Ascendis (ASND) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• Vice President, Investor Relations - Chad Fugere
• President and Chief Executive Officer - Jan Moller Mikkelsen
• Chief Financial Officer - Scott Smith
• Executive Vice President and President, U.S. Market - Jay Donovan Wu

TAKEAWAYS

• Product Revenue -- €366 million, representing 89% growth year over year driven by strong new patient demand across all three marketed therapies.
• YORVIPATH Revenue -- €291 million, up 103% year over year reflecting consistent new patient enrollments in the US and expansion in more than 40 countries.
• SKYTROFA Revenue -- €59 million, representing steady performance as the leading long-acting growth hormone by value in the US market.
• YUVIWEL Revenue -- €16 million, doubling from the previous quarter following its commercial launch in the US in the second quarter.
• Non-IFRS Operating Profit -- €156 million, reflecting a 42.1% margin driven by increased revenue and lower sequential operating expenses.
• Operating Cash Flow -- €189 million for the third quarter, supported by commercial revenue growth and proceeds from the sale of a priority review voucher.
• Full-Year Operating Cash Flow Guidance -- At least €600 million expected for 2026, as the company reaches a self-sustaining financial position.
• US YORVIPATH Enrollments -- Targeted at more than 1,000 new patients per quarter, with management reporting consistent demand trends through the third quarter.
• US Hypoparathyroidism Market -- 70,000 to 90,000 adults, with more than 90% of this population identified as potential candidates for PTH replacement therapy.
• YUVIWEL Patient Enrollments -- Approximately 340 unique patients enrolled through October 2026, with a reimbursement approval rate exceeding 80%.
• Share Repurchases -- 2 million ordinary shares repurchased for approximately $460 million year to date through Nov. 11, 2026.
• Vision 2030 Revenue Goal -- Over €5 billion in annual product revenue targeted by 2030, supported by label expansions and global geographic growth.
• Vision 2035 Revenue Goal -- €10 billion in annual product revenue targeted by 2035, driven by the TransCon technology platform.
• YORVIPATH Global Availability -- Now available in more than 40 countries through commercial launches or named-patient programs, with 15 additional markets planned for 2027.
• Operating Expenses -- €217 million, a decrease of €32 million from the second quarter primarily due to lower litigation costs and the timing of commercial initiatives.
• YORVIPATH Prescriber Growth -- Added 300 new prescribers in the US during the third quarter, increasing both the breadth and depth of clinical adoption.
• COAST Phase 3 Enrollment -- Delayed by several months following regulatory feedback that required a redesigned study structure to include independent treatment arms.
• HighLiGHts Basket Trial -- Anticipated completion of enrollment in the first half of 2027, addressing growth hormone deficiency indications that could double the addressable patient population.
• Cash and Cash Equivalents -- €964 million as of Sept. 30, 2026, representing an increase of €152 million from the end of the second quarter.
• Infant Achondroplasia Clinical Data -- Week 52 sentinel data showed stabilization or improvement in foramen magnum stenosis and linear growth benefits for children aged zero to two years.

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RISKS

• Mikkelsen noted that the COAST Phase 3 combination trial "got enlarged" and "delayed a few months" following regulatory requirements to evaluate the contribution of each component in a three-arm study.

SUMMARY

Ascendis Pharma A/S (NASDAQ:ASND) reported significant growth in product revenue and achieved a net profit for the third quarter. Management stated that financial results were driven by scaling demand for its hypoparathyroidism and growth hormone therapies in the United States and international markets. The company indicated it is transitioning into a sustainable global biopharmaceutical entity with plans to expand into a new therapeutic area while targeting annual revenue goals of 5 billion euros by 2030 and 10 billion euros by 2035.

• Mikkelsen stated, "we are now occupied to take up a new therapeutic area," which will be supported by an internal commercial organization and include at least two to three new products.
• CEO Mikkelsen stated, "Yorvipath has set a high bar and is positioned to be the standard of care in hypoparathyroidism treatment," citing its ability to normalize urinary calcium and improve kidney function.
• The company launched a national disease awareness campaign in September to help US patients identify symptoms and encourage consultation with health care providers.
• Management reported that COAST Phase 2 data showed adding TransCon hGH to TransCon CNP provided a three- to fourfold improvement in height Z-score compared to monotherapy.
• The company expects a European Commission decision on the marketing authorization for navepegritide before the end of 2026, with a planned launch in Germany in the first quarter of 2027.
• Ascendis plans to initiate a Phase 3 trial in children with hypochondroplasia during the fourth quarter of 2026 and a Phase 2 trial in adults with achondroplasia by year-end.

