Ladies and gentlemen, thank you for standing by. Welcome to the second quarter 2026 Ascendis Pharma earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 1 1 on your telephone. You would then hear an automated message advising your hand is raised. We ask that you please limit to one question and return to the queue for additional questions. And to withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugure, Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and thank you, everyone, for joining our second quarter 2026 Financial Results Conference Call. I'm Chad Fugure, Vice President, Ambassador Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Chief Financial Officer, Sherrie Glass, Chief Business Officer, and Jay Wu, Executive Vice President and President, Ascendis U.S. Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. All statements made on this call, other than the statements of historical fact, are forward-looking statements. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of Skytropha, URBPath, and UBWell, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates and our expectation with respect to their continued progress and potential commercialization, our strategic plans, partnerships, and investments, Our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions, and our financial outlook and Vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place under reliance on these statements. We assume no obligation to update these statements if circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section of today's press release and the risk factors section for annual report on Form 20-F filed with the SEC on February 11, 2026. In addition, during this call, we will refer to certain non-IFRS financial measures These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure together with an explanation of why management believe these measures are useful to investors is included in today's press release. Transcon Growth Hormone or Transcon HGH is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency in addition to the treatment of pediatric growth hormone deficiency and in the EU has received MAA authorization for the European Commission for the treatment of pediatric growth hormone deficiency. Transcon PTH is approved in the US by the FDA for the treatment of hypoparathyroidism in adults and the European Commission in the United Kingdom's medicines and healthcare products Regulatory Agency have granted marketing authorization for Transcon PTH replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Transcon CMP is approved in the U.S. by the FDA to increase linear growth in pediatric patients two years of age and older with achondroplasia with open PPCs. Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I've just described, our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call report product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter 2026 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan.

