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ASCENDIS PHARMA A/S earnings calls

ASND · every analyst question and management's answer

Aug 13, 2026 earnings call — TransCon product launches and Q2 financial results

Ascendis reported total revenue of EUR 339 million in Q2 2026, driven by product revenue of EUR 315 million.

Revenue $0.4B (est $0.4B) · EPS $3.29 (est $1.71)

Key quotes

"In the U.S. through June 30, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollment and more than 65% approved for reimbursement in the U.S. through the end of July, really a unique launch."

— Jan Mikkelsen (CEO) · YUVIWEL launch uptake

"Uptake of YORVIPATH has grown steadily since launch, both in the U.S. and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic regions covered by our global commercial infrastructure."

— Jan Mikkelsen (CEO) · YORVIPATH growth and reach

"Our recent week 78 COACH trial data show sustained efficacy over 78 weeks with no compromises to safety and tolerability."

— Jan Mikkelsen (CEO) · Combination therapy progress

Analyst Q&A 13

cash flow and market expansion

Q (Jessica Fye · JPMorgan): How should we update the outlook for operating cash flow this year after the PRV sale? Also, how much of YUVIWEL patient enrollments come from market expansion versus switches?

A: They reiterated guidance of greater than EUR 500 million for Europe and said they will not set an upper bound now because the YUVIWEL launch is early. They said they do not have exact data on where patients come from, but they believe demand is strong and includes switches, patients who stopped therapy, and new patients, so the market is expanding.

"Yes. With respect to our cash flow guidance, just to be clear, greater than EUR 500 million, I thought you -- I heard you say EUR 100 million, so greater than EUR 500 million." — Scott Smith (CFO)

U.S. IP dispute outcomes

Q (Tazeen Ahmad · BofA): What are the possible outcomes of the IP challenge over YUVIWEL and how big could potential payments be in the worst case?

A: They described the ongoing legal battle with BioMarin and noted the disputed patent was fully invalidated in Europe. They explained the U.S. matter is in the ITC process with a single-judge opinion coming in August, further ITC action in December, and emphasized they do not expect this to have a material impact on Ascendis’ path.

"The fact is that this patent that is in discussion got completely invalid in Europe." — Jan Mikkelsen (CEO)

early pipeline IND plans

Q (Gavin Clark-Gartner · Evercore): You said TransCon can support one NCE IND per year. Should we expect an IND this year and what are the plans for the early pipeline?

A: They said two partnered TransCon-based NCEs are in the funnel and they still view both as NCE opportunities, one already in clinic and one expected to enter clinic with Novo Nordisk. They expect at least one new chemical entity will enter clinical trials each year and see that as sustaining the company and enabling future partnerships.

"I still consider the potential that have this year 2 new chemical entities being entered into clinical trials." — Jan Mikkelsen (CEO)

YUVIWEL uptake and seasonality

Q (Yaron Werber · TD Cowen): Is there seasonality to new patient starts and is the current ~50 new patients per month sustainable? Can you be #1 by year-end and overtake BioMarin’s ~750 U.S. patients?

A: They said they are not giving quantitative forward guidance after only 4 months in market and need more data to analyze trends. They said they are encouraged: nearly 80% of centers of excellence have already prescribed YUVIWEL, and patients are coming from switches, prior discontinuation, and true-naive patients, which suggests market expansion.

"We're seeing 80% of them, nearly 80% already in a short 4-month period already prescribed YUVIWEL to their patients." — Jay Wu (PRESIDENT)

YORVIPATH growth pattern

Q (Derek Archila · Wells Fargo): When you said YORVIPATH growth will be like prior quarters, which quarters did you mean and how should we model the rest of the year?

A: They said to expect consistent performance on the KPIs they have provided, for example enrollments, which they expect to continue. They also said prior quarter trends give modelers what they need to forecast Q3, Q4 and Q1 until KPIs are updated, and they aim to give conservative numbers so models are right.

"One is the consistent performance with the KPIs that we've given you, for example, with enrollments, we expect those to continue and be consistent." — Scott Smith (CFO)

hypochondroplasia trial population

Q (Joseph Schwartz · Leerink): How will you define the enrolled population for the hypochondroplasia Phase III? How large is the diagnosed treatable pool versus achondroplasia?

