Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Date

Wednesday, November 12, 2025 at 4:30 p.m. ET

Call participants

  • President and Chief Executive Officer — Jan Moller Mikkelsen
  • Executive Vice President and Chief Financial Officer — Scott T. Smith
  • Chief Business Officer — Sherrie Glass
  • EVP and President, US Markets — Jay Donovan Wu
  • EVP and Chief Medical Officer — Aimee Shu
  • Vice President, Investor Relations — Chad Fugier

Need a quote from a Motley Fool analyst? Email [email protected]

Takeaways

  • Eurvipath revenue -- €143.1 million in calendar Q3, reflecting continued commercial expansion and steady US patient growth.
  • Eurvipath US penetration -- Over 4,250 unique US patients prescribed since launch, with more than 400 new US patients added in October and over 2,000 unique healthcare providers engaged.
  • Eurvipath insurance approval rate -- Around 70% of total US enrollments to date, with the majority of approvals occurring within eight weeks.
  • Addressable US hypoparathyroidism population -- Estimated 82,000-90,000 diagnosed patients, plus 3,000-4,000 new diagnoses annually; currently, less than 5% are treated with Eurvipath.
  • Skytrofa revenue -- €50.7 million in calendar Q3, with 3% sequential demand growth from Q2, offset by €1.6 million in foreign currency headwind.
  • TransCon CNP regulatory status -- Under FDA priority review with a PDUFA date of November 30 and in late-stage label discussions; no additional data requested by the FDA during the current review cycle.
  • Total Q3 revenue -- €214 million, including €20 million in collaboration revenue, of which €13 million was milestone-driven by Eurvipath and increased partner activity.
  • Operating profit -- €11 million in calendar Q3, with positive cash flow and an increase in cash and cash equivalents to €539 million, up from €494 million at the end of Q2.
  • R&D and SG&A expenses -- R&D at €66.9 million (down from €73.5 million calendar Q3 2024), SG&A at €113.4 million (up from €69.8 million calendar Q3 2024), reflecting commercial build-out.
  • Global commercial expansion -- Eurvipath commercially available or distributed via named patient programs in over 30 countries, with new launches in Japan, Germany, Austria, and Spain.
  • Future financial guidance -- Management expects continued Q4 revenue growth for both Eurvipath and Skytrofa, citing new patient additions, stable pricing, and expanding payer and geographic access.
  • TransCon CNP clinical data -- Demonstrated significant improvements in linear growth, leg bowing, and body proportionality in children with achondroplasia, with positive feedback from key opinion leaders.

Summary

Ascendis Pharma (ASND 0.61%) reported accelerating revenue growth driven by Eurvipath's ongoing US and international expansion, accompanied by a stable and broadening base of prescribing physicians. Management stated Eurvipath's US insurance approval rate remains approximately 70%, with a trend toward higher rates among early cohorts and continued maturation over time. Skytrofa achieved both US pediatric and recent adult FDA approvals, contributing materially to overall revenue; the business remains focused on label and geographic expansion for incremental growth. The company highlighted positive operating profit and free cash flow in the quarter, reflecting the operational leverage from completed commercial buildout ahead of new product launches. Late-stage pipeline progress was underscored by TransCon CNP’s ongoing FDA priority review, an expected November 30 PDUFA date, and potential for near-term approval as the third consecutive TransCon product in the portfolio. Management confirmed there were no FDA requests for additional information or data in the TransCon CNP review to date, reducing regulatory uncertainty in the near term.

  • CEO Mikkelsen stated, "less than 5% of US patients are currently on Eurvipath," underscoring substantial future penetration opportunity.
  • Smith indicated, "we achieved positive operating income along with positive cash flow," as a shift to a more durable financial model.
  • Mikkelsen confirmed, "are in the final stages of the label discussion" for TransCon CNP.
  • Management reported continued payer diversity and minimal anticipated changes in Eurvipath’s contracting or gross-to-net dynamics in Q4 and upcoming quarters.
  • The company plans to introduce a non-IFRS EPS measure in future periods, aiming to enhance comparability by excluding specific non-cash, non-operating items.
  • TransCon CNP Phase 3 combination therapy for achondroplasia will initiate enrollment before year-end, with 52-week COAT trial data expected early 2026.

