Sarepta Therapeutics(SRPT)
Search documents
Sarepta Therapeutics: Guidance Suggests A Year Of Upside Likely
Seeking Alpha· 2025-01-16 18:23
Company Overview - Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is a commercial stage pharmaceutical company that markets and sells four different types of drugs for the treatment of Duchenne Muscular Dystrophy (DMD), a genetic disorder characterized by progressive muscle loss [2]. Investment Insights - The investment group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts to watch, buy and sell ratings, product sales forecasts, and integrated financial statements [2]. Analyst Background - Edmund Ingham, a biotech consultant with over five years of experience in the sector, has compiled detailed reports on more than 1,000 companies and leads the Haggerston BioHealth investing group [2].
Sarepta Therapeutics(SRPT) - 2024 Q4 - Annual Results
2025-02-26 21:05
Financial Performance - Preliminary total net product revenue of $638.2 million for Q4 2024 and $1.79 billion for full-year 2024, exceeding full-year guidance by over $100 million[4] - Total product revenue grew by 75% year-over-year in Q4 2024 and 56% over 2023 for the full year[3] - ELEVIDYS net product revenue reached $384.2 million for Q4 2024 and $820.8 million for full-year 2024, exceeding guidance by over $60 million[4] - RNA-based PMO net product revenue totaled $254.0 million for Q4 2024 and $967.2 million for full-year 2024[4] - Year-end 2024 cash, cash equivalents, restricted cash, and investments balance was approximately $1.5 billion[4] - The company reiterates 2025 full-year total net product revenue guidance of $2.9 to $3.1 billion[4] Product Information - ELEVIDYS is a gene transfer therapy for Duchenne muscular dystrophy, addressing the underlying genetic cause through micro-dystrophin production[5][6] - The company has over 40 programs in various stages of development, focusing on precision genetic medicine for rare diseases[18] Regulatory and Safety Considerations - Continued approval for ELEVIDYS in non-ambulatory patients may depend on verification of clinical benefit in confirmatory trials[7] - The company emphasizes the importance of monitoring for adverse reactions following ELEVIDYS administration, including liver injury and myocarditis[11][15]
SRPT Stock Rises 23% in a Year: Time to Buy, Hold or Sell?
ZACKS· 2025-01-06 13:51
Core Viewpoint - Sarepta Therapeutics (SRPT) has experienced a 23% increase in stock price over the past year, outperforming the industry which saw a decline of 15.7% [1][4] Group 1: Stock Performance - SRPT's stock has outperformed the broader Medical sector but slightly underperformed the S&P 500 Index [1] - The stock is currently trading above the 50-day moving average [1] Group 2: Revenue Growth from Elevidys - Elevidys, the first one-shot gene therapy for Duchenne muscular dystrophy (DMD), has shown significant sales performance since its launch in June 2023, contributing over $200 million to revenue in 2023 [5][6] - The FDA expanded Elevidys' label to treat all DMD patients aged four years and older, leading to over $400 million in revenue in the first nine months of 2024 [6] Group 3: Partnerships and Future Revenue - Sarepta has a licensing agreement with Roche, which has exclusive rights to market Elevidys outside the U.S., generating $9.5 million in royalty revenues in Q3 2024 [7] - Management anticipates net product revenues of $2.9-$3.1 billion for 2025, with two-thirds expected from Elevidys sales [8] Group 4: Pipeline Expansion - Sarepta is expanding its pipeline beyond DMD, focusing on multiple innovative gene therapies for various muscular dystrophies [9][10] - The company is conducting late-stage studies on gene therapy candidates for limb-girdle muscular dystrophy and has plans for additional clinical studies [11][12] Group 5: Strategic Acquisitions - In November, Sarepta announced a $500 million deal to acquire seven pipeline programs from Arrowhead Pharmaceuticals, which will enhance its portfolio and expand into new indications [13] Group 6: Market Dependence and Valuation - Despite having four FDA-approved therapies, Sarepta's revenue is heavily reliant on Elevidys, which accounted for over one-third of total revenues in the first nine months of 2024 [14] - The stock trades at a premium with a price/sales ratio of 7.73 compared to the industry average of 1.96 [15] Group 7: Earnings Estimates - Earnings per share (EPS) estimates for 2024 have increased from $1.48 to $2.17, while 2025 estimates have slightly decreased from $10.35 to $10.04 [17] Group 8: Investment Recommendation - Despite trading at a premium, the strong commercial potential of Elevidys and management's plans for diversification make it a recommended addition to investment portfolios [18][19]
