Ascendis Pharma (NASDAQ:ASND) Q1 2026 Earnings Call

0:00 Good day, and thank you for standing by. Welcome to the First Quarter Ascendis Pharma Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message by if your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would like to hand the conference over to your first speaker today, Chad Vice President of Investor Relations. Please go ahead. Thank you, operator, and thank you everyone for joining our first quarter twenty twenty six financial results conference call. I'm Chad Fujair, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Yan Mikkelsen, President and Chief Executive Officer Scott Smith, Chief Financial Officer Sherry Glass, Chief Business Officer and Jay Wu, EVP and President, U. S.

0:55 Market. Before we begin, I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of DURVYPATH, UVWell, and SKYYTORAFA, as well as certain expectations regarding patient access and financial outcomes, our pipeline candidates, and our expectations 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 planned regulatory filings, and our expectations regarding timing and the results of regulatory decisions.

1:41 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. 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 our forward looking statements section in today's press release and the Risk Factors section of our most recent annual report on Form 20 F filed with the SEC on 02/11/2026. TransCon PTH is approved in The U. S. 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 TTH as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

2:34 TransCon CNP is approved in The US by the FDA for the treatment of achondroplasia in children aged two years and older. Continued approval for this indication, which is based on an improvement in annualized growth velocity, may be contingent upon verification description of clinical benefit and confirmatory trials. TransCon HGH is approved in The US 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 from the European Commission for the treatment of pediatric growth hormone deficiency. Otherwise, please note that 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.

3:25 None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our first 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 your questions. With that, let me turn it over to Yan. Thanks, Chad. Good day, everyone here from COVID-nineteen. Our first quarter of twenty twenty six was an IO Naltrexone point five Symmix, with the FDA approval of our third Mantagon product, UEVAL. Our revenues are growing rapidly. We are profitable. We have a pipeline of high value product opportunities to support long term growth.

4:14 Three elements are cementing our position as a leading global biopharma company. First, our diversified product portfolio in one single therapeutic area. Following FDA approval of Urovel, we have now achieved approval of three products in a row across four rare endocrine indications. Second, our rapid revenue growth from our existing endocrine rare disease portfolio, Europants, Eurobell and Skytrofoam, each highly differentiated with long durability. We expect sustained revenue growth for many years to come.

5:00 Third, expanding our pipeline. We have proven our ability to create transformative medicines, addressing unmet medical needs using our TransCon technology platform. To date, we have more than 20 ongoing or planned clinical trials aiming at label and market expansion, including four differentiated new clinical entities in preclinical development. Turning now to Europads. Europads revenue in the first quarter reached €197,000,000.

5:48 Eurotherm revenue for the first quarter was impacted by two one time items, a temporary increase of US patients supported by free drug caused by reimbursement disruption and one time impact of Europe direct related to expanded market access. Scott will explain the financial impact of these two events in his remarks. In The US, new patient enrollment in Q1 remained in line with the strong uptake we have seen in Q4 twenty twenty five with more than 1,000 new patients prescribed Europads during the quarter.

6:36 Through the end of March twenty twenty six more than 6,300 patients have been prescribed Europads by more than 2,700 unique healthcare providers. March was our last revenue month ever for Europads supported by an increased number of new patients as well as patients returning to reimbursement from free drug. Importantly, the enrollment trends we saw in Q1 have continued to improve through April consistent with our guidance. Insurance approval rates and medium time to approval continue to improve. This strong support a strong foundation for revenue growth in 2026 and many years to come.

7:28 Outside The US, Europad is available commercially or to many patient programs in 35 countries including full commercial reimbursement in six of our Europe direct markets with additional launches expected through 2026. Looking ahead, we continue to pursue multiple expansion opportunities for Europads in new markets and indications. This includes doses up to sixty micrograms in The US, global expansion to patients eight twelve to 18, and continued development of 108 TransCon PTH for patients on stable Europad doses. With seventeen thousand to ninety thousand patients living with chronic hyperparameter The US and five to ten times that number outside The US, we remain highly confident in Europet's long term global protections.