Industry glossary

  • PDUFA date: The date by which the FDA commits to a regulatory decision under the Prescription Drug User Fee Act.
  • Gross-to-net: The ratio comparing gross drug sales to net sales after deductions for discounts, rebates, and other adjustments.
  • ER program: Early access or expanded access program, allowing patients to receive investigational therapies ahead of full commercial availability.
  • MAA: Marketing Authorization Application, a regulatory submission seeking approval to market a pharmaceutical product in the EU.
  • Achondroplasia: A rare genetic condition characterized by abnormal bone growth leading to dwarfism.
  • Named patient programs: Mechanisms allowing provision of medicines to individual patients prior to full commercial launch, typically for serious or life-threatening conditions.

Full Conference Call Transcript

Chad Fugier: 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 Jan Moller Mikkelsen, President and Chief Executive Officer; Scott T. Smith, Executive Vice President and Chief Financial Officer; Sherrie Glass, Chief Business Officer; Jay Donovan Wu, EVP and President, US Markets; and Aimee Shu, 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 Skytrofa and Eurvipath, 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. 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 February 12, 2025. TransCon Growth Hormone, or TransCon HGH, is now approved in the US by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency. In addition, the treatment of pediatric growth hormone deficiency 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 US by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission and the United Kingdom's 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 2025 financial results and 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 Moller Mikkelsen: Thanks, Chad. Good afternoon, everyone. In 2025, we accelerated our momentum towards fulfilling our Vision 2030 with key achievements in three areas. First, the global launch of Eurvipath continues to be strong, with a steady increase in new unique patient prescriptions and prescribers as seen in Q1 and Q2, along with expansion in new geographic markets. Second, we made great advancements towards leadership in growth disorders during the quarter. We saw the US approval of Skytrofa in adult growth hormone deficiency, and following our late-cycle meeting with the FDA, we are progressing toward expected approval of TransCon CNP in the US.

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 Eurvipath, Eurvipath continues its strong global launch with revenue of €143 million in the third quarter. Nine months into the launch in the biggest market, the US, patient demand continues growing quarter by quarter. From launch to September, more than 4,250 patients have been prescribed Eurvipath in the US by over 2,000 unique healthcare providers, highlighting the strong steady demand for Eurvipath even during the summer months.

In October, the positive trend continued with Eurvipath being prescribed for more than 400 new patients in the US alone. Positive physician and patient experiences 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 groups who manage hypoparathyroid 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, demonstrating sustained clinically meaningful improvement in kidney function in Eurvipath-treated patients. In addition, we continue working hard to expand patient access in the US.

The overall insurance approval rate since the start of the launch is around 70% of total enrollment, and we believe this figure will continue to increase over time. We currently see approval across all payer types, with a majority of approvals within eight weeks. We are pleased by the robust uptake of Eurvipath in our first three quarters of commercialization in the US. Today, less than 5% of US patients are currently on Eurvipath treatment. We see significant room to grow with around 82,000 to 90,000 patients already diagnosed with chronic hypoparathyroidism in the US and 3,000 to 4,000 new patients being diagnosed every year.

Outside the US, Eurvipath is now available commercially or through named patient programs in more than 30 countries. In Germany, Austria, and Spain, we have now full commercial reimbursement. In Japan, our partner, Taigen, launched Eurvipath commercially last week following approval in August. We are looking forward to the commercial launch of Eurvipath 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 Eurvipath positioned as a first-in-class therapy, we expect sustained patient growth and revenue growth for years to come. As we are building this global market, we are expanding our offerings to patients with hypoparathyroidism.

We are conducting the Pathway 60 trial to support doses up to 60 micrograms of Eurvipath in the US. 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 would be an attractive option for patients on stable doses of Eurvipath. In the new year, we will share more on our plans to maximize Eurvipath's value and reach even more patients. Let's now turn to growth disorders.

