Albireo Pharma, Inc.

Good afternoon and welcome to the ArborAO Pharma First 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 would now turn the call over to your host, Aans Wisdom, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good afternoon, everyone. Thank you for joining today's call. This afternoon, Albareo 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.albareopharma.com. Before proceeding, we would like to note that management's 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 important 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 investor section of our website at www.alboreofarma.com or on the SEC's website. Any forward-looking statements represent our views as of today, May 16, 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, Albarrio's 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 Stevenson, our Chief Commercial Officer, and Dr. Jan Motsen, Chief Scientific Officer and Head of R&D. Before we begin, please note that slides related to our key metrics and revenue for Build Bay 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, I am very 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 BILVE launch, have delivered on all of our clinical development milestones, and are in a strong cash position, $216.7 million on our balance sheet. There are three important drivers of growth for Alvareo. One, the global launch of BILVE in PFIC. Two, expanding the use of BILVE in additional diseases through PFIC. phase three gold standard studies, algal syndrome, and biliary atresia. Three, the rapidly emerging early stage products in our pipeline for adult cholestatic 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 Bilve in PPIC. Pamela?

Thanks, Ron. I'm really pleased with the progress that we have made with Bilvay. The launch is going as planned and we are delivering on our global strategy to reach the estimated 2,500 PFIC patients worldwide who are available for treatment in this rare disease category. Global response from healthcare providers and payers and the impact on patients continues to be positive. To illustrate the demand growth, I will take you through the five key metrics we continue to measure for launch, how we are setting ourselves up for the European launches and pull-through, and key 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, with $2.8 million in the U.S. and 1.9 million in international. While reported revenue was impacted by a drawdown of inventory in the U.S. from the prior quarter, underlying demand continued to grow. So our performance to date represents solid penetration in the U.S. market and growing international sales due to the outstanding performance in Germany, soon to be followed by the bill they launch in the U.K. later this month. We attribute this demand growth to increased physician experience with Bill Bay and an excellent payer response, as we are seeing a high percentage of dispenses. In fact, in Q1, greater than 85% of U.S. insured patients were 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 payers, including Anthem, Aetna, Cigna, and UnitedHealthcare. In addition, we have access 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'd expect in rare disease. These are the patients who are in the trial or patients waiting for a drug option or patients recently diagnosed and quickly prescribed bilbay. 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 times a year. So reach and frequency with the HCPs will be important as we ensure bilve is top of mind as the first drug option versus surgery, and it's top of mind for the HCPs when treating the burdening pruritus symptoms. Another key insight you see across rare diseases is that patient capture is not a straight line, with some months higher than others based on either seasonality, timing of patient visits, or journey to diagnosis and treatment. What is important is that we continually capture new patients, and each patient represents a growth annuity, given that BILVE is a weight-based chronic therapy. Moving to the number of patients on BILVE, or patients who have been approved and reimbursed, we have had 87 reimbursed patient initiations since launch, up from 53 at the end of 2021, a 64% increase quarter over quarter. We believe that our in-house patient support program, Alvareo Assist, is a significant advantage in the speed of gaining access and keeping a lower than expected fill time, as well as a high refill rate, which are currently above 90%. This supports the strong patient annuity with discontinuation rates being low, all pointing to BuildA having the excellent efficacy that we expected. The next metric is the number of potential rollover patients on BILVE. Rollover patients are the number of patients who are currently on drugs 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 in PEDFIC2 open label extension trials or due to being on free drug 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 PEDVIC rollover patients and 16 free drug patients. When we achieve reimbursement, we expect these 18 patients will immediately become revenue generating. While the number of banked patients is 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 a country in the EU gains reimbursement, as all of the bank's patients immediately become revenue generating. So you can see why we are 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 Bay and have prescribed Bill 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 PFIC, the availability of BILVE as the first drug option, and the impact BILVE can have on the treatment of pruritus and PFIC. We are pleased with the launch momentum and the outlook for 2022 as we continue to increase Bill Day prescriptions, building in an annuity of patients. In the U.S., we are focused on maximizing our broad label, which allows physicians to prescribe Bill Day for all PFIC types with all types of pruritus. As we get further into launch, we continue to drive a second wave by focusing on HCPs who have seemingly stable patients. In Europe, We are actively pursuing pricing and reimbursement in the remaining European countries, concurrently adding new patients in our free drug bridging program, and we will convert banked patients to commercial drug as we gain reimbursement. Overall, we are penetrating the market successfully by generating multiple prescriptions by prescriber. I'm really happy with our reach to date 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, before jumping into the other value drivers, I know Pamela has gone into a number of important metrics, but the most important metric is the number of patients that are on drug. And please, the number is increasing, and I'm confident the sales will follow as we gain reimbursement and inventory patterns settle. The second driver of value for Alvareo is our focus on expanding into other pediatric cholestatic liver diseases. We were thrilled to announce the completion of enrollment in the ASSERT study, our phase three pivotal trial in allogel syndrome with Bilbao. The ASSERT 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 a 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 three assert readout and expect top-line results by the end of the year. In addition, we opened an expanded access program in the U.S. and Europe for allogel syndrome. We already have our first patients enrolled, and the response has been outstanding. As with PFIC, we expect to have a significant number of patients roll over into commercial drug from the ASSERT study and from the Early Access Program by the time we achieve approval and launch bilve for allogeal syndrome. Also on track is our gold standard BOLD study, which is the only phase three double-blind randomized placebo-controlled study in biliary atresia that both the FDA and EMA have confirmed would be sufficient for approval. Bellary atresia is the largest pediatric holostatic liver disease with more patients worldwide than PFIC and allogeal combined. FOLD is the study of 200 patients randomized to bilve or placebo and studied over a two-year time frame. 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 PFIC, Algeo, and Bellary Atresia, we project approximately 3,000 to 4,000 pieces to reach and exceed a billion dollars in sales and are confident 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, A3907 and A2342. A3907 is the world's first and only high systemic bioavailable ASBT inhibitor in clinical development. And in our preclinical models, A3907 clearly demonstrates that it is different from the commercially available IVAT inhibitors. Additionally, in a phase one study, A3907 demonstrated excellent systemic exposure and good tolerabilities. and we anticipate starting a Phase II study in an adult liver disease by the end of the year. We also have A2342, which is the world's first and only oral NTCP inhibitor. Development of A2342 is tracking to the profile of the commercially available daily sub-Q NTC inhibitor, with similar potency against NTCP and target engagement, but without the burden of daily injections. Beyond that, we've completed rodent tox studies with no findings or concerns and excellent safety margins for the expected therapeutic dose. We plan to advance A2342 into a phase one study by the end of the year with the intent of proving it to be a unique component of a combination treatment for hepatitis B or D. We have the capability and plans to develop both A3907 and A2342 for rare diseases. At the same time, both assets have garnered strategic interest with the potential to develop the products in more or larger diseases. So overall, we're continuing to deliver against commitments associated with our three value drivers, both 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. Simon?

