Earnings call transcript: Ascendis Pharma misses Q3 2025 EPS forecast

Ascendis Pharma reported its Q3 2025 earnings, revealing a larger-than-expected loss with an earnings per share (EPS) of -1.00, significantly missing the forecasted -0.28. Revenue, however, came in slightly above expectations at 213.63 million euros, compared to the forecast of 213.17 million euros. Despite the revenue beat, the stock price fell by 0.77% following the announcement, closing at 201.16 euros.

Key Takeaways

• Ascendis Pharma's EPS fell short of expectations by a significant margin.
• Revenue surpassed forecasts, though only marginally.
• The stock price declined by 0.77% in aftermarket trading.
• The company achieved positive operating income despite the EPS miss.
• Ascendis Pharma continues to invest in product innovation and market expansion.

Company Performance

Ascendis Pharma's Q3 2025 performance was mixed, with a notable EPS miss overshadowing slight revenue growth. The company achieved a positive operating income of 11 million euros, marking a significant milestone. Revenue from Europath Global saw a substantial increase from the previous quarter, while R&D costs decreased compared to the same period last year. Ascendis Pharma's strategic investments in its TransCon technology platform and product approvals underscore its commitment to long-term growth.

Financial Highlights

• Revenue: 214 million euros, up from the forecast of 213.17 million euros.
• Earnings per share: -1.00, missing the forecast of -0.28.
• Operating income: 11 million euros.
• R&D Costs: 66.9 million euros, down from 73.5 million euros in Q3 2024.
• Cash and cash equivalents: 539 million euros, up from 494 million euros in Q2 2025.

Earnings vs. Forecast

Ascendis Pharma's EPS of -1.00 was a significant miss compared to the forecast of -0.28, resulting in a negative surprise percentage of 257.14%. The revenue beat was minimal, with actual revenue of 213.63 million euros slightly surpassing the forecast of 213.17 million euros. This mixed performance reflects both the challenges and opportunities facing the company.

Market Reaction

Following the earnings release, Ascendis Pharma's stock price fell by 0.77% in aftermarket trading, closing at 201.16 euros. The stock's movement reflects investor disappointment with the EPS miss, despite the revenue beat. The stock remains within its 52-week range, with a high of 216.45 euros and a low of 118.03 euros.

Outlook & Guidance

Looking ahead, Ascendis Pharma expects continued revenue growth in Q4 2025 and is targeting 5 billion euros in annual product revenue by 2030. The company is preparing for the launch of TransCon CNP and plans to expand Europath to additional international markets. Future EPS forecasts indicate a potential return to profitability by FY 2026.

Executive Commentary

CEO Jens highlighted the company's strategic positioning, stating, "We are well positioned to get approval of our third TransCon Phase product in a row." He emphasized the importance of long-term patient treatment, saying, "We expect nearly all patients to be on lifelong treatment." Jens also reiterated the company's Vision 2030, which includes creating value through partnerships.

Risks and Challenges

• Potential delays in product approvals could impact revenue growth.
• Market saturation in key segments may limit expansion opportunities.
• Macroeconomic pressures could affect payer approval rates and pricing strategies.
• Continued investment in R&D may strain financial resources if revenue growth does not keep pace.

Ascendis Pharma's Q3 2025 earnings call highlighted both the company's current challenges and its strategic initiatives aimed at sustaining long-term growth. While the EPS miss was a setback, the company's focus on innovation and market expansion remains a positive indicator for future performance.

Full transcript - Ascendis Pharma AS (ASND) Q3 2025:

Conference Operator: Good day, and welcome to the Third Quarter twenty twenty five Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. I would now like to turn the call over to Chad Fugier, Vice President of Investor Relations at Ascendis Pharma. Please go ahead.

Chad Fugier, Vice President of Investor Relations, Ascendis Pharma: Thank you, operator, and thank you, everyone, for joining our third quarter 2025 financial results conference call. I'm Chad Fugier, Vice President of Investor Relations at Ascendis Pharma. Joining me on the call today are Ian Mickelson, President and Chief Executive Officer Scott Smith, Executive Vice President and Chief Financial Officer Cherry Glass, Chief Business Officer Jay Wu, EVP and President, U. S. Market and Amy Hsu, EVP and Chief Medical Officer.

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 Skytropha and Yorvipath as well as certain expectations regarding patient access and financial outcomes, our pipeline candidates and 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 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, 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 these factors that could cause actual results to differ materially, please see our forward looking statements section in today's press release and the Risk Factors section of our most recent annual report on Form 20 F filed with the SEC on 02/12/2025. 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 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 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. 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 third quarter twenty twenty five financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jens.

Jens, President and Chief Executive Officer, Ascendis Pharma: Thanks, Chad. Good afternoon, everyone. In the 2025, we accelerated our momentum towards fulfilling our Vision 2030 with key achievement in three areas. First, the global launch of Europad continues to be strong with a steady increase in new unique patient prescription and prescribers as seen in Q1 and Q2, along with expansion in new geographic markets. Second, we made great advancement towards leadership in growth disorders during the quarter.

We saw The U. S. Approval of Scitrofa in adult growth hormone deficiency. And following our late cycle meeting with FDA, we are progressing toward expected approval of TransCon CNP in The U. S.