INDUSTRY GLOSSARY

• TransCon: The company's proprietary technology platform designed to create new therapies by combining a parent drug with a linker and a carrier for sustained release of unmodified drugs.
• SKYTROFA: A once-weekly lonapegsomatropin injection approved for the treatment of growth hormone deficiency.
• YORVIPATH: A palopegteriparatide prodrug approved as a parathyroid hormone replacement therapy for adults with chronic hypoparathyroidism.
• YUVIWEL: A once-weekly navepegritide therapy approved for the treatment of pediatric achondroplasia.
• Achondroplasia: A genetic condition and the most common form of short-limbed dwarfism, caused by a mutation in the FGFR3 gene.
• Hypoparathyroidism: A rare endocrine disorder characterized by insufficient levels of parathyroid hormone, leading to low blood calcium and high blood phosphate.
• CHMP: The Committee for Medicinal Products for Human Use, the European Medicines Agency's committee responsible for preparing opinions on marketing authorizations.
• COMP: The Committee for Orphan Medicinal Products, which reviews applications for orphan designation in the European Union.

Full Conference Call Transcript

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Third Quarter 26 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. You will then hear an automated message of passing your hand is raised. And to withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Chad Fugure, Vice President and Investor Relations. Please go ahead.

Chad Fugier: Thank you, operator, and thank you, everyone, for joining our third quarter 26 financial results conference call. I am Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Moller Mikkelsen, President and Chief Executive Officer Scott Smith, Chief Financial Officer and Jay Donovan Wu, Executive Vice President and President, U. S. Market. Before we begin, I would like to remind everyone that certain matters discussed on today's conference call are forward-looking statements relating to future events future financial performance, and management's plans and objectives for the business. These statements are subject to risks uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements.

The risk factors may affect results are described in our annual report on Form 20 F, filed with the SEC on February 11, 2026. As such, report may be updated by other public filings with the SEC from time to time. The forward-looking statements made today are as of the date of this call, and we do not undertake any obligation to update these forward looking statements. Speakers on today's call may also refer to certain non-IFRS financial measures. A reconciliation of these non-IFRS financial measures to the most directly comparable IFRS measures is available in our press release issued today.

Content of this call is not intended to constitute and should not be interpreted as direct or indirect promotion of any of our products or product candidates. A copy of this press release may be obtained by visiting the Investor Relations page of our website at investors.ascendispharma.com. With that, I will turn the call over to Jan.

Jan Moller Mikkelsen: Thanks, Chad. Good day. Everyone. In the third quarter, execution across R and D and commercial continued to drive the transformation of Ascendis. Into a leading global biopharma company. Strengthening our ability to make a meaningful difference for patients. In Q3, we delivered product revenue of €366 million up 89% over last year. And up €51 million over last quarter. Reflecting strong new patient demand across all 3 of our marketed products. Looking ahead, we see 3 complementary drivers of doable growth. First, continued growth for our existing 3 products in already approved indications. Second, expansion of indicationss for our 3 existing products. Including label extension for monotherapy and combination therapy. Third, new products enabled by our TransCon technology platform.

To drive sustainable long term growth. Importantly, our global geographic commercial expansion will further accelerate growth of all 3 drivers over the coming years. As more and more countries will be fully commercialized. Our IND and commercial infrastructure giving us confidence that we can achieve our Vision 2030 goals Of generating over €5 billion in annual product revenue in 2030. And develop multiple new blockbuster products with the TransCon technology platform. which also includes a new therapeutic area. Let us start with the first driver: Continued growth for our existing 3 products, Yorvipath, Yuvivel, and Skytrofa in already approved indications. Europas is the first and only approved treatment for hypoparathyroidism in adults.

And is now available commercially or through named-patient programs in more than 40 countries. Global Yorvipath revenue in the third quarter was €291 million up 103% over last year. And up €39 million over last quarter. In The US, new patient demand in the third quarter was consistent with prior quarters, even during the summer months. With an estimated 70 thousand to 90 thousand adults. That live with chronic hypoparathyroidism in The US. And more than 90% of the estimated number of patients are still potential candidates for Yorvipath PTH, replacement therapy. In September, we launched a US national disease awareness campaign.

Designed to help patients identify symptoms, and empower them to speak with their health care provider about treatment option. We expect the campaigns impact to build gradually. Over the coming quarters and are planning to launch a digital awareness campaigns in 2027. Outside The US, revenue continued to grow. Quarter by quarter. With full commercial availability for Yorvipath in 13 countries and 15 additional markets expected in 2027. Europas robust uptake is supported by clinical data. That showed its ability to maintain normal serum calcium and phosphate and normalized urinary calcium and phosphate excretion and normalize active vitamin D production achieved independent from conventional therapy and improve quality of life. Skeletal health, and kidney function.

To our knowledge, no other therapy in development has shown this depth and breadth of benefit. Across multiple target organ systems. And as the only approved PTH replacement therapy We believe Yorvipath has set a high bar and is positioned to be the standard of care in hypoparathyroidism treatment. For many, many years to come. Looking ahead, we expect sustainable growth in patients with Yorvipath in both established and new markets. As our clinical studies demonstrate that nearly all patients with hypoparathyroidism benefit from treatment. Turning now to Eurovale. Yuvivel is the first and only approved therapy for children with achondroplasia. To offer continuous systemic exposure to active CMP with a once weekly dosing.

In the third quarter, Yuvivel revenue was €16 million. New patient demand in The US has been steady through Q3. We now have around 340 patients enrolled through October. With more than 80% of these already approved from reimbursement. We see patients switching from daily therapy. Returning to medical therapy, and starting treatment for the first time. Yuvivel is growing in The US market. And is on track to unlock its potential to become the market leading therapy for children with achondroplasia. Through October, the number of new Yuvivel enrollment equals nearly half of all US patients on pharmacological treatment before our April launch.

