Ascendis Pharma (NASDAQ:ASND) Q2 2026 Earnings Call

0:00 Ladies and gentlemen, thank you for standing by. Welcome to the Second Quarter twenty twenty six Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you would need to press 11 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. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugert, Vice President of Investor Relations. Please go ahead.

0:47 Thank you, operator, and thank you, everyone, for joining our second quarter twenty twenty six financial results conference call. I'm Chad Fugere, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jen Mickelson, President and Chief Executive Officer Scott Smith, Chief Financial Officer Sherry Glass, Chief Business Officer and Jay Wu, Executive Vice President and President, Ascendis U. S. We begin, I'd like to remind you that this conference call, including the Q and 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 SKYYTORAFA, Yorvipath 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 2,030 objectives.

2:06 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 undue reliance on these statements. We assume no obligation to update these statements as 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 02/11/2026. 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.

3:05 TransCon Growth Hormone or TransCon HDH 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 and The United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for TransCon PTH as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP 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 IPPCs.

3:55 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 and 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 regarding product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter twenty twenty six 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 Jens. Thanks, Chad.

4:42 Good day, everyone. During the second quarter, achievement of important milestones and strong demand for our TransCon products continue to drive the transformation of Ascendis 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 Ascendis growth in the following years. Starting with the long term durability of a highly differentiated approved protein and peptide based combination products, Skytofa, Europads, and Eurowell.

5:42 We believe this product will be the critical driver of our growth story for the next ten to fifteen years through global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings. The continued expansion of the TransCon technology platform enable us to fulfill our plans to file at least one IND or SIMOLY yearly, each based on a new NTE, laying the foundation for strong growth for many decades.

6:28 This will also enable us to establish new therapeutic areas in addition to hypoparous 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 Europas is the first and only approved treatment for adults with hypoparam that address the underlying disease by replacing the missing endogenous PTH throughout the body.

7:25 Uptake of Europad has grown steadily since launch, both in The U. S. And many other countries, reflecting the significant unmet medical need among the more than eight hundred thousand patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure. Outside of The U. S, we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. Europat is now available commercially or through named patient programs in more than 35 countries.

8:19 This illustrates the strength of our ability to execute rapid, broad, global launch of a rare disease product. In The U. S, new patient domain for UAPED in the second quarter has remained robust, consistent with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully imitated Europad treatment continue to stay on therapy, indicating a high level of satisfaction. We continue to be excited by the growth of Europads in The US and outside The US and to see its continued strong launch performance.

9:15 Data from our long term Phase II and Phase III trials of Europas presented in the second quarter highlight by Europass is becoming a standing standard of care in post surgical and all subset of hypoparous, including ultra rare genetic causes like Dejords, ADS1, and ADS2. Results showed sustained response rate of eighty two percent to eighty six percent for the multicomponent endpoint with clinical benefit across multiple organ systems: CNS, kidney, small intestine, and bone plus meaningful improvement in quality of life.

10:04 Patient retention as high as ninety five percent after five years of treatment. Pretty unique. In parallel, we are working to further advance our leadership in hyperbar 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 EuropaDS. Turning now to Eurowell. We believe Eurowell is positioned to become the market leader therapy for achondroplasia.

10:53 Rapid uptake of Eurowell is already transforming The U. S. Market. Across the board we see a highly favorable response among patients and physicians to UOL'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 two twenty enrollment and more than 65% approved for reimbursement in The US through the end of July. Really a unique launch. The rapid uptake is by patients of all kinds of backgrounds.

11:41 Those Swiss returning to medical therapy or starting therapy for achondroplasia for the first time. We believe UOL is really growing The U. S. Market, which is exactly the pattern you will 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 completed people's approach trial showed durable and consistent improvement in growth, leg bone, body population, with a general well tolerated safety profile compared to placebo underscoring why the community is quickly adopting Urovel.

