Q4 2025 Ascendis Pharma A/S Earnings Call

February 11, 2026

Chad Fugere: Thank you for standing by, and welcome to the Ascendis Pharma Q4 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star one one on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star one one again. We ask that you please limit yourself to one question. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Chad Fugere, Vice President, Investor Relations. Please go ahead, sir.

Operator: Thank you for standing by, and welcome to the Ascendis Pharma Q4 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star one one on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star one one again. We ask that you please limit yourself to one question. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Chad Fugere, Vice President, Investor Relations. Please go ahead, sir.

Speaker #1: Thank you for standing by, and welcome to the Ascendis Pharma Fourth Quarter 2020 Earnings Conference Call. At this time, all participants are in listen-only mode.

Speaker #1: After the speaker's presentation , there will be a question and answer session . To ask a question during this session , you'll need to press star one one on your telephone .

Speaker #1: If your question has been answered and you'd like to remove yourself from the queue, simply press star one one again. We ask that you please limit yourself to one question.

Speaker #1: As a reminder , today's program is being recorded . And now I'd like to introduce your host for today's program , Chad Fugure Vice President , Investor Relations .

Chad Fugere: Thank you, Operator, and thank you everyone for joining our Full Year 2025 Financial Results Conference Call. I'm Chad Fugere, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; Jay Wu, Executive Vice President and President, Ascendis US; and Aimee Shu, 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.

Speaker #1: Go ahead, please, sir.

Speaker #2: Thank you . Operator . And thank you , everyone , for joining our full year 2020 . Financial results conference call . I'm Chad Fugure Vice President , Investor Relations at Ascendis Pharma .

Speaker #2: Joining me on the call today are Jan Mikkelsen President and Chief Scott to will conference call . Securities provided by the , J .

Chad Fugere: Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA and YORVIPATH, as well as certain expectations regarding patient access and financial outcomes, our pipeline candidates, and our expectations with respect to their continued progress and potential commercialization, our strategic plans, partnerships, and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing 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.

Speaker #2: forward looking Private Litigation Before that this president , officer Hsu , Financial Glass , Reform statements that I'd like contain executive vice Sherry harbor , the we covered under medical Act .

Speaker #2: Examples of such statements may include , but are not limited to , statements regarding our commercialization and continued development of Skytrofa and your path , certain expectations regarding patient access and financial outcomes .

Speaker #2: Our pipeline candidates and our expectations with respect to continued their progress and potential commercialization . Our strategic plans , partnerships and investments , our goals regarding our clinical pipeline , including the timing clinical of results and trials , are ongoing and planned .

Speaker #2: 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.

Speaker #2: 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 .

Chad Fugere: For additional information concerning the factors that could cause actual results to differ materially, please see our forward-looking statement 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 11 February 2026. 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 to the treatment of pediatric growth hormone deficiency. And in the EU, has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency.

Speaker #2: For additional information concerning the factors that could cause actual results to differ materially , please see our forward looking statements section . In press today's release and the risk Factors section of our most recent annual Report on form 20 F filed with the SEC on February 11th , 2026 .

Speaker #2: TransCon Growth Hormone, or TransCon HGH, is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Speaker #2: In addition to the treatment of pediatric growth hormone deficiency and in the EU has received Ma authorization from the European Commission for the treatment of Pediatric hormone growth deficiency .

Chad Fugere: 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 Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agencies. 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 full year 2025 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for your questions. With that, let me turn the call over to Jan.

Speaker #2: TransCon PTH is approved in the US by the FDA for the treatment of hypoparathyroidism in adults in the European Commission and the United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorisation for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism .

Speaker #2: 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 agencies.

Speaker #2: 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 full-year financial results for 2020 and will provide further business updates following some prepared remarks.

Speaker #2: We'll then open up the call for your questions . With that , let me turn the call over to Jen .

Jan Møller Mikkelsen: Thanks, Chad. Good afternoon, everyone. With strong execution across our business and continued progress toward delivering on our Vision 2030, Ascendis is transforming into a leading global biopharma company. We believe this progression demonstrates the power of our TransCon platform and our R&D capabilities to deliver a sustainable pipeline. While our global commercial infrastructure and financial profile continue to strengthen, we believe we are now at the base of a steep growth curve, where we expect to achieve operating cash flow of around EUR 500 million in 2026, and where we aspire to achieve at least EUR 5 billion in annual product revenue by 2030. At the same time, we are building an expanded pipeline of blockbuster product opportunities. In Q4, we saw multiple achievements across the organization.

Speaker #3: Thanks , Jed . Good afternoon everyone . With strong execution across our business and continue progress to ward delivering on our vision 2030 .

Speaker #3: Ascendis is transforming into a leading global biopharma company . We believe this progression demonstrates the power of our transcon platform and our R&D capabilities to deliver a sustainable pipeline .

Speaker #3: While our global commercial infrastructure and financial profile continue to strengthen, we believe we are now at the base of a steep growth curve, where we expect to achieve operating cash flow of around €500 million in 2026, and where we aspire to achieve at least €5 billion in annual product revenue by 2030.

Speaker #3: And at the same time , we are building an expanded pipeline of blockbuster product opportunities . In the fourth quarter , we saw multiple achievements across the organization , starting with your pants , the fourth quarter was another period of strong execution for the global launch of your pets .

Jan Møller Mikkelsen: Starting with YORVIPATH, the Q4 was another period of strong execution for the global launch of YORVIPATH. Revenue for the quarter was EUR 187 million, bringing full-year 2025 YORVIPATH revenue to EUR 477 million. In the US, access continued to expand. Through year-end, more than 5,300 patients were prescribed YORVIPATH by nearly 2,400 unique healthcare providers, highlighting continued strong and steady demand. To date, less than 5% of US patients are currently on YORVIPATH treatment, highlighting the significant long-term growth opportunity ahead. The overall insurance approval rate is about 70% of the total enrollment, and we continue to see this figure moving higher over time. In addition, we continue to see a majority of approvals within eight weeks.

Speaker #3: Revenue for the quarter was €187 million , bringing full year €2,025 patch revenue to €477 million . In the US . Access continued to expand .

Speaker #3: Two year end more than 5300 patients were prescribed . Pets by nearly 2400 unique healthcare providers , highlighting continued strong and steady demand .

Speaker #3: To date , less than 5% of US patients are currently on your treatment , highlighting the significant long term growth opportunity ahead . The overall insurance approval rate is about 70% of total enrollment , and we continue to see this figure moving higher over time .

Jan Møller Mikkelsen: This provides a strong foundation for expected additional growth in 2026 and beyond, as more patients initiate YORVIPATH in line with treatment guidelines that support its use. Outside the US, we continue to reach more patients. As a reminder, YORVIPATH is now available commercially or through named patient programs in more than 30 countries. We have full commercial reimbursement in 4 countries in our Europe direct markets and 2 countries in our international markets. In Japan, our partner, Chugai, launched YORVIPATH commercially last November. In 2026, we expect full commercial launches in 10 additional new countries. We also advanced development activity to broaden YORVIPATH label in a number of areas. In the US, we are working to expand the range of doses through our Pathway Succeed trial, and globally, we continue to advance clinical trials to expand YORVIPATH to patients under the age of 18.

Speaker #3: In addition, we continue to see a majority of approvals within eight weeks. This provides a strong foundation for expected additional growth in 2026 and beyond.

Speaker #3: As more patients initiate your pets in line with treatment guidelines that support its use outside the US . We continue to reach more patients .

Speaker #3: As a reminder, your pet is now available commercially or through named patient programs in more than 30 countries. We have full commercial reimbursement in four countries in our Europe direct markets and two countries in our international markets.

Speaker #3: In Japan, our partner launched European commercially last November. In 2026, we expect full commercial launches in ten additional new countries.

Speaker #3: We also advanced development activity to broaden your has label in a number of areas . In the US , we are working to expand the range of doses to our pathway 60 trial and globally we continue to advance clinical trials to your pets to patients under the age of 18 .

Jan Møller Mikkelsen: Our work is progressing rapidly on once-weekly TransCon PTH for patients who have been titrated with daily YORVIPATH or conventional therapy and have achieved a stable daily dose for a well-defined period. Last month, at the annual J.P. Morgan Healthcare Conference, we shared preclinical data that support the target product profile for our once-weekly TransCon PTH candidate, matching the released PTH seen with daily YORVIPATH treatment over the entire week, thus providing a comparable efficacy and safety profile. Overall, we remain confident that YORVIPATH has the potential to be a durable, long-term growth driver for Ascendis globally. Turning now to growth disorder, comprising of our once-weekly growth hormone, SKYTROFA, or TransCon Growth Hormone, or once-weekly TransCon CNP. SKYTROFA delivered another solid quarter, with Q4 revenue of EUR 53 million, bringing full year SKYTROFA revenue to EUR 206 million.

Speaker #3: Our work is progressing rapidly on once weekly TransCon PTH eight for patients who have been titrated with daily Europe's of conventional therapy and have achieved a stable daily dose for a well-defined period .

Speaker #3: Last month . At the annual J.P. Morgan Healthcare Conference , we shared preclinical data that support the target product profile for once weekly TransCon PTH eight candidate , matching the released PDAs seen with daily Europe health treatment or the entire week .

Speaker #3: Thus providing a comparable efficacy and safety profile . Overall , we remain confident that your pet has the potential to be a doable long term growth driver for a globally .

Speaker #3: Turning now to growth disorder comprising of our once weekly growth hormone skytrofa or TransCon growth hormone , or once weekly TransCon CNP Skytrofa delivered another solid quarter with Q4 revenue of €53 million , bringing full year revenue to €206 million .

Jan Møller Mikkelsen: This performance reflects the strength and value of the brand. As a reminder, SKYTROFA is now approved in pediatric growth hormone deficiency in the US and adult growth hormone deficiency. Today, SKYTROFA has an overall market share of around 7% in the US. During Q4, we initiated our phase 3 basket trial evaluating TransCon Growth Hormone in additional established growth hormone indications, including ISS, SHOX deficiency, Turner syndrome, and SGA, which comprise up to half of the growth hormone market. Over the long term, these indications represent meaningful opportunity to expand the role of SKYTROFA as a treatment of choice in additional growth disorders. We also see an opportunity to potentially expand SKYTROFA's use to novel indications, where growth hormone has not previously been approved for use, such as achondroplasia in combination with TransCon CNP.

Speaker #3: This performance reflects the strength and value of their brand. As a reminder, Skytrofa is now approved in pediatric growth hormone deficiency in the US and adult growth hormone deficiency today.

Speaker #3: Skytrofa has an overall market share of around 7% in the US . During the fourth quarter , the initiated our phase three basket trial , evaluating TransCon growth hormone in additional established growth hormone indications , including ES shock deficiency , Turner syndrome and SDA , with compromise up to half of the growth market over the long term .

Speaker #3: This indication represent meaningful opportunity to expand the role of Skytrofa as a treatment of choice in additional growth disorder . We also see an opportunity to potentially expand Skytrofa use to novel indication where growth hormone has not previously previously been approved for use , such as achondroplasia .

