed than expected.
It's longer than originally anticipated to get to them.
Pamela will provide more detailed update on these topics and the global launch metrics.
You will see that we've adjusted the metrics in the new format based on Investor feedback the metrics are simplified and now add up to total build eight patients.
As we all know <unk> is our smallest indication, but we're making excellent progress in our objective of expanding beyond Peasy is build a pipeline in a product.
We're on track now with Jill syndrome, and expect to report top line data for the Phase III study in the fall, which is really exciting.
The third is a gold standard perspective intervention trial with 35 sites across North America, Europe , Middle East and Asia Pacific.
With that in mind. We're also very excited about the progress to date with our phase three bold study in biliary atresia with enrollment on track to be completed by the end of this year and a topline data readout in 2024.
Phase III bold trial is the first and only be three evaluating I bet inhibitor in biliary atresia with clinical trial sites spanning the U S Europe , Latin America and China.
Our exchange with the FDA have been very productive and we're excited about bill these potential in this indication biliary atresia is the most common pediatric cholesteric liver disease and the number one reason for pediatric liver transplant across all diseases.
And finally, we're pleased with the two recent appointment to our board of directors strengthening our company with the addition of Susan Allen.
Vice President National business development alliances at Boston Children's Hospital, and he can be deadly former president and CEO of Accelerant pharma.
Susan is a strong leader who enroll at Boston Children's Hospital provides us excellent insight into the health care system challenges and opportunities. In addition to our experience with the major children's hospital, Susan brings a rare blend of both big pharma and biotech strategic planning business development and.
<unk> experience.
<unk> is another successful leader.
So long, which is eventually sold to Merck for over $11 billion.
He brings excellent biotech CEO experience as well as big pharma scale experience for his many years at buyer.
We're fortunate to have both these great leaders joined our board now let me turn it over to Pamela who will take you through the progress of our global launch of build the pizza Pamela. Thanks, Ron we are very pleased with the progress. The team has made with Bill day.
To take you through our Q2 performance I encourage you to reference slide 15 in our corporate deck posted on the investors section of our website.
So let me start with our updated metrics methodology.
We have revised the Q1 figures to match the new methodology.
Having listened to feedback from you as investors and analyst we have adjusted three of our key metrics and added a new metric, we're calling total bill they patients.
So that our metrics are more intuitive and easier to understand.
The net sales in unique prescribers metrics remain the same.
The three updated metrics arc number of reimbursed patients patients pending reimbursement and rollover patients.
Reimbursed patients, meaning patients initiated on reimbursed drug and generating revenue net of patients who have discontinued.
Pending reimbursement, meaning patients with a prescription who are currently in our managed access program.
Or are in the process of getting on reimbursed drug.
Rollover patients, meaning patients in the <unk> expanded access program or in the Patrick two open label extension trial.
It is important to note that this metric no longer includes patients and our managed access program as they are now included in our new pending reimbursement not track.
Together these three metrics add up to our total build a patient's metric which account for all patients currently on or in the process of getting on Bill day worldwide.
Let me give some detail on each of these starting with total bill they patients, which is showing strong quarter over quarter growth from 170 patients at year end 2021 to 207 at the end of Q1 to 245 at the end of Q2.
Total built eight patients increased 18% in the second quarter.
That is 38, new patients added that we did not have at the end of March consistent with the double digit quarter over quarter increase we saw in Q1.
We are very pleased with this increase because it means more physicians are gaining experience with bill day, and seeing firsthand the clinical benefit.
We are seeing that once a physician has a positive experience they are more likely to prescribe, though there again.
Most importantly, this means that more and more patients are getting relief from their debilitating pruritus seen improvements in growth and sleep and enjoying better health outcomes.
This is the reason to believe in the long term value of our drug.
Doctors are telling us this drug works, which is exactly what you want to hear in a launch and why we have 245 patients and that number continues to grow.
Now, let's turn to reimburse patients. We are pleased that reimbursed patients have essentially doubled in the first six months of 2022 from 50 at the end of 2021 to 99 as of the end of June. This is a good indicator of coverage in the U S, Germany, and the U K and we will continue to see this number.
Grow as pricing and reimbursement is granted in additional countries in the U S. Nearly all patients across public and private insurers have a path to coverage for Bill day.