Our growth disorders portfolio comprises our once-weekly growth hormone Skytrofa, approved for growth hormone deficiency, and our once-weekly TransCon CNP, currently under review by the FDA in the US and by the EMA in the EU for children with achondroplasia. Skytrofa is approved in the US and EU for the treatment of pediatric growth hormone deficiency. With this single indication, Skytrofa is established as a high-value brand and treatment of choice for pediatric growth hormone deficiency. Q3 revenue for Skytrofa was €51 million. In July, we received our first label expansion with FDA approval for adult growth hormone deficiency, the first of multiple planned label expansions.

In Q3, we initiated our Phase 3 basket trial of Skytrofa with a range of established growth disorders, including ISS, shock deficiency, Turner syndrome, and SDA. Turning to TransCon CNP, we recently completed a late-cycle meeting with the FDA and are in the final stages of the label discussion. TransCon CNP is under priority review in the US, with a PDUFA date of November 30, and is also under review in the EU, where our MAA filing was validated. TransCon CNP, once weekly, is well-positioned to become the leading treatment for children with achondroplasia, with a full degree of linear growth outcome that can be achieved with monotherapy addressing the overactive tyrosine kinase gene.

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 injection site reactions 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 outcomes for people living with achondroplasia. Earlier this year, we presented 26-week results from the Phase 2 COAT trial of TransCon CNP in combination with TransCon Growth Hormone, which showed around three times 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, accompanied 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 protected role of TransCon CNP as the backbone therapy. Following our recent FDA end-of-phase 2 meeting related to our combination therapy, we plan to initiate a Phase 3 trial this quarter. We anticipate disclosing 52-week data from the COAT trial in early 2026.

With once-weekly growth hormone and once-weekly CNP, 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 disorders. Our Vision 2030 also includes creating value through partnerships, and we see that being achieved through the rapid progress of Taigen in Japan, endocrinologists in metabolic and cardiovascular diseases, VISEN in China, and Iconis in ophthalmology. The once-monthly semaglutide program is making fast progress towards the clinic. And finally, the commercial success of Eurvipath and Skytrofa has already transformed the financial profile of Ascendis. In the third quarter, we achieved positive operating income along with positive cash flow.

For the near term, the building out of our commercial organization is largely completed in advance 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&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 products created by the TransCon technology platform and our unique low-risk drug development algorithm.

Importantly, our current three rare disease endocrine products position us for durable future growth and give us confidence in our aspiration to achieve €5 billion or more in annual profit revenue in 2030. I will now turn it over to Scott. Thank you, Jan.

Scott T. Smith: I would like to reiterate Jan's 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 third-quarter financial results and outlook. But for further details, please refer to our Form 6-Ks filed today. In Q3, Eurvipath global revenue grew to €143.1 million, up from €103 million in Q2, with strong growth partially offset by a €3.6 million foreign currency headwind compared to the previous quarter. In Q3 2025, Skytrofa contributed €50.7 million, with 3% growth in demand offset by a €1.6 million foreign currency headwind compared to the previous quarter.

Including €20 million in collaboration revenue, driven by a €13 million milestone related to Eurvipath and increased partner activity, total Q3 2025 revenue amounted to €214 million. Continuing on to expenses, R&D costs in Q3 were €66.9 million, down from €73.5 million in Q3 2024, primarily driven by the completion of certain clinical trials and development activities. SG&A expenses rose to €113.4 million in Q3 2025 compared to €69.8 million in the same period last year, reflecting the continued impact of global commercial expansion. Total operating expenses for Q3 2025 were €180 million, and operating profit for Q3 2025 was €11 million.

Net finance expense for 2025 was €60.9 million, primarily driven by non-cash items, including a non-cash remeasurement loss of financial liabilities of €47.2 million. Net cash financial income over this period amounted to €400,000. Note that in our 6-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, adjusted for the impact of certain non-cash non-operating items, including those related to our convertible notes. This is intended to increase comparability of period-to-period results. Finally, we ended 2025 with €539 million in cash and cash equivalents, up from €494 million at the end of Q2.

