Sarepta Therapeutics : Update on Strategic Restructure and ELEVIDYS Label

Published: 2025-07-16 18:43:04 ET SRPT

Published on 07/16/2025 at 18:43

July 16, 2025

Patients can't wait for the next breakthrough

in medical research.

Doug Ingram

CEO

Ian Estepan

President and COO

Louise Rodino-Klapac, PhD

President, R&D and Technical Operations

DILLON

Living with Duchenne muscular dystrophy

Doug Ingram

CEO

In order to provide Sarepta's investors with an understanding of its current results and future prospects, forward-looking statements will be made during this presentation. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believe," "anticipate," "plan," "expect," "will," "may," "intend," "prepare," "look," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our preliminary earnings, financial projections and future operations; our pipeline and priorities; ELEVIDYS and the potential benefits of our proposed enhanced regimen; our ongoing and planned clinical trials; the reduction in force and our revised cost structure; the potential for our restructuring activities to reduce costs, help us meet our 2027 financial obligations, maintain access to our revolver, sustain profitability and position us for long-term sustainable growth; our expectation that the revised label for ELEVIDYS will include a black box warning for acute liver injury and acute liver failure; and expected plans and milestones, including our intention to seek alignment with the FDA to test our enhanced regimen in a new cohort of the ENDEAVOR study, our expected near-term milestones in 2025 and 2026 for our programs, including SRP-1001, SRP-1003, SRP-1004 and SRP-1005, submitting the BLA for SRP-9003 later this year, potentially seeking additional strategic alternatives for programs no longer directly funded, and near-term opportunities from the siRNA platform.

Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the reduction in force may take longer or result in more significant charges or cash expenditures than anticipated or otherwise negatively impact the Company and its business plans during and after the period during which the reduction in force is being executed; we may experience delays in treating patients at infusion sites; we may not be able to meet expectations with respect to sales of our products or maintain profitability; we may observe adverse reactions in our clinical trials or in patients who receive our approved products; our products may not be widely adopted by patients, payors or healthcare providers, which would adversely impact our potential profitability and future business prospects; the estimates and judgments the Company makes, or the assumptions on which it relies, in preparing its financial statements could prove inaccurate; 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; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; failure to retain our key personnel or an inability to attract and retain additional qualified personnel could present a challenge to our business objectives; our existing and any future indebtedness could adversely affect our ability to operate our business; our revenues and operating results could fluctuate significantly, which may adversely affect our stock price and our ability to maintain profitability; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

This presentation includes both GAAP information and Non-GAAP information. Non-GAAP research and development expenses are defined as GAAP research and development expenses excluding depreciation and amortization expense and stock-based compensation expense. Non-GAAP selling, general and administrative expenses are defined as GAAP selling, general and administrative expenses excluding depreciation expense and stock-based compensation expense. Non-GAAP research and development expense and Non-GAAP selling, general and administrative expense are important internal measurements for Sarepta. The Company believes that providing such

information in conjunction with Sarepta's GAAP information enhances investors' and analysts' ability to meaningfully compare the

Company's results from period to period and to identify operating trends in the Company's principal business.

Investors should note that the Non-GAAP information included in this presentation is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future, there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Because of the non-standardized definitions, the Non-GAAP financial measure as used by Sarepta in this presentation may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

Disclaimer

Sarepta Therapeutics Inc. published this content on July 16, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on July 16, 2025 at 22:42 UTC.