Thanks, Ron. Let me summarize our financial results for Q1 2022. Bilvey 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 Bilvey 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, inventory levels, however, reflect standard levels for the anticipated growth going forward. As Pamela mentioned, we had 64% quarter-on-quarter growth in the initiation of revenue-generating patients on commercial drug. to Q1, and this growth trajectory gives us great confidence. As a result, for the full year 2022, we anticipate build a reported net product revenue of a minimum of $30 million aligned to the PFIC market opportunity. We'll 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 0.2 million. The increase relates to higher estimated royalty revenue from EA Pharma for for the treatment of chronic constipation, which, as you know, is passed on to healthcare royalty partners. Cost of product revenue was 0.2 million in Q1, Following approval of Bill Day, certain manufacturing and quality headcount costs are now included in cost of product revenue. There were no material costs as materials related to current products sold were expensed prior to approval. Given that 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 headcount and program activities. The increase in program activities related to ongoing preclinical trials, as well as the phase one study of A3907, and were partially offset by a decrease in BILVE PFIC 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 headcount and commercialization activities related to Bilvey, including our sales force and support for global expansion efforts. Net loss for the quarter of 2022 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 the 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 2024 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 would be at this time from a commercialization and clinical standpoint. Every week, we're capturing 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 Bay a billion-dollar product, the key for us is to take Build Bay from a PFIC drug to a leading pediatric cholestatic liver disease drug. We will accomplish this by building our patient base quarter by quarter and plan to expand to allogel syndrome and biliary atresia on the back of our phase three studies. We only need 3,000 to 4,000 patients of the estimated 100,000 pediatric cholestatic patients around the world to reach our aspiration of a billion dollars by the end of the decade. We're also pleased to have our method of use patent term extension granted in 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 A3907 into a Phase II proof of concept study and 82342 into humans for the first time by the end of the year. With this strong portfolio and financial position, we have tremendous opportunity and will continue to stay focused on our growth drivers. It's all very exciting for Alvareo as a company with a first-in-class and first-to-market product for near-term and mid-term growth. We thank everybody for joining us and are now pleased to open the call for Q&A. Operator?

Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before placing the star keys. One moment, please, while we poll for questions. Our first question is from the line of Ritu Baral with Cohen & Co. Please go ahead.

Good afternoon, guys. Thanks for taking the questions. Can you comment on current inventory levels and whether you think those will bop around a little bit in the forward quarters? And also, what are your next estimated or predicted EU launches beyond the UK that could trigger some of these patient boluses? And then I have a very quick follow-up question from a client.

