What the changes say
- New risks center on ELEVIDYS and SRP-9004 fatal liver events, boxed warnings, and resulting adoption uncertainty.
- A 36% workforce reduction, debt refinancing, internal-control strain, and tax-attribute limits add financial and execution risk.
- FDA/HHS changes, Loper Bright, and healthcare price initiatives increase regulatory and reimbursement uncertainty.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
refuse to allow us to enter into supply contracts, including government contracts
Fatal acute liver injury and failure cases involving ELEVIDYS and SRP-9004 could trigger boxed warnings, labeling changes, and further FDA requirements.
- NewRisks Related to Our Business
Workforce reductions in and restructuring of the U.S. Department of Health and Human Services, including at the FDA, may also create regulatory uncertainty, potentially impacting drug and biologic development programs and approvals
HHS and FDA workforce reductions, plus Loper Bright, could create regulatory uncertainty and legal challenges affecting approvals and development programs.
- NewRisks Related to Our Business
the efficacy and safety of our other product candidates and third parties’ competitive therapies
ELEVIDYS deaths from acute liver injury and failure may cause patients, providers, and payers to hesitate, reducing product adoption.
- NewRisks Related to the Development of our Product Candidates
Interim, initial, “topline” and preliminary data from our clinical trials that we announce or publish from time to time are subject to audit and verification procedures and may differ materially from final data as more patient data become available
Preliminary clinical and preclinical data may change after fuller analysis, audits, verification, or additional patient data.
- NewRisks Related to the Development of our Product Candidates
publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and investors or others may not agree with what we determine to disclose
Disagreements over Sarepta’s interpretation or disclosure of interim data could hurt approvals, commercialization, and stock-price stability.
- NewRisks Related to Third Parties
and may have the right to terminate such agreements. In addition, if our strategic partners experience regulatory delays for the development of their clinical product candidates, including clinical holds, our opportunities to commercialize products may be delayed
CROs and collaborators may lack sufficient time, resources, oversight, or compliance in Sarepta’s preclinical and clinical programs.
- NewRisks Related to our Business Operations
for prosecuting corporate and white collar crime which includes health care fraud. Similarly, the DOJ-HHS False Claims Act Working Group enforcement priorities include drug pricing and kickbacks related to drugs paid for by federal healthcare programs
Healthcare-fraud, drug-pricing, and kickback enforcement could produce investigations, fines, operational restrictions, and management distraction.
- NewRisks Related to our Business Operations
Our announced strategic restructuring plan may not result in anticipated reductions in our annual combined research and development and selling, general and administrative expenses and may disrupt our business in unexpected ways
The July 2025 restructuring and 36% workforce reduction may fail to deliver savings while disrupting operations and employee retention.
- NewRisks Related to our Business Operations
These and other tax law changes and anti-avoidance initiative increase uncertainty and may adversely affect our tax provision, cash tax liability and effective tax rate
Tax-law changes and ownership changes could limit Sarepta’s use of net operating losses and tax credits, increasing future tax costs.
- NewRisks Related to our Financial Condition and Capital Requirements
If we fail to maintain effective internal controls, we may not be able to accurately report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock
The July 2025 restructuring could weaken financial-reporting controls, causing inaccurate results, restatements, or reduced investor confidence.
- NewRisks Related to Our Convertible Senior Notes
cash. As of December 31, 2025, the aggregate principal amount of 2027 Notes totaled approximately $158.6 million and the aggregate principal amount of 2030 Notes totaled approximately $893.4 million
Sarepta may lack operating cash to service or refinance approximately $158.6 million of 2027 Notes and $893.4 million of 2030 Notes.
- NewGeneral Risks
Despite our recent workforce reduction, we may in the future seek to expand, our organization and may experience difficulties in managing this growth, which could disrupt our operations
Future expansion after the workforce reduction could strain management, controls, infrastructure, hiring, productivity, and funding for product development.