Thanks, Chad. Good day, everyone. During the second quarter, achievement of important milestones and strong demand for our Transcom products continue to drive the transformation of Ascentis into a leading global biopharma company. The uniqueness of the Transcon technology platform, our strong development and global commercialization capability, and our values of vision are the fundamentals driving this transformation. We believe the same strength will continue to drive Ascendi's growth in the following years. Starting with the long-term durability of our highly differentiated approved protein and peptide based combination products, Skytofa, Neuropaths, and Neuowell. We believe these products will be the key driver of our growth story for the next 10 to 15 years to global commercialization, potential for label expansion, including combination and investment in patient support offerings. The continued expansion of the Transcon technology platform enables us to fulfill our plans by at least one IMD or similarly yearly, each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutic areas in addition to hypopara and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications. This is why we believe Ascendis is well positioned for self-sustained long-term growth. Let's begin with a more detailed look at UroPath. UroPath is the first and only approved treatment for adults with hypopara that addressed the underlying disease by replacing the missing endogenous PTAs throughout the body. Uptake of neuropaths has grown steadily since launch, both in the US and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure. Outside of the US, we see consistent new patient demand and continued expansion of global commercialization branches with full reimbursement. UiPath is now available commercially or through named patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid, broad, global launch of the rare disease product. In the US, new patient demand for UiPET in the second quarter has remained robust. Consist with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully We continue to be excited by the growth of UiPath in the U.S. and outside the U.S. and to see its continued strong lung performance. Data from our long-term Phase II and Phase III trials of UiPath Presented in the second quarter, Highlight by Europass is becoming a standard of care in post-surgery and all subsets of hyperparameters, including ultra-rare genetic causes like discharge, ADS1, and ADS2. Results show sustained response rate of 82% to 86% for for the multi-component endpoint with clinical benefit across multiple organ system, CNS, kidney, small intestine and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after five years of treatment. Pretty unique. In parallel, We are working to further advance our leadership in hyperfarm with additional clinical trials that include expanding the label to include the age from 12 to 18 years and in the U.S. higher doses for patients and developing a once weekly product for the patient that is on stable doses of UroPads. Turning now to UofL. We believe UofL is positioned to become the market leader therapy for acondalplasia. Rapid uptake of UofL is already transforming the U.S. market. Across the board, we see a highly favorable response among patients and physicians to UofL's differentiated profile. In the U.S., through June 30, We had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollment and more than 65% approved for reimbursement in the U.S. through the end of July. Really a unique launch. The rapid uptake is by patient of all kinds of background, those switching, returning to medical therapy, or starting therapy for air contemplation for the first time. We believe UofL is really growing the US market, which is exactly the pattern you would love to see when a highly differentiated product is introduced into air where there still exists a high unmet medical need. Long-term data for the now-complete people's approach trial show durable and consistent improvement in growth, leg bone, body proportionality, along with a generally well-tolerated safety profile, compared to placebo, underscoring why the community is quickly adapting to the overall. In the US, in the EU, a regulatory system for UofL is expected in the fourth quarter of 2026. We are also making UofL available in select international markets through early access programs using the US FDA approval. Longer term, we are pursuing expansion opportunities for Transcon-CMP to ongoing and planned trials. These include Ongoing activities such as infants 0 to less than 2 years of age and we recently announced completion of this target enrollment faster than expected. Adults with achondroplasia, children with hyperchondroplasia and still continue with graphic expansions. Turning now to combination therapy with Transcon-CMP and Transcon-Glutamol. The biological rationale for this combination treatment is clear and extremely well founded on science. Transcon-CMP is removing the limitation caused by the overactive FDR3 pathway, so Transcon-Globin can provide a strong complementary effect. In addition, it has been observed Thank you. Thank you. Thank you. Sustained Transformative Analyzed Growth Velocity, and ATA's HIGH score, including improvement in body proportionality. Based on this result, we believe this unique combination of once-weekly transcon-based therapies will transform the treatment of acondoplasia and other indications over time. Our recent week 78 COAST TRIED data. show sustained efficacy over 78 weeks with no compromises to safety and controllability. This points to the potential for this novel combination to establish a new treatment standard in naturalization. The Phase III combination trial in children with ankyloplasia will begin enrolling later this year. Turning to Skytropha. The once-weekly growth hormone treatment built on the mode of action of unmodified somatopoeia. With indications for pediatric and adult growth hormone deficiency, we continue to be the number one long-acting growth hormone by brand value in the US. We are extremely proud that Skytober recently achieved more than 20,000 unique enrollments This illustrates the strength of our capabilities from supply chain, commercial infrastructure, and on market support to benefit such a large number of rare disease patients. And we are working to make Transcon-Glutamone available to more patients through label and geographic expansions. To support label expansion going that described in our account of pleasure program, We are conducting the phase 3 basket trial investigating Transcon growth hormone in ISS, SDA and Turner syndrome. As an integrated part of our global growth disorder strategy, we expect to launch Transcon growth hormone in the same countries where we also expect to launch Transcon CMP. Turning now to our partnership. In metabolic disorders and obesity, our once-monthly Transcon semi-glutide program with Norvo Nordisk continues to advance. In ophthalmology, our partner Onconis recently initiated a first-in-human clinical trial of the anti-VDF treatment built on the Transcon technology in patients with BED-AMD. In closing, by always putting patients first, Ascendis has delivered three highly differentiated leading Transcon-based products, UroPath, Urovel, and Skytropa. We are on track to achieve our Vision 2030 objective of being a leading global pharma, building on a strong foundation for the future. With that, I will turn the call over to Scott to review our financial results and some additional comments.

Thanks so much, Jan. and good afternoon everyone. I will touch on some key points surrounding our second quarter financial results. For further details, please refer to our form 6K filed today. Total product revenue was 315 million Euro, more than doubling year over year. Total revenue for Q2 2026 was 339 million Euro, which included non-product collaboration revenue of 24 million euro, which further included a 17 million euro milestone related to Transcon CNP. YourVitPath revenue was 252 million euro in Q2, reflecting consistent new patient demand in the US and continued growth outside of the US, reaching blockbuster status on a run rate basis in the second year of launch in the US. Gaitropa contributed €55 million in Q2, which reflects increased demand in the U.S. and includes product sales to a collaboration partner. UVWell was commercially launched in the U.S. during Q2 and generated €8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking. Continuing to expenses, R&D expenses in Q2 were 76 million Euro, up from 59 million Euro in Q1, reflecting continued investment in our pipeline and innovation. Recall Q1 included a favorable 11 million Euro reversal of prior period write-downs of Transcon C&P pre-launch inventories. SG&A expenses were 173 million Euro in Q2, compared to 145 million Euro in Q1, Reflecting additional investments in the commercial launches of Yorvapath and Yuviawell to accelerate growth for the long term. Operating profit of 220 million euro in Q2 included 158 million euro of other operating income related to the sale of the PRV. Non-IFRS operating profit was 92 million euro and non-IFRS operating margin was 27%. Refer to our press release for details. For Q2 26, net profit was 207 million euro and non-IFRS net profit was 61 million euro. We ended Q2 2026 with 812 million euro in cash and cash equivalents which includes the use of 56 million euro in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs. Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and 1.4 billion euro of equity. Turning to our outlook for the rest of 2026, for your Vipath, we expect Growth and performance consistent with prior quarters. For Skytropa, we expect relatively stable revenue in the U.S. For UVWell, we are encouraged by the early demand trends. We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the U.S., reflecting the large unmet medical need and the highly differentiated profile of UVWell. Our Q2 performance reinforces our belief that we can achieve €5 billion in revenues in 2030. With our existing portfolio and our Transcon technology as a strong foundation, we believe we are well positioned to grow revenue to more than €10 billion in the next decades while developing and launching new Transcon products with blockbuster potential. We expect significant operating leverage Thank you. As a reminder to ask a question,

