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Investor releaseQuarter not tagged2026-08-20Ascendis Pharma (ASND) Reports Earnings And Trial Updates, Is It Fully Priced?
Simply Wall St.
Ascendis Pharma (ASND) Reports Earnings And Trial Updates, Is It Fully Priced?
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Ascendis Pharma (NasdaqGS:ASND) caught investor attention after reporting second quarter 2026 results on August 13, alongside fresh clinical updates on its TransCon CNP programs in growth disorders. The company reported second quarter sales of €339.29 million, with net income of €206.97 million and basic earnings per share from continuing operations of €3.22, based on its latest earnings release. See our latest analysis for Ascendis Pharma. Since those announcements, Ascendis Pharma’s share price has moved to $259.62, with a 1-day share price return of 4.33% and a year to date share price return of 5.80%, which indicates gradually building momentum around the earnings and trial updates. If the TransCon CNP data has you watching growth disorder treatments more closely, it can be helpful to see what else is moving in related healthcare AI and data driven drug development. You can start that comparison with the 42 healthcare AI stocks. After a sharp move in Ascendis Pharma following its earnings and TransCon CNP updates, the debate now is simple: Has the stock already priced in the good news, or does the current valuation still leave room for upside? The most followed narrative on Ascendis Pharma puts fair value at $304.60, compared with the recent $259.62 close, and anchors that view in TransCon driven growth and margins. Read the complete narrative. Want to understand why this narrative supports a higher fair value for Ascendis Pharma? It leans on rapid top line expansion, robust profitability, and a future earnings multiple that implies sustained confidence in execution. Result: Fair Value of $304.60 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, there are still watchpoints for Ascendis Pharma, including the risk that YORVIPATH uptake slows or that TransCon CNP approvals and rollouts take longer than analysts expect. Find out about the key risks to this Ascendis Pharma narrative. Given the mix of optimism and caution around Ascendis Pharma, now is a good moment to move quickly and test the numbers yourself using the 4 key rewards and 1 important warning sign. If Ascendis Pharma has you thinking more broadly about your portfolio, this can be a good time to widen your search and compare…Read full documentShow less
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Ascendis Pharma (NasdaqGS:ASND) caught investor attention after reporting second quarter 2026 results on August 13, alongside fresh clinical updates on its TransCon CNP programs in growth disorders. The company reported second quarter sales of €339.29 million, with net income of €206.97 million and basic earnings per share from continuing operations of €3.22, based on its latest earnings release. See our latest analysis for Ascendis Pharma. Since those announcements, Ascendis Pharma’s share price has moved to $259.62, with a 1-day share price return of 4.33% and a year to date share price return of 5.80%, which indicates gradually building momentum around the earnings and trial updates. If the TransCon CNP data has you watching growth disorder treatments more closely, it can be helpful to see what else is moving in related healthcare AI and data driven drug development. You can start that comparison with the 42 healthcare AI stocks. After a sharp move in Ascendis Pharma following its earnings and TransCon CNP updates, the debate now is simple: Has the stock already priced in the good news, or does the current valuation still leave room for upside? The most followed narrative on Ascendis Pharma puts fair value at $304.60, compared with the recent $259.62 close, and anchors that view in TransCon driven growth and margins. Read the complete narrative. Want to understand why this narrative supports a higher fair value for Ascendis Pharma? It leans on rapid top line expansion, robust profitability, and a future earnings multiple that implies sustained confidence in execution. Result: Fair Value of $304.60 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, there are still watchpoints for Ascendis Pharma, including the risk that YORVIPATH uptake slows or that TransCon CNP approvals and rollouts take longer than analysts expect. Find out about the key risks to this Ascendis Pharma narrative. Given the mix of optimism and caution around Ascendis Pharma, now is a good moment to move quickly and test the numbers yourself using the 4 key rewards and 1 important warning sign. If Ascendis Pharma has you thinking more broadly about your portfolio, this can be a good time to widen your search and compare opportunities using targeted stock lists. Target future growth by scanning companies that look mispriced on fundamentals using the 52 high quality undervalued stocks. Strengthen your income stream by reviewing stocks that appear built for reliable payouts through the 12 dividend fortresses. Protect your downside by focusing on companies with steadier profiles using the 78 resilient stocks with low risk scores. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ASND. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-20Ascendis Pharma (ASND) Q2 2026 Earnings Call Transcript
Motley Fool
Ascendis Pharma (ASND) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8 a.m. ET Vice President of Investor Relations - Chad Fugure President and Chief Executive Officer - Jan Mikkelsen Chief Financial Officer - Scott Smith Chief Business Officer - Sherrie Glass Executive Vice President and President, Ascendis U.S. - Jay Wu Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Second Quarter 2026 Ascendis Pharma Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugure, Vice President of Investor Relations. Please go ahead. Chad Fugure: Thank you, operator, and thank you, everyone, for joining our second quarter 2026 financial results conference call. I'm Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; and Jay Wu, Executive Vice President and President, Ascendis U.S. Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. All statements made on this call other than the statements of historical fact are forward-looking statements. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA, YORVIPATH and YUVIWEL, including label expansion and combination treatment, 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 and planned regulatory filings and our expectations regarding the timing and results of regulatory decisions and our financial outlook and Vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place undue r…Read full documentShow less
Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8 a.m. ET Vice President of Investor Relations - Chad Fugure President and Chief Executive Officer - Jan Mikkelsen Chief Financial Officer - Scott Smith Chief Business Officer - Sherrie Glass Executive Vice President and President, Ascendis U.S. - Jay Wu Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Second Quarter 2026 Ascendis Pharma Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugure, Vice President of Investor Relations. Please go ahead. Chad Fugure: Thank you, operator, and thank you, everyone, for joining our second quarter 2026 financial results conference call. I'm Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; and Jay Wu, Executive Vice President and President, Ascendis U.S. Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. All statements made on this call other than the statements of historical fact are forward-looking statements. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA, YORVIPATH and YUVIWEL, including label expansion and combination treatment, 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 and planned regulatory filings and our expectations regarding the timing and results of regulatory decisions and our financial outlook and Vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place 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 of our annual report on Form 20-F filed with the SEC on February 11, 2026. In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believe these measures are useful to investors is included in today's press release. TransCon Growth Hormone or TransCon hGH is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency in addition to the treatment of pediatric growth hormone deficiency and in the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. 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 PTH as a 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 2 years of age and older with achondroplasia with open epiphyses. Continued approval for this indication, which was based on an improvement of annualized growth velocity may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I've just described, our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter 2026 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan. Jan Mikkelsen: Thanks, Chad. 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 and 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 our highly differentiated approved protein and peptide-based combination products, SKYTROFA, YORVIPATH and YUVIWEL. We believe these products will be the key driver of our growth story for the next 10 to 15 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 1 IND or [ CTA ] yearly each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutic areas in addition to hypopara and growth disorder. 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 us begin with a more detailed look at YORVIPATH. YORVIPATH is the first and only approved treatment for adults with hypopara that addressed the underlying disease by replacing the missing endogenous PTH throughout the body. Uptake of YORVIPATH has grown steadily since launch, both in the U.S. and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic regions 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. YORVIPATH is now available commercially or through named patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid broad global launch of a rare disease product. In the U.S., new patient demand for YORVIPATH in the second quarter has remained robust, consistent with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated YORVIPATH treatment continue to stay on therapy, indicating a high level of satisfaction. We continue to be excited by the growth of YORVIPATH in the U.S. and outside the U.S. and to see its continued strong launch performance. Data from our long-term Phase II and Phase III trials of YORVIPATH presented in the second quarter highlight why YORVIPATH is becoming a standing standard of care in postsurgical and all subset of hypopara, including ultra-rare genetic causes like DiGeorge, ADS-1 and ADS-2. Results showed sustained response rate of 82% to 86% for the multicomponent endpoint with clinical benefit across multiple organ systems, CNS, kidney, small intestine and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after 5 years of treatment, pretty unique. In parallel, we are working to further advance our leadership in hypopara 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 YORVIPATH. Turning now to YUVIWEL. We believe YUVIWEL is positioned to become the market leader therapy for achondroplasia. Rapid uptake of YUVIWEL is already transforming the U.S. market. Across the board, we see a highly favorable response among patients and physicians to YUVIWEL's differentiated profile. In the U.S. through June 30, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollment and more than 65% approved for reimbursement in the U.S. through the end of July, really a unique launch. The rapid uptake is by patients of all kinds of background, those switches returning to medical therapy or starting therapy for achondroplasia for the first time. We believe YUVIWEL 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 an area where there still exists a high unmet medical need. Long-term data for the now completed pivotal ApproaCH trial showed durable and consistent improvement in growth like leg bowing, body proportionality along with a general well-tolerated safety profile compared to placebo, underscoring why the community is quickly adopting YUVIWEL. In the U.S. and the EU, a regulatory decision for YUVIWEL is expected in the fourth quarter of 2026. We are also making YUVIWEL available in select international markets through early access program using the U.S. FDA approval. Longer term, we are pursuing expansion opportunities for TransCon CNP to ongoing and planned trials. These include ongoing activities such as infants, 0 to less than 2 years of age, and we recently announced completion of this target enrollment faster than expected. Adults with achondroplasia, children with hypochondroplasia and still continue geographic expansions. 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 overactive FGFR3 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-1 growth hormone axis. This is illustrated by children with achondroplasia have a negative IGF-1 SDS value as shown of the demographic in both our Phase II and Phase III trial. In our COACH clinical trial of children with achondroplasia, this unique combination has demonstrated sustained transformative annualized growth velocity and ACH 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 COACH trial data show sustained efficacy over 78 weeks with no compromises to safety and tolerability. This points to the potential for this novel combination to establish a new treatment standard in achondroplasia. 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 of unmodified somatropin. With indications for pediatric and adult growth hormone deficiency, we continue to be the #1 long-acting growth hormone by brand value in the U.S. We are extremely proud that SKYTROFA recently achieved more than 20,000 unique enrollment. This illustrates the strength of our capabilities from supply chain, commercial infrastructure and market support to benefit such a large number of patients -- rare disease patients. And we are working to make TransCon Growth Hormone available to more patients through label and geographic expansions. To support label expansion as described in our achondroplasia program, we are conducting the Phase III basket trial investigating TransCon Growth Hormone in ISS, SGA and Turner syndrome. As an integrated part of our global growth disorder strategy, we expect to launch TransCon Growth Hormone in the same countries where we also expect to launch TransCon CNP. Turning now to our partnership. In metabolic disorders and obesity, our once-monthly TransCon semaglutide program with Novo Nordisk continue to advance. In ophthalmology, our partner, Eyconis recently initiated a first-in-human clinical trial of the anti-VEGF treatment built on the TransCon technology in patients with wet AMD. In closing, by always putting patient first, Ascendis has delivered 3 highly differentiated leading TransCon-based products, YORVIPATH, YUVIWEL and SKYTROFA. 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. Scott Smith: Thanks so much, Jan, and good afternoon, everyone. I will touch on some key points surrounding our second quarter financial results. For further details, please refer to our Form 6-K filed today. Total product revenue was EUR 315 million, more than doubling year-over-year. Total revenue for Q2 2026 was EUR 339 million which included nonproduct collaboration revenue of EUR 24 million, which further included a EUR 17 million milestone related to TransCon CNP. YORVIPATH revenue was EUR 252 million 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. SKYTROFA contributed EUR 55 million in Q2 which reflects increased demand in the U.S. and includes product sales to a collaboration partner. YUVIWEL was commercially launched in the U.S. during Q2 and generated EUR 8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking. Continuing to expenses. R&D expenses in Q2 were EUR 76 million, up from EUR 59 million in Q1, reflecting continued investment in our pipeline and innovation. Recall, Q1 included a favorable EUR 11 million reversal of prior period write-downs of TransCon CNP prelaunch inventories. SG&A expenses were EUR 173 million in Q2 compared to EUR 145 million in Q1, reflecting additional investments in the commercial launches of YORVIPATH and YUVIWEL to accelerate growth for the long term. Operating profit of EUR 220 million in Q2, included EUR 158 million of other operating income related to the sale of the PRV. Non-IFRS operating profit was EUR 92 million and non-IFRS operating margin was 27%, refer to our press release for details. For Q2 '26, net profit was EUR 207 million, and non-IFRS net profit was EUR 61 million. We ended Q2 2026 with EUR 812 million in cash and cash equivalents, which includes the use of EUR 56 million 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 EUR 1.4 billion of equity. Turning to our outlook for the rest of 2026. For YORVIPATH, we expect growth and performance consistent with prior quarters. For SKYTROFA, we expect relatively stable revenue in the U.S. For YUVIWEL, we are encouraged by the early demand trends. We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the U.S., reflecting the large unmet medical need and the highly differentiated profile of YUVIWEL. Our Q2 performance reinforces our belief that we can achieve EUR 5 billion in revenues in 2030. With our existing portfolio and our TransCon technology as a strong foundation we believe we are well positioned to grow revenue to more than EUR 10 billion 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. Even with these investments, we expect to generate more than EUR 500 million in cash flow from operating activities this year. With that, operator, we are now ready to take questions. Operator: [Operator Instructions] And our first question is going to come from Jessica Fye with JPMorgan. Jessica Fye: On that outlook for at least EUR 500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale. And I was just wondering if you're able to kind of update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded. But curious, if anything more you can add there? And then on that comment that YUVIWEL seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion? Jan Mikkelsen: Thanks, Jess, for the questions. And I have a happy person besides me, Scott. So Scott got the opportunity to be the first one answering questions. So please, Scott. Scott Smith: Yes. With respect to our cash flow guidance, just to be clear, greater than EUR 500 million, I thought you -- I heard you say EUR 100 million, so greater than EUR 500 million. And at this time, we don't want to bound the upper side because we're initial into the launch of YUVIWEL. And that's Europe, by the way, EUR 500 million, Jan likes to point out. Jan Mikkelsen: 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 feeling and how we see it is that with such a strong demand, we have a really strong belief that it is not only coming from switches, it must also coming from either patients that have stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of YUVIWEL that they want to start therapy. And I think this is where we have this strong belief that we see an expansion of the market. Operator: And the next question is going to come from Tazeen Ahmad with Bank of America. Tazeen Ahmad: So Jan, I wanted to get your thoughts about the IP challenge on YUVIWEL. We know obviously what the blue sky scenario is for Ascendis and most of the scenarios look positive. But can you just maybe walk us through what the potential outcomes are? This is for a patent that expires, obviously, in 2030. And so between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst-case scenario could be? Jan Mikkelsen: Thanks, Tazeen, for the question. And it's basically a question that is addressing the ongoing legal I would call it, battle between Ascendis and BioMarin. And let me just come back to some facts. The fact is that this patent that is in discussion got completely invalid in Europe. So we never really come to a discussion if we were infringing and anything like that. So when we see the situation outside U.S., we got the patent invalid immediately to the patent system in Europe. In the U.S., 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 traditional never have really dealt with a lot of cases that dealing with branded pharmaceutical. In the ITC case, there will be a first opinion from a single judge, and he will come with opinion here in August. And then there will be a -- next time will be in December, there will be an opinion from the ITC. And then later on, there will be a potential confirmation of the ITC decision 2 to 3 months after to a presidential order. So you can see we are not guiding any clarification in August in one way or the other way, even if it's positive 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 interest for this product. And when we see the public interest, meaning the element of how these product opportunities are really being serving an unmet medical need in the U.S. market with this rapid uptake of patients is really, really clear that 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 -- it's a U.S., it has been cleared ex U.S. And so whatever has happened, it will not have any material impact on Ascendis pathway. 