And with around 70% of children with achondroplasia in The US still untreated we see a sustainable opportunity ahead to address a significant unmet needs and health complication associated with achondroplasia. In addition to showing significant linear growth improvement, such as height and body proportionality. Durable is to our knowledge the only therapy approved in development to have demonstrated significant improvements in key measure of skeletal proportionality lower limb alignment, spinal canal dimension compared to placebo. He has also shown improvement in health related quality of life. And physical function. With a safety and total tolerability profile comparable to placebo. All elements critical for chronic therapy for children.

Outside The US, we received a positive CHMP opinion in October and a positive COMP opinion to maintain orphan medical product designation if approved, provides the potential for up to 10 years of market exclusivity. We now expect a European Commission decision on our MAA before year end. If approved, we plan our first European launch in Germany in Q1 27. We are also making Yuvivel available in select international markets through Early Access Programs And Expect To Recognize Revenue From Multiple Countries Outside Of The U. S. And EU in the coming quarters. Turning now to Skytofer. The only once weekly growth hormone treatment to provide unmodified somatropin.

Skytrofa remains the number 1 long-acting growth hormone by value in the US. Third quarter revenue was €59 million driven by higher patient demand. Now to our 2nd driver of growth, expansion of indicationss across our 3 marketed products. Which are supported by more than 20 ongoing or planned studies. For Yorvipath, this includes a US trial to increase dosing up to 60 micrograms as well as ongoing multinational trials in patients 8, 12 to 17. We also continue to progress a once-weekly PTH program designed for patients who have a attained stable dosing of daily Yorvipath. For Yuvivel, we are working to expand into additional achondroplasia age groups and hypochondroplasia.

Our ongoing infant trial is fully enrolled, with top line results expected in 2027. This past quarter, we presented early sentinel data for this trial that showed once-weekly TransCon CNP providing stabilization or improvement in foramen magnum stenosis as well as linear growth benefit. In addition, TransCon CNP was generally well tolerated with no reported injection site reactions over 52 weeks. Lastly, plan to initiate a Phase II proof of concept trial in adults with achondroplasia. Before year end. Where we believe TransCon CNP might offer benefit in physical function mobility, chronic pain, fatigue or other areas that affect daily living. We also expect to initiate a phase 3 trial in children with hypochondroplasia this quarter.

For Skytrofa, which is being studied in more indications than any other long acting growth hormone. Our basket trial in patients with ISS SGA, Noonan syndrome, and Turner syndrome is progressing. With growth hormone deficiency representing only about 50% of the available growth hormone market, a pool across these indications could double the patient population addressed by our current playbook. We anticipate complete enrollment in this trial in the first half of 27. Combination therapy with TransCon CNP and TransCon hGH is another important growth driver. Market research suggests this unique combination could become the future standard of care in achondroplasia. Our Phase II COAST trial showed that TransCon hGH added to TransCon CNP led to significant improved efficacy.

Versus TransCon CNP monotherapy. With up to 3- to 4-fold greater improvement in ACH-specific height Z-score as well as improvement in arm span, body proportionality, sustained through 78 weeks. Without any compromise to safety or tolerability. Patient recruitment for our phase 3 combination trial in children with achondroplasia has started. While a separate phase 3 combination trial in children with hypochondroplasia is planned to be initiated in 2027. We continue to expand our global commercial presence. Across all 3 products: working toward full commercialization of our products in more than 50 countries. Turning now to the 3rd driver, new products.

As I mentioned upfront, the TransCon CNP technology platform enables the creation of highly differentiated new products, which we believe will be a major driver of sustainability for Ascendis. With complete freedom to apply our TransCon technology, also in metabolic and cardiovascular diseases, we are progressing multiple programs in these areas. We are executing on our goal of advancing at least 1 new product into clinical development each year. Adding new product to our endocrine rare disease franchise and creating a new therapeutic area focus, which we will disclose in the coming year. We look forward to providing a more comprehensive update on our early stage pipeline programs in early 2027.

In closing, our 3 approved products are driving a financial transformation of Ascendis. Which we expect to further strengthen with expanded labels and global geographic expansion. We are self sustaining and our operating cash flow is increasing. We built our company to benefit patients through internal product innovation. By always putting patients first, we believe Ascendis will deliver consistent, durable growth for many years to come. With that, I will turn the call over to Scott to review our financial results.

Scott T. Smith: Thanks so much, Jan. I will touch on some key points surrounding our third quarter financial results. For further details, please refer to our Form 6 ks filed today. Success of our research and development and commercial capabilities has led to 3 consecutive new products and has transformed Ascendis into a leading global biotech company reaching patients around the world. Total product revenue for Q3 26 was €366 million up 89% year over year and up €51 million sequentially. Reflecting continued durable growth of Yorvipath globally, consistent profitable development of Skytrofa, and continued growth of Yuvivel in The US since its launch in Q2 this year.