Turning to our commercial outlook, primarily driven by the ongoing global launch of Eurvipath, we expect continued revenue growth in the fourth quarter. For Eurvipath specifically, we expect continued growth driven by new patients, stable pricing, payer mix, and contracting in Q4. Longer term, we expect Eurvipath to be driven by continued growth in new patients on therapy, including expansion into additional markets. For Skytrofa, 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 Skytrofa to be driven by geographic and label expansion.

With that, operator, we are now ready to take questions.

Operator: Our first question comes from Jessica Macomber Fye with JP Morgan. Your line is open.

Jessica Macomber Fye: 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 Eurvipath in the US. From here, I think you talked about more than 4,250 as of the end of Q3, putting you at what is that? About 1,150 ads 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. Thank you.

Jan Moller Mikkelsen: Thanks. Yes. First of all, we see a steady stable number of prescriptions being written in the US. When we, in some way, take away the bolus that we have from the ERP program about 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 fearing that prescriptions were not going to be written in the three weeks every physician typically takes out of their quarter in that time. And what I saw, we saw nearly the same number of prescriptions being written that we actually had seen in Q1 and Q2. And it's also following up with what we said in the October month.

We saw more than 400 prescriptions being written in October. Unique prescriptions being written in October. So when I look at this launch, look at the US, I see a very, very stable launch. 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 out a house where you have a strong fundament taking one brick on around every quarter and the house getting taller and taller every quarter.

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

Tazeen Ahmad: Hi, good evening guys. Thanks for taking my 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, you can call it just because of the upcoming holidays, Thanksgiving, Christmas, and 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? Thanks.

Jan Moller Mikkelsen: Let me take the last question. Thanks, Tazeen. First part, let me take the last question because it's an easy one because just no. Just no. No. No. No. It's really simple. So going to the next one, it's more what Scott Logan didn't read the FLS this time, which Chad FLS this time. But, you know, when I look forward in the future, yes, there are some holidays coming up. But when I look back, I was more worried about Q3 actually compared to Q4 because I actually believe that it's a longer summer vacation than in Q3 compared to basically what you will see in Q4. So I see pretty positive on Q4.

I see the excellent increasing our prescription basis from physicians writing prescriptions 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 worries from my side, Tazeen.

Operator: Thank you. Our next question comes from Gavin Clark-Gartner with Evercore ISI. Your line is open.

Gavin Clark-Gartner: Hey, guys. Thanks for taking the questions. I wanted to focus in on the conversion rate for Eurvipath. 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'll be higher? Just had a follow-up on this too.

Jan Moller Mikkelsen: Yeah. 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 you basically some way 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 antibodies block taken into the situation. We're getting the patients. We're getting not only the prescriptions done. We're also getting the approvals done. And we're getting it done in a speed. And as Scott also put emphasis on this, we don't expect anything changing in the contracting environment in Q4. So we some may expect the same GCN 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 Skytrofa after it got matured.

Jay Donovan Wu: Yeah. 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 once 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.

Gavin Clark-Gartner: That is super helpful. And if 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?

Jan Moller Mikkelsen: Nope. That's not what we're saying, Gavin. Because if we go back and look on the early cohort, meaning it's cohort four, March-April, it's much, much higher than the 70%. So this is what you see. The longer time it takes, the more and more are getting approved. And that is basically the element. And this is the question we have, can we really take this tail and shorten 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-Gartner: Okay. The point I'm trying to get at is for a lot of the start forms like, let's take the 3,100 you had through 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 conversion. It's just a matter of time.

Jan Moller Mikkelsen: Exactly. So if you take, for example, going to the cohort from March, April, much higher. If you take the earlier stage cohort now, that is near this month we have is lower than that. So this is how you see it. It's only a question about time.

Gavin Clark-Gartner: Very helpful. Thanks so much.

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

Joseph Schwartz: A question on Eurvipath and then on TransCon CNP. Can you give us your latest views on how Eurvipath has been penetrating the different segments of the hypoparathyroid market as you see it? Where is it gaining the most traction, and where could it do better? And then, you previously emphasized the desire to do more than enhance linear growth in achondroplasia. So I'm wondering to what extent do you think you can obtain differentiated label claims on the TransCon CNP label? Thank you.

