Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX), a pharmaceutical company, disclosed in a regulatory filing with the U.S. Securities and Exchange Commission (SEC) that its previously issued unaudited financial statements for Q2 2023 should no longer be relied upon due to a necessary restatement. The restatement is linked to the review of adjustments, particularly related to PEMFEXY returns and price adjustments, estimated to be in the range of $15.0 million to $20.0 million.

According to the regulatory filing, Eagle Pharmaceuticals identified material weaknesses in its internal control over financial reporting, leading to a re-evaluation of the effectiveness of disclosure controls and procedures. This assessment found the disclosure controls and procedures ineffective as of June 30, 2023. 

The Company said that it intends to file an amendment to its Form 10-Q for Q2 2023 - including restated financial statements -, adding that the restated financials are anticipated to impact previously issued guidance for full-year 2023. 

Additionally, the Company faces default consequences under its credit agreement due to the delay in delivering quarterly financial statements, and an event of default has been triggered. Eagle Pharmaceuticals stated that it is actively seeking waivers and amendments to address these issues, but uncertainties remain about obtaining them.

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