Albireo Pharma, Inc. (ALBO) on Q1 2021 Results - Earnings Call Transcript

Operator: Good day and welcome to the Alboreto Pharma First Quarter 2021 Earnings Conference Call. At this time, I would like to turn the conference over to Mr. Paul. Please go ahead, sir. Paul Bavier: Thank you, operator and good morning everyone. Thank you for joining today's call. This morning, Alboreto issued a press release highlighting its recent business accomplishments and reporting its financial results for the first quarter ended March 31st 2021. 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 bold looking statements regarding the company's plans and expectations. These statements are being made under the private securities litigation Reform Act of 1995. Ron Cooper: Thank you, Paul. And thank you everyone for joining us this morning, Rob rails q1 2021 results and business update. With me today are Simon Harford, our Chief Financial Officer; Dr. Pat horn, our Chief Medical Officer; and Pamela Stephenson, our Chief Commercial Officer; things for today our commercial readiness and corporate growth. At the start of the year, we laid out a plan of how we will expand to a global organization to reach the large 100,000 pediatric cola static patient opportunity around the world and realize our aspiration to exceed $1 billion in the second half of the decade. To deliver on the desperation, we must build a strong global commercial organization to successfully launch build a load of exhibits in defects. Expand beyond people into other rare pediatric conditions and progress our pipeline in adult post static and viral liver diseases. What I'll do is I'll take you through the progress and achievements as we continue to deliver on our objectives and make plans in support of our ambitions. In the short term, our priorities remain. Number one, bring build a motivate Tibet over the line with product approvals in the U.S. and Europe with the issuance of a priority review voucher and a fast start and approved markets. Number two, focus on the global opportunity in cholestatic liver disease progressing our market leading global commercialization approach in the top 25 markets to reach the 100,000 patients with rare cholestatic liver disease. Three continue to enroll patients in our two gold standard global pivotal phase three studies in biliary atresia mold, and algae Ll syndrome, assert a number for advanced a 3907 through phase one, and interface to move a 2342 into the clinic and characterize our other novel bioacid modulators. Commercial residence, starting with our commercialization strategy and launch readiness, with priority with a Friday review and a producer date of July 20 in the U.S., and accelerate assessment in Europe, we've engaged in a good dialogue with regulatory authorities and anticipated in approval and launched in the second half of the year. Simon Harford: Thank you, Ron. Let me quickly summarize our financial results for Q1 2021. Revenues were two million for the first quarter of this year compared to one and a half million for the first quarter of 2020. The higher revenue was due to the estimated royalty revenue received from EA pharma for Olympics to that for the treatment of chronic constipation. The royalty revenue as always is passed on to healthcare royalty partners. R&D expenses were 19 point 9 million for the first quarter of 2021 compared to 16 point 1 million for the first quarter of last year. The higher expenses were principally due to personnel expenses as we continue to increase our headcount and program activities. The increase in program activities was primarily due to build a for the regulatory submission in p fic. And the additional indications for biliary atresia and allergen syndrome as we continue to drive our development programs. In addition, we increased spending for a free 907. As the drug progress is in phase one, these increased expenses were partially offset by the fact that we are no longer developing Ella because of that, and due to lower spend in preclinical programs. Ron Cooper: Super. Thank you, Simon. He started the year strong and marching toward the potential launch of Bilbo while progressing our pipeline proving our ability to deliver against guidance. We need to bring Billy over the line in the U.S. and Europe with the issuance of primary voucher to fast start in the approved markets. That are recap our top priorities. Number one, we're focused on the global cholestatic liver disease opportunities in the top 25 markets starting with P pick regulatory approvals, patient access and commercial distributed the distribution agreements. Do we will continue to enroll patients in Are to global phase three studies that are atresia now jail syndrome, as well as expand beyond pefect. Three, R&D will advance with a three nine no seven phase one under way while moving at 340 in the clinic and characterize our other novel biologic modulators. Overall, our global commercial strategy is solid with buildbase robust value proposition, our high level of readiness and our action to expand beyond p 50. To other diseases. In the coming months, we look forward to now the approval to build a in both the U.S. and Europe in updating you on our launch efforts. So, more to come on that. Thank you, everyone, for joining us. And we're pleased on the call now for Q&A. Operator over to you. Operator: And we'll take our first question from Eun K. Yang with Jeffries. Please go ahead. Eun Yang: Thank you, so much for questions. So, I think for Pete's sake in the past, you've mentioned that