Now, let's look at pending reimbursement the number of patients pending reimbursement in the quarter increased to 68.
This group of patients will eventually and hopefully as soon as possible transition to becoming revenue generating going forward.
We are progressing well with completion of pricing and reimbursement in Italy, Belgium and Scotland.
This is a direct result of the experience of our market access team and the recognition of my payers at the innovation that bill they represents with our pivotal phase III clinical trial data.
In Italy, Bill <unk> has been granted full therapeutic innovation status by I thought the Italian medicines agency, which will ensure dedicated national funding and inclusion into regional formularies within 60 days from the publication of the degree and the National Gazette Journal anticipated next month.
Together with Scotland in Belgium. These results confirm our thesis that payers see the high unmet need added clinical benefit robustness of the phase III scientific evidence and overall value of Bill day.
With 14 dossier submitted to date, we anticipate coverage in additional European markets. This year, which will trigger conversions of patients who are pending reimbursement to become a revenue generating.
Let's now look at rollover patients as a reminder, these 78 patients are either in the expanded access program or the perfect. Two open label extension trial, and they will roll over onto reimbursed drug over time.
This metric is anticipated to decrease as patients roll off the extension trial at the end of 72 weeks and onto revenue generating product in reimbursed markets.
Moving onto net sales bill they achieved $5 9 million of net revenue in the quarter, resulting in $10 5 million year to date with revenue from the U S. Germany and recently the addition of the U K.
U S revenue was $3 5 million in Q2.
In the U S. We are pleased with the significant increase in the number of unique prescribers as our field team connects with patients as is common and rare diseases.
We are seeing however that is taking longer than originally anticipated due to the broader prescribing base.
International performance is going well with $2 4 million in revenue due to strong performance in Germany.
This is proof of our ability to quickly connect patients and get them reimbursed on a global scale.
As Ron mentioned earlier the reality is that we are seeing greater variability than anticipated in terms of weight and patients starting on bill that in.
A larger proportion of our discontinuation have come from older heavier and that's higher revenue generating higher revenue patients as they transition to liver transplant due to the progressive nature of their disease.
I want to stress that we are in the early stages, where small variations can make a big difference.
The range of patients is wide in terms of age and weight with teenagers and adults, bringing 10 times. The initial revenue a small babies yet in the long term are smaller patients will create a larger revenue annuity as their health improves and they get back onto the growth curve.
Given that both the compliance rate and refill rates are tracking well above 80%. We are confident in this revenue opportunity.
Finally, our last metric is a unique prescribers, we have increased the number of build a prescribers in the U S to 73 by the end of June up from 57 at the end of March as a result of the expertise we are building and the new targeting approaches we are using to connect prescribers and patients.
This is an additional 16 prescribers, who had not previously written a prescription for bill that.
The acceleration in the U S prescriber base confirms our beliefs that the available patients are there but are finding but we are finding that they are taking longer to access to the 30% of prescribers being outside our key center.
These prescribers include community and office based physicians as well as adult prescribers.
Now that these H C piece had a therapeutic option to prescribe to their patients they do not need to refer them to large centers as they had to do in the past for transplants.
In summary, we are making excellent progress in terms of total Bill day patients. We continue to expand the prescriber base to encourage more experience with bill pay.
And we are gaining reimbursement in important markets, such as Italy, and Belgium due to the strong pivotal phase III data and our ability to execute our market access strategies now I'll turn it back to Ron.
Thanks, Pamela I wanted to quickly touch on our one of a kind early development assets, a 390 790 2342.
Did you mean out of seven is the world's first and only oral high systemically bio available E. S. P D inhibitor in clinical development.
And in our preclinical models <unk> seven clearly demonstrates its differed from the commercially available I bet inhibitors. In addition in the phase one study <unk> three nano seven demonstrated excellent systemic exposure and good tolerability.
We anticipate starting a phase II study in adult liver disease by the end of 2022.
We will share more details about our development approach free reading out a separate later this year.
Second asset for adult liver disease, a 2342 deserves a few words, a two or three or four two is the world's first and only oral and T. C. P inhibitor.
And on advancing a 2342 into a phase one study by the end of this year.
The intent of proving it to be a unique component of combination treatment for hepatitis B or D.
