On February 27, 2024, Viatris issued a press release reporting its fourth quarter and full year 2024 financial results and providing an update concerning its Indore, India facility. The press release states that “[f]ollowing an inspection of Viatris’ oral finished dose manufacturing facility in Indore, India in June 2024 the Company received a warning letter and import alert from the U.S. Food and Drug Administration (FDA) in December 2024” and that [t]he import alert affects 11 actively distributed products. . . .” Further, the press release states that “[t]he Company currently estimates the negative impact on 2025 total revenues to be approximately $500 million and to 2025 adjusted EBITDA to be approximately $385 million.”

Additionally, Viatris advised that following the FDA’s June 2024 inspection, “[t]he Company immediately implemented a comprehensive remediation plan” and that it was “more than halfway through its remediation efforts and expects to be completed in a few months at which time the Company anticipates requesting FDA to conduct a reinspection of the facility.” However, the Company said that while “product continues to be shipped from the Indore facility to markets outside the U.S., the Company currently anticipates some impact in other markets, including to parts of its ARV business in Emerging Markets and to select generic products in Europe.”

Following this news, the price of Viatris stock fell $1.71 per share, over 15%, to close at $9.53 per share on February 27, 2025.

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