Yorvipath revenue was €291 million in Q3 up EUR 39 million from Q2 reflecting consistent new patient demand, trends, and metrics in The U. S. And continued consistent growth outside of The U. S. In growth disorders, Skytrofa performance was steady with revenue of €59 million in Q3 up €4 million sequentially. Yuvivel revenue in Q3 was €16 million doubling from €8 million in Q2 its first quarter on the market in The U. S, reflecting steady new patient demand, and high approval rates. Turning to expenses. Operating expenses fell to €217 million in Q3 down €32 million from €249 million in Q2, primarily driven by lower litigation costs and timing of commercial initiatives.

Reported operating profit was €125 million in Q3, Non-IFRS operating profit was €156 million. Reflecting a margin of 42%. Refer to our press release for more details. cash flow from operating activities was €189 million in Q3, And for full year 2026, we now expect cash flow from operating activities of at least €600 million We ended Q3 26 with €964 million in cash. An increase of €152 million from the end of Q2 primarily reflecting operating cash flow partially offset by €52 million of treasury share purchases. Subsequent to September 30 through November 11, 2026. We spent an additional $273 million repurchasing 1.2 million ordinary shares of Ascendis.

Year to date total we have repurchased a total of 2 million shares for approximately $460 million. Turning to our outlook for the fourth quarter of 26. Yorvipath, we expect growth and performance consistent with prior quarters in The U. S and outside The U. S. For Skytrofa, we expect relatively stable revenue in The US. For Yuvivel, we expect demand growth and approval trends to continue in The US. In addition to these drivers, we expect additional growth to come from continued global commercial expansion of Yorvipath and availability of Yuvivel in select international markets. As well as launches in the EU.

Longer term, we expect label expansion activities across our existing portfolio and investments in our new TransCon product pipeline, to drive launch of new indications, new major markets, or new products each year. Reflecting our solid foundation for achieving our revenue goal of more than €5 billion in 2030 and €10 billion in 2035. With that, operator, we are now ready to take questions.

Operator: Thank you. To withdraw your question, please press *11 again. And we ask you to please limit to 1 question and please return to the queue for any additional questions. And our first question today is going to come from Jessica Fye with JPMorgan. Your line is now open.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. You mentioned ambitions for multiple new blockbuster products and a new therapeutic area. So when could we expect to learn more about that new therapeutic area might be? Are the new blockbusters you alluded to within endocrinology, or in the new area? Thanks.

Jan Moller Mikkelsen: Thanks, Jessica. You know, we have a really, really strong focus on building unbelievable sustainability of Ascendis Pharma. And when we look on the 2 fundamental element we have in our vision 2030, is to drive revenue, which clearly we are doing extremely well. The other 1 is to focus on building sustainability in it. And what we are accepting is that, yes, we can continue to make a few major blockbusters inside rare endocrine diseases. But we are also into a situation where we are feeling now we are occupied to take up a new therapeutic area.

The therapeutic area will be built with a foundation for at least 2 to 3 new product in a pipeline as we did in rare disease endocrine. This is the only way we believe we can have the responsibility to really have synergies have economy of scale, or really can build up an internal commercial organization to support such a new therapeutic area. We will believe that the majority of these new products will be done by internal development, but we also extremely open when we see a new therapeutic area that we potentially will in licensing 1 or 2 product that can basic work in synergy with the internal development of that.

And when do you want to get that knowledge? It will come in the coming year. We feel really, the key element for us. We are not discussing so much of our early stage. We feel that from a the element of what we see with the transcript CNP where we went out too early to discuss it. We got the consequence of that. So from that perspective, we keep it much, much longer to us. And we also believe that it is less material for us out from the way when we see how we develop in the product. Revenue perspective.

But there is no doubt we have which we already started this year, to develop at least 1 new product every year that is built on a new chemical entity. Thank you.

Operator: And the next question will come from Tazeen Ahmad with Bank of America. Your line is open.

Tazeen Ahmad: Hi guys, good morning. Thanks for taking my question. A quick 1 for you again and then a follow-up on a bigger picture. Are you still trending at about 1 thousand script per quarter for Yorvipath? And then secondly, on operating cash flow, you have given us an increase in guide for that for this year. Can you talk about longer term, how we should be thinking about the importance of that number and the rate of increase next year and beyond? Thanks.

Jan Moller Mikkelsen: Thanks a lot, Tazeen. What we did with Yorvipath is basically the way we also will do it with Yuvivel. When we came out with Yorvipath, we gave you unique prescription quarter by quarter in The US and give you some kind of algorithm for ex US. And when we felt that we have done that in a sufficient number of quarters where we basically are moving over to what I call the results of everything, revenue, we will stop to give basic unique new enrollment every quarter. We felt that when we have perhaps 4 to 5 quarters of perhaps shorter, perhaps longer, depending on how things go.

Then we will be in a position that you can really develop a model really solid on the revenue numbers how we are progressing in the future. At that time, we will stop to give unique prescription number for Yuvivel.

Operator: And the next question will come from Gavin Clark-Gartner with Evercore. Your line is open.