Dropped
- DroppedRisks Related to Our Business
prohibition on direct-to-consumer advertising or drug marketing practices
- DroppedRisks Related to Our Business
on how the Catalyst decision is ultimately implemented. Legislation has been introduced to amend the Orphan Drug Act in a way that may prevent these effects of the Catalyst decision, but it is unclear if or when such legislation could be enacted
- DroppedRisks Related to Our Business
of operations. In addition, to the extent we rely on Roche to commercialize any products for which we obtain regulatory approval, we will receive less revenues than if we commercialized these products ourselves
- DroppedRisks Related to the Development of our Product Candidates
development timelines, there is no assurance that any future hold would not have a material adverse effect. A clinical hold, or any of the above factors, may be out of our control and could materially impair our development timelines, expenses and results of operations
- DroppedRisks Related to the Development of our Product Candidates
track and breakthrough therapy designations, including early interactions with the FDA, but the exact mechanisms have not yet been announced by the FDA
Drug-pricing transparency, patient-program scrutiny, and government reimbursement reform.
- DroppedRisks Related to Third Parties
We rely on third parties to conduct some aspects of our early-stage research and pre-clinical and clinical development. The inadequate performance by or loss of any of these third parties could affect the development and commercialization of our product candidate development
- DroppedRisks Related to Manufacturing
Furthermore, any problems in our manufacturing process or the facilities with which we contract make us a less attractive collaborator for potential partners, including larger pharmaceutical companies and academic research institutions, which could limit our access to additional attractive development programs
- DroppedRisks Related to Manufacturing
We also rely on a third party to design, manufacture, obtain and maintain regulatory approval for necessary diagnostic tests for ELEVIDYS. Any delay or failure by us or our collaborators to develop or obtain regulatory approval of the necessary diagnostic tests could harm our business, possibly materially
- DroppedRisks Related to Manufacturing
We also may encounter problems hiring and retaining the experienced scientific, quality control and manufacturing personnel needed to operate our manufacturing process which could result in delays in our production or difficulties in maintaining compliance with applicable regulatory requirements
- DroppedRisks Related to Manufacturing
obligated to expend time, money and effort in production, record keeping and quality control to seek to assure that the product meets applicable specifications and other requirements
- DroppedRisks Related to our Intellectual Property
Even when our patent claims are allowed, the claims may not issue, or in the event of issuance, may not be sufficient to protect our products, product candidates or platform technologies or may be challenged in post-grant proceedings by third parties
Orphan-drug exclusivity risks, including Catalyst-related changes and insufficient product availability.
- DroppedRisks Related to our Business Operations
We continue to monitor changes in tax laws in the U.S. and the impact of proposed and enacted legislation in the international jurisdictions in which the company operates, which could materially impact our tax provision, cash tax liability and effective tax rate
- DroppedGeneral Risks
We have expanded, and may continue to expand, our organization and may experience difficulties in managing this growth, which could disrupt our operations
Reworded
- 100% rewrittenRisks Related to our Business Operations
Comprehensive tax reform in the U.S. and other jurisdictions in which we operate and future guidance could adversely affect our business and financial condition
The discussion shifts from detailed TCJA and CARES Act provisions to unpredictable future tax changes and the Inflation Reduction Act’s 15% book minimum tax.
Was: Comprehensive tax reform in the U.S. and future guidance could adversely affect our business and financial condition
- 84% rewrittenRisks Related to Our Convertible Senior Notes
Servicing our 2027 Notes and 2030 Notes requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt
The debt discussion adds the August 2025 exchange of $700 million of 2027 Notes for 2030 Notes, shares, and approximately $127.3 million cash.
Was: Servicing our 1.25% notes due 2027 (the “Notes”) requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt
- 82% rewrittenRisks Related to Manufacturing and CMC
The third parties we use in the manufacturing process for our products and product candidates may fail to comply with cGMP regulations
The shown text is substantively unchanged, with only minor wording and formatting edits.
- 62% rewrittenRisks Related to Our Business
Healthcare policy reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent commercial success of our products and product candidates
The risk now specifically highlights the Inflation Reduction Act and 2025 presidential directives targeting drug prices.
- 61% rewrittenRisks Related to the Development of our Product Candidates
Clinical development is lengthy and uncertain. Clinical trials of our product candidates may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which could have a material adverse impact on our business
The shown excerpt is substantively unchanged and continues to describe lengthy, costly, uncertain clinical development.
- 58% rewrittenRisks Related to the Development of our Product Candidates
Our products or product candidates may cause undesirable side effects, result in new safety signals or have other properties that could delay or prevent regulatory approval of product candidates, limit the commercial potential or result in significant negative consequences following any potential marketing approval
The risk now names 2025 ELEVIDYS and SRP-9004 deaths from acute liver failure and the resulting ELEVIDYS boxed warning.