12:31 In The US, in The EU, a regulatory decision for Urovel is expected in the fourth quarter of twenty twenty six. We are also making Eurovale available in select international markets through early access programs using the U. S. FDA approval. Longer term, we are pursuing expansion opportunities for TransCon CNP through ongoing and planned trials. These include ongoing activities such as infants, zero to less than two years of age, and we recently announced completion of this target enrollment faster than expected. Adult with achondroplasia, children with hypochondroplasia, and still continue with geographic expansions.

13:24 Turning now to combination therapy with TransCon CNP and TransCon Growth Hormone. The biological rationale for this combination treatment is clear and extremely well founded on science. TransCon CNP is removing the limitation caused by the overactive FTR3 pathway. So TransCon Growth Hormone can provide a strong complementary effect. In addition, it has been observed that in achondroplasia there is a partial impairment of the IGF-one growth hormone axis. This is illustrated by children with achondroplasia having negative IGF-one SDS value as shown of the demographic in both our phase two and phase three trials.

14:24 In our post clinical trial of telomere achondroplasia, this unique combination has demonstrated sustained transformative analyzed growth velocity and ATH Height 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 achondroplasia and other indications over time. Our recent week 78 trial data show sustained efficacy over seventy eight weeks with no compromises to safety and tolerability. This points to the potential for this novel combination to establish a new treatment standard in naturalization.

15:15 The Phase III combination trial in children with achondroplasia will begin enrolling later this year. Turning to Skytrofa. The once weekly growth hormone treatment built on the mode of action on unmodified somatopy. 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 U. S. We are extremely proud that KYTOVA recently achieved more than 20,000 unique enrollment. 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.

16:08 And we are working to make TransCon Growth Hormone available to more patients through label angiographic expansions. To support label expansion going that's described in our achondroplasia program, we are conducting the Phase III 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 Tumor in the same countries where we also expect to launch TransCon CNP. Turning now to our partnership. In metabolic disorders and obesity, our once monthly transconcemic glutide program with Novo Nordisk continue to advance.

17:00 In ophthalmology, our partner Conis recently initiated a first in human clinical trial of the anti VEGF treatment built on the TransCon technology in patients with Vet AMD. In closing, by always putting patients first, Ascendis has delivered three highly differentiated leading TransCon based products: Europas, Eurobell, and Skytopa. We are on track to achieve our Vision 2030 objective of being a leading global biopharma, 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.

17:50 Thanks so much, Ian, 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 six ks filed today. Total product revenue was EUR $315,000,000, more than doubling year over year. Total revenue for Q2 twenty twenty six was EUR $339,000,000, which included non product collaboration revenue of EUR 24,000,000, which further included a €17,000,000 milestone related to TransCon CNP. EurvaPath revenue was €252,000,000 in Q2, reflecting consistent new patient demand in The U. S. And continued growth outside of The U. S, reaching blockbuster status on a run rate basis in the second year of launch in The U. S.

18:49 SKYTROFA contributed €55,000,000 in Q2, which reflects increased demand in The U. S. Includes product sales to a collaboration partner. UviWell was commercially launched in The U. S. During Q2 and generated EUR8 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 and D expenses in Q2 were EUR 76,000,000, up from EUR 59,000,000 in Q1, reflecting continued investment in our pipeline and innovation. Recall, Q1 included a favorable EUR 11,000,000 reversal of prior period write downs of TransCon CNP prelaunch inventories.

19:39 SG and A expenses were €173,000,000 in Q2 compared to €145,000,000 in Q1, reflecting additional investments in the commercial launches of Yorvapath and UVwell to accelerate growth for the long term. Operating profit of €220,000,000 in Q2 included €158,000,000 of other operating income related to the sale of the PRV. Non IFRS operating profit was EUR 92,000,000 and non IFRS operating margin was 27. Refer to our press release for details. For Q2 twenty twenty six, net profit was EUR $2.00 7,000,000 and non IFRS net profit was EUR 61,000,000.

20:32 We ended Q2 twenty twenty six with EUR $812,000,000 in cash and cash equivalents, which includes the use of €56,000,000 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 €1,400,000,000 of equity. Turning to our outlook for the rest of 2026. For Yorvipath, we expect growth and performance consistent with prior quarters. For SKYTROPA, we expect relatively stable revenue in The U. S. For Uvuel, we are encouraged by the early demand trends.

