Q1 2022 Albireo Pharma Inc Earnings Call
Good afternoon, and welcome to the Albertville pharma first quarter 2022 earnings calls 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 all three doses sensitive going to call it.
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Please note that this conference is being recorded.
I would now turn the call over to your host onshore.
Managing director of lifestyle advisors. Thank you you may begin.
Okay.
Thank you operator, and good afternoon, everyone. Thank you for joining today's call. This afternoon Albert issued a press release highlighting its recent business accomplishments and financial results for the first quarter ended March 31, 2022. This press release is accessible via the company's website.
At Www Dot Albury Alpharma 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 actual results may differ materially due to various <unk>.
Certain factors, including those described in the risk factors section of our most recent Form 10-K and subsequent SEC filings. These filings can be accessed from the investors section of our website at www <unk> com or on the SEC's website.
Any forward looking statements represent our views as of today may 16th 2022, 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, Albert <unk>, President and Chief Executive Officer Ron.
Thank you Hans and thank you everybody for joining US with me today are Simon Harford, our Chief Financial Officer, Pamela Stephenson and our Chief commercial officer.
Dr. Jan Madsen, our Chief Scientific officer, and head of R&D.
Before we begin please note that slides related to our key metrics and revenue for building uptake are available on our website. If you wish to look at them during the call.
While we're still early in the launch process.
Pleased that today, we reported another positive quarter with excellent execution on both the commercial and development fronts, and we're continuing to build a strong business base.
At this stage, we're on track with the Bill Baywatch have delivered on all of our clinical development milestones are and are in a strong cash position $216 $7 million on our balance sheets.
There are three important drivers of growth for Alba rail, what the global launch of Bill pay and perfect.
Expanding the use of bill they in additional diseases through phase III Gold standard studies al Jill syndrome, and Billary atresia.
Three the rapidly emerging early stage products in our pipeline for Alto Cola static and viral liver diseases.
We are looking forward to a bright future with multiple milestone readouts.
Now, let me turn it over to Pamela to talk about the global launch of Bill Baker Pamela Thanks, Ron I'm really pleased with the progress that we've made with Bill day.
Launch is going as planned and we are delivering on our global strategy to reach the estimated 2500 patients worldwide, who are available for treatment in this rare disease category.
Global response from health care providers, and payers and the impact on patients continues to be positive.
To illustrate the demand I will take you through the five key metrics. We continue to measure for launch how we're setting ourselves up for the European launches in pull through and she takeaways that will give us insights into future growth.
Starting with the total net product revenue.
We reported a total of $4 7 million in Q1.
It's $2 8 million in the U S and one 9 million in international.
Reported revenue was impacted by a draw down of inventory in the U S from the prior quarter underlying demand continued to grow so our performance to date represent solid penetration in the U S market and growing international sales due to the outstanding performance in Germany soon to.
Followed by the Bill they launch in the U K later this month.
We attribute this demand growth to increase physician experience with Bell Bay and an excellent payer response as we are seeing a high percentage of dispensers in fact in Q1 greater than 85% of U S insured patients reimbursed.
We are also very pleased with our time to fill which for most patients is less than 30 days. This is due to strong coverage across all plans and positive coverage decisions from all of the U S major payors, including anthem, Aetna, Cigna and United Health care.
In addition, we have accessed through state Medicaid and are pleased with increased improvements in coverage policies.
In Europe , we are building off the positive nice recommendation and eagerly await the outcome of 12 pricing and reimbursement submissions and expect to know more in the coming months.
Moving to the number of new prescriptions. These are the total new prescriptions generated.
As we reported we've had 145 new patient prescriptions in the first eight months of this rare disease launch.
As presented in our corporate overview deck slide 18 shows that we are building a growth annuity with new patient starts continuing to increase.
What this shows is that we have successfully captured the first wave of patients you would expect in rare disease. These are the patients who are in the trial or patients waiting for a drug option our patients recently diagnosed and quickly prescribed a dull day.
We are now focusing on capturing that second wave of patients who are under care, but not in crisis. They are seemingly stable patients visiting their doctor a couple of times a year.
The reach and frequency with the H C piece will be important as we ensure builder. It's top of mind is the first drug option versus surgery, and it's top of mind for the H C. P. When treating the burdening pruritus symptoms.
Another key insight you see across rare diseases is that patient capture it's not a straight line with summer months higher than others based on either seasonality timing of patient visits our journey to diagnosis and treatment.
What is important is that we continually capture new patients and each patient represents a growth of annuity.