We have the ability and resources to develop both of these assets on our own for a single rare disease, but both product candidates have garnered interest from strategic partners considering wider development plans.
Let me turn it over to Simon.
Thank you Ron let me summarize our financial results for the second quarter of 2022.
Bill pay global net product revenue was $5 $9 million U S revenue was three and a half million dollars and international revenue was $2 $4 million.
Royalty revenue was $2 $3 million compared to $2 $4 million last year, a decrease of $100000. All royalty revenue is passed on to healthcare royalty partners.
Cost of product revenue was $800000 following approval to build a certain amount of factoring in quality head count costs are now included in cost of product revenue.
When no material costs is materials related to current products sold were expensed prior to approval.
Bill Day was approved during the third quarter of 2021. Therefore, there was no cost of product revenue last year.
R&D expenses were $22 $9 million compared to $29 million for the same period of 2021 an increase of $2 million.
Increase in R&D expenses were principally due to expenses related to clinical program activities personnel expenses, including stock based compensation and other costs as we continue to increase our head count program activities. The.
The increase in program activities related to ongoing phase III clinical trials, so biliary atresia knowledgeable syndrome as well as build a P. FIC expenses and were partially offset by a decrease in preclinical expenses and a three nine O seven due to completion of phase one study.
Selling general and administrative expenses were $21 $6 million compared to $16 $9 million last year, an increase of $4 $7 million. The increase is attributable to personnel and related expenses as we continue to increase our.
Head count and commercialization activities related to Bill day, including our sales force and support for global expansion efforts.
Net loss for the second quarter of 2022 was $39 $9 million or a loss of $2.04 per share compared to a loss of $36 $4 million or a loss of $1 90 per share for the second quarter of 2021.
The company had cash and cash equivalents of $181 million as at the end of the second quarter versus $216 $7 million as of March 31st 2022.
The company expects to have sufficient cash into 2024 based on current revenue and expense projections, while total build a patients continue to progress well the variability on weight of starting patients and time to find patients in the U S means we.
We are adjusting our 2022 revenue guidance to $24 million with that let me turn it back to Ron for closing remarks.
Thank you Simon.
The weak, we're capturing more and more patients, creating a stronger and stronger annuity for growth clinical trials are on track or ahead of expectations as we advance our plans to make build a billion dollar probably the key for us to build from.
From a <unk> drug to a leading pediatric cholesteric liver disease drug we will accomplish this by building our patient base quarter by quarter and plan to expand to eligible syndrome and biliary atresia patients on the back of our phase III studies, and finally continued focus on progressing our early asked.
As an adult liver disease, 80, 397%, a two or three or four.
This strong portfolio and financial position, we have a tremendous opportunity and we'll continue to stay focused on our goal growth drivers.
It's all very exciting for all of the rail as a company with a first in class and first to market product for near and midterm growth. We thank everybody for joining us.
Pleased to open the call now for Q&A operator.
Thank you we will.
The question answer session.
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We will pause for a moment and the callers join the queue.
Thank you.
The first question is from Barry Super All with Cowen. Please go ahead.
Hi, guys.
Yes.
No.
Yeah.
Okay cool.
Okay.
Thanks.
Fuzzy but.
He started a gain I think we're hearing you now.
Okay.
Oh.
Yeah.
A little bit more volatile.
Oh yeah.
Hmm.
Oh Wow.
Yeah.
Hum.
Great read too.
I apologize I apologize.
I apologize, we're really having a hard time hearing you now.
No problem.
Yeah.
Alright, thank you so much.
The next question is syndrome.
With Jefferies. Please go ahead.
Thank you can you hear me okay.
We hear you perfectly well. Thank you okay. Great. Thank you. Okay. So I have a question on Allergan syndrome data expected. This fall so in eligible syndrome study.
The doses of 120, what is in perfect. He started.
F 40 so.
Given day to 30 times, a higher dose.
We the same similar study design and endpoints, how do you see the F.
I think because he is safety.
Compared to what we saw in perfect.
Okay.
Thank you for the question Yeah, I think we're pretty excited about the assert study and those results speaking announced just around the corner. This fall as you know a surge is the very first and only gold standard randomized placebo.
