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Sarepta (SRPT) Q4 Earnings & Sales Beat Estimates, Stock Up
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Sarepta Therapeutics, Inc. (SRPT - Free Report) reported a loss of $1.24 per share in the fourth quarter of 2022, narrower than the Zacks Consensus Estimate of a loss of $1.28 per share. The loss was also narrower than the year-ago quarter’s loss of $1.42 per share.
The company reported an adjusted loss of 53 cents per share compared with an adjusted loss of 77 cents in the year-ago quarter. The adjusted figure excludes one-time items, depreciation and amortization expenses, interest expenses, income tax benefit, stock-based compensation expenses and other items.
Sarepta recorded total revenues of $258.4 million, up 28.3% year over year. Revenues beat the Zacks Consensus Estimate of $249.4 million. The year-over-year increase in revenues was driven by the sales of Sarepta’s three currently approved RNA-based PMO therapies for DMD.
Quarter in Detail
Sarepta’s commercial portfolio includes three drugs approved for treating Duchenne muscular dystrophy (“DMD”) — Exondys 51, Vyondys 53 and Amondys 45.
The company derived product revenues of $235.9 million, up 32.0% year over year. The upside was driven by an increase in demand for its DMD products.
The company recorded $22.5 million in collaboration revenues, primarily from its licensing agreement with Roche (RHHBY - Free Report) . In the year-ago period, management had recorded $22.7 million as collaboration revenues, which were also received from Roche.
Sarepta and Roche entered into a licensing agreement to develop SRP-9001, its investigational gene-therapy candidate for DMD, in 2019. Per the agreement, Roche has exclusive rights to launch and commercialize SRP-9001 in ex-U.S. markets.
Adjusted research and development (R&D) expenses totaled $186.8 million in the fourth quarter, up 6.4% year over year. This surge is attributable to the increase in manufacturing expenses for ramping up production for SRP-9001.
Adjusted selling, general & administrative (SG&A) expenses were $86.6 million, up 44.1% year over year.
Full-Year Results
Sarepta reported total revenues of $933.0 million in 2022, up 32.9% year over year. The company incurred a loss of $8.03 per share for the full year compared with a loss of $5.15 per share in the year-ago period. The adjusted loss in 2022 was $3.06 per share compared with an adjusted loss of $3.80 per share in 2021.
Pipeline Updates
Last November, Sarepta and partner Roche announced that the FDA accepted the biologic license application (BLA) seeking accelerated approval for SRP-9001 in DMD. The BLA has been granted priority review and a final decision is expected before May 2023-end.
Alongside its earnings, Sarepta also announced that it had completed the mid-cycle meeting with the FDA on SRP-9001 BLA. Per the company, the agency officials posed questions on Chemistry, Manufacturing and Controls (CMC) for SRP-9001 that have been duly addressed by management. Based on these responses, the FDA has formally confirmed no significant safety issues with the BLA filing and does not intend to hold an advisory committee (AdCom) meeting on SRP-9001 BLA. Shares of Sarepta were up 17% in after-hours trading on Feb 28, likely on this announcement.
In the past year, Sarepta’s shares have surged 60.7% against the industry’s 10.9% fall.
Image Source: Zacks Investment Research
Last month, management announced that it has initiated the early-stage VOYAGENE study which is evaluating SRP-9003 for the treatment of limb-girdle muscular dystrophy Type 2E/R4. The study will enroll both ambulant and non-ambulant patients.
Allogene’s stock has declined 26.1% in the past year. Allogene’s loss estimates for 2023 have narrowed from $2.84 to $2.83 per share in the past 60 days.
Allogene beat earnings estimates in each of the last four quarters, the average surprise being 8.33%. In the last reported quarter, the company delivered an earnings surprise of 7.04%.
Amarin’s stock has declined 36.4% in the trailing 12 months. Amarin’s loss estimates for 2023 narrowed from 8 cents per share to 6 cents in the past 60 days.
Amarin beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions, the average negative surprise being 14.29%. In the last reported quarter, Amarin’s earnings beat estimates by 200.00%.
