Ascendis Pharma A/S (ASND) Q1 2026 Earnings Call Transcript
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Overview
The earnings call summary presents a positive outlook with strong growth expectations for YORVIPATH and SKYTROFA, new partnerships, and expanding patient access. The Q&A section confirms stable demand and increasing physician adoption, despite some uncertainty in revenue specifics and guidance deferrals. The management's confidence in product efficacy and unmet medical needs further supports a positive sentiment. The stock price is likely to react positively, driven by strategic growth initiatives and market expansion.
Key Financial Performance
YORVIPATH global revenue EUR 197 million in Q1 2026, impacted by two onetime items: a temporary increase of U.S. patients supported by free drug due to reimbursement disruption and a onetime impact in Europe Direct related to expanded market access. Combined impact of these items was approximately EUR 15 million.
SKYTROFA revenue EUR 44 million in Q1 2026, reflecting consistent underlying demand with an expected drawdown in channel inventory built in Q4 2025.
Total Q1 2026 revenue EUR 247 million, including EUR 6 million in collaboration revenue.
R&D expenses EUR 59 million in Q1 2026, down from EUR 78 million in Q4 2025, due to a write-up of YUVIWEL inventory (EUR 11 million) following U.S. FDA approval and lower clinical activity across the portfolio.
SG&A expenses EUR 145 million in Q1 2026, up from EUR 136 million in Q4 2025, reflecting continued impact of global commercial expansion.
Total operating expenses EUR 204 million in Q1 2026.
Operating profit EUR 25 million in Q1 2026, reflecting a 10% operating margin. Non-IFRS operating profit was EUR 55 million with a 22% operating margin.
Net finance expense EUR 63 million in Q1 2026, primarily driven by noncash items, including a remeasurement loss of financial liabilities of EUR 34 million. Net cash financial expense was about EUR 1 million.
Net profit EUR 629 million in Q1 2026, including recognition of a EUR 679 million deferred tax asset. Non-IFRS net profit was EUR 18 million, or EUR 0.27 per share.
Cash and cash equivalents EUR 573 million at the end of Q1 2026, including the impact of EUR 60 million from a share repurchase program and net settlement of certain RSUs.
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Operating Highlights
YUVIWEL Approval: FDA approval of YUVIWEL, the third TransCon product, for growth disorders. Early commercial availability in April 2026 with over 60 children prescribed by 35 healthcare providers.
YUVIWEL Clinical Results: Demonstrated improvements in growth outcomes, body proportionality, physical function, and quality of life in clinical trials. Plans for label expansion to include infants under 2 years and children with hypochondroplasia.
SKYTROFA Performance: Maintained a 7% share of the U.S. growth hormone market. Expected label expansion to double the addressable patient population.
TransCon CNP and Growth Hormone Combination: Phase II COACH trial showed significant improvements in achondroplasia-specific height Z-score, body proportionality, and spinal canal dimensions. Potential to eliminate invasive surgeries for achondroplasia.
YORVIPATH Global Expansion: Commercially available in 35 countries with full reimbursement in six European markets. Plans for further market and indication expansion.
YUVIWEL International Expansion: Plans to launch in selected international markets through early access programs. EU regulatory decision expected in Q4 2026.
Revenue Growth: Q1 2026 revenue reached EUR 247 million, driven by YORVIPATH and SKYTROFA. Operating profit of EUR 25 million with a 10% margin.
Cost Management: R&D expenses decreased to EUR 59 million in Q1 2026. SG&A expenses rose to EUR 145 million due to global commercial expansion.
Oncology Focus Shift: Discontinued internal development of TransCon IL-2 beta/gamma in oncology to align with strategic focus. Exploring alternative ways to maximize asset value.
Partnerships: Advancing TransCon semaglutide with Novo Nordisk and TransCon anti-VEGF with Eyconis towards clinical trials.
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Risk or Challenges
Reimbursement Disruption: Temporary increase in U.S. patients supported by free drug due to reimbursement disruption impacted YORVIPATH revenue in Q1.
Regulatory Approvals and Contingencies: Continued approval for TransCon CNP is contingent upon verification and description of clinical benefit and confirmatory trials, posing a risk to sustained market presence.
Market Access Challenges: Commercial reimbursement for YORVIPATH is only available in six European markets, with additional launches pending, which could delay revenue growth.
