Sarepta Therapeutics Files 2023 Annual Report on Form 10-K
Ticker: SRPT · Form: 10-K · Filed: Feb 28, 2024 · CIK: 873303
Sentiment: neutral
Topics: Sarepta Therapeutics, 10-K, Annual Report, Pharmaceutical, Gene Therapy
TL;DR
<b>Sarepta Therapeutics filed its 2023 10-K, providing a comprehensive overview of its financial performance, business operations, and associated risks.</b>
AI Summary
Sarepta Therapeutics, Inc. (SRPT) filed a Annual Report (10-K) with the SEC on February 28, 2024. Sarepta Therapeutics, Inc. filed its 2023 Form 10-K on February 28, 2024, reporting on its fiscal year ended December 31, 2023. The filing details Sarepta's business operations, financial condition, and risk factors. Key financial data and operational metrics for the fiscal year 2023 are presented. The report includes information on executive compensation, revenue segments, and debt levels. Sarepta Therapeutics is classified under Pharmaceutical Preparations (SIC 2834).
Why It Matters
For investors and stakeholders tracking Sarepta Therapeutics, Inc., this filing contains several important signals. This 10-K filing is crucial for investors and stakeholders to assess Sarepta's financial health, strategic direction, and potential growth opportunities, particularly concerning its drug pipeline and commercial performance. Understanding the detailed risk factors outlined in the report is essential for evaluating the company's ability to navigate challenges in the pharmaceutical industry, including regulatory hurdles and market competition.
Risk Assessment
Risk Level: medium — Sarepta Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as detailed in the risk factors section.
Analyst Insight
Investors should review the detailed financial statements and risk factors in the 10-K to understand Sarepta's performance and outlook for its gene therapy products.
Key Numbers
- 2023-12-31 — Fiscal Year End (Conformed period of report)
- 2024-02-28 — Filing Date (As of date)
- 001-14895 — SEC File Number (SEC file number)
- 930797222 — IRS Number (IRS number)
Key Players & Entities
- Sarepta Therapeutics, Inc. (company) — Filer name
- 2023 (date) — Fiscal year end
- February 28, 2024 (date) — Filing date
- Cambridge, MA (location) — Business address
- 2834 (industry_code) — Standard Industrial Classification
- Elevidys (product) — Mentioned in context with Nationwide Children's Hospital
FAQ
When did Sarepta Therapeutics, Inc. file this 10-K?
Sarepta Therapeutics, Inc. filed this Annual Report (10-K) with the SEC on February 28, 2024.
What is a 10-K filing?
A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Sarepta Therapeutics, Inc. (SRPT).
Where can I read the original 10-K filing from Sarepta Therapeutics, Inc.?
You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Sarepta Therapeutics, Inc..
What are the key takeaways from Sarepta Therapeutics, Inc.'s 10-K?
Sarepta Therapeutics, Inc. filed this 10-K on February 28, 2024. Key takeaways: Sarepta Therapeutics, Inc. filed its 2023 Form 10-K on February 28, 2024, reporting on its fiscal year ended December 31, 2023.. The filing details Sarepta's business operations, financial condition, and risk factors.. Key financial data and operational metrics for the fiscal year 2023 are presented..
Is Sarepta Therapeutics, Inc. a risky investment based on this filing?
Based on this 10-K, Sarepta Therapeutics, Inc. presents a moderate-risk profile. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as detailed in the risk factors section.
What should investors do after reading Sarepta Therapeutics, Inc.'s 10-K?
Investors should review the detailed financial statements and risk factors in the 10-K to understand Sarepta's performance and outlook for its gene therapy products. The overall sentiment from this filing is neutral.
Risk Factors
- Regulatory Risks [high — regulatory]: The company faces significant risks related to the stringent regulatory environment for pharmaceutical products, including the lengthy and uncertain process of obtaining and maintaining regulatory approvals.
- Market Competition [medium — market]: Sarepta operates in a competitive market with other companies developing and marketing therapies for similar rare diseases, which could impact market share and pricing.
- Financial Performance and Funding [medium — financial]: The company's ability to achieve profitability and secure future funding is dependent on the successful commercialization of its products and continued investment in research and development.
- Manufacturing and Supply Chain [medium — operational]: Disruptions in manufacturing or the supply chain for its complex therapies could adversely affect the company's ability to meet demand.