8:30 I will now turn to our growth disorder branches. With one week, the Eurobel and Oxon, our once weekly growth hormone, skydrofem, we believe Ascendis is uniquely positioned to strengthen its leadership in those disorders. Our U. S. Commercial infrastructure built and refined since GATRONBA launched in 2021 has enabled a focused and high impact launch for Eurowell which became commercially available in early April. Since then Urovel has already been prescribed for more than 60 children by more than 35 unique healthcare providers.

9:19 With children approved for reimbursement as fast as a few days. Eurobell has shown compelling results compared to placebo across multiple clinical trials In addition to linear growth outcomes, these results include improvements in leg bone, spinal canal dimensions, body optionality, physical function, and health related quality of life compared to placebo without compromising safety or tolerability. We believe these outcomes reflect UOL's unique ability to provide continuous systemic CMT exposure throughout the body over the weekly dosing interval.

10:06 Looking ahead we plan to make ULVAD available in selected international markets through early access programs using the US FDA approval. As a reminder our global infrastructure costs over 70 countries and has already generated product revenue for us in more than 35 countries. In EU a regulatory decision on our marketing authorization application for UOL is expected in the fourth quarter of twenty six. We are also pursuing label expansion for UAVL through ongoing trials. These include infants under two years of age with achondroplasia and children with hypochondroplasia, as well as geographic label expansion clinical trials.

10:58 Turning now to scytofen. In The US, scytofen maintains consistent performance as a premium product with 7% share of the overall pro form a market reflecting steady demand across pediatric and adult patients as the only once weekly product delivering unresolved somatropes. With the expected label expansion that could double the addressable patient population in The US and geographic expansion outside The US, we believe Skytofen will remain a cornerstone product in our growth disorder portfolio. Turning to our pipeline. This includes combination therapy with once weekly TransCon CNP and TransCon Growth Hormone for children with achondroplasia.

11:52 In our phase two co stripe, we have reported on precedent results that exceeds the already compelling foundation established by UOL monotherapy. Week 52 data from codes presented in January showed improvement in achondroplasia specific height set score that indicate a triple of efficacy compared to TransCon CRP monotherapy along with improvement in body proportionality. More recently we shared additional big 52 data that showed improvement in lower limb alignment as well as an accelerated improvement in spinal canal dimensions and an improvement in arm strength not previously demonstrated with pharmacotherapy within a treatment year.

12:47 Based on this finding, we believe our unique combination therapy of TransCon CRP and TransCon Growth Hormone could potentially eliminate the need for high invasion procedure such as leg lengthening, arm lengthening and leg straightening surgeries. We believe that this combination therapy could become the preferred treatment option for achondroplasia. I will now briefly turn to oncology. In our Phase onetwo I believe trial we have elevated TransCon year two Betagarmin in combination with paclitaxel in patients with late stage Plagiolizumab, resistant ovarian cancer or CLG. Medium OS improved up to ten months from six to seven months from historical front groups with a general well tolerated safety profile validated the science on TransCon IL-two beta galvanic.

13:45 As for internal oncology development, those not aligned with our strategic focus, we have decided to discontinue internal development of TransCon IL-two pentagarmin in oncology and will explore other ways to maximize the value of this assays. Turning now to our partnership, our once monthly TransCon semaglutide with Novo Nordisk continue to advance towards the clinic. And Arconis TransCon anti VEGF also reigns on track to enter the clinic this year. These programs further highlight the broader potential of our TransCon technology platform to address product opportunities in larger indications. In closing, in the first quarter of twenty twenty six we made significant progress across our business and our ability to make a meaningful difference for patients.

14:38 We have three FDA approved TransCon products across four indications, growing revenues, improving cash generation and a pipeline to support long term growth. I will now turn the call over to Scott to review our financial results. Thanks a lot, Jens, and good afternoon, everyone. I will touch on some key points surrounding our first quarter financial results, which reinforce our confidence for growing operating profit and cash flow into the future. For further details, please refer to our Form six ks filed today. EuropaPath global revenue was €197,000,000 in Q1. The first quarter was characterized by steady global uptake and normal seasonality, as well as two one time items.