Pipeline Development Costs: High R&D expenses and global commercial expansion costs, including EUR 145 million SG&A expenses in Q1, could strain financial resources.
Oncology Program Discontinuation: Internal development of TransCon IL-2 beta/gamma in oncology has been discontinued, potentially impacting diversification and future revenue streams.
Financial Liabilities: Net finance expense of EUR 63 million in Q1, including remeasurement loss of EUR 34 million, could affect financial stability.
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Guidance & Outlook
Revenue Growth: The company expects sustained revenue growth for many years, driven by its diversified product portfolio and rapid revenue growth from its existing endocrine rare disease portfolio, including YORVIPATH, YUVIWEL, and SKYTROFA.
YORVIPATH Expansion: The company plans to pursue multiple expansion opportunities for YORVIPATH in new markets and indications, including doses up to 60 micrograms in the U.S., global expansion to patients aged 8 to 18, and continued development of once-weekly TransCon PTH for patients on stable YORVIPATH doses. The company remains confident in YORVIPATH's long-term global potential, with 70,000 to 90,000 patients in the U.S. and 5 to 10 times that number outside the U.S.
YUVIWEL Growth: YUVIWEL is expected to expand into selected international markets through early access programs using U.S. FDA approval. A regulatory decision on its marketing authorization application in the EU is expected in Q4 2026. The company is also pursuing label expansion for YUVIWEL through ongoing trials, including infants under 2 years of age with achondroplasia and children with hypochondroplasia.
SKYTROFA Expansion: The company expects SKYTROFA to maintain its position as a premium product with a 7% share of the overall growth hormone market. Label expansion could double the addressable patient population in the U.S., and geographic expansion outside the U.S. is also planned.
Pipeline Development: The company has more than 20 ongoing or planned clinical trials, including four new clinical entities in preclinical development. This includes combination therapy with once-weekly TransCon CNP and TransCon Growth Hormone for children with achondroplasia, which has shown promising results in improving body proportionality and reducing the need for invasive procedures.
Oncology Strategy: The company has decided to discontinue internal development of TransCon IL-2 beta/gamma in oncology and will explore other ways to maximize the value of these assets.
Partnerships: The company is advancing its once-monthly TransCon semaglutide with Novo Nordisk towards the clinic and expects Eyconis TransCon anti-VEGF to enter the clinic this year.
Financial Outlook: The company expects meaningful improvement in operating margin over the course of 2026 and beyond, driven by revenue scaling.
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Shareholder Return Plan
Share Repurchase Program: In Q1 2026, Ascendis Pharma executed a share repurchase program, spending EUR 60 million on repurchasing shares and settling certain RSUs.
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Key Q&A
Q:Can you estimate what U.S. YORVIPATH sales were in the quarter, considering the onetime impact to Europe Direct?
A:Management explained that a single country event in Europe due to an early access program caused a onetime write-down, impacting Q1 results. For modeling, the algorithm of adding 4-5 per quarter was shifted into Q2, with underlying patient demand remaining stable.
Q:What are the reauthorization rates for YORVIPATH, and how is usage among physicians evolving?
A:Reauthorization rates show no meaningful differences compared to new patients, with approvals typically within 4-8 weeks. Physician usage is increasing, with over 2,700 prescribers and 10% having over five enrollments. Both new and existing prescribers are expanding their scope of eligible patients.
Q:Can you provide a split of the EUR 15 million YORVI revenue between Europe and the U.S., and comment on YUVIWEL's ITC case?
A:Management suggested a rough 50/50 split between Europe and the U.S. for YORVI revenue. Regarding YUVIWEL, they expressed confidence in its market presence despite the ITC case, citing unmet medical needs and strong clinical data.
Q:What is the enrollment speed for the Phase III TransCon CNP and Growth Hormone combo trial, and what are YORVIPATH discontinuation rates?
A:The Phase III trial shows 100% retention after nearly 18 months, indicating high satisfaction with treatment benefits. No specific discontinuation rates for YORVIPATH were provided.
Q:Is it reasonable to assume 1,000 new YORVIPATH patients per quarter, and will new script numbers be shared going forward?
A:Management expects steady enrollment and revenue progression, indicating transparency in sharing numbers despite previous reluctance.
Q:What is the potential impact of YORVIPATH 60 micrograms being on the label, and what percentage of patients are dose-capped at 30 micrograms?