about, 500 to 700 addressable patients in the U.S. Most of them have been identified. So, in the U.S., the question is, what would be the kind of gating factors to reach the patients and get them on the block? And second question is on the European pricing side. So, in the U.S., EU, your commercial day, you talked about pricing range, but in EU I just say Germany would have the highest pricing, but overall, what do you think a pricing band would be? Pamela Stephenson: Thank you. Hi, to answer your question, you asked first, around the gating factors in the U.S. with the estimated pefect prevalence, you had mentioned that we shared our commercial day, the 500 to 700 addressable patients. In the U.S., the gating factors to reach this market potential are twofold, one is ensuring that patients have access to therapy. And what we're doing there is with the payers and showing that they are educated around pefect. And secondly, with Alba rail assist our customized Patient Support Program, which will help individual patients navigate through reimbursement. And so to answer your questions, those we will be working as quickly as possible. And we know that payers it takes it takes time to move through that process right through the through the reimbursement process for each individual payer. So, we'll be moving quickly, to ensure me they are addressing that gating factor. On your second question around European pricing, we've done a lot of work. And as in Europe, the reimbursement process, including Germany, is dependent on your ability to show the value of the product and be able to demonstrate efficacy through your clinical data, especially robust clinical data. And as we look across Europe, we're confident in in the in the pricing band that other rare disease analogs have been able to secure art. So, it's, if you look across these analogues, it's quite well within the range, typically, we see a list prices that are within 20% to 30%, of what you're going to see in the U.S. and that, that's the, that's the analogs that we're looking at. So, just closing, we're excited, we're ready to go. And both in Europe and in the U.S. Thank you. Ron Cooper: Thanks for the question. Just to add, Pamela said, probably the biggest issues for uptake is access and as Hamlin said, we're working actively here in the U.S., but also right around the world with our submissions. So, what we would like to do as quickly as possible is get to the 20 estimated between 20 320 800 available patients, right? So, that's where our focus is, but as Pamela says, is access here in the U.S. and access Europe as well. Eun Yang: Thanks for the questions you. Operator: Will take our next question from the Ritu Baral with Cowen and Company, please go ahead. Ritu Baral: Good morning, guys. Thanks for taking the questions. And I'm going to beg your forgiveness as a as a jaded analyst who has been dealing with the FDA requests. Given your upcoming produce a date in July, has there Have there been any new questions or submissions to the agency submitted that you could drive a three month extension of the putting for like we have, like we've seen all around. And then right now, as far as we know, without disclosing anything you can our labeling discussions plan to start on a relatively timely basis per usual schedules. Ron Cooper: Thanks for the questions I'm sure that that's been a challenge for you on multiple fronts. Appreciate I can't really get into the specifics as our depth on our dialogue with the FDA. Suffice to say that the pefect has high unmet medical need, there's no approved drug, our data and the epic one and Pesic two studies, so great advocacy and great tolerability. And thus far, I think we've enjoyed a good dialogue with the agency. They've been engaged in and timely, so we feel pretty confident about our July 20 Paducah date and the subsequent launch for Bill Bay in the U.S. Ritu Baral: Got it. Thanks for thanks for addressing that. And then I guess as you think about your hires, as you mentioned, algorithm assist seems to be hired up in your field forces in place. Can you talk about what can you just reiterate sort of the headcount in both of those, and then who are the hires that you have made in in those positions? What's their experience? Where are they from? And do they have preexisting relationships with pediatric hematologist or those specialist centers? Pamela Stephenson: Thanks for the question, Ritu, and I'll let Pamela talk about a little bit of the background. But in terms of numbers, what we said is we typically have about 10 representatives in the U.S., in addition to the dozen representatives, trigger therapeutics as a partner we haven't really given the details in terms of the care coordinators, but suffice to say the care coordinators, there'll be enough individuals there to deal with any patients all the prescriptions to help those patients navigate through the process of getting access to build and when maybe you can talk a little bit about the background of our teams. Yes, so on our sales team, we've had the good fortune of just being able to recruit and attract type, really high caliber, experienced sales professionals who have been working in detail, and I'd say there's two different things we're looking for that we've been able to achieve. The first is experience in hepatology spades, so, to your point, they know ologists have great experience, really understand and have existing relationships. And then the second would be the rare disease. So, being able to understand how in an environment, we're