Sarepta Q4 Earnings Lag Estimates, Revenues Gain on Gene Therapy Sales

Sarepta Therapeutics, Inc. SRPT reported fourth-quarter 2024 earnings per share (EPS) of $1.50, which missed the Zacks Consensus Estimate of $1.87. However, the reported figure was significantly higher than the year-ago period’s 47 cents due to higher product sales.The loss included depreciation and amortization costs and stock-based compensation expenses. The adjusted EPS in the quarter was $1.90 compared with 82 cents in the year-ago period.Sarepta recorded total revenues of $658.4 million, up 66% year over year. The upside was driven by sales of Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). The reported figure beat the Zacks Consensus Estimate of $640 million.See the Zacks Earnings Calendar to stay ahead of market-making news.Shares were down 1% in pre-market trading today, likely due to the mixed quarterly results.Year to date, the stock has lost 12% against the industry’s 7% growth.Image Source: Zacks Investment ResearchMore on SRPT’s EarningsSarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and Elevidys, all targeting DMD indications.SRPT product revenues surged 75% year over year to $638.2 million, driven by increased demand for its marketed products. The metric beat the Zacks Consensus Estimate of $608 million and our model estimate of $619 million.The company generated around $254 million from the product sales of its three PMO therapies. The figure rose nearly 9% year over year.Sarepta generated $384.2 million from Elevidys sales compared with $181 million in third-quarter 2024. The metric beat the Zacks Consensus Estimate of $369 million. This beat was likely due to the therapy’s label expansion, which was approved by the FDA toward the end of June 2024 to treat all DMD patients, regardless of ambulation status.SRPT recorded around $20.3 million as collaboration and other revenues associated with commercial Elevidys supply to Roche RHHBY. This figure also included $4.9 million received as royalty revenues from Elevidys sales by RHHBY in ex-U.S. territories. In the year-ago period, management recorded $31.7 million under this head, most of which was also received from Roche.Sarepta and Roche entered into a licensing agreement in 2019 to develop Elevidys. Per the agreement, RHHBY has exclusive rights to launch and commercialize Elevidys in ex-U.S. markets.Discussion on SRPT’s Operating CostsAdjusted research and development (R&D) expenses totaled $172.7 million, up 5% year over year. The upside was primarily caused by an increase in clinical costs incurred during the quarter.Adjusted selling, general & administrative (SG&A) expenses totaled $131.6 million, up 25% year over year. This was primarily caused by an increase in professional service expenses incurred by the company for Elevidys’ launch.Full-Year 2024 ResultsSarepta reported total revenues of $1.9 billion in 2024, up 53% year over year.EPS for the full year was $2.34 against a loss of $5.80 in the year-ago period. The adjusted EPS in 2024 was $3.69 against an adjusted loss of 64 cents per share in 2023.SRPT’s 2025 GuidanceManagement reiterated its net product revenue projection for full-year 2025 between $2.9 billion and $3.1 billion. It expects more than two-thirds of this revenue to be generated from Elevidys.At the conference call, Sarepta also issued fresh guidance on expenses for the year. It expects the combined adjusted R&D and SG&A expenses to be in the $1.2-$1.3 billion range.Updates on SRPT’s Pipeline & Other NewsEarlier this month, Sarepta closed the recently signed multi-billion dollar deal with Arrowhead Pharmaceuticals ARWR. With the completion of the deal, Sarepta now holds exclusive rights to ARWR’s seven pipeline programs, which include four in active clinical development that are being evaluated in separate phase I/II studies.The first is SRP-1001 (formerly ARO-DUX4), which is being developed as a potential treatment for patients with facioscapulohumeral muscular dystrophy (FSHD), while SRP-1003 (formerly ARO-DM1) is being developed to treat myotonic dystrophy type 1 (DM1). The remaining candidates, SRP-1002 (formerly ARO-MMP7) and SRP-1004 (formerly ARO-ATXN2), are being developed to treat idiopathic pulmonary fibrosis (IPF) and spinocerebellar ataxia 2 (SCA2) indications, respectively.Last month, Sarepta reported positive top-line results from part 2 of the phase III EMBARK study evaluating Elevidys in crossover-treated DMD patients aged 4-7 years. These patients had received a placebo in part 1 of the study and crossed over at 52 weeks. Data from this part of the study showed that treatment with Elevidys demonstrated significant functional improvements in the North Star Ambulatory Assessment (NSAA), Time to Rise (TTR), and 10-meter walk/run (10MWR) tests compared to a pre-specified, propensity-weighted external control group.Sarepta is currently evaluating SRP-9003, an investigational gene therapy, in the late-stage EMERGENE study for treating Limb-girdle muscular dystrophy (LGMD) type 2E/R4 (LGMD2E/R4). It plans to submit a regulatory filing with the FDA in mid-2025 for SRP-9003 in the given indication. If the data is positive, Sarepta intends to submit a regulatory filing seeking accelerated approval for SRP-9003 in the given indication before 2025-end.Management is also studying another investigational gene therapy candidate, SRP-6004, in the phase I NAVIGENE study for treating ambulatory patients with LGMD type 2B/R2. In December, Sarepta announced that it has started a clinical study on gene therapy candidate SRP-9004 in LGMD type 2D. Management is also on track to start a clinical study on another gene therapy, SRP-9005, for LGMD type 2C, in early 2025. Both studies are designed to support the FDA’s approval under the accelerated pathway.Sarepta Therapeutics, Inc. Price Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. QuoteSRPT’s Zacks RankSarepta currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank  #1 (Strong Buy) stocks here.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks