Ascendis Pharma A/S NASDAQ: ASND reported first-quarter 2026 results highlighted by the U.S. FDA approval of its third TransCon product, YUVIWEL, and continued growth across its rare endocrine portfolio. President and CEO Jan Mikkelsen said the quarter marked “FDA approval of our third TransCon product, UbeWell,” adding that the company’s “revenues are growing rapidly” and that Ascendis is “profitable” with “a pipeline of high-value product opportunities to support long-term growth.”
Commercial portfolio: YORVIPATH, SKYTROFA, and early YUVIWEL launch
Mikkelsen emphasized the company’s position in rare endocrine disease, pointing to three FDA-approved TransCon products across four rare endocrine indications and more than 20 ongoing or planned clinical trials aimed at label and market expansion.
In hypoparathyroidism, management reiterated long-term expectations for YORVIPATH, citing an estimated 70,000 to 90,000 chronic hypoparathyroidism patients in the U.S. and “5 to 10 times that number outside the U.S.” Mikkelsen said Ascendis continues to pursue expansion opportunities including doses up to 60 micrograms in the U.S., expansion to patients aged 12 to 18 globally, and development of a once-weekly TransCon PTH option for patients stable on YORVIPATH.
In growth disorders, Mikkelsen said Ascendis believes it is “uniquely positioned to strengthen its leadership” by pairing once-weekly YUVIWEL with once-weekly growth hormone SKYTROFA. He said YUVIWEL became commercially available in early April and, since then, had been prescribed for “more than 60 children by more than 35 unique healthcare providers,” with some children “approved for reimbursement as fast as a few days.”
Management described YUVIWEL’s clinical profile as extending beyond linear growth. Mikkelsen said data across trials showed improvements in “leg bone, spinal canal dimensions, body proportionality, physical function, and health-related quality of life compared to placebo without compromising safety or tolerability,” which he attributed to continuous systemic exposure over the weekly dosing interval.
On early YUVIWEL demand, executives declined to quantify how many initial prescriptions were switches versus new starts, with Mikkelsen saying it was “too early” after only several weeks on the market. Jay Wu, EVP and President of the U.S. market, said the company was seeing prescriptions across three groups previously discussed: patients switching from VOXZOGO, patients previously on VOXZOGO who discontinued and were on no therapy, and patients who had not started therapy at all.
For SKYTROFA in the U.S., Mikkelsen said the product maintained “consistent performance as a premium product” with “7% share of the overall growth hormone market,” reflecting demand across pediatric and adult patients. He added that expected label expansion could “double the addressable patient population” in the U.S., alongside geographic expansion.
First-quarter revenue and profitability
Chief Financial Officer Scott Smith reported total first-quarter 2026 revenue of EUR 247 million, including EUR 6 million in collaboration revenue. He said YORVIPATH generated EUR 197 million of global revenue in the quarter, while SKYTROFA contributed EUR 44 million.
Smith said YORVIPATH revenue was affected by two one-time items: U.S. patients temporarily transitioning to free drug and “a one-time impact in Europe direct related to expanded market access.” The combined impact was “approximately EUR 15 million,” according to Smith. In Q&A, Mikkelsen characterized the Europe impact as a single-country event tied to an early access program that had been running for roughly 15 to 16 months, which required a write-down in that market.
On SKYTROFA, Smith said sequential performance reflected “consistent underlying demand” plus an “expected drawdown in channel inventory built in Q4.”
Expenses for the quarter included:
- R&D: EUR 59 million, down from EUR 78 million in Q4 2025; Smith said R&D benefited from an EUR 11 million write-up of YUVIWEL inventory due to FDA approval and lower clinical activity.
- SG&A: EUR 145 million, up from EUR 136 million in Q4 2025, reflecting global commercial expansion.
Total operating expenses were EUR 204 million, and operating profit was EUR 25 million, representing a 10% operating margin. Smith reported non-IFRS operating profit of EUR 55 million and a non-IFRS operating margin of 22%. “As revenue scales, we expect meaningful improvement in our operating margin,” Smith said, adding that the improvement should be visible “over the course of 2026 and beyond.”