Jan Moller Mikkelsen: Let me take the last question. As I said in the prepared remarks, we are in the late-stage discussion about the label, 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, Aimee Shu's discussion, our medical affairs discussion with the teams, it's really to explain the benefit they see beyond linear growth. And it's clear unique effect in leg bowing, unique effect in changing body proportionality.

And we will have peer-reviewed publications really supporting all these claims that will come out and 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. We saw and we saw an element once with hypoparathyroidism where it was impossible to get into the labeling our element of patient benefit related to cognitive function, although quality of life, and everything like that. And everyone recognized it. Everyone sees it. Everyone sees that is the best thing. I think this is the key thing from our labeling discussion is to 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 to Joe?

Jay Donovan Wu: Yeah. Could we repeat the first part of that question?

Joseph Schwartz: Yeah. Sure. I was just wondering, you know, you've outlined the different segments of the market based on how controlled the patients are. So I was wondering, you know, how are you making inroads into those segments lately? Where are you getting the most traction, and where could you do better?

Jay Donovan Wu: Yep. So when you think about the 80,000 to 90,000 patients that Jan had referenced early in the call, I think there's probably a group that we would describe as, you know, 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 perhaps they've gotten used to some elements of it and therefore haven't been either self-identifying some of their symptoms as being related to the underlying condition and or 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.

Jan Moller Mikkelsen: Yeah. If I can add something, Jay, I see it from two different perspectives, how often you come into the endocrinologist. This is one way. And those how we targeted it and defined something that is not defined on medical terms, but only on how often you see an endocrinologist related to being controlled, partly controlled, or uncontrolled. And what I also try to look at is to look on where are they coming from? Are they coming from the post-surgery? Are they coming from the genetic part? Are they coming from the immunological part? I see them coming from everywhere. So for example...

Operator: Ladies and gentlemen, please stand by. Again, please standby. The conference call will begin. Please continue.

Joseph Schwartz: Where did you last hear us at?

Jan Moller Mikkelsen: I think this was Joe, your question about the...

Joseph Schwartz: Yep. Sec. Welcome back. So I guess I was wondering about your progress within the different levels of control and where you can do better and, you know, just how you've been able to penetrate patients in each of these segments.

Jan Moller Mikkelsen: Yeah. I think, Jay, at least I heard Jay's response to it. And my additional comments were that when we did the targeting of our physicians, we made it out from the claims database where we defined three groups: controlled, partly controlled, and uncontrolled. It's nothing to do with medical terms. But basically, it's an acceleration, how we basically are looking at the patient seeing an endocrinologist. So what I also look at is do we see all patient groups in our patient being coming on Eurvipath 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 at different elements of genetic, or immunological, we also see all different groups of patients, even patients from the ADH1, which are really, really less than 1% in the claim database. We already have about 15 patients on treatment with this symptom, which really gives us hope that we basically see the same penetration everywhere in all different of the hypoparathyroid patients in this way.

Operator: Thank you. Our next question comes from Li Watsek with Cantor. Your line is open.

Li Watsek: Hi, guys. Thanks for taking my questions. I guess just on Eurvipath, can you maybe just give us a little color on payer mix and potential contracting not just in Q4, but also in 2026? And should we sort of expect, you know, still minimum contracting and sort of stable growth to net for the next few quarters?

Jan Moller Mikkelsen: I think, Scott more or less addressed it in his prepared remarks. There will be no changes into Q4. If we look forward, will there be potentially more contracting than we have seen now? And Jay can comment on that. 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 Eurvipath really have all the characteristics of the product. It's a first-in-class. There's 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. Jay, do you have further comments on the long-term perspective of contracting?

Jay Donovan Wu: Yeah. 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 speaks for itself, we don't anticipate any major contracting that's gonna 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.

Jan Moller Mikkelsen: And when we look at the competitive landscape, we don't believe any of what we see in the competitive landscape will really make us move into a much more highly contracted product as we see really the best-in-class properties compared to everything we see.

Li Watsek: And then, you know, just curious about the TransCon CNP and the phase two meeting. In terms of the phase three, you know, 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?

