Sarepta Therapeutics (SRPT) is a commercial-stage biopharmaceutical company focused on developing unique RNA-targeted therapeutics, gene therapy, and other genetic products targeted for rare neuromuscular diseases. Sarepta’s first product on the market, Exondys 51 (eteplirsen), is indicated for treating Duchenne muscular dystrophy (or DMD).
In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion for eteplirsen. Sarepta has requested a re-examination of this opinion, and the process is expected to be completed by the end of 2018.
Sarepta has also initiated a market access program for the drug in key European, North American, South American, and Asian countries where it has not been approved. The access program provides a mechanism for physicians to prescribe eteplirsen for patients who meet pre-specified criteria.
Sarepta Therapeutics generated revenues of $73.53 million in the second quarter compared to $35.01 million in Q2 2017. The increase was due to higher sales of Exondys due to higher demand.
For fiscal 2018 and fiscal 2019, Sarepta is expected to generate revenues of $302.25 million and $428.48 million, respectively, compared to revenues of $154.58 million in fiscal 2017.
Sarepta Therapeutics incurred cost of sales of $6.73 million in the second quarter compared to $506,000 in the second quarter of 2017.
In the next and final part of this series, we’ll look at Sarepta Therapeutics’ bottom line and valuation metrics.