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Gilead posts profit, says HIV prevention drug on track for mid-June

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By Deena Beasley

(Reuters) -Gilead Sciences on Thursday reported a first-quarter profit, but revenue was flat, as higher sales of drugs for HIV and liver disease, along with expense tightening, offset lower cancer drug sales.

The company's shares fell about 3% to $102.75 in after-hours trading.

Adjusted earnings per share came in at $1.81, just ahead of the average analysts' estimate of $1.79, as compiled by LSEG. Revenue of $6.7 billion was flat compared to a year ago and shy of the $6.8 billion expected by analysts.

Gilead's in-line product sales, slight EPS beat and lower expenses were "positive," while the key catalyst for the company's shares will be a "clean and smooth approval" in the United States of lenacapavir for preventing HIV, said Jefferies analyst Michael Yee.

The Food and Drug Administration is expected to decide by June 19 whether to approve the drug as a twice-yearly injection for HIV prevention.

"We haven't seen or heard anything to date that would alter our expectations for launch," Gilead CEO Daniel O'Day said in an interview.

Investors have been concerned about signals that the Trump administration could act to reduce government funding for HIV programs, including a planned review of the Centers for Disease Control and Prevention's HIV prevention division.

O'Day said Gilead continues to discuss with government officials the importance of support for programs to diagnose HIV infection and link people to care.

"The information we are getting is that they understand that," he said.

Gilead's quarterly sales of HIV drug Biktarvy rose 7% to $3.15 billion, roughly in line with Wall Street estimates, while sales of liver disease drugs rose 3% to $758 million.

The California-based biotech has previously said its HIV revenue would be largely flat in 2025 because of changes to the federal government's Medicare health plan for people age 65 and over aimed at reducing out-of-pocket costs for beneficiaries.

Sales of cancer drug Trodelvy fell 5% to $293 million, below analysts' estimates of $362 million, due to pricing and inventory issues. Cell therapy product sales fell 3% to $464 million, which Gilead attributed to increased U.S. competition.

Gilead recently reported successful results from a trial of Trodelvy for treating an aggressive form of breast cancer, which it said should eventually help boost demand for the drug.

The company also said it is working to expand use of its cell therapy products and has new options in development.