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Sarepta (SRPT) Q4 Earnings & Sales Beat Estimates, Stock Up
Sarepta Therapeutics, Inc. (SRPT - Free Report) reported a loss of $1.24 per share in the fourth quarter of 2022, narrower than the Zacks Consensus Estimate of a loss of $1.28 per share. The loss was also narrower than the year-ago quarter’s loss of $1.42 per share.
The company reported an adjusted loss of 53 cents per share compared with an adjusted loss of 77 cents in the year-ago quarter. The adjusted figure excludes one-time items, depreciation and amortization expenses, interest expenses, income tax benefit, stock-based compensation expenses and other items.
Sarepta recorded total revenues of $258.4 million, up 28.3% year over year. Revenues beat the Zacks Consensus Estimate of $249.4 million. The year-over-year increase in revenues was driven by the sales of Sarepta’s three currently approved RNA-based PMO therapies for DMD.
Quarter in Detail
Sarepta’s commercial portfolio includes three drugs approved for treating Duchenne muscular dystrophy (“DMD”) — Exondys 51, Vyondys 53 and Amondys 45.
The company derived product revenues of $235.9 million, up 32.0% year over year. The upside was driven by an increase in demand for its DMD products.
The company recorded $22.5 million in collaboration revenues, primarily from its licensing agreement with Roche (RHHBY - Free Report) . In the year-ago period, management had recorded $22.7 million as collaboration revenues, which were also received from Roche.
Sarepta and Roche entered into a licensing agreement to develop SRP-9001, its investigational gene-therapy candidate for DMD, in 2019. Per the agreement, Roche has exclusive rights to launch and commercialize SRP-9001 in ex-U.S. markets.
Adjusted research and development (R&D) expenses totaled $186.8 million in the fourth quarter, up 6.4% year over year. This surge is attributable to the increase in manufacturing expenses for ramping up production for SRP-9001.
Adjusted selling, general & administrative (SG&A) expenses were $86.6 million, up 44.1% year over year.
Full-Year Results
Sarepta reported total revenues of $933.0 million in 2022, up 32.9% year over year. The company incurred a loss of $8.03 per share for the full year compared with a loss of $5.15 per share in the year-ago period. The adjusted loss in 2022 was $3.06 per share compared with an adjusted loss of $3.80 per share in 2021.
Pipeline Updates
Last November, Sarepta and partner Roche announced that the FDA accepted the biologic license application (BLA) seeking accelerated approval for SRP-9001 in DMD. The BLA has been granted priority review and a final decision is expected before May 2023-end.
Alongside its earnings, Sarepta also announced that it had completed the mid-cycle meeting with the FDA on SRP-9001 BLA. Per the company, the agency officials posed questions on Chemistry, Manufacturing and Controls (CMC) for SRP-9001 that have been duly addressed by management. Based on these responses, the FDA has formally confirmed no significant safety issues with the BLA filing and does not intend to hold an advisory committee (AdCom) meeting on SRP-9001 BLA. Shares of Sarepta were up 17% in after-hours trading on Feb 28, likely on this announcement.
In the past year, Sarepta’s shares have surged 60.7% against the industry’s 10.9% fall.
Image Source: Zacks Investment Research
Last month, management announced that it has initiated the early-stage VOYAGENE study which is evaluating SRP-9003 for the treatment of limb-girdle muscular dystrophy Type 2E/R4. The study will enroll both ambulant and non-ambulant patients.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Sarepta currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector include Allogene (ALLO - Free Report) and Amarin Corporation (AMRN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allogene’s stock has declined 26.1% in the past year. Allogene’s loss estimates for 2023 have narrowed from $2.84 to $2.83 per share in the past 60 days.
Allogene beat earnings estimates in each of the last four quarters, the average surprise being 8.33%. In the last reported quarter, the company delivered an earnings surprise of 7.04%.
Amarin’s stock has declined 36.4% in the trailing 12 months. Amarin’s loss estimates for 2023 narrowed from 8 cents per share to 6 cents in the past 60 days.
Amarin beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions, the average negative surprise being 14.29%. In the last reported quarter, Amarin’s earnings beat estimates by 200.00%.