Company: SRPT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029973
Chunk: 232

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 232
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 generated an operating income of $218.1 million for the year ended December 31, 2024, our accumulated deficit to date was $4.2 billion. Although we currently have four commercially approved products in the U.S., we believe that it will take us some time to attain positive cash flow from operations. Since our products and product candidates target small patient populations, the per-patient drug pricing must be high in order to recover our development and manufacturing costs, fund adequate patient support programs, fund additional research and achieve profitability. We may be unable to maintain or obtain sufficient sales volumes at a price high enough to justify our product development efforts and our sales, marketing and manufacturing expenses. 

We have generally incurred expenses related to research and development of our technologies and product candidates and from general and administrative expenses that we have incurred while building our business infrastructure. We anticipate that our expenses will increase substantially if and/or as we:

•continue the commercialization of our products in the U.S.;

•expand the global footprint of our products outside of the U.S.;

•establish our sales, marketing and distribution capabilities;

•continue our research, pre-clinical and clinical development of our product candidates;

•respond to and satisfy requests and requirements from regulatory authorities in connection with development and potential approval of our product candidates;

•initiate additional clinical trials for our product candidates;

•seek marketing approvals for our product candidates that successfully complete clinical trials;

•acquire or in-license other product candidates;

•maintain, expand and protect our intellectual property portfolio;

•increase manufacturing capabilities, including capital expenditures related to our real estate facilities and entering into manufacturing agreements;

•hire additional clinical, quality control and scientific personnel; and

•add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

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Because of the numerous risks and uncertainties associated with developing biopharmaceutical products, we are unable to predict our ability to continue to generate profitability or the extent of it.

Our existing and any future indebtedness could adversely affect our ability to operate our business. 

On February 13, 2025, we entered into a $600.0 million revolving credit agreement with JPMorgan Chase Bank, N.A., as administrative agent and as collateral agent, the lenders party thereto, and Sarepta Therapeutics Investments, Inc., a Delaware corporation and wholly owned subsidiary, which we refer to as the “Credit Agreement”. To the extent we draw amounts under the Credit Agreement in the future,