Albireo neuer big player im Pharma-Milliardenmarkt

bin mal wieder klein eingestiegen in erwartung guter zahlen heute... fingers crossed!

https://ir.albireopharma.com/news-releases/...lts-and-business-update

"Die Laufzeit des Bylvay-Patents für die Anwendungsmethode wurde in einer Reihe von Ländern, darunter Italien, verlängert, was eine Exklusivität bis 2036 in Europa bedeutet."

Kann den Satz jemand deuten? Sind damit Konkurrenzprodukte (Mirum) ausgeschlossen oder ist deren andere Zusammensetzung eine andere "Anwendungsmethode"? Ich bin leider kein Jurist. :D Das sind so ein Geschwurbel, was ich leider nicht verstehe.

Ansonsten dürfte es wohl zu wenig sein, als erwartet. Oder?

Jahresprognose ist mit 30 Millionen derart niedrig, dass sie sie eigentlich nur übertroffen werden kann.
Im Grunde kann es ja jetzt beinahe nur jedes Quartal mehr an Umsatz werden. Da weitere Länder und Patienten dazu kommen. Aber sonderlich großartig war das Q1 leider nicht.

5 bis 10% Minus heute, oder übersehe ich irgendwas positives? Ja, die Steigerung der Patientenanzahl war gut. Dürfte aber wohl nicht beachtet werden.

"Albireo Pharma, Inc. (ALBO) CEO Ron Cooper on Q1 2022 Results - Earnings Call Transcript
May 16, 2022 10:59 PM ETAlbireo Pharma, Inc. (ALBO)

Albireo Pharma, Inc. (NASDAQ:ALBO) Q1 2022 Earnings Conference Call May 16, 2022 4:30 PM ET

Company Participants

Hans Vitzthum - Managing Director-LifeSci Advisors, LLC

Ron Cooper - President & Chief Executive Officer

Pamela Stephenson - Chief Commercial Officer

Simon Harford - Chief Financial Officer

Conference Call Participants

Ritu Baral - Cowen

Eun Yang - Jefferies

Brian Skorney - Baird

Andreas Argyrides - Wedbush Securities

Ed Arce - H.C. Wainwright

Operator

Good afternoon, and welcome to the Albireo 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. [Operator Instructions] Please note that this conference is being recorded.

I would now turn the call over to your host, Hans Vitzthum, Managing Director of LifeSci Advisors. Thank you. You may begin.

Hans Vitzthum

Thank you, operator, and good afternoon, everyone. Thank you for joining today's call. This afternoon, Albireo 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.albireopharma.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 Investors section of our website at www.albireopharma.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, Albireo's President and Chief Executive Officer. Ron?

Ron Cooper

Thank you, Hans, and thank you, everybody, for joining us. With me today are Simon Harford, our Chief Financial Officer; Pamela Stephenson, our Chief Commercial Officer; and Dr. Jan Mattsson, Chief Scientific Officer and Head of R&D.

Before we begin, please note that slides related to our key metrics and revenue for Bylvay 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 Bylvay launch have delivered on all of our clinical development milestones and are in a strong cash position of $216.7 million on our balance sheet. There are three important drivers of growth for Albireo. One, the global launch of Bylvay in PFIC; two, expanding the use of Bylvay in additional diseases through Phase III gold standard studies, Alagille 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 Bylvay in PFIC. Pamela?

Pamela Stephenson

Thanks, Ron. I'm really pleased with the progress that we have made with Bylvay. 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 health care 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 Bylvay launch in the U.K. later this month.

We attribute this demand growth to increase physician experience with Bylvay 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 fail, which for most patients is less than 30 days. This is due to strong coverage across all plants and positive coverage decisions from all of the U.S. major payers, including Anthem, Aetna, Cigna and United Healthcare.

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 8 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 Bylvay.

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. So reach and frequency with the HCPs will be important as we ensure Bylvay 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 Bylvay is a weight-based chronic therapy.

Moving to the number of patients on Bylvay, 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, Albireo Assist is a significant advantage in the speed of gaining access and keeping a lower-than-expected fall 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 Bylvay having the excellent efficacy that we expected.