15:31 Patients temporarily transitioned to free drug in the quarter of The U. S. And a one time impact in Europe Direct related to expanded market access. The combined impact of these two items was approximately €15,000,000 Skytropha contributed €44,000,000 in Q1. On a sequential basis, performance reflected consistent underlying demand with the expected drawdown in channel inventory built in Q4. Including €6,000,000 in collaboration revenue, total Q1 twenty twenty six revenue amounted to €247,000,000 Continuing to expenses. R and D expenses in Q1 were €59,000,000 down from €78,000,000 in Q4 'twenty five.

16:19 R and D in Q1 was favorably impacted by a write up of UBOL inventory consisting of €11,000,000 due to U. S. FDA approval and lower clinical activity across the portfolio. SG and A expenses rose to €145,000,000 in Q1 twenty twenty six compared to €136,000,000 in Q4 twenty twenty five, reflecting continued impact of global commercial expansion. Total operating expenses for Q1 twenty twenty six were $2.00 €4,000,000 and operating profit was €25,000,000 reflecting a 10% operating margin. Non IFRS operating profit was €55,000,000 and non IFRS operating margin was 22%.

17:07 As revenue scales, we expect meaningful improvement in our operating margin, which will be visible over the course of 2026 and beyond. Net finance expense for Q1 twenty twenty six was €63,000,000 primarily driven by non cash items, including remeasurement loss of financial liabilities of €34,000,000 Net cash financial expense for Q1 'twenty six was about €1,000,000 Net profit for Q1 twenty twenty six was €629,000,000 which included recognition of a €679,000,000 deferred tax asset in the P and L. Refer to our six ks for more detail. Non IFRS net profit was €18,000,000 or EUR $2.07 per share.

18:00 We ended Q1 twenty twenty six with EUR $573,000,000 in cash and cash equivalents, which includes the impact of €60,000,000 in Q1 from our previously announced share repurchase program and net settlement of certain RSUs. In April, we successfully completed our transition to a direct listing of our ordinary shares on NASDAQ. We believe this will broaden access to global investment in the company, which has the potential to further enhance institutional ownership and trading liquidity for Ascendis shares. In May, we completed the full redemption of all of our outstanding convertible senior notes. Finally, today, we announced that we entered into an agreement to sell our PRV for $187,500,000 in cash.

18:51 The PRV was awarded by the U. S. FDA upon approval of UB Well in February. Turning to our commercial outlook. For YorbaPath, we expect continued steady underlying increase in patients on therapy and the reversal of onetime factors seen in Q1 to drive strong growth sequentially in Q2. For SKYYROPHA, we expect stable revenue throughout the year following a similar seasonal pattern to 2025. Regarding YuvaWell, as Yan indicated earlier, we are encouraged by the early demand trends and look forward to sharing more with you on our Q2 call. With that, operator, we are now ready to take questions. Thank you. At this time, we'll conduct a question and answer session. As a reminder to answer a question, you'll need to press 11 on your telephone and wait for your name to be announced.

19:45 To withdraw your question, please press 11 again. And our first question comes from the line of Jessica Fye of JPMorgan. Your line is now open. Hey, guys. Good morning. Thanks so much for taking my question. I was wondering if you could help us estimate what U. S. Yorvy Pass sales were in the quarter. I think in the past you had run through an algorithm to consider, but I know the press release noted some one time impact to Europe direct as well. So just trying to get a better sense of The U. S. Versus ex U. S. Split this time around. Thank you. I think this Scott that will give you just a little bit more background on the financial element, specific that one time in Europe direct. It's actually happening when we sometime and specific for one single country because we had an early access program that was running for nearly fifteen months, sixteen months, and it gave us a one time event where we needed to write down for this single case. It's not something that really happening in other countries, but it was a single country event which basically impacted our Europeans, say, Q1 results. Scott, you can give you a little bit more flavor on the finance numbers.

21:16 Yes, Jess, for modeling purposes, it's probably a little bit more of an impact, but I would say that the best way to think about it is take the algorithm that we laid out where you're at four to five a quarter, and for Q1, basically that addition was just shifted into Q2. And then from there, the algorithm continues. But I think just one of the key elements I will take into regard is basically the underlying patient demand, because I think the key element is really that we continue the same successful, you can say, rollout of the launch both in US where we now as we have providing you the number of initiated new patients on treatment with Europan and as we have given in our previous guidance we still 100% correct in that where we really see the same stability, we see the same flow coming in and Jay can comment about how he already starting to improve both the time to reimbursement and the numbers. I do know, Jay, will you comment about your effort in really improving what we call the reimbursement duration for The US?