That bill pay is a weight based chronic therapy.
Moving to the number of patients on bill they are patients who have been approved and reimbursed.
We have had 87 reimbursed patient initiations since launch up from 53 at the end of 'twenty, 'twenty, one 864% increase quarter over quarter.
We believe that our in house patient support program El Dorado assessed as a significant advantage in the speed of gaining access and keeping a lower than expected sell pie as well as a high refill rate Chuck.
Currently about 90%.
This supports the strong patient annuity with discontinuation rates being low all pointing to build a having the excellent efficacy that we expected.
The next metric is the number of potential rollover patients on bills a rollover.
Rollover patients or the number of patients who are currently on drug and available to transition to commercial sales in the future.
In Q4, we reported around 90 potential rollover patients and now in Q1, we have about 110.
This is an important metric during the launch period as it provides visibility of the patients waiting to transition to reimbursed commercial drugs. Following their completion and Patrick two open label extension trial are due to be in on free drag until reimbursement is received in multiple European countries.
To help demonstrate why the rollover numbers are so important and how these numbers can translate to sales. Let me give you. An example of what we are seeing.
For example in one country. We currently have two Patrick rollover patients and 16 free drug patients when we achieve reimbursement we expect that these 18 patients will immediately become revenue generating.
While the number of banked patients it's different in each country. Each of these countries will be a step change as the reimbursement switches on and patients become revenue generating.
Like the U S. It is a significant step change when our country in the EU gains reimbursement at all of the banks patients immediately become revenue generating so you can see why we're excited about achieving reimbursement in these important global markets.
Last launch metric is unique prescribers in the U S.
We have 57 unique prescribers, who believe in bill pay and have prescribed still bay.
We are really pleased with this level of penetration and expect this number to grow slowly with time.
At the same time, our model is efficient as over 75% of prescriptions are coming from key centers.
Moving forward our teams will continue to focus on awareness and education of pizza.
Ill ability of pizza as the first strike.
The availability of Bill pay is the first drug option and the impact Bill they can have on the treatment of pruritus and pizza.
We are pleased with the launch momentum and the outlook for 2022 as we continue to increase build a prescriptions building an annuity of patients in the U S. We are focused on maximizing our broad label, which allows physicians to prescribe bill say for all pizza types with all types of.
Operators.
As we get further into launch we continue to drive a second way by focusing on Hcp's, who has seemingly stable patients.
In Europe , we are actively pursuing pricing and reimbursement and the remaining European countries concurrently, adding new patients and our free drive bridging program and we will convert.
<unk> patients to commercial drug as we gain reimbursement.
Overall, we are penetrating the market successfully by Janet generating multiple prescriptions by prescriber I'm really happy with our reach today and continued engagement with the remaining targets, while expanding our geographic footprint now let me hand, it back to Ron to cover the other two value drivers.
Great. Thanks, Pamela now.
Now before jumping into the other value drivers I know Pamela has gone into a number of important metrics.
The most important metric is the number of patients that are on drug.
I'm pleased that number is increasing.
I'm confident the sales will fall as we gain reimbursement and inventory patterns.
Yeah.
The second driver of value for Albemarle is our focus on expanding into other pediatric cold static liver diseases.
We were thrilled to announce the completion of enrollment in the assert study our phase III pivotal trial, you know Jill syndrome with building.
The assent trial exceeded enrollment expectations with 52 patients versus an original target of 45 and timing consistent with our guidance.
Given the challenges of recruiting.
Studies during Covid and are commercially available treatment option. This really does speak to the interest in prescribing community and the ability of our clinical team to execute.
We're looking forward to the phase III assert readout and expect top line results by the end of the year.
In addition, we opened in the expanded access program in the U S and Europe for allergy Olson.
Already have our first patients enrolled and the response has been outstanding.
As with <unk>, we expect to have a significant number of patients roll over into commercial blood from the <unk> study and from the early access program by the time, we cheap approval at launch Bill day for allergy Olson.
So on track is our gold standard bold study, which is the only phase III double blind randomized placebo controlled study in beverage Trisha that both the FDA and EMA have confirmed would be sufficient for approval biliary atresia is the largest pediatric <unk> liver disease with more patients worldwide in P 50 analogy.
Combined.
This is a study of 200 patients randomized to building or placebo and studied over a two year timeframe, we expect to announce enrollment completion. This year keeping us on track with guidance of a top line data readout in 2024.
