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Sarepta (SRPT) Q4 Earnings Beat Estimates, Revenues Up Y/Y
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Sarepta Therapeutics, Inc. (SRPT - Free Report) reported earnings of 47 cents per share in the fourth quarter of 2023, against the Zacks Consensus Estimate of a loss of 3 cents. In the year-ago period, the company posted a loss of $1.24 per share.
The loss included depreciation and amortization expenses and stock-based compensation expenses. The adjusted earnings per share in the quarter stood at 82 cents against the year-ago period’s adjusted loss of 61 cents per share.
Sarepta recorded total revenues of $396.8 million, up 54% year over year. The upside was driven by sales of Sarepta’s four approved marketed therapies for Duchenne muscular dystrophy (“DMD”).The reported revenues beat the Zacks Consensus Estimate of $382.1 million.
Shares were up 1.8% in after-market trading on Feb 28, likely due to the better-than-expected earnings results. In the year so far, the stock has surged 46.2% compared with the industry’s 2.2% rise.
Image Source: Zacks Investment Research
Quarter in Detail
Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the recently approved Elevidys gene therapy, all targeting DMD indication.
The company’s product revenues were up 55% year over year at $365.1 million, in line with our model estimates. The upside was driven by an increased demand for its marketed products.
Sarepta generated around $233.9 million from the product sales of its three PMO therapies, down 1% year over year.
During the fourth quarter, the company generated $131.2 million from Elevidys sales compared with $69.1 million in the third quarter. Elevidys received accelerated approval from the FDA last year in June as the first gene therapy for DMD and wascommercially launched in third-quarter 2023.
The company recorded $31.7 million in collaboration revenues, primarily from its licensing agreement with Roche (RHHBY - Free Report) . In the year-ago period, management recorded $22.5 million as collaboration revenues, which were also received from Roche.
Sarepta and Roche entered into a licensing agreement in 2019 to develop Elevidys. Per the agreement, Roche has exclusive rights to launch and commercialize Elevidys in ex-U.S. markets.
Adjusted research and development (R&D) expenses totaled $165.1 million in the fourth quarter, down 12% year over year. This downside was caused by a decline in manufacturing expenses incurred during the quarter.
Adjusted selling, general & administrative (SG&A) expenses were $105.7 million, up 22% year over year. The upside was driven primarily by an increase in professional service expenses incurred by the company for Elevidys’ launch.
Full-Year Results
Sarepta reported total revenues of $1.24 billion in 2023, up 33% year over year. The company incurred a loss of $5.80 per share for the full year compared with a loss of $8.03 in the year-ago period. The adjusted loss in 2023 was 64 cents per share compared with an adjusted loss of $3.32 in 2022.
Recent Updates
Earlier this month, Sarepta announced that the FDA accepted its efficacy supplement to the biologics license application (BLA), seeking to expand the treatment label for Elevidys. The FDA assigned the Priority Review status to the company’s Elevidys filing, and a final decision is expected by Jun 21, 2024. The purpose of the efficacy supplement is two-fold. It seeks to expand the labeled indication for Elevidys to treat all DMD patients, irrespective of age and ambulation status. Subject to approval, it will also convert the Elevidys accelerated approval to a traditional approval.
Last month, Sarepta reported positive data from part B of the phase II MOMENTUM study evaluating SRP-5051 in DMD patients aged eight to 21 years who are amenable to exon 51 skipping. Data from the study showed that patients who received the target dose (i.e., nearly 30 mg/kg) of SRP-5051 every four weeks achieved mean dystrophin expression of 5.17% and mean exon skipping of 11.11% at 28 weeks. Per management, these results were substantially higher than those observed in Exondys 51, which requires weekly doses.
However, some patients who received SRP-5051 experienced hypomagnesemia (low levels of magnesium) and hypokalemia (low levels of potassium). The company intends to meet with the FDA to discuss the results and plan its next steps.
In January, Sarepta also announced that it has started screening patients in the phase III EMERGENE study to evaluate SRP-9003 for the treatment of Limb-girdle muscular dystrophy (LGMD) type 2E (LGMD2E/R4). The study will enroll 15 participants, both ambulatory and non-ambulatory, aged four years and older.
Sarepta currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy) at present, Adicet carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have risen from 69 cents to 71 cents. Year to date, shares of PBYI have rallied 52.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 23.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.
