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☆ Gilead quarterly profit falls on COVID sales drop, legal settlement charge
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +2 min

[1/2] Gilead Sciences is seen during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File PhotoCompanies Gilead Sciences Inc FollowAug 3 (Reuters) - Gilead Sciences (GILD.O) on Thursday reported lower second-quarter profit as costs from a legal settlement and sharply lower sales of its COVID-19 treatment offset another strong performance by HIV drugs. The drugmaker raised its full-year revenue forecast, even as it trimmed its estimate for COVID antiviral Veklury due to lower pandemic-related hospitalizations. Wall Street analysts had expected an adjusted profit of $1.64 per share on revenue of $6.44 billion, according to Refinitiv data. The California-based company raised the low end of its 2023 revenue forecast range to $26.3 billion from $26.0 billion, but kept the high end at $26.7 billion.

Persons: Mike Blake, Gilead, Deena Beasley, Michael Erman, Bill Berkrot Organizations: Gilead Sciences, REUTERS, Wall Street, Thomson Locations: Oceanside , California, U.S, Gilead, California

Companies Gilead Sciences Inc FollowJuly 21 (Reuters) - Gilead Sciences Inc (GILD.O) said on Friday it was stopping a late-stage trial of its blood cancer combination treatment following an analysis that showed it would not be effective. Gilead, whose shares dropped over 1% in after-market trading, recommended that treatment with magrolimab in patients with MDS should be stopped. The company gained access to magrolimab with its $4.9 billion buyout of Forty Seven Inc in March 2020. Magrolimab is also in development for other types of cancer such as acute myeloid leukemia and solid tumours. Reporting by Sriparna Roy in Bengaluru Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

Persons: Gilead, Robert W, Baird, Brian Skorney, Magrolimab, Sriparna Roy, Vinay Dwivedi Organizations: Gilead Sciences, Gilead Sciences Inc, Seven Inc, Thomson Locations: Bengaluru

Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it. The government received four patents for HIV prevention drug regimens that CDC researchers invented. Its lawsuit claims the patents also cover Gilead's pre-exposure prophylaxis (PrEP) drug regimen for lowering HIV infection risk. The U.S. Food and Drug Administration approved Gilead's Truvada for HIV prevention in 2012 and approved its related drug Descovy for the same purpose in 2019. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.

March 30 (Reuters) - A federal judge in Texas on Thursday blocked Obamacare's mandate that health insurance plans cover pre-exposure prophylaxis against HIV (PrEP) and other preventive care including cancer and diabetes screenings. U.S. District Judge Reed O'Connor in Fort Worth, Texas, said the PrEP mandate violated a federal religious freedom law and that the other preventive care mandates were based on recommendations by an illegally appointed task force. The ruling was a victory for conservative businesses and individuals that sued to challenge the mandates in 2020. The U.S. Department of Health and Human Services, which oversees Obamacare, did not immediately respond to a request for comment. Reporting By Brendan Pierson in New York; Editing by Mark PorterOur Standards: The Thomson Reuters Trust Principles.

☆ First Drugs Facing Medicare Price Penalty Named by U.S.
▼ + stars: | 2023-03-15 | by ( Stephanie Armour | Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Humira, which treats rheumatoid-arthritis, is one of the 27 drugs named by U.S. health officials whose prices went up more than the rate of inflation. U.S. health officials released the first list of drugs paid for by the government’s Medicare insurance program whose prices went up more than the rate of inflation and and will face a penalty under a new federal law. The Centers for Medicare and Medicaid Services on Wednesday named 27 drugs that had the large price increases, including rheumatoid-arthritis treatment Humira from AbbVie Inc. and Yescarta lymphoma therapy from Gilead Sciences Inc., and will face the price-increase penalty in the form of a rebate.

☆ First Drugs Facing Medicare Price Penalty Are Named
▼ + stars: | 2023-03-15 | by ( Stephanie Armour | Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Humira, for rheumatoid arthritis, is one of the drugs facing a price-increase penalty. U.S. health officials released the first list of drugs paid for by the government’s Medicare insurance program whose prices went up more than the rate of inflation and will face a penalty under a new federal law. The Centers for Medicare and Medicaid Services on Wednesday named 27 drugs that had the large price increases, including rheumatoid-arthritis treatment Humira from AbbVie Inc. and Yescarta lymphoma therapy from Gilead Sciences Inc., and will face the price-increase penalty in the form of a rebate.

"Starting on April 1, Medicare beneficiaries will pay lower coinsurance for Part B drugs that raise prices faster than inflation," White House Domestic Policy Adviser Susan Rice told reporters on a press call. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. The government will start invoicing the companies for the rebates in 2025 but Medicare will start reducing out-pocket-costs for members in April. Medicare began examining the price increases in October 2022 for Medicare Part B drugs, often used in the hospital, that are complicated biologic drugs or drugs with only one manufacturer. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.