Gavin Clark-Gartner: Hey, guys. Great quarter. Just on Yorvipath. So the press release noted ex US really strong new patient demand. Just wanted to clarify. Are you saying there that the XUS revenue is accelerating or increasing from the trends that you are seeing before. And on The US side for Yorvipath, were there any other trends to call out this quarter? Just kinda like a change in continuation rates over time, anything on channel inventory or anything else to call out there?

Jan Moller Mikkelsen: I think what I would give just a little bit more, a big picture about how we see the world and then we can go down to the more concrete definition. And I think both Scott and Jay will like to add into at that time. So when I see the world, and I would like to make it a little bit simplified, I take just the U.S. and then I take ex-U.S. Even ex-U.S. is a big box of many boxes and different way to do it. And then US have a pretty fast penetration when we think about the U.S.

It looks extremely stable as you have seen it, quarter by quarter when we are referring to the element of unique new enrollment. And nothing has changed to what we have said before. We always expect to get more than 1 thousand new patient every quarter. So that can give you a simple modeling in it. When we come to ex US, we need to accept that it is built on many, many different boxes. Part of that is Europe where we got an approval with EMEA, and we are now building 1 country by other country. to be fully reimbursed.

Many of these countries today basic the vast majority of ex US are built on named patient program and early access programs. They are fine but they are not like a full commercial thing. So ex US is much, much, much slower than the U.S. and you build it gradually, and you take a box by box by box. But in the end, if you have enough 50 boxes, you really have a tall house in the end. And this is what we are doing in the ex US. And you can hear what we said 13 countries more or less fully commercial. 2 of them just came in the last month. I can give you the name.

It was basically Switzerland and Norway. So 2 more coming. Next year, we released at least 15 new will come in. And when this country get fully commercial, you start to accelerate But it is slow in the beginning, but it comes. This is why when we look on our progression and peak, the 5 billion in 2030, is not really the peak sale of our current product opportunity. Even in the existing indication because it takes much longer basically, to hit peak sales in this way. Jay, Scott, do you have anything to add?

Operator: Go ahead, Scott.

Scott T. Smith: I would just say from my side, nothing to add.

Jay Donovan Wu: And on my end, I was just going to reaffirm Jan's narrative around continued momentum in The US. Right? So no trend break. We are still incredibly encouraged by what we are seeing. When you think about what Jan had shared in his opening remarks in that there is still ample opportunity The U. S. As you think about the number of patients that have not yet been exposed to Yorvipath but could potentially benefit from it, we are seeing that continued steady uptake in those patients that historically have not experienced Yorvipath before.

And then across all metrics, when we look at both adoption rate, field execution, whether it is breadth or depth, again, we are seeing that continued stability and momentum that you would hope and expect for a market that is continuing to grow?

Jan Moller Mikkelsen: Thanks, Jay. And, do not forget there is still new patient coming in every year. 3 thousand to 4 thousand new patient every year. And I believe when Yorvipath will be really taken up as an established treatment, when you get the diagnosis of chronic hypoparathyroidism. I believe a much, much, much larger portion of these 3 thousand or 4 thousand patients will basically take it very, very natural. To immediately start on the pTH replacement therapy with Yorvipath. Great. Thanks, guys.

Operator: Thank you. And the next question comes from Yaron Werber with TD Securities. Your line is open.

Yaron Werber: Great. Thanks so much. Maybe I just a couple of questions. 1 for Scott. I think you announced a $400 million share buyback in September, and you know, from, from the calculation, I think you have you have, I essentially bought back $273 million just this quarter. Just so how much is left now, for you to deploy? And then secondly, on Yuvivel, I think BioMarin is saying that they are seeing now a share loss of sort of, you know, 5% more recently kind of ongoing losses.

And it sounds like you have done about 60 PFSs in each of the last 2 months of the quarter, let's call it August September, is that sort of a good run rate to consider for Q4 and onwards? Thank you.

Jan Moller Mikkelsen: Let me take the last question. I do not think we have the capability to understand BioMarin's numbers And so I will ask you to refer this question to BioMarin directly. We know how many new patient we are getting every weeks. So I think that is the key element for us.

Scott T. Smith: Scott will take the first question. Yeah. Yaron, on the, we spent about $330 million out of the $400 million that we announced in the current program. We also. In the total, we had a program at the beginning of the year. And, of course, you know, there is potentially additional programs coming. But total about $330 million out of the $400 million so far.

Jan Moller Mikkelsen: So we have done what we said we want to do. I think we have bought back around 2 million shares now. So that is a really sustainable part of the share just this year. And, you know, when we look forward, we will have ample free cash flow the coming year I am not saying we can buy back all the shares, but at least we can buy a sustainable amount of Thank you.

Operator: And the next question will come from Joe Schwartz with Leerink Partners. Your line is open.

Joe Schwartz: highlighting, thanks. You talk about Yorvipath's progress penetrating the different sub populations of patients you outlined at the launch, those who are uncontrolled, partially controlled, controlled. And is that still the right way to. For us to best understand how you can continue to generate at least 1 thousand new patient enrollments each quarter. Thanks.