Third, our strong operating fundamentals led to positive operating profit, signaling the beginning of sustained revenue and earnings growth for Ascendis. Now I will provide some specific comments on our commercial and late stage portfolio. Starting with Europads. Europads continued its strong global launch with revenue of €143,000,000 in the third quarter. Nine months in the launch in the biggest market, The U.

S. Patient demand continues growing quarter by quarter. From launch to the September, more than four thousand two hundred and fifty patients have been prescribed Uroplans in The U. S. By over 2,000 unique health care providers, highlighting the strong steady demand for Europets even during the summer months.

In October, the positive trend continued with Europet being prescribed for more than 400 new patients in The U. S. Alone. Positive physician and patient experience are driving a high rate of compliance, And we expect most patients will be on lifelong PTH therapy. We are expanding our physician reach each quarter within the endocrinology community.

And we are also expanding to other physician group who manage hypoparam patients. As an example, at last week's American Society of Nephrology meeting, we presented three years of kidney function data across our combined clinical trials, demonstrated through state clinical meaningful improvement in kidney function in the Europast treated patients. In addition, we continue working hard to expand patient access in The U. S. The overall insurance approval rate since the start of the launch is around seventy percent of total enrollment and we believe this figure will continue to increase over time.

We currently see approvals across all payer types with a majority of approvals within eight weeks. We are pleased by the robust uptake of Europads in our first three quarters of commercialization in The U. S. Today, less than five percent of U. S.

Patients are currently on Ulfast treatment. We see significant room to grow with around eighty thousand to ninety thousand patients already diagnosed with chronic hyperpara in The U. S. And three thousand to four thousand new patients being diagnosed every year. Outside The U.

S, Europet is now available commercially all through named patient program in more than 30 countries. In Germany, Austria and Spain, we have now full commercial reimbursement. In Japan, our partner, Tyjane, launched Europad commercially last week following approval in August. We are looking forward to the commercial launch of Europad in additional countries in the coming years. With a broad label covering hypoparathyroidism for all causes, international treatment guidelines that recommend PTH replacement therapy and UroPET position as first in class therapy, we expect sustained patient growth and revenue growth for years to come.

As we're building this global market, we're expanding our offerings to patients with hypoparib. We are conducting the pathway 60 trial to support doses up to sixty micrograms of Europet in The U. S. We plan to begin a clinical trial for people 18 this quarter, and we are advancing our new once weekly TransCon PTH product candidate, which we believe will be an attractive option for patients on stable doses of Europads. In the new year, we will share more on our plans to maximize Europads' value and reach even more patients.

Let's now turn to growth disorder, which today compiles of our once weekly growth hormone SKYTOVA approved for growth hormone deficiency and our once weekly TransCon CP currently under review by FDA in The U. S. And by EMEA in EU for children with achondroplasia. SKYTOFER is approved in The U. S.

And EU for treatment of pediatric growth hormone deficiency. With this single indication, SKYTOFER is established as a high value brand and treatment of choice for pediatric growth hormone deficiency. Q3 revenue for SKYTOVA was EUR 51,000,000. In July, we received our first label expansion with FDA approval of for adult growth hormone deficiency, the first of multiple planned label expansion. In Q3, we initiated our Phase III basket trial of Scott Trooper with a range of established growth disorder, including ISS, shock deficiency, Turner syndrome and FDA.

Turning to TransCon CNP. We recently completed a late cycle meeting with the FDA and are in the final stage of the label discussion. TransCon CNP is under priority review in The U. S. With a PDUFA date of November 30 and is also under review in The EU where our MAA file was readily validated.

TransCon CRP once weekly is well positioned to become the leading treatment for children with achondroplasia, with the full degree of linear growth outcome that can be achieved with monotherapy addressing the overactive thiocin-two kinase. In addition, TransCon CNP achieved statistical improvement in leg bowing compared to placebo, increasing spinal canal dimension, a safety and tolerability profile compared to placebo with a very low rate of injector cycloaddressin and no cases of symptomatic hypertension. We are confident in TransCon CNP's ability to be a leading therapy. While we believe TransCon CNP monotherapy is transformative by itself, we want to further enhance outcome for people living with achondroplasia. Earlier this year, we presented twenty six week results from the Phase II COAT trial of TransCon CNP in combination with TransCon Growth Hormone, which showed around 3x improved linear growth compared to what had been observed with monotherapies over the same time period.

This resulted in healthy linear growth in children with achondroplasia, higher than that observed with an average state of children, accommodated by improvement in body proportionality and without acceleration of bone age. This data has been recognized by key opinion leaders as groundbreaking. Based on this data, we believe over time the standard of care in achondroplasia will include combination therapy as a treatment option, building on the potential role of TransConstia P as the backbone therapy. Following our recent FDA end of Phase II meeting related to our combination therapy, we plan to initiate a Phase III trial this quarter. We anticipate disclosing 52 read data from the COVES trial in early twenty twenty six With once weekly growth hormone and once weekly CMP, two highly differentiated medicines both as monotherapy and in combination, we believe Ascendis is well positioned to become the global leader in many different growth disorder.