going into sort of the targeted 60 centers, understanding and knowing how to put up sell through the entire center. And so those two attributes, I would say are the most important things. And we've been successful in being able to have those attributes on our team. And then, as Ron mentioned, that bolstered by our partnership with true VR, because they have those existing relationships as well. And they're very experienced. And then the final thing is recency of experience. So, we're taking people right out of the field right now who've been selling through the COVID environment. And so they have the virtual selling skills. So, that's, that's the makeup of our sales team. And then on the care coordinator side, again, we are we have hired care coordinators who have been doing this their entire career they have been working from the highly experienced companies that have their own in house patient support programs, who are who are very skilled at speaking with patients and families. As well as understanding how to navigate the complex reimbursement environment in the U.S. So, really pleased and excited by the caliber of people we've been able to, to attract care coordinators who have had rare disease, that sort of rare disease. So, we're on his retargeted Rare Disease companies. Ritu Baral: Yes, super. And sorry, last question that I want to speak sleep. Again, any last allowances for the COVID roll off period that you're going to be launching into? We've heard from other companies that patient doctor interactions have been down across a number of disease states, and just wondering how much of that is applicable for pediatric prostatic diseases. And do you see any trends in that sort of patient clinician interaction? Ron Cooper: That's fine the first half we find that in this serious rare diseases like this, that the interactions with the between the patients and the physicians has remained quite strong, either through in person visits and or virtual visits. So, we don't anticipate an impact in terms of patients being able to see their providers primarily because of the severity of this disease. Got it? Thanks for Thanks for letting me sleep that one and put the rest. Ritu Baral: Thanks, for you too. Operator: And we'll take our next question from Liana Moussatos with Wedbush Securities, Inc. Please go ahead. Liana Moussatos: Thank you for taking my questions, and congratulations on your project progress. For the label, are there any, do you expect a broad label? Or are there any bogeys that that could happen for likely? Pamela Stephenson: Well, Liana, as you can appreciate it, I really can't comment on it directly on our regulatory interactions. Suffice to say that we as we've submitted all five modules, both to the FDA and the AMA, we submitted the peptic tastic data, which was what hit both primary endpoints and showed good tolerability, we also submitted the best pick to open label data as well as interim cut. And within that, we have had to pick one, two and three patients. So, they have all the information or an active dialogue with them. And we're looking forward to sharing with you more details as we get past the due for date of July 20. Liana Moussatos: Thank you. Operator: Thanks. And we'll take the next question from Brian Skorney With Robert W. Baird & Co, please go ahead. Brian Skorney: Hey, good morning, everyone. Thank you for taking my question. I just want to kind of give a little help and trying to think through the near term guidance on build a sales and just kind of how to think about it a little bit on a medium term. And so for the near term, how do we kind of think about that in terms of sort of new, entirely new starts for stations on the expanded access program? And can you discuss it all the size of the expanded access program sample right now and the sort of timeline we can think about, we're converting those from the program to commercial form. And then on the medium term side of things, when you think about that 600 patient available U.S. market? How many patients are there really ideal and under care? And if I look at something like the launch of a kaleidoscope, a product, this we had 90% of the patients on treatment about a year end? There's a bit of an outlier, but what do we how should we be thinking about feedback in that context and the differences you see in the markets that would sort of anticipate sort of a longer road to higher penetration? Ron Cooper: Thanks. Alright, great. Brian, let me try to characterize how we see how we see this year going, I think the way to think about this year is there's still a lot of variables that aren't quite clear yet. And so that's why we've given guidance for sales in the low single digit millions. So, what's not that we don't know exactly the date of approval and remember that that's approval for both the U.S., right, the producer date of July 20, but also Europe. And remember, what we're trying to do is access the 2300 to 2800 patients. From a global perspective that are available that are, and these are people that are eligible for treatment right now. So, what so one of the things that we have to add, first of all, we have to have the Pro Bowl so both the U.S. and Europe are pretty important and we're still working on the our European approval, so we're we don't always Acting, that's going to cripple you feel confident that's going to occur the second half of the year. The second thing is the sequencing of access, right? As Pamela has spoken about. We've got a we've been in dialogue with insurance companies