<unk> study and with that we hope to show really strong efficacy and great Tolerability and these certain study similar to what we saw in the Patrick's studies right.
As it relates to your question in regards to dose you know I think that's another it's one step at a time right, let's get the results from the <unk> study and then following the results of the search so you will be submitting that to the regulatory authorities and we'll get into dialogue with them.
But yeah.
So one one and a follow up question to that is at 120 microgram per kilogram dose do you expect a side of that.
Be a potentially greater that have 40 microgram data used in perfect as a starting dose.
Well I think it will have to wait until we see the data, but if you go back to the <unk> study, where we use both the 40 and 120 doses. We saw very similar levels of Tolerability. So I think our expectation would be that we'd have excellent tolerability is.
In the search study.
Just like we saw in the pet six study.
Okay. That's helpful.
Question is.
Oh, sorry, sorry, if I interrupt you noga.
Go ahead go ahead.
Yeah. So you.
In the prepared remarks, you mentioned that in perfect Ah patients more dispersed than expected in the U S and prescribing ER prescribers of base station like a 30% outside the two centers. So do you think that there would there be similar with.
Where the allergist syndrome patients and with that do you think you would need to.
Ben do you want to sales Rep base.
Oh, Hi Inn in Panama, and thank you for the question. So I'll just start by saying you know what.
We're really pleased with how we're doing in terms of getting out to more unique prescribers with about 28% increase to 73 prescribers.
You know for allergy L. We anticipate a similar type of prescriber base with those key centers that will be because that will continue to call on and they're you know and there maybe patients out and in the community like we're finding with pizza and the good news is we're out there finding those unique.
Scribe and expanding our prescriber base. So we're really really confident that we will not need to expand our our field team and maybe one or two more reps, but nothing beyond that that's the great thing about our model.
The exact same pediatric hepatology prescribed for P pick for allergy L. Billary atresia so.
We think that we're sized appropriately to be able to.
Take advantage of those opportunities.
Okay. My last question.
Pam mentioned that compliance and refill rate is greater than 80%.
Does that kind of imply that discontinuation rate.
You mentioned that it's a you know order and you know a higher body weight patients Hum do you think the discontinuation rate is as you know some error.
Around less than 20%.
Okay.
So let me just take a step back to clarify so so no. These are two different rates right. So the the the compliance and persistency rate that I was speaking to really has to do in any given month. The patients who are on therapy at the end of the month did they take all of their pills. They get all of that will be felt.
On time, and so that that's what we were really pleased without being quite quite high.
Second question is a different question that you were asking was round you know around the discontinuation. So that's a different a different metric that is a metric that we are.
We are seeing is right in line with expectations, what we would think for for a rare disease, but I do just wanted to clarify that those are two different metrics.
Oh, great. Thank you, so you're not disclosing the discontinuation rate.
Well, that's one of the reasons, we changed our metric slightly you see from previous quarters are you and you see that in we are a new metric called the reimbursed patients right and that's it.
On drug at this time and they connect directly to revenue and that would be inclusive of individuals that have withdrawn therapy, that's probably the more relevant metric for you.
Okay. Thank you very much okay.
Yeah.
Thank you.
The next question is from Tim Lugo with William Blair. Please go ahead.
Hey, guys, thanks for taking them.
A couple here just so you mentioned a broader prescriber base can you maybe talk about how much that is than originally planned I know you were just saying that you expect.
To expand the sales force much if at all.
But how many more you shouldn't be you know.
Targeting.
And then second.
On the right.
International rig constantly.
Do you have any collateral.
I'd be in each of those markets and pricing.
Pricing looks like.
Yeah.
The lock when you were a little choppy honestly I just want to make sure that we get the questions correct right I think that your first question was around.
The prescriber base is in the U S. How much broader that is in your second question I think was around the international markets and I believe what you're asking about what we.
There's a number of patients that are there and what we anticipate for price I just want to make sure that that's what they were.
Correct.
Okay.
So so you Pamela why don't you why don't you grab a hold of that yeah. So first on the question on the broader prescriber base I mean.
What we're seeing is that we're still quite focused on the hundred physicians that we've always talked about into 60 key centers that that is there's there's depth. There in terms of the physicians and centers and patients that are there and then and beyond that you know as we look.