SRPT Finishes Enrolment in Late-Stage Study for Rare Muscular Disorder
ZACKS· 2024-12-19 14:45
Core Insights - Sarepta Therapeutics has completed enrollment and dosing in the phase III EMERGENE study for its gene therapy SRP-9003 targeting limb-girdle muscular dystrophy (LGMD) Type 2E/R4 [1][2] - Positive data from the EMERGENE study is anticipated in the first half of 2025, with plans for regulatory filing for accelerated approval if results are favorable [2] - LGMD2E/R4 is an ultra-rare genetic disease with no current treatment options beyond symptom management, leading to significant mobility loss and early mortality [3] Company Developments - Sarepta has initiated a clinical study for another gene therapy candidate, SRP-9004, targeting LGMD type 2D, and plans to start a study for SRP-9005 for LGMD type 2C in Q1 2025 [4][5] - The studies are designed to support FDA approval under the accelerated pathway [5] Stock Performance - Year-to-date, Sarepta's shares have increased by 24.7%, contrasting with a 10.5% decline in the industry [8] Commercial Portfolio - Sarepta's commercial portfolio includes three approved RNA-based PMO therapies and the one-shot gene therapy Elevidys, which is the first of its kind for DMD in the U.S. [9][10] - Elevidys generated approximately $437 million in product sales in the first nine months of 2024, compared to over $200 million in the previous year [10] - The company’s therapies, including Exondys 51, Vyondys 53, and Amondys 45, have strong demand and are expected to address nearly a third of all DMD patients in the U.S. [11]
FDA's new accelerated approval guidance to benefit rare disease drug development, analysts believe
Proactiveinvestors NA· 2024-12-13 16:20
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers news and insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4][5] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production and search engine optimization [5]
Wall Street Analysts See a 47.95% Upside in Sarepta Therapeutics (SRPT): Can the Stock Really Move This High?
ZACKS· 2024-12-13 15:56
Summary of Key Points Core Viewpoint - Sarepta Therapeutics (SRPT) has seen a 14.1% increase in share price over the past four weeks, closing at $124.47, with a potential upside of 48% based on Wall Street analysts' mean price target of $184.15 [1] Price Target Analysis - The average of 20 short-term price targets ranges from a low of $75 to a high of $217, with a standard deviation of $32.08, indicating variability in estimates [2] - The lowest estimate suggests a decline of 39.7%, while the highest indicates a potential upside of 74.3% [2] - A low standard deviation signifies greater agreement among analysts regarding price movement [7] Earnings Estimates and Analyst Sentiment - Analysts are increasingly optimistic about SRPT's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - Over the last 30 days, one estimate has increased, leading to a 4.7% rise in the Zacks Consensus Estimate for the current year [10] - SRPT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [11] Caution on Price Targets - While consensus price targets are popular among investors, they may not reliably indicate actual stock price movements, and should be approached with skepticism [5][8] - Analysts often set optimistic price targets due to business incentives, which can lead to inflated estimates [6]
SRPT Inks $11B Licensing Deal With Arrowhead for Rare Gene Therapies
ZACKS· 2024-11-27 17:35
Shares of Sarepta Therapeutics (SRPT) rose nearly 14% on Tuesday after announcing that it has entered into an exclusive global licensing and collaboration agreement with Arrowhead Pharmaceuticals .ARWR Deal Expands Sarepta’s PipelinePer the deal terms, Sarepta will acquire exclusive rights to Arrowhead’s seven pipeline programs, which include four in active clinical development and the remaining three in preclinical development. These programs are being developed against a broad range of genetic diseases in ...