in Europe in the U.S., but it does take time for them to process as well, we're in an active dialogue with payers within Europe as well. And that will take some time as well. So, we've got to work our way through that. So, think of this year as the year of where we sort of sort through the access part of these resorts to the regulatory process. And then your question about EAP patients and open label patients. Part of that is if people are in different countries, right? So, think about those patients as sort of correlating with that time of when we get approval. And, and we get access. So, as we think about this year, the patients that we were talking about here, the 2300 to 2800 not available patients, these are patients that are available for therapy, they are in various stages of early diagnosis or waiting for treatment, and we'll try and access them as quickly as possible, get access for them, get them into Alberto assists, put nice white gloves around them and take care of them and help them grow into being stronger and healthier children. Brian Skorney: Thanks, Ron Operator: And take our next question from Ed Arce with Wainright & Co. Please go ahead. Ed Arce: Hey, thanks for taking my questions. And congrats on the continued progress across the pipeline. Couple questions from me. Probably first for Pamela. We're just a little over two months away from the Paducah date now. And of course, you've mentioned that your reps are on boarded and doing the appropriate outreach, as well as the team at revere as well as your abuela assist. Seems like everything is in place. I'm wondering what is the focus between now and produce as you know the last few weeks in terms of know what still may need to get done for that day one readiness. Ron Cooper: Thanks for the question. Yes, we're two months away from the Paducah date, but we're ready to go now. So, as mentioned we hired we've trained for onboarding, onboarding. And so we are ready to go from an operational perspective, from a from a team perspective. And the one outstanding item is the final FDA approved label. So, between now and then as we get more insight on that label, we keep training and training and training, in fine tuning. But we're ready to go. There's really nothing left. We could launch tomorrow, we've gone through all of the critical tasks that needed to get done. So yes, from a commercial perspective, we're ready to go. We've just been waiting for the approval. Pamela Stephenson: Yes, I think that is the team has been practicing, right and practicing what it looks like you how we generate prescriptions, how we deliver drug, right, and now we made sure that throughout the roses, that the patients have a really great experience. So, there's just some things you just can't do until you get the final label, right. It's supposed to be the final label, we'll be moving very quickly. Of course. So, just one follow-up for me on these commercial partnerships, as you mentioned, he just recently signed your second and third, I know there's 25 markets that you're focused on globally. wondering if you could help us understand which of those are most likely amenable to partnerships, either on a regional basis or a country by country basis as you continue to march forward. High emphasis Simon set so as we've looked at regional partnerships, our approach has really been to say let's focus first and foremost on those major markets, where we will be able to launch relatively quickly following U.S. and European anticipated approval. So, if you look at top 10 market overall, several countries come in to the top here. And outside of Europe in the U.S., and those include Turkey, Saudi Arabia, and part parts of the Gulf region, as well as Brazil, in Latin America. So, we've really tried to focus on some of those key top markets, because they typically allow for fairly early access in and of themselves as markets as well as being a good opportunity. And as we discussed our commercial day. Yes, more than 50% of revenue, typically in similar analogues in rare diseases, comes from markets outside of the U.S., then we have for the longer term, we also have sort of looking at the opportunity to China. As we said, on commercial day, that's not in our top 25 markets currently of what we sort of projected going forward. That that is a good opportunity, particularly for biliary atresia, longer term. But to go to a market such as DAC, we would want to make sure that we have the right milestones in place and that we are getting appropriate value from an opportunity such as that but near term focus, Turkey, Saudi, to have the top 10 markets. And then Brazil's another important one. Ed Arce: That's very helpful, laying out the timeline. I appreciate it. Congrats again. Thank you. Operator: We'll take our next question from Tim Lugo with William Blair. Please go ahead. Tim Lugo: Thanks for the question. And I know, everyone's probably excited about another regulatory question. But just following up on some of the, I guess, anxiety from the, from the analyst community. Last year, the agency had difficulty in kind of executing manufacturing inspections because of the pandemic. But hopefully, that's not as much of an issue now, with the U.S. opening back up, can you update us on your manufacturing status? And how confident you are from a regulatory perspective? Ron Cooper: I know there's anxiety out there. But to be honest, I'm not anxious. Right. I think we feel that with confidence, right. From a manufacturing perspective. As I said, we submitted the full