Sarepta (SRPT) Rises on Solid Q4 and 2023 Preliminary Results
Shares of Sarepta Therapeutics, Inc. SRPT were up 5.4% on Jan 8 after the company announced robust preliminary results for the fourth quarter and full-year 2023.
Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the newly approved gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), all targeting the Duchenne muscular dystrophy (“DMD”) indication.
Q4 & 2023 Preliminary Results
Preliminary total net product revenues are expected to be around $1.14 billion for the full year of 2023. The preliminary expected net product revenues do not include revenues from collaborations.
Preliminary net product revenues from RNA-based PMO therapies are expected to be around $234.3 million and $945 million for the fourth quarter and full-year 2023, respectively.
Preliminary net product revenues from RNA-based PMO therapies exceeded the company’s previously issued guidance of $925 million for the full year.
For the fourth quarter and full-year 2023, SRPT anticipates Elevidys net product sales to be approximately $131.3 million and $200.4 million, respectively.
Per management, preliminary net product sales of Elevidys significantly exceeded the consensus.
Our model estimate for Elevidys net product sales stands at $90 million and $159 million for the fourth quarter and full-year 2023, respectively.
Preliminary cash, cash equivalents and investments were almost $1.7 billion as of Dec 31, 2023.
Shares of Sarepta have declined 13.9% in the past year compared with the industry’s decrease of 12.9%.
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The FDA granted accelerated approval to Elevidys for treating ambulatory pediatric patients aged between four and five years with DMD in June 2023. Following the accelerated nod, Elevidys became the first approved gene therapy for DMD.
Last month, SRPT submitted an efficacy supplement to the biologics license application (BLA), with the FDA seeking to expand the treatment label for Elevidys in DMD.
The BLA supplement seeks full approval for Elevidys to treat all DMD patients, irrespective of age and ambulation status. It also requests the FDA to grant priority review to the submission.
Sarepta has developed Elevidys in collaboration with Roche RHHBY. Sarepta and Roche entered into a licensing agreement in 2019 to develop and commercialize Elevidys jointly.
Per the agreement, Roche has exclusive rights to launch and commercialize Elevidys in ex-U.S. markets. SRPT records collaboration revenues from RHHBY from this licensing agreement.
Zacks Rank & Other Stocks to Consider
Sarepta currently carries a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the healthcare sector are AnaptysBio, Inc. ANAB and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for AnaptysBio’s 2024 loss per share have narrowed from $6.44 to $6.38. In the past year, shares of ANAB have inched up 2.5%.
Earnings of AnaptysBio beat estimates in two of the last four quarters while missing the same on the remaining two occasions. ANAB delivered a negative four-quarter average earnings surprise of 6.48%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 4.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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