Company: SRPT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029973
Chunk: 236

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 236
---
 For example, the trading prices of biopharmaceutical companies have been highly volatile as a result of inflation and increased interest rates and overall market volatility. In addition, our operations and performance may be affected by political or civil unrest or military action, including the ongoing conflict between Russia and Ukraine. Additionally, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has often been instituted against these companies. Such litigation could result in substantial costs and a diversion of our management’s attention and resources.

-62-

Our revenues and operating results could fluctuate significantly, which may adversely affect our stock price and our ability to maintain profitability.

Our revenues and operating results may vary significantly from year-to-year and quarter-to-quarter as well as in comparison to the corresponding quarter of the preceding year. Variations may result from one or more factors, including, without limitation:

•timing of purchase orders;

•changes in coverage and reimbursement policies of health plans and other health insurers, especially in relation to those products that are currently manufactured, under development or identified for future development by us;

•re-authorizations processes that may be required for patients who initially obtained coverage by third parties, including government payors, managed care organizations and private health insurers;

•transition from temporary billing codes established by the CMS to permanent medical codes;

•timing of approval of applications filed with the FDA;

•timing of product launches and market acceptance of products launched;

•changes in the amounts spent to research, develop, acquire, license or promote new and existing products;

•results of clinical trial programs;

•serious or unexpected health or safety concerns with our product or product candidates and any resulting clinical holds;

•introduction of new products by others that render one or more of our products obsolete or noncompetitive;

•the ability to maintain selling prices and gross margins on our products;

•increases in the cost of raw materials contained within our products and product candidates;

•manufacturing and supply interruptions, including product rejections or recalls due to failure to comply with manufacturing specifications;

•timing of revenue recognition relating to our distribution agreements;

•changes in estimates or potential asset impairments;

•the ability to protect our intellectual property from being acquired by other entities;

•the ability to avoid infringing the intellectual property of others; 

•the impact of the COVID-19 or similar pandemics; and 

•the addition or loss of customers.

In addition, in one or more future periods, our results of operations may fall below the expectations of