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 taken into the perspective what it means for Ascendis. And out from that, I see it's not really is a material element for our destiny to be a leading biopharma and hit the EUR 5 billion in 2030. Operator: And our next question will come from Gavin Clark-Gartner with Evercore. Gavin Clark-Gartner: 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? Jan Mikkelsen: It was because I somewhat felt that the 2 product opportunities that we have developed through our partnership built on the TransCon technology will still consider as an NCE, the one that's now in clinic with Eyconis and the other one we expect to go into the clinic now with Novo Nordisk is still somewhere being developed to the TransCon technology funnel. And again, perhaps I shouldn't have done that, but I still believe I feel some kind of a little bit of ownership on these 2 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 2 new chemical entities being entered into clinical trials. And I think Kennett and his team and anyone else, they are working very hard on that there will be at least one of these new chemical entities coming into every year now. And I'm really proud about that. But it's also addressing the sustainability of Ascendis independent of going out and buying something no one else want to have. And I think this is where we really feel extremely pleasant by the situation by being a fundamental company that's building on a strong, strong technology platform that provide both sustainability for ourselves, but also a continued flow of potential partner licensing. Operator: And the next question will come from Yaron Werber with TD Cowen. Yaron Werber: Great. A question on YUVI. Do you expect that there is some seasonality in terms of new patient starts in the summer as kind of kids are going on vacation. We're getting a lot of questions on sort of the 60 patient start forms kind of in April and now you're sort of at 220. It sounds like there's like 50 per month now. Is that sort of sustainable from now on? And then it sounds like you're planning -- you think you could be the #1 brand by the end of the year. BioMarin, we think, has about 750 patients on drug you think in the U.S. Are you kind of referring to getting to a higher number than that by, let's say, late February? Jan Mikkelsen: Thanks for the question. I actually don't think Ascendis have really made some clear forward-looking statement related to how we see YUVIWEL being accelerating and expanding the market in a quantitative manner. I don't think we have come with any kind of indication related to that. I have no doubt it will do it, but it's not the same thing that we're going to quantify it currently. I think after basic only 4 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 on trends and other things like that. But 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. Jay Wu: Thanks, Jan. As Jan mentioned before, 4 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 YUVIWEL uptake, whether it's prescriber reach, we talk a lot a bit before around this space, there's quite a few centers of excellence. We're seeing 80% of them, nearly 80% already in a short 4-month period already prescribed YUVIWEL to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm, I think you can see in early days we're seeing a very positive trajectory. While we don't explicitly collect information on what therapy or non-therapy, a patient is coming from. And again, that's driven largely by the fact that we have a broad label. So we don't need that information in order to ensure that this patient can get on therapy. This is rare disease. So qualitatively, we have heard confirmed anecdotes across all 3 categories for which our patients are coming from. And those 3 categories, again, are: one, patients that are switching from current therapy; 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 YUVIWEL, 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. Jan Mikkelsen: Just to summary to add on to Jay's excellent comments. Ultimately, we have no doubt we will be #1 in the achondroplasia space. Ultimately, we will expand the market because of the unmet medical need. And that is just with the monotherapy. And when you look at how commitment we are after this era, where we now are making a complete new standard with the [indiscernible] treatment. I believe we have dedicated to be not #1 in the first year, but continue to build for the next 5 to 10 years with monotherapy combination integrated treatment regimes. And I believe with our once-weekly TransCon product built on growth hormone and CNP we are extremely, extremely well positioned really to be the leader in this segment. Operator: And our next question will come from Derek Archila with Wells Fargo. Derek Archila: Congrats on the progress. Scott, I just wanted you to clarify a comment on YORVIPATH growth for the rest of the year. I think you said it's going to be like prior quarters. I guess which 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 could just clarify which quarters you are referring to? Scott Smith: Yes, Derek, thanks for the question. I think that 2 points. One is the consistent performance with the KPIs that we've given you, for example, with enrollments, we expect those to continue and be consistent. The other would be -- and you could refer to our prior quarters and maybe Chad can point to prior comments. But I think that now that we've seen the full year, you know the various trends that 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. Chad Fugure: Just to give you some kind of what is our value in this year. The value for us, we want to give you -- we want to give you not so you basic getting a lower number, so we look like heroes. We want to give you the number so you are right nearly every time. And I think this is the way we try to come up with our different mathematic algorithm, 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 somewhere feeling always comfort with the guidance we give you. Operator: And our next question will come from Joseph Schwartz with Leerink. Joseph Schwartz: Congrats on all the progress. As you embark on a Phase III in hypochondroplasia, I wanted to ask how you're defining the enrolled population? And how do you -- how large do you see the diagnosed treatable pool of hypochondroplasia patients who are not already being treated in some cases, if they're at the more severe end versus achondroplasia? Jan Mikkelsen: Yes. This is from -- 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 is the underlying disease is. And then you go out and do more and more and more genetic testing. And then when you find a mutation in the FGFR3 receptor and you find it in the right regions, and then you suddenly are not an ISS patient, but then you find hypochondroplasia patient, even if you don't have, you can say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia patient that we saw for 10 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 [indiscernible] will have a short status without potential have the other element that you see for the phenotype of that. So this is where you can then -- when you go into ISS, are you defined it from a genetic perspective or you define it for a phenotype or anything like that. And we are in a situation where when you see the clinical trial, how we're doing it, you will basically see that it's one of the pathway we have selected. Operator: And our next question will come from Daniel Bronder with Cantor. Daniel Bronder: Congrats on the quarter. On for Li Watsek. We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics? Jan Mikkelsen: Just to recall, the COACH trial is the combination trial where we're combining the 2 TransCon based product, our TransCon Growth Hormone and TransCon CNP. And I have to say, when I look on elements like arm span, it's actually -- we already reported some of the data. We have reported the 52-week 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 we have so many IR people I don't know all names now. So from that perspective, it is already came out. And I have to say there was one of the -- I will say, extremely positive surprises I saw because when we look on monotherapy, but either a CNP-based one or a growth hormone based one, we did not see the expected hopeful development that we can hope for. But we definitely saw it when we look under combination therapy. 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 kind of limb elongation surgeries in achondroplasia, both related to both legs and arms by that. And it's this Slide #5, as I remember it. And what we see, Scott, read up. Scott Smith: The unprecedented improvements in the arm span with combination were plus 9.4 centimeters with TransCon CNP naive cohort 7.9 centimeters with the TransCon CNP-treated cohort. Jan Mikkelsen: So it was really and... Scott Smith: Compared to limb lengthening surgery, 8 centimeter. Jan Mikkelsen: 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. Operator: And our next question will come from Yun Zhong with Wedbush. Yun Zhong: I wanted to confirm that you have not provided prescription number for YORVIPATH in case I missed anything. And 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. 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? Jan Mikkelsen: You are right. And I think it's starting to be a little bit positive 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. 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 in enrollment of unique new patients. And here, we are referring to the U.S. with about 1,000 new patients every quarter, and we don't believe really. Now we went over to YUVIWEL. So now we're starting to give you a unique prescription enrollment of YUVIWEL instead. So we always -- we have one product opportunity where you will have something to play with numbers and everything like that. Scott, do you have some comments to the last one? Scott Smith: Yes. I think our comments were directed to assume the metrics that we've given YUVIWEL are consistent because Jan 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. Operator: And the next question comes from Alex Thompson with Stifel. Alexander Thompson: Jan, I appreciate the color you provided to Tazeen's question around the ongoing legal battle with BioMarin. I guess as we think about potential scenarios here and again, acknowledging sort of this idea around the public interest of the product and unmet need. Do you see a settlement as a reasonable scenario to think about? Or is that really not something that you think is reasonable? Jan Mikkelsen: 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. Operator: And the next question will come from Maxwell Skor with Morgan Stanley. Maxwell Skor: 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? Jan Mikkelsen: I think you're 100% correct. And when we see a patient being successful coming into a treatment with YORVIPATH coming over titration part on it and be into the treatment after that, we see extremely, extremely low dropout. And I think that illustrates one thing, the patient satisfaction with this treatment because now often being asked, what can we do more for these patients in the therapeutic treatment on it. And want to see the satisfaction that it is in this way, then I think that there is an extremely good precision, 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 1 diabetes and other things like that. So now you're addressing the element where we're saying is we developed this year with a once-weekly 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 patient off of conventional therapy. At the same time, you increase the PTH in replacement therapy. And this is why 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 basic and hold the patient in this period. So we also can make that extremely successful. So when you get a prescription, we know everything will be much more successful for the patient not just after they are really 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? Jay Wu: Absolutely. I can chat a little bit more about certainly, the investments that we're making and also to answer your questions around drop-off and re-auths. 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. . And then for re-auth, that's actually pretty routine for us. So there really isn't much there in terms of it being a measurable effects on any kind of ongoing patient support, we have patients re-authing 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 we've deemed our patient access liaisons, they support patients both pre prescription as well as through the prescription process and post. So essentially, we've seen a lot of success in early days with this field team being able to engage with this patient community. They have appreciated this high level of support and we, of course, support them throughout the journey to ensure that we're optimizing for patient experience. Jan Mikkelsen: One thing that's imminent. Now we focus more on U.S., but there is still a world outside U.S. Outside the U.S., we have not seen the same level of drop out in this phase. It looked like the interaction is pretty well established between the physician and the patients and support system, we need to see it without this kind of drop out. So it basically is a U.S. issue. And so therefore, we know we can get it to function. We just need to ensure that the support system also in U.S. is strong enough to be sure that it's not a problem. Operator: And our next question will come from Eric Joseph with Citi. Eric Joseph: As far as your named access 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 name patient programs could be meaningful contributors to patient volumes this year for YUVIWEL in particular. Jan Mikkelsen: Okay. I just wanted to ask what product you were referring to. Eric Joseph: YUVIWEL. Jan Mikkelsen: Yes. I can guarantee that as we basic in our prepared remarks, tried to put emphasis on. We have a global infrastructure in commercialization and patient support, product supply and everything like that. Just the number of SKYTROFA rare disease patients we have taken over to the system, more than 20,000 patients. We are having the system functional more than in 35 different countries. So we're not a company that just need to get started. We already have established all this infrastructure. And what we're doing is that we are utilizing this established infrastructure basically that got established because of YORVIPATH because this is what we did with YORVIPATH. We're using exactly the same infrastructure also for YORVIPATH. So we will be where patient is, and we'll be quite sure we will also serve the patient outside U.S. and potentially the market is much larger outside U.S. And I think we hope we also will see a large penetration in the U.S. where another short-acting product really failed to do it. And we believe because of the highly differentiated nature of YUVIWEL, 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. And 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. Operator: And the next question will come from Luca Issi with RBC CM. Unknown Analyst: [indiscernible] for Luca. Circling back to YUVIWEL, and Jay the 3 categories that you very nicely touched on for the naive switch and discontinued patients that are not on script. BioMarin mentioned on their second quarter call that less than 100 patients have switched off of VOXZOGO. So the simple math that we're trying to do here is that it leaves you with about 70 patients in the second quarter who are naive or return to treatment. So that's taken off the switch patients. But 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 VOXZOGO stopped treatment and are now returning to treatment but to YUVIWEL? And separately, very quickly, if you've commented or not on the ex U.S. strategy for YUVIWEL, given the decision is pending and the [indiscernible] coming very soon this year. Jan Mikkelsen: I like your way of doing all the calculation, anything like that. I cannot support it or I cannot deny it because I don't have the factual 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 U.S. for me to understand your question, was this reflecting what is the limitation in the ex U.S.? Or what was the question? Unknown Analyst: Thanks for asking to clarify it. More about are you committed to running the show by ourselves or you're considering partnering given that 70% of the VOXZOGO sales is historically coming from ex U.S. can be a quite heavy lifting? Jan Mikkelsen: Yes. But -- so basic in the ex U.S., we have our direct markets, which are, I think, 60, 70, 80 where we have our own commercial infrastructure, anything like that is pretty, pretty clear what we're doing there. Then we have our sales and distribution agreement. And this is, I think, it's 70 countries or something like it. Well, Scott it's... Scott Smith: 80 Jan Mikkelsen: 80 countries that is covering this sales and distribution agreement. And the vast majority of all of them are all 3 products. So basic is already established infrastructure for the distribution. And then we have the 2 other. The third model where we have our partnerships, one in Japan, one in China, and they also have all the 3 products. So we don't need to go out and make any new agreements for anything -- everything is established. Everything is running on full speed. And we -- for some of the EU direct market, we're just waiting for our expected approval here in Q4 this year. Operator: And our last question is going to come from Faisal Khurshid with Jefferies. Faisal Khurshid: Just wanted to ask a little bit on the YORVIPATH life cycle 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 YORVIPATH? Jan Mikkelsen: Yes. What we see today is that we are enrolling the trial in the U.S. where we're evaluating the 30 to 60 dose ranges in 2 different means that has been aligned with the FDA in their design, what they wanted to see. And we see that enrollment going extremely fast. So we expect very, very, very fast. And you can say, label expansion in the place where we don't have up to the 60. So we see that basic -- just on execution. And your second question was related to? Faisal Khurshid: On weekly YORVIPATH, any update there? Jan Mikkelsen: Yes. I think there's no news in this way that we're just executing and getting it into the market as fast as possible from the expectation that we see that not as any kind of LCM activity, but more a patient support for patients that really are in the stable dosing which are not a lot after they have been in a situation where there have been stabilized with our daily treatment. Operator: 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. Jan Mikkelsen: Thanks a lot, everyone. Before you buy stock in Ascendis Pharma A/s, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Ascendis Pharma A/s wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $432,621!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,314!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 20, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Ascendis Pharma A/s. The Motley Fool has a disclosure policy. Ascendis Pharma (ASND) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-14Ascendis Pharma Reports Solid Yorvipath Quarter; Yuviwel Off to Strong Start, RBC Says
MT Newswires
Ascendis Pharma Reports Solid Yorvipath Quarter; Yuviwel Off to Strong Start, RBC Says
Ascendis Pharma's (ASND) Q2 results showed a solid rebound for Yorvipath, while the early launch of
Investor releaseQuarter not tagged2026-08-13Ascendis Pharma AS (ASND) (Q2 2026) Earnings Call Highlights: Revenue Doubles to EUR315 ...
GuruFocus.com
Ascendis Pharma AS (ASND) (Q2 2026) Earnings Call Highlights: Revenue Doubles to EUR315 ...