Global approvals for P. Fig Algeo biliary atresia, we project approximately three to 4000 pieces to reach and exceed $1 billion in sales.
And often in achieving this in the second half of the decade.
The third driver of value is in our two unique one of a kind early development assets 80, 397, and 8234 to three.
<unk> 907 is the worlds first and only high systemic bio available ASB T inhibitor in clinical development.
And in our preclinical models <unk> literally demonstrates that it is different from the commercially available <unk> inhibitors Adil.
Additionally, in a phase one study <unk> three nano seven demonstrated excellent systemic exposure and good tolerability and we anticipate starting a phase II study in an adult liver disease by the end of the year.
We also have a two to $3 four two which is the world's first and only oral N T. C. P inhibitor.
Development of a 2342 is tracking to the profile of the commercially available daily sub Q and T C inhibitor.
With similar potency against anti C P and target engagement, but without the burden of daily injections.
Beyond that we've completed rodent Tox studies with no findings concerns and excellent safety margins for the expected therapeutic dose.
Planned two advanced E 2342 into a phase one study by the end of the year with the intent of proving it to beat a unique component of a combination treatment for hepatitis B or D.
We have the capabilities and plans to develop <unk> 978 to $3 four two where rare diseases at the same time, both assets have garnered strategic interests with the potential to develop the product and more or larger diseases.
So overall, we're continuing to deliver against commitments associated with our three value drivers.
On the commercial and development sides of the business.
With that I'll hand, it over to Simon to take you through the revenue breakdown and financials for the first quarter.
Thanks, Ron Let me summarize our financial results for Q1 2022.
<unk> reported net product revenue was $4 $7 million for the quarter with $2 8 million in the U S and $1 9 million of international net product revenue.
As we said on the year end 2021 earnings call in early March we expected Q1 build they reported net product revenue to be lower than demand due to destocking of initial launch inventory from the prior quarter and that is reflected in reported net product revenue this quarter.
The end of Q1, the inventory levels. However reflects standard levels for the anticipated grades going forward.
As Pamela mentioned, we had 64% quarter on quarter growth and the initiation of revenue generating patients on commercial drug for Q1, and this growth trajectory gives us great confidence as a result for the full year 2022, we anticipate bill pay reported net product revenue.
You have a minimum of $30 million aligned the perfect market opportunity.
We will update you further once we have better visibility on the timing of launches in European markets.
Royalty revenue was $2 2 million for the first quarter of 2022, compared with $2 million for the first quarter of last year, an increase of <unk> 2 million.
The increase relates to higher estimated royalty revenue from EA pharma for <unk> for the treatment of chronic constipation, which as you know is passed on to healthcare royalty partners.
Cost of product revenue was <unk> 2 million in Q1, following approval to build a certain manufacturing and quality head count costs are now included in cost of product revenue. The window material costs is materials related to current products sold were expensed prior to approval.
Given the Bill day was approved during the third quarter of 2021, there was no cost of product revenue for the first quarter of last year.
R&D expenses were $21 9 million for the first quarter compared with $19 9 million in the same quarter last year, an increase of 2 million. The increase in R&D expenses. This year was principally due to expenses related to clinical and preclinical program activities personnel.
Expenses, including stock based compensation and other costs as we continue to increase our head count on program activities.
The increase in program activities related to ongoing preclinical trials as well as the phase one study of <unk> 907, and were partially offset by a decrease in <unk> expenses.
SG&A expenses were $16 9 million in Q1 compared to $15 3 million in the same period last year, an increase of $1 6 million.
The increase is attributable to personnel and related expenses as we continue to increase our head count and commercialization activities relates to Bill day, including our sales force and support for global expansion efforts.
Net loss for the quarter of 2022 with.
It was $42 $4 million or a loss of $2 19 per share compared to a net loss of $43 $7 million or a loss of $2 29 per share for the first quarter of 2021.
As of March 31st the company had cash and cash equivalents of $216 $7 million versus $248 1 million at the end of December 2021, we are reiterating our guidance that current cash is sufficient to last into 'twenty.
24 based upon our current revenue and expense projections, so with that let me turn the call back over to Ron for closing remarks. Thanks Simon.
We are where we thought we'd be at this time, we're commercialization and clinical standpoint.
Every week, we're capturing more pieces, creating a stronger and stronger annuity for growth.
Trials are on track or ahead of expectations as we advance our plans to make build $1 billion, probably the key for US is Dave bilby with pubic drug to a leading pediatric colas static liver disease drug we will accomplish this by building our patient base quarter by quarter and plans to expand to our <unk> syndrome.
