Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

London: Gilead Sciences on Thursday reported slightly higher-than-expected quarterly earnings on flat revenue, as higher sales of drugs for HIV and liver disease along with expense tightening offset lower cancer drug sales . Adjusted earnings per share came in at $1.81, just ahead of the average analysts' estimate of $1.79 a share, as compiled by LSEG. In the year-earlier quarter, Gilead posted a loss due to acquisition and impairment charges. Revenue of $6.7 billion was flat compared to a year ago and shy of the $6.8 billion expected by analysts. Sales of HIV drug Biktarvy rose 7 per cent to $3.15 billion, roughly in line with Wall Street estimates, while sales of liver disease drugs rose 3 per cent 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 per cent to $293 million, below analysts' estimates of $362 million, due to pricing and inventory issues. Cell therapy product sales fell 3 per cent to $464 million, which Gilead attributed to lower U.S. demand. Sales of COVID-19 antiviral Veklury fell 45 per cent to $302 million, while analysts had forecast $392 million. For the full year, Gilead said it still expects adjusted earnings of $7.70 to $8.10 per share on product sales of $28.2 billion to $28.6 billion, which includes the known impact of tariffs so far imposed by the Trump administration. The U.S. Food and Drug Administration is expected to decide by June 19 whether to approve Gilead's HIV drug lenacapavir 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. He also 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," O'Day said. Gilead's research and development expenses for the quarter were $1.4 billion, compared with $1.5 billion a year earlier, while sales and administrative costs dropped to $1.3 billion from $1.4 billion. (Reporting By Deena Beasley Editing by Bill Berkrot)

Dive Brief:Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations. Gileads oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gileads breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.Gileads HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.Dive Insight:Gilead has invested heavily in oncology over the last several years, using a string of deals to amass a portfolio of cancer drugs and cell therapies.That effort has produced somewhat mixed results. Trodelvy the product of a $21 billion buyout of Immunomedics hasnt yet lived up to initial expectations, though clinical results earlier this week in a tough-to-treat form of breast cancer could help improve its outlook. And while Gileads cell therapy revenue has steadily grown over the years, the companys flagging first quarter total suggest competition is eroding its market share, wrote Leerink Partners analyst Daina Graybosch in a Friday note to clients.Gileads core business, though, continues to drive the bulk of its revenue. Sales of its once-a-day oral drug Biktarvy grew 7% to $3.1 billion, while sales of another HIV medicine, Descovy, surged 38% to $586 million.Lenacapavir, which the company already sells as Sunlenca, could further improve its outlook. The drug was approved in 2022 for people whose HIV infections cant be controlled by existing treatments. But a pair of large studies last year showed it to be highly effective at preventing infections as well, positioning it to change the dynamics of the so-called pre-exposure prophylactic, or PrEP market currently dominated by pills.Gilead faces some uncertainty ahead, as Trump administration cuts to a global HIV program could affect the drugs rollout. The administration has also eliminated a Centers for Disease Control and Prevention office focused on HIV policy and prevention. Gilead faces greater regulatory (and therefore commercial) risk from the Department of Health and Human Services, which could affect lenacapavirs coverage and reimbursement kinetics,Leerinks Graybosch wrote.Company executives, though, arent expecting any such issues as of yet.We haven't heard or seen anything that would cause us to alter our plans or expectations for the ...PrEP launch, or adversely affect our HIV business, said Gilead CEO Daniel ODay during a call with investors.Chief Commercial Officer Johanna Mercier also said the company believes the U.S. market will continue to grow “quite rapidly“ and accelerate with the coming launch.Gilead shares fell about 3% on Friday, but have climbed nearly 60% over the last year. '