March 19, 2020 – In addressing the COVID-19 pandemic, Sarepta is proactively monitoring, assessing potential impacts, and working to avoid or minimize any interruption or delay in our plans or inconvenience or harm to patients. We intend to do everything reasonably possible to reduce the potential exposure to the virus causing COVID-19, meet the needs of patients, healthcare providers and employees, ensure the uninterrupted supply of our approved therapies and continue to execute our research and development plans. Importantly, as previously announced on our fourth quarter earnings call, with significantly in excess of $2 billion of cash on hand, all of which external cash is conservatively invested entirely in ultra-short-term U.S. government securities, Sarepta is in a privileged place to weather this crisis, remain focused on our patients and our mission, and come through this challenging period strongly.
Sarepta is operating under guidance from federal agencies, including the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), which designate healthcare companies as “critical infrastructure” with a special responsibility to maintain normal work schedules. Importantly, our partners and suppliers share these special responsibilities to maintain operations as critical infrastructure and ensure the integrity of the supply chain.
Sarepta continues to provide an uninterrupted supply of its therapies to patients and the Company has activated business continuity plans to minimize disruption to patients.
The Company is closely monitoring its currently active clinical trials to avoid study protocol violations and to accommodate any delays in scheduled visits to address COVID-19. In this regard, Sarepta is informed by the direction and flexibility provided by the United States Food and Drug Administration in its Guidance entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” We are closely monitoring all our studies to minimize disruption and delay in either dosing or follow-up visits. With respect to our active gene therapy trials, all dosing in the main studies has taken place and we are working within the FDA Guidance to avoid or minimize delays in trial follow-up visits during this acute period.
- Patients taking Sarepta products are encouraged to work closely with their physicians and can also call SareptAssist for guidance at 1-888-727-3782. Please read our community letter here.
- COVID-19 has created new considerations and challenges for participants in clinical trials. The FDA guidance on clinical trial conduct during the pandemic will guide us as we work through this crisis and we will work closely with clinical trial sites to ensure that patient safety remains the top priority.
- We are evaluating options such as where we can adapt trial protocols to allow for virtual interactions and reduce risk for patients, while remaining fully compliant with Good Clinical Practice and continuing to advance these important investigational treatments.
Employees and Community:
- In addition to patients, the health and safety of Sarepta’s employees is paramount.
- Facility-dependent employees, including those needed to maintain manufacturing and clinical research, are reporting to work under strict protocols designed to ensure they remain healthy.
- The company is supporting employees, including remote work, and leveraging virtual meeting technology and encouraging them to follow local guidance.
- Sarepta has suspended all international business travel, non-essential domestic business travel and attendance at conferences and other large events.
This document contains forward-looking statements. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding our work to avoid or minimize any interruption or delay in our plans or inconvenience or harm to patients; our intention to do everything reasonably possible to reduce the potential exposure to the virus causing COVID-19, meet the needs of patients, healthcare providers and employees, ensure the uninterrupted supply of our approved therapies and continue to execute our research and development plans; our cash position putting us in a place to weather this crisis, remain focused on our patients and our mission, and come through this challenging period strongly; our plan to work closely with clinical trial sites to ensure that patient safety remains the top priority; and the potential to adapt trial protocols to allow for virtual interactions and reduce risk for patients, while continuing to advance these important investigational treatments.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the COVID-19 pandemic could create economic and financial disruptions and could lead to operational difficulties that could result in interruption in the supply of our products, reduced sales of our products, interruption or delay in our research and development plans, delays in our clinical studies, inability to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, or inconvenience or harm to patients; and those risks identified under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2019 and 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 Sarepta's 2019 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Source: Sarepta Therapeutics, Inc.