And <unk> on the back of our Phase III studies.
We only need three to 4000 patients of the estimated 100000 pediatric cholestasis pieces around the world to reach our aspiration for $1 billion by the end of the decade.
We're also pleased by our method of use patent term extension granted a number of countries, providing us exclusivity into 2036 in Europe , and giving us sufficient time to build this business.
And then beyond the pediatric liver space, we expect to advance <unk> into a phase two proof of concept study in <unk> to $3 42 into humans for the first time by the end of the year.
With this strong portfolio and financial position.
We have tremendous opportunity and we will continue to stay focused on our growth drivers.
It's all very exciting for all of the rail as a company with a first in class and first to market products for near term and mid term growth.
We thank everybody for joining us.
Now pleased to open the call for Q&A.
Operator.
Thank you.
At this time, we'll be conducting a question and answer session.
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One moment, please while we poll for questions.
Yeah.
Our first question is from the line of a redo, but all the Cowen and co. Please go ahead.
Good afternoon, guys. Thanks for taking the questions.
Can you comment on your.
Current inventory levels, and whether you think those.
Those will Bob around a little bit in the forward quarters and also what are you are next.
Estimated or predicted EU launches beyond the UK that could trigger some of these patient bonuses and then I have a very quick follow up question from a client.
Okay. Thank you retail why.
Simon do you take the inventory question and then Pam if you can talk about EU launches sure Hi, Ritu.
Suffice it to say that.
In Q1, there was some destocking of the inventory that we had talked about in terms of buildup in Q4, but where we are right. Now is current levels reflect very much sort of standard levels for anticipated growth going forward. So frankly, we don't really anticipate talking about inventory.
Going forward that was during the initial launch uptake we're through that period. So what you see in reported revenue going forward, which should reflect pretty accurately demand.
And the way too high.
On your question regarding the European launches as you know, we have reimbursement in Germany and in the UK and we have submitted reimbursement dossiers and another 12 countries. So we are in active negotiations in key European countries, and we look forward to those countries coming online second half of the year will continue to focus on.
On the big five EU and beyond and we'll update you as we go once we get home pricing and reimbursement.
Fair enough and then just quickly moving to allergy I'll.
Have somebody asking about how you think pricing will work in LNG I'll, just maybe a general thoughts on net price of your average patient.
<unk> in contrast to <unk> I understand you can't give exact numbers, but just on a relative basis would be helpful. For the models. Thank you.
Thanks, retail, yes, probably a little bit early for US I think first off we're super excited to have the assert study over enrolled and reading out this year to have a major phase III readout.
Obviously, we have to see what that readout, what the data says and then we have to see what the regulators say from a label perspective that will drive where we are from a price perspective, but we think we feel pretty confident that we'll be in a corridor, that's a competitive price.
Got it thank you.
Thank you. Our next question is from the line of <unk> Yang with Jefferies. Please go ahead.
Well. Thank you. So in terms of per say there are 100 electrical patients in the U S.
And given that or the VIX you're ready.
On a pro drug why isn't it capturing patients more quickly.
And when you say 600 eligible patients are you are those are they.
Patients are not material from an electronics plant at the same time, having some kind of liver function.
So your line chopped up a little bit re too, but I think that I think you had some questions around uptake and sort of how we see the available patients. So.
The way the way that we estimate the market, we start with prevalence and prevalence or patients that are.
That our lives right and have the disease, and then to get to available patients.
The available market patients what we do is we take the patients that have had surgery and are medically eligible and that gets us to the 2500 patients globally and I think that's what we're really focused in on we believes the global opportunity.
Opportunity.
Both both in Europe in particular and in the U S and I think we're super excited that we are.
We're banking a lot of patients in Europe , and our penetration in the U S is going as planned.
The reality of it is you know this is a rare disease and what we're finding is that when we get out there right now we're getting the early patients. The early patients that are newly diagnosed or had been waiting now our work is going to the next group of patients that theres not as much urgency to treat but they are.
There are sub optimally managed and were actually find that as we get to those patients are getting really great results. So we're delighted with the performance thus far.
Okay, and then I have a follow up question on the prior question on the Allergist syndrome.
I think so.
You said you are starting with a 40 microgram per kilogram dose.
Going off to one 'twenty, what does the allergy all the dosing to one plenty micro that folks kilogram.
Kinda trial. So this is a weight based there.
Sure thing.
Boucher differential do you think are potentially.
