EyePoint Pharmaceuticals, Inc.

Current report

This section augments and updates certain risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2024 (the Annual Report). The following risk factors should be read together with the other risk factors disclosed in the Annual Report. In addition to the other information in this Quarterly Report on Form 10-Q, all of the risk factors should be carefully considered in evaluating us and our common stock. Any of these risks, many of which are beyond our control, could materially and adversely affect our financial condition, results of operations or cash flows, or cause our actual results to differ materially from those projected in any forward-looking statements. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not identified below because they are common to all businesses. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. For more information, see “Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q.

Current report

We are in discussions with the U.S. Department of Justice regarding its ongoing investigation related to sales, marketing and promotional practices, including as pertain to DEXYCU®. If we are unable to reach an acceptable negotiated resolution with the government, the DOJ may commence an action against us, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows. In addition, we have expended and expect to continue to expend significant financial and managerial resources responding to the DOJ subpoena and engaging in discussions with the DOJ regarding a negotiated resolution of the matter.

Current report

As previously disclosed, in August 2022, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts (DOJ) seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU®(DOJ Subpoena), which we commercialized from 2019 to 2023.

Current report

We have been cooperating fully with the government in connection with this matter and are in discussions with the DOJ regarding a possible negotiated resolution, which, if achieved, may require us to make further undertakings. Based on discussions to date, we believe that any negotiated resolution of this matter, which involves a civil qui tam action filed under seal, would not be material to the Company’s business or financial condition. However, there is no guarantee that we will be able to reach final agreement with the government.

Current report

In addition, if we are unable to reach a negotiated resolution of this matter, the DOJ may commence an action against us. Under applicable law, the DOJ has the ability to impose sanctions on companies which are found to have violated the provisions of applicable laws, including civil monetary penalties and other remedies. The resolution of any such enforcement action, should there be one, could have a material adverse effect on our business, financial condition, results of operations, and cash flows. We have also expended and expect to continue to expend significant financial and managerial resources responding to the DOJ Subpoena and engaging in discussions with the DOJ regarding a possible negotiated settlement, which, could also have an adverse effect on our business, financial condition, results of operations, and cash flows.

Previous report

There have been no material changes to the risk factors previously disclosed in Part I, “Item 1A, Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 6, 2025.