Company: SRPT
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-064412
Chunk: 1

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Part II, Item 1
Chunk 1
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For material legal proceedings, please read Note 16, Commitments and Contingencies to our unaudited condensed consolidated financial statements included in this report. 

Item 1A. Risk Factors.

Set forth below and elsewhere in this report and in other documents we file with the SEC are descriptions of risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements contained in this report. Because of the following factors, as well as other variables affecting our operating results, past financial performance should not be considered a reliable indicator of future performance and investors should not use historical trends to anticipate results or trends in future periods. The risks and uncertainties described below are not the only ones facing us. Other events that we do not currently anticipate or that we currently deem immaterial also affect our results of operations and financial condition.

Risks 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.

The commercial success of our products continues to depend on, and the commercial success of any future products would depend on, a number of factors attributable to one of our products or the products of our competitors, including, but not limited to:  

•the effectiveness of our sales, managed markets, marketing efforts and support for our products;

•the generation and dissemination of new data analyses and the consistency of any new data with prior results, whether they support a favorable safety, efficacy and effectiveness profile of our products and any potential impact on our FDA accelerated approval status and/or FDA package insert for our products;

•the effectiveness of our ongoing commercialization activities, including negotiating and entering into any additional commercial, supply and distribution contracts, ongoing manufacturing efforts and hiring any additional personnel as needed to support commercial efforts;

•our ability to timely comply with FDA post-marketing requirements and commitments, including through successfully conducting additional studies that confirm clinical efficacy, effectiveness and safety of our products and acceptance of the same by the FDA and medical community since continued approval may be contingent upon verification of a clinical benefit in confirmatory trials, particularly in light of FDA's expanded expedited withdrawal procedures as set forth in FDORA;

•the occurrence of any side effects, adverse reactions or misuse, or any unfavorable publicity in these areas;

•the generation of evidence describing payers, patients and/or societal value of our products; 

•whether we can consistently manufacture our products and product candidates at acceptable costs;

•the rate and consistency with which our