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Sarepta Soars on Q2 Earnings & Sales Beat, Resumes Elevidys Deliveries
ZACKS· 2025-08-07 14:32
Key Takeaways Sarepta Therapeutics, Inc. (SRPT) reported second-quarter 2025 adjusted EPS of $2.02, which beat the Zacks Consensus Estimate of $1.11. This beat was mainly due to higher-than-expected collaboration revenues coupled with lower operating expenses incurred during the quarter. In the year-ago period, the company posted an adjusted EPS of 43 cents. The adjusted figures exclude depreciation and amortization costs, stock-based compensation expenses and gains on strategic investments. Including these ...
Sarepta to Report Q2 Earnings: What's in Store for the Stock?
ZACKS· 2025-08-04 16:11
Core Viewpoint - Sarepta Therapeutics is expected to report second-quarter 2025 earnings on August 6, with significant increases in sales and earnings per share compared to the previous year, despite recent challenges related to safety issues with its gene therapy products [1][11]. Financial Performance - The Zacks Consensus Estimate for total sales is approximately $530 million and earnings per share (EPS) is $1.11, indicating a substantial increase from the prior year [1][11]. - Preliminary net product revenues for the second quarter are reported at $513 million, including $282 million from Elevidys sales [3][11]. - Adjusted R&D and SG&A expenses for the quarter are estimated to be around $294 million [3]. Product Portfolio and Market Challenges - Sarepta has four marketed products targeting Duchenne muscular dystrophy (DMD), including the gene therapy Elevidys and three PMO therapies [2]. - Recent safety concerns have arisen due to three patient deaths linked to its gene therapy treatments, leading to a temporary market withdrawal of Elevidys [4][5]. - The FDA has recently cleared Elevidys for use in ambulatory patients, allowing Sarepta to resume shipments [6]. Strategic Initiatives - To address safety issues, the company is developing a new protocol for Elevidys administration in non-ambulatory patients and plans to submit these findings to the FDA [7]. - A restructuring plan has been initiated to save nearly $400 million annually starting in 2026, which includes laying off 36% of its workforce, approximately 500 employees [8]. - Sarepta aims to generate around $300 million in annual savings by reprioritizing its pipeline, focusing on siRNA programs acquired from Arrowhead Pharmaceuticals [9]. Earnings Surprise History - The company's performance has been mixed, with earnings missing estimates in two of the last four quarters, resulting in a negative average surprise of 194.53% [12]. - The stock has underperformed the industry so far this year [12]. Earnings Prediction - Currently, Sarepta has an Earnings ESP of 0.00% and a Zacks Rank of 4 (Sell), indicating a low likelihood of an earnings beat [14].
Sarepta Therapeutics Inc. (SRPT): 根据CBER主任的评论,Elevidys的完全批准可能保持不变
Goldman Sachs· 2025-05-30 02:35
Investment Rating - The investment rating for Sarepta Therapeutics Inc. (SRPT) is "Buy" with a 12-month price target of $100, indicating a potential upside of 160.8% from the current price of $38.35 [8][9]. Core Insights - The commentary from the newly-appointed FDA CBER Director, Dr. Vinay Prasad, suggests that the full approval of Elevidys for ambulatory patients is likely to remain intact, barring any serious safety events [1][6]. - There is a risk to Elevidys' accelerated approval in non-ambulatory patients, which constitutes approximately half of the market, depending on confirmatory data expected in 2027 [1][6]. - The company has projected $13 billion in free cash flow by the end of 2030 and is focusing on pipeline diversification, including early Phase 1 data in other muscular dystrophies [1]. Financial Projections - Revenue projections for SRPT are estimated to grow from $1.9 billion in 2024 to $4.3 billion by 2027 [9]. - The EBITDA is expected to improve significantly, moving from a loss of $102.6 million in 2025 to a profit of $2.1 billion by 2027 [9]. - The forecasted Free Cash Flow yield is projected to increase from -2.8% in 2024 to 64.0% by 2027 [9]. Regulatory Environment - The new CBER Director emphasized the importance of regulatory flexibility in rare diseases and gene therapy, indicating a supportive stance towards maintaining previous approvals unless new safety concerns arise [2][6]. - The Director's approach suggests that accelerated approval pathways will continue to be utilized, particularly in the context of rare diseases and oncology [6]. Market Context - The market capitalization of SRPT is currently $3.7 billion, with an enterprise value of $3.3 billion [9]. - The company is facing competitive risks as other firms are also developing treatments for Duchenne muscular dystrophy (DMD), including RNA-based therapies and gene therapies [8].
SRPT Q1 Earnings Miss, Sales Beat, Stock Slides 21% on '25 View Cut
ZACKS· 2025-05-07 13:35
Core Viewpoint - Sarepta Therapeutics reported a significant adjusted loss in Q1 2025, primarily due to a one-time charge related to a multi-billion-dollar deal with Arrowhead Pharmaceuticals, missing earnings expectations by a wide margin [1][2] Financial Performance - The company recorded total revenues of $744.9 million, an 80% increase year over year, driven by sales of Elevidys, surpassing the Zacks Consensus Estimate of $698.2 million [3] - Product revenues rose 70% year over year to $611.5 million, although this figure fell short of the Zacks Consensus Estimate of $664 million [4] - Elevidys sales generated $375 million, down from $384.2 million in the previous quarter, missing estimates due to safety concerns and site-related constraints [5] - Collaboration and other revenues associated with Elevidys supply to Roche amounted to approximately $133.3 million, significantly up from $54 million in the year-ago period [6] Operating Costs - Adjusted R&D expenses surged to $749.2 million from $178.1 million year over year, reflecting increased costs related to the Arrowhead deal [8] - Adjusted SG&A expenses totaled $107.1 million, a 7% increase year over year, driven by higher professional service expenses [9] Guidance and Market Reaction - Sarepta revised its full-year net product revenue guidance to between $2.3 billion and $2.6 billion, down from a previous forecast of $2.9-$3.1 billion, citing safety concerns and administrative complexities [10] - Following the revised guidance, shares of Sarepta fell 21% in after-hours trading, with a year-to-date decline of 62% compared to a 3% decline in the industry [11] Pipeline Developments - The company is advancing several investigational gene therapies, including SRP-9003 for Limb-girdle muscular dystrophy and SRP-6004 for LGMD type 2B/R2, with data expected in 2025 [17][18] - Sarepta's licensing agreement with Roche for Elevidys allows Roche exclusive rights to market the product in non-U.S. markets, which has implications for revenue generation [7]