Sarepta reports Q3 EPS (13c), consensus (48c)

Reports Q3 revenue $399.36M, consensus $337.03M. “We are pleased to have met our primary post-marketing obligation with the completion of ESSENCE, a particularly challenging trial to execute in the context of these ultra-rare diseases that heterogeneously degenerate over the course of decades. We look forward to discussing the ESSENCE results and the real-world evidence for AMONDYS 45 and VYONDYS 53 with the FDA,” stated Doug Ingram, chief executive officer, Sarepta (SRPT). Discussions between FDA and Sarepta in the safety labeling process for Elevidys are expected to be finalized in the near-term with an outcome that includes a box warning and the removal of non-ambulatory indication from the Indication and Usages section of the Prescribing Information. Discussions with FDA are also ongoing regarding Sarepta’s proposed study to evaluate an additional immunosuppression regimen toward re-including non-ambulatory in the label. Readouts of FSHD and DM1 phase 1/2 studies from both SAD and MAD cohorts expected in early 2026. At the WMS meeting, Sarepta presented new data on ELEVIDYS, as well as updates from our PMO and LGMD 2E programs. Additionally, multiple independent studies were presented, including preliminary analysis of safety, tolerability and efficacy of a prophylactic sirolimus protocol for patients receiving delandistrogene moxeparvovec-rokl gene therapy. The company has taken steps this quarter to further strengthen its financial foundation by extending the maturity of a meaningful portion of its convertible notes to 2030, enhancing liquidity with the disposition of its Arrowhead equity investment, and achieving expense savings above stated cost restructuring targets.