This article first appeared on GuruFocus. Total Product Revenue: EUR315 million in Q2 2026, more than doubling year-over-year. Total Revenue: EUR339 million, including EUR24 million in non-product collaboration revenue (with a EUR17 million milestone related to TransCon CNP). YORVIPATH Revenue: EUR252 million in Q2, reflecting consistent US demand and continued global growth. SKYTROFA Revenue: EUR55 million in Q2, reflecting increased US demand and including product sales to a collaboration partner. YUVIWEL Revenue: EUR8 million in its first quarter on the US market, reflecting strong demand and rapid conversion to paid therapy. R&D Expenses: EUR76 million in Q2, up from EUR59 million in Q1, reflecting continued pipeline investment. SG&A Expenses: EUR173 million in Q2, compared to EUR145 million in Q1, reflecting investments in commercial launches. Operating Profit: EUR220 million in Q2, including EUR158 million of other operating income from the sale of a PRV. Non-IFRS Operating Profit: EUR92 million, with a non-IFRS operating margin of 27%. Net Profit: EUR207 million in Q2; non-IFRS net profit was EUR61 million. Cash and Cash Equivalents: EUR812 million at the end of Q2 2026, after using EUR56 million for share repurchases. Cash Flow Outlook: Expects to generate more than EUR500 million in cash flow from operating activities in 2026. Warning! GuruFocus has detected 5 Warning Sign with ASND. Is ASND fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total product revenue more than doubled year-over-year to EUR315 million in Q2 2026, with YORVIPATH achieving blockbuster status on a run-rate basis in its second year of US launch. YUVIWEL, launched in the US during Q2, generated EUR8 million in its first quarter on the market, with rapid uptake to over 220 enrolled patients and more than 65% approved for reimbursement by end of July. YORVIPATH shows strong patient retention (95% after five years) and sustained response rates of 82-86% across multiple organ systems, supporting its position as a standard of care in hypoparathyroidism. The company is on track to achieve its Vision 2030 objective of EUR5 billion in revenues, with a strong pipeline including combination therapy (TransCon CNP + TransCon Growth Hormone) showing…Read full documentShow less
This article first appeared on GuruFocus. Total Product Revenue: EUR315 million in Q2 2026, more than doubling year-over-year. Total Revenue: EUR339 million, including EUR24 million in non-product collaboration revenue (with a EUR17 million milestone related to TransCon CNP). YORVIPATH Revenue: EUR252 million in Q2, reflecting consistent US demand and continued global growth. SKYTROFA Revenue: EUR55 million in Q2, reflecting increased US demand and including product sales to a collaboration partner. YUVIWEL Revenue: EUR8 million in its first quarter on the US market, reflecting strong demand and rapid conversion to paid therapy. R&D Expenses: EUR76 million in Q2, up from EUR59 million in Q1, reflecting continued pipeline investment. SG&A Expenses: EUR173 million in Q2, compared to EUR145 million in Q1, reflecting investments in commercial launches. Operating Profit: EUR220 million in Q2, including EUR158 million of other operating income from the sale of a PRV. Non-IFRS Operating Profit: EUR92 million, with a non-IFRS operating margin of 27%. Net Profit: EUR207 million in Q2; non-IFRS net profit was EUR61 million. Cash and Cash Equivalents: EUR812 million at the end of Q2 2026, after using EUR56 million for share repurchases. Cash Flow Outlook: Expects to generate more than EUR500 million in cash flow from operating activities in 2026. Warning! GuruFocus has detected 5 Warning Sign with ASND. Is ASND fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total product revenue more than doubled year-over-year to EUR315 million in Q2 2026, with YORVIPATH achieving blockbuster status on a run-rate basis in its second year of US launch. YUVIWEL, launched in the US during Q2, generated EUR8 million in its first quarter on the market, with rapid uptake to over 220 enrolled patients and more than 65% approved for reimbursement by end of July. YORVIPATH shows strong patient retention (95% after five years) and sustained response rates of 82-86% across multiple organ systems, supporting its position as a standard of care in hypoparathyroidism. The company is on track to achieve its Vision 2030 objective of EUR5 billion in revenues, with a strong pipeline including combination therapy (TransCon CNP + TransCon Growth Hormone) showing unprecedented improvements in arm span (up to +9.4 cm) in the COACH trial. Ascendis has a robust global commercial infrastructure, with YORVIPATH available in more than 35 countries and SKYTROFA reaching over 20,000 unique patients, enabling rapid expansion for YUVIWEL and future products. The company ended Q2 2026 with EUR812 million in cash, no bank or convertible debt, and expects to generate more than EUR500 million in operating cash flow this year, providing financial stability for continued growth. The ongoing ITC legal battle with BioMarin over YUVIWEL (TransCon CNP) creates uncertainty, with a first opinion expected in August 2026 and a final decision potentially delayed until late 2026 or early 2027, which could impact US market access. YORVIPATH patient enrollment in the US has plateaued at approximately 1,000 new patients per quarter, and the company has stopped providing specific numbers, which may limit visibility into growth trends. SG&A expenses increased significantly to EUR173 million in Q2 (up from EUR145 million in Q1), reflecting heavy investments in commercial launches that could pressure near-term profitability. The company has not provided quantitative guidance on YUVIWEL's market expansion or the split between new, switched, and returning patients, making it difficult to assess the sustainability of its rapid uptake. R&D expenses rose to EUR76 million in Q2 (up from EUR59 million in Q1), driven by pipeline investments, but the company has not yet filed an IND for a new chemical entity this year, despite its goal of at least one annually. The company faces potential seasonality in YUVIWEL patient starts during summer months, and management has not provided clear guidance on whether the current monthly enrollment pace of ~50 patients is sustainable. Q: On that outlook for at least $500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale. And I was just wondering if you're able to kind of update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded. But curious, if anything more you can add there? And then on that comment that YUVIWEL seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion.A: Scott Smith (CFO): With respect to our cash flow guidance, just to be clear, greater than EUR500 million. At this time, we don't want to bound the upper side because we're initial into the launch of YUVIWEL. Jan Mikkelsen (CEO): We don't have really the insight in exactly the distribution of where the patients are coming from. Our general feeling is that with such a strong demand, it's not only coming from switches. This must also come from patients that had stopped therapy or new patients that are coming to a situation because of the highly differentiated nature of YUVIWEL that they want to start therapy. This is where we have this strong belief that we see an expansion of the market. Q: So Jan, I wanted to get your thoughts about the IT challenge on YUVIWEL. We know, obviously, what the blue trend scenario is for Ascendis. And most of the scenarios a little positive, but can you just maybe walk us through what the potential outcomes are? This is for a patent that expires, obviously, in 2030, and so between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst case scenario could be?A: Jan Mikkelsen (CEO): This patent got completely invalid in Europe. In the US, BioMarin selected to go to the ITC case. In the ITC case, there will be a first opinion from a single judge here in August, and then the next time will be in December. That 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. After the first initial opinion from a single judge, there is a huge opportunity to provide what we call interest for this product. When we see the public interest, the element of how these product opportunities are really serving an unmet medical need in the US market with this rapid uptake is really clear that there is a huge public interest to keep that. I cannot remember one single case in the US where a branded product that provides a benefit to US patients had been denied. Whatever happens, it will not have any material impact on Ascendis' pathway. It's not really a material element for our destiny to be a leading biopharma with EUR5 billion in 2030. Q: Question on YUVI. The -- do you expect that there is some seasonality in terms of new patient starts in the summer as kind of kids are going on vacation. We're getting a lot of questions on sort of the 60 patient start forms kind of in April, and now you're sort of 220, it sounds like there's like 50 per month now. Is that sort of sustainable from now on? And then it sounds like you're planning -- you think you could be the #1 brand by the end of the year. BioMarin, we think, has about 750 patients on drug, you think, in the US are you kind of referring to getting to a higher number than that by, let's say, late February?A: Jan Mikkelsen (CEO): I don't think Ascendis has really made some clear forward-looking statements related to how we see YUVIWEL accelerating and expanding the market in a quantitative manner. After basically only four months in the market, I feel really not prepared to come with clear guidance before we have more quarters. Jay Wu (President, Ascendis US): Four months in, we're not prepared to give longer-term guidance, but we're incredibly encouraged by what we're seeing today. When you look at prescriber reach, nearly 80% of centers of excellence already prescribed YUVIWEL to their patients in a short four-month period. We have heard confirmed anecdotes across all three categories for which our patients are coming from: patients switching from current therapy, patients that previously discontinued pharmacological therapy and now want to return, and a group of patients that historically have sat out and now want to try a therapeutic option for the first time. Jan Mikkelsen (CEO): We have no doubt we will be #1 in the achondroplasia space. We will expand the market because of the unmet need. We are dedicated to continue to build for the next 5 to 10 years with monotherapy and combination integrated treatment regimes. Q: 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?A: Jan Mikkelsen (CEO): The two product opportunities that we have developed to our partnership built on the TransCon technology will still consider at NCE. The one that is now in clinic with Iconis and the one we expect to go into the clinic now with Novo Nordisk. I still consider potentially having this year two new chemical entities being entered into clinical trials. Kenneth and his team are working hard on that, and there will be at least one of these new entities coming into every year now. This addresses the sustainability of Ascendis independent of going out and buying something no one else wants to have. We feel extremely blessed by having a strong technology platform that provides both sustainability for self but also a continued flow of potential partner by licensing. Q: Congrats on the progress. Scott, I just wanted you to clarify a comment on YORVIPATH growth for the rest of the year. I think you said it's going to be like prior quarters, I guess which 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 could just clarify which quarters you are referring to?A: Scott Smith (CFO): I think that 2 points. One is the consistent performance with the KPIs that we've given you, for example, with enrollments. We expect those to continue and be consistent. The other would be that now that we've seen a full year the various trends that will come into play related to Q3 and Q4 and then Q1 next year. We think folks did a pretty good For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-13Ascendis Pharma Reports Second Quarter 2026 Financial Results
GlobeNewswire
Ascendis Pharma Reports Second Quarter 2026 Financial Results
– Q2 2026 product revenue of €315 million (+105% Y/Y), comprising €252 million for YORVIPATH®, €55 million for SKYTROFA®, and €8 million for YUVIWEL® – Through July 31, more than 220 unique YUVIWEL patient enrollments in the U.S. – Substantial pipeline updates: presented long-term Phase 2 & 3 YORVIPATH data, shared Week 78 COACH Trial data, and completed target enrollment for pivotal infant reACHin Trial – Settled all convertible notes and Ascendis added to multiple Russell U.S. Indexes – Conference call today at 8:00 am ET COPENHAGEN, Denmark, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2026, and provided a business update. “Our patient focus has driven achievement of important milestones and strong demand for our TransCon products as Ascendis continues to transform into a leading biopharma company,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “This focus on addressing unmet medical needs continues to drive a growing pipeline of innovative TransCon programs, further positioning Ascendis for durable, long-term growth in rare endocrine diseases and new therapeutic areas.” Select Highlights & Anticipated 2026 Milestones YORVIPATH(palopegteriparatide, developed as TransCon PTH) SKYTROFA(lonapegsomatropin, developed as TransCon hGH) YUVIWEL(navepegritide, developed as TransCon CNP) TransCon CNP + TransCon hGH Combination Therapy(navepegritide plus lonapegsomatropin) Week 78 COACH Trial data showed sustained unprecedented efficacy over 78 weeks with no compromise to safety or tolerability. To date, 100% of the 21 enrolled children completed 78 weeks of treatment and remain on therapy in the COACH Trial. Expect to initiate enrollment in Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia in the fourth quarter of 2026. Key Financial Highlights Total product revenue for the second quarter of 2026 increased to €315 million, reflecting year-over-year growth of +105%. Total revenue for the second quarter of 2026 was €339 million. Operating profit for the second quarter of 2026 totaled €220 million, reflecting a margin of 65%. On a non-IFRS basis, operating profit was €92 million*, reflecting a margin of 27%*. Net profit for the second quarter of 2026 totaled €207 million, or €2.83 per diluted share. On a non-IFRS basi…Read full documentShow less
– Q2 2026 product revenue of €315 million (+105% Y/Y), comprising €252 million for YORVIPATH®, €55 million for SKYTROFA®, and €8 million for YUVIWEL® – Through July 31, more than 220 unique YUVIWEL patient enrollments in the U.S. – Substantial pipeline updates: presented long-term Phase 2 & 3 YORVIPATH data, shared Week 78 COACH Trial data, and completed target enrollment for pivotal infant reACHin Trial – Settled all convertible notes and Ascendis added to multiple Russell U.S. Indexes – Conference call today at 8:00 am ET COPENHAGEN, Denmark, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2026, and provided a business update. “Our patient focus has driven achievement of important milestones and strong demand for our TransCon products as Ascendis continues to transform into a leading biopharma company,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “This focus on addressing unmet medical needs continues to drive a growing pipeline of innovative TransCon programs, further positioning Ascendis for durable, long-term growth in rare endocrine diseases and new therapeutic areas.” Select Highlights & Anticipated 2026 Milestones YORVIPATH(palopegteriparatide, developed as TransCon PTH) SKYTROFA(lonapegsomatropin, developed as TransCon hGH) YUVIWEL(navepegritide, developed as TransCon CNP) TransCon CNP + TransCon hGH Combination Therapy(navepegritide plus lonapegsomatropin) Week 78 COACH Trial data showed sustained unprecedented efficacy over 78 weeks with no compromise to safety or tolerability. To date, 100% of the 21 enrolled children completed 78 weeks of treatment and remain on therapy in the COACH Trial. Expect to initiate enrollment in Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia in the fourth quarter of 2026. Key Financial Highlights Total product revenue for the second quarter of 2026 increased to €315 million, reflecting year-over-year growth of +105%. Total revenue for the second quarter of 2026 was €339 million. Operating profit for the second quarter of 2026 totaled €220 million, reflecting a margin of 65%. On a non-IFRS basis, operating profit was €92 million*, reflecting a margin of 27%*. Net profit for the second quarter of 2026 totaled €207 million, or €2.83 per diluted share. On a non-IFRS basis, net profit was €61 million*, or €0.90 per diluted share*. As of June 30, 2026, Ascendis Pharma had cash and cash equivalents totaling €812 million, which includes the use of €56 million in the second quarter for our previously announced share repurchase program and the net settlement of certain Restricted Stock Units. As of December 31, 2025, cash and cash equivalents totaled €616 million. During the second quarter, the Company closed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer with payment of €158 million in cash, net of transaction-related expenses. The PRV was awarded by the FDA upon approval of YUVIWEL in February 2026. Effective May 6, 2026, the Company completed its previously announced optional redemption process with respect to all outstanding $575 million of 2.25% Convertible Senior Notes due 2028, resulting in the conversion of all outstanding notes. The conversions resulted in the settlement of the current liabilities of convertible notes to equity, comprising borrowings and derivative liabilities totaling €719 million as of the redemption date. After the close of market on June 26, 2026, the Company was added to multiple Russell U.S. Indexes, including the Russell 3000, Russell 1000, Russell 2500 and Russell Midcap Indexes. * See “Non-IFRS Financial Measures” below for definitions of these non-IFRS measures and a reconciliation to the most directly comparable IFRS measures. Second Quarter 2026 Financial Results Total revenue for the second quarter of 2026 was €339 million, compared to €158 million during the same period in 2025. Research and development expenses for the second quarter of 2026 were €76 million, compared to €72 million during the same period in 2025. The higher expenses were due to increased clinical trial activities within the Endocrinology Rare Disease pipeline, offset by reduced clinical trial activities within Oncology. Selling, general, and administrative expenses for the second quarter of 2026 were €173 million, compared to €108 million during the same period in 2025. The increase was primarily due to the continued impact from commercial expansion, including global launch activities. Total operating expenses for the second quarter of 2026 were €249 million compared to €180 million during the same period in 2025. Operating profit for the second quarter of 2026 was €220 million, compared to an operating loss of €53 million during the same period in 2025. The increase was primarily driven by growth in product revenue and sale of the PRV for €158 million in cash, net of transaction-related expenses. Net finance income for the second quarter of 2026 was €6 million, compared to €22 million in the same period in 2025. The change was primarily driven by non-cash items. For the second quarter of 2026, Ascendis Pharma reported a net profit of €207 million, or €3.22 per basic share and €2.83 per diluted share, compared to a net loss of €39 million, or €0.64 per basic share and €0.82 per diluted share for the same period in 2025. Cash flows from operating activities for the six months ended June 30, 2026, were €274 million compared to €22 million used during the same period in 2025. The increase in cash flows from operating activities was primarily related to commercial revenue growth and sale of the PRV. As of June 30, 2026, Ascendis Pharma had 66,189,926 ordinary shares outstanding, of which 516,642 were held as treasury shares. For the second quarter of 2026, non-IFRS operating profit was €92 million, compared to a non-IFRS operating loss of €23 million for the same period in 2025. For the second quarter of 2026, non-IFRS net profit was €61 million, or €0.90 earnings per diluted share, compared to a non-IFRS net profit of €4 million, or €0.07 earnings per diluted share, for the same period in 2025. Conference Call and Webcast Information Ascendis Pharma will host a conference call and webcast today at 8:00 am Eastern Time (ET) to discuss its second quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, results, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) anticipated timing of a regulatory decision from the European Medicines Agency, (ii) anticipated timing and plans of clinical trials and development activities, including expected timing of patient recruitment and trial initiation, (iii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, (iv) Ascendis’ use of TransCon to create new and potentially best-in-class therapies, (v) plans for regulatory filings and label expansions, and (vi) expectations regarding continued patient demand, product uptake, reimbursement coverage, future growth and market positioning. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third-party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on-market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom-to-operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA®, YORVIPATH®, and YUVIWEL® are trademarks owned by the Ascendis Pharma group. © August 2026 Ascendis Pharma A/S. Non-IFRS Financial Measures In addition to the financial information prepared in accordance with IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board and as adopted by the European Union, this press release contains certain non-IFRS financial measures, including Non-IFRS Operating Profit/(Loss), Non-IFRS Net Profit/(Loss), Non-IFRS operating profit/(loss) margin, and Non-IFRS diluted earnings per share (“Non-IFRS Diluted EPS”). These non-IFRS measures are provided as supplemental information and should be considered in addition to, and not as a substitute for or superior to, the comparable measures prepared in accordance with IFRS. Management believes these non-IFRS measures support management’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate comparisons among current and past periods. Since non-IFRS measures do not have standardized definitions and meanings, they may differ from the non-IFRS measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures. Because these non-IFRS measures are not prepared in accordance with IFRS, they should not be viewed as superior to IFRS reported measures, nor should they be used on their own or as replacements for the IFRS financial information included in this press release. Additionally, our non-IFRS measures may differ from similarly labeled measures used by other companies due to variations in calculation methods or the size and nature of adjusted items. Investors should note that several of the items excluded from these non-IFRS measures have been recognized in prior periods and may continue to be recognized in future periods. The Company reports Non-IFRS Operating Profit/(Loss), Non-IFRS Net Profit/(Loss), Non-IFRS operating profit/(loss) margin and Non-IFRS Diluted EPS as non-IFRS measures, which exclude the following specified items: (i) Share-based compensation costs. Although share-based compensation is a recurring expense, the Company excludes it from non-IFRS measures because the amount and timing of recognition depend on the value of the underlying equity instruments, which can fluctuate based on factors unrelated to the Company’s operating performance during the period. (ii) Other operating income from sale of PRV. The Company excludes income recognized from the sale of its PRV because it does not reflect the Company's ongoing operating activities. (iii) Share of (profit)/loss of associates. The Company excludes its share of the profit or loss of equity-method investees because these amounts are not within the control of the Company and do not reflect the Company’s core operating performance. (iv) Remeasurement (gain)/loss of derivative liabilities. The Company excludes the fair-value remeasurement of derivative liabilities associated with its convertible notes because these amounts depend on movements in the Company’s share price and other market inputs and are not indicative of the Company’s underlying operating performance. (v) Remeasurement (gain)/loss of royalty funding liabilities. The Company excludes gains and losses arising from the remeasurement of royalty funding liabilities as these amounts are driven by changes in estimates of future royalty payment obligations under the Company’s royalty funding agreements and do not reflect the Company’s underlying operating performance. (vi) Recognition of previously unrecognized deferred tax assets. The Company excludes the one-time recognition of previously unrecognized deferred tax assets because this item reflects a reassessment of the recoverability of historical tax attributes rather than the Company’s current period operating performance. Income taxes related to the foregoing items are adjusted accordingly, considering the individual impact of each item, the relevant tax jurisdiction, applicable tax rates, and the deductibility of the item. For further details regarding valuation of derivative liabilities, and the recognition of previously unrecognized deferred tax assets, please refer to “Note 3 – Significant Accounting Judgements andEstimates,” contained in our Interim Report on Form 6-K, for the period ended June 30, 2026 and “Note 3 – Significant Accounting Judgements and Estimates,” contained in our Annual Report on Form 20-F, for the year ended December 31, 2025. The following table provides a reconciliation of the most directly comparable IFRS measures to Non-IFRS Operating Profit/(Loss), Non-IFRS Net Profit/(Loss) and Non-IFRS Diluted EPS.
Investor releaseQuarter not tagged2026-08-13Ascendis Pharma A/S Q2 Earnings Call Highlights
MarketBeat
Ascendis Pharma A/S Q2 Earnings Call Highlights
Interested in Ascendis Pharma A/S? Here are five stocks we like better. Ascendis reported strong Q2 results, with total revenue of EUR 339 million and product revenue of EUR 315 million, more than double the prior-year period. Non-IFRS operating profit reached EUR 92 million, while the company ended the quarter with EUR 812 million in cash and no bank or convertible debt. Yorvipath remained the key growth driver, generating EUR 252 million in revenue and maintaining roughly 1,000 new U.S. patient enrollments per quarter. Ascendis is pursuing label expansions, higher-dose options and a once-weekly formulation. Yuviwel’s U.S. launch gained early traction, producing EUR 8 million in first-quarter revenue and enrolling more than 220 patients by the end of July. Ascendis expects EU and U.K. regulatory decisions in Q4 2026 and continues to advance its broader TransCon pipeline and partnerships. Can BioMarin Stock Live Up to Wall Street’s High Expectations? Ascendis Pharma A/S (NASDAQ:ASND) reported second-quarter 2026 total revenue of EUR 339 million, including EUR 315 million in product revenue, as demand for its three commercial TransCon-based therapies continued to increase. Chief Financial Officer Scott Smith said product revenue more than doubled from the prior-year period. Total revenue also included EUR 24 million in non-product collaboration revenue, including a EUR 17 million milestone related to TransCon CNP. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be 3 Oversold Stocks with Big RSI Rebound Potential The company reported an operating profit of EUR 220 million, which included EUR 158 million of other operating income from the sale of a priority review voucher. Non-IFRS operating profit was EUR 92 million, representing a 27% non-IFRS operating margin. Net profit was EUR 207 million, while non-IFRS net profit was EUR 61 million. Ascendis ended the quarter with EUR 812 million in cash and cash equivalents after using EUR 56 million for its share-repurchase program, including the net settlement of certain restricted stock units. Smith said the company has no bank debt or convertible debt following the settlement of its convertible notes, and reported EUR 1.4 billion in equity. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand President and Chief Executive Officer Jan Mikkelsen said Yorvipath, the company’s treatme…Read full documentShow less
Interested in Ascendis Pharma A/S? Here are five stocks we like better. Ascendis reported strong Q2 results, with total revenue of EUR 339 million and product revenue of EUR 315 million, more than double the prior-year period. Non-IFRS operating profit reached EUR 92 million, while the company ended the quarter with EUR 812 million in cash and no bank or convertible debt. Yorvipath remained the key growth driver, generating EUR 252 million in revenue and maintaining roughly 1,000 new U.S. patient enrollments per quarter. Ascendis is pursuing label expansions, higher-dose options and a once-weekly formulation. Yuviwel’s U.S. launch gained early traction, producing EUR 8 million in first-quarter revenue and enrolling more than 220 patients by the end of July. Ascendis expects EU and U.K. regulatory decisions in Q4 2026 and continues to advance its broader TransCon pipeline and partnerships. Can BioMarin Stock Live Up to Wall Street’s High Expectations? Ascendis Pharma A/S (NASDAQ:ASND) reported second-quarter 2026 total revenue of EUR 339 million, including EUR 315 million in product revenue, as demand for its three commercial TransCon-based therapies continued to increase. Chief Financial Officer Scott Smith said product revenue more than doubled from the prior-year period. Total revenue also included EUR 24 million in non-product collaboration revenue, including a EUR 17 million milestone related to TransCon CNP. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be 3 Oversold Stocks with Big RSI Rebound Potential The company reported an operating profit of EUR 220 million, which included EUR 158 million of other operating income from the sale of a priority review voucher. Non-IFRS operating profit was EUR 92 million, representing a 27% non-IFRS operating margin. Net profit was EUR 207 million, while non-IFRS net profit was EUR 61 million. Ascendis ended the quarter with EUR 812 million in cash and cash equivalents after using EUR 56 million for its share-repurchase program, including the net settlement of certain restricted stock units. Smith said the company has no bank debt or convertible debt following the settlement of its convertible notes, and reported EUR 1.4 billion in equity. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand President and Chief Executive Officer Jan Mikkelsen said Yorvipath, the company’s treatment for adult hypoparathyroidism, continued to show robust demand in the United States and internationally. Yorvipath is commercially available or supplied through named-patient programs in more than 35 countries, according to the company. Smith said Yorvipath generated EUR 252 million in second-quarter revenue, reflecting new U.S. patient demand and international growth. He said the product reached blockbuster status on a run-rate basis during its second year after U.S. launch. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Management said it continues to see roughly 1,000 unique new U.S. patient enrollments per quarter, although it does not intend to provide that metric every quarter unless the trend changes. Mikkelsen said patients who complete the titration period and establish treatment generally show low discontinuation rates. Ascendis is pursuing additional Yorvipath development initiatives, including a potential label expansion for patients ages 12 to 18, higher-dose options in the U.S., and a once-weekly formulation for patients stable on daily dosing. Mikkelsen said the company is enrolling a U.S. study evaluating dose ranges from 30 to 60, with enrollment progressing quickly. Yuviwel, Ascendis’ treatment for pediatric patients with achondroplasia, launched commercially in the U.S. during the second quarter and contributed EUR 8 million of revenue in its first quarter on the market. Smith said the early launch reflected strong demand, rapid conversion to paid therapy and limited channel stocking. Through June 30, Ascendis had enrolled more than 170 unique U.S. patients in Yuviwel. Enrollment surpassed 220 patients by the end of July, with more than 65% approved for reimbursement, Mikkelsen said. Jay Wu, executive vice president and president of Ascendis’ U.S. business, said nearly 80% of centers of excellence had prescribed Yuviwel within four months of launch. He said patients have included those switching from existing therapy, returning to pharmacological treatment after previously discontinuing it, and starting drug therapy for the first time. Management did not provide patient-start guidance or quantify the proportion of Yuviwel demand originating from switches versus market expansion. However, Mikkelsen said the company believes the product is expanding the achondroplasia treatment market and could ultimately become the market leader. Ascendis expects regulatory decisions for Yuviwel in the European Union and United Kingdom during the fourth quarter of 2026. The company is also supplying the product through early-access programs in select international markets and said it already has commercial, distribution and partnership infrastructure in place for markets outside the U.S. The company plans to begin enrollment later this year in a Phase III trial of a combination of TransCon CNP and TransCon growth hormone for children with achondroplasia. Mikkelsen said 78-week data from the COACH trial showed sustained efficacy and no apparent compromise in safety or tolerability. Chief Scientific Officer Kennett Sprogøe said the combination produced arm-span improvements of 9.4 centimeters among TransCon CNP-naive participants and 7.9 centimeters among previously treated participants. Skytrofa generated EUR 55 million in second-quarter revenue, including product sales to a collaboration partner. Smith said the company expects relatively stable U.S. Skytrofa revenue for the remainder of 2026. Mikkelsen said Skytrofa has surpassed 20,000 unique enrollments and remains the leading long-acting growth hormone brand by value in the U.S. Ascendis is conducting a Phase III basket study of TransCon growth hormone in idiopathic short stature, small for gestational age and Turner syndrome. It also plans to expand TransCon CNP into additional populations, including infants younger than age 2, adults with achondroplasia and children with hypochondroplasia. The company said enrollment in its infant program was completed faster than expected. In partnerships, Mikkelsen said Novo Nordisk continues to advance a once-monthly TransCon semaglutide program for metabolic disorders and obesity. Separately, partner Eikonis initiated a first-in-human study of a TransCon-based anti-VEGF treatment in patients with wet age-related macular degeneration. For 2026, Ascendis expects Yorvipath growth to remain consistent with recent quarterly trends and forecasts more than EUR 500 million in cash flow from operating activities. Smith reiterated the company’s target of EUR 5 billion in revenue by 2030. Ascendis Pharma A/S is a Denmark‐based biopharmaceutical company focused on developing innovative therapies for rare endocrine diseases. Founded in 2015 and headquartered in Hellerup, the company leverages its proprietary TransCon drug delivery platform to create long‐acting prodrugs designed to improve safety, efficacy and patient convenience. Ascendis Pharma maintains research and development operations in Europe and the United States, with clinical studies spanning North America, Europe and Asia. The company's lead product, lonapegsomatropin (Skytrofa®), is a once‐weekly growth hormone therapy approved by the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Ascendis Pharma A/S Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-13Ascendis Pharma's Q2 Adjusted Earnings, Revenue Rise
MT Newswires
Ascendis Pharma's Q2 Adjusted Earnings, Revenue Rise
Ascendis Pharma (ASND) reported Q2 non-IFRS earnings Thursday of 0.90 euros ($1.04) per diluted shar
TranscriptFY2026 Q22026-08-13FY2026 Q2 earnings call transcript
Earnings source - 109 paragraphs
FY2026 Q2 earnings call transcript
Ladies and gentlemen, thank you for standing by. Welcome to the second quarter 2026 Ascendis Pharma earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will 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. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugere, Vice President of Investor Relations. Please go ahead.
Thank you, Operator, and thank you everyone for joining our second quarter 2026 financial results conference call. I'm Chad Fugere, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Chief Financial Officer, Sherrie Glass, Chief Business Officer, and Jay Wu, Executive Vice President and President, Ascendis U.S. Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under their 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 SKYTROFA, YORVIPATH and YUVIWEL, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates and our expectation with respect to their continued progress and potential commercialization, our strategic plans, partnerships and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions, and our financial outlook and Vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place 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 of our annual report on Form 20-F filed with the SEC on February 11, 2026. In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believe these measures are useful to investors, is included in today's press release.
TransCon Growth Hormone, or TransCon hGH, is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency. In the EU, it has received MAA authorization for the European Commission for the treatment of pediatric growth hormone deficiency. TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults. The European Commission and the United Kingdom's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as a 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 epiphases.
Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I have 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 will discuss our second quarter 2026 financial results, and we will provide further business updates. Following some prepared remarks, we will then open up the call for questions. With that, let me turn it over to Jan.
Thanks, Chad. Good day, everyone. During the second quarter, achievement of important milestones and strong demand for our TransCon products continued 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 and visions 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 our highly differentiated approved protein and peptide-based combination products, SKYTROFA, YORVIPATH, and YUVIWEL.