22:31 Sure, when you think about our reimbursement, we're seeing improved metrics across the board. So first and foremost, we've talked a little bit about our upstream coverage now expanding to about eighty percent of patient lives, which we're feeling really good about given the time on market. And I think again, a testament to the compelling clinical value proposition that we have. We're also seeing continued rapidity as it relates to patients being approved for reimbursement upon entering the funnel. So again, over half approved within eight weeks of enrollment. And we are seeing continued progress against patients moving through the funnel, whether it's upstream as the enrollments are coming in, but also supporting patients as they're entering into the funnel.

23:24 Great, thank you. Thank you. One moment for our next question. Our next question comes from the line of Tasina Mehta of Bank of America. Your line is now open. Hi, guys. Good morning. Thanks for taking my question. Mine will also be on Yorvi, and maybe this is for Jay. Can you talk about the reauthorization rates that you're seeing now that patients are starting to annualize at this time of year? Any things to point out about things that were maybe unexpected or taking a little bit longer? And then can you talk about usage among physicians? So is there a way of providing a split between how much of use is coming from first time physicians versus an increasing use among doctors who've tried Yorvipath before?

24:17 Thanks. Okay, there was multiple questions. I hope you got everyone down. Will you start on some of them? Sure. I think I heard a few questions. One, which maybe I'll start with towards the end, which is prescriber breadth and depth, I think was the question. We're seeing continued traction across both. So as Yan mentioned earlier in the script, we've had over 2,700 prescribers, which again is an addition of about a 300 plus quarter over quarter, which we're feeling really good about. So that would answer your question around new prescribers. And then within existing prescribers, we're also feeling really good because the average prescription per physician continues to increase as well.

25:07 In fact, 10% ish of prescribers have now over five enrollments for patients. Again, as you think about the provider landscape here, they all do have a different patient volume just given how diffuse the patient volume is. But generally speaking, we're seeing not only one additional prescribers sign on to your path given the strong patient satisfaction scores that we're seeing, but then because of those positive patient experiences, we're also seeing providers expand their scope of who they deem to be eligible, given that lab values alone are not the reason that patients should be treated. Okay, thanks. And then reauthorization was the last one. Reauthorization, yes, that was the first part of your question. We're not seeing any meaningful differences in terms of approval rates for a re auth versus necessarily a patient that's coming in at the top of the funnel.

26:06 We typically again have shared that four to eight week timeframe. We've seen those numbers continue to increase in terms of speed, which I referenced earlier with the first analyst question. But we're not seeing any meaningful difference with the reauthor coming in versus a new patient coming in. Generally, what you'll see is if it's a reauthor of an existing payer insurance where there hasn't been a change in insurance, you might see some faster timeline there. But if it's a brand new insurance, then you're obviously going to treat it as just a brand new case, so to speak. You. One moment for our next question. Our next question comes from the line of Aaron Werber of TD Cowen. Your line is now open.

26:55 Great. Thanks so much. Maybe a quick follow-up and then a question on UVL. A follow-up on YorVi. So of the 15,000,000 should we roughly kind of split it, like half in Europe and half in The U. S? I don't know if you can give us any sort of view on that. And then for UVWELL, in the ITC cases progressing, the briefing document, the briefs are out kind of back and forth. And it looks like the court is kind of siding with both parties. What I know you've been importing drug in the meantime. Any view sort of on how much capacity you might be able to have in the system by the time a decision is rendered? Thank you. First of all, I believe when you see the uptick in the prescriptions of UOVEL in The US, we have more than sixty children being prescribed UOVEL treatment in less than four or five weeks.

28:01 I think it illustrates the unmet medical need that exists in The US related to an improved treatment in achondroplasia, And I believe what we have seen of clinical data in our multiple trials with UAVL just as a monotherapy is really describing the reason why we see this take up. This is not just of having a once weekly product. This is providing a tolerability profile and documented effect on benefit beyond linear growth. And I think everyone is aligning with the unmet medical need, the public interest always to have a product as CEO in the market.