On the pricing intelligence syndrome could at least three times higher than peers.
Yeah again U S.
As I said to reach you I think we really have to wait till we see the data and we have discussions with the regulators you might recall in the U S that we had a dosage range of <unk> 40 to 120 <unk>.
And we finished with the agency in the U S with a 48 and $1 20 doses tried and so we have to get the data first we have to talk to the regulators to two to determine what the dosage would be and then from there we.
We will look at price, but we're pretty confident we can manage all of those things.
Thank you.
Thank you.
Our next question is from Onyx.
Our next question is from the line of Bains Coney with Baird. Please go ahead.
Hey, good afternoon, guys. Thanks for taking my question I think with the inventory dynamics in <unk> in the you know whatever drawdown. There wasn't one gives a lot of uncertainty about the U S growth. So maybe you would think about providing what actual demand sales were for the two quarters I'm just gotta.
Got a handle for looking at what the actual U S growth is and maybe qualitatively would you be able to discuss how to think about the U S contribution.
To that $30 million versus ex U S. What else needs to happen, besides sort of Germany, and UK being online to achieve about $30 million number. Thanks.
So Brian this is Simon.
I think it is.
Terms of the situation with us through the inventory discussion pretty much at the end of March So as I mentioned earlier going forward, we don't really anticipate talking about inventory because all reported revenue should be fairly closely aligned.
With our demand and revenue so we decided to put out there.
Our full year guidance of a minimum.
Of $30 million, which is very much in our minds aligned to.
The perfect opportunity going forward to help you as you think through.
How we might progressed during the year I think if you think about the sort of the building blocks to that savi mentally.
A simple way maybe to take it is yes.
If you recognize that in Q1, we essentially when you have revenue from patients.
In the U S and Germany, Yes, if you annualize the Q1 number roughly roughly you're at $20 million and then there is growth off that and we expect further growth obviously in both of those markets. Then on top of that you have the situation whereby we feel pretty good.
Good about reimbursement.
In most European countries. The question, though and the variable here is timing of those because a few months here all that can actually make quite a big difference, which is why we're just indicating that at a minimum of $30 million at this point in time.
Any of the other thing I think you should be sort of.
Feeling pretty good about and helping you sort of.
Develop your multiples going forward.
That 64% quarter on quarter.
Increase in people, who are already on Bill day.
And sort of generating revenue is continuing to grow quite nicely as we project forward roll forward into the rest of the year.
So hopefully that gives you a little bit of color.
Overall on a global basis.
Yes. Thank you.
Okay.
It's Brian .
Our next question is from the line of Tim Lugo with William Blair. Please go ahead.
Hey, guys. This is lachlan on for Tim Thanks for taking the question.
Go ahead Lachlan.
Yeah can you guys hear me.
Now we cannot we can yeah.
Okay, great sorry about that.
I was just wondering on the topic of epidemiology.
I'm wondering if what youre seeing in the field and hearing from physicians is aligning with.
Have your expectations.
Heading into the launch or if you're kind of identifying any new patients.
And then.
Clarification, Pat I think my line was cutting in and out of it but it sounded like you said about 55% of prescriptions coming from key centers.
Is that correct and if so where the others coming from prescribers that are not being called on them or are they.
Just.
Prescribing not allocate central.
Yes, it could go off with Ron here. So so first of all we look at our estimates will receive in the field pretty much as to say right. So we'd reiterate we think theres 2500, PV patients around the world and then it was 75% of our prescriptions are coming from key centers. So we're really pleased about.
Because our business model is about targeted areas not spending as much resource and so we're pleased from the bigger centers, we're getting most of the prescriptions. The rest are coming from some of the smaller centers.
Got it thanks.
Thanks Martin.
Thank you our next.
The next question is from the line of Andrea <unk> with Wedbush Securities. Please go ahead.
Good afternoon, and thanks for taking our questions. So for PC like looking at the early launch dynamics.
Percentage of patients are receiving free drug and you might have mentioned this in your prepared remarks, but can you guide us as to when patients will no longer be receiving free drug also what kind of discontinuation rates are you seeing and then for LNG O enrollment.
Enrollment has been as expected can you elaborate as to what is driving patients to the study when there is already approved bold on the market. Thanks.
So Pamela why don't you why don't you address in dresses.
Questions on.
The free drug and discontinuation of alcohol and I'll speak about the eligible study alright, so as we mentioned 85%.
Fences or patients in Q1 that were insured.
We got reimbursed drug.
