(Reuters) – Viatris forecast annual revenue and profit below Wall Street estimates on Thursday, two months after the U.S. health regulator restricted imports from one of the drugmaker’s key plants in India.
Shares of Viatris fell 14.6% in premarket trading.
Viatris in December 23, 2024 disclosed that the U.S. Food and Drug Administration (FDA) has restricted imports of 11 products from its facility in Indore, India due to violations of federal requirements.
The company estimated on Thursday that the FDA action will reduce its 2025 total revenues by about $500 million and adjusted core earnings by about $385 million.
“Although in the past we and investors had assumed a minimal impact from Indore warning letter, today’s guidance shows a significant negative impact,” said Ashwani Verma, an analyst at brokerage UBS.
The Canonsburg, Pennsylvania-based Viatris forecast 2025 revenue between $13.5 billion and $14 billion, below analysts’ estimates of $14.27 billion, according to data compiled by LSEG.
The company expects 2025 adjusted earnings per share between $2.12 and $2.26, compared with estimates of $2.59.
The FDA has permitted exceptions for four Viatris products due to shortage concerns, though the specific products have not been disclosed.
Viatris, formed through the merger of generic drugmaker Mylan and Pfizer’s Upjohn business in 2020, has generic and branded drugs in its portfolio, including erectile dysfunction drug Viagra, anti-anxiety medication Xanax, epilepsy treatment Lyrica and arthritis treatment Celebrex.
The drugmaker also fell short of market expectations for fourth-quarter revenue and profit.
On an adjusted basis, the company reported a profit of 54 cents per share, compared with analysts’ estimates of 57 cents per share, according to data compiled by LSEG.
It reported a revenue of $3.52 billion for the fourth quarter, compared with analysts’ average estimate of $3.61 billion.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
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