We believe these products will be the key driver of our growth story for the next 10-15 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 enables us to fulfill our plans to file at least one IND or similarly yearly, each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutic areas in addition to hypopara and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications. This is why we believe Ascendis is well-positioned for self-sustained long-term growth. Let us begin with a more detailed look at YORVIPATH.
YORVIPATH is the first and only approved treatment for adults with hypoparathyroidism that address the underlying disease by replacing the missing endogenous PTH throughout the body. Uptake of YORVIPATH has grown steadily since launch, both in the U.S. and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure. Outside of the U.S., we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. YORVIPATH is now available commercially or through named patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid, broad global launch of a rare disease product. In the U.S., new patient demand for YORVIPATH in the second quarter has remained robust, consistent with prior quarters.
In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated YORVIPATH treatment continue to stay on therapy, indicating a high level of satisfaction. We continue to be excited by the growth of YORVIPATH in the U.S. and outside the U.S., and to see its continued strong launch performance. Data from our long-term phase II and phase III trials of YORVIPATH presented in the second quarter highlight why YORVIPATH is becoming a standard of care in post-surgical and all subsets of hypoparathyroidism, including ultra-rare genetic causes like DiGeorge syndrome, ADH1, and ADH2. Results showed sustained response rate of 82%-86% for the multicomponent endpoint, with clinical benefit across multiple organ systems, CNS, kidney, small intestine, and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after five years of treatment. Pretty unique.
In parallel, we are working to further advance our leadership in hypoparathyroidism 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 YORVIPATH. Turning now to YUVIWEL. We believe YUVIWEL is positioned to become the market leader therapy for achondroplasia. Rapid uptake of YUVIWEL is already transforming the U.S. market. Across the board, we see a highly favorable response among patients and physicians to YUVIWEL's differentiator profile. In the U.S., through June 30, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollments and more than 65% approved for reimbursement in the U.S. through the end of July. Really a unique launch.
The rapid uptake is by patients of all kinds of backgrounds, those switching, returning to medical therapy or starting therapy for achondroplasia for the first time. We believe YUVIWEL is really growing the U.S. market, which is exactly the pattern you would love to see when a highly differentiated product is introduced into an area where there still exists a high unmet medical need. Long-term data for the now completed pivotal ApproaCH trial show durable and consistent improvement in growth, leg bone, body proportionality, along with a general well-tolerated safety profile compared to placebo, underscoring why the community is quickly adopting YUVIWEL. In the U.S. and the E.U., a regulatory decision for YUVIWEL is expected in the fourth quarter of 2026. We are also making YUVIWEL available in select international markets through early access program using the U.S. FDA approval.
Longer term, we are pursuing expansion opportunities for TransCon CNP to ongoing and planned trials. These include ongoing activities such as infants 0 to less than 2 years of age, and we recently announced completion of this target enrollment faster than expected. Adults with achondroplasia, children with hypochondroplasia, and still continue with geographic expansions. 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 FGFR3 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-1 growth hormone axis. This is illustrated by children with achondroplasia have a negative IGF-1 SDS value as shown of the demographic in both our phase II and phase III trial.
In our COACH clinical trial for children with achondroplasia, this unique combination has demonstrated sustained transformative analyzed growth velocity and age-adjusted 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 COACH trial data show sustained efficacy over 78 weeks with no compromises to safety and tolerability. This point to the potential for this novel combination to establish a new treatment standard in achondroplasia. 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 somatropin. 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 SKYTROFA recently achieved more than 20,000 unique enrollments. This illustrates the strength of our capabilities from supply chain, commercial infrastructure, and on market support to benefit such a large number of rare disease patients. We are working to make TransCon growth hormone available to more patients to label and geographic expansions. To support label expansion drawing that described in our achondroplasia program, we are conducting the phase III basket trial investigating TransCon growth hormone in ISS, SGA, and Turner syndrome. As an integrated part of our global growth disorder strategy, we expect to launch TransCon growth hormone in the same countries where we also expect to launch TransCon CNP. Turning now to our partnership. In metabolic disorders and obesity, our once-monthly TransCon semaglutide program with Novo Nordisk continue to involve events.
In ophthalmology, our partner, Eyconis, recently initiated a first in human clinical trial of the anti-VEGF treatment built on the TransCon technology in patients with wet AMD. In closing, by always putting patient first, Ascendis has delivered three highly differentiated leading TransCon-based product, YORVIPATH, YUVIWEL, and SKYTROFA. 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.
Thanks so much, Jan. Good afternoon, everyone. I will touch on some key points surrounding our second quarter financial results. For further details, please refer to our Form 6-K filed today. Total product revenue was EUR 315 million, more than doubling year over year. Total revenue for Q2 2026 was EUR 339 million, which included non-product collaboration revenue of EUR 24 million, which further included a EUR 17 million milestone related to TransCon CNP. YORVIPATH revenue was EUR 252 million 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. SKYTROFA contributed EUR 55 million in Q2, which reflects increased demand in the U.S. and includes product sales to a collaboration partner.
UBEGLA was commercially launched in the U.S. during Q2 and generated EUR 8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking. Continuing to expenses, R&D expenses in Q2 were EUR 76 million, up from EUR 59 million in Q1, reflecting continued investment in our pipeline and innovation. Recall Q1 included a favorable EUR 11 million reversal of prior period write-downs of TransCon CNP pre-launch inventories. SG&A expenses were EUR 173 million in Q2 compared to EUR 145 million in Q1, reflecting additional investments in the commercial launches of YORVIPATH and UBEGLA to accelerate growth for the long term. Operating profit of EUR 220 million in Q2 included EUR 158 million of other operating income related to the sale of the PRV. Non-IFRS operating profit was EUR 92 million, and non-IFRS operating margin was 27%.
Refer to our press release for details. For Q2 2026, net profit was EUR 207 million and non-IFRS net profit was EUR 61 million. We ended Q2 2026 with EUR 812 million in cash and cash equivalents, which includes the use of EUR 56 million 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 EUR 1.4 billion of equity. Turning to our outlook for the rest of 2026. For YORVIPATH, we expect growth and performance consistent with prior quarters. For SKYTROFA, we expect relatively stable revenue in the U.S. For UBEGLA, we are encouraged by the early demand trends.
We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the U.S., reflecting the large unmet medical need and the highly differentiated profile of UBEGLA. Our Q2 performance reinforces our belief that we can achieve EUR 5 billion in revenues in 2030. With our existing portfolio and our TransCon technology as a strong foundation, we believe we are well-positioned to grow revenue to more than EUR 10 billion 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. Even with these investments, we expect to generate more than EUR 500 million in cash flow from operating activities this year.
With that operator, we are now ready to take questions.
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We ask you please limit to one question and return to the queue for additional questions. Our first question is going to come from Jessica Fye with JPMorgan. Your line's open.
Hey, guys. Good morning. Thanks for taking my question. On that outlook for at least EUR 500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale, and I was just wondering if you are able to update your cash flow expectations for the year. I know it is sort of like a greater than is unbounded, but curious if anything more you can add there. On that comment that SKYTROFA 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. The other happy person besides me, Scott. Scott got the opportunity to be the first one answering questions. Please, Scott.
Yeah. With respect to our cash flow guidance, just to be clear, greater than EUR 500 million. I thought I heard you say EUR 100 million, so greater than EUR 500 million. At this time, we don't want to bound the upper side because we're initial into the launch of YUVIWEL. That's euro, by the way, EUR 500 million, Jan likes to point out.
Just related to the question, 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. Our general feelings and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from switches, it's most also coming from either patient that had stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of YUVIWEL that they want to start therapy. I think this is where we have this strong belief that we see an expansion of the market.
Thank you.
Thank you. The next question is going to come from Tazeen Ahmad with Bank of America. Your line's open.
Hey, good morning. Thanks for taking my question. Jan, I wanted to get your thoughts about the IP challenge on YUVIWEL. We know obviously what the blue sky scenario is for Ascendis, and most of the scenarios look positive, but can you just maybe walk us through what the potential outcomes are? This is for a patent that expires obviously in 2030, and so between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst case scenario could be? Thanks.
Thanks, Tazeen, for the question, and it basically is a question that is addressing the ongoing legal, I would call it battle, between Ascendis and BioMarin. Let me just come back to some facts. The facts is that this patent that we discussion got complete invalid in Europe, so we never really come to a discussion if we were infringing and anything like that. So when we see the situation outside U.S., we got the patent invalid immediately to the patent system in Europe. In the U.S., 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 traditional never have really dealt with a lot of cases that 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. 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. 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. When we see the public interest, the element of how this product opportunities are really being serving an unmet medical need in the U.S. market with this rapid uptake of patients, it's really, really clear that is a huge public interest to keep that. Just recall, I cannot remember one single case in the U.S. where a branded product that provides a benefit to U.S. patient has been denied. But you can see we just in a case where it's only is a U.S., it has been cleared ex-U.S. So whatever it happened, it will not have any material impact on Ascendis pathway. I can guarantee that. People take it up as a life and death for Ascendis.
This is a total not taken into the perspective what it mean for Ascendis. Out from that, I see it's not really is a mature element for Ascendis to be a leading biopharma and hit the EUR 5 billion in 2030.
Thank you. Our next question will come from Gavin Clark-Gartner with Evercore. Your line's open.
Hey, guys. Thanks for taking the question. I actually just wanted to ask on the earlier pipeline. You noted in your prepared remarks that TransCon platform can fuel
One IND for an NCE annually. I guess there hasn't been one yet this year. Should we expect one in the near term? What exactly are the go-forward plans for the earlier pipeline? Thank you.
It was because I in some way felt that the two product opportunities that we have developed to our partnership built on the TransCon technology will still consider at a NCE, the one that now in clinic with Ascendis and the other one we expect to go into the clinic now with Novo Nordisk. It's still some way being developed to the TransCon technology funnel. Kevin, perhaps I shouldn't have done that, but I still believe, I feel some kind of little bit ownership on these two product opportunities. At least we have major upside in both of them. So out from that perspective, I still consider we potentially will have this year two new chemical entities being entered into clinical trials.
I think Kenneth and his team and anyone else, they are working very hard on that will be at least one of these new chemical entities coming into every year now. 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 want to have. I think this is where we really feel extremely pleasant by the situation, by being a fundamental company that building on a strong technology platform that provide both sustainability for ourselves, but also a continued flow of potential partner licensing.
Great. Thank you.
Thank you. The next question will come from Yaron Werber with TD Cowen. Your line's open.
Great. Thanks so much. Question on YUVIWEL. Do you expect that there is some seasonality in terms of new patient starts in the summer as kids are going on vacation? We are getting a lot of questions on sort of the 60 patient start forms in April, and now you are sort of at 220. It sounds like there is like 50 per month now. Is that sort of sustainable from now on? It sounds like you are planning, you think you could be the number one brand by the end of the year. BioMarin, we think, has about 750 patients on drug. Are you thinking in the U.S., are you kind of referring to getting to a higher number than that by, let us say, late February? Thank you.
Thanks for the question. I actually do not think Ascendis has really made some clear forward-looking statement related to how we see YUVIWEL being accelerating and expanding the market in a quantitative manner. I do not think we have come with any kind of indication related to that. I have no doubt it will do it, but it is not the same thing that we are going to quantify it currently. I think after basically 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 on trends and other things like that.
But one person that really can give you a good feedback, now we talk about the U.S. market, is Jay, and he is extremely enthusiastic about what he is seeing, and you can give the latest way what you see how the market will develop.
Thanks, Jan. As Jan mentioned before, four months in, we are not prepared to give longer term guidance, but what we can say is we are incredibly encouraged by what we are seeing to date. When you look at some of the fundamentals behind the YUVIWEL uptake, whether it is prescriber reach, we talk a lot a bit before around this space. There are quite a few centers of excellences. We are seeing 80% of them, nearly 80% already in a short four-month period, already prescribe YUVIWEL to their patients. So even in early days, we are seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm, I think you can see in early days, we are seeing a very positive trajectory.
While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy. This is rare disease, so qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from. And those three categories again are, one, patients that are switching from current therapy. Two, patients that have previously discontinued pharmacological therapy and has now wanted to return to pharmacological treatment. Then third, a group of patients that historically have set out and have said based on the clinical profile of YUVIWEL, they now want to try a therapeutic option for the first time.
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. Ultimately I have no doubt we will be number one in the achondroplasia space. Ultimately, we will expand the market because of the unmet medical need, and that is just with the monotherapy. When you look at how commitment we have to this area, where we now are making a complete new standard with the combined treatment. I believe we are dedicated to be not number one in the first year, but continue to build for the next 5-10 years with monotherapy combination integrated treatment regimes. I believe with our once weekly TransCon product built on Voluma and CNP, we are extremely well-positioned really to be the leader in this segment.
Thank you. Our next question will come from Derek Archila with Wells Fargo. Your line's open.
Hey, good morning, and thanks for taking the questions. Congrats on the progress. Scott, I just wanted you to clarify a comment on your YORVIPATH growth for the rest of the year. I think you said it is going to be like prior quarters. I guess, which 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 have given you, for example, with enrollments. We expect those to continue and be consistent. The other would be, and you could refer to our prior quarters and maybe Chad can point to prior comments. But I think that now that we have seen a 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 here. The value for us, 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. 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. I think this is a way we like to be extremely transparent with everything, what we perform. So we quite sure that you basically can go out and really somewhere feeling always comfort with the guidance we give you.
Great. Thank you.
Thank you. Our next question will come from Joseph Schwartz with Leerink. Your line's 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 are defining the enrolled population. How large do you see the diagnosed treatable pool of hypochondroplasia patients who are not already being treated in some cases if they are at the more severe end versus achondroplasia? Thank you.
This is a very interesting question because it is actually someway going into the situation on how we basic are to genetic testing, taking a big patient group that was in old days were called ISS, idiopathic knee. We have no clue what is the underlying diseases. Then you go out and do more genetic testing. When you find a mutation in the FGFR3 receptor, and you find it in the right regions, then you suddenly are not an ISS patient, but then you are a hypochondroplasia patient, even if you do not have, you could say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia that we saw for 10 years ago.
Therefore, you can see the ISS population is somewhere getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason why you potentially have a short status without potentially have the other element that you see for the phenotype of that. This is where you can think when you go into ISS, are you defined it from a genetic perspective, or you define it for a phenotype or anything like that? We are in a situation where when you see the clinical trial, how we are doing it, you will basically see that is one of the pathway we have selected.
Thank you.
Thank you. Our next question will come from Daniel Bronder with Cantor. Your line's open.
Hey, team. Congrats on the quarter. I am on for Lee Waczak. We were just wondering if you could give us a little more color on the quality-of-life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics?
Just to recall, the COACH trial is the combination trial where we combining the two TransCon-based product, our TransCon growth hormone and TransCon CNP. I have to say, when I look on an element like arm span, we already reported some of the data. We have reported the 52 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. We have so many IR people, I do not know their names anymore. From that perspective, it already came out. I have to say, it was one of the, I will say, extremely positive surprises I saw because when we looked on monotherapy, but either a CNP-based one or a growth hormone-based one, we did not saw the expected hopeful development that we could hope for.
But we definitely saw it when we look on the combination therapy. Then you can ask me, what is the scientific reason why you see it much more influenced benefit by the combination therapy? I have to say, I don't know. But what we saw was an arm span that really gave us this hope with the combination therapy. You basically will be in a position that you basically could avoid all kind of limb elongation surgeries in achondroplasia, both related to both legs and arms by that. It is the slide number 5 as I remember it. What we see, Scott, read up.