Jan Møller Mikkelsen: TransCon CNP is expected to be the first and only once-weekly treatment for children with achondroplasia, providing the full linear growth outcome that can be achieved with monotherapies, addressing the overactive FGFR3 tyrosine kinase. In addition, in our pivotal trial, TransCon CNP achieved significant improvement in leg bowing compared to a placebo, increasing spine and canal dimension, and a similar safety and tolerability profile compared to placebo, with a very low rate of injection site reaction and no cases of symptomatic hypertension. In the US, our NDA for children with achondroplasia remains under review with a PDUFA date of February 28. In the EU, the MAA review is underway following our submission last October, with a regulatory decision expected in Q4 2023.

Speaker #3: In combination with TransCon CNP . TransCon CNP is expected to be the first and only once weekly treatment for children with achondroplasia , providing the full linear growth outcome that can be achieved with monotherapies addressing the overactive fgfr three tyrosine can kinase .

Speaker #3: In addition , in our pivotal trial , TransCon CNP significant in achieved leg bowing improvement compared to placebo . Increasing spinal column dimension and a similar safety and tolerability profile compared to placebo with a very low rate of injection site and reaction no of cases symptomatic hypertension in the US , our NDA for children with achondroplasia remains under review , with the date of February 28th .

Speaker #3: In the EU, the review is underway, following our submission last October, with a regulatory decision expected in the fourth quarter of 2026.

Jan Møller Mikkelsen: Recruitment of our ongoing trial in infants with achondroplasia 0 to 2 is going well, and we anticipate complete enrollment later this year. Turning to the combination therapy. Our 52-week COACH data in achondroplasia underscore the potential power of dual treatment with TransCon CNP and TransCon growth hormone, where continuous exposure to CNP enables the benefit of sustained exposure to unmodified growth hormone. In comparison, monotherapy trials of daily growth hormone in achondroplasia delivered only a limited effect on growth and no reported benefit beyond linear growth. Our 52-week data from the phase 2 combination trial support our vision to significantly raise the bar for treatment of achondroplasia, with linear growth improvements in achondroplasia's specific height score that were 3 to 4 times what has been shown with CNP or daily growth hormone monotherapies in the same time period.

Speaker #3: Recruitment of our ongoing trial in infants with achondroplasia, aged 0 to 2, is going well, and we anticipate complete enrollment later this year.

Speaker #3: Turning to the combination therapy , our 52 week data in achondroplasia underscore the potential power dual of treatment with TransCon CNP and TransCon growth hormone .

Speaker #3: We are continuous exposure to CNP enables the benefit of sustained exposure to unmodified growth hormone . In comparison , monotherapy trials of growth daily hormone in plasma delivered only a limited effect on growth and no reported benefit on linear growth .

Speaker #3: Our 52-week data from the phase two combination trial support our vision to significantly raise the bar for treatment of aplasia, with linear growth improvements in achondroplasia-specific height score that were three to four times what has been shown with CNP or daily growth hormone monotherapies in the same time period combination.

Speaker #3: Our 52 week data from the phase two combination trial support our vision to significantly raise the bar for treatment of aplasia with linear growth improvements in achondroplasia specific height score that were 3 to 4 times what has been shown with CNP or daily growth hormone monotherapies in the same time period combination addition , the trial In accelerated improvements in body proportionality and for the first time , a meaningful improvement in arm span has been reported without compromising safety or ability .

Jan Møller Mikkelsen: In addition, the combination trial demonstrated accelerated improvement in body proportionality, and for the first time, a meaningful improvement in arm span has been reported without compromising safety or tolerability. Importantly, this benefit beyond height are meaningful to the achondroplasia community and have been a core objective of our patient-focused development program in both our monotherapy and combination therapy programs. Importantly, all children completed 52 weeks of treatment and remain in the trial, reinforcing the benefit of treatment and acceptable treatment burden of the once-weekly regimen. These phase 2 results demonstrate the effect of these complementary therapies, supporting that TransCon CNP act in synergy with growth-promoting effect of TransCon growth hormone and has positive effect beyond linear growth.

Speaker #3: Importantly , this benefit beyond height are meaningful to the contemplated community and have been a core object of our patient focused development program in both our monotherapy and combination therapy programs .

Speaker #3: Importantly, all children completed 52 weeks of treatment and remain in the trial, reinforcing the benefit of treatment and the acceptable treatment burden of the once-weekly regimen.

Speaker #3: These phase two results demonstrate the effect of these complementary therapies supporting their TransCon CNP act in synergy with growth, the effect of TransCon promoting hormone, and has positive beyond effects on linear growth.

Jan Møller Mikkelsen: We believe over time, the standard care in achondroplasia and other growth disorders, long term, will include dual therapy as a treatment option, building on the potential role of TransCon CNP as an essential fundamental therapy. We recently held a successful end-of-phase 2 FDA meeting and scientific advice meeting in EU to align on our phase 3 trial for this novel combination approach for treating children with achondroplasia. We also remain on track for additional COACH trial updates, including week 78 by mid-year and week 104 by year-end, and plan to explore further opportunity in other growth disorders. To sustain durable long-term growth for Ascendis well into the next decade, we plan to continue to invest in label expansion of our current products in rare endocrine diseases.

Speaker #3: We believe, over time, the standard of care in Asia and other growth disorders, long term, will include dual therapy as a treatment option. Building on the role and potential of TransCon CNP as an essential fundamental therapy, we recently held a successful End-of-Phase 2 FDA meeting and a scientific advice meeting in the EU to align on our Phase 3 trial for this novel combination approach for treatment of children with achondroplasia.

Speaker #3: We also remain on track for additional trial updates , including week 78 . By mid-year and week 104 by year end , and plan to explore further opportunities in other growth disorders .

Speaker #3: To sustain durable long growth for Ascendis well into the next decade , we plan to continue to invest in label expansion of our current products in rare endocrine diseases .

Jan Møller Mikkelsen: In addition, we have a strong focus on the development of new blockbuster product opportunities, both inside and outside rare endocrine diseases, to, to fuel significant product revenue growth in the future. Looking at our partnerships, TransCon Technologies support a continuous flow of highly differentiated product opportunities across multiple therapeutic areas, more than we can develop and commercialize ourselves. For this reason, our Vision 2030 includes a focus on creating additional value through partnership and collaboration. Our collaboration with Novo Nordisk for once monthly TransCon semaglutide continue to advance towards the clinic. At Arcus, TransCon anti-VEGF is on track to enter the clinic this year. In Japan, Chugai Pharma received approval for Europe in August 2025, and commercial launched it in November 2025. In addition, recent approval of SKYTROFA in China in late January 2026. In summary, 2025 was another positive and transformative year for this.

Speaker #3: In addition , we have a strong focus on the development of new blockbuster product opportunities , both inside and outside . Rare endocrine diseases to to full significant product revenue growth in the future Looking at .

Speaker #3: Our partnerships, TransCon Technologies, support a continuous flow of highly differentiated product opportunities across multiple therapeutic areas—more than we can develop and commercialize ourselves.

Speaker #3: For this reason, our Vision 2030 includes a focus on creating additional value through partnership and collaboration. Our collaboration with Novo, for one, on monthly TransCon continues, and Semaglutide towards advancing the clean at our TransCon Anti-VEGF is on track to enter the clinic this year in Japan. Japan received approval for us on August 25th, and commercial launch is set for November 2025.

Speaker #3: In addition , recent approval of Skytrofa in China in late January 26th , in summary , 2025 was another positive and transformative year for changes , with two commercial TransCon products .

Jan Møller Mikkelsen: With two commercial TransCon products, continue to scale the potential approval of the third high-value TransCon product in the coming weeks and a growing pipeline of highly differentiated programs, we believe we have the fundamentals in place to deliver durable long-term growth. A rapidly strengthening financial profile keep us confident to achieve an expected operating cash flow of around EUR 500 million in 2026, and our aspiration to achieve at least EUR 5 billion in annual product revenue by 2030, all consistent with our Vision 2030 strategy. I will now turn the call over to Scott.

Speaker #3: Continue to scale the potential approval of the third high-value product in TransCon in the coming weeks, and a growing pipeline of highly differentiated programs.

Speaker #3: We believe we have the fundamentals in place to deliver long, durable term growth and a rapidly strengthening profile. This gives us the ability to achieve an expected operating cash flow of around €500 million in 2026, and our aspiration to achieve at least €5 billion in Adderall product revenue by 2030, all consistent with our Vision 2030 strategy.

Scott Smith: Thank you, Jan, and thank you, Chad, for a well-read FLS. The significant achievements we made in 2025 provide us with substantial financial strength to drive our strategic priorities and goals in 2026, which include achieve blockbuster status for YORVIPATH, solidify our leadership in hypoparathyroidism through rapid progress of our label, expanding clinical trials of TransCon PTH, while advancing development of our once-weekly PTH candidate. Successfully launch TransCon CNP, if approved in the US and other countries around the world, and expand our leadership and growth disorders through clinical and regulatory progress with once-weekly SKYTROFA, including in combination with once-weekly TransCon CNP. With that, I will touch on some key points surrounding our fourth quarter and full year financial results, which we mostly already announced at J.P. Morgan. But for further details, please refer to our annual report on Form 20-F filed today.

Speaker #3: I will now turn the call over to Scott .

Speaker #4: Thank you . Jan , and thank you , Chad , for well-read FLS . The significant achievements we made in 2025 provide us with substantial financial strength to drive our strategic priorities and goals in 2026 , which include achieve blockbuster status for Iowa Path , solidify our leadership and hyperparathyroidism through rapid progress of our label , expanding clinical trials of TransCon PTH while advancing development of our once weekly PTH candidate .

Speaker #4: Successfully launched TransCon CNP . If approved in the and other US countries around the world and expand our leadership and disorders growth through clinical and regulatory progress .

Speaker #4: once weekly With skytrofa , including in combination with once weekly TransCon CNP . With that , I will touch on some key points surrounding our fourth quarter and full year financial results , which we mostly already announced at JP Morgan .

Scott Smith: As previously announced in January, YORVIPATH delivered strong global performance in Q4 2025, with revenue increasing to EUR 187 million, up from EUR 140 million in Q3. Foreign currency had a negligible impact compared to the previous quarter. Total YORVIPATH revenue for 2025 was EUR 477 million. For the full year, the weaker US dollar negatively impacted YORVIPATH revenue by approximately EUR 27 million. SKYTROFA contributed EUR 53 million in Q4, with negligible foreign currency impact compared to Q3 2025. Total SKYTROFA revenue for 2025 was EUR 206 million. For the full year, the weaker US dollar negatively impacted SKYTROFA revenue by approximately EUR 9 million.

Speaker #4: But for further details , please refer to our annual Report on form 20 F filed today . As previously announced in January , Europe have delivered strong global performance in Q4 2025 , with revenue increasing to €187 million , up from €140 million in Q3 .