Please press star 11 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 11 again. We ask you please limit to one question and return to the queue for additional questions. And our first question is going to come from Jessica Phi with JP Morgan. Your line's open.

Hey, guys. Good morning. Thanks for taking my question. On that outlook for at least $500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale, and I was just wondering if you're able to kind of update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded, but curious if anything more you can add there. And then on that comment that UVWell seems to be expanding the market, Is it possible to estimate how much of these patient enrollments are coming from market expansion? Thank you.

Thanks, Jess, for the questions. And the other happy person besides me, Scott. So Scott got the opportunity to be the first one answering questions. So please, Scott.

Yeah, with respect to our cash flow guidance, Just to be clear, greater than 500 million. I heard you say 100, so greater than 500 million. And at this time, we don't want to bound the upper side because we're initial into the launch of JubaWell. And that's Euro, by the way, 500 million Euro, Jan likes to point out.

And just related to the question, and it comes back to what we Some communicated last time we had this call that we don't have really the insight in exactly the distribution of where the patients are coming from. And our general feelings and how we see it is that with such a strong demand, We have a really strong belief that it's not only coming from switches, it's most also coming from either patient that had stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of UofL that they want to start therapy. And I think this is where we have this strong belief that we see an expansion of the market. Thank you.

Thank you. And the next question is going to come from Tazine Ahmad with Bank of America. Your line's open.

Hey, good morning. Thanks for taking my question. So, Jan, I wanted to get your thoughts about the IT challenge on UVL. We know obviously what the blue sky scenario is. For Ascendus and, you know, most of the scenarios look positive, but can you just maybe walk us through what the potential outcomes are? This is for a patent that expires, obviously, in 2030. And so between now and then, can you just tell us what could happen and what the potential for, you know, payments that Ascendus would need to make in the worst case scenario could be?

Thanks, Saseen, for the question. And it's basically a question that is addressing the ongoing legal, I would call it, battle between Ascentis and Biomarine. And let me just come back to some facts. The fact is that this patent that we discussed got complete invalid in Europe. So we never really come to a discussion if we were infringing and anything like that. So when we see the situation outside US, we got the patent invalid immediately to the patent system in Europe. In the US, we never managed to come into the patent system because BioMarine selected to go to the ITC case which are a system which we can easily say traditionally never have really dealt with a lot of cases that dealing with branded pharmaceuticals. In the ITC case there will be a first opinion from a single judge and he will come with an opinion here in August and then there will be a more, next time will be in December, there will be an opinion from the ITC and then later on there will be a potential confirmation of the ITC decision two to three months after to a presidential order. So you can see we are not getting any clarification in August in one way or the other way. Even if it's possible for one company and negative for the other one, it's not really any kind of decision where it's going to be ending. And after the first initial opinion from a single judge, because the ITC case will be I cannot remember how many judges that will be part of that decision. There is a huge opportunity to provide what we call interest for this product. And when we see the public interest, meaning the element of how this product opportunities are really being Serving an unmet medical need in the U.S. market with this rapid, rapid uptake of patients, it's really, really clear that it is a huge public interest to keep that. And just recall, I cannot remember one single case in the U.S. where a branded product that provides a benefit to U.S. patients has been denied. But you can see we're just in a case where it's only in the U.S., it has been cleared, ex-U.S., And so whatever it happened, it will not have any material impact on Ascendi's pathway. I can guarantee that. It's some kind of, people take it up as a life and death for Ascendi's. This is a total not taken into the perspective what it means for Ascendi's. And out from that, I see it's not really as a material element for our destiny to be a leading biopharma and hit the 5 billion in 2030.

