Sarepta Expects Prelim Gene Therapy Revenue To Be $131M In Q4, $200M For Fiscal Year

Monday, Sarepta Therapeutics Inc SRPT reported preliminary FY23 net product revenue of $1.145 billion.

The Cambridge, Massachusetts-based company said preliminary Elevidys net product revenue is expected to be $131.3 million for Q4 and $200.4 million for FY23, significantly exceeding consensus.

Fourth quarter and full-year 2023 net product revenue for Sarepta's RNA-based PMOs are expected to be approximately $234.3 million and $945.0 million, respectively.

As of Dec. 31, 2023, Sarepta had preliminary cash, cash equivalents, restricted cash, and investments of approximately $1.7 billion.

Also Read: Sarepta/Roche's Closely Watched Duchenne Gene Therapy Faces More FDA Scrutiny - Stock Tanks.

According to Wedbush, the preliminary revenue indicates a significant patient demand for Elevidys, reinforcing the belief that Elevidys is poised to lead in treating Duchenne muscular dystrophy (DMD). The firm anticipates additional value as Elevidys' usage expands, particularly if its label is widened.

Wedbush notes that Sarepta is seeking the removal of the age and ambulatory status restrictions on Elevidys' current label, along with a request for priority review and the submission of the post-marketing requirement requesting conversion of Elevidys' accelerated approval to traditional approval. 

The company expects an FDA response on the filing for Elevidys/DMD in early March 2024 and a PDUFA date in August 2024, making ~86% of DMD patients eligible for Elevidys treatment. 

Wedbush currently projects FY30 sales for Elevidys of $8.65 billion.

The analyst keeps the Outperform rating with a price target of $224.

Price Action: SRPT shares are up 9.77% at $112.64 on the last check Tuesday.

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