Key Takeaways SRPT expects Q2 sales of $530M and EPS of $1.11, both up significantly from the prior year.Elevidys sales hit $282M in Q2, though safety issues led to a temporary market withdrawal.SRPT plans $400M in annual savings via layoffs, pipeline reprioritization and restructuring.We expect Sarepta Therapeutics (SRPT) to report second-quarter 2025 earnings on Aug. 6, after market close. The company’s earnings missed estimates by a wider margin in the last reported quarter.The Zacks Consensus Estimate f ...

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].

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]