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Sarepta (SRPT) Q4 Earnings Beat Estimates, Revenues Up Y/Y
Sarepta Therapeutics, Inc. (SRPT - Free Report) reported earnings of 47 cents per share in the fourth quarter of 2023, against the Zacks Consensus Estimate of a loss of 3 cents. In the year-ago period, the company posted a loss of $1.24 per share.
The loss included depreciation and amortization expenses and stock-based compensation expenses. The adjusted earnings per share in the quarter stood at 82 cents against the year-ago period’s adjusted loss of 61 cents per share.
Sarepta recorded total revenues of $396.8 million, up 54% year over year. The upside was driven by sales of Sarepta’s four approved marketed therapies for Duchenne muscular dystrophy (“DMD”).The reported revenues beat the Zacks Consensus Estimate of $382.1 million.
Shares were up 1.8% in after-market trading on Feb 28, likely due to the better-than-expected earnings results. In the year so far, the stock has surged 46.2% compared with the industry’s 2.2% rise.
Image Source: Zacks Investment Research
Quarter in Detail
Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the recently approved Elevidys gene therapy, all targeting DMD indication.
The company’s product revenues were up 55% year over year at $365.1 million, in line with our model estimates. The upside was driven by an increased demand for its marketed products.
Sarepta generated around $233.9 million from the product sales of its three PMO therapies, down 1% year over year.
During the fourth quarter, the company generated $131.2 million from Elevidys sales compared with $69.1 million in the third quarter. Elevidys received accelerated approval from the FDA last year in June as the first gene therapy for DMD and wascommercially launched in third-quarter 2023.
The company recorded $31.7 million in collaboration revenues, primarily from its licensing agreement with Roche (RHHBY - Free Report) . In the year-ago period, management recorded $22.5 million as collaboration revenues, which were also received from Roche.
Sarepta and Roche entered into a licensing agreement in 2019 to develop Elevidys. Per the agreement, Roche has exclusive rights to launch and commercialize Elevidys in ex-U.S. markets.
Adjusted research and development (R&D) expenses totaled $165.1 million in the fourth quarter, down 12% year over year. This downside was caused by a decline in manufacturing expenses incurred during the quarter.
Adjusted selling, general & administrative (SG&A) expenses were $105.7 million, up 22% year over year. The upside was driven primarily by an increase in professional service expenses incurred by the company for Elevidys’ launch.
Full-Year Results
Sarepta reported total revenues of $1.24 billion in 2023, up 33% year over year. The company incurred a loss of $5.80 per share for the full year compared with a loss of $8.03 in the year-ago period. The adjusted loss in 2023 was 64 cents per share compared with an adjusted loss of $3.32 in 2022.
Recent Updates
Earlier this month, Sarepta announced that the FDA accepted its efficacy supplement to the biologics license application (BLA), seeking to expand the treatment label for Elevidys. The FDA assigned the Priority Review status to the company’s Elevidys filing, and a final decision is expected by Jun 21, 2024. The purpose of the efficacy supplement is two-fold. It seeks to expand the labeled indication for Elevidys to treat all DMD patients, irrespective of age and ambulation status. Subject to approval, it will also convert the Elevidys accelerated approval to a traditional approval.
Last month, Sarepta reported positive data from part B of the phase II MOMENTUM study evaluating SRP-5051 in DMD patients aged eight to 21 years who are amenable to exon 51 skipping. Data from the study showed that patients who received the target dose (i.e., nearly 30 mg/kg) of SRP-5051 every four weeks achieved mean dystrophin expression of 5.17% and mean exon skipping of 11.11% at 28 weeks. Per management, these results were substantially higher than those observed in Exondys 51, which requires weekly doses.
However, some patients who received SRP-5051 experienced hypomagnesemia (low levels of magnesium) and hypokalemia (low levels of potassium). The company intends to meet with the FDA to discuss the results and plan its next steps.
In January, Sarepta also announced that it has started screening patients in the phase III EMERGENE study to evaluate SRP-9003 for the treatment of Limb-girdle muscular dystrophy (LGMD) type 2E (LGMD2E/R4). The study will enroll 15 participants, both ambulatory and non-ambulatory, aged four years and older.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Key Picks
Sarepta currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy) at present, Adicet carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have risen from 69 cents to 71 cents. Year to date, shares of PBYI have rallied 52.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 23.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.