Speaker #4: Foreign currency had had a negligible impact compared to the previous quarter . Total revenue for 2025 was €477 million . dollar US full For the year , the negatively impacted revenue by your approximately €27 million .

Speaker #4: Skytrofa contributed €53 million in Q4 , with negligible foreign currency impact compared to Q3 25 total Skytrofa revenue for 2025 was €206 million .

Scott Smith: Including EUR 7 million in collaboration revenue, total Q4 2025 revenue amounted to EUR 248 million, and total revenue for full year 2025 was EUR 720 million. Continuing on to expenses. As previously announced, total operating expenses for Q4 were EUR 214 million, and total operating expenses for the full year 2025 were EUR 761 million, as we previously noted. Operating profit for Q4 2025 was EUR 10 million, with Q4 operating cash flow of EUR 73 million. As we have discussed for some time, below operating profit, the drivers include the non-cash accounting related to our convertible notes. Net finance expense, which was primarily driven by non-cash items, including remeasurement loss of financial liabilities of EUR 106 million, was EUR 93 million net.

Speaker #4: For the full year, the weaker US dollar negatively impacted Skytrofa revenue by approximately €9 million, including €7 million in collaboration revenue.

Speaker #4: Total Q4 2025 . Revenue amounted to €248 million , and total revenue for full year 2025 was €720 million , continuing on to expenses as previously previously announced , total operating expenses for Q4 were €214 million and total operating expenses for the full year 2025 were €761 million .

Speaker #4: As we previously noted , operating profit for Q4 was €10 million , 2025 with Q4 cash operating flow of €73 million . As we have for some discussed time below , operating profit , the drivers include the non-cash accounting related to our convertible notes , non net finance expense , which was primarily driven by non-cash items , including remeasurement loss of financial liabilities of €106 million was €93 million , net net cash financed financial expense .

Scott Smith: Net cash, financial expense, however, for the full year 2025 was about EUR 8 million. In future periods, we may introduce a non-IFRS EPS measure, adjusting for the impact of certain items to increase the comparability of period-to-period results. We ended 2025 with EUR 616 million in cash and cash equivalents, as previously reported, up from EUR 560 million as of 31 December 2024. Turning to our commercial outlook and to help inform your revenue modeling for the coming year. For YORVIPATH, we expect continued strong revenue growth in 2026, based on steady patient uptake, with some expected seasonality in reported revenue throughout the year. For SKYTROFA, we expect to follow a similar seasonal pattern to 2025, with full year revenue growth expected to track growth in prescriptions.

Speaker #4: However , for the full year , 2025 was about €8 million . In future periods we may introduce a non EPs measure adjusting for the impact of certain items to increase the comparability of period to period results .

Speaker #4: We ended 25 with €616 million in cash and cash equivalents . As previously reported , up from €560 million as of December 31st , to our 24 .

Speaker #4: We ended 25 with €616 million in cash and cash equivalents . As previously reported , up from €560 million as of December 31st , to our 24 . Turning outlook and to commercial help inform your revenue modeling for the coming for we Iowa , expect continued strong revenue growth in 2026 , based on steady patient uptake , with some expected seasonality in reported revenue throughout the year .

Speaker #4: For Skytrofa, we expect to follow a similar seasonal pattern to 2025, with full-year revenue growth expected to track growth in prescriptions longer term.

Scott Smith: Longer term, SKYTROFA revenue is expected to come through geographic and label expansion. As always, we continue to watch the euro/USD exchange rate for any potential impact. And finally, we also look forward to the potential US approval of TransCon CNP later this month, which, as a reminder, has been excluded from this 2026 outlook. With that, operator, we are now ready to take questions.

Speaker #4: Skytrofa revenue is expected to come through geographic and label expansion. As always, we continue to watch the Euro–US dollar exchange rate for any potential impact, and we...

Speaker #4: Finally , we also look forward to the potential US approval of TransCon CNP later this month , which , as a reminder , has been excluded from this 2026 outlook .

Jan Møller Mikkelsen: Certainly. Once again, ladies and gentlemen, we ask that you please limit yourself to one question each. Our first question comes from the line of Jess Fye from J.P. Morgan. Your question, please?

Operator: Certainly. Once again, ladies and gentlemen, we ask that you please limit yourself to one question each. Our first question comes from the line of Jess Fye from J.P. Morgan. Your question, please?

Speaker #4: With that, operator, we are now ready to take questions.

Speaker #1: Certainly . And once again , ladies and gentlemen , we ask that you please limit yourself to one question each . Our first question comes from the line of Jess Fine from JP .

Jess Fye: Hey guys, good afternoon. Thanks so much for taking my question. What's your confidence level heading into the TransCon CNP PDUFA? Are you comfortable that the issue leading to the review extension has been resolved to the FDA's satisfaction? Thank you.

Speaker #1: Your question please .

Speaker #5: guys . Good afternoon . Hey Thanks so much for taking my question . What's your confidence level heading into the TransCon CNP ? Are you comfortable that the issue leading to the review extension has been resolved to the FDA's satisfaction ?

Jan Møller Mikkelsen: Yes. Can you remember, you asked me a question one time at the JPM conference, and can you remember my answer?

Speaker #5: Thank you .

Speaker #3: can And yes , you remember you asked me a question one time . And the DFM conference . And can you remember my answer ?

Jess Fye: I do remember the answer.

Jan Møller Mikkelsen: What was your question? You can ask the same question.

Jess Fye: I remember your answer, but it was about a different product, if I recall. But your answer was yes.

Speaker #5: I do remember the answer .

Jess Fye: I remember your answer, but it was about a different product, if I recall. But your answer was yes.

Speaker #3: And your question? You can ask the same question.

Jan Møller Mikkelsen: Yes. So this is the same. You asked me, "Will TransCon PTH be approved?" And I said, "Yes." And you can ask me the same question today: Will TransCon CNP be approved? And I will say yes.

Speaker #5: I remember your answer, but it was about a different product, if I recall. But your answer was yes.

Speaker #3: Yes . So this is the same . You asked me , will TransCon PTH be approved ? And I said yes . And you the same me can ask Will today .

Jess Fye: Thank you.

Speaker #3: TransCon CNP will be approved? Yes, I say it will.

Chad Fugere: Thank you. And our next question comes from the line of Tazeen Ahmad from Bank of America. Your question, please.

Operator: Thank you. And our next question comes from the line of Tazeen Ahmad from Bank of America. Your question, please.

Speaker #5: Thank you .

Tazeen Ahmad: Hi, good afternoon. Thanks for taking my question. You mentioned a 70% insurance approval rate in the US so far for YORVIPATH. Where is that relative to where you thought it would be at this stage of the launch? And what is it going to take to expand that to a higher number? Where do you think- how long do you think it's gonna be before you get to 100%, basically? Thank you.

Speaker #1: Thank you. And our next question comes from the line of Tazeen Ahmad from Bank of America. Your question, please.

Speaker #6: Hi . Good afternoon . Thanks for taking my question . You mentioned a 70% insurance approval rate in the US so far for your path .

Speaker #6: Where is that relative to where you thought it would be at this stage of the launch? And what is it going to take to expand that to a higher number?

Jan Møller Mikkelsen: I think it would be infinity, because I've never seen a product hitting 100%. So I think the highest bar I have seen is something like an 85% or something like that, perhaps up to 90%. The element of where we are today, I'm really highly satisfied with it because it's also a compromise about how aggressive you're going into contracting and other things like that. So I think it's a balance between the two thing, where in the end, the overall and ultimate goal is basically to provide most value back to our shareholder and others in this way, and at the same time, help the patient to, as fast as possible, to come on treatment. I do not know, Jay, if you have additional comments to my, I would not say pre-prepared remark.

Speaker #6: Where do you think you are? How long do you think it's going to be before you get to 100%? Basically, thank you.

Speaker #3: I think it will be infinity because I never seen a product hitting 100% . So I think the highest bar I've ever seen is something like an 85% or something like that , perhaps up to 90 .

Speaker #3: The element of where we are today , I'm really highly with satisfied a compromise how , because about you're going into contracting like that .

Speaker #3: So, and other, I think it's a between balance, the two things where, in the end, the overall and ultimate goal is basically to provide the most value back to our shareholders and others in this way.

Speaker #3: And at the same time, help the patient to as fast as possible get on treatment. I do not know if you have additional comments to mine.

Jay Wu: Yeah, I would say two things. One is that we're very happy with the overall approval rate that we're seeing, and I think the speed in which you're seeing this product be covered, again, is a testament to the strong clinical value proposition that we're seeing in hypoparathyroidism. It is the first and only approved therapy in this category. So again, this approval rating, based on where we are today, is something that we are very encouraged by. I think to your second part of the question, Tazeen, which is, you know, when might you get to 100%? I echo what Jan said earlier as well, which is, I don't know that many drug analogues will get to 100%, and that actually has less to do with coverage.

Speaker #3: I will not say pre-prepared remarks.

Speaker #7: Yeah , I would say two things . One is that we're very happy with the overall approval rate that we're seeing , and I think the speed in which you're seeing this product be covered again is a testament to the strong clinical value proposition that we're seeing in hyperparathyroidism .

Speaker #7: It is the first and only approved therapy in this category . So again , this approval rating based on where we are I think encouraged we are by .

Speaker #7: today is very to your second part of question to which is the when might you get to 100% ? I echo what Jan said earlier as well , which is , I don't know that many drug analogs will get to 100% , and that actually has less to do with coverage .

Jay Wu: It also has to just do with every single enrollment that comes in, not every single one of them will be eligible relative to the label. So there's some element of just natural filtering that comes that way. But more importantly, what I would say is that there are state Medicaid plans, for example, that review things on a staggered cycle. So you will anticipate that some of this will creep up over time, but it will take some time before it continues to inch upwards.

Speaker #7: And it also has to do with every single enrollment that comes in; not every single one of them will be eligible relative to the label.

Speaker #7: So there are some element of just natural filtering that comes that way . But more importantly , what I would say is that there are state Medicaid plans , for example , that review things on a staggered cycle .

Jan Møller Mikkelsen: Yeah.

Speaker #7: So you will anticipate that some of this will creep up over time , but it will take some time before it continues to inch upwards .

Tazeen Ahmad: Okay.

Jan Møller Mikkelsen: But I think still, we need to somehow... This is a US discussion. The US discussion is built on 70% of all approvals in enrollment are there. So when you go in and look on an old cohort that perhaps has been six months through it, you actually will get a much higher number on it. Just as to clarify, the 70% on it, that is when you take everyone accumulated. If you take an old cohort, it's much higher. And when you go ex-US, the system is quite different. When you get a prescription, you in -- nearly in every other country, you are automatically approved. So you can say the 100%, yes, it's basic. When you get a prescription outside US, in traditional countries, you will be 100% eligible and already approved for reimbursement.

Speaker #3: Yeah , but but I think I think still we need to some way . This is a us discussion . The US discussion is built on 70% of all in approvals enrollment .

Speaker #3: Are there . So when you look go in old been it , had on cohort that and perhaps an your actual will get an much number on it .

