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REUTERS/Robert GalbraithCompanies Novartis AG FollowAmgen Inc Follow(Reuters) - Amgen Inc sued Novartis AG's Sandoz in New Jersey federal court Monday, accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents. Amgen asked the court to block Sandoz's biosimilars of the drugs until its patents expire. Thousand Oaks, California-based Amgen sold $3.6 billion worth of Prolia and $2 billion worth of Xgeva last year, according to a company report. The FDA accepted Sandoz's application for biosimilar versions of the Amgen biologic drugs — which are derived from living cells, unlike traditional small-molecule drugs — in February. Amgen said the proposed biosimilars infringe 21 patents covering Prolia and Xgeva.

☆ AbbVie's weak newer drug sales fan worries as Humira faces rivals
▼ + stars: | 2023-04-27 | by ( ) www.reuters.com time to read: +2 min

April 27 (Reuters) - AbbVie Inc (ABBV.N) on Thursday missed quarterly revenue estimates for its newer treatments, fueling concerns over the drugmaker's attempts to cushion the blow to sales from blockbuster Humira losing patent exclusivity. The company's shares tumbled 6% in premarket trade as investors shrugged off a raised annual profit forecast. In the first quarter, Humira recorded sales of $3.54 billion, compared with analysts' average estimate of $3.58 billion. That helped Abbvie beat sales expectations. AbbVie had trimmed its full-year profit expectations earlier this month by 8 cents, citing a $150 million hit from acquired in-process research and development (IPR&D) and milestone expenses.

☆ Drugmaker AbbVie trims profit forecasts on IPR&D expenses
▼ + stars: | 2023-04-05 | by ( Reuters Staff | ) www.reuters.com time to read: +1 min

REUTERS/Brian Snyder(Reuters) -AbbVie Inc on Wednesday lowered its full-year and first-quarter profit expectations, citing a $150 million hit from acquired in-process research and development (IPR&D) and milestone expenses. The company estimated first-quarter adjusted earnings to be between $2.31 and $2.41 per share from an earlier range of $2.39 to $2.49. It now sees 2023 adjusted earnings to be between $10.62 and $11.02 per share, compared with its prior forecast of $10.70 to $11.10. Analysts on average were expecting full-year earnings of $11.07 per share, according to Refinitiv IBES data. AbbVie is scheduled to report first-quarter earnings on April 27.

Stabilization of Humira sales after the initial erosion, coupled with strong growth of its newer drugs Skyrizi and Rinvoq for autoimmune disorders, could provide a floor to its earnings in 2024. "Now it's a question of what will the volume erosion look like?" In the fourth quarter, Humira sales dropped 26.5% to $573 million in international markets such as Europe, where it already faces competition from multiple less expensive versions. Overall, Humira sales rose 4.6% to $5.58 billion, in line with estimates, lifted by growth in the U.S. market. Excluding items, AbbVie earned $3.60 per share in the fourth quarter, beating analysts' average estimates by 4 cents.

☆ AbbVie's 2023 profit forecast misses as Humira faces heat from rivals
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +2 min

Most analysts are expecting the stock to be driven by management's comments on Humira sales this year during the investor conference call. AbbVie's weak forecast suggests that Humira rivals could nibble away at the blockbuster drug's market share at a faster pace this year than analysts' projections. In the fourth quarter, Humira sales dropped 26.5% to $573 million in international markets such as Europe, where it already faces competition from multiple cheaper versions. Overall, Humira sales rose 4.6% to $5.58 billion, in line with estimates, lifted by growth in the U.S. market. Excluding items, AbbVie earned $3.60 per share in the fourth quarter, beating analysts' average estimates of $3.56 per share.

☆ Roche flags 2023 earnings decline on slump in Covid products
▼ + stars: | 2023-02-02 | by ( ) www.cnbc.com time to read: +2 min

A view of the Roche towers, designed by architects Herzog and de Meuron, the headquarters of the Swiss pharma giant Roche, in Basel. Roche warned of a decline in 2023 earnings, as revenue growth from new drugs including haemophilia treatment Hemlibra and multiple sclerosis drug Ocrevus would not make up for a steep demand drop for Covid treatments and diagnostic testing. Sales and core earnings per share were expected to decrease at a "low single-digit" percentage this year, the Swiss drugmaker said in a statement on Thursday. Last year, group revenue edged 1% higher to 63.3 billion Swiss francs ($69.78 billion), the company reported, beating market expectations of 63.2 billion francs, while core operating profit gained 1% to 22.2 billion Swiss francs, just shy of the average analyst estimate of 22.4 billion francs. The decline equates to 5 billion Swiss francs, in his estimate.