Key Dates
- 2023-12-31: Fiscal Year End — Reporting period for the 10-K
- 2024-02-28: Filing Date — Date the 10-K was officially filed with the SEC
Filing Stats: 4,386 words · 18 min read · ~15 pages · Grade level 15.9 · Accepted 2024-02-28 16:01:45
Key Financial Figures
- $0.0001 — nge on which registered Common Stock, $0.0001 par value SRPT The NASDAQ Stock Mar
Filing Documents
- srpt-20231231.htm (10-K) — 4901KB
- srpt-ex10_71.htm (EX-10.71) — 40KB
- srpt-ex10_72.htm (EX-10.72) — 42KB
- srpt-ex10_73.htm (EX-10.73) — 41KB
- srpt-ex10_74.htm (EX-10.74) — 38KB
- srpt-ex10_77.htm (EX-10.77) — 45KB
- srpt-ex21_1.htm (EX-21.1) — 5KB
- srpt-ex23_1.htm (EX-23.1) — 4KB
- srpt-ex31_1.htm (EX-31.1) — 10KB
- srpt-ex31_2.htm (EX-31.2) — 10KB
- srpt-ex32_1.htm (EX-32.1) — 8KB
- srpt-ex32_2.htm (EX-32.2) — 8KB
- img78802856_0.jpg (GRAPHIC) — 58KB
- img78802856_1.jpg (GRAPHIC) — 55KB
- 0000950170-24-022036.txt ( ) — 18773KB
- srpt-20231231.xsd (EX-101.SCH) — 2324KB
- srpt-20231231_htm.xml (XML) — 3508KB
Business
Item 1. Business 6
Risk Factors
Item 1A. Risk Factors 32
Unresolved Staff Comments
Item 1B. Unresolved Staff Comments 69
Cybersecurity
Item 1C. Cybersecurity 69
Properties
Item 2. Properties 71
Legal Proceedings
Item 3. Legal Proceedings 71
Mine Safety Disclosures
Item 4. Mine Safety Disclosures 71 PART II 72
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 72
Reserved
Item 6. Reserved 72
Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 73
Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 84
Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data 84
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 84
Controls and Procedures
Item 9A. Controls and Procedures 84
Other Information
Item 9B. Other Information 85
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 85 PART III 86
Directors, Executive Officers and Corporate Governance
Item 10. Directors, Executive Officers and Corporate Governance 86
Executive Compensation
Item 11. Executive Compensation 86
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 86
Certain Relationships and Related Transactions, and Director Independence
Item 13. Certain Relationships and Related Transactions, and Director Independence 86
Principal Accounting Fees and Services
Item 14. Principal Accounting Fees and Services 86 PART IV 87
Exhibits, Financial Statement Schedules
Item 15. Exhibits, Financial Statement Schedules 87
Form 10-K Summary
Item 16. Form 10-K Summary 94 - i - Forward-Looking Information This Annual Report on Form 10-K, including the "Management's Discussion and Analysis of Financial Condition and Results of Operations" section in Item 7, and other materials accompanying this Annual Report on Form 10-K contain forward-looking statements or incorporate by reference forward-looking statements. Statements that are not purely historical are forward-looking statements. Forward-looking statements are often identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may," "estimate," "could," "continue," "ongoing," "predict," "potential," "likely," "seek" and other similar expressions, as well as variations or negatives of these words. These statements address expectations, projections of future results of operations or financial condition, or other "forward-looking" information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements include, but are not limited to: our belief that our proprietary technology platforms and collaborations can be used to develop potential therapeutic candidates to treat a broad range of diseases; our expectation that our partnerships with manufacturers will support our clinical and commercial manufacturing capacity for our Duchenne muscular dystrophy ("Duchenne") gene therapy programs and Limb-girdle muscular dystrophy ("LGMD") programs, while also acting as a manufacturing platform for potential future gene therapy programs, and our belief that our current network of manufacturing partners is able to fulfill the requirements of our commercial plan; our expectation that Aldevron LLC ("Aldevron") will provide Good Manufacturing Processes ("GMP")-grade plasmid for our LGMD programs, as well as plasmid source material for future gene therapy programs; our plan to continue building out
Business
Item 1. Business. Overview We are a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases. Applying our proprietary, highly-differentiated and innovative technologies, and through collaborations with our strategic partners, we have developed multiple approved products for the treatment of Duchenne muscular dystrophy ("Duchenne") and are developing potential therapeutic candidates for a broad range of diseases and disorders, including Duchenne, Limb-girdle muscular dystrophies ("LGMDs") and other neuromuscular and central nervous system ("CNS") related disorders. To date, we have developed and commercialized the following four approved products for the treatment of Duchenne: EXONDYS 51 (eteplirsen) Injection ("EXONDYS 51"), VYONDYS 53 (golodirsen) Injection ("VYONDYS 53"), AMONDYS 45 (casimersen) Injection ("AMONDYS 45"), and ELEVIDYS. Each of these approved products, and the indications for which they have been approved for, is described under the heading "Our Commercial Products" in this Item 1. Technology and Platforms Exon skipping is intended to promote the production of an internally truncated but functional dystrophin protein. The original phosphorodiamidate morpholino oligomer ("PMO") structure and variations of this structure that are so-called PMO-based (collectively "PMO-based") are central to our proprietary chemistry platform. PMO technologies can be used to selectively up-regulate or down-regulate the production of a target protein through pre-mRNA splice alteration. PMO-based compounds have the potential to be designed to create more, less, or none of certain proteins, or produce analogues of endogenous proteins. This technology can be used to correct disease-causing genetic errors by inducing the targeted expression of novel proteins. The PMO chemistry platform i