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Sarepta (SRPT) Q2 Earnings Top Estimates, Sales Lag, View Weak
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Sarepta Therapeutics, Inc. (SRPT - Free Report) posted earnings of 7 cents per share in second-quarter 2024, beating the Zacks Consensus Estimate of breakeven earnings. In the year-ago period, the company posted a loss of 27 cents.
The loss included depreciation and amortization expenses and stock-based compensation expenses. Adjusted earnings per share in the quarter stood at 44 cents against the year-ago period’s adjusted loss of $1.01 per share.
Sarepta recorded total revenues of $362.9 million, up 39% year over year. The upside was driven by sales of its four approved marketed therapies for Duchenne muscular dystrophy (DMD). However, the top line missed the Zacks Consensus Estimate of $386.9 million.
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.
SRPT product revenues were up 51% year over year to $360.5 million, driven by increased demand for its marketed products. The metric missed the Zacks Consensus Estimate and our model estimate, both of which were pegged at $373 million.
Sarepta generated around $238.8 million from the product sales of its three PMO therapies, relatively flat year over year.
The company generated $121.7 million from Elevidys sales compared with $133.9 million in first-quarter 2024. 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.
Elevidys sales missed the Zacks Consensus Estimate and our model estimate of $143 million and $150 million, respectively. This miss was likely due to the ‘exceptionally narrow and restrictive label’ initially granted to the therapy by the FDA when it was initially approved last year. The agency expanded Elevidys’ label toward the end of June 2024.
SRPT recorded around $2.4 million as contract manufacturing collaboration revenues associated with commercial Elevidys supply delivered to Roche (RHHBY - Free Report) . In the year-ago period, it registered $22.3 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 expenses totaled $153.9 million, down 27% year over year. The downside was primarily caused by the capitalization of commercial batches of Elevidys manufactured after its approval in June 2023.
Adjusted selling, general & administrative expenses were $106.0 million, up 17% year over year. This was primarily caused by an increase in professional service expenses incurred by the company for Elevidys’ launch.
Guidance
For 2025
Alongside the earnings release, management issued fresh guidance for full-year 2025. It expects net product revenues in the range of $2.9-$3.1 billion. However, the guidance failed to impress investors, who dragged the stock down 10% in after-market trading on Aug 7. These investors pointed out that the guidance was below Wall Street expectations. The Zacks Consensus Estimate for 2025 product revenues stood at $3.2 billion.
In the year-to-date period, the stock has surged 45.2% against the industry’s 4.4% decline.
Image Source: Zacks Investment Research
For 2024
Though SRPT did not issue any numbers for 2024, management did mention in the conference call that it expects to see a quarter-over-quarter jump in Elevidys sales by nearly one-third in the third quarter, followed by a doubling of revenues from the third to the fourth quarter. This delayed growth, despite label expansion, is due to the enrolment process from form to infusion which takes between three to five months.
Recent Updates
Earlier in June, the FDA expanded Sarepta’s label to treat all DMD patients aged four years and older. While the agency granted full approval for the therapy to treat ambulatory DMD patients (those who can still walk), it has granted accelerated approval for non-ambulatory patients.
Management is still required to conduct a confirmatory study to convert the accelerated approval for non-ambulatory DMD patients to a full one. SRPT is currently conducting the phase III ENVISION study to evaluate the safety and efficacy of gene therapy in non-ambulatory and ambulatory DMD patients. This study also satisfies regulatory requirements for Elevidys’ approval outside the United States.
In June, Sarepta’s partner Roche announced that the European Medicines Agency (EMA) has validated and initiated review of the marketing authorization application (MAA) for Elevidys. The MAA seeks approval for the therapy to treat ambulatory patients aged three through seven years. A final decision is expected next year.
Alongside the earnings release, Sarepta also announced that the FDA has granted fast track designation to gene therapy candidate SRP-9003 for treating Limb-girdle muscular dystrophy type 2E (LGMD2E/R4). The therapy is currently being evaluated in the late-stage EMERGENE study in the same indication.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 8.5%.
