Revenue and earnings trends
Sarepta Therapeutics (SRPT) has returned 169.97% YTD (year-to-date). In the second quarter, it reported EPS of -$0.43, surpassing the consensus estimate by $0.46. EXONDYS 51 sales were $73.5 million in the quarter, which is a YoY (year-over-year) rise of 110%. EXONDYS sales were $138 million in the first half of 2018. The company expects to report $295 million–$305 million in sales of EXONDYS 51 in 2018.
Analyst recommendations for Sarepta Therapeutics
The consensus recommendation for Sarepta Therapeutics over the next 12 months is a “buy.” Of the 21 analysts covering the stock in September, seven have recommended a “strong buy,” 13 have recommended a “buy,” and one has recommended a “hold.”
Wall Street analysts have projected a 12-month consensus target price of $188.58, which is a 25.54% rise over its closing price on September 13.
By the end of 2018, Sarepta Therapeutics plans to submit a rolling NDA (New Drug Application) to the FDA for golodirsen, an investigational phosphorodiamidate Morpholino oligomer (or PMO) therapy, in Duchenne muscular dystrophy (or DMD) due to deletions in the DMD gene related to exon 53 skipping. The company has estimated that 8% of DMD patients have exon 53 amenable mutations in their DMD gene. The company expects an FDA decision in 2019.
Sarepta Therapeutics is studying another investigational PMO therapy, casimersen, in the Phase 3 ESSENCE trial for DMD patients with DMD gene mutations amenable to exon 45 skipping. The company has conducted a Type C meeting with the FDA related to this trial. These efforts may accelerate the FDA approval process for casimersen.
While 13% of the DMD patient population is currently eligible for treatment with EXONDYS 51, regulatory approvals for casimersen and golodirsen are expected to expand the addressable market opportunity for Sarepta Therapeutics to 30% of the DMD patient population.
Next, let’s look at the growth trends for Regenxbio.