A: They explained many children formerly labeled idiopathic short stature (ISS) are being reclassified as genetic testing finds FGFR3 mutations, so the ISS pool is shrinking as testing increases. They said enrollment definition will reflect that genetic and phenotypic approach and that the trial follows one of those chosen pathways.

"And then you go out and do more and more and more genetic testing." — Jan Mikkelsen (CEO)

arm span and quality-of-life data

Q (Daniel Bronder · Cantor): Can you give more color on quality-of-life measures in COACH, specifically arm span and other benefits?

A: They reminded listeners COACH is the combination trial of TransCon Growth Hormone and TransCon CNP and that 52-week data were reported. They highlighted strong arm-span gains with combination therapy versus monotherapy, noting the combination showed arm-span improvements that could avoid limb-lengthening surgery.

"The unprecedented improvements in the arm span with combination were plus 9.4 centimeters with TransCon CNP naive cohort 7.9 centimeters with the TransCon CNP-treated cohort." — Scott Smith (CFO)

YORVIPATH prescription and enrollment numbers

Q (Yun Zhong · Wedbush): Have you provided prescription numbers for YORVIPATH? Can you give more quantitative info and will you report sales range guidance soon?

A: They said they have repeatedly reported roughly 1,000 unique new patients per quarter in the U.S. as a steady-state measure and had planned to stop repeating it but resumed after Q1. They said they are now shifting to providing YUVIWEL unique prescription enrollment metrics and to assume previously given metrics remain unless changed.

"Here, we are referring to the U.S. with about 1,000 new patients every quarter, and we don't believe really." — Jan Mikkelsen (CEO)

possibility of legal settlement

Q (Alexander Thompson · Stifel): Given the BioMarin dispute and public interest arguments, is a settlement a reasonable scenario?

A: He gave a brief answer emphasizing flexibility and patient focus. He said he will always do what is best for patients.

"And one of the things I really want to do, I will always do what is best for patients." — Jan Mikkelsen (CEO)

YORVIPATH dropout and reauthorization

Q (Maxwell Skor · Morgan Stanley): Are dropouts still mainly during titration and how are reauthorizations trending?

A: They said most dropouts occur during the titration period and that dropouts fall sharply once patients clear titration. Reauthorizations are routine and not a measurable issue, and they have invested in patient-facing roles to support patients pre-prescription through ongoing care to improve retention.

"Yes, as we've shared before, the majority of the drop-off is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense." — Jay Wu (PRESIDENT)

named/early access programs and ex-U.S. plans

Q (Eric Joseph · Citi): Where are you running named/early access programs for YUVIWEL, do eligibility rules depend on prior treatment, and could these programs meaningfully add volumes this year?

A: They said Ascendis already has global commercialization and patient-support infrastructure from prior rare-disease products, supporting more than 20,000 patients and functioning in more than 35 countries. They are using that existing infrastructure for YUVIWEL and will serve patients outside the U.S.; they plan to give more ex-U.S. guidance later in the year.

"We are having the system functional more than in 35 different countries." — Jan Mikkelsen (CEO)

ex-U.S. distribution and partnerships

Q (RBC CM): Does your view of switch versus naive patients align with public numbers, and will you run ex-U.S. commercialization yourself or partner?

A: They said they cannot confirm the public calculations because they lack the specific data. For ex-U.S., they described three models: direct markets, sales-and-distribution in about 80 countries, and partnerships in Japan and China, and said infrastructure is already established and approvals are expected in some EU markets in Q4.

"We don't need to go out and make any new agreements for anything -- everything is established." — Jan Mikkelsen (CEO)

YORVIPATH label expansion and weekly form

Q (Faisal Khurshid · Jefferies): Status of getting a higher dose (up to 60) into the U.S. label and any update on a weekly YORVIPATH formulation?

A: They said a U.S. trial evaluating the 30 to 60 dose ranges is enrolling quickly, aligned with FDA design, and they expect fast enrollment toward label expansion. On weekly YORVIPATH they said there is no news: work continues and the weekly option is being viewed as patient support for those on stable dosing rather than a primary lifecycle event.

"Yes. What we see today is that we are enrolling the trial in the U.S. where we're evaluating the 30 to 60 dose ranges in 2 different means that has been aligned with the FDA in their design, what they wanted to see." — Jan Mikkelsen (CEO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

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