In its fourth-quarter earnings conference call, Sarepta Therapeutics (SRPT) highlighted its submission of an NDA (new drug application) in the fourth quarter seeking FDA approval for investigational PMO (phosphorodiamidate morpholino oligomer) based RNA therapy Golodirsen in DMD (Duchenne muscular dystrophy) amenable to the exon 53 skipping indication. The FDA has set the PDUFA (Prescription Drug User Fee Act) date for this NDA as August 19, 2019. If approved, Golodirsen is expected to target 8% of the total DMD patient population.
Sarepta Therapeutics is also evaluating investigational therapy casimersen for DMD patients amenable to exon 45 skipping in its ESSENCE study. The company expects to file an NDA for this therapy in fiscal 2019. According to the company’s fourth-quarter earnings conference call, if approved by the FDA, casimersen is expected to add 8% of the total DMD patients to Sarepta’s addressable market. According to the company’s investor presentation, Amarin (AMRN) expects the label expansion of Vascepa based on REDUCE-IT trial results to prove to be a multi-billion dollar market opportunity in future years.
Wall Street projections
Wall Street analysts have projected Sarepta Therapeutics’ SG&A (selling, general, and administrative) expense to sales percentages to be 63.40%, 42.84%, and 25.20% for fiscal 2019, fiscal 2020, and fiscal 2021, respectively. Wall Street analysts have projected Amarin’s SG&A expense to sales percentage to be 78.95%, 55.71%, and 41.21% for fiscal 2019, fiscal 2020, and fiscal 2021, respectively.
Wall Street analysts have projected Sarepta Therapeutics’ research and development expense to sales percentage to be 98.08%, 60.73%, and 33.94% for fiscal 2019, fiscal 2020, and fiscal 2021, respectively. Wall Street analysts have projected Amarin’s R&D (research and development) expense to sales percentage to be 11.46%, 4.93%, and 4.20%, for fiscal 2019, fiscal 2020, and fiscal 2021, respectively.
Amarin is expected to dedicate a much higher percentage of its total sales to SG&A but a lower percentage of its total sales to R&D activities as compared to Sarepta Therapeutics from fiscal 2019 to fiscal 2021.
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