To the potentially around a thousand other potential prescribers, what we're doing with that is we're able through advanced analytics to really have a better understanding of which of those physicians are most likely to prescribe. So we've been really going instead of deep a lot on the centers and then abroad on the broader prescribe.
Or base.
On your second question in terms of reimbursement outside of the U S. As I mentioned you know that is that is if that is going well. The negotiations have gone well, we're really pleased with Italy, and Belgium in Scotland are bringing those countries and faster than we've seen for industry benchmarks and that kind of the.
Number of patients in each of the countries.
I'd, just say I look to your country population estimates.
As a guide there because there's.
You know that that's something that we're you know.
They are not able to disclose at this time, but it's something that I think.
You can see from your population models.
Overall, and then the pricing I think again as expected the pricing is right in line with with what we had expected in terms of rare disease pricing in European market.
Thanks.
A quick follow up you mentioned that.
And the key centers.
All of them described.
Are you seeing as much debt.
Or are they.
Do you want them to.
No you're absolutely right, it's one one or two patients in the broader prescriber base.
But it's game.
Remember, we're still early in the launch process right. So that's what we would expect but that gets us pretty excited right because once they start we anticipate that as few patients as they identify new patients that they will be depth of prescribing.
Yeah, Yeah, it makes sense.
Okay.
The next question is from Brian <unk> with Baird. Please go ahead.
Okay. Thanks team for taking my question I was hoping you can talk briefly about the uptake in the EU now have reimbursement in the U K, Italy, and Belgium, but it sounds like the older and doesn't start to contribute until October .
I wanted to get an idea of how much of a contributing factor U K and Italy were this quarter versus Germany.
And how much growth you may have seen in Germany, and then on the U S. Since last quarter, there was an inventory drawdown, where U S sales effectively.
Over these last three quarters I mean, it just seems like if I kind of back out some reasonable inventory expectations for that for core for fourth quarter stocking followed by Destocking last quarter and today is for and it all seems to be sort of in that $3 billion can you talk a little bit about the U S specific dynamics in terms of reimbursed patients on pending reimbursement.
Thanks.
Okay.
So hi, Brian This is Simon in terms of the EU really the way you need to sort of think about revenue going forward for the remainder of this year is that in sort of Q3, we would expect to continue to be primarily patients from the countries that have already launched.
The U S, Germany and the UK.
As you know the U K launch so that they can in late May as we fast forward then into Q4 that is where you should expect to see the Italian Belgium patients stop flowing through as Pamela I think was saying in Italy for example.
We've completed the negotiations.
We still have to wait for publication and then regional rollout region by region, So that would stop happening.
Strongly in the fourth quarter of this year.
You think about the topic of your question on inventory in the U S that really was a.
Yeah, a two quarter phenomenon and as we said we were back to sort of steady state.
Inventory at the end of Q1, so specifically to your question.
Greg's beta.
In Q1, and Q2 in the U S. Yes. It is fair to say the revenue numbers were flat due to that weight variability between patients.
But the more meaningful metric here in our minds is really these reimbursed patients hence why we've given it to you.
Actually on drug and generating revenue at the end of the culture and that continues to grow.
Okay, Great. That's helpful. Thank you.
Okay.
The next question is from Manhattan, Arce with H C. Wainwright. Please go ahead right.
Uh huh.
Hi, guys. Thanks for taking my questions.
Firstly for me.
I appreciate the extra detail on the non <unk>.
Patients.
Wanted to first confirm that.
I think as you've mentioned revenue generating patients right now stand at right now and with Verdier stands at 99.
And if that in fact the case.
Could you help us understand.
The average time to conversion for both depending on the rollover patients.
And then.
Hum.
In the U S do you have.
A range that you could provide for us.
The gross to net pricing.
Pricing.
And I have a follow up thank you.
Yeah.
So Ed just so first off you're asking about the the the revenue patients. So it is 99 patients that they've that drive the revenue Pamela will take the question about the average time and then and then Simon can talk about the pricing.
Pricing in the U S.
So high and so your question on the average time to conversion on the two categories pending reimbursement and rollover patients. What's your question correct.
Correct.