Jan Moller Mikkelsen: Yeah. That is an interesting question because I basically have never seen anything longer than a 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 packet 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 two trial. So I think that is basically the element of what I never have seen in this way. And Aimee Shu went to the FDA meeting, so she can basically just give you the view about what she basically got feedback from that perspective.

Aimee Shu: Yeah. So, Li, happy to say that we found our reviewers at FDA to be appropriately open-minded about duration here. But there's obviously a regulatory pathway, and that's usually one year of data.

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

Yaron Benjamin Werber: Maybe, Jan, maybe a couple of questions. Number one, just on gross to net. When we're kind of we were at around just over 4,200, 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 that gross to net discounts are higher than that? That wouldn't make any sense because I got 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 didn't see much seasonality in Q3.

And then finally, US versus European sales for Eurvipath in the quarter, was it like around $4 million or so in Europe this quarter as well? Thank you.

Jan Moller Mikkelsen: Yeah. That was three questions. The element of what I will take what we said in the beginning of the year is still what we really are seeing. We said we will expect ex-US to be around €4 million to €5 million 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 expected it to potentially have seen it in Q3 because I expected the physician to be gone for three weeks.

And when we not really saw a major impact in Q3, I don't expect to see any impact in Q4. So 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 T. Smith: Yeah. So, I think your question was the, the 70% approvals and the time to time to, revenue. We could probably follow-up offline on, you know, how you're thinking about things. But just remember also when there's an approval, it's this isn't the exact same thing as patient on drug. Right? They get approved, and then sometimes, you know, sometimes it's soon. Sometimes it takes a while. But, that's probably the only thing to keep in mind, Yaron.

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

Martin Auster: Hey, guys. Thanks for taking the question. I'll try not to be too greedy and just keep it to a couple. First, on Eurvipath, and I was wondering if you could comment if you've got any sense of early data on what patient retention looks like from folks 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 TransCon CNP is sort of coming to market and improve upon that and improve overall penetration rates of treated folks with achondroplasia?

Jan Moller Mikkelsen: Thanks, Martin, for the question. The first one is really, really, we spend a lot of time on it. Spend a lot on the analytical. And we are losing very, very, very, very few when they have initiated treatment. Very few percentages. 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 conviction therapy. You start to do it.

You need to take it off, and I believe if there is not a good interaction between both the physician, the case where we get case and monitoring and everything like that. It is a more difficult period for the time. This is why the titration. That was why we started all this one daily product because we know we could never get this titration to function with a once-weekly product. So that is where we see. When we see after four to six weeks when we're starting to be stable, we as 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. When you have a look on vosoritide, it's doing really poorly in the US. They're saying that they're doing really good outside the US. I think they're doing really poorly in the US. That 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 groups, 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 comorbidity because we believe that is really why patients should take the 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 patient related to that topic.

Martin Auster: Thanks, Jan. Looking forward to November 30.

Operator: As a reminder, please limit yourself to one question and a follow-up. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi: 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 vosoritide daily injection experienced patients? And if you are expecting a decent-sized contribution from the latter, can you maybe speak to what your market research suggests the appetite is on potential switch strategies and just sort of what percentage of the existing, you know, treated patient base might you might think ultimately convert? Thanks for taking the question.

Jan Moller Mikkelsen: Thanks so much for the question. Yes. We expect that to be a lot of switches. We enrolled patients in the places where vosoritide is commercially available. Free for the patient. We enrolled it there was other treatment alternatives. You call them treatment alternatives. We were in a position that preferred it. Out from the perspective they'll stay not only the once-weekly profile, but the lack of injection site reaction. Really, to be in a position, you need to worry about any risk of hypertension. And anything like that. That was really one of the key developments. 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 will 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, seventy percent of all patients will be treated today. And there will be switch. They are just waiting for it. We know they are waiting for it because they ask for it all the time. When will it be approved? In Europe? If you go to the US, 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 how we would build up the commercial strategy.

Paul Choi: Okay. Great. Thank you.

Operator: Our next question comes from Yun Zhong with Wedbush. Your line is open.

