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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals a strong financial performance with significant revenue growth and a successful launch of YORVIPATH. Despite increased SG&A expenses due to global expansion, the company shows a positive outlook with steady patient enrollment and high compliance rates. The Q&A section highlighted management's efforts to improve processes and their optimistic view of market potential. Although some guidance was not provided, the overall sentiment is positive, suggesting a potential stock price increase of 2% to 8% over the next two weeks.
Total Product Revenue EUR 153.7 million for Q2 2025, which includes a negative sequential foreign currency exchange rate impact of EUR 7.6 million.
SKYTROFA Revenue EUR 50.7 million for Q2 2025, including a EUR 1.8 million negative currency impact.
YORVIPATH Revenue EUR 103 million for Q2 2025, more than doubling from EUR 44.7 million in Q1 2025, despite a negative sequential currency headwind of EUR 5.8 million. Growth driven by strong uptake in the U.S. and steady performance outside the U.S.
R&D Costs EUR 72 million for Q2 2025, decreased from EUR 83.5 million in the same period last year, primarily due to lower development costs for growth disorders.
SG&A Expenses EUR 107.6 million for Q2 2025, increased from EUR 74.3 million in the same period last year, primarily driven by global commercial expansion.
Operating Expenses EUR 180 million for Q2 2025.
Net Finance Income EUR 22 million for Q2 2025, driven primarily by noncash items.
Net Cash Financial Expenses EUR 5.3 million for Q2 2025.
Cash and Cash Equivalents EUR 494 million as of June 30, 2025, compared to EUR 518 million as of March 31, 2025. The EUR 24 million sequential decrease includes EUR 19 million due to cash translation to euro.
YORVIPATH: Revenue in Q2 reached EUR 103 million, more than doubling from Q1. Over 1,500 prescribers wrote prescriptions for around 3,100 unique patients in the U.S. Strong growth is also seen in Europe and international markets. The product is expected to become a blockbuster for treating hypoparathyroidism.
TransCon CNP: FDA granted priority review with a PDUFA date of November 30, 2025. It has shown significant improvement in safety and effectiveness for treating achondroplasia. Interim Phase II results from a combination therapy trial with TransCon Growth Hormone showed boosted healthy growth in achondroplasia.
SKYTROFA: Q2 revenue was EUR 51 million. Recently received FDA approval for adult growth hormone deficiency, with further label expansions planned. It is a high-value brand for pediatric growth hormone deficiency and is expected to drive long-term growth.
YORVIPATH Global Expansion: Commercial agreements cover more than 75 countries. Full commercial launches in Germany, Austria, and Spain, with additional launches expected in Europe and international markets. Japan approval is anticipated later this quarter.
Revenue Growth: Total Q2 product revenue was EUR 153.7 million, driven by strong performance of YORVIPATH and SKYTROFA. Sequential growth across global markets remains strong.
Cost Management: R&D costs decreased to EUR 72 million, while SG&A expenses increased to EUR 107.6 million due to global commercial expansion.
Vision 2030: Focused on achieving blockbuster status for multiple products and expanding innovation. Preparing for additional label expansions and new clinical trials to drive long-term growth.
Currency Exchange Rate Impact: The company faced a negative sequential foreign currency exchange rate impact of EUR 7.6 million, which affected overall revenue.
R&D Cost Reduction: R&D costs decreased to EUR 72 million from EUR 83.5 million in the same period last year, primarily due to lower development costs for growth disorders. This could indicate a potential risk of underinvestment in future innovation.
SG&A Expense Increase: SG&A expenses increased to EUR 107.6 million from EUR 74.3 million in the same period last year, driven by global commercial expansion. This rise in expenses could pressure profitability if revenue growth does not keep pace.
Cash Flow and Currency Translation: The company experienced a EUR 24 million sequential decrease in cash, with EUR 19 million attributed to cash translation to euro. This highlights exposure to currency fluctuations.
Regulatory and Approval Risks: The company is awaiting FDA approval for TransCon CNP with a PDUFA date of November 30, 2025. Delays or negative outcomes could impact strategic objectives and revenue projections.
Market Access and Reimbursement: While YORVIPATH has seen strong uptake, the company is still working on securing reimbursement in additional European countries. Delays in reimbursement could slow revenue growth.
Competitive Pressures: The company acknowledges that no publicly disclosed drug in clinical development matches YORVIPATH's efficacy and safety. However, emerging competitors could challenge this position.
Economic and Operational Risks: The company is expanding globally, which increases exposure to economic uncertainties and operational challenges in diverse markets.
Revenue Growth: The company expects continued revenue growth driven by the global launch of YORVIPATH and the recent label expansion for SKYTROFA for adult growth hormone deficiency.
YORVIPATH Projections: YORVIPATH is expected to achieve multiple billions of euros annually in peak sales over time, with continued strong demand and global uptake. The company anticipates further acceleration of revenue growth as reimbursement becomes available in additional European countries and with the expected approval in Japan later this quarter.
SKYTROFA Growth: Long-term growth for SKYTROFA is expected to be driven by label expansion, including the recent approval for adult growth hormone deficiency. A Phase III basket trial is planned to begin later this year to include additional indications.
TransCon CNP: The FDA has accepted the NDA submission for TransCon CNP for priority review, with a PDUFA date of November 30, 2025. The company anticipates approval and plans to start a Phase III study of combination therapy in children with achondroplasia by the end of 2025.
Combination Therapy for Achondroplasia: The company plans to release 12-month data for the combination therapy of TransCon CNP and TransCon Growth Hormone later this year and initiate a pivotal combination trial in hypochondroplasia.
Cash Flow Projections: The company expects to become cash flow positive on a quarterly basis this year, supported by the strong performance of YORVIPATH and SKYTROFA.
The selected topic was not discussed during the call.
The earnings call presents a strong financial performance with expected revenue growth from YORVIPATH and SKYTROFA, supported by label expansions and global launches. The company anticipates becoming cash flow positive, which is a positive indicator. The Q&A section highlights confidence in overcoming challenges, with high patient retention rates and strategic market penetration. The overall sentiment is positive, supported by optimistic guidance and strategic growth plans, likely leading to a stock price increase in the short term.
The earnings call reveals a strong financial performance with significant revenue growth and a successful launch of YORVIPATH. Despite increased SG&A expenses due to global expansion, the company shows a positive outlook with steady patient enrollment and high compliance rates. The Q&A section highlighted management's efforts to improve processes and their optimistic view of market potential. Although some guidance was not provided, the overall sentiment is positive, suggesting a potential stock price increase of 2% to 8% over the next two weeks.
Despite strong revenue growth and a new partnership with Novo Nordisk, the earnings miss, high operating expenses, and vague management responses in the Q&A session create uncertainty. The lack of clear guidance on reimbursement and revenue split, alongside cash flow concerns, offset the positive impact of the partnership and product launches. The neutral shareholder return plan further contributes to a neutral sentiment.
The earnings call presents a mixed sentiment. Positive aspects include strong revenue growth for YorvaPath and collaboration with Novo Nordisk. However, there are concerns about rising operating expenses and supply chain challenges. The Q&A reveals uncertainties in reimbursement and lack of clarity in some responses, leading to a cautious market sentiment. No shareholder return plan was announced, which might disappoint investors. The overall sentiment is neutral, with no major negative or positive catalysts to significantly impact the stock price.
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