Wall Street Analysts Think Sarepta Therapeutics (SRPT) Could Surge 42.11%: Read This Before Placing a Bet
ZACKS· 2024-11-27 16:00
Shares of Sarepta Therapeutics (SRPT) have gained 0.2% over the past four weeks to close the last trading session at $130.50, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $185.45 indicates a potential upside of 42.1%.The mean estimate comprises 20 short-term price targets with a standard deviation of $31.14. While the lowest estimate of $80 indicates a 38.7% decline from the ...
Why Is Sarepta Therapeutics (SRPT) Down 1.9% Since Last Earnings Report?
ZACKS· 2024-09-06 16:38
Company Overview - Sarepta Therapeutics reported earnings of 7 cents per share for Q2 2024, surpassing the Zacks Consensus Estimate of breakeven earnings, compared to a loss of 27 cents in the same period last year [2] - Total revenues reached $362.9 million, reflecting a 39% year-over-year increase, although it fell short of the Zacks Consensus Estimate of $386.9 million [3] - Product revenues increased by 51% year over year to $360.5 million, driven by heightened demand for marketed products, but missed the consensus estimate of $373 million [4] Product Performance - Sales from Elevidys amounted to $121.7 million, down from $133.9 million in Q1 2024, missing estimates of $143 million and $150 million due to a restrictive FDA label [5] - Contract manufacturing collaboration revenues from Elevidys supplied to Roche were approximately $2.4 million, a significant decrease from $22.3 million in the previous year [6] Expense Management - Adjusted R&D expenses totaled $153.9 million, down 27% year over year, primarily due to the capitalization of expenses related to Elevidys [7] - Adjusted selling, general, and administrative expenses rose by 17% year over year to $106.0 million, driven by increased professional service expenses for Elevidys' launch [7] Financial Guidance - Management anticipates a quarter-over-quarter increase in Elevidys sales by nearly one-third in Q3 2024, followed by a doubling of revenues from Q3 to Q4 [8] - For 2025, the company expects net product revenues to be in the range of $2.9 billion to $3.1 billion [8] Market Sentiment - There has been a downward trend in estimates revisions, with the consensus estimate shifting by -112.78% [9] - Sarepta Therapeutics currently holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [11] Industry Comparison - Sarepta operates within the Zacks Medical - Biomedical and Genetics industry, where Halozyme Therapeutics has seen a 12.1% increase in stock price over the past month [12] - Halozyme reported revenues of $231.35 million, a year-over-year increase of 4.7%, with an EPS of $0.91 compared to $0.74 a year ago [13]
Biotech Stock Flashing Bull Signal
Forbes· 2024-08-14 18:39
Core Insights - Sarepta Therapeutics (SRPT) experienced a significant decline after reaching a three-year high of $173.25 on June 21, closing lower in six of the last seven weeks, but has shown a positive bounce off the $125 level this week, maintaining a 36% year-to-date gain [1] Stock Performance - The stock's recent pullback has brought it within one standard deviation of its 126-day moving average, with historical data indicating that similar occurrences have led to a 75% chance of the stock being higher one month later, averaging an 11.1% gain [2] - If the stock continues to rise from its current price of $131.21, it could surpass the $145 mark, which was a support level last month [2] Analyst Sentiment - Despite some disappointment with the latest earnings report, analysts remain optimistic about Sarepta Therapeutics, with 17 out of 19 analysts maintaining "buy" ratings [3] - Following a global selloff, Piper Sandler has categorized Sarepta as one of eight "high-quality" defense stocks in the biopharma sector amid market volatility [3]