A:Management stated that while some patients may benefit from higher doses, those capped at 30 micrograms still experience significant benefits. A trial is ongoing to evaluate dose titration up to 60 micrograms.
Q:Are physicians hesitant to switch achondroplasia patients to YUVIWEL due to potential future treatments, and has YUVIWEL been prescribed with SKYTROFA?
A:Management highlighted strong uptake of YUVIWEL, with over 10 prescriptions per week, indicating unmet medical needs. They acknowledged some off-label combination use with SKYTROFA but emphasized awaiting Phase III trial results for formal promotion.
Q:How many of the 60 YUVIWEL enrollments were new starts versus switches, and what types of patients are most likely to switch?
A:Management noted enrollments across all patient types (new starts, switches, and previously discontinued patients) but stated it is too early to determine trends.
Q:What is the approach for hypochondroplasia treatment, and will it involve monotherapy or combination therapy?
A:Management plans to align the strategy for hypochondroplasia with that of achondroplasia, starting with monotherapy and potentially moving to combination therapy.
Q:What are the mechanics of the free drug program for YORVIPATH, and will it continue in Q2?
A:The free drug program supports patients with temporary insurance lapses or under/uninsured status. While some patients transitioned back to reimbursement, the program will continue for those in need.
Q:What are your expectations for AstraZeneca's enebo Phase III data, and how does it compare to YORVIPATH?
A:Management expressed skepticism about enebo's approvability, emphasizing YORVIPATH's superior efficacy and long-term treatment benefits.
Q:What proportion of achondroplasia patients initiate treatment at age 2 or older, and how does YUVIWEL address unmet needs?
A:Management believes YUVIWEL's benefits beyond linear growth will appeal to a broad range of patients, including older children and newborns, addressing comorbidities and quality of life.
Q:What is the cumulative U.S. insurance approval rate for YORVIPATH, and is the EUR 500 million operating cash flow target reaffirmed?
A:The cumulative approval rate has increased to the mid-70% range. Management will provide updated guidance on the cash flow target after Q2.
Q:What is the capital allocation strategy given revenue from three commercial products and recent financial activities?
A:Management prioritizes R&D investment to sustain long-term growth, with further updates expected after Q2.
Q:Review of Unclear Management Responses
A:Management avoided directly answering questions about the specific split of YORVIPATH revenue between Europe and the U.S., the exact percentage of patients dose-capped at 30 micrograms, and the proportion of achondroplasia patients initiating treatment at age 2 or older. Additionally, they deferred providing updated guidance on the EUR 500 million operating cash flow target until after Q2.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
CNP TransCon
Direct market
Europe Direct
FDA approval
Investor Relations
Officer Chief
Phase II
President Investor
Scott
TransCon PTH
TransCon beta
TransCon product
YUVIWEL
ability
beta gamma
canal dimension
care provider
child
clinic
development TransCon
dos
endocrine
enrollment
foundation
gamma oncology
health care
hypochondroplasia
infrastructure
lengthening
monotherapy
need
outcome
portfolio
product opportunity
revenue
technology platform
treatment hormone
trial TransCon
ASND Transcript
Ascendis Pharma A/S (ASND) Q1 2026 Earnings Call Transcript
Positive5-9
The earnings call summary presents a positive outlook with strong growth expectations for YORVIPATH and SKYTROFA, new partnerships, and expanding patient access. The Q&A section confirms stable demand and increasing physician adoption, despite some uncertainty in revenue specifics and guidance deferrals. The management's confidence in product efficacy and unmet medical needs further supports a positive sentiment. The stock price is likely to react positively, driven by strategic growth initiatives and market expansion.
Ascendis Pharma A/S (ASND) Presents at TD Cowen 46th Annual Health Care Conference Transcript
Neutral3-4
Ascendis Pharma A/S (ASND) Q4 2025 Earnings Call Transcript
Positive2-11
The earnings call reveals strong growth prospects driven by product launches and market expansion, particularly for YORVIPATH and TransCon CNP. Despite some competitive and pricing uncertainties, management's confidence in their differentiated products and global infrastructure suggests positive sentiment. The strategic plan outlines ambitious revenue targets, supporting a positive outlook. However, lack of clear guidance on pricing and competition could temper enthusiasm slightly. Overall, the sentiment leans towards positive, anticipating a stock price increase within the 2% to 8% range.
Ascendis Pharma A/S (ASND) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
ASND Report
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