Thank you. And our next question will come from Gavin Clark Gartner with Evercore. Your line's open.

Hey, guys. Thanks for taking the question. I actually just wanted to ask on the earlier pipeline. You noted in your prepared remarks that TransCon platform can fuel one IND for an NCE annually. I guess there hasn't been one yet this year. Should we expect one in the near term? And what exactly are the go-forward plans for the earlier pipeline? Thank you.

It was because I've in some way felt that the two product opportunities that we have developed to our partnership built on the Transcon technology will still consider at the NCE, the one that now we clinic with Iconis and the other one we expect to go into the clinic now with Nova Nordisk. It's still some way being developed to the Transcon technology funnel. And Kevin, perhaps I shouldn't have done that, but I still believe, I feel some kind of little bit ownership on these two product opportunities. At least we have major upside in both of them. So from that perspective, I still consider the potential that we have this year, two new chemical entity being inserted into clinical trials. And I think Kennett and his team and anyone else They are working very hard on that there will be at least one of these new chemical entities coming into every year now. And I'm really proud about that. But it's also addressing the sustainability of Ascentis, independent of going out and buying something no one else wants to have. And I think this is where we really feel extremely pleasant by the situation, by being a fundamental Company that building on a strong, strong technology platform then provide both sustainability for ourselves, but also a continued flow of potential partner licensing. Great. Thank you.

Thank you. And the next question will come from Joran Werber with TD Coen. Your line's open.

Great, thanks so much. Questioning UV, do you expect that there is some seasonality in terms of new patient starts in the summer as kind of kids are going on vacation? We're getting a lot of questions on sort of the 60 patient start forms kind of in April and now you're sort of at 220. It sounds like there's like 50 per month now. Is that sort of sustainable from now on? And then it sounds like you're planning, you think you could be the number one brand by the end of the year. Biomarin, we think, has about 750 patients on drug, you think, in the US. Are you kind of referring to getting to a higher number than that by, let's say, late February? Thank you.

Thanks for the question. I actually don't think Ascendis have really made some clear forward-looking statement related to how we see your well-being accelerating and expanding the market in a quantitative manner. I don't think we have come with any kind of indication related to that. I have no doubt it will do it, but it's not the same thing that we're going to quantify it currently. I think after basic only four months in the market, I feel really not prepared to come with clear guidance to it before we have more quarters really into our, you can say, energy vehicle system where we basically can look on trends and other things like that. One person that really can give you a good feedback now we talk about the U.S. market is Jay and he's extremely enthusiastic about what he's seeing and you can give the latest weight what you see how the market will develop.

Thanks, Jan. As Jan mentioned before four months in we're not prepared to give longer term guidance but what we can say is we're incredibly encouraged by what we're seeing today. When you look at some of the fundamentals behind the UVOL uptake, whether it's prescriber reach, we talk a lot a bit before around this space, there's quite a few centers of excellences. We're seeing 80% of them, nearly 80% already in a short four month period, already prescribe UVOL to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, When you look at the patient enthusiasm, I think you can see in early days, we're seeing a very positive trajectory. While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy. This is rare disease, so qualitatively we have heard confirmed anecdotes across all three categories for which our patients are coming from. And those three categories again are, one, patients that are switching from current therapy, two, patients that have previously discontinued pharmacological therapy and have now wanted to return to pharmacological treatment, and then third, a group of patients that historically have set out and have said based on the clinical profile of UVOL, they now want to try a therapeutic option for the first time. So all that again to underscore there is existing unmet need here and because of our profile, we're definitely seeing that patients are coming out of the woodwork from growing the market standpoint and we're just getting started.

I just do some way to add on to Jay's excellent comments. Ultimately, I have no doubt we will be number one in the acondalplasia space. Ultimately, we will expand the market because of the unmet medical need. And that is just with the monotherapy. And when you look at how commitment we have to this era, where we now are making a complete new standard with the compound treatment, I believe we are dedicated to be not number one in the first year but continue to build for the next five to ten years with monotherapy combination integrated treatment regimes and I believe with our once weekly Transcon product built on Rotamo and CMP We are extremely, extremely well positioned really to be the leader in this segment.