28:57 We will continue to be in a position that we have such a strong belief that in this case here too, like it was in Europe, we can prove that this IP case should never have existed and only is built on false promises. So I'm 100% confident Eurobell is here to stay and it will always be a treatment option for patients with achondroplasia in The US. I hope that answers your question related to that part. The other part, I think you are somewhere in the right estimate when you think about it.

29:53 Thank you. One moment for our next question. Our next question comes from the line of Gavin Clark Gardner of Evercore ISI. Your line is now open. Hi, this is Izzy on for Gavin. We have two quick questions. Number one is for the phase three ACON CMP and growth hormone combo trial. Can you share any update on the enrollment speed? And secondly, what are you seeing in your VPAT discontinuation rates over time? So when we talk about, as I understood your question right, it was related to the combination trial, the phase two trial we call the coach trial, and we basic are now, I do not know how many years we are into the trial now, but I think we are two years and then one and a half year now in it. And I think we see basic and extremely high element of protection in this trial. To my knowledge, last time we looked, it was 100%, and I think it's really been harder to get more than 100% in a clinical trial, to my knowledge, and I think that's a very, very, very few trials where you have 100% retention after nearly eighteen months.

31:13 So from that perspective, I think it's really illustrating and addressing the satisfaction with the benefit you see in the treatment compared to the burden of treatment. And I think that is really the key element that we always are looking in the fundamentals. We want to see benefit for patients. This is why we're working, and we will continue to focus on that. Thank you. One moment for our next question. Our next question comes from the line of Leigh Wasek of Cantor. Your line is now open. Hey, thanks guys. I guess on YORI, new patient, as you mentioned, steady growth, Is it reasonable for us to assume 1,000 is sort of the number that we should be looking at for the coming quarters?

32:11 And will you be sharing new script number going forward? Thanks. That's a great question. Now, some way going back to last time I said I would not have come up with more prescription data for Europanz because I believe that the revenue progression was so clear and when I said that there was a big, big, big, what I call the element of some interesting funds that pushed back and saying I didn't want to come up with numbers because it must be really, really bad. And now we have illustrated for one quarter more that they are not bad, they are extremely good and exactly as predictable as we have said in this way. And I expect a steady state enrollment in all the quarters because that is what we expect. We are only touching a small amount of this patient group. We have so much more patient that is coming new patient every year.

33:13 So I'm somewhat giving up to say that I will not come up one quarter more because last time I said we will not come up with one quarter and then I got basic press because I didn't want to listen to that. We didn't want to come up a number because they're bad. I don't hide anything. I always want to be transparent. And this is why I said come up with a number, then you can see it. So I think that they can continue to be so transparent on everything what we're doing so you always have the best possible opportunity to see how well we have performed in our fundamentals. Thank you. One moment for our next question. Our next question comes from the line of Alex Thompson of Stifel. Your line is now open.

34:03 Hey, thanks for taking the question. This is Patrick on for Alex. Could you guys just talk about the potential impact of the URV60 micrograms being on the label? Maybe what percentage of those six thousand three hundred patients in The U. S. Is dose capped at 30 with maybe less than ideal supplementation levels? This is a question which is very, very difficult for us to answer today because we see different kinds of uptitration in both different situations in clinical trials and also situations in what I call more real world. We are following it a lot. We are now open for enrollment in our trial where we are having two arms in our duration of dose titration over 30 up to 60, and we will enroll that in a decent speed.

35:09 We only do that in The US because this is the only place where we restrict it down to 30 and not have 60, and we believe that even if you are coming up to thirty micrograms, you still have a major benefit to be still on thirty micrograms compared to many of the positive effect that Europath is still providing to it. So I think you can say yes, there is somewhat of a benefit to go higher, But today, we're still providing the benefit to the patient that needs to stop on searching micrograms. Thank you. One moment for our next question. Our next question comes from the line of Joe Schwartz of Leerink Partners. Your line is now open.

36:02 Great. Thanks so much for taking my question. So some physicians we have spoken with have suggested that they might not want to put their office staff through the reimbursement challenges of switching their achondroplasia patients to a once weekly injection only to then later switch them to once daily pill in the not too distant future. Is this a dynamic that you guys are aware of? And what can Ascendis do to help support the achondroplasia patient or physician community rather and encourage uptake? And then have any my second question is, have any physicians prescribed Yuval in combination with Skytrova since Yuval was approved?