Yes, so the Dallas, that's going to differ based on the different countries. So it dependent those two categories are the number of patients for example in Italy in those countries and any of the markets that we have you know don't have reimbursement yet the 14th dossiers for which we submit it. So we'll have a you know well how to.
You know a good number of those patients from Italy as Simon has just mentioned rolling over at Q4 and then.
Now the other countries as they come online will have some ah patients in Belgium in any other countries into 'twenty two 'twenty three so yeah. We're really excited that we're gonna have Ah patients rolling over Q4 as well into early next year.
And then there's a as you know I'm in the US there are some there are.
U S patients in that number too that are going through reimbursement and very pleased with our time to fill in when you last were able to quickly get patients through that through that process of prior authorization and onto drug.
And yeah I think in terms of the question about about gross to net.
Currently.
<unk> to 50% of patients in the U S. A medicaid patient so they're at the standard Medicaid.
Discount the remainder of patients.
Obviously commercial payer and those discounts are very very different until the state for Medicaid so.
Those two things sort of drives the mix as it relates to gross to net.
Okay.
Alright.
Alright, well then.
One additional.
A question if I look at the total patients growing from $1 70.
Fourth quarter 207 in the first and $2 45, this past quarter.
Those are growth rates of 21, 8% and then.
Yeah.
Is that a.
Is that a reasonable way to think about the growth trajectory through the remainder of this year and to manage it.
Okay.
Well I think that I think first of all what we're really excited about is the new capture of patients right. It's roughly the same quarter on quarter right. So it's 37% 38. So that's very consistent that means patients are out there.
I think that you know.
<unk> had difficult for us to do so because in fact, we have reimbursements that are coming in there's a lot of dynamics, but all I can say is the fact that we've been consistent quarter to quarter is very pleasing to us and these are new patients that will become revenue generating over time.
Thanks, so much that's helpful. Thanks, so much.
The next question is from Andrew Yes argue rise with Wedbush Securities.
Right.
Hi.
Oh, yeah. Good afternoon. Thanks for taking my questions just a couple here.
Can you just provide clarity on the number of new rollover patients 78 versus the one provided at the end of Q1.
And.
And then I don't know if I caught all of the details here because it's been a bit choppy, but you're seeing growth across key metrics. So what's driving the reduced sales guidance.
And then I have one follow up I'm sorry.
Right.
So why don't we why don't we do this in reverse order why don't you talk about the sales guidance and then maybe you could just help Andreas global with the metrics that Pamela.
Yeah and dress in terms of the sales guidance of 24 million for.
2022.
Really what's driving that is yeah. The the two items that have been referenced several times here. One is just the time to connect to patients in the U S. Given the broader.
Our subscriber base than we had originally anticipated and then secondly, obviously, we've had quite some variability in terms of patient starts.
Between sort of Ah patient groups.
And that's the other factor here in the equation, particularly as early on we have probably more advanced.
So it's a disease heavier patients.
Quickly then sort of transitioning to liver transplant, whereas what we're seeing now is more.
The patient you would expect to get which is the babies or influence.
The good news about those is they generate less revenue to begin with we catch them benefit them as patients.
They continue to grow with this progressive disease Piecyk. So that's the biggest driver. If you think about first half second half first half of the year, we had 10 and a half million of revenue.
This would apply.
Implied foresight to 24 million, a 13 and a half and the second half and again I would expect to see.
Continued growth in both quarters from the markets, where we're already launched and then a little bit of a step up in Q4 for the Italy, and Belgium patients.
And so Andreas on your first question on the.
Difference between what we reported in the Q1 category of potential rollover patients in the end of Q2 category rollover patients. The first thing to keep in mind is that we changed and update that the definition of that category. So that's partially what's driving the difference. We took we removed that patients that are on our managed access program.
Graham and put those into the pending reimbursement category. So that's partially why you're seeing the difference in the number there and then in addition to that we've been rolling over our patience because within that category now right as the open label, Patrick two extension patients as well as the EAP patients and so as we came online with the U K we rolled over.
Patients and as patients in Germany hit the 72 week, Mark we rolled them over as well just a couple of different dynamics that would explain the difference in numbers there.
Okay and have you provided.
Hum.
The target number of U S. Prescribers and then if so I don't know what whatever that is what's the average number of patients purpose scriber.
The estimate.
Yeah.