Our Vision 2030 also includes creating value through partnerships and we see that being achieved through the rapid progress of Tygene in Japan. VISEN in China, ICONIC in ophthalmology and Novo Nordisk in metabolic and cardiovascular diseases, where the once monthly semaglutide program is making fast progress towards the clinic. And finally, the commercial success of Europad and Scartova has already transformed the financial profile of Ascentis. In the third quarter, we achieved positive operating income along with positive cash flow. For the near time, the building out of our commercial organization is largely completed in banks of future global launches.

For the medium term, label expansion, LCM activities have been initiated to maximize the value of our current products. At the same time, for long term sustainability, our R and D organization continues to advance the TransCon technology platform to ensure a constant flow of new programs and potential new products. In summary, with TransCon CNP nearing potential approval, Ascendis is well positioned to get approval of its third TransCon Phase product in a row. This highlights the uniqueness of Ascendis, the continuous development of highly differentiated product created by the TransCon technology platform and our unique low risk drug development algorithm. Importantly, our current three rare disease endocrine products positioning us for durable future growth and give us confidence in our aspiration to achieve €5,000,000,000 or more in annual product revenue in 2030.

I will now turn it over to Scott.

Scott Smith, Executive Vice President and Chief Financial Officer, Ascendis Pharma: Thank you, Jens. I would like to reiterate Jens' comments that the positive operating income development seen in Q3 signals the transformation of our financial profile with sustained revenue and cash flow growth. With that, I will touch on some key points surrounding our third quarter financial results and outlook, but for further details, please refer to our Form six ks filed today. In Q3, Euromipath global revenue grew to €143,100,000 up from €103,000,000 in Q2 with strong growth partially offset by a €3,600,000 foreign currency headwind compared to the previous quarter. In Q3 twenty twenty five, Skytropha contributed €50,700,000 with 3% growth in demand offset by a €1,600,000 foreign currency headwind compared to the previous quarter.

Including €20,000,000 in collaboration revenue driven by a €13,000,000 milestone related to Eurvipath and increased partner activity, total Q3 twenty twenty five revenue amounted to €214,000,000 Continuing on to expenses. R and D costs in Q3 were €66,900,000 down from €73,500,000 in Q3 twenty twenty four, primarily driven by completion of certain clinical trials and development activities. SG and A expenses rose to €113,400,000 in Q3 twenty twenty five compared to €69,800,000 in the same period last year, reflecting continued impact of global commercial expansion. Total operating expenses for Q3 twenty twenty five were €180,000,000 and operating profit for Q3 twenty twenty five was €11,000,000 Net finance expense for the 2025 was €60,900,000 primarily driven by non cash items, including non cash remeasurement loss of financial liabilities of €47,200,000 Net cash financial income over this period amounted to €400,000 Note that in our six ks filed this evening, we provide more detail on the components of finance income and expenses. In future periods, we plan to introduce a non IFRS EPS measure adjusting for the impact of certain non cash non operating items, including related to our convertible notes.

This is intended to increase comparability of period to period results. Finally, we ended the 2025 with €539,000,000 in cash and cash equivalents, up from €494,000,000 at the end of Q2. Turning to our commercial outlook, primarily driven by the ongoing global launch of YorbaPath, we expect continued revenue growth in the fourth quarter. For YorbaPath specifically, we expect continued growth driven by new patients, stable pricing, payer mix and contracting in Q4. Longer term, we expect YorbaPath to be driven by continued growth in new patients on therapy, including expansion into additional markets.

For SKYYROPA, we believe that sequential revenue growth should continue to track growth in prescriptions with stable pricing, payer mix and no changes in contracting with offsets potentially driven by currency as we saw in Q3. Longer term, we expect growth for Skytropha to be driven by geographic and label expansion. With that operator, we are now ready to take questions.

Conference Operator: Thank you. Our first question comes from Jess Fye with JPMorgan. Your line is open.

Jess Fye, Analyst, JPMorgan: Hey guys, good afternoon. Thanks so much for taking my question. I was hoping you could speak to your expectations for the rate of new patient enrollments on your VPATH in The U. S. From here.

I think you talked about more than 4,250 as of the end of 3Q putting you at, what is that about eleven fifty adds or maybe a little more relative to June 30. Can we think of that as kind of like a good number to work off of from here? Should it continue to kind of drift lower a little bit? Just hoping you can frame some expectations there. Thanks,

Jens, President and Chief Executive Officer, Ascendis Pharma: Jes. First of all, we see a really a stable number of prescription being written in The U. S. When we, in some way, take away the bolus that we have from the ERP program of the 200 plus patients we have in the ERP program. When we think about Q3, I'm actually pretty surprised positively about Q3 because I was feared that prescription not going to be written in the three weeks, physician typical takeout of their quarter in that time.

And what I saw, we saw nearly the same number of prescriptions being written that we actually have seen in q one and q two. And it's also following up with what we said in the October month. We sold more than 400 prescriptions being written in October, unique prescriptions being written in October. So when I look at these lungs, look at The US, I see a very, very stable lungs. And what we're also doing, we're building a fundament, like a strong, strong fundament because patients stay on lifelong treatment.

And therefore, when you start a patient, it basically is continued quarter by quarter. So it's building at a house where you have a strong fundament taking one brick around every quarter and the house getting taller and taller every, every quarter.

Jess Fye, Analyst, JPMorgan: Thank you.

Conference Operator: Thank you. Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.