The unprecedented improvements in the arm span with a combination were +9.4 cm with a TransCon CNP naive cohort, and 7.9 cm with a TransCon CNP treated cohort.
It was really an-
Compared to limb lengthening surgery, centimeters gain.
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. Our next question will come from Yun Zhong 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 YORVIPATH in case I missed anything. I know that you said the patient demand remain robust in the quarter, so I wonder if there is any additional quantitative information that you can provide. Going forward, are you going to provide that number in the coming quarters? I think you had this question before at the beginning of the launch. 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 message that we see steady state, steady state, and steady state. We said in last year that we will stop coming with this because it was too repetitive. Then because people doubted for the Q1, then we also come out with the Q1, and it was the same number again. 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. with about 1,000 new patients every quarter. We don't believe really. Now we went over to Europe. Now we're starting to give you a unique prescription enrollment of Europe instead.
We always rather have one product opportunity where you will have something to play with numbers and everything like that. Scott, you have some additional comments for the last one?
Yeah. I think our comments were directed to assume that the metrics that we've given you are consistent because Jan wants to make our script shorter, so we don't want to repeat them more, and you should just assume that until we change it.
Great. Thank you.
Thank you. The next question comes from Alex Thompson with Stifel. Your line's open.
Great. Thanks for taking the question. I appreciate the color you provided to Tazeen's question around the ongoing legal battle with BioMarin. I guess as we think about potential scenarios here, and again, acknowledging this idea around public interest of the product and unmet need, do you see a settlement as a reasonable scenario to think about, or is that really not something that you think is reasonable? Thank you.
Alex, I think I'm a very flexible person, and one of the things I really want to do, I will always do what is best for patients.
Thank you. 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 your durability. I was just wondering if dropouts are still mostly during the titration phase, and if you can comment at all on how re-auths are trending. Thanks.
I think you are 100% correct. When we see a patient being successful coming into a treatment with YORVIPATH, coming over titration part, and being into the treatment after that, we see extremely low dropout. I think that illustrates one thing, the patient satisfaction with this treatment. Because now often being asked, what can we do more for these patients in the therapeutic treatment? When I see the satisfaction that is in this way, then I feel that there is an extremely good physician retention and everything which really show that. We are still developing once weekly for patient on stable doses, just to give patient 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 caption monitoring and anything like that.
We can help the patient like it happening in Type 1 diabetes and other things like that. Now you are addressing the element where we saying is, we developed this here 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 is really complex to take patient off of conventional therapy. At the same time, you increase the PTH in replacement therapy. There was a why we made it as a once daily, is really to facilitate the best possible titration. Still, we know it can be problematic for some patients. Jay can try to explain what we now doing to basic handhold the patient in this period. We also can make that extremely successful.
When you get a prescription, we know everything will be much more successful for the patient, not just after they are really being stable in the titration. Jay, will you explain of the effort you are building in to really to get that to be as soft as possible?
Absolutely. Can chat a little bit more about certainly the investments that we are making and also to answer your questions around drop-off and re-auths. Yes. As we have shared before, the majority of the drop-offs is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense. For re-auths, that is actually pretty routine for us, so there really is not much there in terms of it being a measurable effect on any kind of ongoing patient support. We have patients re-offing throughout the year, and it is just part of our day-to-day operations. From an investment standpoint, we have invested heavily in patient-facing roles for which we have deemed our patient access liaisons. They support patients both pre-prescription as well as through the prescription process and post.
Essentially, we have 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 are optimizing for patient experience.
Great. Thank you very much.
One thing that is in a minute. Now we focus on mostly U.S., but there is still a world outside U.S. Outside U.S., we have not seen the same level of dropout in this phase. It looked like the interaction is pretty well established between the physician and the patients and support system, really to see it without this kind of dropout. So it is basically is a U.S. issue, and Jay. Therefore, we know we can get it to function. We just need to ensure that the support system also in U.S. is strong enough to be sure that is not a problem.
Very helpful. Thank you.
Thank you. Our next question will come from Eric Joseph with Citi. Your line's open.
Hey. Thanks for taking the questions. As far as your named patient programs or your early access programs, can you elaborate a little bit on which markets you are 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 YUVIWEL in particular.
Okay. I just wanted to ask what product you were referring to.
UBEGLA.
Yeah. I can guarantee that as we based in our prepared remark, try to put emphasis on, we have a global infrastructure in commercialization and patient support, product supply, and everything like that. The number of so we are not a company that just need to get started. We already have established all this infrastructure. And what we are doing is that we are utilizing this established infrastructure based that got established because of YORVIPATH, because this is what we did with YORVIPATH. We are using exactly the same infrastructure also for YUVIWEL. So we will be where patient is, and we will be quite sure we will also serve the patient outside U.S., and potentially the market is much larger outside U.S. And I think, we hope we also will see a large penetration in the U.S. where another short-acting product really failed to do it.
We believe because of the highly differentiated nature of YUVIWEL, we will see a complete different pickup in the U.S. But it is definitely, we have a strong focus on the ex-U.S. And 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. The next question will come from Luca Issi with RBC Capital Markets. Your line is open.
Great. Thanks so much for taking our question. This is Cathy for Luca Issi. Circling back to YUVIWEL, Jay Wu, the three categories that you very nicely touched on for the naive switch and discontinued patients that are not on script. BioMarin mentioned on their second quarter call that less than 100 patients have switched off of VOXZOGO. The simple math that we are trying to do here is that it leaves you with about 70 patients in the second quarter who are naive or return to treatment. That is taken off the switched patients. 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 VOXZOGO, stopped treatment and are now returning to treatment, but to YUVIWEL?
Separately, very quickly, if you have commented or not on the ex-U.S. strategy for YUVIWEL, given the decision is pending and may come very soon this year. Thanks so much.
I like your way of doing all the calculation, anything like that. I cannot support it, or I cannot deny it because I do not have the factual insight to some way to confirm anything of the numbers. I also saw the number that came out, but I cannot really support it because I do not have the insight from our own numbers to really come out and come with any statement that indicate if I am aligned or not aligned with. Related to the ex-U.S., for me to understand your question, was this reflecting what is the limitation in the ex-U.S., or what was the question?
Oh, thanks. Thanks for asking to clarify. More about are you committed to running the show by yourself or you are considering partnering, given that 70% of the VOXZOGO sales is historically coming from ex-U.S. can be a quite heavy lifting.
Yeah, but basically in the ex-U.S., we have our direct market which are, I think, 60, 70, 80 where we have our own commercial infrastructure. It's pretty clear what we are doing there. Then we have our sales and distributions agreement, and this is, I think it's 70 countries or something like that where it's got this-
80.
Oh, 80 countries that is covering this sales and distributions agreement. The vast majority of all of them are all three product. That is already established infrastructure for the distribution. Then we have the two other, the third model where we have our partnerships, one in Japan, one in China, and they also have all the three product. We do not need to go out and make any new agreements for anything. Everything is established. Everything is running on full speed. For some of the EU direct market, we are just waiting for our expected approval here in Q4 this year.
Okay. Thank you.
Thank you. Our last question is going to come from Faisal Khurshid with Jefferies. Your line is open.
Hey, guys. Thank you for taking the question. Just wanted to ask a little bit on the YORVIPATH life cycle strategy. Can you give us an update on the latest on getting the higher dose into the label for FDA? Also any update on weekly YORVIPATH. Thank you.
Yeah. What we see today is that we are enrolling the trial in the U.S. where we're evaluating the 30-60 dose range in two different means that has been aligned with the FDA in their design, what they wanted to see. We see that enrollment going extremely fast, so we expect very fast, and you can say label expansion in the place where we don't have up to the 60. So we see that basic just on execution. Your second question was related to?
On weekly YORVIPATH, any update there?
Yeah, I think there's no news in this way that we just executing and getting it into the market as fast as possible out from the expectation that we see that not as an any kind of LCM activity, but more a patient support for patient that really are in the stable dosing, which are not a lot after they have been in a situation where they have been stabilized with our daily treatment.
Great. Thank you.
Thank you. This is all the time that we have for questions today. This does conclude today's conference call, and thank you for participating. You may now disconnect.
Thanks a lot, everyone
Investor releaseQuarter not tagged2026-08-06Ascendis Announces COACH Week 78 Results and Provides Update on Achondroplasia Programs and YUVIWEL® Uptake in the U.S.
GlobeNewswire
Ascendis Announces COACH Week 78 Results and Provides Update on Achondroplasia Programs and YUVIWEL® Uptake in the U.S.
TransCon® CNP and TransCon hGH combination therapy Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increase in healthy, proportional growth TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body proportionality, and lower-limb alignment Completed target enrollment for pivotal reACHin Trial supporting planned regulatory filings for infants 0 to Safety and tolerability of monotherapy and combination therapy remained consistent with previously reported data More than 170 unique YUVIWEL patient enrollments in the U.S., with more than 65% approved for reimbursement, through June 30 COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided updates across its achondroplasia programs. “The rapid uptake of YUVIWEL in the United States underscores its highly differentiated profile and reflects our core values and our patient-centered development of therapies,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “We are very pleased to see continued unprecedented results from our combination therapy trial, which further reinforce our commitment to ensure that as many children as possible can access YUVIWEL.” Combination Therapy Update (TransCon CNP + TransCon hGH; navepegritide + lonapegsomatropin) Treatment with the combination of once-weekly TransCon CNP and once-weekly TransCon hGH continued to demonstrate durable growth in children with achondroplasia, with a mean annualized growth velocity (AGV) meeting or exceeding the 97th percentile of children of average stature, without compromising safety or tolerability at Week 78. Highlights of the Topline Week 78 COACH Trial Results Consistent with Week 26 and Week 52 results, mean AGV for children treated with combination therapy through Week 78 remained at or above the 97th percentile AGV of children of average stature, with changes over time following age-related growth patterns, and sustained increases in ACH height Z-score, indicating a tripling of efficacy compared to TransCon CNP monotherapy. Children treated with combination therapy demonstrated continued improvements in body proportionality through Week 78, aligning with the increase in linear growth. Safety and tolerability were consistent with those observed for TransCon CNP and TransCon hGH monothera…Read full documentShow less
TransCon® CNP and TransCon hGH combination therapy Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increase in healthy, proportional growth TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body proportionality, and lower-limb alignment Completed target enrollment for pivotal reACHin Trial supporting planned regulatory filings for infants 0 to Safety and tolerability of monotherapy and combination therapy remained consistent with previously reported data More than 170 unique YUVIWEL patient enrollments in the U.S., with more than 65% approved for reimbursement, through June 30 COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided updates across its achondroplasia programs. “The rapid uptake of YUVIWEL in the United States underscores its highly differentiated profile and reflects our core values and our patient-centered development of therapies,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “We are very pleased to see continued unprecedented results from our combination therapy trial, which further reinforce our commitment to ensure that as many children as possible can access YUVIWEL.” Combination Therapy Update (TransCon CNP + TransCon hGH; navepegritide + lonapegsomatropin) Treatment with the combination of once-weekly TransCon CNP and once-weekly TransCon hGH continued to demonstrate durable growth in children with achondroplasia, with a mean annualized growth velocity (AGV) meeting or exceeding the 97th percentile of children of average stature, without compromising safety or tolerability at Week 78. Highlights of the Topline Week 78 COACH Trial Results Consistent with Week 26 and Week 52 results, mean AGV for children treated with combination therapy through Week 78 remained at or above the 97th percentile AGV of children of average stature, with changes over time following age-related growth patterns, and sustained increases in ACH height Z-score, indicating a tripling of efficacy compared to TransCon CNP monotherapy. Children treated with combination therapy demonstrated continued improvements in body proportionality through Week 78, aligning with the increase in linear growth. Safety and tolerability were consistent with those observed for TransCon CNP and TransCon hGH monotherapies. Combination therapy was generally well-tolerated, with a low incidence of injection site reactions and generally mild treatment-emergent adverse events (TEAEs). To date, 100% of the 21 enrolled children completed 78 weeks of treatment and remain on therapy in the COACH Trial. Additional data from Week 78 of COACH to be presented at an upcoming medical meeting. COACH Trial DesignCOACH is an ongoing prospective Phase 2 open-label trial to investigate the efficacy, safety, and tolerability of combined treatment with once-weekly TransCon CNP at 100 µg/kg/week and once-weekly TransCon hGH at a starting dose of 0.30 mg/kg/week (“combination therapy”) in children with achondroplasia aged 2 to 11 years. The trial included a cohort of TransCon CNP treatment-naïve children (N=12, mean age 5.26 years) and a cohort of previously TransCon CNP-treated children (N=9, mean age 8.32 years), who had received TransCon CNP (100 µg/kg/week) for a mean of 2.56 years in clinical trials. The trial population is representative of children with achondroplasia and the prior treatment benefits of TransCon CNP monotherapy. “I became involved in advocacy in part because parents were increasingly eager to learn more about emerging drug development programs,” said Chandler Crews, Founder of The Chandler Project. “YUVIWEL is a new treatment option that has brought hope to many in our community seeking to prevent complications of achondroplasia that may, without effective pharmacologic treatment, lead to chronic pain, mobility issues, surgeries, and impact on quality of life.” Monotherapy Update(TransCon CNP; navepegritide) In completed and ongoing clinical trials of children with achondroplasia, treatment with once-weekly TransCon CNP monotherapy demonstrated durable improvements in height, as well as benefits beyond height, and a safety and tolerability profile similar to placebo, including a low rate of injection site reactions, consistent with the incidence rate reported in the FDA label. Week 104 data from the pivotal ApproaCH Trial of TransCon CNP at 100 µg/kg once-weekly in children with achondroplasia aged 2 to 11 years demonstrated: Completed target enrollment for pivotal reACHin Trial, supporting planned regulatory filings for infants 0 to <2 years of age with achondroplasia. To date, 96% of the 140 children enrolled in the AttaCH long-term open-label extension trial remain on TransCon CNP monotherapy, with up to nearly 6 years of treatment, or are in the ongoing COACH combination therapy trial. In the European Union, a decision is anticipated in the fourth quarter of 2026 for the Marketing Authorisation Application for TransCon CNP as a monotherapy for children with achondroplasia. “I am excited to see compelling long-term efficacy, safety, and tolerability data for TransCon CNP monotherapy,” said Carlos Bacino, MD, FACMG, Professor of Molecular and Human Genetics, Baylor College of Medicine and Texas Children’s Hospital. “TransCon CNP has demonstrated positive effects compared to placebo on multiple aspects of skeletal growth, including statistically significant improvements in height and lower-limb alignment, with growing long-term data highlighting its unprecedented efficacy when used in combination with TransCon hGH. That and its once-weekly administration and low rate of injection site reactions mark it as an important potential new treatment option for children with achondroplasia.” “We are encouraged to see research on navepegritide continue to examine areas the achondroplasia community has identified as important, including outcomes beyond linear growth,” said Mike Hughes, Chair, Biotech Industry Liaison Committee, Little People of America. “The ApproaCH findings add to our understanding of body proportionality and lower-limb alignment, while continued study will be important to determine whether these anatomical changes translate into meaningful differences in function, mobility, or the future need for surgical intervention. Clear, balanced evidence can help individuals and families make informed decisions aligned with their own goals and values, including whether treatment is right for them.” YUVIWEL U.S. Launch Update through June 30, 2026(navepegritide; developed as TransCon CNP) More than 170 unique patient enrollments by approximately 90 prescribing healthcare providers, with more than 65% approved for reimbursement, through June 30, 2026. All enrollments through this date reflect patients new to YUVIWEL therapy. A slide presentation with these updates will be made available on the Investors & News section of the Ascendis Pharma website: https://investors.ascendispharma.com. About TransCon CNP and TransCon hGHTransCon CNP (navepegritide) is a prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed to provide continuous exposure of active CNP to receptors on tissues throughout the body to counteract the overactive FGFR3 signaling in achondroplasia. TransCon hGH is a prodrug of somatropin administered once weekly, providing sustained release of active, unmodified somatropin. In February 2026, TransCon CNP was approved by the U.S. Food & Drug Administration (FDA) under the trade name YUVIWEL® to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. TransCon hGH (lonapegsomatropin) is investigational in achondroplasia and other indications and is approved and marketed as SKYTROFA® for the treatment of pediatric and adult growth hormone deficiency. About AchondroplasiaAchondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, and is associated with an increased risk of muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia can vary from individual to individual and across different stages of life. Throughout infancy and childhood, observed complications include spinal abnormalities, enlarged brain ventricles, impaired muscle strength and reduced stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; some of which persist or worsen in adulthood. These medical complications can affect physical well-being and quality of life, and may be impacted by a range of individual, clinical, and social factors. Some individuals with achondroplasia require multiple procedures and surgeries to address specific functional or anatomical concerns. About Ascendis Pharma A/SAscendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) planned regulatory filings for infants 0 to <2 years of age with achondroplasia, (ii) the anticipated timing of a regulatory decision for the Marketing Authorisation Application for TransCon CNP as a monotherapy for children with achondroplasia, (iii) the potential benefits of TransCon CNP monotherapy and combination therapy with TransCon hGH, (iv) Ascendis’ clinical development activities, including the teACH, reACHin, and AttaCH trials, (v) Ascendis’ commercialization activities and efforts to provide access to YUVIWEL, and (vi) Ascendis’ ability to apply its TransCon technology platform to develop new therapies with best-in-class potential. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third‑party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on‑market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom‑to‑operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA® and YUVIWEL® are trademarks owned by the Ascendis Pharma group. © August 2026 Ascendis Pharma A/S.
