uniQure N.V.

Revenue for the 3 months ended June 30, 2026 was $5.8 million, up from $5.3 million in the same period of 2025. Research and development expense was $34 million, down from $35.4 million year over year, and selling, general and administrative expense was $17.4 million versus $13.5 million a year ago. Cash, cash equivalents and investment securities totaled $810.3 million as of June 30, 2026, compared with $622.5 million at December 31, 2025. Management reiterated that cash is expected to fund operations into 2030. No quarterly EPS figure was given in the call. On guidance, uniQure said it remains on track for a third-quarter AMT-130 BLA submission, a third-quarter U.K. submission, and September 4-year AMT-130 data, while the confirmatory-study design is still being finalized with FDA.

Matt Kapusta framed the quarter as a major regulatory step forward, saying the company received FDA and MHRA guidance that clarifies AMT-130’s near-term path. He emphasized that the BLA package is being built around the 3-year data, that the confirmatory study is being prepared in parallel, and that the company is moving into the second half of the year with strong momentum. His tone was confident and focused on execution, commercial readiness, and keeping the company funded through multiple milestones.

Christian Klemt highlighted a stronger balance sheet after the follow-on offering, with cash, cash equivalents and investment securities rising to $810.3 million from $622.5 million at year-end 2025. He walked through second-quarter revenue of $5.8 million, R&D expense of $34 million, and SG&A of $17.4 million, noting higher SG&A mainly reflected hiring to support potential AMT-130 commercialization. He said the current cash position should support operations into 2030, including the confirmatory trial, commercial launches, ongoing clinical programs, and potential late-stage pipeline investments.

Analysts focused heavily on whether an AdCom is likely, how quickly the confirmatory study can be operationalized, and whether enrollment could become a gating factor for approval. Management said they most likely expect an AdCom but believe the package is complete and self-contained, and they repeated that accelerated approval does not require confirmatory enrollment to be complete, only that the trial be feasible and well underway in a timely manner. They also said the confirmatory study design and sample size are still being finalized with FDA, and they declined to give a specific enrollment estimate or speculate on the content of a potential AdCom.