Speaker #3: higher Justice to clarify , the 70% on it . That is , when you take everyone accumulated . If you take an old cohort , it's much higher .

Speaker #3: And when you go excuse the system is quite different . When you get a prescription , you in nearly in every other country you are at approved .

Speaker #3: So you can say the 100% 'yes' is basic. When you get a prescription outside the US, in traditional countries, you will be 100% electable and already approved for reimbursement.

Tazeen Ahmad: Got it. Thank you for the color.

Chad Fugere: Thank you. And our next question comes from the line of Gavin Clark-Mayfield from Evercore ISI. Your question, please.

Operator: Thank you. And our next question comes from the line of Gavin Clark-Mayfield from Evercore ISI. Your question, please.

Speaker #6: Got it. Thank you for the color.

Gavin Clark-Gartner: Hey, guys. Thanks for taking the question. Just on your YORVIPATH pricing, so there's an 8% WAC increase in January. Maybe you could just discuss how net pricing will trend this year, including how to kind of quantify the magnitude of the Q1 seasonality here.

Speaker #1: Thank you. And our next question comes from the line of Gavin Clark, Gartner from Evercore ISI. Your question, please.

Speaker #8: Hey guys, thanks for taking the question. Just on your pricing—so an 8% whack, there's an increase in... Maybe you could just discuss how net January...

Speaker #8: Pricing will vary year to year, kind of including how to quantify the magnitude of the Q1 seasonality here.

Jan Møller Mikkelsen: I don't think we really are discussing net prices. We will love to do it, but we are never done it, and I don't think we ever will discuss net prices.

Speaker #3: I don't think we really are discussing net prices. We would love to do it, but we have never done it. And I don't think we ever will discuss.

Gavin Clark-Gartner: Maybe if I could just ask a follow-up then.

Jan Møller Mikkelsen: Yeah.

Gavin Clark-Gartner: Just on patient enrollment, are you planning to still report those forms going forward for YORVIPATH, or maybe just focus more on revenue?

Speaker #3: Net prices .

Speaker #8: If I could just ask a follow-up, then, just on patient enrollment, are you planning to still report those forms going forward for your path?

Jan Møller Mikkelsen: I think in the end, Gavin, it's 100% right. We will focus on revenue, because now we basically have been in the market now in the US. We are on the market for about 4 quarters now. When we come to here, the fifth quarter, I think you have seen a steady state development from 25, where we basically got to be an increase in basic revenue from both US and ex-US, about EUR 40 to 50 million net every quarter. I think you will somehow see a stability in how we are executing in it. We still have ex-US. We will expect 10 additional countries being fully reimbursed next year, and sure that is always improving the, what we call the net revenue we will generate outside the US.

Speaker #8: Or maybe just focus more on revenue?

Speaker #3: I think in the in Kevin , is 100% right . We will focus on revenue because now we basically have been in the market now in the US , we're on the market for about four now .

Speaker #3: When we come to here , the fifth quarter , I think you have seen a steady state development from 25 where we basically an got both increase from in revenue and xu us about 40 to €50 million , net quarter .

Speaker #3: I think you every will somewhere see a stability in how we are executing in it . We still have us . We will expect ten additional countries being fully reimbursed next year , and sure , that is always improving the what we call the net revenue .

Chad Fugere: Thank you. And our next question comes from the line of Yaron Werber from TD Cowen. Your question, please.

Operator: Thank you. And our next question comes from the line of Yaron Werber from TD Cowen. Your question, please.

Speaker #3: We will generate outside the US.

Yaron Werber: Great, thanks so much. I have a sort of two, not really related, but I'm gonna try to link them to keep it as one question. Maybe the first one, can you give us a little bit of a sense for your YORVIPATH, how it's being used out there? I mean, it's almost like when you look at this 2,400 unique prescribers and 5,300 unique patient enrollments. So is it that each physician just has sort of one or two patients in the practice, or are they prescribing it sort of there, and then they're going deeper? And then secondly, just at the end of phase 2 meeting with FDA relating to CNP and growth hormone for achondroplasia, maybe just can you give us a little bit of an update?

Speaker #1: Thank you. And our next question comes from the line of Yaron Weber from TD Cowen. Your question, please.

Speaker #9: Great . Thanks so much . I have a sort of two not really related , but I'm going to try to link them to to keep it as one question .

Speaker #9: Maybe the first one. Can you give us a little bit of a sense for your V? How it's used being out there?

Speaker #9: I mean , it's almost like when you when you look at there's 2400 unique prescribers and , and 5300 unique patient enrollments . So is it that each physician just has sort of 1 or 2 patients in the practice , or are they prescribing it sort of there , and then they're going deeper .

Speaker #9: And then secondly , just the end of phase two meeting with FDA relating to CNP and growth hormone for achondroplasia , maybe just can you give us a little bit of an update ?

Yaron Werber: What was the outcome, and when will you start the phase 3? Thanks.

Jan Møller Mikkelsen: Okay, that's perfect. I think, Jay, you can give some about how we both expanding the physician prescriber thing base, but also go in more in the deep of the different patients, but still are far away to reach the level where we want to be. Jay?

Speaker #9: What was the outcome, and when will you start the phase three? Thanks.

Speaker #3: Okay . That's perfect . I think J you can give some about how we both expanding the physician prescriber thing base , but also go in more in the deep of the different But patient .

Jay Wu: Yep. So in the US, I think the question is really around segmentation and what types of patients are being treated. So if you think about the prescriber base, which is where you first started your question from, we are seeing broad uptake across the entire range of prescribers, right? So to your point, there are some physicians that might only see a couple patients, but there's also some physicians that might see upwards of 10 patients, right? So more importantly, because we are seeing broad uptake across both high decile and low decile providers, we're not seeing a major discrepancy as to the type of prescriber that would prescribe, but we are seeing that breadth continue to increase. As it relates to the number of patients per physician, we're also seeing the depth of prescribing per physician also increase over time, which again, is encouraging.

Speaker #3: We still are far away from reaching the level where we want to be.

Speaker #7: Yeah . So in the US , I think the question is really around segmentation and what types of patients are being treated . So if you think about the prescriber base , which is where you first started , your question from , we are seeing broad uptake across the entire range of your prescribers .

Speaker #7: So, to the point, there are—right—some physicians that only might see a couple patients, but there's also some physicians that might see upwards of ten patients.

Speaker #7: of Right ? So more importantly , because we are seeing broad uptake across both high decibel and low decile providers , we're not seeing a major discrepancy as to the type of prescriber that would prescribe , but we are seeing that breadth continue to increase as it relates to the patients per number of physician .

Jay Wu: That's both a testament to positive experience that they have with YORVIPATH, as well as increased awareness of the hypoparathyroidism condition, and now there being an option for it amongst patients. I think the last thing I would say is, when you think about the types of patients that come through, you can look at it in two ways, right? One, which is the vast majority of them are post-surgical, so about 70%. The remaining 30%, perhaps due to other factors, whether it's genetic, autoimmune, et cetera. We're seeing broad uptake across both of those segments, so that isn't a major driver.

Speaker #7: We're also seeing the depth of prescribing per physician also increase over time , which again , is encouraging . That's both a testament to positive experience that they have with your path as well as increased awareness of the hypoparathyroidism condition .

Speaker #7: they're And now being an option for it amongst patients . I think the last thing I would say is , when you think about the types of patients through , that come you can look at it in two ways , right ?

Speaker #7: One , which is . vast The majority of them are post-surgical . So about 70% the , remaining 30% , perhaps due to other factors , whether it's genetic , autoimmune , etc.

Jay Wu: I think really where you're seeing some of the earlier uptake is patients that are self-aware of the condition that they have, are linking the symptoms that they have to the underlying condition that they have, and therefore, a combination of them advocating for themselves, as well as providers having conviction in the product as well. So all in all, we're seeing broad uptake across provider groups as well as patient segments as well.

Speaker #7: . And we're seeing broad uptake both of across those segments so that isn't a major driver . And I think really where you're seeing some of the earlier uptake is patients that are self aware of the condition that they have are linking the symptoms that they have to the underlying condition that they have , and therefore a combination of them advocating for themselves as well as providers having conviction in the product as well .

Speaker #7: So all in all , we're seeing broad uptake provider across groups as well as patient segments as well .

Chad Fugere: Thank you. Our next question comes from the line-

Operator: Thank you. Our next question comes from the line-

Jan Møller Mikkelsen: Okay.

Chad Fugere: Joseph Schwartz.

Operator: Joseph Schwartz.

Jan Møller Mikkelsen: Before you start, perhaps I can answer the last part of the question related to the COACH trial. Yes, we had extremely positive meetings, both from US side and from the EU side. It was really impressive feedback to the, to the data. They have never seen data before that we've seen are providing this kind of benefit to an achondroplasia treatment, and I'm not only talking about the linear growth, where we, based on a Z-score, got a 3- to 4-fold more than you can see with monotherapies in the same time period, but also [there was a] unique element, like such an improvement in body proportionality. But what was really, what really I have never really seen in such a meaningful manner, was a really important element, the arm span, where we also saw in the combination trial a unique improvement in arm span.

Speaker #1: Thank you . And our next question comes from the line of Joseph Schwartz .

Speaker #3: Before you start , perhaps I can answer the last part of the question to related the coach trial . had Yes , we positive meeting extremely , both US from side the from EU and side .

Speaker #3: It was really impressive feedback . We got to the data that have never seen data before , that basic are providing this kind of benefit to an account treatment , and I'm not only talking about the linear growth , where we basic on a set score got 3 to 4 fold more that you can see with Monotherapies in the same time period , but also unique was element like such an improvement in body proportionality .

Speaker #3: But what was really what really . Have never really seen in such a meaningful manner was an really important element . The arm span , where we also saw in the combination trial and unique improvement in arm span and Amy sitting here besides me with doing , and to she's get this trial recruited as fast .

Jan Møller Mikkelsen: Amy is sitting here with the Teysman, and she's really doing everything to get this trial recruited as fast. We're ready to go, protocol is finished and everything. We open site. Just remember that our pivotal trial in monotherapy, we recruited it just in 3 or 4 months, just because of the interest of the patient. So therefore, the bar for Amy is very, very, very high, if she need to do that faster. Sorry to for coming in.

Speaker #3: We are ready to go . Protocol is finished and everything we open sites . Just remember that the our pivotal trials in monotherapy .

Speaker #3: We recruited the just in 3 or 4 months just because of the interest of the patient . So therefore the bar for Amy is a very , very , very high if she need to do that faster .

Chad Fugere: Absolutely, no problem. Our next question comes from the line of Joseph Schwartz, from Leerink Partners. Your question, please.

Operator: Absolutely, no problem. Our next question comes from the line of Joseph Schwartz, from Leerink Partners. Your question, please.

Speaker #3: So, too, for coming in.

Joseph Schwartz: Hi, this is Heidi Jacobson on for Joseph Schwartz. Thanks so much for taking our question. So can you help us understand how the TransCon CNP launch could factor into your EUR 500 million operating cash flow target for 2026, particularly with respect to launch investment and early revenue contribution? Thanks.