Earnings of Entrada Therapeutics beat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 5.0%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
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Sarepta (SRPT) Q2 Earnings Top Estimates, Sales Lag, View Weak
Sarepta Therapeutics, Inc. (SRPT - Free Report) posted earnings of 7 cents per share in second-quarter 2024, beating the Zacks Consensus Estimate of breakeven earnings. In the year-ago period, the company posted a loss of 27 cents.
The loss included depreciation and amortization expenses and stock-based compensation expenses. Adjusted earnings per share in the quarter stood at 44 cents against the year-ago period’s adjusted loss of $1.01 per share.
Sarepta recorded total revenues of $362.9 million, up 39% year over year. The upside was driven by sales of its four approved marketed therapies for Duchenne muscular dystrophy (DMD). However, the top line missed the Zacks Consensus Estimate of $386.9 million.
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.
SRPT product revenues were up 51% year over year to $360.5 million, driven by increased demand for its marketed products. The metric missed the Zacks Consensus Estimate and our model estimate, both of which were pegged at $373 million.
Sarepta generated around $238.8 million from the product sales of its three PMO therapies, relatively flat year over year.
The company generated $121.7 million from Elevidys sales compared with $133.9 million in first-quarter 2024. 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.
Elevidys sales missed the Zacks Consensus Estimate and our model estimate of $143 million and $150 million, respectively. This miss was likely due to the ‘exceptionally narrow and restrictive label’ initially granted to the therapy by the FDA when it was initially approved last year. The agency expanded Elevidys’ label toward the end of June 2024.
SRPT recorded around $2.4 million as contract manufacturing collaboration revenues associated with commercial Elevidys supply delivered to Roche (RHHBY - Free Report) . In the year-ago period, it registered $22.3 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 expenses totaled $153.9 million, down 27% year over year. The downside was primarily caused by the capitalization of commercial batches of Elevidys manufactured after its approval in June 2023.
Adjusted selling, general & administrative expenses were $106.0 million, up 17% year over year. This was primarily caused by an increase in professional service expenses incurred by the company for Elevidys’ launch.
Guidance
For 2025
Alongside the earnings release, management issued fresh guidance for full-year 2025. It expects net product revenues in the range of $2.9-$3.1 billion. However, the guidance failed to impress investors, who dragged the stock down 10% in after-market trading on Aug 7. These investors pointed out that the guidance was below Wall Street expectations. The Zacks Consensus Estimate for 2025 product revenues stood at $3.2 billion.
In the year-to-date period, the stock has surged 45.2% against the industry’s 4.4% decline.
Image Source: Zacks Investment Research
For 2024
Though SRPT did not issue any numbers for 2024, management did mention in the conference call that it expects to see a quarter-over-quarter jump in Elevidys sales by nearly one-third in the third quarter, followed by a doubling of revenues from the third to the fourth quarter. This delayed growth, despite label expansion, is due to the enrolment process from form to infusion which takes between three to five months.
Recent Updates
Earlier in June, the FDA expanded Sarepta’s label to treat all DMD patients aged four years and older. While the agency granted full approval for the therapy to treat ambulatory DMD patients (those who can still walk), it has granted accelerated approval for non-ambulatory patients.
Management is still required to conduct a confirmatory study to convert the accelerated approval for non-ambulatory DMD patients to a full one. SRPT is currently conducting the phase III ENVISION study to evaluate the safety and efficacy of gene therapy in non-ambulatory and ambulatory DMD patients. This study also satisfies regulatory requirements for Elevidys’ approval outside the United States.
In June, Sarepta’s partner Roche announced that the European Medicines Agency (EMA) has validated and initiated review of the marketing authorization application (MAA) for Elevidys. The MAA seeks approval for the therapy to treat ambulatory patients aged three through seven years. A final decision is expected next year.
Alongside the earnings release, Sarepta also announced that the FDA has granted fast track designation to gene therapy candidate SRP-9003 for treating Limb-girdle muscular dystrophy type 2E (LGMD2E/R4). The therapy is currently being evaluated in the late-stage EMERGENE study in the same indication.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Other Key Picks
Sarepta currently has a Zacks Rank #2 (Buy). A couple of other top-ranked stocks in the overall healthcare sector include Entrada Therapeutics (TRDA - Free Report) and Immatics (IMTX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 8.5%.
Earnings of Entrada Therapeutics beat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 5.0%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.