Investor releaseQuarter not tagged2026-08-06Ascendis to Report Second Quarter 2026 Financial Results and Provide Business Update on August 13, 2026
GlobeNewswire
Ascendis to Report Second Quarter 2026 Financial Results and Provide Business Update on August 13, 2026
COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it plans to report second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, before the open of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on August 13, 2026, at 8:00 a.m. Eastern Time (ET) to discuss its second quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ plan to report financial results, provide a business update and host a conference call and live webcast on a certain date, (ii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients and (iii) Ascendis’ use of TransCon to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the i…Read full documentShow less
COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it plans to report second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, before the open of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on August 13, 2026, at 8:00 a.m. Eastern Time (ET) to discuss its second quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ plan to report financial results, provide a business update and host a conference call and live webcast on a certain date, (ii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients and (iii) Ascendis’ use of TransCon to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third‑party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on‑market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom‑to‑operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © August 2026 Ascendis Pharma A/S.
Investor releaseQuarter not tagged2026-05-15Ascendis Pharma (NASDAQ:ASND) Is Posting Healthy Earnings, But It Is Not All Good News
Simply Wall St.
Ascendis Pharma (NASDAQ:ASND) Is Posting Healthy Earnings, But It Is Not All Good News
Even though Ascendis Pharma A/S (NASDAQ:ASND) posted strong earnings recently, the stock hasn't reacted in a large way. We looked deeper into the numbers and found that shareholders might be concerned with some underlying weaknesses. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. One key financial ratio used to measure how well a company converts its profit to free cash flow (FCF) is the accrual ratio. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. The ratio shows us how much a company's profit exceeds its FCF. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. While it's not a problem to have a positive accrual ratio, indicating a certain level of non-cash profits, a high accrual ratio is arguably a bad thing, because it indicates paper profits are not matched by cash flow. To quote a 2014 paper by Lewellen and Resutek, "firms with higher accruals tend to be less profitable in the future". Over the twelve months to March 2026, Ascendis Pharma recorded an accrual ratio of 1.28. That means it didn't generate anywhere near enough free cash flow to match its profit. Statistically speaking, that's a real negative for future earnings. Indeed, in the last twelve months it reported free cash flow of €45m, which is significantly less than its profit of €495.9m. Given that Ascendis Pharma had negative free cash flow in the prior corresponding period, the trailing twelve month resul of €45m would seem to be a step in the right direction. However, that's not all there is to consider. The accrual ratio is reflecting the impact of unusual items on statutory profit, at least in part. The good news for shareholders is that Ascendis Pharma's accrual ratio was much better last year, so this year's poor reading might simply be a case of a short term mismatch between profit and FCF. As a result, some shareholders may be looking for stronger cash conversion in the current year. See our latest analysis for Ascendis Pharma That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their es…Read full documentShow less
Even though Ascendis Pharma A/S (NASDAQ:ASND) posted strong earnings recently, the stock hasn't reacted in a large way. We looked deeper into the numbers and found that shareholders might be concerned with some underlying weaknesses. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. One key financial ratio used to measure how well a company converts its profit to free cash flow (FCF) is the accrual ratio. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. The ratio shows us how much a company's profit exceeds its FCF. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. While it's not a problem to have a positive accrual ratio, indicating a certain level of non-cash profits, a high accrual ratio is arguably a bad thing, because it indicates paper profits are not matched by cash flow. To quote a 2014 paper by Lewellen and Resutek, "firms with higher accruals tend to be less profitable in the future". Over the twelve months to March 2026, Ascendis Pharma recorded an accrual ratio of 1.28. That means it didn't generate anywhere near enough free cash flow to match its profit. Statistically speaking, that's a real negative for future earnings. Indeed, in the last twelve months it reported free cash flow of €45m, which is significantly less than its profit of €495.9m. Given that Ascendis Pharma had negative free cash flow in the prior corresponding period, the trailing twelve month resul of €45m would seem to be a step in the right direction. However, that's not all there is to consider. The accrual ratio is reflecting the impact of unusual items on statutory profit, at least in part. The good news for shareholders is that Ascendis Pharma's accrual ratio was much better last year, so this year's poor reading might simply be a case of a short term mismatch between profit and FCF. As a result, some shareholders may be looking for stronger cash conversion in the current year. See our latest analysis for Ascendis Pharma That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. The fact that the company had unusual items boosting profit by €7.5m, in the last year, probably goes some way to explain why its accrual ratio was so weak. While it's always nice to have higher profit, a large contribution from unusual items sometimes dampens our enthusiasm. When we crunched the numbers on thousands of publicly listed companies, we found that a boost from unusual items in a given year is often not repeated the next year. And, after all, that's exactly what the accounting terminology implies. Ascendis Pharma had a rather significant contribution from unusual items relative to its profit to March 2026. As a result, we can surmise that the unusual items are making its statutory profit significantly stronger than it would otherwise be. Ascendis Pharma had a weak accrual ratio, but its profit did receive a boost from unusual items. On reflection, the above-mentioned factors give us the strong impression that Ascendis Pharma'sunderlying earnings power is not as good as it might seem, based on the statutory profit numbers. So if you'd like to dive deeper into this stock, it's crucial to consider any risks it's facing. Case in point: We've spotted 3 warning signs for Ascendis Pharma you should be mindful of and 2 of them are a bit concerning. In this article we've looked at a number of factors that can impair the utility of profit numbers, and we've come away cautious. But there is always more to discover if you are capable of focussing your mind on minutiae. Some people consider a high return on equity to be a good sign of a quality business. While it might take a little research on your behalf, you may find this free collection of companies boasting high return on equity, or this list of stocks with significant insider holdings to be useful. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-08Ascendis (ASND) Q1 2026 Earnings Call Transcript
Motley Fool
Ascendis (ASND) Q1 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET President and Chief Executive Officer — Jan Mikkelsen Chief Financial Officer — Scott Smith Chief Business Officer — Sherrie Glass EVP and President, U.S. Market — Jay Wu Vice President, Investor Relations — Chad Fugure Need a quote from a Motley Fool analyst? Email [email protected] Chad Fugure: Thank you, operator, and thank you, everyone, for joining our first quarter 2026 financial results conference call. I'm Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; and Jay Wu, EVP and President, U.S. 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 YORVIPATH, YUVIWEL and SKYTROFA, 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 result of regulatory decisions. 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 February 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 P…Read full documentShow less
Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET President and Chief Executive Officer — Jan Mikkelsen Chief Financial Officer — Scott Smith Chief Business Officer — Sherrie Glass EVP and President, U.S. Market — Jay Wu Vice President, Investor Relations — Chad Fugure Need a quote from a Motley Fool analyst? Email [email protected] Chad Fugure: Thank you, operator, and thank you, everyone, for joining our first quarter 2026 financial results conference call. I'm Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; and Jay Wu, EVP and President, U.S. 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 YORVIPATH, YUVIWEL and SKYTROFA, 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 result of regulatory decisions. 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 February 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 PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP is approved in the U.S. by the FDA for the treatment of hypochondroplasia in children aged 2 years and older. Continued approval for this indication, which is based on an improvement in annualized growth velocity may be contingent upon verification and description of clinical benefit and confirmatory trials. TransCon hGH is 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 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. 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 2026 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 Jan. Jan Mikkelsen: Thanks [indiscernible] Good day, everyone, here from Copenhagen. The first quarter of 2026 was [indiscernible] inflection point for Ascendis, with the FDA approval of our third [indiscernible] product, YUVIWEL. Our revenues are growing rapidly. We are profitable. We have a pipeline of high-value product opportunities to support long-term growth. 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 YUVIWEL, we have now achieved approval of 3 products in a row across 4 rare endocrine indications. Second, our rapid revenue growth from our existing endocrine rare disease portfolio, [indiscernible], YUVIWEL and SKYTROFA, each highly differentiated with long durability, we expect sustained revenue growth for many years to come. 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 4 new clinical entities in preclinical development. Turning now to YORVIPATH. Global YORVIPATH revenue in the first quarter reached EUR 197 million. YORVIPATH revenue for the first quarter was impacted by 2 onetime items. A temporary increase of U.S. patients supported by free drug caused by reimbursement disruption and onetime impact of Europe Direct related to expanded market. Scott will explain the financial impact of these two events in his remarks. In the U.S., new patient enrollment in Q1 remained in line with the strong uptake we have seen in Q4 2025, with more than 1,000 new patients prescribed YORVIPATH during the quarter. Through the end of March 2026, more than 6,300 patients have been prescribed YORVIPATH by more than 2,700 unique health care providers. March was our last revenue month ever for YORVIPATH, supported by an increased number of new patients, as well as patients returning to reimbursement from free drug. Importantly, the enrollment trend we saw in Q1 have continued 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. Outside the U.S., YORVIPATH is available commercially or to [indiscernible] patient programs in 35 countries, including full commercial reimbursement in 6 of our Europe Direct markets, with additional launches expected through '26. Looking [ forward ] ahead, we continue to pursue multiple expansion opportunities for YORVIPATH in new markets and indications. This includes doses up to 60 micrograms in the U.S., global expansion to patients 8, 12 to 18 and continued development of once-weekly TransCon PTH for patients on stable YORVIPATH [ process ]. With 70,000 to 90,000 patients living with chronic hypopara in the U.S., and 5 to 10x that number outside the U.S., we remain highly confident in YORVIPATH's long-term global potential. I will now turn to our growth disorder [indiscernible]. With week our once-weekly growth hormone, SKYTROFA, we believe Ascendis is uniquely positioned to strengthen its leadership in those disorders. Our U.S. commercial infrastructure built and refined since SKYTROFA launched in 2021 has enabled a focused and high-impact launch for YUVIWEL, which became commercially available in early April. Since then, YUVIWEL has already been prescribed for more than 60 children by more than 35 unique health care providers. With children approved for reimbursement as fast as a few days, YUVIWEL has shown compelling results compared to placebo across multiple clinical trials in addition to linear growth outcomes. These results include improvements in final [indiscernible] dimensions, body operationality, physical function and health-related quality of life compared to placebo, without compromising safety or tolerability. We believe this outcome reflects YUVIWEL's unique ability to provide continuous systemic [ CMP ] exposure throughout the body over the weekly dosing interval. Looking ahead, we plan to make YUVIWEL available in selected international markets through early access programs using the U.S. FDA approval. As a reminder, our global infrastructure covers 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 YUVIWEL is expected in the fourth quarter of '26. We are also pursuing label expansion for YUVIWEL to ongoing trials. These include infants on the 2 years of age with hypochondroplasia and [ 7 with ] hypochondroplasia as well as geographic label expansion in clinical trials. Turning now to SKYTROFA. In the U.S., SKYTROFA maintained consistent performance as a premium product with [ 7% ] share of the overall growth hormone market, reflecting steady demand across pediatric and adult patients as the only once-weekly product delivering on [indiscernible]. With the expected label expansion that could double the addressable patient population in the U.S. and geographic expansion outside the U.S., we believe SKYTROFA 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 hypochondroplasia. In our Phase II COACH trial, we have reported unprecedented results that exceeds the already compelling foundation established by YUVIWEL monotherapy. Week 52 data from COACH presented in January showed improvement in hypochondroplasia specific height score that indicates a triple of efficacy compared to TransCon CNP monotherapy, along with improvement in body proportionality. More recently, we shared additional week 52 data that showed improvement in lower limb alignment, as well as an [indiscernible] improvement in spinal can dimensions and an improvement in arm strength, not previously demonstrated with pharmacotherapy within a single treatment. Based on this finding, we believe our unique combination therapy of TransCon CNP and TransCon Growth Hormone could potentially eliminate the need for highly invasive procedure such as [indiscernible] and leg straightening surgeries. We believe that this combination therapy could become the preferred treatment option for hypochondroplasia. I will now briefly turn to oncology. In our Phase I/II [indiscernible] trial, we have elevated TransCon IL-2 beta gamma in combination with [indiscernible] in patients with late-stage [ platinum-resistant ] ovarian cancer or PRC. Median OS improved up to 10 months from 6 to 7 months from historical [indiscernible] with a general well-tolerated safety profile, validated the science on TransCon IL-2 [indiscernible]. As further internal oncology development does not align with our strategic focus, we have decided to discontinue internal development of TransCon IL-2 beta [ gamma ] in oncology and will explore other ways to maximize the value of these assets. Turning now to our partnership. Our once-monthly TransCon semaglutide with Novo Nordisk continue to advance towards the clinic and [indiscernible] TransCon anti-VEGF also remain 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 2023, we made significant progress across our business and our ability to make a meaningful difference for patients. We have 3 FDA-approved TransCon products across 4 indications, growing revenues, improving cash generation and a pipeline that supports long-term growth. I will now turn the call over to Scott to review our financial results. Scott Smith: Thanks a lot, Jan, 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 6-K filed today. YORVIPATH global revenue was EUR 197 million in Q1. The first quarter was characterized by steady global uptake and normal seasonality as well as 2 onetime items. Patients temporarily transitioned to free drug in the quarter in the U.S. and a onetime impact in Europe direct related to expanded market access. The combined impact of these 2 items was approximately EUR 15 million. SKYTROFA contributed EUR 44 million in Q1. On a sequential basis, performance reflected consistent underlying demand with the expected drawdown in channel inventory built in Q4. Including EUR 6 million in collaboration revenue, total Q1 2026 revenue amounted to EUR 247 million. Continuing to expenses. R&D expenses in Q1 were EUR 59 million, down from EUR 78 million in Q4 '25. R&D in Q1 was favorably impacted by a write-up of YUVIWEL inventory consisting of EUR 11 million due to U.S. FDA approval and lower clinical activity across the portfolio. SG&A expenses rose to EUR 145 million in Q1 2026, compared to EUR 136 million in Q4 2025, reflecting continued impact of global commercial expansion. Total operating expenses for Q1 2026 were EUR 204 million and operating profit was EUR 25 million, reflecting a 10% operating margin. Non-IFRS operating profit was EUR 55 million and non-IFRS operating margin was 22%. 