SEC Investigates Viatris for Alleged Misconduct

2025-03-27 companies

New York, Wednesday, 26 March 2025.
The SEC is probing Viatris following investor allegations of misleading business practices, with stock falling 15% after Q4 2024 results. Financial impacts could be substantial.

Manufacturing Facility Issues Trigger Investigation

The investigation stems from issues at Viatris’s (NASDAQ: VTRS) manufacturing facility in Indore, India, where FDA inspections conducted in June 2024 led to significant regulatory actions. The FDA issued a warning letter to CEO Scott A. Smith on December 19, 2024, citing non-compliance with Good Manufacturing Practices [3]. Following this, an import alert was implemented on December 23, 2024, affecting 11 products including crucial medications like lenalidomide and everolimus [2].

Financial Impact and Market Response

The regulatory challenges have resulted in substantial financial implications for Viatris. The company projects a negative impact of approximately $500 million on 2025 total revenues and $385 million on adjusted EBITDA [2][3]. When these projections were announced on February 27, 2025, Viatris’s stock price plummeted by $1.71 per share, equating to a 15.21% decline, closing at $9.53 [5]. The market reaction has led to a loss of over $2 billion in shareholder value [3].

Multiple Law Firms Launch Investigations

Several prominent law firms have initiated investigations into Viatris’s conduct. Faruqi & Faruqi, LLP [1], Rosen Law Firm [2], and Hagens Berman [3] are all examining potential securities law violations. The investigations focus particularly on whether Viatris may have delayed disclosing material information about the FDA inspection and its potential impact on the company’s financial outlook [3]. As of March 26, 2025, Viatris stock trades at $8.96, showing continued market pressure [6].

Remediation Efforts and Future Outlook

Viatris reports being ‘more than halfway through its remediation efforts’ at the Indore facility and anticipates completing these improvements within the next few months [5]. While product shipments continue to markets outside the U.S., the company faces ongoing scrutiny from investors and regulatory bodies [2]. The SEC investigation remains active, with Viatris expected to release additional information by April 15, 2025 [4].

Sources

Viatris investigation SEC claims