Jess Fye, Analyst, JPMorgan: Hi, good evening guys. Thanks for taking

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: my

Jess Fye, Analyst, JPMorgan: questions. I just wanted to get a sense of how you're thinking about the rest of this quarter. Are you expecting to see impact from seasonality? I guess we can call it just because of the upcoming holidays, Thanksgiving, Christmas into New Year's. And do you think that the script trends for December would be directionally lower, let's say, than what you're seeing what you saw for October?

And then if I could ask about the TransCon CNP review, You said you're in final labeling discussions, which is good to hear. Can you just confirm whether or not you've had any requests for any type of data from the agency in the review cycle?

Jens, President and Chief Executive Officer, Ascendis Pharma: Thanks. Let me take the last question. Thanks, Christine, first. But let me take the last question first because it's an easy one because just no. Just no, no, no, no.

So it's really simple. So going to the next one. It's more about Scott Lugen. He didn't read the FLS this time. Chad did the FLS this time.

But when I'm looking forward in the future, yes, there is some holidays come up. But when I look back, I was more worried about Q3 as compared to the Q4 because I have to believe that it's a longer summer vacation than in Q3 compared to basic what you will see in Q4. So I see pretty positive on Q4. I see the actual increasing our prescription basis from physician writing prescription with more than 500 new prescribers, meaning that having a broader, broader boat where there's more and more that can come in rowing on the ship. And this is where I feel pretty confident about it.

So no worry from my side, Tatine.

Jess Fye, Analyst, JPMorgan: Our

Conference Operator: next question comes from Gavin Clark Gardner with Evercore ISI.

Gavin Clark Gardner, Analyst, Evercore ISI: Hey, guys. Thanks for taking the questions. I wanted to focus in on the conversion rate for YorbaPath. I'm wondering why it's only 70%, and you noted that you expect it to be higher over time. How much higher do you expect it to be?

And when do you think it

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: will be higher? Just had

Gavin Clark Gardner, Analyst, Evercore ISI: a follow-up on this, too.

Jens, President and Chief Executive Officer, Ascendis Pharma: Yes. This is a question we have gotten multiple times every quarter. And what we have said in the previous quarter, we expect that it's going to be maturing over time, and it will go higher than that. And that is typical of what we have seen in launches. And I actually had a long discussion with Jay about it today.

And what is when we see it mature brand? Is that 85% or is it 90%? Or what is really for the mature brand that your basic summary are ending up at that time. And I think from a modeling perspective is that we feel extremely well where we are today. We still have an anti yeast block taken into consideration.

We're getting the patients. We're getting not only the prescription done, we're also getting the approvals done and we're getting it done in speed. And as Scott also put emphasis on this, we don't expect anything changing in the contracting environment in Q4. So we somewhat expect the same GTN for this product that we are seeing in both Q1, Q2 and here in Q3 and no changes to it. But Jay, you can also take a little bit of our discussion about the future, about what is really for a mature brand.

Is that where we are today? And also, we see a much higher number for SKYYTOVAR after it got matured.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Yes. Thank you for the question. As mentioned before, we're really encouraged about the 70% approval rate that we're seeing now. It's actually about what we expected or guessed at the beginning of the year, just based on what we know about the clinical value proposition of the drug, which, again, is incredibly positive and has been resonating with a lot of the payer accounts for which we are speaking with. To answer your question, Gavin, directly in terms of what that peak approval rate could be and at what timeframe, that's really hard to say, right?

When you look at some of the analogs for similar drugs, that could, in some instances, take multiple years. And the reality is, you get to a certain high percentage, the remaining becomes a little bit more difficult, simply just given the heterogeneous landscape of the payers, right? It becomes quite fragmented. A lot of the government payers might review it on different timetables. So we are meeting a lot of those timetables where they're at.

And again, we're continuing to talk about the incredible positive clinical value proposition that we're seeing. And that alone is resonating with a lot of them, which is why we continue to see that approval rate go up over time. That is super helpful. And if

Gavin Clark Gardner, Analyst, Evercore ISI: I could just ask a like specific follow-up on that, like for the 4,250 forms reported through the end of this quarter, are you guys basically saying you expect the conversion on this to be 70% and then trending higher per everything you just laid out after that?

Jens, President and Chief Executive Officer, Ascendis Pharma: No. That's not what we're saying, Gary. Because if we go back and look on the early cohort, meaning it's cohort for March, April, it's much, much higher than the seven-zero percent. So this is what you see. The longer time it takes, you more and more be getting approved.

And that is basically the element. And this is the question we have. Can we really take this tail and shorting down the tail so we're basically getting the higher percentage that we see from the cohort we had in the beginning of the year, which are much higher than the 70%, can we start that to get it in a shorter time frame?

Gavin Clark Gardner, Analyst, Evercore ISI: Okay. Like, the point I'm trying to get at is for for a lot of the start form like, let's take the 3,100. You got there under June. Maybe you've had close to 70% conversion, but the rest of the 30% is not really lost at this point. Some more still may come through as conversions.

It's just a

Conference Operator: matter of time.

Jens, President and Chief Executive Officer, Ascendis Pharma: Exactly. So if you take, for example, going to the cohort from March, April, March higher, if you take the earlier stage cohort now on that is near this month we have, it's lower than that. So this is how you see it. It's the only question about timing.

Gavin Clark Gardner, Analyst, Evercore ISI: Very helpful. Thanks so much.