Well what I can tell you is what we've provided is that that 100 key top prescribers remains the same there the ones in the 60 centers that are very much focused on has been focused on and then beyond that what we are looking at is because of the the broader prescriber base.
<unk> patients. If you you know some patients who are out more into the community with the community gastro.
Urology as well as the adult hepatology is weak.
There's a number of about 1000 more potential prescribers out there that we are currently actively targeting.
And in terms of depth to address too early for us to be able to say, we're still early in the launch right. So obviously, we'd like to see as much depth of prescribing with all of these right, but yeah to us are pretty excited that.
The number has gone up to two.
72, sorry, $2 73, right. So theres more people prescribing, we'd anticipate that over time, there's going to be greater depth as well.
Okay and last one if I caught this correctly.
The a certain timeline the timeline for the readout on the search has moved from year end.
Paul I don't know if you caught you discussed this but what's there.
The contributing factors. So that's why in some time now thank you.
Yeah.
Yeah. Thank you Andreas we just wanted to refine our guide is to be a little bit more accurate right and so we're pretty excited that it started study is fully enrolled.
First gold standard Phase III study gel syndrome.
Hope to see some good data around the corner.
Great. Thank you.
Okay.
The next question is from <unk> to bring it all with Cowen. Please go ahead.
Yeah.
Hi, This is Neil on for Ritu.
My question was the.
Hi.
Sorry, the line is still a little bit choppy.
Severe that the question is around the discontinuation that youre seeing.
Do you characterize it more as the patients that are progressing towards meeting, but there is always a bit more of a tolerability issue.
And then sorry.
Comparing that to what you saw in the phase three study.
Okay.
Alright, let me take that question and the first I'll just start with saying that the discontinuation are right in line with what we would expect and what we've seen in other rare disease and we're really pleased that we are not seeing discontinuation due to efficacy. So two to your question. There you know that.
The one that one of the reasons that we see in this quarter at least we've seen some patients discontinue with the fact that they were you know they weren't they had advanced liver disease. They were already on path to liver transplant physician was prescribing sort of as a last resort to help with the patient as they as they were getting ready for transplant. So.
Those patients that are just went on to transplant and and they had to stop Bill day.
And the other reasons that we would see sort of more family social dynamics that you often see in any disease category with some of the discontinuation, but again you know what I would just say is that this does not concerning and the discontinuation.
Right in line with expectations.
Okay. So I'm going to follow him with a couple of questions. So that sort of ties into what you were describing last quarter about targeting those relief to patients.
And my understanding of what that category of patients would include perhaps more of those same patients that you cracked sizes, probably having higher discontinuation rates. How do you expect that to them instead of feed into your numbers. How do you expect your numbers just shake out and then also can you help quantify or it gets done.
That idea of how the average size or age of the patients have changed.
Having said that to sort of start there.
Studying now.
Yeah.
Sure Let me, let me talk a little bit about what we're seeing because what we are seeing is a lot of new younger babies starting therapy in and that you know that is something that we're really excited about because they are they're going to be with us for the long term and so that that is a trend that we're seeing.
In terms of Ah patient starts I think overall the age what I would say it's early in the launch it's still early we're seeing a lot of variability we are seeing younger patients older patients heavier patients later patients and with you that with our pricing dynamic that that does cause a lot of variability and.
I think that that's in the short term over the long term and we're really excited them as at patient numbers grow we think things will smooth out.
Yeah, and I would just to add to that email as you think about sort of.
Wrapping used you know when you start at the beginning with a relatively small number of patients if you've got a teenage there were significantly more obviously with weight based dosing than if you're starting with a sort of a baby infant.
Ironically, though over the long term those patients that you want to catch up early in the progression of the disease, the younger and like to ones will be the ones that create the.
Continuous annuity.
Over the long term so.
So that's something to think about as you model.
Thanks Simon.
Great.
We have reached the end of the recession.
I will now turn the call Turan retracing remarks.
Sure.
Great well, thank you operator, and thank you all for attending today's conference call.
I am very proud of our organization's ability to deliver and execute as planned and thank each and every one of our employees for their commitment drive in innovation.
Keep you updated as we continue to advance all the rails mission to provide hope to families.
With patients with liver disease in the entire liver community. Thanks very much.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
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