Heidi Jacobson: Hi, this is Heidi Jacobson on for Joseph Schwartz. Thanks so much for taking our question. So can you help us understand how the TransCon CNP launch could factor into your EUR 500 million operating cash flow target for 2026, particularly with respect to launch investment and early revenue contribution? Thanks.

Speaker #1: Absolutely . No problem . Our next question comes from the line of Joseph Schwartz from Leerink Partners . Your please question .

Speaker #10: Hi . This is Heidi Jacobson on for Joe Schwartz . Thanks so much for taking our question . So can you help us understand how the TransCon CNP launch could factor into your 500 million operating cash flow target for 2026 , particularly respect to launch investment Thanks contribution ?

Jan Møller Mikkelsen: It's pretty, pretty simple. It's not incorporated. So when we coming into the launch, we see the initial uptake, which we believe will be pretty high, not only in the US, but also outside US, because we can utilizing the US approval to go to countries outside US, especially in the international market. So from that perspective, we will come and provide you a better guidance and improved guidance when we have seen that. Scott is smiling, or you're counting money or what are you doing?

Speaker #3: It's pretty pretty simple . not It's incorporated . So when we coming into the lungs , we see the initial uptake , which we believe will be pretty high .

Speaker #3: Not only in the US but also outside the US, because we can utilize the US approval to go to countries outside the US, especially in the international market.

Speaker #3: So from that we perspective , will come and provide you a better guidance and improved guidance when we have seen that God is smiling , accounting money are doing .

Ellie Merle: Taxes and money.

Jan Møller Mikkelsen: Taxes and money.

Jan Møller Mikkelsen: Okay. So we will come back after that.

Jay Wu: Great. Thanks.

Heidi Jacobson: Great. Thanks.

Speaker #4: Taxes and money. Money.

Speaker #3: Okay, so have you ever come back after that?

Chad Fugere: Thank you. Our next question comes from the line of Derek Archila from Wells Fargo. Your question, please.

Operator: Thank you. Our next question comes from the line of Derek Archila from Wells Fargo. Your question, please.

Speaker #10: Great . Thanks .

Derek Archila: Hey, good afternoon. Thanks for taking the questions. Yeah, I just wanted to understand your confidence level around your YORVIPATH growth ex-US. You know, obviously, the launch in Germany and Austria, is that like a good proxy, or is it going to be more depth in those types of countries than just kind of expansion in, you know, I guess I think you said 10 additional countries. So how will that be sequenced through the year? Thanks.

Speaker #1: Thank you . And our next question comes from the line of Derek Arcilla from Wells Fargo . Your question please

Speaker #11: good . for taking Hey , Thanks the Yeah . confidence wanted to I just around your level growth . ex-US . You know , obviously the launch in Germany and Austria , is that like a good proxy or is it going to be more depth in those types of countries and then just kind of expansion in I guess I think you said ten additional countries .

Jan Møller Mikkelsen: That is extremely complicated answer, because the heterogeneity of the ex-US is so heterogeneous that we cannot really compare to what we, for example, seeing in Spain now, what we see in France, what we see in Germany, what we're seeing in Austria. It's really different things because we see different speed of penetration. For example, Germany has fewer endos, so the bottleneck is really more tight. It takes longer, longer, longer time to get them on a therapy because there is fewer endo in the general population. If we go to Spain, there is more, there is more in France, and we also see therefore, a faster uptake because we basically have a pipeline that really is larger. When we get so many other, you know, ten more additional countries based on full commercial, we will see different uptake.

Speaker #11: So how will that be sequenced through the year ? Thanks .

Speaker #3: That is extremely complicated . Answer . Because the heterogenicity of the excuse is so heterogenic that we cannot really compare to what we , for example , seeing in Spain now , what we're seeing in France , what we see in Germany , what we're seeing in Austria , it's really different things because we see different speed of penetration .

Speaker #3: For example , Germany has less endos , so the bottleneck is a little more tight . It takes longer , longer , longer time to get them on a fewer therapy because general in the into there is population .

Speaker #3: If , there Spain to more , there is we go is more in France . And we also see , therefore a faster uptake because we basically have a pipe that is really is larger .

Speaker #3: When we get so many other ten more no additional countries basic on full commercial , we will see different uptake . But what we are doing is everything will be accumulated in the way where we now see from 30 to 35 countries .

Jan Møller Mikkelsen: But what we are doing is everything will be accumulated in the way where we now see from 30 to 35 countries, named patient programs. And when we go full commercial, what we see every place, it's basically an acceleration of patient uptake. Because of the burdensome nature of a named patient program, it takes so much effort really to get every single patient on it, and every patient deserves to be on the treatment. So when you come to 2026, we will see initial speeding up in all this country, and when we come to 2027, 2028, you will continue to do it because just the nature, we just got a approval now in Canada, and we basically taking one country after the country, first going in and getting approval, and then we're going to full reimbursement.

Speaker #3: Named patient programs . And when we go full commercial , what we see every place it's basic is an acceleration of patient uptake .

Speaker #3: Because of the burdensome nature of a named patient program, it takes so much effort, really, to get every single patient on it, and every patient deserves to be on the treatment.

Speaker #3: So when you come to 26 , we will see initial Speeding up . these countries . And when we come to 2728 , you will continue to do it because just the nature .

Speaker #3: We just got a proven now in Canada and we basically taking one country after the country first going in and getting approval , and then we're going to full reimbursement .

Chad Fugere: Thank you. Our next question comes from the line of Lee Wacek from Cantor. Your question, please.

Operator: Thank you. Our next question comes from the line of Lee Wacek from Cantor. Your question, please.

Li Watsek: Hey, thank you so much for taking our question. It's Daniel Brenner on for Lee. Can you give us a little bit of color on how you expect your TransCon CNP launch to go? It seems like there is a few patients who aren't currently on treatment. Where do you think you will capture the majority of patients initially?

Daniel Brenner: Hey, thank you so much for taking our question. It's Daniel Brenner on for Lee. Can you give us a little bit of color on how you expect your TransCon CNP launch to go? It seems like there is a few patients who aren't currently on treatment. Where do you think you will capture the majority of patients initially?

Speaker #1: Thank you . Our next question comes from the line of Lee Watzke from Cantor . Your question please .

Speaker #12: you so much Hey , thank for taking our question . It's Daniel Bronner on for Lee . Can you give us a little bit of color on how you expect your transplant launch to go ?

Speaker #12: It seems like there are a few patients who aren't currently on treatment . Where do you think you will capture the majority of patients initially ?

Jan Møller Mikkelsen: Pretty clear. The improvement that we see with TransCon CNP to what we can provide, not only related to when we look on tolerability, injection site reaction, having 120 injection site reaction compared to one every second year, being in a position to look on no risk of hypertension, to the element of just having the improvement on the once weekly product, and then show the data package that we have generated with TransCon CNP for first time ever shown in a well-controlled trial against placebo benefit beyond linear growth. For example, the leg bone, which we have shown multiple times, we have shown improvement in muscle strength, we have improved quality of life. I think this is obvious.

Speaker #3: Pretty clear . The improvement that we see with TransCon CNP to what we can provide , not only when related to we look on totality injection site reaction , having 120 injection site reaction compared to one every second year being a position to look on .

Speaker #3: No risk of hypertension to the element of just having the improvement over once-weekly product, and then show the data package that we have generated with TransCon CNP for the first time ever, shown in a well-controlled trial against placebo—benefit beyond linear growth.

Speaker #3: For example , the leg bowing , which we have shown multiple times , we have shown improvement in muscle strength . We have improved quality of life .

Jan Møller Mikkelsen: Every patient that decide to be on treatment should have the opportunity to have the best possible treatment option, and I think there is a public interest in the US to ensure that is always will happen.

Speaker #3: I think this is obvious every patient that decide to be on treatment should have the opportunity to have the best possible treatment option , and I think there in the is a public interest US to ensure that is always will happen .

Chad Fugere: Thank you. And our next question comes from the line of Ellie Merle from Barclays. Your question, please.

Operator: Thank you. And our next question comes from the line of Ellie Merle from Barclays. Your question, please.

Ellie Merle: Hey, guys. Thanks so much for taking my question. Curious if you can elaborate on your strategy for commercializing TransCon CNP ex-US. Just given the majority of YORVIPATH sales are ex-US, could you elaborate on your strategy for the commercial launches globally and the degree of investment that that will take? And then just a second question on TransCon CNP. In the US, just can you talk a little bit more about how you're thinking about the cadence of uptake, and which segments do you expect the most uptake from between, say, treatment-naive versus switches? Thanks.

Speaker #1: Thank you. And our next question comes from the line of Elie Merle from Barclays. Your question, please.

Speaker #13: Hey guys , thanks so much for taking my question . Curious if you could elaborate on your strategy for commercializing TransCon CNP ex-US ?

Speaker #13: Just given the majority of those sales are ex-US, could you elaborate on your strategy for the commercial launches globally and the degree of investment that that will take?

Speaker #13: And then just a second question on TransCon CNP in the US . Just can you talk a little bit more about how you're thinking about the cadence of uptake and which segments do you expect the most uptake from between , say , treatment ?

Jan Møller Mikkelsen: Yeah. I will dive a little bit back now, because what we did when we said that we want to have a global commercial effort, we actually started all our infrastructure building to YORVIPATH. And now you see what we have done with YORVIPATH. We recognized YORVIPATH's fast revenue, commercial revenue for more than 30 countries. We are penetrating them exactly as we can do. We will reach 60 to 70 countries in less than 2 to 3 years. So what we have done, we already have built up the infrastructure to be ready, that we can take our integrated pipeline of rare disease endocrine products basically into all these different countries in already the set up we are establishing around YORVIPATH.

Speaker #13: Naive versus switches? Thanks.

Speaker #3: Yeah , I will die a little bit back now because what we did when we said that we want to have a global commercial effort actually , we started all our infrastructure building to europids .

Speaker #3: now And you see what we have done with Europe as we recognized their fast revenue , commercial revenue for more than 30 countries .

Speaker #3: We are penetrating them exactly as we can do. We will reach 60 to 70 countries in less than 2 to 3 years.

Speaker #3: So what we have done , we already have built up the infrastructure to be ready that we can take our integrated pipeline of rare disease , endocrine product , basic into all these different countries .

Jan Møller Mikkelsen: So this is a positive element that we are not, and you can say, a company that need first to take up an infrastructure to support a globalization. We have already established that. So I feel really, really, really confident that all the success we see now with YORVIPATH on a global scale, we will just take it in. Don't forget, for example, also even in Japan, the collaboration we have with Chugai is for all three products. The same thing in China and other places. So when we make this agreement, we're not making single product, single country. We make it as a basic, as a pipeline product. And this is why we don't need to go out and make new agreements or anything. It's just getting done extremely fast from that perspective.

Speaker #3: In already the set up by establishing around Europe . So this is the positive element that we are not . And you can say a company that need first to take up and infrastructure to support a globalization , we have already established that .