Conference Operator: Thank you. Our next question comes from Joe Schwartz with Leerink Partners. Your line is open.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Great. Thanks very much. A question on Europath and then on TransCon CNP. Can you give us your latest views on how Europay has been penetrating the different segments of the hypoparam market as you see it? Where is it beginning the most traction?

And where could it do better? And then, you previously emphasized the desire to do more than enhanced linear growth in achondroplasia. So I'm wondering to what extent do you think you can obtain differentiated label claims on TransCon CNP label? Thank you.

Jens, President and Chief Executive Officer, Ascendis Pharma: Let me take the last question. As I said in the prepared remarks, we are in the late stage discussion about the labeling. And I cannot really comment about what will really be in the final labeling in this perspective. What is really the key element for me in my discussion with patients, my discussion with physicians, Amy Schuh's discussion, our medical affairs discussion with the teams. It's really to explain the benefit that's seen behind the growth.

And it's clear, unique effect in leg bone, unique effect in changing body proportionality. And we will have peer reviewed publications really supporting all this claim that will come out, really give us an opportunity to take and talk with the patient, talk with the physician about this benefit in it. I think this is the key thing for me. I saw an element once with HypoPair where facing it was impossible to forget into the labeling our element of patient benefit related to cognitive function, a lot of quality of life and everything like that. And everyone recognizes it.

Everyone see it. Anything see that is the best thing. I think this is the key thing from our labeling discussion is have no restrictions. Have a really safe product, really show our efficacy and safety in the best possible manner in this way. Jay, will you take the first part of the question in this one?

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: To Joe? Yes. Could we repeat the first part of that question? Yes, sure. I was just wondering, you've outlined the different segments of the market based on how controlled the patients are.

So I was wondering, how

Gavin Clark Gardner, Analyst, Evercore ISI: are

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: you making inroads into those segments lately? Where are you getting the most traction? And where could you do better? Yes. So when you think about the eighty ninety thousand patients that Yan had referenced earlier in the call, I think there's probably a group that we would describe as highly symptomatic, patients are well aware of their symptoms, articulating those symptoms to a physician.

And within those, I would say we're doing quite well, particularly since the patients themselves are likely the ones that are in the offices most frequently, and are keeping the appointments on the books to be able to essentially get some of that information and also be on their way to actually get prescribed the product. I think where we're continuing to work on are some of the patients for which maybe they're not either self identifying some of their symptoms as being related to the underlying condition, and or perhaps they've gotten used to some elements of it, and therefore haven't been as motivated to establish care and retain established care with a specialist. And I think that's why, as we think about how we can continue to transform this market, there will be an element of patient activation as well, simply because there is going to be a certain level of disease education required, particularly for a space like this, where it is about redefining what's possible and kind of the status quo for how to manage this type of condition.

Jens, President and Chief Executive Officer, Ascendis Pharma: Yes. If I can add something, Jay. I see it from two different perspectives. How often you come into the endo. This is one way.

And also how we targeted it and defined something that is not defined on medical terms, but only on how often you see an endo related to being controlled, partly controlled or and what I also trying to look at, I try to look on where are they coming. Are they coming from the post surgical? Are they coming from the genetic part? Are they coming from the immunological part? I see them coming from everywhere.

So for example,

Conference Operator: Ladies and gentlemen, please stand by. Please continue.

Chad Fugier, Vice President of Investor Relations, Ascendis Pharma: Where did you last hear us at?

Scott Smith, Executive Vice President and Chief Financial Officer, Ascendis Pharma: I think this was Joe, your question about

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Yes. Hi. Welcome back. So, I guess, I was wondering about your progress within the different levels of control and where you can do better and just how you're been able to penetrate patients in each of these segments.

Jens, President and Chief Executive Officer, Ascendis Pharma: Yes. I think, Jay at least I heard Jay's response to it. And my additional comments was that when we did the targeting of our physician, we made it out from the claims database where we defined three group controlled, party controlled and in control. It's nothing to do with medical terms, but basic is acceleration, how we basically are looking on the patients. Seeing and physician.

So what I also looking at is do we see old patient group in our patient being coming on Europad's treatment. And when I see that, it's pretty clear that we are in a position we see that obviously post surgical. But when we look on different element of generic, genetic or immunological, we also see all different groups of patients, even patients from the ADH-one, which are really, really less than one percent in the claim database. We already have about 15 patients on treatment with this symptom, which really give us a hope that we basically will see the same penetration everywhere in all different of the hypoparab patients in this way.

Conference Operator: Our next question comes from Lee Wasek with Cantor.

Jess Fye, Analyst, JPMorgan: I guess just on VOLLOGY pads, can you maybe just give us a little bit color on payer mix and potential contracting, not just in Q4, but also in 2026? And should we sort of expect still minimum contracting and sort of stable gross to net for the next few quarters?

Jens, President and Chief Executive Officer, Ascendis Pharma: I think Scott more or less addressed it in his prepared remark. There would be no changes into Q4. If we look forward, will there be potentially more contracting that we have seen now? And Jay can comment on, we are in a position where contracting would not anyway change dramatically our GJN in any kind of financial modeling in this perspective. And we see Europads really have all the characteristics of the product.