36:52 Thanks. Answering your first part of the question, I think the number speaks for itself. When you think about it, more than 10 prescriptions per week, this is a rare disease product. I think it talks about the unmet need and the willingness for basic. Physician. In connection with the parents in connection with the child to basic to. Have the desire to take them on a treatment video of it.

37:41 I think it says everything the numbers you can go out and ask one physician. Can go out and ask one parents. I look at numbers from a statistic. The numbers talks for itself. Related to the last question. I cannot someway. Discuss an element. We cannot promote. We cannot promote anyway in duration the combination therapy. We have disclosed the benefit of the combination therapy, And then it's up to the physicians if they really want to prescribe it or not prescribe it. And. To my knowledge, and I can be pretty open about it, yes, it happens and I understand why.

38:32 This is the only way you basically can be in a position where you basically can avoid any kind of surgeries, which I think is such a positive element for any child with achondroplasia to avoid these invasive surgeries. And I think this is the reason why the physicians do it. And sure, we're looking forward to finalize the phase three trial. We're looking forward to have it on label. So we really also can go out and promote it actively. Thanks for the insights. You. One moment for our next question. Our next question comes from the line of Ellie Merle of Barclays. Your line is now open.

39:22 Hi. This is Jasmine on for Ellie. Thank you for taking our question. Just kind of a follow-up to the last question. For you, Guell, can you say how many of those 60 enrollments were new starts versus switches? And more generally, do you think the initial population is going to be more new starts or switches? And what kind of patients do you think are the most likely to initially want to switch? Thank you. The insight you're asking for is the insight we will develop in the coming months and quarters. After five weeks to try to come with a general statement about what kind of patient, what kind of preference they have to go on to your treatment. I think it's too early for us to come with a conclusion but it is such a topic.

40:12 The only thing I can say, and Jay you can add on, what we see is basic coming from everywhere. It's not just a new patient, it's not just Swiss patient, it's coming everywhere from where we expect it also to come from. And one of the things we have done at Ascendis that Jay has made an impact on to help the physician, the patient, is really to have a pal that can go out and really help the physician, the patients everywhere to get through this journey to be sure they can come on the right treatment.

40:59 Jay, do you have anything to add? Yeah, I think you summed it up well. The only two additional things I would add is one, to Yan's point, we're seeing across all segments. And we've discussed before the three areas or types of patients that we envision coming are one, patients currently on Voxelgo that are switching over. Two, patients that were previously on Voxelgo, but since discontinued and were on no therapy. And then three, a patient that perhaps had never made the decision to start therapy at all. And we are seeing anecdotally that it's coming across all three of those groups. And I think really what that underscores is the continued and existing unmet need that exists in achondroplasia today, even with the existing therapy on market, which I think emphasizes the value of having you well on the market and the compelling value proposition that it offers patients.

41:57 I think the second area that Yan was talking about is our continued investment and just making sure that everything we're doing is hand in glove with patients, both as it relates to partnerships with the patient advocacy groups. But also as it relates to our scaling up of our patient access liaison team, which is our patient facing field group that invests in the support and the journey as they go through the continuum of prescription to ultimately being on therapy. All right, thank you. Thank you. One moment for our next question. Our next question comes from the line of Yun Zhong of Wedbush. Your line is now open. Hi, good morning. Thank you very much for taking the question. My question is on the monotherapy for hypochondriacalgia.

42:52 I remember that there have been some changes in terms of approach for that program, whether you're going to pursue that indication at all, and whether it's going to be mono or combo or maybe just wanted to know the, are you able to share any information regarding the thought process behind the decision if this is the final decision that you are going to just using monotherapy to target hypochondriacalasia? Thank you very much. Yeah, I think the strategy that we have applied to end communication where we started with monotherapy and then moving forward to the addition to combination therapy, I think you will see that as there will be alignment between the strategic approach that we have used in achondroplasia, we will likely also use in hypochondroplasia.