Patients are and so there are a few patients who are on three drugs, but we are actively working to transition those patients onto paid for block.
So the first question that you asked on the second.
While we're not sharing our discontinuation rate at this time, what I can tell you is that we have only seen a small number of discontinuation, which has been in line with what you would expect for a rare disease launch and the other dynamic here is that it's a fluid number and we have some patients who are coming off therapy, while others are deciding to come back on.
And real easy none of these discontinuation had been for efficacy. They are you know theres not really a trend there.
Humanistic or family beliefs that sometimes come into play, but yeah. Those are one offs and overall, we're very pleased with the number of patients who are continuing on therapy with dull day.
Great great. Thanks Pamela.
<unk> fronts, we're super excited I think we're excited first of all that.
You know that our team has been able to operate effectively in this crazy COVID-19 environment.
<unk> has been able to get sites up and going and have been able to working with our investigators recruit the study.
On our guidance, but actually over recruitment study I think that this speaks to the unmet medical need analogy is the number of patients out there the heterogeneous nature of patients and the need for treatment options. So we're looking forward to a major phase III readout later this year and then of course subsequent filing commercialized.
The Bill day.
In eligible syndrome.
Alright. Thanks.
To address.
Thank you Nick.
Question is from the line of aid us with Etsy when right ankle. Please go ahead.
Hi, everyone. Thanks for taking my questions can you hear me okay.
We can hear you loud and clear thank you.
Great Great. So a few questions from me.
Firstly.
I appreciate.
The minimum built a revenue guidance for the year and the extra color that you provided there.
Simon.
Wondering though if.
Just a question around that if we as we think about.
The cadence of flow through the remaining quarters of this year.
With $4 seven overall net sales this quarter versus seven.
In 2021.
Just wondering if.
As you know worked through and destock to normal levels.
Is next quarter looking Oh.
We're above that 7 million level.
And then I have a couple of follow ups.
Hi, Ed This is Simon.
Yeah. The reality is is Q1 was clearly the lowest quarter.
Because of the fact that it will reporting that sort of draw down in inventory. So go.
Going forward when it's more on a demand basis, obviously, what you would expect to see quarter by quarter and I think a good proxy is the patients who are currently on Bill day and generating rapidly you are continuing to build so the way I would think about the remaining three quarters is each quarter.
It should be building on the next quarter in terms of demand.
So the answer is yes, you would expect Q2 to be higher than Q1, just by definition of the way the patient to building over time and I would just remind you add this pamela stated.
We have a dozen pricing and reimbursement submission.
In Europe underway, we have 110 patients that are on drug that.
Or potential rollovers, so unlike what we've experienced thus far which has been relatively linear growth, we're going to have spikes of growth right sure going to be step changes and so as Pam outlined that one example, right of eight patients in that country that will flip over we have other countries like that as well.
So as we think about the year assignment is as said we're going to see that base continues to grow we are going to add new patients in the U S and Germany and then once you layer in some nice European countries, but theyre not going to come in in a linear way theyre going to be step cheap.
Right, Okay fair enough.
In addition.
You know just thinking through this.
Restocking issue as you've noted worked through already by the end of March.
<unk>.
Just thinking are there any other headwinds to sales growth that we should be aware of or could come up.
And then.
As I work through the model or wondering if you could share what the average gross to net adjustment is so far in the launch thank you.
Wanted to speak about gross to net side of that and I'll just address it.
Sure.
In terms of gross to net add obviously, we don't report it in our financials, because we report net revenue, but what I can say is as you would kind of expect in the U S.
Biggest driver is.
Six of patients between commercial insured page patients Medicaid patients.
Medicaid patients tapper sort of mandatory I think it's 23% discount commercial payers tend to be obviously less than that.
So that drives the overall mix.
All of them that are comprehensive of say, but it's sort of the EBITDA range of less for commercial payers.
Three odd percent.
Medicaid patients.
And Ed to your question, we see lots of additional opportunities to drive revenue going forward. So there are no additional headwinds other than what we've experienced since the beginning of launch.
Okay.
Yeah.
Great. Thanks again.
Thank you Ed.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Ron Cooper for closing remarks.
Thank you operator, and thank you all for attending today's conference call.
I'm proud of our organization to build need to deliver and execute as planned and thank each and every one of our employees for their commitment drive and innovation.
Keep you updated as we continue to advance albarino sufficient to provide hope to families of patients with liver disease and the entire Liberty community and thank you all for your continued support.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Yes.
Some windows.
Yes, I know.