It's a first in class as only one treatment option. And we see it actually being not only being prescribed, but also being reimbursed to the level that we have hoped for. Dave, you have further comments to the long term perspective of contracting?

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Yes. I would just reaffirm what you shared. Consistent contracting strategy in Q4 as previously discussed, given the first and only nature of what we have and the fact that the clinical value proposition speaks for itself, we don't anticipate any major contracting that's going to deviate above and beyond what we've shared before, which is more minor contracting around ensuring a frictionless patient experience. So again, nothing substantial or anything meaningful above and beyond what we've discussed to date. Any changes will be minor.

Jens, President and Chief Executive Officer, Ascendis Pharma: And when we look at the we can say the competitive landscape, we don't believe any of the what we see in the competitive landscape will really make us to move into a much more highly contracted product as we see really the best in class properties compared to everything what we see.

Jess Fye, Analyst, JPMorgan: And then just curious about the TransCon CNP and the Phase II meeting. In terms of the Phase III trial design, should we assume that FDA would require a one year data on annualized growth velocity? And anything that you can share on the powering assumption?

Jens, President and Chief Executive Officer, Ascendis Pharma: Yeah. That is an interesting question because I basically have never seen anything longer than one year clinical trial in any growth disorder. I've seen a lot of perception about something that could be taken up as two years, but I've never seen any regulatory package that has more than one year controlled treatment in this. We have already what we call long term data that will be generated from our Phase II trial. So I think that is basically the element of what I never have seen for in this way.

And Amy Xu went to the FDA meeting, so she can basically just give you the view about what she basically got a feedback from that perspective.

Jess Fye, Analyst, JPMorgan: Yes. So Lee, happy to say that we found our reviewers at FDA to be appropriately open minded about appropriately clinically open minded about duration here. But there's obviously a regulatory pathway, and that's usually one year of data.

Conference Operator: Thank you. Our next question comes from Yaron Werber with TD Cowen. Your line is open.

Yaron Werber, Analyst, TD Cowen: Great. Thanks so much. Yaron, maybe a couple of questions. Number one, just on gross to net. When we're kind of we were at around just over four 200 and we had like a 65% approval, but we were getting to higher numbers for the quarter.

So I'm wondering whether and we had 18% gross to net. Is it possible the gross to net discounts are higher than that? That wouldn't make any sense because I guess the question kind of like, what am I missing? And then maybe secondly, are you it sounds like you may be very subtly intimating to expect some impact from the holidays in Q4. Are we reading it correctly?

Because you didn't see much seasonality in Q3. And then finally, U. S. Versus European sales for your view in the quarter. Was it like around €4,000,000 or so in Europe this quarter as well?

Jens, President and Chief Executive Officer, Ascendis Pharma: Yes. There was three questions. The element of what I will take what we said in the beginning of the year is still what we really have seen. We said we will expect ex U. S.

Be around €4,000,000 to €5,000,000 increase every quarter because we have not really expanded it more to fully commercial countries, which we did now in here in Q3, but we first see the effect on that perspective in this way. Related to the seasonality on it, I don't expect any to see any seasonality in Q4. That is pretty clear. I expect it to potentially to have seen it in Q3 because I expect the physician to be gone for three weeks. And when we're not really so a major impact in Q3, I don't expect to see any impact in Q4.

Scott, he's really the guy with the numbers and everything like that. So he really is good at that. So Scott, can you take the first question?

Scott Smith, Executive Vice President and Chief Financial Officer, Ascendis Pharma: Yes. So I think your question was the 70% approvals and the revenue. Time We could probably follow-up offline how you're thinking about things. But just remember also when there's an approval, this isn't the exact same thing as patient on drug, right? They get approved and then sometimes it's soon, sometimes it takes a while.

But that's probably the only thing to keep in mind, Yaron.

Conference Operator: Thank you. Our next question comes from Martin Auster with Raymond James. Your line is open.

Jens, President and Chief Executive Officer, Ascendis Pharma: Hey, guys. Thanks for taking the question.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: I'll try not to be too greedy and just keep it to a couple. First, on Yorvapat, and I was wondering if

Jens, President and Chief Executive Officer, Ascendis Pharma: you could comment if you've got

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: any sense of early data on what patient retention looks like from who've started up on drug this year? And then second, on TransCon CNP, I guess, from a commercial perspective, when we look at this market, it looks a little underpenetrated for a rare disease market compared to some other comps. I'm curious if you guys have a sense as to sort of why that's the case and if you think transplant C and P is sort of coming to market and improve upon that and improve overall penetration rates of treated folks with achondroplasia?

Jens, President and Chief Executive Officer, Ascendis Pharma: Thanks, Martin, for the question. The first one is really, really spend a lot of time on it, spend a lot on the analytical. And we are losing very, very, very few patients when they have initiated treat, very few percentage. And if we lose them, it's basic in the first four to six weeks, meaning is that we are now trying to go back how can we potentially help them in the titration phase. And I think that is always the element where you start on a system where you are on conventional therapy.

You start to do it. You need to take it off. And I believe if there are not yet a good interaction between both the physician, the place where they get patient monitoring and everything like that. It's a more difficult period for the time. This is why the titration.

That's why we started all this one daily product because we know we could never get this titration to function without once weekly product. So that is where we see. When we see after four to six weeks when we're starting to be stable, exactly as I said here, we expect nearly all patients to be on lifelong treatment. This is like building the fundament stronger and stronger. And Martin, I agree with you.