Yun Zhong: Hi. Good afternoon. Thank you very much for the questions. So the first question on the label extension, to the higher dose, I assume the pricing is gonna be the same. So would you expect any direct impact on maybe the number of patients on treatment and the reported revenue, please?

Jan Moller Mikkelsen: First of all, when we look on treatment in a dose larger than the 30 dose, it's only restricted to the US. And currently, when we see in many countries there is a few percentage of patients that really need it in a commercial setting. We accept some patients that really need it, and they are in many cases, already on treatment in the US. By having this trial, the patients that basically will need more than 30 in the US will now have availability because they can join us in the clinical trial. The clinical trial, as Aimee can explain, is a very rare simple. Single-arm study. You can explain how many patients we have.

It's basically just a safety trial.

Aimee Shu: Yep. So single-arm, 18 subjects who will be titrated as they need based on serum calcium. Using the higher doses.

Jan Moller Mikkelsen: So it's basically an 18 patient, six-month trial. For safety perspective. And that will be the triggering point to also in the US having. I don't think it will have a material impact in any way on our revenue.

Yun Zhong: 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? Thank you very much.

Jan Moller Mikkelsen: We see an improvement month by month, and when we look at the data today, with about the 50% and the eight weeks that is the data we see today.

Yun Zhong: Okay. Great. Thank you.

Operator: Our next question comes from Alexander Thompson with Stifel. Your line is open.

Alexander Thompson: 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 US, and what kind of growth do you expect to see from here? Assuming there's successful label expansion? Thank you.

Jan Moller Mikkelsen: This patient group is a quite different patient group compared to the pool of the patients we talk today in the US and other countries. Many of these young children are coming from more the genetic and immunological part. Anoxamos from head and neck operation. Still, that can be posterior to patient at that stage too. These patients are in a severe case because if you have hypoparathyroidism 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 twenties. Because of the high burden of the treatment that has been available today conventional therapy. And when we look at the number, there will not be a number that ever came 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.

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

Luca Issi: Great. 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 NetSerra. 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. Thanks so much.

Jan Moller Mikkelsen: Yeah. Let me take the last question first. About our collaboration. And when I look at the collaboration, and the look on the 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 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 the 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 too 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 last phase three 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.

Scott T. Smith: Enrollment as a metric? Yeah. The enrollment as a metric is a question that we discussed a lot. And we want commerce on it, when you're feeling that we are in a position that revenue coming to a level that we are reporting now really 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're now taking bricks by bricks, quarter by quarter, and we're building this revenue base up more and more.

And you can nearly from a 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 in one time the number of new prescriptions is not really meaningful for you. You will just see a quarterly revenue growth that basically is just reflecting at the addition of new patients.

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

Maxwell Nathan Skor: Great. Thank you for taking my questions. I was just wondering when we can expect preclinical data supporting Eurvipath's potential for weekly dosing? And also, could you share your outlook on Eurvipath's trajectory in Europe? Should we think about a potential ramp next year? Thank you.

Jan Moller Mikkelsen: Yeah. Typically, what we're doing is that we will like, in the beginning of the year, there is a conference and likely there'll be typically 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 T. Smith: Oh, the if the if he's talking the, the guidance on OUS. Ex-US what we said for this year here is a 4 to 5 million increase. Quarter by quarter. What we said this will further be accelerated when we come into '26. 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 in to the being fully commercial in '26 and '27.

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

Clara Dong: 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 the US and ex-US revenue split for Eurvipath. And then in terms of the US launch momentum, is there any specific timeline for any upcoming reimbursement decision in any market and any pricing dynamic we should keep in mind as you expand internationally? Thank you.

Jan Moller Mikkelsen: Okay. So we gave you an algorithm basic in the beginning of the year. We said that when you look in Q4, '24, that was about 14 million in net revenue. All this net revenue was basic ex-US. And we expect it to add 4 to 5 million net revenue in '25 every quarter. So you can nearly add 14 plus five plus five plus five plus five, and then you have the Q4. What we saw in here in '25 we got Spain. Full commercial. We are in a situation where we not compromise the value because we have a durable 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 expect. To add on in twenty-six.

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

Jan Moller Mikkelsen: Thanks a lot.