By Kamal Choudhury
(Reuters) -Viatris forecast annual revenue and profit below Wall Street estimates on Thursday, mainly due to a worse-than-feared hit to sales from import restrictions on the drugmaker’s manufacturing plant in India.
Shares of the Canonsburg, Pennsylvania-based Viatris fell about 17% to $9.34 in morning trade. A $500 million to $650 million share buyback program also fell below investor expectations, analysts said, further dragging down shares.
Viatris in December said the U.S. Food and Drug Administration (FDA) had restricted imports of 11 products from its facility in Indore, India due to violations found during an inspection.
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.
Restrictions on a generic version of Bristol-Myers Squibb’s blood cancer drug Revlimid was driving the hit, company executives said.
CEO Scott Smith said the company is on track to finish remediation and is hopeful of an FDA re-inspection by the end of this year or early 2026.
The company forecast 2025 revenue between $13.5 billion and $14 billion, below analysts’ estimates of $14.27 billion, according to data compiled by LSEG.
It expects 2025 adjusted earnings per share between $2.12 and $2.26, below estimates of $2.59.
Viatris, formed through the merger of Mylan and Pfizer’s off-patented drugs business in 2020, sells branded medicines such as erectile dysfunction drug Viagra as well as generic ones.
On an adjusted basis, Viatris reported a quarterly profit of 54 cents per share, compared with estimates of 57 cents per share.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