The next metric is the number of potential rollover patients on Bylvay. Rollover patients are 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 reimburse commercial drugs following their completion in PEDFIC 2 open-label extension trial 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 2 PEDFIC 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 banked patients immediately become revenue-generating. So you can see why we are excited about achieving reimbursement in these important global markets. Flat launch metric is unique prescribers in the U.S. We have 57 unique prescribers who believe in Bylvay and have prescribed Bylvay. 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 PFIC as the first drug -- sorry, the availability of Bylvay as the first drug option and the impact Bylvay 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 Bylvay prescriptions, building an annuity of patients. In the U.S., we are focused on maximizing our broad label, which allows physicians to prescribe Bylvay 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 bank to patients to commercial drug as we gain reimbursement. Overall, we are penetrating the market successfully by generating multiple prescriptions by prescribers. 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.

Ron Cooper

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. I'm pleased the number is increasing, and I'm confident that sales will follow as we gain reimbursement in the inventory patterns ASCERT. The second driver of value for Albireo is our focus on expanding into other pediatric cholestatic liver diseases. We were thrilled to announce the completion of enrollment in the ASCERT study, our Phase 3 pivotal trial in Alagille syndrome with Bylvay.

The ASCERT 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 3 ASCERT 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 Alagille 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 ASCERT study and from the early access program by the time we achieve approval and launch Bylvay for Alagille syndrome.

Also on track is our gold standard BOLD study, which is the only Phase 3 double-blind, randomized, placebo-controlled study in Biliary Atresia that both the FDA and EMA have confirmed would be sufficient for approval. Biliary Atresia is the largest pediatric cholestatic liver disease with more patients worldwide than PFIC analogy combined. BOLD is a study of 200 patients randomized to build or placebo and studied over a 2-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, Alagille and Biliary Atresia, we project approximately 3,000 pieces to 4,000 pieces to reach and exceed $1 billion in sales and 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 IBAT inhibitors.

Additionally, in a Phase 1 study, A3907 demonstrates excellent systemic exposure and good tolerability. And we anticipate starting a Phase 2 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 subcu NTCP inhibitor with similar potency NTCP and target engagement, but without the burden of daily injections.

Beyond that, we've completed rodent tox studies with no finds of concerns and excellent NTCP margins for the expected therapeutic dose. We plan to advance A2342 into a Phase 1 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 capabilities and plans to develop both A3907 and A2342 for rare diseases. At the same time, both the 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 side 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?

Simon Harford

Thanks, Ron. Let me summarize our financial results for Q1 2022. Bylvay 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 Bylvay 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, reflects 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 for Q1. And this growth trajectory gives us great confidence. As a result, for the full year 2022, we anticipate builder 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 Elobixibat for the treatment of chronic constipation, which as you know, is passed on to health care royalty partners.

Cost of product revenue was $0.2 million in Q1, following approval of Bylvay a 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 Bylvay 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 1 study of A3907 and were partially offset by a decrease in Bylvay 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 Bylvay, 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 31, 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.

Ron Cooper

Thanks, Simon. We are aware 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 $1 billion product, the key for us to stability 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 Alagille syndrome and Biliary Atresia on the back of our Phase 3 studies.

We only need 3,000 patients to 4,000 patients of the estimated 100,000 pediatric cholestatic patients around the world to reach our aspiration of $1 billion by the end of the decade. We're also pleased by 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 2 proof-of-concept study in A2342 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'll continue to stay focused on our growth drivers. It's all very exciting for Albireo as a company with a first-in-class first-to-market product for near-term and midterm growth.

We thank everybody for joining us and are now pleased to open the call for Q&A. Operator?

Question-and-Answer Session

Operator

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from the line of Ritu Baral with Cowen & Co. Please go ahead.

Ritu Baral

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

Ron Cooper

Okay. Thank you, Ritu. Why don't Simon, you take the inventory question and Pamela, you can talk about the new launches.

Simon Harford

Sure. Hi, Ritu. Suffice it to say that in Q1, there was some destocking of the inventory that we have 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, you 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?

Pamela Stephenson

And Ritu, hi. 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 5 EU and beyond, and we'll update you as we go once we gain pricing and reimbursement.