43:49 I can basically tell you that we're using the same principle between the two indications. The two indications is very much aligned in the fundamentals of the disease. There's only, you can say, different mutation, different severity, and other things like that, and we will implement the same thinking in treatment regime between these two indications. Thank you. One moment for our next question. Our next question comes from the line of Luca Asai, RBC Capitals. Your line is now open. Great. Yeah, thanks so much for taking my question. Maybe Jay or Scott, can you educate us on the mechanics of this free drug for Yorvipat?

44:35 Who are the patients that got the free drug? For how long do they stay on free drug? And are you expecting any patients still on free drug in Q2? Or is this just a kind of Q1 phenomenon? Any color there, much appreciated. And then super quickly, I think AstraZeneca's presenting the Phase III data for Enevo this week in the European Congress on Endocrinology. Wondering if you can comment on what are your expectations for that data? Thanks so much. Yeah, I can, in some way, start from the last question, and then I can move it up, then Jay can take over in the end. The compound we are talking about in the end is the amyloid compound, and you know we have discussed that on many earnings calls, the lack of information that was related to data.

45:28 Now that is disclosed some kind of information of the data packet one year after finalization of the phase three trial. And for me, and I think the key question, do this data packet provide an approvability of any way of this compound? And to my best judgment, I hope this product never will be approved, and I don't see really as possibility that it should be and going to be approved. So I think when we look on the competitive landscape for treatment in hypoperil, I see Europads, our once weekly approach to stable patient on Europads, is really providing the fundamentals for a twenty-thirty years treatment regime where I don't see anything that really can live up to the benefit we will see in the treatment with Europan or any other product that is currently in clinical development from that perspective.

46:38 Related to the first part of your question, you're right. We started to take over a heat December group of patients over to free drug because the essential part of your path is that you cannot stop. If you first have started taking you over to basic the element on what we call the conventional therapy, this basically is a disaster for the patient. So if there was a hiccup in the reimbursement, which there was a hiccup and it's something we had done, corrective action to ensure that we can handle it much better next year, we were in a position that we took and Scott explained the impact of that here in Q1 to take already from December until March series of patients on free drug and they are now coming back to be fully reimbursed.

47:36 And we are in a position that Jay and the organization in The US are some way have built up network or other things that can help it, that we're ending in the same situation one time more. I didn't have you any comments too? Again, think you summarized the need for Bridge program well. I think just to clarify the earlier question, there is two types of free programs. We have bridge program, which again is pretty standard across the industry for those that have experienced a temporary insurance lapse. But we also just have our patient assistance program for patients that are under insured or uninsured.

48:21 So I think that's an important point to note because there will always be some patients that qualify for the patient assistance program. So we don't anticipate that that will ever go away completely knowing that there will always be a certain level of patients that qualify for that. Yeah, I think that is a clarification. That's great from Jay. Where we talk about this number of patients is only what we exceeded as access compared to the base level of patients. We always will help and provide free drug if there is an element of something where there is a disruption of the normal way to have drug. It's such an essential drug for the patients that we always will take our patient focus first and if there's a patient that gets disrupted, we will do everything to help this patient and that includes also to take them for period on free drugs until the disruption is getting solved, and we will always be there for the patients.

49:26 Thanks so much. Thank you. One moment for our next question. Our next question comes from the line of Maxwell Skor of Morgan Stanley. Your line is now open. Hello. This is Selena on for Max. Thanks for taking our question. Given the relatively low treatment penetration in oncogenoplasia in The U. S. To date, what proportion of patients typically initiate treatment at age two years or older? I think some way to roll it a little bit back, because you can ask a question, Why do you have undertreatment in The US?

50:12 And I think actually this is the key question to find out how can we really help this patient better. And I think, and we believe, that the under treatment is facing the cause of lack of the right efficacy to show real benefit beyond linear growth. Many of these parents, children see linear growth as a key element. They really want us to address all the comorbidities, specifically if you can avoid leg surgeries or changing the pain complication with leg bone.

51:07 You can avoid lengthening, leg lengthening, and I believe by having this focus on these elements, and here I talk about the older children. If we go to a younger newborn, yes, if we can avoid any kind of spinal stenosis by having early intervention from newborns, Yes, there will be a major benefit for immediate treatment in the newborn state. So I believe our product profile that we have generated with you were showing as the only product, clear benefit beyond linacol compared to placebo.