21:22 We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in The US, reflecting the large unmet medical need and the highly differentiated profile of Yuval. Our Q2 performance reinforces our belief that we can achieve EUR 5,000,000,000 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 EUR 10,000,000,000 in the next decades, while developing and launching new TransCon products with blockbuster potential. We expect significant operating leverage as revenue scales through the balance of the year, while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long term revenue aspirations.

22:18 Even with these investments, we expect to generate more than EUR 500,000,000 in cash flow from operating activities this year. With that operator, we are now ready to take questions. Thank you. And our first question is going to come from Jessica Fye with JPMorgan. Your line is open. Hey, guys. Good morning. Thanks for taking my question. On that outlook for at least $500,000,000 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.

23:23 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 I'm a 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, than, 500,000,000, I thought you, I heard you say 100, so greater than 500,000,000. And at this time, we don't want to bound the upper side because, we're initial into the launch of Yuviel. And that's Euro, by the way, euros 500,000,000, Jan likes to point out.

24:13 And just related to the question, and it comes back to what we 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 domain, we have a really strong belief that it's not only coming from switches, it must also coming from either patients that had stopped therapy or new patients that basically coming to a situation because of the highly differentiated nature of Uovel that will want to start therapy.

25:06 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 Tazeen Ahmad with Bank of America. Your line is open. Hey, good morning. Thanks for taking my question. So Yan, I wanted to get your thoughts about the IT challenge on UVL. We know obviously what the blue sky scenario is for Ascendis, 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.

25:51 And so between now and then, can you just tell us what could happen and what the potential for, you know, payments that Ascendis would need to make in the worst case scenario could be? Thanks. Thanks, Sassine, for the question. And it's basically a question that is addressing the ongoing legal, I would call it battle between Ascendis and BioMarine. And let me just come back to some facts. The fact is that this pattern that we discussed got complete invalid in Europe, so we never really come to a discussion if we were infringing and anything like that.

26:46 So when we see the situation outside The 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 BioMarin 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 are dealing with branded pharmaceutical. 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.

27:44 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 taken to a decision for, I cannot remember how many judges that will be part of that decision, there is a huge opportunity to provide what we call public interest for this product.

28:43 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 for 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 had been denied. But you can see me 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 Ascendis pathway.

29:31 I can guarantee that. It's some kind of people take it up as a life and death for Ascendis. This is a total not taking into the perspective what it means for Ascendis. 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 5,000,000,000 in 2030. Thank you. And our next question will come from Gavin Clark Gardner with Evercore. Your line is open. Hey guys, thanks for taking the question. I actually just wanted to ask on the earlier pipeline. So 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.

30:29 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 as a NCE, the one that now we clinic with Iconis and the other one we expect to go into the clinic now with Novo Nordisk. It's still some way being developed through the TransCon technology funnel. And again, 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 have this year two new chemical entities being entered into clinical trials.

31:19 And I think Kenneth 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 Ascendis independent of going out and buying something no one else wants to have. And I think this is where we really feel extremely plasmid by the situation by being a fundamental company that's building on a strong, strong technology platform that provides both sustainability for ourselves, but also a continued flow of potential partner licensing. Great. Thanks.

32:08 Thank you. And the next question will come from Yaron Werber with TD Cowen. Your line is open. Great. Thanks so much. Question on UV, do you expect that there is some seasonality in terms of new patient starts in the summer? There's 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 a two twenty. 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 seven fifty 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.

33:00 Thanks for the question. I actually don't think Ascendis have really made some clear forward looking statements, 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 would 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, analytical system where we basically can look at trends and other things like that.

33:51 But the 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 way what you see how the market will develop. Thanks, Jan. As Yan 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 Yuvala 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 prescribed Yuvalu to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product.

34:49 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.