Ritu Baral

Fair enough. And then just quickly moving to Alagille. Has somebody asking about how you think pricing will work in Alagille? Just maybe a general thought on net price of your average patient compares and contrast to PFIC. I understand you can't give exact numbers, but just on a relative basis, it would be helpful for the models. Thank you.

Ron Cooper

Thanks, Ritu. Yes, I'm probably a little bit early for us. I think, first off, we're super excited to have the ASCERT study overenrolled and reading out this year to have a major Phase 3 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. So that will drive where we are from a price perspective, but we think we feel pretty confident that we'll be in a quarter or that's a competitive price.

Ritu Baral

Got it. Thank you.

Operator

Thank you. Our next question is from the line of Eun Yang with Jefferies. Please go ahead.

Eun Yang

Thank you. So in terms of PFIC, there are 600 eligible patients in the U.S. And given that odevixibat the only approved the drug, why isn't it capturing else patients more quickly. And when you say 600 eligible patients, are you -- those literal patients who are not liver transplant at the same time having some good liver function [indiscernible].

Ron Cooper

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. So the way that we estimate the market, we start with prevalence and prevalence are patients that are live, 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 where we're really focused in, we believe it’s 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 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, our 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're suburbs to be manage. And we actually find that as we get to those patients, we're getting really great results. So we're delighted with the performance thus far.

Eun Yang

Okay. And then I have a follow-up question on the prior question on the Alagille syndrome in on pricing. So in PEDFIC, you are starting with the 40 microgram or kilogram dose and going up to 120. What is the age the dosage 120 microgram or kilogram in the trial. So this is a way based those things. And also the post is different. So do you think of potentially the pricing Alagille syndrome, could it be 3x higher than PFIC?

Ron Cooper

Yes. Again, 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.

Eun Yang

Thank you.

Operator

Thank you. Our next question is from the line of Brian Skorney with Baird. Please go ahead."

The question now 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 build 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.

Brian Skorney

Yes, thank you.

Ron Cooper

Thank you.

Operator

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

Unidentified Analyst

Hey, guys. This is Lockton [ph] on for Tim. Thanks for taking the questions.

Ron Cooper

Go ahead, Lockton.

Unidentified Analyst

Yes. Can you guys hear me?

Ron Cooper

Now we can.

Simon Harford

Now we can, yes.

Unidentified Analyst

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 clarification. But, I think my line is cutting in and out of it, but it sounded like you said about 55% of prescriptions are coming from key centers. Is that correct? And if so, where are the others coming from are the prescribers that are not being called on or are they just a prescriber, not at a key center.

Ron Cooper

Hey, it's Ron here. So first of all, we look at our estimates, what we're see in the field pretty much as to say, 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.

Unidentified Analyst

Got it. Thanks.

Ron Cooper

Thanks, Lockton.

Operator

Thank you. Next question is from the line of Andreas Argyrides with Wedbush Securities. Please go ahead.

Andreas Argyrides

Hello, good afternoon. Thanks for taking my questions. So for PFIC, 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 Alagille, 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.

Ron Cooper

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

Pamela Stephenson

Right. So as we mentioned, 85% of expenses or patients in Q1 that were insured were we got reimbursed drug for those patients. And so there are a few patients who are on 3 drugs, but we are actively working to transition those patients onto paid for drug. 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. We have some patients who are coming off therapy, while others are deciding to come back on. And really, these -- none of these discontinuations have been for efficacy. They are -- there's not really a trend. There's some sort of humanistic or family beliefs that sometimes come into play. But those are one-offs. And overall, we're very pleased with the number of patients who are continuing on therapy with Bylvay.

Ron Cooper

Great. Thanks, Pamela. on the Alagille front, we're super excited, right? I think we're excited, first of all, 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 time on our guidance, but actually over recruit the study. I think that this speaks to the unmet medical need analogy, 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 3 readout later this year. And then, of course, subsequent filing and commercialization of bile in allege syndrome.

Andreas Argyrides

Got it, thanks.

Ron Cooper

Thanks, Andreas.

Operator

Thank you. Our next question is from the line of Ed Arce with H.C. Wainwright & Co. Please go ahead.

Ed Arce

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

Ron Cooper

We can hear you louder and clear, Ed, thank you.

Ed Arce

Great, Ron. So a few questions from me. Firstly, I appreciate the minimum Bylvay revenue guidance for the year and the extra color that you provided there.