51:58 It needs always to be placebo controlled because there is a development to the child so you cannot say, Oh, we also improve arm span or arm length. Yes, child with achondroplasia actually have a big increase in arm length, so you always need to really show it compared to a placebo controlled trial. It's the only way you can really adjust the benefit of the medical treatment needed. So the question and the answer to you is I believe Yorvil will be appealing product to the vast majority of parents, children in The US also because it will provide a way to address the comorbidities like important one leg bowing, arm strength, everything like that that you basic will see benefit for not only to quality of life that's associated with it, but also the element of physical strength.

53:05 Thank you. One moment for our next question. Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open. Hi, thank you and good morning and congrats on the good start with you as well. I was just wondering if you could clarify in terms of the 60 more than 60 prescriptions you've seen to date, whether it's more driven by treatment naive patients or switches, any quantification there would be great. And I'm also curious in terms of your early starts or through the quarter, if you're seeing potential utilization in the below two years of age population, even though that's not officially on label yet. Thank you.

53:52 Yeah, We need to come with a meaningful answer. We need longer time because we only have been there for four or five weeks now, and we want to make sure that what we see in the initial part of the launch is also being representative of what we'll see in the later stage of the lungs. So Paul, we can discuss it as Jay said in a perfect manner. We see patients coming in for all three different groups, which was a new group, patient that had discontinued and patient that come directly on switching for vosoritide. So often that we see it coming in for all three different groups. In the initial launch we will expect to see perhaps one mix and when we come a little bit longer into the launch we will potentially see a switch in the different three classes. And this is why really to make it meaningful we need to wait longer time before we can give you something you can do the right modeling on. But when I look at this number becoming up more than 10 patients per week, it's just an orphan drug indication.

55:06 I'm extremely proud that our product profile is getting so well recognized in the society in this way. Under two, I cannot comment on that currently. Okay, thank you. Yeah, hey, good morning and thanks for taking the questions. For the 70% cumulative US insurance approval rate that you previously cited, Can you give us any more color on what that cumulative rate looks like today? And then second, the EUR 500,000,000 operating cash flow target that you laid out previously, Are you reaffirming that guidance given the Q1 trends that you're seeing? And how should we think about the contribution of UVL to that target? Thank you.

55:54 Yeah, the last one, we would like to come back in Q2 because we have a lot of positive element coming in now. We have the selling of our PIVVC team and those of you were going much much stronger than I even myself had hoped for. So apart from that, we will come with a claims guidance, but we will prefer to do it after our Q2 call, and we will give you what will be reflected on '26. Scott is saying yes to me. And Jay, you can give the factual number, how it's improving the overall numbers. Sure. So the overall cumulative approval rate since launch has continued to creep up as well. I think we're now closer to mid 70%, which again is incredibly high for any rare disease asset, much less one that has been on the market for the amount of time that we have.

56:55 A lot of that is just a function of time, given the favorable access policies that we have. So even some enrollments that might be many months old are coming through on appeal online, which would affect the cumulative approval rate over time. But given that it is a lagging indicator, it will take quite a bit of time for that metric to mature. Got it. Thank you. You. One moment for our next question. And our last question comes from the line of Cecilia Hernandez of Van Lanshaw, Kempen. Your line is now open. Hi. Thanks for taking our questions. This is Sandrine on for Shishida.

57:42 So given the revenue now from trade commercial products, the redemption of the convertible notes and the sales of the PRV, can you tell us anything of your on your capital allocation strategy? What is the order of priority for you guys? I think, Scott, the one really to answer the last question for today. So Scott, get this opportunity now. Thanks a lot, Ian. Of course, as you've seen with our R and D success, a key component for us is to invest in R and D and allocate capital there to continue to sustain not only into the 2030s, but the 40s and beyond with the continuous flow of new products.

58:27 I think Yan highlighted four new NCEs in his prepared remarks, and you'll learn about more of those in the coming future. And of course, I think after we give an update after Q2, as Yan mentioned, to our outlook for the rest of the year, you may get more color at that point as well. Thank you. That's all the time we have for questions. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.