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SRPT Beats on Q3 Earnings & Sales, Discontinues PPMO-Based DMD Program
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Sarepta Therapeutics (SRPT - Free Report) posted third-quarter 2024 adjusted earnings per share (EPS) of 62 cents, which beat the Zacks Consensus Estimate of a loss of 15 cents. Earnings rose 99% year over year, driven by encouraging product sales during the quarter.
The adjusted earnings did not include depreciation and amortization expenses and stock-based compensation costs. Including these items, EPS was 34 cents against the year-ago period’s reported loss of 46 cents.
Sarepta recorded total revenues of $467.2 million, up 41% year over year. The upside was driven by sales of its four approved marketed therapies for Duchenne muscular dystrophy (DMD). The reported figure beat the Zacks Consensus Estimate of $399.9 million.
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on SRPT’s Earnings
Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the one-shot gene therapy Elevidys, all targeting DMD indication.
SRPT product revenues rose 39% year over year to about $430 million, driven by increased demand for its marketed products. The metric beat the Zacks Consensus Estimate and our model estimate of $392 million each.
The company generated around $249 million from the product sales of its three PMO therapies. The figure rose nearly 4% year over year.
Sarepta generated $181 million from Elevidys sales compared with about $122 million in second-quarter 2024. The metric beat the Zacks Consensus Estimate and our model estimate of $162 million and $160 million, respectively. 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 $37.4 million as collaboration and other revenues associated with commercial Elevidys supply to Roche (RHHBY). This metric also included $9.5 million received as royalty revenues from Elevidys sales by RHHBY in ex-U.S. territories. In the year-ago period, management recorded $22.5 million under this head, all of which were 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.
Adjusted research and development expenses totaled $199.8 million, up 22% year over year. The upside was primarily caused by an increase in costs associated with the termination of a manufacturing and supply agreement with an affiliate of Thermo Fisher in August.
Adjusted selling, general & administrative expenses totaled $100.2 million, up 8% year over year. This was primarily caused by an increase in professional service expenses incurred by the company for Elevidys’ launch.
SRPT Reiterates Guidance
In the conference call, management reiterated its guidance for fourth-quarter 2024 and full-year 2025. Though it did not provide any exact guidance for 2024, it expects Elevidys revenues in the fourth quarter of 2024 to double on a sequential basis.
For 2025, management also maintained its previously issued guidance of $2.9-$3.1 billion for net product revenues. It expects two-thirds of the revenues to be generated from Elevidys sales, and the rest from PMO products.
Updates on SRPT’s Pipeline & Other News
Alongside the earnings release, Sarepta also announced its decision to discontinue its entire PPMO program, which also includes the investigational exon 51 skipping DMD candidate SRP-5051. Management made this decision after assessing the program's risk-benefit profile and considering the ‘evolving therapeutic landscape’ for DMD indication.
The above decision was possibly the reason behind the nearly 2% fall in Sarepta’s share price in after-market trading on Wednesday. Investors were unhappy with management dismissing a pipeline drug that was expected to enter late-stage development in the coming months. In the year-to-date period, the stock has surged 32.7% against the industry’s 2.5% decline.
Image Source: Zacks Investment Research
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.
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.
It also plans to start two clinical studies on SRP-9004 to treat LGMD type 2D and SRP-9005 in LGMD type 2C, by 2024-end and early 2025, respectively. Both these studies will be designed to support the FDA’s approval under the accelerated pathway.
In the past 60 days, estimates for Amicus Therapeutics’ 2024 EPS have moved up from 21 to 22 cents. EPS estimates for 2025 have increased from 49 to 53 cents during the same period. Year to date, shares of FOLD have lost 17.3%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 23.96%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 31.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.
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SRPT Beats on Q3 Earnings & Sales, Discontinues PPMO-Based DMD Program
Sarepta Therapeutics (SRPT - Free Report) posted third-quarter 2024 adjusted earnings per share (EPS) of 62 cents, which beat the Zacks Consensus Estimate of a loss of 15 cents. Earnings rose 99% year over year, driven by encouraging product sales during the quarter.
The adjusted earnings did not include depreciation and amortization expenses and stock-based compensation costs. Including these items, EPS was 34 cents against the year-ago period’s reported loss of 46 cents.
Sarepta recorded total revenues of $467.2 million, up 41% year over year. The upside was driven by sales of its four approved marketed therapies for Duchenne muscular dystrophy (DMD). The reported figure beat the Zacks Consensus Estimate of $399.9 million.
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on SRPT’s Earnings
Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the one-shot gene therapy Elevidys, all targeting DMD indication.
SRPT product revenues rose 39% year over year to about $430 million, driven by increased demand for its marketed products. The metric beat the Zacks Consensus Estimate and our model estimate of $392 million each.
The company generated around $249 million from the product sales of its three PMO therapies. The figure rose nearly 4% year over year.
Sarepta generated $181 million from Elevidys sales compared with about $122 million in second-quarter 2024. The metric beat the Zacks Consensus Estimate and our model estimate of $162 million and $160 million, respectively. 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 $37.4 million as collaboration and other revenues associated with commercial Elevidys supply to Roche (RHHBY). This metric also included $9.5 million received as royalty revenues from Elevidys sales by RHHBY in ex-U.S. territories. In the year-ago period, management recorded $22.5 million under this head, all of which were 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.
Adjusted research and development expenses totaled $199.8 million, up 22% year over year. The upside was primarily caused by an increase in costs associated with the termination of a manufacturing and supply agreement with an affiliate of Thermo Fisher in August.
Adjusted selling, general & administrative expenses totaled $100.2 million, up 8% year over year. This was primarily caused by an increase in professional service expenses incurred by the company for Elevidys’ launch.
SRPT Reiterates Guidance
In the conference call, management reiterated its guidance for fourth-quarter 2024 and full-year 2025. Though it did not provide any exact guidance for 2024, it expects Elevidys revenues in the fourth quarter of 2024 to double on a sequential basis.
For 2025, management also maintained its previously issued guidance of $2.9-$3.1 billion for net product revenues. It expects two-thirds of the revenues to be generated from Elevidys sales, and the rest from PMO products.
Updates on SRPT’s Pipeline & Other News
Alongside the earnings release, Sarepta also announced its decision to discontinue its entire PPMO program, which also includes the investigational exon 51 skipping DMD candidate SRP-5051. Management made this decision after assessing the program's risk-benefit profile and considering the ‘evolving therapeutic landscape’ for DMD indication.
The above decision was possibly the reason behind the nearly 2% fall in Sarepta’s share price in after-market trading on Wednesday. Investors were unhappy with management dismissing a pipeline drug that was expected to enter late-stage development in the coming months. In the year-to-date period, the stock has surged 32.7% against the industry’s 2.5% decline.
Image Source: Zacks Investment Research
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.
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.
It also plans to start two clinical studies on SRP-9004 to treat LGMD type 2D and SRP-9005 in LGMD type 2C, by 2024-end and early 2025, respectively. Both these studies will be designed to support the FDA’s approval under the accelerated pathway.
SRPT’s Zacks Rank
Sarepta currently has a Zacks Rank #3 (Hold).
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Amicus Therapeutics (FOLD - Free Report) and Biogen (BIIB - Free Report) . While FOLD sports a Zacks Rank #1 (Strong Buy) at present, BIIB 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 Amicus Therapeutics’ 2024 EPS have moved up from 21 to 22 cents. EPS estimates for 2025 have increased from 49 to 53 cents during the same period. Year to date, shares of FOLD have lost 17.3%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 23.96%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 31.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.