Ron Cooper

Simon? Wondering, though, if -- just a question around that as we think about the cadence to flow through the remaining quarters of this year, with 4.7% overall net sales this quarter versus 7% in 2021 just wondering as if, as you've now work through and destocked to normal levels, is next quarter looking at or above that $7 million level? And then I have a couple of follow-ups.

Simon Harford

Ed, this is Simon. Yes, the reality is that 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 building 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.

Ron Cooper

And I would just remind you, as Pamela stated we have a dozen pricing and reimbursement position 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, the 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, as said, 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 where you layer in some nice European countries, but they're not going to come in in a linear way. They're going to be step too.

Ed Arce

Right. Okay. Fair enough. In addition, just thinking through this restocking issue, as you've 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, I wondering if you could share what the average gross to net adjustment is so far in the launch. Thank you.

Ron Cooper

Why don't you speak about gross to net side and then I'll just address that…

Simon Harford

Yes, 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.

Ron Cooper

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

Ed Arce

Got it. Thanks, again.

Ron Cooper

Thank you, Ed.

Operator

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.

Ron Cooper

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 plan and thank each and every one of our employees for their commitment, try and innovation to keep updated as we continue to advance Albireo's vision to provide hope to families of patients with liver disease and the entire liver community. And thank you all for your continued support.

Operator

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation."

wurden per gestern nicht Zahlen veröffentlicht? Weiß jemand mehr?  

Lieber Gott lass es Hirn regnen

bitte beim nächsten wieder posten, ich hasse es, mich durch den ganzen Kram durchklicken zu müssen und lese das lieber hier.

Hier mein Senf:

1.: Zur Frage wegen den Patenten - wenn der Patentschutz abgelaufen ist, kommen die Ratiopharms etc. an und können den Wirkstoff ebenfalls verkaufen. Ab dann geht der Preis entsprechend rapide in den Keller, weil ab da Preiskampf stattfindet.

2.: Das führt dazu, dass man diese Milliarde nur in der Zeit von 2030 bis 2036 sehen wird. Wenn man bis dahin nichts nachsetzt, versteht sich.

3.: Die großen Firmen haben dieses Dilemma auch, daher sind die ständig auf der Jagd nach neuen Patenten -  Buyouts.

4.: Die Preisfrage lautet also in gewissen Rahmen auch: könnte ein Bigplayer die Vermarktung schneller hinbekommen als Albireo? Das wäre nämlich die Synergie. Und es klingt so, als wäre das möglich. Andererseits ist man bei BA erst 2025 fertig, setzt also 5 Jahre bis zum Peaksale ein.

5.: Wenn PFIC auch 5 Jahre bis zum Peak braucht und der bei 250Mio liegt, von denen wir dieses Jahr 30 schaffen, dann wäre die Reihe vermutlich ca. 30 - 70 - 120 - 180 - 250. Jedes Jahr 10 Mio neu dazu, das geht ja bezaubernd gut auf. Leider wird es anscheinend keine stärker exponentielle Steigung geben. Wobei man die Gewichtszunahme der Patienten eventuell noch stärker einrechnen müsste.

6.: Ich hoffe trotzdem mal  und es klang auch so - als wären die 30 Mio eher Kategorie "unvermeidbar mit deutlich Platz nach oben" als "könnte klappen, wenn es gut läuft".

7.: Das mit dem Inventory und den resultierenden mageren Verkäufen verstehe ich so, dass da noch Patienten Medikament aus den Trials in ihrem Bestand haben und daher noch nichts nachkaufen müssen, sehe ich das richtig?

8.: Es klingt bei Cooper ein bissl nach "wir bearbeiten die Zentren, der Rest ist zu aufwendig". Damit wäre ich nicht einverstanden. Die Preise sind hoch genug, dass man praktisch auf jeden Paienten einen eigenen Aussendienstler ansetzen könnte. Ich hoffe eher mal, dass Cooper meint, dass Patienten außerhalb der Zentren kaum diagnostiziert werden. Wenn die Patienten vom Dorf kommen und nicht im Zentrum leben können, wird der Hausarzt eingearbeitet und verschreibt das. So kommen dann die Prozente außerhalb der Zentren zustande.