If you look on vosoritide, it's doing really poorly in The U. S. They're saying they're doing really good outside The U. S. I think they're doing really poorly in U.

S. They should be much, much higher. And I believe that because they're not really addressing what we really should address, the comorbidities. And I believe this is where we come in with a differentiated product. This is why when I talk with different patient organization group and really they ask me a simple question.

Jan, would you have taken the primary endpoint to be linear growth if you were the first product? And I said, no, we will never have done that. We will really have addressed how we're really addressing the comorbidities because we believe that is really why patients should take that treatment, help them to the comorbidities, really help them in this way. And this is where I believe we have an extremely positive dialogue with all the patients and the patients related to that topic.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Thanks, Jen. Looking forward to November 30.

Conference Operator: Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Hi, good afternoon, and thanks for taking my question. I also want to stay on TransCon CNP and maybe ask on the commercial strategy as you launch it and particularly for next year. Are you primarily going to target de novo patients? Or are you expecting a good portion of the revenue mix to be from CMP daily injection experienced patients? And if you are expecting a decent sized contribution from the latter, can you maybe speak to what the your market research suggests the appetite is on potential switch strategies and just sort of what percentage of the existing treated patient base might you might think ultimately convert?

Jens, President and Chief Executive Officer, Ascendis Pharma: Thanks so much for the question. Yes. We expect that to be a lot of switches. We enrolled patients in the places where vosoritide were commercially available free for the patient. We enrolled it where there was other treatment alternatives, if you call them treatment alternatives.

We were in a position that preferred it. From the perspective, it is that not only the once weekly profile, but the lack of injection site reaction. We need to be in a position, you don't need to worry about any risk of hypertension and anything like that. That was really one of the key milestones. And also, at that time, we not even have really the clarity of beyond linear growth, the benefit beyond linear growth.

So when I look today, it is going to be a large portion on switch patients when you have therapy being implemented to a high level, which it is in some European countries. In some European countries, sixty percent, seventy percent of all patients will be treated today and they will be switched. They are just waiting for it. We know they are waiting for it because they are asked for it all the time when it will be approved in Europe. If you go to U.

S, because of not high penetration, there will be many more new patients coming in because there's not too many to switch off. So this is what we see and how we will build up the commercial strategy.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Okay, great. Thank you.

Conference Operator: Thank you. Our next question comes from Yan Zhong with Wedbush. Your line is open.

Yan Zhong, Analyst, Wedbush: Hi, good afternoon. Thank you very much for taking the questions. So the first question on the label extension to the higher dose. I assume the pricing is going to be the same. So would you expect any direct impact on maybe the number of patient on treatment and reported revenue, please?

Jens, President and Chief Executive Officer, Ascendis Pharma: First of all, when we look on treatment in a dose larger than the thirty dose, it's only restricted to The US. And currently, when we see in many countries, there is few percentage of patients that really need it in a commercial setting. We have said there is some patients that really need it, and they are, in many cases, on treatment in The U. S. By having this trial, the patient that basic will need more than thirty in The U.

S. Will now have availability because they can join us in the clinical trial. The clinical trial, as Amy can explain, is a very, very simple single arm study. You can explain how many patients we have. It's basically a safety trial.

Jess Fye, Analyst, JPMorgan: Yes. So single arm, there'll be 18 subjects who will be titrated as they need based on serum calcium using the higher doses?

Jens, President and Chief Executive Officer, Ascendis Pharma: So it's basically, it's an 18 patient, six months trial for safety perspective, and that will be the triggering point to also in The U. S. Having. I don't think it will have a material impact in any way on our revenue.

Yan Zhong, Analyst, Wedbush: I see. Thank you for the clarification. Then a follow-up question on the payer discussion. I believe that initially, you said roughly it takes about eight weeks to get payer approval then, I think last quarter you said three months and then this quarter just now you probably, set a month. Was that just a random maybe fluctuation or was there any meaningful change in terms of how long it takes for payers to approve coverage, please?

We

Jens, President and Chief Executive Officer, Ascendis Pharma: see an improvement month by month. And when we look at data today with about the 50% and the eight weeks, that is the data we see today.

Yan Zhong, Analyst, Wedbush: Okay, great. Thank you.

Conference Operator: Thank you. Our next question comes from Alex Thompson with Stifel. Your line is open.

Jay Wu, EVP and President, U.S. Market, Ascendis Pharma: Hi, this is Charles on for Alex. Maybe a bit of a different question, but in terms of the sort of adolescent buckets of hypoparathyroid patients you're looking at, I guess, like, what kind of patient size does this represent in The U. S? And what kind of growth do you expect to see from here, assuming there's successful label expansion?

Jens, President and Chief Executive Officer, Ascendis Pharma: This patient group is a quite different patient group to compare to the pool of the patients we talk today in U. S. And other countries. Many of these young children are coming from more the genetic and immunological part and not so much from head and neck operations. Still, that can be costurative patients at that stage too.