Wall Street's main indexes continued their losing streak for a fourth straight session on Monday as investors shied away from riskier bets, worried that the Federal Reserve's interest rate hikes could push the U.S. economy into recession. The Fed has managed to slow the economy down so it's likely that earnings estimates (for Q4) are going to come down. Treasuries fell following the BOJ's shock move, with the benchmark 10-year Treasury yield rising to a three-week high of 3.66%. Earlier, data showed U.S. single-family homebuilding tumbled in November as higher mortgage rates continued to depress housing market activity. A slew of other economic data due this week including consumer confidence and core inflation will provide more clues to investors on future interest rate hikes.

☆ Britain's NICE recommends against NHS use of 5 COVID treatments as not cost-effective
▼ + stars: | 2022-11-16 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

The review, conducted by the National Institute for Health and Care Excellence (NICE) and published on Wednesday, is its first involving COVID-19 treatments as the pandemic enters a new phase. The recommendations are a draft, NICE said, and until final guidance is published, access to COVID-19 medicines will continue as is. NICE acknowledged that there is evidence that Merck's molnupiravir and Gilead Sciences Inc's (GILD.O) hospital-administered antiviral remdesivir are effective at treating COVID-19. It also recommended against three other COVID treatments, including GSK (GSK.L) and partner Vir Biotechnology's (VIR.O) sotrovimab, an antibody therapy that the World Health Organization recommended against in September. One expert said that some of the COVID treatments NICE recommended against are an important part of the British government's current strategy.

DETROIT/WASHINGTON, Nov 7 (Reuters) - Stellantis (STLA.MI) said on Monday it is pausing all paid advertising posts on Twitter as it waits to see what the platform will look like under the leadership of its new owner Elon Musk. “We're pausing paid advertising posts until we have a clearer understanding of the future of the platform under its new leadership," the automaker said of Twitter in a statement to Reuters. Musk has said Twitter has suffered a "massive" revenue drop since he took over 10 days ago. Stellantis joins a number of major companies that have halted advertising on Twitter, including United Airlines (UAL.O), General Mills Inc (GIS.N) luxury automaker Audi of America and General Motors Co (GM.N). Gilead Sciences Inc (GILD.O) said earlier on Monday the company and its unit Kite were in the "process of pausing advertising" on Twitter.

WASHINGTON, Nov 7 (Reuters) - The U.S. Supreme Court on Monday rebuffed a bid by Bristol Myers Squibb Co's Juno Therapeutics Inc to reinstate a $1.2 billion award it won in its patent fight with Gilead Sciences Inc (GILD.O) subsidiary Kite Pharma Inc over a lymphoma drug. The justices turned away Juno's appeal of a lower court's ruling throwing out the award in the litigation over Kite's biologic drug Yescarta, in a case that could have repercussions for the cutting-edge biologic drug industry. Juno and Sloan Kettering Institute for Cancer Research sued Kite in 2017 in federal court in Los Angeles, accusing it of copying technology that the institute licenses to Juno. Juno and Sloan Kettering have told the Supreme Court that the Federal Circuit's decision to invalidate the patent and other rulings against biologic patents have been "devastating for innovation." On Nov. 4, the Supreme Court took up another patent case involving biologic drugs, agreeing to hear Amgen's bid to revive patents on its cholesterol drug Repatha.

☆ Gilead, Kite in process of pausing Twitter advertising
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

Nov 7 (Reuters) - Gilead Sciences Inc (GILD.O) said on Monday the company and its unit Kite were in the "process of pausing advertising" on Twitter, after Elon Musk completed his takeover of the social media company. In a statement to Reuters, Gilead said it was monitoring its advertising spend and waiting to better understand how community standards and content moderation will be handled on Twitter now. Gilead joins a growing list of U.S. companies, including General Motors (GM.N) and General Mills (GIS.N), who have either paused or are in the process of re-evaluating advertising on the social media platform. Last week, the Wall Street Journal reported Oreo maker Mondelez International Inc (MDLZ.O) and U.S. drugmaker Pfizer Inc (PFE.N) had also temporarily halted advertising with Twitter. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

Sept 28 (Reuters) - A federal judge in New York has frozen the assets of dozens of people and entities accused of operating a massive nationwide scheme to distribute counterfeit bottles of Gilead Sciences Inc (GILD.O) HIV drugs, including two alleged "kingpins." HIV drugs accounted for $7.6 billion of Gilead's $12.6 billion revenue in the first half of the year. read moreThe newly added defendants include alleged "kingpins" Lazaro Roberto Hernandez, who was arrested on drug counterfeiting and money laundering charges in June as part of a related federal investigation and remains under house arrest, and Armando Herrera, who lives in Florida. The Foster City, California-based company first announced it was pursuing counterfeiters in August 2021, shortly after filing its lawsuit. read moreIn addition to the alleged kingpins, the case now includes alleged mid-level leaders and a complex web of shell companies, distributors and pharmacies.

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