35:36 Two, patients that have previously discontinued pharmacological therapy and has now wanted to return pharmacological treatment. And then third, a group of patients that historically have set out and have said based on the clinical profile of Yuval, 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. Just to summary to add on to Jay's excellent comments. Ultima Tip, I have no doubt we will be number one in the achondroplasia space.

36:24 Ultima Tip, 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 combo 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 both hormone and CMP, we are extremely, extremely well positioned really to be the leader in this segment.

37:17 Thank you. And our next question will come from Derek Archila with Wells Fargo. Your line is 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 repast growth for the rest of the year. I think you said it's going to be like prior quarters. Guess, 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 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.

38:03 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 will 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.

38:51 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 some way 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 Leerink. Your line is open. Hi, congrats on all the progress. Thanks for taking my question. As you embark on a Phase III in hypochondroplasia, I wanted to ask how you're defining the enrolled population?

39:40 And how do you 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 basic are to genetic testing, taking a big patient group that was in old days what called ISS, idiopathic, meaning we have no clue what the underlying disease is. And then you go out and do more and more and more genetic testing.

40:27 And then when you find a mutation in the FTR3 receptor and you find it in the right regions, and then you suddenly are not an ISS patient, but then you are a hypochondroplasia patient even if you don't have, you can say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia that we saw for ten years ago. So therefore you can see the ISS population is some way getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason why you will have a short status without potentially have the other element that you see for the phenotype of that.

41:13 So this is where you can send when you go into ISS, you define it from a genetic perspective or are you defining 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 pathways we have selected. Thank you. Thank you. And our next question will come from Daniel Bronder with Cantor. Your line is open. Hey team, congrats on the quarter. I'm on for Lee Watsak. We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial.

42:04 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 trial is the combination trial where we combining the two TransCon based products, our TransCon growth hormone and TransCon CNP. And I have to say when I look on an element like arm span, it's actually we have already reported some of the data. We have reported the fifty two weeks data. And if you cannot find that deck, I can send it to you or Scott can send it or Chad can send it or I don't know. Know we have so many IR people I don't know what names are more. So from that perspective, it's 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 with either a CMP based one or a growth hormone based one, we did saw the expected hopeful development that we can hope for, but we definitely saw it when we looked on the combination therapy.

43:28 And then you can ask me what is the scientific reason why you see it much more influenced benefit by the combination therapy? And I have to say I don't know. But what we saw was an arm span that was really give us this hope with the combination therapy you basically will be in a position that you basically could avoid all kinds of lymph elongation surgeries in achondroplasia, both related to both legs and arms by that. And it's slide number five as I remember it, and what we see, Scott read up. The, unprecedented improvements in the arm span with combination were plus 9.4 centimeters with, transcon CNP naive cohort and 7.9 centimeters with the transcon CNP treated cohort.

44:26 So it was really an Compared to limb lengthening surgery in centimeters scale. Exactly, exactly. I have to say it was one of the days where I felt it was worth to go to a 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 Yoripath in case I missed anything. So I know that you said the patient demand remained robust in the quarter, so I wonder if there is any additional quantitative information that you can provide.

45:17 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 are right. And I think it's starting to be a little bit repetitive every quarter come out and saying that we have about more than 1,000 patients being unique enrolled per quarter. We have continued that measure 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.

46:06 And then because people doubted for 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 U. S. About 1,000 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 Urovel instead. So we always know that we have one product opportunity where you will have something to play with, with numbers and everything like that. Scott, you have some comments to the last one? Yeah, think Yun, our comments were directed to assume that the metrics that we've given you are consistent because Yun wants to make our script shorter, so we're not don't want to repeat them more. And you should just assume that until we change it.

47:03 Great, thank you. Thank you. And the next question comes from Alex Thompson with Stifel. Your line is open. Great. Thanks for taking the question. And Yan, appreciate the color you provided to Zeen'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 public interest of the product and unmet need, do you see, you know, 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.

47:56 Thank you. And the next question will come from Maxwell Skor with Morgan Stanley. Your line is open. Great. Thank you very much for taking my question. Just a quick one on YorViPath 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 EuropaX, coming over titration part on it, and being into the treatment after that, we see extremely, extremely low dropout.