But COVID-19 vaccine sales exceeded diminished expectations and demand for cancer drug Darzalex helped drive the fourth-quarter profit beat. The company reported $689 million in quarterly COVID-19 vaccine sales from outside the United States. J&J said it expects U.S. sales of Stelara to be flat to lower in 2023 due to competition from less expensive biosimilars in certain regions. It forecast adjusted 2023 earnings of $10.45 to $10.65 per share, above analysts' estimates of $10.35. Excluding items, J&J earned $2.35 per share for the quarter, topping analysts' estimates by 12 cents, according to IBES data from Refinitiv.

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☆ Merck could keep its patent edge by shifting Keytruda cancer drug to a simple shot
▼ + stars: | 2022-12-02 | by ( Michael Erman | ) www.reuters.com time to read: +7 min

If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. "The clock for that patent would start ticking from the time we would get that patent approved." Drug patents have a guaranteed term of exclusivity for 20 years after receiving a patent under U.S. law, but sometimes the companies are able to add additional patents that extend their exclusivity. Merck's patents on the subcutaneous version of Keytruda could protect that formulation until at least 2040, according to Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Access & Knowledge (I-MAK). Northwell's Mulloy said moving patients to subcutaneous versions of drugs also opens up spots in infusion centers for additional patients.

☆ World’s Top-Selling Drug Going Off Patent Means Big Bucks for Middlemen
▼ + stars: | 2022-11-27 | by ( David Wainer | ) www.wsj.com time to read: 1 min

AbbVie’s Humira has raked in about $200 billion over its lifetime. Starting next year the highest-grossing drug of all time, AbbVie ‘s Humira, will finally face competition from copycat biologics in the U.S. Yet the makers of the complex generics known as biosimilars won’t necessarily be the biggest winners. The top beneficiaries could instead be the middlemen such as Cigna and CVS Health , which will negotiate and dispense the drugs to patients.

One of the biggest makers of generic drugs, Israeli-based Teva said it aims eventually to secure a 10% global market share of biosimilars. A division of Novartis (NOVN.S), Sandoz is currently the second biggest player after Pfizer Inc (PFE.N) in the biosimilar market by gross sales globally, per IQVIA data, cited by Sandoz. Sandoz launched eight biosimilar drugs between 2017 and 2021, including a version of Bristol-Myers’ multiple myeloma drug Revlimid. The analysis projected the value of the global biosimilar market could more than triple to an estimated $74 billion by 2030. Sandoz and Teva are both working on biosimilars for Humira.

☆ Here are Monday's biggest analyst calls: Amazon, Nio, Disney, Carvana, Coinbase, Costco & more
▼ + stars: | 2022-11-21 | by ( Michael Bloom | ) www.cnbc.com time to read: +8 min

JPMorgan reiterates Amazon as top idea JPMorgan said the e-commerce giant is well positioned heading into the holiday season. " Morgan Stanley initiates Las Vegas Sands as overweight and names DraftKings as a top pick Morgan Stanley said in its initiation of Las Vegas Sands that it sees an attractive risk/reward. Morgan Stanley downgrades MongoDB to equal weight from overweight Morgan Stanley said in its downgrade of the database platform company that it's concerned about slowing growth for MongoDB. JPMorgan reiterates Charles Schwab as overweight JPMorgan said Charles Schwab is well positioned as one of the biggest "distributors of third-party mutual funds." Morgan Stanley upgrades Restaurant Brands to equal weight from underweight Morgan Stanley said it likes that the owner of brands such as Burger King appointed the former Domino's CEO as executive chairman.

☆ J&J stock dip after earnings beat reflects 2022 outperformance rather than the results
▼ + stars: | 2022-10-18 | by ( Zev Fima | ) www.cnbc.com time to read: +11 min

On an adjusted operational basis, which excludes the impact of acquisitions and divestitures and currency, sales rose 8.2%. Management said on the call they continue to see this business on track for its 11th consecutive year of above-market adjusted operational sales growth in 2022. Driving the results were increased sales of Stelara on the back of market growth and market share gains in Crohn's Disease and Ulcerative Colitis. Women's Health sales increased 7.9% on an operational basis to $225 million versus the $222 million expected. On a reported basis, management tightened their EPS guidance range to $10.02 to $10.07 from $10 to $10.10 previously.

☆ Finding yield in health care stocks during the market storm
▼ + stars: | 2022-09-23 | by ( Bertha Coombs | ) www.cnbc.com time to read: +3 min

Investors have looked to health care as a port in the storm during the stock market's volatility over the last year. In health care, "you still have companies that are throwing off good yield, so you get stability and good dividend yields." Biotech and pharmaceuticals industries have an average dividend yield of 2.6%, ranking just behind the consumer staples, utilities, and energy sectors. Just two stocks made the grade: drug maker AbbVie and pharmacy and health services giant CVS Health. The company, which includes pharmacy benefits as well the Aetna health insurance division, has a dividend yield of 2.1%.

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