Thank you. And our next question will come from Derek Archila with Wells Fargo. Your line's open.

Hey, good morning and thanks for taking the questions. Congrats on the progress. Scott, I just wanted you to clarify a comment on your repath growth for the rest of the year. I think you said it's going to be like prior quarters. What quarters are you referring? Because I think the quarter over quarter growth in 1Q was negatively impacted, saw some catch up here in the second quarter. So, yeah, maybe you can just clarify which quarters you are referring to. Thanks.

Yeah, Derek, thanks for the question. I think that two points. One is the consistent performance with the KPIs that we've given you. For example, with enrollments, we expect those to continue and be consistent. The other would be, and you could refer to our prior quarters and maybe Chad can point to prior comments, but I think that now that we've seen the full year, you know the various trends that'll come into play related to Q3 and Q4 and then Q1 next year. So we think actually folks did a pretty good job modeling out Q2 and now you have all the information you need to model the rest of the year going forward until we update basically the KPIs.

Just to give you some kind of what is our value in this year. The value for us we want to give you, we want to give you not so you basic getting a lower number so we look like heroes. We want to give you the number so you are right nearly every time. And I think this is a way we try to come up with our different mathematic algorithm and how we see it and give you all the information for you really to be right in this manner. And I think this is a way we like to be extremely transparent with everything what we perform. So we're quite sure that you basically can go out and really someday feeling all this comfort with the guidance we give you. Great, thank you.

Thank you. And our next question will come from Joseph Schwartz with Learing. Your line's open.

Hi, congrats on all the progress. Thanks for taking my question. As you embark on a phase three in hypochondriplasia, I wanted to ask how you're defining the enrolled population and how large do you see the diagnosed treatable pool of hypochondriplasia patients? who are not already being treated in some cases. They're at the more severe end versus achondroplasia. Thank you.

This is a very interesting question because it's actually some way going into the situation on how we basically are to Genetic testing, taking a big patient group that was in old days were called ISS, idiopathic meaning we have no clue what is the underlying diseases and then you go out and do more and more genetic testing and then when you find a mutation in the FDR3 receptor and you find it in the right regions and then you suddenly are not an ISS patient But then you are a hypochondriplasia patient even if you don't have the phenotype of looking like an achondroplasia patient or a hypochondriplasia that we saw for 10 years ago. So therefore you can see the ISS population is in some way getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason Why you protect will have a short status without potential have the other element that you see for the phenotype of that. So this is where you can think when you go into ISS, are you defined it from a genetic perspective or you define it for a phenotype or anything like that? And we are in a situation where when you see the clinical trial, how we're doing it, you will basically see that it's one of the pathway we have selected. Thank you.

Thank you. And our next question will come from Daniel Bronder with Kaner. Your line's open.

Hey team, congrats on the quarter. I'm on for Lee Watzak. We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics?

Just to recall, the coach triad is the combination triad where we combine the two Transcon-based products, our Transcon-Glutamone and Transcon-CMP. And I have to say, when I look on an element like arm span, it's absolutely We have already reported some of the data. We have reported the 52 weeks data. And if you cannot find that, I can send it to you, or Scott can send it, or Chad can send it, or I don't know. We have so many people that don't know their names. So from that perspective, this already came out. And I have to say, there was one of the I will say extremely positive surprises I saw because when we looked on monotherapy but either a CMP based one or a growth hormone based one we did not saw the expected hopeful Thank you very much for your time. In a position that you basically could avoid all kinds of limb elongation surgeries in acondalplasia, both related to both legs and arms by that. And it's the slide number five, as I remember it. And what we see, Scott read up.

The unprecedented improvements in the arm span with a combination were plus 9.4 centimeters with a Transcon-CNNP-naive cohort and 7.9 centimeters with a Transcon-CNNP-treated cohort.

So it was really an...

Compared to limb lengthening surgery, centimeters.

Exactly, exactly. I have to say, it was one of the days where I felt it was worth the go-to job and really can see the benefit of what we're doing.

Okay, thank you.

Thank you. And our next question will come from Yoon Jong with Wedbush. Your line is open.