module, the full CMC module. In our phase three study, we use the plan commercial formulation, in that we spoke to we had a good dialogue with the FDA a couple years ago when we're executing on that plan. And that seems to be on track. So, we feel pretty confident, again, about our approval around our producer date of July 20. And as Pamela said, we're ready to go from all fronts. That's, that's great to hear them, let's kind of look forward into 2022, when hopefully, well less anxious given the patient dynamics in the U.S., with your partner to severe, but also what should be a European approval knock on wood hopefully by then. Do you expect a significant portion of revenues in 2022 could be coming from Europe and maybe even a larger portion, then what would be we will be seeing from the U.S. Now again, added, as I said in my earlier response, there are there are just some there, there are multiple unknowns in this case, right, so the exact date of our U.S. approval, we think it's going to be the date of the 20th of July, we're in good dialogue with Europe, so the exact date of that, and then also, how these regional partnerships kick in, and I'll access coincidence. So, some of those ones we're going to, we'll see. But frankly, we're focused on the global opportunity for fraud. Excellent. We're building a pediatric cholestatic liver disease drug, we want to get at the end around 100,000 individuals around the world and when it comes to pefect, that range of 2300 to two to 2800 page guide individuals, we're going to try and get to them as quickly as possible. And given that there are more patients outside the U.S. It's quite possible that we'll be seeing a higher than anticipated contribution from Europe, but it's really too early to say. Tim Lugo: Alright, great. Thank you for all the color Thanks. Operator: Let's take our next question from Yasmeen Rahimi, Piper Sandler & Co., please go ahead. Yasmeen Rahimi: Hi, Pam. Thank you so much for sharing all the updates a couple questions for you. Maybe the first one would be, Can you shed light into what to expect to continuing to enroll and have patience on? Have you been able to collect event rates, event rates, meaning coming off of confrontation with or late events? Is there a potential that regulators could ask for those types of data points, and it may even require a separate study to be conducted. So, I would love to hear your thoughts on that. And then maybe the second one is on the PRV. So, what is in your view, the likelihood of being granted the PRV at the approval, and then I have a follow up. Pamela Stephenson: This is Pamela, and I can take the one on the pet stick to study. So, that is our ongoing studies looking at the long-term safety and efficacy of Olympic sebagian patients with all types of pieces. And there, we are really collecting those long term outcomes, we're looking at time to biliary diversion surgery time for liver transplant, whether patients can cover surgery with either from the biliary diversion surgery or liver transplant patient. So, that is that is an ongoing study as continuing as planned. The plans for that study are well known to both of the regulatory agency in terms of post marketing commitment, certainly those will be part of the discussion with ongoing regulatory agency. And then I guess to add to that, yes, we did answer your question about the PRB. And when we are in dialogue with, with both regulatory agencies, the FDA and the AMA, we have confirmed at that time that pennsic. One, on its own, was all that we needed to do with submission perspective. For approval, much like the single study of gold, the single study of assert is needed for approval. So, additional data that we yay for pethick to give additional color, the interview cards. And so those are the types of things we'll continue to talk through in terms of post approval commitment, as Pat indicated. Now, as it relates to the PRV, we'd announced a couple of years ago that, in fact, the FDA has deemed Oda vixa, that as being PRV eligible, so we are PRV. Eligible. And I think the way you need to think about that is that approval, pretty much yet equals PRV being granted, right? So, we have to fulfill the requirements, the PRV, which is doing the TED fix, study and submitting the drug, there are some administrative pieces that that that have to occur do on approval, but we feel pretty confident that the PRV will be issued on approval. And as those are quite valuable. We sit in a very good cash position. So, we have the luxury of I mean, we need the PRV so that we plan to monetize them, or monetize at the right time. Yasmeen Rahimi: Thank you, Ron. And think your path to color. Maybe a follow up, Germany may be one of the largest market opportunity there. And also, you can go in with no pricing, being able to get market access faster. Can you help us understand sort of how many patients have been identified in Germany, just to kind of help us understand more granularly on some of the larger opportunities, like how many patients that are placed in Germany alone, that could be available for therapy. Ron Cooper: Yes, thanks for that question. Yes, we were pretty excited about Germany because as you said, it's in areas a fair amount of people then immigrate into Germany with the disease. So, I think we has pretty good, pretty good level of disease, we really are keeping leader support. And, and as you said, it has good pricing at this time. We're not giving country by country detail in terms in terms of numbers, but suffice to say that in terms