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Ascendis Pharma (ASND) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

Ascendis Pharma Q2 FY26 — Strong TransCon Product Uptake and Pipeline Advancement

Ascendis Pharma delivered a strong Q2 FY26, driven by robust uptake of its TransCon products, SKYTROFA, YORVIPATH, and the successful commercial launch of YUVIWEL. The company is advancing its pipeline, including combination therapies and new chemical entities, while navigating an ongoing patent dispute for YUVIWEL. Management remains confident in achieving its Vision 2030 objectives, supported by its differentiated technology platform and global commercial infrastructure.

Highlights

5
  • Total product revenue more than doubled year-over-year to EUR 315 million.

  • YORVIPATH revenue reached EUR 252 million in Q2, achieving blockbuster status on a run rate basis in its second year.

  • YUVIWEL generated EUR 8 million in revenue in its first quarter on the market, with over 220 patients enrolled and >65% approved for reimbursement by end of July.

  • SKYTROFA achieved over 20,000 unique enrollments, maintaining its position as the #1 long-acting growth hormone by brand value in the U.S.

  • Non-IFRS operating profit was EUR 92 million, with a non-IFRS operating margin of 27%.

Concerns

3
  • Ongoing ITC legal battle with BioMarin regarding YUVIWEL patent, with a first opinion expected in August and a full ITC decision in December.

  • R&D expenses increased to EUR 76 million in Q2 from EUR 59 million in Q1, reflecting continued pipeline investment.

  • SG&A expenses increased to EUR 173 million in Q2 from EUR 145 million in Q1, driven by commercial launch investments.

Guidance & targets

CategoryTargetConfidence
Cash flow from operating activities
>EUR 500 million
high materiality
High
YORVIPATH growth and performance
consistent with prior quarters
medium materiality
Medium
SKYTROFA U.S. revenue
relatively stable revenue
medium materiality
Medium
Total revenue
EUR 5 billion
high materiality
High
Total revenue
>EUR 10 billion
high materiality
High
Operating leverage
significant operating leverage
medium materiality
Medium
Phase III combination trials (achondroplasia) enrollment
begin enrolling
medium materiality
High
YUVIWEL EU regulatory decision
expected
high materiality
High
TransCon Growth Hormone launch
launch in same countries as TransCon CNP
medium materiality
High
YORVIPATH higher dose label expansion (US)
very, very, very fast
medium materiality
High

Segment performance

SegmentRevenueYoYQoQMargin
YORVIPATH
First and only approved treatment for adults with hypoparathyroidism, addressing underlying disease. Strong global commercialization and patient satisfaction.
New patient demand: consistent with prior quartersPatient retention: 95% after 5 yearsResponse rate (multi-covenant endpoint): 82% to 86%Commercial availability: >35 countries
EUR 252 millionblockbuster status on a run rate basis in the second year of launch——
SKYTROFA
Once-weekly growth hormone treatment for pediatric and adult growth hormone deficiency. Strong demand and established commercial infrastructure.
Unique enrollments: >20,000Market position: #1 long-acting growth hormone by brand value in the U.S.
EUR 55 million———
YUVIWEL
Commercially launched in the U.S. during Q2. Rapid uptake and believed to be expanding the achondroplasia market. EU regulatory decision expected Q4 2026.
Unique patients enrolled (through June 30): >170Unique patients enrolled (through end of July): >220Reimbursement approval (through end of July): >65% of enrolled patients
EUR 8 million———

Deals & partnerships

Novo Nordisk Once-monthly TransCon semiglutide program

Program continues to advance in metabolic disorders and obesity.

Iconis Anti-VEGF treatment built on TransCon technology

Clinical trial initiated in patients with AMD.

Risks & headwinds

ITC legal battle with BioMarin over YUVIWEL patent August 2026 (first opinion), December 2026 (ITC decision), Q1 FY27 (presidential order)

Patent expires in 2030. First opinion from single judge in August, ITC decision in December, potential presidential order 2-3 months after.

Mitigation:Management emphasizes public interest in patient access for YUVIWEL and states the patent was invalidated in Europe. Believes it will not materially impact Ascendis's pathway.

YORVIPATH titration phase dropouts in the U.S. Ongoing

Majority of dropouts occur during titration.

Mitigation:Investment in patient-facing roles (patient access liaisons) to provide high-touch support and education during the titration journey.

What to watch in Q3 FY26

YUVIWEL EU regulatory decision

Q4 FY26
Current Pending
Target Approval decision

Why it matters

EU approval would significantly expand YUVIWEL's market reach and revenue potential.

In the EU, a regulatory decision for YUVIWEL is expected in the fourth quarter of 2026.

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Q&A highlights

Clarification on the '>EUR 500M' operating cash flow guidance given the PRV sale, and estimation of YUVIWEL patient enrollments coming from market expansion vs. switches.

Scott Smith reaffirmed the '>EUR 500M' operating cash flow guidance for FY26, declining to provide an upper bound due to early YUVIWEL launch. Jan Mikkelsen stated that with strong YUVIWEL demand, they believe it's expanding the market by attracting new patients or those returning to therapy, not just switches, but couldn't quantify the split.

“we don't have really the insight in exactly the distribution of where the patients are coming from. And our general feelings and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from switches. This must also coming for either patients that had stop therapy or new patients that base are coming to a situation because of the highly differentiated nature of Newell that they want to start therapy.”

asked by Jessica Fye · answered by Jan Mikkelsen

2 min read 6 chapters

Detailed narrative

TransCon Technology Platform & Vision 2030

Ascendis Pharma is transforming into a leading global biopharma company, driven by its TransCon technology platform and strong development/commercialization capabilities. The company aims to achieve EUR 5 billion in revenues by 2030 and over EUR 10 billion in the next decades, supported by its existing portfolio and continuous innovation. The platform enables filing at least one IND for a new chemical entity (NCE) annually, laying a foundation for sustained growth and expansion into new therapeutic areas.

YORVIPATH Performance & Expansion

YORVIPATH, the first and only approved treatment for adult hypoparathyroidism, continues to see robust uptake in the U.S. and global expansion, now available in over 35 countries. Long-term Phase II/III data show sustained response rates of 82-86% for the multi-covenant endpoint and 95% patient retention after 5 years, highlighting its potential as a standard of care. The company is pursuing label expansion for 12-18 year olds, higher doses in the U.S., and developing a once-weekly product for patients on stable doses.

YUVIWEL Launch & Market Expansion

YUVIWEL's U.S. commercial launch has seen rapid uptake, generating EUR 8 million in its first quarter. Over 220 unique patients were enrolled and more than 65% approved for reimbursement by the end of July. Management believes YUVIWEL is expanding the achondroplasia market by attracting new patients and those returning to therapy, rather than just switches, with nearly 80% of centers of excellence already prescribing it. An EU regulatory decision is expected in Q4 2026.

Combination Therapy for Achondroplasia

Ascendis is developing a unique combination therapy of TransCon CNP and TransCon Growth Hormone for achondroplasia. Recent week 78 COACH trial data demonstrated sustained efficacy, good safety, and tolerability, showing unprecedented improvements in arm span (+9.4 cm for naive, 7.9 cm for treated cohorts). This combination aims to establish a new treatment standard, with Phase III trials beginning later this year, and is expected to transform treatment for achondroplasia and other indications.

SKYTROFA Leadership & Pipeline

SKYTROFA remains the #1 long-acting growth hormone in the U.S., with over 20,000 unique enrollments, demonstrating the strength of Ascendis's commercial infrastructure. The company is pursuing label and geographic expansions, including Phase III basket trials for TransCon Growth Hormone in ISS, SDA, and Turner syndrome. The broader pipeline includes a once-monthly TransCon semiglutide program with Novo Nordisk and an anti-VEGF treatment with Iconis in ophthalmology, which recently initiated a first-in-human clinical trial.

ITC Legal Battle Update

The company is engaged in an ITC legal battle with BioMarin regarding a YUVIWEL patent. The patent was invalidated in Europe. In the U.S., a first opinion from a single judge is expected in August, followed by a full ITC decision in December, and a potential presidential order 2-3 months later. Management emphasizes the public interest in patient access for YUVIWEL and believes the U.S. case will not materially impact Ascendis's long-term pathway or its Vision 2030 objectives.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.