Was: Our product candidates may cause undesirable side effects or have other properties that could delay or prevent regulatory approval of product candidates, limit the commercial potential or result in significant negative consequences following any potential marketing approval
- 57% rewrittenRisks Related to Third Parties
Any such events may result in decreased product sales, lower product revenue, loss of revenue, and/or reputational damage, which would harm our results of operations and business
The shown text is unchanged, continuing to address third-party distribution, compliance, and adverse-event reporting risks.
- 53% rewrittenRisks Related to Our Business
Historical revenues from eteplirsen, golodirsen and casimersen through our EAP outside the U.S. may not continue and we may not be able to continue to distribute our products through our EAP
The risk adds current geopolitical issues as a threat to EAP revenue and removes the statement that providers may doubt product benefits.
- 53% rewrittenGeneral Risks
We may incur substantial costs in connection with litigation and other disputes
- 50% rewrittenRisks Related to the Development of our Product Candidates
the recruitment and retention of employees, consultants or contractors with the required level of expertise
- 50% rewrittenRisks Related to our Business Operations
Failure to comply with healthcare and other regulations may subject us to substantial penalties and our business, operations and financial condition could be adversely affected
Was: Failure to comply with healthcare and other regulations is subject to substantial penalties and our business, operations and financial condition could be adversely affected
- 44% rewrittenRisks Related to Our Business
Even though certain of our products have received accelerated approval from the FDA, they face future post-approval development and regulatory requirements, which present additional challenges for us to successfully navigate
Was: Even though EXONDYS 51, VYONDYS 53, AMONDYS 45 and ELEVIDYS have received accelerated approval from the FDA, they face future post-approval development and regulatory requirements, which present additional challenges for us to successfully navigate
- 44% rewrittenRisks Related to Our Business
We face intense competition and rapid technological change, which may result in other companies discovering, developing or commercializing competitive products
- 34% rewrittenRisks Related to Our Business
Further, the potential commercial success of our product candidates as well as continued commercialization of ELEVIDYS will depend on additional factors, including the capacity of any infusion centers responsible for the administration of our product candidates and ELEVIDYS
Was: Further, the potential commercial success of our product candidates as well as ELEVIDYS will depend on additional factors, including the capacity of any infusion centers responsible for the administration of our product candidates and ELEVIDYS
- 32% rewrittenRisks Related to Our Convertible Senior Notes
We may not have the ability to raise the funds necessary to repurchase the 2027 Notes or the 2030 Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the 2027 Notes or the 2030 Notes
Was: We may not have the ability to raise the funds necessary to repurchase the Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the Notes
- 32% rewrittenGeneral Risks
Unfavorable and uncertain global economic conditions could harm our business, financial condition or results of operations
- 31% rewrittenRisks Related to our Business Operations
Failure to retain our key personnel or an inability to attract and retain additional qualified personnel would cause our future growth and our ability to compete to suffer
- 31% rewrittenRisks Related to Our Common Stock
Our stock price is volatile and may fluctuate due to factors beyond our control
- 30% rewrittenRisks Related to Our Business
We are highly dependent on the commercial success of our products. We may not be able to meet expectations with respect to sales of our products or maintain profitability and positive cash-flow from operations
- 29% rewrittenRisks Related to the Development of our Product Candidates
We may not have the resources required to meet regulatory requirements and successfully navigate what is generally a lengthy, expensive and extensive approval process for commercialization of drug product candidates
- 28% rewrittenRisks Related to Our Common Stock
general market conditions in our industry or in the economy as a whole
- 26% rewrittenRisks Related to Our Business
establish superior intellectual property positions
- 26% rewrittenRisks Related to the Development of our Product Candidates
We may not be able to advance all of our programs, and we may use our financial and human resources to pursue particular programs and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success
- 25% rewrittenRisks Related to Our Business
The patient populations living with the diseases we target are small and have not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected
Was: The patient population suffering from Duchenne, LGMDs, CMT 1A, FSHD and DM1 is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected
- 21% rewrittenRisks Related to Our Common Stock
a super-majority (66 2/3%) of the voting power of all of the then-outstanding shares of capital stock are required to amend, rescind, alter or repeal our bylaws and certain provisions of our certificate of incorporation
- 20% rewrittenRisks Related to Our Business
We are subject to uncertainty relating to reimbursement policies which, if not favorable, could hinder or prevent the commercial success of our products and/or product candidates
All 69 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01We are highly dependent on the commercial success of our products. We may not be able to meet expectations with respect to sales of our products or maintain profitability and positive cash-flow from operations30% rewritten