These patients are in a severe case because if you have hypoparrow in such a young age, a lot of developmental part is really affected not to have the right calcium hemostasis, phosphate hemostasis and bone hemostasis in the body today. So I see it as really as high level of severity of disease to have it also in this extremely young age. I even have seen young people that had it from young that already have kidney transplantation in the 20s because of the high burden of the treatment that has been available today with conventional therapy. And when we look on the number, there will not be a number that ever can come up to the level that you see in the adult population, but it's not changing the severity of really making a treatment available for this patient group.

Conference Operator: Thank you. Our next question comes from Luca Issy with RBC. Your line is open.

Luca Issy, Analyst, RBC: Great. Thanks so much for taking my question. Based on the unique patient enrollment, is that a metric that you're committed to report going forward? Or are you planning to sunset that metric at some point? And if it is the latter, can you talk about whether that could be Q4?

Or would that be later than that? And then maybe if I can ask about Novo Nordisk, can you just talk about how that collaboration is going? Obviously, lots going on in Novo, given again new leadership in place and obviously just lost the deal on NetSera. So wondering if you're seeing any disruption with that collaboration with them or maybe the opposite, actually, an acceleration of that collaboration. So any thoughts there?

Much appreciated. Yes.

Jens, President and Chief Executive Officer, Ascendis Pharma: Let me take the last question first about our collaboration. And when I look on the collaboration and we look on that once monthly semaglutide, which I believe have a unique profile because of the slowly release from the product system to a level where the Tmax is very late, and therefore, you don't have a high slope. So likely, the tolerability as we have seen in animal model really can also be established in the clinical trials in humans in this way. As we are responsible for last element of the collaboration, There has definitely not been any disruption, and there has definitely not been any lack of interest in this program. And this is not one single program.

It's, as I said in our press release, it's a series of programs that we are working on. So we definitely have not seen any kind of lack of interest and is progressing with the speed, which we can do it to in this really positive collaboration as fast as we can do. We believe that when they come to the late stage, sure, the muscle of a company like Novo Nordisk to make a large Phase III trial in multiple ways is really unique because they really have the capacity and unique level of expertise to do it. Sadly now, I forgot the first question. Enrollment as a metric?

Yes. The enrollment as a metric is a question that we discuss a lot. And we want to comment on it. When you're feeling that we are in a position that revenue that we are reporting now really are coming to a level where you're feeling that it's really coming to a stage where the addition of new patients really are not changing so much of the overall. As I said, we're building a strong fundament quarter by quarter.

The strong fundament is building a really tall house. And we are now taking bricks by bricks, quarter by quarter, and we're building this revenue base up more and more. And you can hear it from just a mathematic modeling, think about it, when we are much more further in the launch, the addition of new patients just are not giving the same impact on the overall actual revenue at that stage. And therefore, I believe at one time, the number of new prescriptions is not really meaningful for you. You will just see a quarterly revenue growth that basically are just reflecting the addition of new patients.

Conference Operator: Thank you. Our next question comes from Maxwell Skor with Morgan Stanley. Your line is open.

Chad Fugier, Vice President of Investor Relations, Ascendis Pharma: Great. Thank you for taking my questions. I was just wondering when we can expect preclinical data supporting YorViPAS potential for weekly dosing? And also, could you share your outlook on YorViPAS trajectory in Europe? How should we think about a potential ramp next year?

Jens, President and Chief Executive Officer, Ascendis Pharma: Typically, what we're doing is that we will like in the beginning of the year, there is a conference and likely there will be typical that will come up with data and status on our new product opportunities, and we expect to repeat the same element year by year. So a good time to expect to see data will be at the beginning of this year.

Scott Smith, Executive Vice President and Chief Financial Officer, Ascendis Pharma: If he's talking the guidance on OUS? Ex U. S,

Jens, President and Chief Executive Officer, Ascendis Pharma: what we said for this year here is a DKK 4,000,000 to 5,000,000 increase quarter by quarter. And what we said, this will further be accelerated when we come into 'twenty six because we will have an addition of more and more countries. When we come into January, we will give you the perspective of what countries we expect to add into the being fully commercial in 2026 and 2027.

Conference Operator: Thank you. And we'll take our last question from Clara Dong with Jefferies. Your line is open.

Jess Fye, Analyst, JPMorgan: Hi, thanks for taking our question. And just to follow-up on the previous question and apologize if you've mentioned already, but it will be great if you can confirm The U. S. And ex U. S.

Revenue split for Europas. And then in terms of the ex U. S. Launch momentum, is there any specific time line for any upcoming reimbursement decision in any market and any pricing dynamic we should keep in mind as you expand internationally? Thank you.

Jens, President and Chief Executive Officer, Ascendis Pharma: Okay. So we gave you an algorithm basic in the beginning of the year. We said that when you look in Q4 twenty twenty four, that was about DKK 14,000,000 in net revenue. All this net revenue was basic ex U. S.

And we expect it to add $4,000,000 to $5,000,000 net revenue in $25 every quarter. So you can nearly add 14,000,000 to 5,000,005 million plus 5,000,000 and then you have the Q4. What we saw in here in 2025, we got Spain full commercial. We are in a situation where we not compromise the value because we have a doable product that basically will be here for twenty years. So for us, it's more important to really have the value being created in the right manner.

And what we will give you here at the beginning of the year, the perspective of what and how many new countries we expect to add on in 2026.

Conference Operator: Thank you. And that's all the time we have. Thank you for joining. You may now disconnect. Good day.

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