Okay. Thank you, Rita. Why don't, Simon, you take the inventory question, and then Pamela, you can talk about the new 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, and we're through that period. So what you see in reported revenue going forward should reflect pretty accurately demand.

And to reach you high, on your question regarding the European launches, as you know, we have reimbursement in Germany and in the U.K., and we have submitted reimbursement dossiers in 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. We'll continue to focus on the big five, EU and beyond, and we'll update you as we go once we gain pricing and reimbursement.

Fair enough. And then just quickly moving to Alageel, I have somebody asking about how you think pricing will work in Alageel. Just Maybe a general thoughts on net price of your average patient, compare and contrast to PfeC. I understand you can't give exact numbers, but just on a relative basis would be helpful for the models. Thank you.

Thanks, Reto. Yeah, probably a little bit early for us. I think, first off, we're super excited to have the ACERT study over and rolled and reading out this year to have a major phase three 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 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 Yoon Yang with Jefferies. Please go ahead.

Thank you. So in terms of PIVX, there are 600 eligible patients in the U.S. And given that the Vixivir is the only approved drug, why isn't it capturing eligible patients more quickly? And when you say 600 eligible patients, are you Those eligible patients are not eligible for liver transplant at the same time having some good liver function.

So your line chopped off a little bit, Ritu, but I think you had some questions around uptake and sort of how we see the available patients. The way that we estimate the market, we start with prevalence, and prevalence are patients that are alive, right, and have the disease. And to get to available patients, the available market patients, what we do is we take the patients that have had surgery and are medically ineligible, and that gets us to the 2,500 patients globally. And I think that's what we're really focused in. We believe this is a global opportunity, both in Europe in particular and in the U.S. And I think we're super excited that 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 have been waiting. Now our work is going to the next group of patients that there's not as much urgency to treat, but they are suboptimally managed. And we're actually finding that as we get to those patients, we're 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 allergy syndrome pricing. So, you know, in PFIG, you are starting with a 40-microgram-per-kilogram dose and going off to 120, where the dosage is 120-microgram-per-kilogram in the trial. So this is a weight-based dosing, and also, you know, the dosage is different. So do you think potentially the pricing in allergy syndrome could be three times higher than PFIC?

Yeah, again, Yoon, as I said to Ritu, I think we really have to wait until 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 PFIC from 40 to 120, and we finished with the agency in the U.S. with a 40, 80, and 120 dosage, right? And so we have to get the data first. We have to talk to the regulators to determine what the dosage would be. And then from there, we will look at price. But we're pretty confident we can manage all of those things.

Thank you. Thank you.

Thank you.

Next question is from Our next question is from the line of Brian Scorney with Baird. Please go ahead.

Hey, good afternoon, guys. Thanks for taking my question. I think with the inventory dynamics in 4Q and whatever drawdown there was in 1Q, there's 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 to just get 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 US contribution to that 30 million versus ex-US? What else needs to happen besides sort of Germany and UK being online to achieve that 30 million number? Thanks.

So, Brian, this is Simon. I think in terms of the situation, we're now 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 our reported revenue should be fairly closely aligned with our demand revenue. So, we decided to put out there a full year guidance of a minimum of $30 million, which is very much in our minds aligned to the PFIC opportunity going forward. to help you as you think through how we might progress during the year. I think as you think about the sort of the building blocks to that 30 million, a simple way maybe to take it is, yeah, if you recognize that in Q1 we essentially only had revenue from patients in the U.S. and Germany, yeah, 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 about reimbursement in those European countries. The question, though, and the variable here is timing of those, because a few months here or there can actually make quite a big difference, which is why we're just indicating at a minimum of 30 million at this point in time. And then the other thing I think you should be sort of feeling pretty good about in helping you sort of develop your models going forward is that 64% quarter-on-quarter patient increase in people who are already on Bilvey and sort of generating revenue is continuing to grow quite nicely as we project forward and roll forward into the rest of the year. So hopefully that gives a little bit of color overall on a global basis.

Yes, thank you. Thanks, Brian.

Thank you. Our next question is from the line of Tim Lugo with William Blair. Please go ahead.

Hey, guys.

This is Lugo. Thanks for taking the questions. Go ahead, Lachlan. Yeah, can you guys hear me? Now we can.

Now we can, yeah. Okay, great. Sorry about that. I was just wondering, on the topic of epidemiology, wondering if what you're seeing in the field and hearing from physicians is aligning with sort of your expectations heading into the launch or if you're kind of identifying any new patients. And then a second question, clarification. Pam, I think my line was cutting in and out of it, but it sounded like you said about 55% of prescriptions are coming from key centres. Is that correct? And if so, where are the others coming from? Are they prescribers that are not being called on or are they just a prescriber not at a key centre?