Speaker #3: I feel so really, really, really confident that all the success we see now with Europe on a global scale, we will just take it in.

Speaker #3: Don't forget , for example , us even in Japan , the collaboration we have with Teijin is for all three products , the same thing in China and other places .

Speaker #3: So when we make this agreement , we not making single product , single country , we make it as a as a basic , pipeline product .

Speaker #3: And this is why we don't need to go out and make new agreements or anything. It's just going down extremely fast. From that perspective.

Chad Fugere: Thank you. And our next question comes from the line of Leland Gershell from Oppenheimer. Your question, please.

Operator: Thank you. And our next question comes from the line of Leland Gershell from Oppenheimer. Your question, please.

Speaker #1: Thank you . And our question next comes from the line of Leland Gershel from Oppenheimer . Your question , please .

Leland Gershell: Oh, great. Thank you for taking our question. I want to ask, Ken, you know, as we look at the EUR 5 billion number you've put out there for product sales by 2030. I know you're, you're not giving specific product guidance here, but if you could share with us sort of how you think about the relative contributions of your presumably three products by that point in time in terms of how they'll weigh into that total sum. Obviously, you've got much more expansion opportunity in hypoparathyroidism. You've got TransCon CNP potentially launching soon, and SKYTROFA perhaps getting additional indications in combination. So I'd love to just hear, maybe just philosophically, how your outlook adds up with those three parts. Thank you.

Speaker #2: Oh , great .

Speaker #14: for Thank you question . I want to ask an , you know , as we look at the €5 billion number you've put out there for , for product sales by 2030 .

Speaker #14: specific guidance getting Now , you're not product but if you could share with us sort of how you think relative about the contributions of your presumably three products by that point in time , in terms of how they'll way into that total sum , obviously , you've got much more expansion opportunity in Hyperparathyroid you've got TransCon CNP , potentially launching soon , and Skytrofa perhaps getting additional indications in combination .

Jan Møller Mikkelsen: Yeah, that is an element where we always in our forecasting are operating under different assumptions, where we're basically building up models for each single country, and then we accumulate that on a global setup. We first basically are taking the 2026, we're taking the 2027, 2028, and 2029. Then what we're doing, we always will go in and look on the risk balance. Where do we have extra potential upside that we can explore? What are we going to do with this on it? But I think what makes Ascendis unique today is that we are not a single product in a single region. We will have three approved products in perhaps 20 different indications in about 30, 40 countries. Meaning that what we really want to do, we will not be dependent on one single product in one single region.

Speaker #14: Love to. So I would just hear maybe, just philosophically, how your outlook adds up with those three parts. Thank you.

Speaker #3: Yeah, that is an element where we always, in our forecasting, are operating under different assumptions, where we’re basically building up a model for each single country.

Speaker #3: And then we accumulate that on a global setup . And we first basically are taking the 26 . We take the 27 , and 28 then And you're always what we're doing , will go in and balance .

Speaker #3: the Where risk look on do we have its potential extra we can upside that explore . What are we going to do with this ?

Speaker #3: But I think what makes this unique today is that we are not a single product in a single region. We will have three approved products in perhaps 20 different indications in about 30 to 40 countries. I mean, is that what we really want to do?

Jan Møller Mikkelsen: This is how we build up a sustainable company that basically have a continued stable revenue flow for multiple year. And don't forget, these product opportunities we have, when I look on the pipeline for each of them, I definitely not have sleepless night, night, I can guarantee that. There is no doubt that when I see the profile and how we design it to be best in class, we also see that realizing. And out from that perspective, is combination product with lifespan of IP extremely long. This is where you have the du- durability of it, and this is why we take the value perspective of each single product opportunity instead of fast revenue. This is not how we operate.

Speaker #3: We will not be dependent on one single product in one single region. This is how we build up a sustainable company that basically has a continued stable revenue flow for multiple years. And don't forget this product opportunity.

Speaker #3: We have . When I look on the pipeline for each of them are not have sleepless definitely night . that guarantee there is no doubt that when I see the profile and how we design it to best in be class , we also see that realizing and from that perspective is combination product with life span of IP , extremely long .

Speaker #3: This is where you have the dual durability of it . And this is why we value take the perspective of each single product opportunity .

Jan Møller Mikkelsen: We go for value, and because the element of that is this is the product really deserve this treatment, because we're really providing not only a unique benefit for the patient, but also for the society and everyone.

Speaker #3: Instead , fast revenue . This is not how we operate . We go for value . And because the element of is that this is the product really deserve this treatment , because we're really providing not only a unique benefit for the patient , but also for the society and everyone .

Leland Gershell: Great. Thanks very much.

Chad Fugere: Thank you. And our next question comes from the line of Paul Choi from Goldman Sachs. Your question, please.

Operator: Thank you. And our next question comes from the line of Paul Choi from Goldman Sachs. Your question, please.

Speaker #14: Great. Thanks very much.

Paul Choi: Hi, good afternoon, and thanks for taking our question. I think your phase 2 reach-in study is scheduled to reach primary completion next month, and so will you be in a position to file an sNDA for the newborn incident population this year? And, in the terms of the newborn incident population, in your discussions with the FDA and EMA, for your phase 3 combination study, does your study design allow for those newborn patients to be included in the study population, or will that require a separate study? Thank you.

Speaker #1: Thank you. And our next question comes from the line of Paul Choi from Goldman Sachs. Your question, please.

Speaker #15: Hi . Good afternoon . Thanks for taking our question . I think study phase two region your is scheduled to reach primary completion next And so month .

Speaker #15: will you be in a position to Snda file an for the newborn incident population that this year and in terms of the newborn incident population , you in your discussions with the FDA and EMA for your phase three combination study , does your study design allow for for those newborn patients to be included in the study population , or will that separate study ?

Jan Møller Mikkelsen: I think, when you discussed a label discussion, that's typical, is different between... Now, I just take the two main regulatory areas, because we can also take Japan into it. But if you take, for example, US, it's much harder someday to be coming to a situation where they will accept a label expansion to the infant without having the data in hands. Where in Europe is much more flexible because you have a discussion with them, and you can have and basically what I call it, partly rolling addition of data that is being generated to our trial. So there will be likely a difference between the three geographic regions now simplified. Japan is mostly perhaps the easiest way to get it down to infant immediately.

Speaker #15: Thank you .

Speaker #3: I think when you discuss a label discussion , that's typical is different between now I just take the two main regulatory areas because we can also Japan take it .

Speaker #3: into But if you take , for example , us , it's much harder somewhere to be coming to a situation there will accept and expansion to label the infant without the data having and hands we are in Europe , it's much more flexible because you have a discussion with them and you can have and basically what I call party rolling addition of that data is being generated to our trial .

Speaker #3: So there will be likely a difference between the three geographic regions . Now simplified , Japan is mostly , perhaps the easiest way to get it down to infant immediately .

Jan Møller Mikkelsen: But what we are doing now is to ensure we generate the right data, and we're doing that in a trial. It's a placebo-controlled trial. And what we see is everything what we hope for. It's living up to our expectation. Why I can say that? Because in the enrollment, we have 6 patients on a, what I call, visible treatment on it. You take them in, and there is no randomization, and we can follow them. And, Aimee can tell a few word about the benefit we really have seen from that perspective.

Speaker #3: But what we are doing now is to ensure we generate right the data , and we're doing that in a trial . It's a placebo controlled trial , and what we see is everything .

Speaker #3: What we hope for , it's living up to our expectation . Why ? I can say that because in the enrollment we six patients have on what call a a treatment .

Speaker #3: You take them on it, in, and there is no randomization, and you can follow them. And Amy can tell a few words about the benefit we really have seen from that perspective.

Aimee D. Shu: So Jan is talking about the Sentinel kids who are not part of the randomized piece of the infant study, and they are doing well, tolerating the medicine as well as we would expect, growing and starting to see early signals of the other benefits as well, particularly radiology.

Speaker #16: So Jen's talking about the Sentinel kids who are not part of the randomized piece of the study . And they are doing well tolerating the medicine as well as we would expect .

Jan Møller Mikkelsen: Yeah. So we really are so pleased with the progress we're doing in helping patients with achondroplasia, not only on linear growth but also benefit beyond linear growth.

Speaker #16: Growing and starting to see early signals of the other benefits as well , particularly radiology .

Speaker #3: Yeah . So we really so pleased with the progress we're doing in helping patients with achondroplasia , not only on linear growth , but also benefit beyond linear growth .

Chad Fugere: Thank you. And our next question comes from the line of Yun Zhong from Woodbush Securities. Your question, please.

Operator: Thank you. And our next question comes from the line of Yun Zhong from Woodbush Securities. Your question, please.

Operator: Hi, good afternoon. Thank you very much for taking the question. My question is on the weekly TransCon PTH. Is it reasonable to expect that the program could potentially enter the clinic in 2026, or do you think that there's no such need to rush? And also, you mentioned matching PK to the daily product. So with data from YORVIPATH available, what do you see as the most efficient clinical pathway to maybe take the weekly PTH to approval?

Yun Zhong: Hi, good afternoon. Thank you very much for taking the question. My question is on the weekly TransCon PTH. Is it reasonable to expect that the program could potentially enter the clinic in 2026, or do you think that there's no such need to rush? And also, you mentioned matching PK to the daily product. So with data from YORVIPATH available, what do you see as the most efficient clinical pathway to maybe take the weekly PTH to approval?

Speaker #1: Thank you . And our next question comes from the line of yunxiang from Wedbush . Your question please .

Speaker #1: Thank you. And our next question comes from the line of Yunxiang from Wedbush. Your question, please.

Speaker #17: Hi. Good afternoon. Thank you very much for taking the question. The question is on the weekly TransCon PTH. Is it reasonable to expect that the program could potentially enter the clinic in 2026?

Speaker #17: Or do you think that there's no such need to rush? And also, you mentioned matching PK to the daily product. So with data from the UAV path available, what do you see as the most efficient clinical pathway to maybe take the weekly PTH to approval?

Jan Møller Mikkelsen: I think what you're addressing is two things that is interconnected. Because if you, for example, can show the PK profile, and it can even be healthy volunteers or patients with hypoparathyroidism, that over the entire week of treatment, you basically are bioequivalent to daily. And that is the aspiration, how we designed it, that you basically will always be in an equivalent PTH level compared to your previous daily dose for the entire week. Then we know you basically will get the expected safety, the expected tolerability from that perspective, and this will make a much, much more simplified, easy way to conduct the clinical trial. And that was why we designed it exactly in this manner.

Speaker #3: I think what you are addressing is two things . That is interconnected , because if you , for example , can show the PK profile and they can even be healthy volunteers or patients with hypopara that over the entire week of treatment , you basically are bioequivalent to Europa .

Speaker #3: And that is where aspiration , how we designed it , that you basically will always be in an equivalent PTH level compared to Europe , has daily dose for the entire week .