- 02Even though certain of our products have received accelerated approval from the FDA, they face future post-approval development and regulatory requirements, which present additional challenges for us to successfully navigate44% rewritten
- 03refuse to allow us to enter into supply contracts, including government contractsNew
- 04We are subject to uncertainty relating to reimbursement policies which, if not favorable, could hinder or prevent the commercial success of our products and/or product candidates20% rewritten
- 05Healthcare policy reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent commercial success of our products and product candidates62% rewritten
- 06Workforce reductions in and restructuring of the U.S. Department of Health and Human Services, including at the FDA, may also create regulatory uncertainty, potentially impacting drug and biologic development programs and approvalsNew
- 07Our products may not be widely adopted by patients, payors or healthcare providers, which would adversely impact our potential profitability and future business prospects
- 08the efficacy and safety of our other product candidates and third parties’ competitive therapiesNew
- 09Further, the potential commercial success of our product candidates as well as continued commercialization of ELEVIDYS will depend on additional factors, including the capacity of any infusion centers responsible for the administration of our product candidates and ELEVIDYS34% rewritten
- 10We may not be able to expand the global footprint of our products outside of the U.S
- 11regulatory authorities outside the U.S. may adopt new or revised approval policies and regulations
- 12Historical revenues from eteplirsen, golodirsen and casimersen through our EAP outside the U.S. may not continue and we may not be able to continue to distribute our products through our EAP53% rewritten
- 13If we are unable to successfully maintain and further develop internal commercialization capabilities, sales of our products may be negatively impacted
- 14The patient populations living with the diseases we target are small and have not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected25% rewritten
- 15We face intense competition and rapid technological change, which may result in other companies discovering, developing or commercializing competitive products44% rewritten
- 16establish superior intellectual property positions26% rewritten
- 17Future sales of ELEVIDYS may decrease sales growth, or reduce sales, of our PMO products, which could negatively impact our operating results, including through potential inventory write-offs
Risks Related to the Development of our Product Candidates
- 18We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates
- 19severity of the disease under investigation
- 20If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business and on our ability to maintain our accelerated approval in the U.S
- 21the recruitment and retention of employees, consultants or contractors with the required level of expertise50% rewritten
- 22Clinical development is lengthy and uncertain. Clinical trials of our product candidates may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which could have a material adverse impact on our business61% rewritten
- 23Our products or product candidates may cause undesirable side effects, result in new safety signals or have other properties that could delay or prevent regulatory approval of product candidates, limit the commercial potential or result in significant negative consequences following any potential marketing approval58% rewritten
- 24If there are significant delays in obtaining, or if we are unable to obtain or maintain required regulatory approvals, we will not be able to commercialize our product candidates in a timely manner or at all
- 25We may not have the resources required to meet regulatory requirements and successfully navigate what is generally a lengthy, expensive and extensive approval process for commercialization of drug product candidates29% rewritten
- 26We may not be able to advance all of our programs, and we may use our financial and human resources to pursue particular programs and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success26% rewritten
- 27Interim, initial, “topline” and preliminary data from our clinical trials that we announce or publish from time to time are subject to audit and verification procedures and may differ materially from final data as more patient data become availableNew
- 28publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and investors or others may not agree with what we determine to discloseNew
Risks Related to Third Parties
- 29If we are unable to maintain our agreements with third parties to distribute our products to patients, our results of operations and business could be adversely affected
- 30Any such events may result in decreased product sales, lower product revenue, loss of revenue, and/or reputational damage, which would harm our results of operations and business57% rewritten
- 31and may have the right to terminate such agreements. In addition, if our strategic partners experience regulatory delays for the development of their clinical product candidates, including clinical holds, our opportunities to commercialize products may be delayedNew
- 32Our reliance on third parties requires us to share our proprietary information, which increases the possibility that a competitor will discover them or that our proprietary information will be misappropriated or inadvertently disclosed
Risks Related to Manufacturing and CMC
- 33The third parties we use in the manufacturing process for our products and product candidates may fail to comply with cGMP regulations82% rewritten
Risks Related to our Intellectual Property
- 34Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable
- 35Our business prospects will be impaired if third parties successfully assert that our products, product candidates, or platform technologies infringe proprietary rights of such third parties
- 36defend litigation or administrative proceedings which might be costly whether we win or lose, and which could result in a substantial diversion of financial and management resources
Risks Related to our Business Operations
- 37Failure to comply with healthcare and other regulations may subject us to substantial penalties and our business, operations and financial condition could be adversely affected50% rewritten
- 38for prosecuting corporate and white collar crime which includes health care fraud. Similarly, the DOJ-HHS False Claims Act Working Group enforcement priorities include drug pricing and kickbacks related to drugs paid for by federal healthcare programsNew
- 39Our announced strategic restructuring plan may not result in anticipated reductions in our annual combined research and development and selling, general and administrative expenses and may disrupt our business in unexpected waysNew
- 40Failure to comply with data privacy and security laws and regulations could adversely affect our operating results and business
- 41If we, our collaborators, or any third-party manufacturers engaged by us or our collaborators fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business
- 42Comprehensive tax reform in the U.S. and other jurisdictions in which we operate and future guidance could adversely affect our business and financial condition100% rewritten
- 43These and other tax law changes and anti-avoidance initiative increase uncertainty and may adversely affect our tax provision, cash tax liability and effective tax rateNew
- 44Our employees, principal investigators, consultants and strategic partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
- 45Failure to retain our key personnel or an inability to attract and retain additional qualified personnel would cause our future growth and our ability to compete to suffer31% rewritten
Risks Related to our Financial Condition and Capital Requirements
- 46We have previously incurred operating losses and we may not maintain profitability
- 47Our existing and any future indebtedness could adversely affect our ability to operate our business
- 48If we fail to maintain effective internal controls, we may not be able to accurately report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stockNew
- 49Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights
- 50The estimates and judgments we make, or the assumptions on which we rely, in preparing our consolidated financial statements and condensed consolidated financial statements could prove inaccurate
Risks Related to Our Common Stock
- 51Our stock price is volatile and may fluctuate due to factors beyond our control31% rewritten
- 52general market conditions in our industry or in the economy as a whole28% rewritten
- 53Our revenues and operating results could fluctuate significantly, which may adversely affect our stock price and our ability to maintain profitability
- 54Provisions of our certificate of incorporation, bylaws and Delaware law might deter acquisition bids for us that might be considered favorable and prevent or frustrate any attempt to replace or remove the then-current management and board of directors
- 55a super-majority (66 2/3%) of the voting power of all of the then-outstanding shares of capital stock are required to amend, rescind, alter or repeal our bylaws and certain provisions of our certificate of incorporation21% rewritten
- 56Future sales of our common stock in the public market could cause our share price to fall
Risks Related to Our Convertible Senior Notes
- 57Servicing our 2027 Notes and 2030 Notes requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt84% rewritten
- 58cash. As of December 31, 2025, the aggregate principal amount of 2027 Notes totaled approximately $158.6 million and the aggregate principal amount of 2030 Notes totaled approximately $893.4 millionNew
- 59We may not have the ability to raise the funds necessary to repurchase the 2027 Notes or the 2030 Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the 2027 Notes or the 2030 Notes32% rewritten
- 60In connection with the 2027 Notes, we entered into capped call transactions (the “Capped Call Transactions”) with certain financial institutions. The Capped Call Transactions are expected to generally reduce the potential dilution upon conversion of the 2027 Notes into shares of our common stock
General Risks
- 61Unfavorable and uncertain global economic conditions could harm our business, financial condition or results of operations32% rewritten
- 62We may be subject to product liability claims and our insurance may not be adequate to cover damages
- 63Despite our recent workforce reduction, we may in the future seek to expand, our organization and may experience difficulties in managing this growth, which could disrupt our operationsNew
- 64Our sales and operations are subject to the risks of doing business internationally
- 65changes in tax laws and tariffs
- 66We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively
- 67We may incur substantial costs in connection with litigation and other disputes53% rewritten
- 68The increasing use of social media platforms and artificial intelligence tools presents new risks and challenges
- 69We or the third parties upon whom we depend may be adversely affected by natural disasters and/or terrorism attacks, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
Other Sarepta Therapeutics 10-Ks
- FY2024 10-K risk factors70 risks
Sarepta faces heavy risks around commercial adoption, regulatory approval conditions, and third-party manufacturing dependencies for its rare disease therapies. The company relies heavily on maintaining reimbursement coverage and navigating strict post-approval requirements for products like Elevidys and its PMO portfolio.
Filed Feb 28, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.