Yeah, I'll go to Ron here. So first of all, we look at our FE estimates, what we're seeing in the field pretty much is the same, right? So we reiterate, we think there's 2,500 PFIC patients around the world. And then it was 75% of our prescriptions are coming from key centers. So we're really pleased about that because our business model is about targeted areas, not spending as much resource. And so we're pleased that from the biggest centers, we're getting most of the prescriptions. The rest are coming from some of the smaller centers.

Thank you.

Our next question is from the line of Andrea with Redbush Securities. Please go ahead.

Good afternoon. Thanks for taking our questions. So for PSEC, looking at the early launch dynamics, What 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 AllerGeal, enrollment has been as expected. Can you elaborate as to what is driving patients to the study when there is an already approved drug on the market? Thanks.

So Pamela, why don't you address Andreas' questions on free drug and discontinuation, and I'll speak about the Allogel study.

Right. So as we mentioned, 85% of dispenses or patients in Q1 that were insured, we got reimbursed drugs for those patients. And so there are a few patients who are on free drugs, but we are actively working to transition those patients on to paid for drugs. That's sort of 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 discontinuations, which has been in line with what you would expect for a rare disease launch. And the other dynamic here is that is a fluid number of, you know, we have some patients who are coming off therapy while others are deciding to come back on And really, none of these discontinuations have been for efficacy. They are, you know, there's not really a trend. There's some sort of humanistic or family beliefs that sometimes come into play, but, you know, those are one-offs. And overall, you know, we're very pleased with the number of patients who are continuing on therapy with Bill Day.

Great, great. Thanks, Pamela. And, you know, on the LGL front, you know, we're super excited, right? I think we're excited, first of all, that... you know, that our team has been able to operate effectively in this crazy COVID environment and has been able to get sites up and going and have been able to, working with our investigators, recruit the study on time, on our guidance, but actually over-recruit the study. I think that just speaks to the unmet medical need analogy of 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 and commercialization to build an ineligible syndrome.

All right. Thanks. Thanks, Andreas.

Thank you. Our next question is from the line of Ed Ars with HC, Wayne, Bright & Co. Please go ahead.

Hi, everyone. Thanks for taking my questions. Can you hear me okay?

We can hear you loud and clear, Ed. Thank you.

Great. Great, Ron. So a few questions from me. Firstly, I appreciate the minimum bill of revenues guidance for the year and the extra color that you provided there, Simon. Wondering, though, if Just a question around that. As we think about the cadence of flow through the remaining quarters of this year, with 4.7 overall net sales this quarter versus 7 in 2021, just wondering if, as you now work through and destock to normal levels, is next quarter looking... at or above that $7 million level.

And then I have a couple follow-ups.

Hi, Ed, this is Simon. Yeah, the reality is Q1 was clearly the lowest quarter because of the fact that we were reporting that sort of drawdown in inventory. So 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 Build A and generating revenue are continuing to build. So the way I would think about the remaining three quarters is each quarter 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 patients are building over time.

And I would just remind you, as Pamela stated, we have a dozen pricing and reimbursement submissions in Europe underway. We have 110 patients that are on drug that are potential rollovers. So unlike what we've experienced thus far, which has been relatively linear growth, we are going to have spikes of growth, right, which are going to be step changes. And so, as Pamela outlined, that one example, right, of 18 patients in that country, that will flip over. We have other countries like that as well. So, as we think about the year, Simon has said, you know, we're going to see that base continue to grow. We are going to add new patients in the U.S. and Germany, and then we're going to layer in some nice European countries, but they're not going to come in in a linear way.

They're going to be step cheap.

Right. Okay. Fair enough.

In addition, you know, just thinking through this pre-stocking issue, as you noted, worked through already by the end of March. 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, wondering if you could share what the average gross-to-net adjustment is so far in the launch. Thank you.

Why don't you speak about gross-to-net, Simon, and I'll just address sales growth.

Yeah, sure. In terms of gross to net, Ed, 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., the biggest driver is mix of patients between commercial insurance paid patients and Medicaid patients. Those Medicaid patients have a sort of mandatory, I think it's 23%, Discount commercial payers tend to be, obviously, less than that overall. So that drives the overall mix. More than that, I can't really sort of say, but it's sort of in that range of less for commercial payers, 23-odd percent for Medicaid patients.

Yeah, and to add to your question, you know, we see lots of additional opportunities to drive revenue going forward. So there are no additional headwinds other than what we've experienced at the beginning of launch.

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's ability to deliver and execute as planned, and thank each and every one of our employees for their commitment, drive, and innovation. We'll keep you updated as we continue to advance Alvareo's mission to provide hope to families of patients with liver disease and the entire liver 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.