Hi. Excuse me. Good morning. Thank you very much for taking the question. I wanted to confirm that you have not provided prescription number for UriPath in case I missed anything. So I know that you said the patient demand remain robust in the quarter. So I wonder if there is any additional quantitative information that you can provide. And going forward, are you going to provide that number in the coming quarters? And I think you had this question before at the beginning of the launch. And when do you expect that you will feel comfortable providing a guidance in terms of the sales range on actual revenue? Thank you very much.

You're right. And I think it's starting to be a little bit repetitive. Every quarter come out and saying that we have more than 1000 patients being unique enrolled per quarter. We have continued that message that we see steady state, steady state and steady state. And we said in last year that we will stop coming with this because it was too repetitive. And then because people doubted for the Q1, then we also come up with the Q1 and it was the same number again. And what we're writing is that we see a robust steady state enrollment of unique new patients. And here we are referring to the US with about 1000 new patients every quarter. And we don't believe really. Now we went over to Europe. So now we're starting to give you a unique prescription enrollment of your valence debt. So we always have one product opportunity where you will have something to play with, with numbers and everything like that. Scott, you have some comments for the last one?

I think our comments were directed to assume that the metrics that we've given you are consistent because Yen wants to make our script shorter, so we don't want to repeat them more. And you should just assume that until we change it. Great. Thank you.

Thank you. And the next question comes from Alex Thompson with Stiefel. Your line's open.

Great. Thanks for taking the question, and I appreciate the color you provided to Zine's question around the ongoing legal battle with Biomarin. I guess as we think about potential scenarios here, and again, acknowledging sort of this idea around the public interest of the product and unmet need, Do you see a settlement as a reasonable scenario to think about, or is that really not something that you think is reasonable? Thank you.

Alex, I think I'm a very flexible person. And one of the things I really want to do, I will always do what is best for patients.

Thank you. And the next question will come from Maxwell Score with Morgan Stanley. Your line is open.

Great. Thank you very much for taking my question. Just a quick one on your VPath durability. I was just wondering if dropouts are still mostly during the titration phase and if you can comment at all on how reauthorizations are trending. Thanks.

I think you're 100% correct. And when we see A patient being successful coming into a treatment with uropax, coming over the titration part on it and being into the treatment after that, we see extremely, extremely low dropout. And I think that illustrates wanting the patient satisfaction with this treatment. Because I'm often being asked, what can we do more for these patients in the therapeutic treatment on it? And when I see the satisfaction that it is in this way, then I feel that there is an extremely good position, retention, and everything would really show that. We still develop. We will look at other ways to improve their life, like for example at-home capsule monitoring and anything like that. We can help the patient like it's happening in type 1 diabetes and other things like that. So now you're addressing the element where we're saying is we developed this year with a once-weekly Thank you very much for your time. but still we know it can be problematic for some patients and Jay can try to explain what we now doing to basically handhold the patient in this period so we also can make that extremely successful so when you get a prescription we know everything will be much more successful for the patient not just after they're barely being stable in the titration so Jay Will you explain of the effort you're building in to really to get that to be as soft and as possible?

Absolutely. Can chat a little bit more about certainly the investments that we're making and also to answer your questions around drop-off and re-ops. Yes, as we've shared before, the majority of the drop-offs is during that titration period in terms of when patients experience The most amount of change and where additional education and a higher touch support model makes sense. And then for re-offs, that's actually pretty routine for us, so there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support. We have patients re-offing throughout the year and it's just part of our day-to-day operations. From an investment standpoint, we've invested heavily and patient facing roles for which we've deemed our patient access liaisons. They support patients both pre-prescription as well as through the prescription process and post. So essentially we've seen a lot of success in early days with this field team being able to engage with this patient community. They have appreciated this high level of support and we of course support them throughout the journey to ensure that we're optimizing for patient experience.

Great, thank you very much. One thing that's in a minute. Now we focus on some US, but there is still a world outside US. Outside US, we have not seen the same level of dropout in this phase. It looked like the interaction is pretty well established between the physician and the patients and support system really to see it without this kind of dropout. So it's basically a US issue and date. So therefore, we know we can get it to function. We just need to ensure that the support system also in the US is strong enough to be sure that it's not a problem. Very helpful. Thank you.

Thank you. And our next question will come from Eric Joseph with Citi. Your line's open.