Speaker #3: Then we know you basically will get the expected safety where exaggerated tolerability from that perspective . And this will make a much , much more simplified , easy way to conduct the clinical trial .

Operator: Okay, thank you very much.

Yun Zhong: Okay, thank you very much.

Speaker #3: This was why we designed it exactly in this manner.

Chad Fugere: Thank you. And our next question comes from the line of Luca Issi from RBC. Your question, please.

Operator: Thank you. And our next question comes from the line of Luca Issi from RBC. Your question, please.

Speaker #17: Okay . Thank you very much .

Luca Issi: Oh, great. Thanks so much for taking my question. Congrats on the progress. Maybe, Jan, kind of big picture. I think one of your goals for 2030, as you articulated J.P. Morgan, is to remain an independent and profitable biotech company, and we obviously have seen many successful example of that in our industry recently. However, how are you thinking about maybe continuing that same vision under the broader umbrella of a larger pharmaceutical company? I guess the question is, how are you thinking about strategic path A versus strategic path B at this point? So any call there, much appreciated. And then maybe Jay, quickly, I think BioMarin has announced that they will file Voxzogo for full approval, versus I believe you will initially get approved on an accelerated approval basis for TransCon CNP. How should we think about that difference?

Speaker #1: Thank you. And our next question comes from the line of Lucchese from RBC. Your question, please.

Speaker #18: Oh, great. Thanks so much for taking my question. Congrats on the progress. Maybe you could kind of give a big picture. I think one of your goals for 2030, as you articulated at JP Morgan, is to remain an independent and profitable biotech company, and we obviously have seen many successful examples of that in our industry recently.

Speaker #18: think do you about maybe However , how continuing that same vision ? Under the broader umbrella of a larger pharmaceutical company ? I guess the question is , how do you thinking about strategic path A versus strategic path B at this point ?

Speaker #18: So any call there ? Much appreciated . And then maybe Jay , quickly , I think bomber has announced that they will file Voxzogo for full approval versus I believe you will initially get approved on an accelerated approval basis for TransCon CNP .

Luca Issi: Will that have implications for formulary access and reimbursement, or you don't view that difference as material for adoption, given you obviously have a less frequent dosing versus? Any thoughts?

Speaker #18: How should we think about that difference ? Will that have implications for formulary access and reimbursement ? Or you don't view that difference as material for adoption , given you obviously have a less frequent dosing versus .

Jan Møller Mikkelsen: I think I will, I think I will liberate Jay for answering the last question. I think, when I look on discussion on accelerated approval, that BioMarin are filing for that has no impact on our regulatory pathway and approvals and other things like that. Totally independent. It's not any way how you can build up any barrier or any way in this way. The second thing, yes, in our vision, there is independent, and I believe that is a great word because we want to be independent, like a teenager growing up. And one of the things you... At least I have four children, I'm teaching them, when they're going to be 18, you need to be financially independent as the first element in their life.

Speaker #3: Thanks so much . I think I think I will liberate Jay for answering the last question . I think when I look on this discussion on accelerated approval , that primary are filing for that has no no impact on our regulatory pathway .

Speaker #3: And approval . And other things like that . Totally independent . It's not any way how you can build up any barrier or any way in this way .

Speaker #3: The second thing , yes , in our vision , there is independent and I believe that is a great word because we want to be independent like a teenager growing up .

Speaker #3: And one of the things you at least I have four children . I'm teaching them when they're going to be 18 . You need to be financial independent as the first element in their life .

Jan Møller Mikkelsen: And I think that is a great thing to see as Ascendis Pharma now moving away from being a teenager, but basically can go up to a more adult life because we have shown now we are completely independent on basically asking investors and others for any kind of revenue. And I think this is how we see independence.

Speaker #3: And I think that is great thing a to see . Ascendis Pharma now moving away from being a teenager . basic But can go up to a more adult life because we have shown now we are complete independent on basic asking investors and others for any kind of I .

Luca Issi: Super helpful. Thank you.

Chad Fugere: Thank you. As a reminder, ladies and gentlemen, we ask you to please limit yourselves to one question. You may get back in the queue as time allows. Our next question comes from the line of Maxwell Skor from Morgan Stanley. Your question, please.

Operator: Thank you. As a reminder, ladies and gentlemen, we ask you to please limit yourselves to one question. You may get back in the queue as time allows. Our next question comes from the line of Maxwell Skor from Morgan Stanley. Your question, please.

Speaker #3: We think this is how revenue is seen and independency.

Speaker #3: . Super

Speaker #18: helpful . Thank you .

Speaker #1: Thank you . And as a reminder , ladies and gentlemen , we ask you to please limit yourself to one question . You may get back in the queue as time allows .

Aimee D. Shu: Great. Thank you very much. My question was asked, but I'll just take a shot at this. Could you give any color on the once monthly TransCon semaglutide program? Any gating factors, when we should expect an update? Any additional color would be helpful. Thank you.

Maxwell Skor: Great. Thank you very much. My question was asked, but I'll just take a shot at this. Could you give any color on the once monthly TransCon semaglutide program? Any gating factors, when we should expect an update? Any additional color would be helpful. Thank you.

Speaker #1: Our next question comes from the line of Maxwell score from Morgan Stanley . Your question please

Speaker #1: Our next question comes from the line of Maxwell Score from Morgan Stanley. Your question, please.

Speaker #19: Great . very much . My question was asked , but I'll just take a shot at this . Can you give any color on the once monthly transcon semaglutide program ?

Jan Møller Mikkelsen: ... Yeah, let me go back to all the elements and all the IP we have done, piles of data, and everything like that before we went into this extremely productive collaboration with our neighbor in Copenhagen, Novo Nordisk. What was really the idea behind once-monthly semaglutide? The idea was to be sure that you can get fast weight loss, in the same time, have high level of tolerability. So just think about it. I can define it. You have a naked GLP-1 molecule, that's basic. When you give it in a weekly or potentially want to use a weekly product in a once-monthly, you need to add up much, much more compound to compensate for the half-life to have and last.

Speaker #19: Are there any gating factors as to when we should expect an update? Any additional color would be helpful. Thank you.

Speaker #3: Yeah . Let me go to back all the element and all the IP we have done filed and data and everything like that before we went into this extremely productive collaboration with our neighbor in Copenhagen , Novo Nordisk was , what really idea the Monty once Semaglutide behind and the idea was to be sure that you can get fast weight loss in the same time , have high level of tolerability , and so just think about I can define it .

Speaker #3: You have a naked one molecule that basic when you give it in an weekly or potentially want to use a weekly product in a once you need to add up more most , most compound to compensate for the half life to have a last but doing there you add a high max dose and because it's naked , you will have better short tmax , meaning that you will have a stiff curve from the lowest level just before you start to give a dose up to the maximum concentration that is basically what often gives the tolerability issue the , where you get element that basically limit to stay on people treatment and what you can achieve .

Jan Møller Mikkelsen: By doing this, you add a high max dose, and because it's naked, you will have very short Tmax, meaning that you will have a steep curve from the lowest level just before you start to give a dose, up to the maximum concentration. That is basically what often gives the tolerability issue, where you get the element that basically limits people to stay on treatment and what you can achieve. So this is what I call the naked product. This is like Minjuvi and everything. This is a naked profile. What we're doing now is defining what we call TransCon semaglutide. So even if you give it high dose, you liberate it slowly, slowly, slowly, so you're getting a very, very long Tmax. By doing that, you basically have a slope that is not as steep at all that you see with a naked molecule.

Speaker #3: So this is what I call the naked product. This is like Matsura and everything. It's a naked protein. What we're doing now is, and what we're defining, we call pact in semaglutide.

Speaker #3: So even if you give high dose , you liberate it slowly , slowly , slowly . So you're getting a very , very long tmax by doing that , you basically have a slope that is not as steep at all that you see with a naked molecule .

Jan Møller Mikkelsen: Then you can see you still have a big AUC, because you basically provide so much compound, give it over the entire month, and then at the same time, you don't have this steepness in the slope, and by that, you don't have that. So it was designed to have maximal weight loss as fast as possible with the best tolerability profile, and that was how we designed it at that time.

Speaker #3: Then you can see you still have a big AUC, because you basically provide some compound, give it over the entire month, and then at the same time, you don't have this steepness in the slope.

Speaker #3: And by that, you don't have that. So, it was designed to have maximal weight loss as fast as possible with our best solubility profile.

Chad Fugere: Thank you. Our next question comes from the line of Alex Thompson from Stifel. Your question, please.

Operator: Thank you. Our next question comes from the line of Alex Thompson from Stifel. Your question, please.

Speaker #3: And designed it at time that .

Alex Thompson: Hey, great. Thanks for taking our question. I guess maybe, maybe for Scott, could you talk a little bit about, you know, OpEx trajectory in 2026 in the context of the CNP launch and then sort of the SKYTROFA label expansion, both with mono and, the combo, pivotal studies? Thanks.

Speaker #1: Thank you . And our next question comes from the line of Alex Thompson from Stifel . Your question please .

Speaker #20: Hey , great . Thanks for taking our question . I guess maybe maybe for Scott . Could you talk a little bit about opex trajectory in 2026 and the context of the CMP launch , and then sort of the Skytrofa label expansion , both with mono and the combo pivotal studies .

Scott Smith: Yeah, no problem. I think that, so we talked a little bit about this at the Morgan conference event. But I think using Q4 OpEx as a run rate for the full year is, you know, not a bad way to think about it, and if things change, we come in and update you. And I think overall, everything related to CNP, you know, as we said before, we'll come out and discuss more, you know, following, following approval.

Speaker #20: Thanks .

Speaker #4: Yeah . No problem . I think that so we talked a little bit about this . We talked about a little bit about this at the at the Morgan Conference event .

Speaker #4: But I think using Q4 OpEx is a run rate for the for the full year is , you know , not a bad way to think about it .

Speaker #4: And if things change , we come in and update you . And I overall , think everything related to CNP , you know , as we've before , we'll come out following and discuss more , you know , following approval

Jan Møller Mikkelsen: Yeah, but that's mainly related to the revenue, because what we have now, we have a really mature company. It's not like we take something in a pipeline. We're actually taking product out of the pipeline all the time. So R&D are basic constant for the last three or four years. Sure, our global commercialization, specific, the direct market, we have built up already now, adding a few more people there, not major impact on anything like that. This is the benefit of a pipeline in the same therapeutic area and scale that we have now.

Speaker #3: But

Speaker #3: that's . mainly related to Yeah . the revenue because what we have now , we have a really mature company . It's not like we take something in in a pipeline .

Speaker #3: We actually taking product out of the pipeline all the time . So basically constant for the last 3 or 4 years . Sure .

Speaker #3: Our global commercialization, specifically the direct market, we have built up already. Now we’re adding a few more people. They're not a major impact or anything like that.

Alex Thompson: Thanks, appreciate it.

Speaker #3: This is the benefit of a pipeline in the same therapeutic area . And scale that we have now .

Chad Fugere: Thank you. And our next question comes from the line of Kulpat Patel from Wolfe Research. Your question, please.