Jan Moller Mikkelsen: Thanks, Joe. I. Let me go back and give you a little bit of a perspective how we see the fragmentation of the hypoparathyroidism patients. First of all, there is no medical definition of mild moderate, or severe. Of hypoparathyroidism. it is like being pregnant. You are pregnant or not. The same as hypoparrow. You have hypoparathyroidism or not. Then you can say the burden of disease for the society, for the patient, can be variable. And this is where you can say, when we, for example, make health economic calculation in some countries, We basically are defining patient groups there is a huge burden for them, and they are taken up as the preferred treatment staff in this way.

When we look at the clinical data, we have generated, that is not 1 single patient group that we not see major benefit of being on Yorvipath. Treatment. So when you take it from a clinical perspective, I would say basic nearly everyone should be on treatment with Yorvipath. So I am not feeling that this then you can talk about some patient group are much more already motivated to it. And I think Jay can give a really great away how we activating different patient groups, but it is not up from the perspective that is more or less a treatment benefit because all of them would see a major treatment benefit.

Jay Donovan Wu: Yeah. And thank you for opening that, commentary. In addition to severity, what I would say is we also think about patient segmentation in the etiology of the disease. And we also see that whether it is a genetic driver or whether it is a postsurgical. And again, we see consistent uptake across all groups in that regard. As Yan mentioned before, because severity is not a clinically defined definition from a quantitative and claims based perspective, that is not something that we would be able to track quantitatively in a reliable and meaningful way. But when you look at the underlying fundamentals, this is where we do feel incredibly encouraged.

I mentioned earlier, we are still seeing strong metrics across the board. So, for example, we have added another 300 prescribers, new prescribers in just the last quarter alone, which shows you that despite the fact that the space is incredibly diffuse, we are still seeing additional traction around physicians' prescribing for the first time. For existing physicians that had prescribed in an earlier cohort, we are also seeing them prescribe a greater number of patients So the depth of prescription has also been increasing. Which, again, reaffirms perhaps what your hypothesis was in the original question, which is are we also seeing uptake in additional types of patients And from that lens, we do see that the breadth of.

And the depth specifically of the patient types is also increasing. And then lastly, when you think about how we are continuing to shape this market, it is a large market in The US. About 70 thousand to 90 thousand patients. So we know that a lot of our efforts need to be not just about educating physicians, but about educating patients. Since sometimes and often the limiting factor is a patient themselves may not have established care or have not gone in to see their endocrinologist recently.

So we have been investing quite a bit in both digital efforts education, and awareness campaigns in addition to supporting patients throughout the journey especially as they are seeking to understand, to learn more about the therapy itself.

Jan Moller Mikkelsen: Thanks for all the color. But, Joe, just to follow-up on it, you can say when we made the initial way to look on patient, it was not from a clinical perspective. It was a way how we define and how often they are seeing an endo. Because we wanted to be quite sure that the barrier for a patient to see an endo will not be a barrier for being prescription. So we will focus on the areas where we know there was patient coming already in predefined time frame to see an endo.

And for us, what we started in the beginning where we call uncontrolled patient if you see the endo perhaps 4 times a year or something like that. What Jay is doing now, whether he is already amazing efforts in, for example, direct-to-consumer TV campaigns and other thing is he building up that now we start to understand I need to go to the doctor because I really have the symptoms of having this.

And this is why we, for example, have taken the group that we call control, which was nearly half of them, because they are only seeing, perhaps, an endo every second year They are starting now to go to an endo, and therefore, they have the possibility to come in treatment. So you can see what Jay is doing. he is basically following up on the same way we were thinking when we started the launch. And this is likely why it is so successful, and we see this constant flow every quarter.

Operator: Thank you. And our next question is going to come from Derek Archila with Wells Fargo. Your line is now open.

an: highlighting. This is Simona on for Derek. Thanks for taking our question. I had a question on the operating leverage. So as the Yorvipath launch scales, how should we think about the cadence and key drivers of operating margin expansion into 2027? Where should the greatest leverage come from? And how much continued investment should we expect behind the commercial infrastructure?

Jan Moller Mikkelsen: I think this is such a complicated question that it need to go to Scott.

Scott T. Smith: Yeah. I mean, I think that you have obviously seen pretty dramatic in the operating margin in the last 3 quarters. So, at mid- to low-40s is pretty good. I think that part of what you are asking for requires us to give the 2027 outlook, which I think, potentially, we come with that, early in 2027. But for the time being, I would refer to my prepared remarks on the development of the 3 products with the 3 indications as well as near term launches. And then maybe, you know, maybe, if there is other comments to add, but I think that our commercial infrastructure is fairly well built.

I do not know, Jay, if you want to comment more on that. But I do not see I do not see large developments in our commercial SG&A infrastructure. And at the same time, investing as much as we are in R&D for the near term, it will probably be not a large amount of euro that we are putting in place.

Jay Donovan Wu: I agree with that, Scott. From a commercial infrastructure standpoint, we have largely built out to the scale that we need to sustain what we believe will fuel future growth for our products, both in The US as well as I think we are in the right ballpark outside We do envision that we will continue to have investment outside of the U.S., as Jan had mentioned in his prepared remarks as well. But I think we are in the right ballpark.