Thanks for taking the questions. As far as your named patient programs or early access programs, can you elaborate a little bit on which markets you're active in, whether eligibility might be determined by treatment status of a patient, and just generally how we should think about whether named patient programs could be meaningful contributors to patient volumes this year? Thanks. For you in particular.

Okay, I just wanted to ask what product you were referring to.

You do well.

Yeah, I can guarantee that as we basic in our preferred remarks try to put emphasis on, we have a global infrastructure in commercialization and patient support, product supply and everything like that. Just the number of sclerotrophic rare disease patients we have taken over to the system, more than 20,000 patients. We are having the system function more than in 35 different countries. So we're not a company that just needs to get started. We already have established all this infrastructure. And what we're doing is that we're utilizing this We will be where patient is and we will be quite sure we will also serve the patient outside US and potentially the market is much larger outside US. And I think we hope we also will see a large penetration in the U.S. where another short-acting product really failed to do it. And we believe because of the highly differentiated nature of UofL, we will see a complete different pickup in the U.S. But it's definitely, we have a strong, strong, strong focus on the ex-U.S. We will give you some guidance when we come later in the year so you can give also building up a model for the XUS.

Excellent. Thanks for taking the question.

Thank you. And the next question will come from Luca Issy with RBCM. Your line is open.

Great, thanks so much for taking our question. This is Kathy Perlucca. So going back to Uliwell and Jade, the three categories that you very nicely touched on for the naive, switch, and discontinued patients that are not on Scripps, BioMarine mentioned on their second quarter call that less than 100 patients have switched off of Voxilvo. So the simple math that we're trying to do here is that it leaves you with about 70 patients in the second quarter who are naive or return to treatment. So that's taken off the SWISH patients. So does that align with the numbers or impression that you have, and how does the dynamic look like between the truly naive patients and the patients who were once involved with ZOGO stopped treatment and are now returning to treatment, but to UvWell? And separate very quickly if you've commented or not on the ex-US strategy for UvWell, given the decision is pending and EMA coming very soon this year. Thanks so much.

I like your way of doing all the calculation, anything like that. I cannot support it or I cannot deny it because I don't have the facts of insight to some way to confirm anything of the numbers. I also saw the numbers that came out. But I cannot really support it because I don't have the insight from our own numbers to really come out and come with any statement that indicate if I'm aligned or not aligned with. Related to the XUS, for me to understand your question, was this reflecting what is the limitation in the XUS or what was the question?

Thanks for asking to clarify more about are you committed to running the show by yourself or you're considering partnering, given that, you know, 70% of the Vox Local sales is historically coming from ex-USS can be a quite heavy lifting.

Yeah, but so basically in the ex-USS we have our direct market, which starts in 60, 70, 80, where we have our own commercial infrastructure, anything like that. It's pretty, pretty clear what we're doing there. Then we have our sales and distributions agreement. And this is, I think it's 70 countries or something like that. 80 countries that is covering this sales and distributions agreement. And the vast majority of all of them are all three products. So basically there is already established infrastructure for the distribution. And then we have the two other, the third model where we have our partnerships, one in Japan, one in China, and we also have all the three products. So we don't need to go out and make any new agreements for anything. Everything is established. Everything is running on full speed. And we, for some of the EU direct market, we're just waiting for our Expected approval here in Q4 this year.

Thank you. And our last question is going to come from Faisal Khurshid with Jefferies. Your line is open.

Hey, guys. Thank you for taking the question. I just wanted to ask a little bit on the uropath life cycle strategy. Can you give us an update on the latest on getting the higher dose into the label for FDA? Then also any update on weekly urobopath. Thank you.

Yeah. What we see today is that we are enrolling the trial in the U.S. where we're evaluating the 30 to 60. Those frames in two different means that has been aligned with the FDA in their design what they wanted to see and we see that enrollment going extremely fast so we expect very very fast and you can say label expansion in the place where we don't have up to the 60 So we see that basic just on execution. And your second question was related to?

On weekly overpass, any update there?

Yeah, I think there's no news in this way that we're just executing and getting it into the market as fast as possible. Out from the expectation that we see that not as any kind of LCM activity, but more as patient support for patients that really are in the stable dosing, which are not a lot after they have been in a situation where they have been stabilized with our daily treatment. Great. Thank you.

Thank you. This is all the time that we have for questions today. This does conclude today's conference call and thank you for participating. You may now disconnect.