Ich habe lange nicht mehr reingeschaut. Aber jetzt erst. Oh Gott was sind das denn für Prognosen. Die Zahlen sind abgrundtief schlecht. Wie wollen die in drei Jahren 1 Milliarde $ umsetzen?

Klar. Zahlen können immer besser sein.
Aber: Management hat die eigenen Aussicht getroffen!

Auch bin ich es leid zu sagen, dass second half of the decade nicht 2025 entspricht  

war auch eine andere (die lag eher bei 7 Mio). Aber wer das Transcript aufmerksam gelesen hat oder im Call war, der wird vermutlich feststellen, dass der Investment-Case hier nach wie vor voll intakt ist. Oder sieht das einer anders? Die 30 Mio für dieses Jahr sind sehr konservativ, nach meiner Einschätzung und so, wie sie erklärt wurden.
Das (bzw. mein) Problem ist halt, dass die eigene Erwartungshaltung zu bullish war, jedenfalls hinsichtlich die kurzfristigen Umsatzentwicklung. Man ist in der Marktdurchdingung nicht so schnell, wie ich das gedacht hatte.
Der Markt macht jetzt halt daraus, was er macht. Das Umfeld ist gerade gnadenlos, wenn die eigenen Prognosen nicht weit übertroffen werden. Wohl dem, der bislang noch nicht dabei ist und über Cash verfügt. Aber ob man es mit dem Spruch "der Kurs sagt immer die Wahrheit" oder aber "investiere, wenn das Blut in den Straßen fließt" hält, muss jeder selber wissen.

 

muss ich auch sagen: der hier so oft als unfähig hingestellte Konkurrent hat seinen launch bislang besser im Griff

Ende des Jahres aus - bzw. in 7 Monaten?
- Approval in ALGS?
- P2 in A3907 eingeleitet (ggfs. mit vorheriger Verpartnerung)?
- P1 in 2342 eingeleitet (ggfs mit vorheriger Verpartnerung)?
- in UK für 6 Monate Umsatz (on top zu den 30 Mio)?
- Umsatz andere EU Staaten anteilig on top zu den 30 Mio (110 rollover Patienten)?
..ich interpretiere die 30 Mio jedenfalls so, als dass sich diese bereits durch US + Germany einfahren lassen...diese Umsätze werden mit jedem Quartal exponentiell wachsen....

und gerade eine Market-Kap von 430 Mio. Auf dem Niveau gebe ich nix ab. Aber Albo muss in den kommenden earnings liefern. Sonst ändere ich hier meine Gewichtung

Sehe ich auch so. Erst wenn eine größere Anzahl an relevanten Ländern das Mittel zugelassen hat, sieht man doch überhaupt, was die Firma an Umsatz generiert! Die genannten Termine kommen ja tatsächlich noch und könnten positiv überraschen. Ich gedulde mich noch bis Ende des Jahres und gehe da von höheren Kursen aus.  

Gab es nicht Ende letzten Jahres die Nachricht das Cooper mit 3.5 Mo eingestiegen ist?

Is der blöd oder weiss der mehr? Völlig unverständlich.

BK

denkt halt langfr, also bis ende der Dekade und guckt nicht täglich auf den Kurs. hab ich ja schonmal gesagt, die hohe Insti Quote hier ist fluch und Segen zugleich. ein paar bauen ab und das Ding ist im Sinkflug. werden wir auch wieder in die andere Richtung erleben

sagt uns, der Unterschied zwischen 4,7 mio und zB 10 mio im ersten Quartal beträgt 150 mio marketkap.....ja ne, is klar....

Bin seit Biodelzeiten bei. Guck auch nich jeden Tag. So langsam nervt es.

Halt auch länger aus. Aber .....



BK

glaub mir. heute nen scotch. oder 2. BG

Ebenfalls positiv sind die 110 Roll-over Patienten, somit hat Albireo bereits 255 Patienten, die annualisiert etwa 80 Mio. (255*310k) einspielen können. (Ich rechne immer mit 310k, da sowohl Medicaid Patienten als auch internationale Preise mit Abschläge versehen werden müssen). Das heißt gelingt es Albireo weiterhin, so viele neue Patienten anzusprechen, geht die Tendenz definitiv in die richtige Richtung, auch wenn es eben lange dauert. Weitere europäische Länder werden dann zu genüge ja im 2H folgen, und die kommen alle noch on top.