Operator: Thank you. And our next question is going to come from Li Watsek with Cantor Fitzgerald. Your line is open.

Li Watsek: Hey, guys. Congrats on the quarter Maybe just 1 on Yuvivel. Looks like you have got pretty strong demand in The US. I wonder if you can just comment on the potential impact from the oral drug coming to the market next year. And what do you hope to accomplish with your recent citizen petition letter?

Operator: I think there were multiple question into your question in this way.

Jan Moller Mikkelsen: The way we have developed Yuvivel on our TransCon CNP, we have built it on different stages. Stage 1 is the monotherapy where we have now approved Yuvivel in The US. We have a positive opinion and 10 years positive opinion for also exclusivity in Europe. We see how it is penetrating US. With a speed that really talk about how it is really being defined as an improvement to existing therapy in this way.

We are in a position that this is stage 1 because when we look on the combination therapy that is coming now afterwards, we actually see that we are in a position we can have such an integrated treatment regime that we can complete a void or surgery procedure for a patient and basic generate and treatment regime really addressing all of the major comorbidities. This has been our vision. This has been our aspiration to have such a strong integrated packet combined with the mono and the dual therapy that we really can provide to the patient to the physician, to the society, a treatment regime where you address all the established comorbidity that you are seeing today.

Any new treatment needs to show the same thing. First of all, it needs to show the safety. And what we have seen with all the years and I will not say I do not know how many patient-years have been treated with CNP therapy. It really have proven to be 1 of the most safest treatment we ever have seen, That is really being recognized by physician patient, and other element. And the way we are providing in giving CNP therapy with our sustained release have really shown complete new improvement that has not been seen with the short acting CMPs. And that is what you need to do.

And from that perspective, you can say that it is not only about efficacy, that you need to have the integrated packet to, but you also need to show the safety in all aspect living up because safety is the key element in any pharmaceutical development and specific when you come to a growing child. There are so many processes throughout the body that need to be matured in the right manner. And this is where there is so much literature that working with unspecific tyrosine kinases have shown on unexpected side effects in preclinical models And we feel obligated to live up to our values about safety first for the patients.

And from that perspective, we are not asking any product to be stopped. We believe in choices for patients, but we are asking to be sure that it is going to the right safety perspective in it. And that is the only thing we are asking for. And I feel everyone should do that. You should do it. Everyone should do it. Everyone should do because we are here to benefit the patient and the society and everyone. Thank you.

Operator: And our next question will come from Yun Zhong with Wedbush. Your line is open.

Yun Zhong: highlighting, good morning. Thank you very much for taking the question. And this is actually related to your comments to the previous question. So, for combo therapies for achondroplasia, I believe you said before that you do not expect the treatment option to be chronic 1 for patients. So just curious what do you see as the potential impact on the revenue growth? Is it mainly for patients that are already on monotherapy or potentially can drive new patient adoption.

And on the revenue, so ex US versus US, do you expect the same pattern as Voxzogo that eventually majority of the revenue will be coming from ex US and so at what point do you expect that change to happen? Thank you very much.

Jan Moller Mikkelsen: Okay. The question is about how do we really as I understood you right, the combination therapy, how do we see that into the fundamental of the therapy we have with Yuvivel. No doubt, Yuvivel is the fundamental CMP therapy. What we have seen with the combination and dual therapy by adding in growth hormone, You basically are boosting the effect 3 to 4 effects in effect size. Meaning is that if you just look at linear growth, you are basically getting in 1 year the basic element of 3 to 4 years monotherapy treatment in it. And I believe that is a really unique opportunity for any child to reach a new level.

But what it is also doing is unlocking new biology where we see much less effect, for example, on arm span. I have just taken 1 thing, arm span on monotherapy. But when we combined it basic in the element of a dual therapy with growth hormone, We see that you are in a position that you are getting such a growth that you basically can avoid. Arm lengthening procedure because it is growing to a completely different level, which you need and cannot achieve with monotherapy.

So therefore, the combination of these 2, where you have a paracrine system with CMP, overcoming the active FGFR3 receptor, you basic unlock a complete new biology treatment with a growth stimulation effect by growth hormone. And I believe this is a paradigm shift that is totally taken up to a completely new bar. And you asked me a question, how do we see it? Because when you look on vosoritide, it has a very unnatural way to have revenue recognition from you can say, a typical rare disease product, because it is recognized about 75% of ex US compared to 25 percent in.

Typical USA will be 60/40 or 50/50 or 60/40 with perhaps the most normal, where 60% will come from US. And so when I see it, what is really the missing fact Missing factor is US. People saying, this product is doing exactly well ex US. I have a complete different view. it is doing horribly in the U.S. And why did it not do well? Really good in The US? Because there was not really going in and providing the benefits to the patients. What they really wanted to have They wanted to see that you can address comorbidities. And that is what we are focused on.

We accept that we will provide length but we also know that what we really are focused and really addressing which are really appealing for everyone. If you can avoid a child to go to years of operations—leg bones, other things like that. Then Everyone Can Say It Makes Sense To Be On Treatment. So what I expect to see is I expect That We Will See The Same Great Penetration Ex US, We Will Take Over The Market Exactly As We Do In US. And we will see a much larger growth inside The US. Thank you.