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 2026 was EUR 63 million, primarily driven by noncash items, including remeasurement loss of financial liabilities of EUR 34 million. Net cash financial expense for Q1 '26 was about EUR 1 million. Net profit for Q1 2026 was EUR 629 million, which included recognition of a EUR 679 million deferred tax asset in the P&L. Refer to our 6-K for more detail. Non-IFRS net profit was EUR 18 million, or EUR 0.27 per share. We ended Q1 2026 with EUR 573 million in cash and cash equivalents, which includes the impact of EUR 60 million 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 USD 187.5 million in cash. The PRV was awarded by the U.S. FDA upon approval of YUVIWEL in February. Turning to our commercial outlook. For YORVIPATH, 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 SKYTROFA, we expect stable revenue throughout the year following a similar seasonal pattern to 2025. Regarding YUVIWEL, as Jan 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. Operator: [Operator Instructions] And our first question comes from the line of Jessica Fye of JPMorgan. Jessica Fye: I was wondering if you could help us estimate what U.S. YORVIPATH 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 onetime 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. Jan Mikkelsen: I think that Scott will give you just a little bit more background on the financial element, specific onetime in Europe Direct. And 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 15 months, 16 months. And it gave us a onetime 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 YUVIWEL, you can say, Q1 results. But Scott, you can give you a little bit more flavor on the financial numbers. Scott Smith: Yes. And just for modeling purposes, it's probably a little bit more of an impact. But I would say the best way to think about it is take the algorithm that we laid out where you add 4 to 5 a quarter. And for Q1, basically that addition was just shifted into Q2. And then from there, the algorithm continues. Jan Mikkelsen: But I think just one of the key element 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 U.S. where we now -- as we have provided you the number of indicated new patients on treatment with YORVIPATH. And as we have given in our previous guidance, we're 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's already starting to improve both the time to reimbursement and the numbers. I do not, Jay, will you comment about your effort in really improving what you call the reimbursement situation for the U.S. Jay Wu: 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 80% 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 8 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. Operator: Our next question comes from the line of Tazeen Ahmed of Bank of America. Tazeen Ahmad: 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 your YORVIPATH before? Jan Mikkelsen: Okay. There was multiple questions. I hope you got everyone down. Will you start on some of them? Jay Wu: 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 Jan mentioned earlier in the script, we've had over 2,700 prescribers, which again is an addition of about 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. In fact, over -- about 10%-ish of prescribers have now over 5 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 prescriber sign on to YORVIPATH 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. Tazeen Ahmad: Okay. And then reauthorization was the last one. Jay Wu: And reauthorization, yes, that was the first part of your question. We're not seeing any meaningful differences in terms of approval rates for re-auth versus necessarily a patient that's coming in at the top of the funnel. We typically, again, have shared that 4- to 8-week time frame. 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 re-auth coming in versus a new patient coming in. Generally, what you'll see is if it's a re-auth of an existing payer insurance where there hasn't been a change in insurance, you might see some faster time line 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. Operator: Our next question comes from the line of Yaron Werber of TD Cowen. Yaron Werber: Great. Maybe a quick follow-up and then a question on YUVIWEL. A follow-up on YORVI. So of the [ $15 million ], 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 YUVIWEL, in the ITC case is progressing, the bridge 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? Jan Mikkelsen: First of all, I believe when you see the uptick in the prescriptions of in the U.S. We have more than 60 children being prescribed YUVIWEL treatment in less than 4 or 5 weeks. I think it illustrates the unmet medical need that exists in the U.S. related to an improved treatment in hypochondroplasia. And I believe what we have seen of clinical data in our multiple trials with YUVIWEL 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 documentated effect on benefit beyond linear growth. And I think everyone is aligning with the unmet medical need, the public interest for this to have a product [indiscernible] in the market. 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 promises. So [indiscernible] I'm confident YUVIWEL is here to stay, and it will always be a treatment option for patients with hypochondroplasia in the U.S. 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. Operator: Our next question comes from the line of Gavin Clark-Gartner of Evercore ISI. Unknown Analyst: This is [indiscernible] on for Gavin. We have 2 quick questions. Number one is for the Phase III [indiscernible] and growth hormone combo trial, can you share any update on the enrollment speed? And secondly, what are you seeing in your discontinuation rates over time? Jan Mikkelsen: So when we talk about -- as I understood your question right, it was related to the combination trial, the Phase II trial we call [indiscernible] trial. And we basically are now -- I do not know how many years we are into the trial now, but I think we are 2 years in 1.5 years now. And I think we see basically an extremely high element of retention in this trial. To my knowledge, last time, 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 few trial where you have 100% retention after nearly 18 months. 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 are always 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. Operator: Our next question comes from the line of Li Watsek of Cantor Fitzgerald. Li Wang Watsek: I guess on new patient adds 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? And will you be sharing new script number going forward? Jan Mikkelsen: That's a great question. Now some going back to the last time I said I will not come up with more prescription data for YORVIPATH because I believe that the revenue progression was so clear. And when I said that there was a big, big, what I call element of some interesting funds that pushed back and saying, I didn't want to come out with numbers because it must be really, really bad. And now we have illustrated for 1 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 some more patient that is coming new patients every, every, every year. So I'm somewhat giving up to say that I will not come out 1 quarter more because last time, I said we will not come out with one quarter and then I got basic press because I didn't want to listen to that, that we didn't want to come up with a number because they are bad. I don't hide anything. I always want to be transparent. And this is why I come out with a number, then you can see it. So I think we will continue to be so transparent on everything what we're doing. So you always have the best possible opportunity to see how well we are performing in our fundamentals. Operator: Our next question comes from the line of Alex Thompson of Stifel. Unknown Analyst: This is Patrick on for Alex. Could you guys just talk about the potential impact of the YORVI 60 micrograms being on the label? And maybe what percentage of those 6,300 patients in the U.S. is dose caps at 30 with, maybe less than ideal supplementation levels? Jan Mikkelsen: This is a question which are very difficult for us to answer today because we see different kind of [ up titration ] in both different situation in clinical trials and also sideration 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 2 arms in our evaluation of dose titration 30 up to 60. And we will enroll that in a decent speed. We only do that in the U.S. because it's the only place where we restricted down to 30 and not have 60. And we believe that even if you are coming up to 30 micrograms, you still have a major benefit to be still on 30 microgram compared to many of the positive effect that YORVIPATH is still providing to it. So I think you can say, yes, there is someone that will benefit to go higher. But today, we're still providing the benefit to the patient that need to stop on 30 micrograms. Operator: Our next question comes from the line of Joe Schwartz of Leerink Partners. Joseph Schwartz: So some physicians we've spoken with have suggested that they might not want to put their office staff through the reimbursement challenges of switching their hypochondroplasia patients to a once-weekly injection only to then later switch them to a 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 hypochondroplasia patient, or physician community rather and encourage uptake? And then have any -- my second question is, have any physicians prescribed YUVIWEL in combination with SKYTROFA since YUVIWEL was approved? Jan Mikkelsen: 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 [indiscernible] rare disease product. I think they talk about the unmet need and the willingness for basic physician in connection with the parents, in connection with the child to basically to have the desire to take them on a treatment with YUVIWEL. I think it says everything with numbers. You can go out and ask one physician. You 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 some way discuss an element we cannot promote. We cannot promote anyway [indiscernible] combination therapy. We have disclosed the benefit of the combination therapy. And that is 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. 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 just a positive element for any child with hypochondroplasia to avoid the invasive surgeries. And I think this is the reason why the physician do it. And sure, we're looking forward to finalize the Phase III trial. We're looking forward to have it on label. So we really also can go and promote it. Operator: Our next question comes from the line of Ellie Merle of Barclays. Unknown Analyst: This is Jasmine on for Ellie. Just kind of a follow-up to the last question. For YUVIWEL, 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 see more new starts or switches? And what kind of patients do you think are the most likely to initially want to switch? Jan Mikkelsen: The insight you're asking for is the insight we will develop in the coming months and quarter. After 5 weeks to try to come with a general statement about what kind of patient, what kind of preference they have to go on to YUVIWEL treatment. I think it's too early for us to come with a conclusion but it is such a topic. The only thing I can say, and Jay, you can add on, what we see is basically coming from everywhere. It's not just naive patients. It's not just [ switch ] patients. 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 [indiscernible] impact on to help the physician, the patient is really to have a part 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. Jay, do you have anything to add? Jay Wu: Yes. I think you summed it up well. The only 2 additional things I would add is, one, to Jan's point, we're seeing across all segments. And we've discussed before the 3 areas or types of patients that we envision coming are. One, patients currently on VOXZOGO that are switching over. Two, patients that were previously on VOXZOGO 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 3 of those groups. And I think really what that underscores is the continued and existing unmet need that exists in hypochondroplasia today even with the existing therapy on market, which I think emphasizes the value of having YUVIWEL on the market and the compelling value proposition that it offers patients. I think the second area that Jan was talking about is our continued investment in 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 invest in the support and the journey as they go through the continuum of prescription to ultimately being on therapy. Operator: Our next question comes from the line of Yun Zhong of Wedbush. Yun Zhong: My question is on the monotherapy for hypochondroplasia. 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 hypochondroplasia? Jan Mikkelsen: Yes. I think the strategy that we have applied to [ achondroplasia ] where we started with monotherapy and the addition to combination therapy. I think you will see that there will be alignment between the strategic approach that we have used in [ achondroplasia ], we will likely also use in hypochondroplasia. I can basically tell you that we're using the same principle between the 2 indications. The 2 indication 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 2 indications. Operator: Our next question comes from the line of Luca Issi, RBC Capital. Luca Issi: Maybe Jay or Scott, can you educate us on the mechanics of the free drug for YORVIPATH? 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 super quickly, I think AstraZeneca has presented their Phase III data for [indiscernible] this week in the European Congress on Endocrinology. So wondering if you can comment on what are your expectations for that data? Jan Mikkelsen: Yes. I can start from the last question, and then I can move it up and then Jay can take over in the end. The compound we are talking about in the end is the amyloid compound. And we have discussed that on many earnings calls, the lack of information that was related to data. Now that is disclosed some kind of information of the data package 1 year after finalization of the Phase III trial. And for me, and I think the key question, do this data package 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 hypopara, I see YORVIPATH, our once-weekly approach to stable patient on YORVIPATH is really providing the fundamentals for a 20, 30 years treatment regime where I don't see anything that really can give up to the benefit we will see in the treatment with YORVIPATH or any other product that is currently in clinical development from that perspective. Related to the first part of your question, you're right. We started to take already December a group of patients over to free drug because the essential part of YORVIPATH is that you cannot stop we first have started taking over to basically 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 that was a hiccup and it's something we have 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 and series of patients on free drug, and they are now coming back to be fully reimbursed. And we are in a position that -- and the organization in the U.S. some way have built up network or other things that can help it that we're not ending in the same situation on time. Jay, have you any comments too? Jay Wu: Again, I think you summarized the need for bridge program well. I think just to clarify the earlier question, there is 2 types of [indiscernible] 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 underinsured or uninsured. 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. Jan Mikkelsen: Yes. 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 success 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 a drug for the patients that we are -- 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 a period of free drugs until the disruption getting solved, and we will always be there for the patients. Operator: Our next question comes from the line of Maxwell Skor of Morgan Stanley. Unknown Analyst: This is [indiscernible] on for Max. Given the relatively low treatment penetration in [indiscernible] in the U.S. to date, what proportion of patients typically initiate treatment at age 2 years or older? Jan Mikkelsen: I think some way to roll it a little bit back because you can ask the question why you have under treatment in the U.S? 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 undertreatment is basically the cause of lack of the right efficacy to show real benefit beyond linear growth. Many of these parents, children don't see linear growth as a key element. They really want us to address all the [ comorbidity ], specific if you can avoid surgeries, or changing the pain [indiscernible] with leg bone. You can avoid [indiscernible]. And I believe by having this focus on these elements and here, I talk about the older children. If you go to the younger newborn, yes, if we can avoid any kind of spinal stenosis by having early intervention from newborn, yes, there will be a major benefit for treatment in the state. So I believe our product profile that we have generated [indiscernible] a product, clear benefit compared to placebo. It needs always to be placebo controlled because there is a development to. So you cannot say, we also improve a [indiscernible] child with 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 just the benefit of the medical treatment in it. So the question and the answer to you is I believe will be appealing product to the vast majority of parents, children in the U.S. also because they provide a way to address the comorbidities. So important one, everything that you basically will see benefit for not only quality of life that's associated with it, but also the element of physical strength. Operator: Our next question comes from the line of Paul Choi of Goldman Sachs. Kyuwon Choi: Congrats on the good start with YUVIWEL. 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 2 years of age population, even though that's not officially on label yet. Jan Mikkelsen: Yes. We need to come with a meaningful answer. We need longer time because we only have been there for 4 or 5 weeks now. And we want to be 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 launch. So Paul, we can discuss it, as Jay said, in a perfect manner. We see patients coming in for all 3 different groups, which was in a new group, patients that have discontinued [indiscernible] and patients that come directly on switching for [indiscernible]. So out from that, we see it coming in for all 3 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 3 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 we're coming up more than 10 patients per week, it's an orphan drug indication. I'm extremely proud that our product profile is getting so well recognized in the society in this way. Under 2, I cannot comment on that currently. Unknown Analyst: For the 70% cumulative U.S. 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 million 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 [indiscernible] to that target? Jan Mikkelsen: [indiscernible] one, we would like to come back in Q2 because we have a lot of positive data coming in now. We have the selling of our PMV and launch of YUVIWEL going much, much stronger than even myself hope. So apart from that, we will come with that 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 [indiscernible] number, how it's improving the overall numbers. Jay Wu: 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. 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. Operator: And our last question comes from the line of [ Cecilia Hernandez ] of [indiscernible]. Unknown Analyst: This [indiscernible] is on for [indiscernible]. So given the revenue now from commercial products, the redemption of the convertible notes and the sales of the [ PRP ], can you tell us anything on your capital allocation strategy? What is the order of priority for you guys? Jan Mikkelsen: I think Scott you want really to answer the last question for today. So Scott get this opportunity now. Scott Smith: Thanks a lot, Jan. Of course, as you've seen with our R&D success, a key component for us is to invest in R&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. I think Jan highlighted 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 Jan mentioned, to our outlook for the rest of the year, you may get more color at that point as well. Operator: 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. Before you buy stock in Ascendis Pharma A/s, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Ascendis Pharma A/s wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Ascendis Pharma A/s. The Motley Fool has a disclosure policy. Ascendis (ASND) Q1 2026 Earnings Call Transcript was originally published by The Motley Fool