Zudem wurde im Call erneuert von dem Potenzial, A3907 auch außerhalb von den rare disease Bereichen in adult cholestatic liver (NASH) einzusetzen, eventuell mit einem Partner. Und es wurde BestätigB We have the capabilities and plans to develop both A3907 and A2342 for rare diseases. At the same time, both the assets have garnered strategic interest with the potential to develop the products in more or larger diseases.stätigt, A2342 als kombinationstherapie einzusetzen:
We have the capabilities and plans to develop both A3907 and A2342 for rare diseases. At the same time, both the assets have garnered strategic interest with the potential to develop the products in more or larger diseases.

Also gerade bei der Marktkapitalisierung (22$*20Mio Aktien = 440 Mio) ist Albireo mit 220 Mio Cash.
Patent gibt Schutz gegenüber Generika, aber nicht gegenüber anderen, neu zugelassenen Wirkstoffen (wie beispielsweise Maralixibat)

Reimbursement, die Versicherer lassen die Leute verhungern.
Q2 geht dann richtig vorwärts, da wird das Reimbursement nachgeholt. Q3 ist dann etwas schwächer, weil Urlaubssaison. Und Q4 endet mit Weihnachten, in der letzten Woche passiert da auch in keinem Büro irgendwas.

Aber echt krass zu sehen, daß wegen 1 Million weniger Umsätze als gewünscht (nicht angesagt, nur herbeigesehnt) der Firmenwert um 100 Mio runterrauscht. Das entspricht dieser Million in 100 Quartalen, also 25 Jahren. Bis dahin ist man nicht nur längst bei einer Milliarde Umsatz (einpreisen bitte, wenn wir doch langfristig denken...) und setzt auf eine einzelne Mio einen großen,braunen Haufen - in 25 Jahren ist sogar schon der Patentschutz abgelaufen. Das ist total irre!

Die 30 Mio im Jahr klingen natürlich reichlich wenig, das sind ja nur 100 von den 650 Patienten in Amiland, um auf die Summe zu kommen. ROW mit Null. Es ist anscheinend wirklich zäh, zu den Docs durchzukommen. Ich bin allerdings auch noch gespannt, wie sich die Gewichtszunahme der Patienten auswirken wird. von 40 auf 80 ng macht praktisch aus einem Patienten zwei, bzw. bei den größeren von 80 auf 120 macht aus zwei Patienten drei. Da wir eh langfristig denken müssen (und Kinder teilweise erstaunliche Wachstumssprünge machen), wird sich das bis 2030 noch erheblich bemerkbar machen.

Zum Vergleich mit Mirum: Die haben die doppelte Summe eingenommen, allerdings in einer doppelt so großen Indikation. Deren Marktdurchdringung ist also sehr ähnlich.

und noch was: So wilde Preiskapriolen wegen Nichtigkeiten werden gerne als Indiz für einen BO gewertet. Albireo will es ja angeblich gerne alleine machen, andererseits sagt niemand nein, wenn die richtigen Scheine auf dem Tisch liegen und die Instis Cash sehen wollen.

wer die Geduld so lange (bis 2030) hat, könnte reichlich belohnt werden. Da ist dann PFIC womöglich Portokasse und BA und A3907 ein ganz anderes Zugpferd. Aber will ich mal ehrlich zu mir selber sein, es ist mit der Geduld nicht immer einfach an Tagen wie diesen, wo es richtig auf die Nüsse gibt.
Vielleicht hilft das:
https://www.youtube.com/watch?v=f0lPhT7vSVA

Auf Buy Out spekuliere ich nicht mehr. Aktuell ca. 250 Bios unter Cash (war jüngst ein entsprechend interessanter Artikel auf seeking alpha). Weshalb sollte es also ausgerechnet Albo treffen, so gut und günstig die Firma auch dasteht.....BP kann mit seinen Cash Beständen aktuell den ganzen Biotech Sektor kaufen, wenn sie wollten

Bis 2030? Hahahaha
Bis dahin sind vielleicht schon einige von uns tot