Operator: And our next question will come from Faisal Khurshid with Jefferies. Your line is open.

Faisal Khurshid: Hey, guys. Thank you for taking the question. Congratulations on starting the COAST Phase 3 combination study. I just want to ask 1 quick detailed question on the trial design. So could you explain why there is a monotherapy growth hormone arm in the study and also, like, how you are thinking about sort of the potential for long duration of benefit for the combination. Thank you.

Jan Moller Mikkelsen: Yeah. The question is referring to, why, we redesigned our phase 3 trial, and I am totally honest. Yes. We redesigned it because we got strong regulatory feedback. And we do not want to run a phase 3 trial without being successful and get it approved in the end. And from The US, there was a strong ask to live up to what we call the roots of combination. And that is meaning you need to evaluate the contribution of each single element in a combination trial And this is why we built in an independent arm that only are providing the transcon growth hormone. And that was why it started with 3 active arms, instead of 2 active arms.

So to sum up, you have a TransCon CNP active arm, You have a TransCon growth hormone active arm. And then you have a combination of dual therapy arm. And all of them are randomized and all of them are aligned in a mathematic way how to. We really can show improvement compared to each single arm. And it was why the trial exactly got enlarged. Also got delayed a few months. Got it. Thank you.

Operator: Thank you. And the next question will come from Colpitt Kapital with Wolfe Research. Your line is open.

an: Hey. This is Gagan on for Colpitt. Thanks for taking the question. Curious about what impact you expect the existing and new DTC campaigns in 2027 to make. And if there are also DTC campaigns going on in. Or planned in Europe. I know you mentioned there is no medical definition of severity, But as a result of these efforts, are you seeing any shifts in patient mix with respect to disease severity? Thanks.

Jan Moller Mikkelsen: Yeah. I think just. I would take only 1 part of that question is in disease severity. There is no definition or disease severity from medical terms. We define something like controlled or uncontrolled, but it was mainly defined out for how often they will see an endo. That is not in any guidelines or any place element that define the severity of the disease. This way. Jay will explain how he is throwing out all the different campaigns and. But the element is that is where there are few countries. I actually think there is only 2 countries in the world where you can make direct to CV campaigns. And, 1 of them are, US.

Jay Donovan Wu: Yeah. that is right. So in The US, specifically, we are seeing initial encouraging signs that the educational and advertisement campaigns that we have been making have been reaching, the right communities in order for them to be able to learn more about the product and then ultimately actually initiate conversations with their endocrinologist. As an example, we have seen an uptick in the number of patients or prospective patients leveraging find-a-provider tools, and then next we have also heard a number of patients that have come through the funnel cite some of the educational campaigns, as the first time that they actually saw something that mirrored what they were experiencing that actually inspired them to go see an endocrinologist.

So while a lot of that information is anecdotal to start, what is typical with some of these campaigns is that it does take multiple impressions, for them to be inspired some kind of change in action or behavior So a lot of that deeper, more quantitative analysis, it will take some time to be able to get a better view for what that full picture looks like. As Yan had mentioned before as well around patient severity, because this is not a clinical definition that can be traced back to something quantitative in claims.

What we are resting on is mostly qualitative insights And, again, based on what we said before, both in terms of the depth of prescribing, which is increasing at a physician level, which suggests that there prescribing to a broader base of patients that they are seeing, coupled with qualitatively, we do hear patients, again, historically not connect symptom to disease but are now doing so. Both of those things in tandem suggest that we are fundamentally shaping, the types of patients that come in even if it is not a clinically defined type of patient.

Jan Moller Mikkelsen: Great. Thanks.

Operator: Thank you. And our last question will come from Maxwell Skor with Morgan Stanley. Your line is open.

Maxwell Skor: Thank you very much for taking my question. So just on hypochondroplasia, how are you thinking about the size of the diagnosed treatable population relative to achondroplasia? And where do you see TransCon CNP fitting into the treatment landscape as it evolves? Thank you.

Jan Moller Mikkelsen: Interesting question. Because, with genetic testing, you are still redefining patients that, for example, often were qualified into ISS idiopathic short stature if you did not have a clear phenotype you can say, a phenotype that got associated with the hyperactive FGFR3 receptor system. And today, when we defined it, we likely are defining from genetic testing where people would always need to have genetic testing. But also at the same time have phenotypical effect on it. So we have trials going on in ISS which is pretty successful in this way, and we see growth hormone as really the fundamental treatment in the ISS population.

But if we go over to hypochondroplasia, there should be a well-defined mutation in the FGFR3 receptor, and it should be localized such a way that it also have so huge impact that it provide a phenotypic effect on it. So you could say we use a little bit more of a narrow definition of hypochondroplasia, but it is also related to the reimbursement system that exists in many countries where if you want to utilize a more costly therapy, you also need to justify it to the clinical benefit you get to the therapy. Thank you.

Operator: Thank you. And this is all the time that we have for questions today. We would like to. This will also conclude today's conference call. We would like to thank you for joining. And now you may disconnect. Thank you.

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