of patients that are available for treatment X us we anticipate somewhere between 17 120 100 patients, so pretty significant opportunity there as well. Kill on putting in my question. Yasmeen Rahimi: Thank you Operator: And we'll take our next question from Joseph stringer with Needham & Company, LLC. Please go ahead. Joey Stringer: Everyone. Good morning, thanks for taking our question. Just one on the kind of like competitive side of things to quickly be first to market in us for Pacific and in, in Europe things go well, likely first to market but to be a competitor coming to market in the first part of 2022. In Europe, and just wanted to get your thoughts on how you see that affecting your current commercial and discussions with around reimbursement of things in Europe? And maybe, would there be any sort of read through to, to your -- us, and launch discussions? Thank you. Ron Cooper: Yes, I think what we're really excited about Joe, is that we're taking a leadership approach with build a, with all diseases right around the globe, right. So, when you think about that, the Pethick study, the bold study, the asserts study, these are all gold standard, or double blind, placebo controlled studies, right. And so they should help us gain approval if the latter two are successful in multiple regions around the world, right. So, we feel really good about our leadership approach. But that's not only about regulatory approval that also is from an access perspective, right. And so that will actually that is level one class one type information. Now, we're going to supplement that with the Napa Natural History database, and the burden of care study, and we put together a pretty compelling access package. And when you consider in the in the in the Pethick data, we have both typic, one, two and three patients. So, there's a lot of really interesting, interesting data there. So, as a result, we believe that we will have a leadership approach for both regulatory approvals and access across multiple indications for building and building buildings and what we will believe we believe will be a billion dollar product the second part of the decade. Pamela Stephenson: Thanks for the question. Ron Cooper: Thanks, Joey. Operator: Appears there are no further questions. At this time. I'd like to turn the conference back to CEO Ron Cooper for any additional or closing remarks. Ron Cooper: Great, thanks operator. Well, first of all, thank you all for it for attending today's conference call. You as we continue to ready for approval, we'll update you on our regulatory filings and launch planning as well as the advancement of our clinical programs. As part of our growth strategy, really appreciate your attention today. We have a lot of exciting year through milestones ahead of us and our strong financial position will enable us to continue to advance operators mission, which is to provide hope to families of patients with liver disease and the entire liver community. Thanks again to all of you for your continued support. Have a great day. Operator: This concludes today’s call. Thank you for your participation. You may now disconnect.
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Albireo Pharma’s Bylvay EU Launch Begins in Germany

Albireo Pharma, Inc. (NASDAQ:ALBO), an emerging pharmaceutical company focusing on the development and commercialization of drugs for the treatment of liver and gastrointestinal diseases including Bylvay (odevixibat) for the treatment of progressive familial intrahepatic cholestasis (PFIC), announced that Bylvay is now available to patients in Germany, making it the first drug on the European market for PFIC.

With Germany having the largest EU market potential of the ~1,900 patients living with PFIC outside of the U.S., the launch of Bylvay in Germany is a major opportunity for the company to establish a following and build up revenue before expanding into additional European countries.

Analysts at Wedbush increased their price target on the company’s shares to $84 from $82, maintaining their outperform rating. While their current net revenue estimates of $5.8 million and $30.9 million for 2021 and 2022, respectively account for typical initial launch challenges, they anticipate net revenues reaching over $713 million in 2028 following a growth inflection point in 2023 as a result of likely broad payer coverage.

Albireo Pharma’s Bylvay EU Launch Begins in Germany

Albireo Pharma, Inc. (NASDAQ:ALBO), an emerging pharmaceutical company focusing on the development and commercialization of drugs for the treatment of liver and gastrointestinal diseases including Bylvay (odevixibat) for the treatment of progressive familial intrahepatic cholestasis (PFIC), announced that Bylvay is now available to patients in Germany, making it the first drug on the European market for PFIC.

With Germany having the largest EU market potential of the ~1,900 patients living with PFIC outside of the U.S., the launch of Bylvay in Germany is a major opportunity for the company to establish a following and build up revenue before expanding into additional European countries.

Analysts at Wedbush increased their price target on the company’s shares to $84 from $82, maintaining their outperform rating. While their current net revenue estimates of $5.8 million and $30.9 million for 2021 and 2022, respectively account for typical initial launch challenges, they anticipate net revenues reaching over $713 million in 2028 following a growth inflection point in 2023 as a result of likely broad payer coverage.