Smith reported a net finance expense of EUR 63 million, driven primarily by non-cash items including a EUR 34 million remeasurement loss of financial liabilities. Net cash financial expense was about EUR 1 million.
Net profit was reported at EUR 629 million, which Smith said included recognition of a EUR 679 million deferred tax asset. Non-IFRS net profit was EUR 18 million, or EUR 0.27 per share.
Cash position and notable corporate actions
Ascendis ended the quarter with EUR 573 million in cash and cash equivalents. Smith said this figure included the impact of EUR 60 million in the quarter from the company’s previously announced share repurchase program and net settlement of certain restricted stock units.
Smith also highlighted several post-quarter developments:
- In April, Ascendis completed its transition to a direct listing of its ordinary shares on Nasdaq, which Smith said could broaden access for global investors and potentially enhance institutional ownership and trading liquidity.
- In May, the company completed the full redemption of all outstanding convertible senior notes.
- Ascendis announced an agreement to sell its priority review voucher (PRV) for $187.5 million in cash; the PRV was awarded by the FDA upon approval of YUVIWEL in February.
Patient access and reimbursement metrics
Management discussed reimbursement progress and a temporary increase in free-drug support for YORVIPATH patients. Wu said “upstream coverage” had expanded to “about 80% of patient lives.” He also said the company was seeing faster approvals, with “over half approved within 8 weeks of enrollment.”
Addressing the free-drug dynamics, Mikkelsen said Ascendis moved some patients to free drug beginning in December due to a “hiccup in the reimbursement,” emphasizing that treatment interruption is highly disruptive for patients. Wu clarified that Ascendis uses two types of free-drug programs: a bridge program for temporary insurance lapses and a patient assistance program for underinsured or uninsured patients, noting that some level of assistance program utilization is expected to persist.
Wu also said the cumulative U.S. insurance approval rate since launch had continued to rise and was “closer to mid 70%.” He described it as a lagging indicator that can increase over time as older enrollments are approved on appeal.
Pipeline updates: achondroplasia combination therapy and oncology decision
Ascendis highlighted its achondroplasia combination strategy using TransCon CNP with TransCon hGH in the Phase II COACH trial. Mikkelsen said Week 52 data presented in January showed an improvement in achondroplasia-specific height Z-score indicating “a triple of efficacy compared to TransCon CNP monotherapy,” along with improvements in body proportionality. He added that more recent Week 52 data showed improvements in lower limb alignment, accelerated improvement in spinal canal dimensions, and improvement in arm span within a single year—outcomes he said had not previously been demonstrated with pharmacotherapy in that timeframe.
On trial execution, Mikkelsen said retention in COACH was “100%” after nearly 18 months, calling it rare in clinical trials.
In oncology, Mikkelsen said Phase I/II IL-Believe trial results for TransCon IL-2 beta/gamma in combination with paclitaxel in late-stage platinum-resistant ovarian cancer showed median overall survival improving “up to 10 months” from “6-7 months” historical controls with a generally well-tolerated safety profile. However, he said Ascendis decided to discontinue internal oncology development because it does not align with the company’s strategic focus, and it will “explore other ways to maximize the value of these assets.”
Looking ahead, Smith said the company expects YORVIPATH to see “strong growth sequentially in Q2” as one-time factors reverse, while SKYTROFA is expected to show stable revenue through the year following a similar seasonal pattern to 2025. On capital allocation, Smith said the company’s priority includes continued investment in R&D to sustain product flow “into the 2030s” and “the 2040s and beyond.”
About Ascendis Pharma A/S NASDAQ: ASND
Ascendis Pharma A/S is a Denmark‐based biopharmaceutical company focused on developing innovative therapies for rare endocrine diseases. Founded in 2015 and headquartered in Hellerup, the company leverages its proprietary TransCon drug delivery platform to create long‐acting prodrugs designed to improve safety, efficacy and patient convenience. Ascendis Pharma maintains research and development operations in Europe and the United States, with clinical studies spanning North America, Europe and Asia.
The company's lead product, lonapegsomatropin (Skytrofa®), is a once‐weekly growth hormone therapy approved by the U.S.
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