Operator: Thank you. And our next question comes from the line of Kulpat Patel from Wolfe Research. Your question, please.

Speaker #20: Thanks . Appreciate it .

[Analyst] (Wolfe Research): Yeah, hey, thanks for taking the question. I had, I had one on the competitive landscape. Wondering how you're thinking about this internally as other agents like and encaleret are looking to expand into the chronic hypoparathyroidism landscape. And then, does your longer term outlook for your repath include that potential impact from such emerging agents? Thank you.

Kalpit Patel: Yeah, hey, thanks for taking the question. I had, I had one on the competitive landscape. Wondering how you're thinking about this internally as other agents like and encaleret are looking to expand into the chronic hypoparathyroidism landscape. And then, does your longer term outlook for your repath include that potential impact from such emerging agents? Thank you.

Speaker #1: you . Thank And our next question comes from the line of Patel from Wolfe Research . Your question , please .

Speaker #7: Yeah . Hey ,

Speaker #21: Thanks for taking the question . I had one on the competitive landscape , wondering how you're thinking about this internally as other like agents .

Speaker #21: And looking to expand into the chronic hyperparathyroidism landscape, and then does your longer-term outlook for your Repatha include that potential impact from such emerging agents?

Jan Møller Mikkelsen: So I can be polite, or I can be a straight shooter. I've seen a lot of idiotic ideas. This one is really one of the most idiotic ideas I heard about. You have a patient that is missing a hormone, PTH, and giving encaleret is not increasing and providing any hormone to this. We're talking about a hormone replacement therapy, where you helping multiple organs, the brain, so you have better cognitive effects. The bone need to have the right metabolic system. The kidney need to have the right phosphate elimination. It need to have the right calcium absorption. And I can continue one organ after the other organ, and then you believe you can take a compound, encaleret, that basic are a calcium synthesizing compound, take it into a person that don't have the hormone, and then you think you have a treatment.

Speaker #21: Thank you .

Speaker #3: So, I could be polite, or I can be a straight shooter. I have seen a lot of idiotic ideas. This one is really one of the most idiotic ideas I have heard about.

Speaker #3: You have a patient that is missing at hormone . PTH . And giving ankle . It is not increasing and providing any harm to this .

Speaker #3: talking We're about a hormone replacement therapy where you helping multiple organs . The brain . have So you better effects . The bone need to have the right metabolic system .

Speaker #3: The kidney needs to have the right phosphate elimination. It needs to have the right calcium absorption. And I can continue one organ after the other organ.

Speaker #3: And then you believe you can take a compound and collect that . Basic are a calcium synthesizing compound . Take it into and person that don't have the hormone .

Jan Møller Mikkelsen: It's really one of the most scientific, I will say, ideas, where I cannot see any kind of meaningful effect that it will help the patient. You can increase basically the element of one single thing, absorption of calcium, but that is not anyway coming in as a hormone replacement therapy. No, we have not calculated that in. There has an idea in AGS-1 patient, which have a mutation in the calcium synthesizer one. It makes sense for this small amount of patients, it makes sense, but not for a person that miss PGH.

Speaker #3: And then you think you have a treatment. It's really one of the most scientific, I will say, ideas where I cannot see any kind of meaningful effect that it will have on the patient.

Speaker #3: You can increase, basically, the element of one single thing: absorption of calcium. But that is not the way any coming in as a hormone replacement therapy.

Speaker #3: So no , we have not calculated that in there has an idea in ads . One patient which have an mutation in the calcium synthesizer , one it makes sense for this small amount of patients .

Speaker #3: It makes sense, but not for a person that misses PTH.

[Analyst] (Wolfe Research): Got it. Thank you.

Kalpit Patel: Got it. Thank you.

Chad Fugere: Thank you. And our next question comes from the line of Faisal Khurshid from Jefferies. Your question, please.

Operator: Thank you. And our next question comes from the line of Faisal Khurshid from Jefferies. Your question, please.

Speaker #21: Got it . Thank you .

Speaker #1: Thank you . And our next question comes line from the of Faisal Khurshid from Jefferies . Your question please .

Kelly Shi: Hey, guys. Thanks for taking the question. Just wanted to ask, Jan, maybe because you're giving some open thoughts on the competitive landscape. Can you discuss your latest thoughts on the CNP competitive landscape, including upcoming FGFR data from BridgeBio and also the earlier stage long-acting CNP from BioMarin?

Faisal Khurshid: Hey, guys. Thanks for taking the question. Just wanted to ask, Jan, maybe because you're giving some open thoughts on the competitive landscape. Can you discuss your latest thoughts on the CNP competitive landscape, including upcoming FGFR data from BridgeBio and also the earlier stage long-acting CNP from BioMarin?

Speaker #11: Hey guys . Thanks for taking the question .

Speaker #22: I just wanted to ask maybe because you're giving some open thoughts on competitive landscape . Can you discuss your latest thoughts on CNP the competitive landscape , including update , upcoming Fgfr data from Bridgebio and also the earlier stage long acting CNP from Biomarin ?

Jan Møller Mikkelsen: Yeah. I think that is an interesting aspect, because we have seen the benefit of CNP therapy for multiple years now. We have seen it in a large patient population, and one of the thing I 100% align with BioMarin on, is that the CNP therapy has shown to be extremely safe and well tolerated, except that you have element like, if you take too high concentration, you can get hypotension, you can get injection site rise, if you're not really encapsulated. And so when I see the CNP therapy, I understand why BioMarin are trying to copy us, and trying to develop a product that basically providing and sustained liberation of CNP over one week. Because they have seen out from our data how we highly differentiated compared to Voxzogo type.

Speaker #3: Yeah , I think that is an interesting . Aspect because . We have seen the benefit of CNP therapy for multiple years now .

Speaker #3: We are seeing it in a last patient population, and one of the things I 100% align with BioMarin on is that the CNP therapy has shown to be extremely safe and well tolerated, except that you have elements like if you take too high a concentration, you can get hypertension, you can get injection site rise.

Speaker #3: If you're not really encapsulated . And so when I see the CNP therapy , I why binary are trying to us . copy And trying to develop an product that basically are providing and sustained liberation of CNP over because they one week seen from our data how we highly differentiated , to compared Vosoritide .

Jan Møller Mikkelsen: So that is a completely different case about, do they really have a once-weekly product or not? You cannot just take that out from AUC. You need to see the profile over one week and other things like that. So as I have not seen this data or anything on the long-acting product for BioMarin, I do not know if anyone can judge that it is a viable product opportunity in any way. Then we need to see the PK profile, get the half-life and all the different things, then we can take a judgment about it. The element of tyrosine kinase is a completely different element for me, because that is an element of using a non-specific action of a compound that basically is addressing the tyrosine kinase.

Speaker #3: So different case about they really have do a once weekly product or not ? cannot . You Just that out from AOC to see the profile over one week and other things like that .

Speaker #3: So as I'm not seen these data on anything on the long acting product for Biomarin , I do not know if anyone can just that is a while viable product opportunity in any way .

Speaker #3: Then we need to see the . PK fold , get the half life and all the different things . Then we can take adjustment about it .

Speaker #3: The element of tyrosine is completely different for element me because that is an element of using a nonspecific action of a compound that basically are addressing the kinase.

Jan Møller Mikkelsen: If you go to BridgeBio, it's a non-specific tyrosine kinase that both inhibit the three different compounds, FGFR-1, FGFR-2, and FGFR-3. This is why it's called non-specific. What I'm not worried about, I'm not worried that you will see a treatment effect, because when you address the tyrosine kinase, you basically see an improvement in linear growth, because you basically are in a position that you are inhibit the super active pathway. Will they see the same kind of benefit that we see beyond linear growth? That is up to them to show. Can they see an improvement in muscle strength? Can they see an improvement in long bone? Can they see all the elements of improved quality of life with that? But what worries me is the non-specific thing, and I really don't care about phosphate.

Speaker #3: And if you go to the Bridgebio , it's a nonspecific tyrosine kinase that both inhibit the three different compounds . FDR one , FDR two , and Fgfr3 .

Speaker #3: This is why it's called nonspecific . And what I'm not worried about . I'm not a word that you will see and treatment effect , because when you address the tyrosine kinase , you basically will see an improvement in linear growth because your basic ion position that you are in hibit the super active pathway will the see the same kind of benefit that we see in linear growth .

Speaker #3: That is up to them to show. We see, can an improvement in muscle strength—can we see an improvement in basic leg bone?

Speaker #3: Can we see all the element of improved quality of life with that ? what But were me is the nonspecific thing . And I really don't care about phosphate .

Jan Møller Mikkelsen: People say, "Oh, Jan, are you worried about that they have elevated phosphate?" First of all, elevated phosphate, you cannot go in and grade it 1, 2, or 3, 4. You need to see on the patient, what is the phosphate level before treatment and after treatment. Because then you see, do the treatment on each single subject have an impact on the phosphate level? If it has impact on the phosphate level, we know it's a non-specific inhibition of FGFR1. And when you have a non-specific inhibition of FGFR1, you also have non-specific inhibition of FGFR2. And when you know that FGFR2 is one of the key receptor that is part of really the CNS development of the brain, I'm extremely worried. Because it's not, not something you really see easily in a preclinical model. You don't see it anyway in short-term clinical trials.

Speaker #3: People say , oh again , are you worried about they have elevated phosphate . First of all , elevated phosphate . You cannot go in and grade one , two or 3 or 4 .

Speaker #3: You need to see, on the patient, what the phosphate level is before treatment, and after treatment. Because then you see the effect of the treatment on each single subject.

Speaker #3: Have an impact on the phosphate level . If it has impact on the phosphate level , know it's a nonspecific inhibition of FDR .

Speaker #3: One . And when you have a nonspecific inhibition of FDR one , you also have nonspecific inhibition of fgfr2 . And when you know that Fr2 is one of the key receptor , that is part of really the CNS development of the brain , I'm extremely is not because this worried something you really see easily in preclinical a model .

Jan Møller Mikkelsen: You see it after 3, perhaps 4, 5 years of treatment. You know, that worried me out from our patient focus. How can you really accept that any patient should take this risk without being extremely well informed about it?

Speaker #3: You don't see it anyway in short term clinical trials . You see it after three , perhaps 4 or 5 years of treatment .

Speaker #3: You know , that worried me out from our patient focus . How can you really accept that any patient should take this risk ?

Kelly Shi: Got it. Thank you for your insight.

Faisal Khurshid: Got it. Thank you for your insight.

Speaker #3: Without being extremely well-informed about it?

Chad Fugere: Thank you. This does conclude the question and answer session as well as today's program. Thank you, ladies and gentlemen, for your participation. You may now disconnect. Good day.

Operator: Thank you. This does conclude the question and answer session as well as today's program. Thank you, ladies and gentlemen, for your participation. You may now disconnect. Good day.

Speaker #22: Got it . Thank you for your insight .

Speaker #1: Thank you . This does conclude the question and answer session as well as today's program . Thank you , ladies and gentlemen , for your participation .

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