48:50 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 physician retention and everything would really show that. We still develop once weekly for patients on stable doses just to give patients the choice if they want to do it in this way. We will look at other ways to improve their life like, for example, at home calcium monitoring and anything like that. We can help the patient like it's happening in type one diabetes and other things like that.

49:48 So now you're addressing the element where we're saying is we developed this year with a once weekly profile, even if we could make it sorry, once daily because we wanted to do the titration most easily because it's really complex to take patients off of conventional therapy at the same time you increase the PTH in replacement therapy. And there was a way we made it as a once daily this really to facilitate the best possible titration, but still we know it can be problematic for some patients. And Jay can try to explain what we're now doing to basically handhold the patient in this period. So we also can make that extremely successful.

50:41 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 reauths. Yes, as we've shared before, the majority of the drop off 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.

51:29 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 reauthoring throughout the year and it's just part of our day to day operations. From an investment standpoint, we've invested heavily in patient facing roles for which 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.

52:21 Great. Thank you very much. One thing that's element, now we focus on ASND US, but there is still a world outside US. Outside US, we have now seen the same level of dropout in this phase. It looked like the interaction is pretty well established between the physician and the patient and support system really to see it without this kind of dropout. So it's basically is 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.

53:09 Very helpful. Thank you. Thank you. And our next question will come from Eric Joseph with Citi. Your line is open. Hey, thanks for taking the questions. As far as your named access, your named patient programs or your 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 prepared 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 scheduled for rare disease patients we have taken over to the system, more than 20,000 patients.

54:23 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 established infrastructure basic that got established because of Europads, because this is what we did with Europads. We're using exactly the same infrastructure also for Eurobell. So we will be where the 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.

55:15 Where another short acting product really failed to do it. And we believe because of the highly differentiated nature of Uruvel, 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 ex U. S. Excellent. Thanks for taking the question. Thank you. And the next question will come from Luca Issy with RBCM. M. Your line is open. Great. Thanks so much for taking our question.

56:00 This is Cathy for Luka. Circling back to you really well, and Jay, the three categories that you very nicely touched on for the naive, switch and discontinued patients that are not on script, BioMiner mentioned on their second quarter call that less than one 100 patients have switched off of VOXZOVO. So, the simple math that we're trying to do here is that it leaves you with about seventy patients in the second quarter who are naive or returned 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 on VoxoGo, stopped treatment and are now returning to treatment but to UVwell? And separately, very quickly, if you've commented or not on the ex US strategy for UVwell given the decision is pending and EMA to come in very soon this year? Thanks so much.

56:56 I like your way of doing all the calculation. Anything 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 ex US, for me to understand your question, was this reflecting what is the limitation in the ex U. S, or what was the question?

57:42 Thanks for asking to clarify. What about are you committed to blind the show by yourself, or are you considering partnering given that, you know, 70% of the moxilogastal that's historically coming from Ex U. S. Can be a quite heavy lifting? Yeah, but so basically in the Ex U. S. We have our direct market. We're starting sixty, seventy, 80 where we have our own commercial infrastructure or 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. Well, it's got this don't know. Eight zero. Oh, 80 countries that is covering this sales and distribution agreement.

58:30 And then vast majority of all of them are all three products. So basic, 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 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.

59:20 And our last question is going to come from Faisal Kershed with Jefferies. Your line is open. Hey guys, thank you for taking the question. Just wanted to ask a little bit on the YorbaPath lifecycle strategy. Can you give us an update on the latest on getting the higher dose, into the label for FDA? And then also any update on weekly YorbaPath? Thank you. Yeah. What we see today is that, we are enrolling the trial in The US where the evaluating the thirty to sixty dose range in two different means that has been aligned with the FDA in their design, what they wanted to see.

1:00:06 And we see that enrollment going extremely fast, so we expect very, very, very fast and you can say label expansion in the place where we don't have up to the sixty. So we see that basic on 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 in any kind of LCM activity, but more at 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.

1:01:13 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.