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☆ Roche's Q3 sales down 3% on currency headwinds, drop in COVID sales
▼ + stars: | 2023-10-19 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

Quarterly sales came in at 14.3 billion Swiss francs ($15.9 billion), the Swiss drugs and diagnostics maker said in a statement, broadly in line with analyst estimates. A high-dose version of Eylea for less frequent injections won U.S. approval in August, creating doubt among analysts that a string of forecast-beating Vabysmo sales can continue. CEO Thomas Schinecker - who is keen to restore Roche's drug development record - said he was looking to acquire drug assets in all stages of development but that there was no rush. He pointed to 10% sales growth during the quarter, excluding currency headwinds and the slump in COVID sales. However, it predicted a less pronounced decline in sales of COVID-19 products of about 4.5 billion Swiss francs, from a previous estimate of a drop of 5 billion francs.

Persons: drugmaker Roche, Arnd, Roche, Regeneron, Thomas Schinecker, Schinecker, Ludwig Burger, Friederike Heine, Elaine Hardcastle Organizations: REUTERS, Bayer, Thomson Locations: Basel, Switzerland, COVID, Swiss

☆ Regeneron expects FDA decision on higher-dose Eylea this year
▼ + stars: | 2023-08-03 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid/File PhotoAug 3 (Reuters) - Regeneron Pharmaceuticals (REGN.O) expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday. The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent (CTLT.N). Regeneron said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August. Regeneron said the higher-dose Eylea was manufactured on the same line as pozelimab, its experimental drug being reviewed to treat a rare blood disease.

Persons: Brendan McDermid, Regeneron, Wells, Mohit Bansal, Bayer, Sanofi, Khushi, Sriraj Organizations: Regeneron Pharmaceuticals, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Westchester, Tarrytown , New York, U.S, Eylea, Bengaluru

☆ US FDA declines to approve Regeneron's higher-dose Eylea, shares tumble
▼ + stars: | 2023-06-27 | by ( ) www.reuters.com time to read: +2 min

The Food and Drug Administration cited an ongoing review of inspection findings at a third-party filler of the higher dose for the decision. Eylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's (ROG.S) rival treatment Vabysmo was approved last year for wet AMD. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 milligrams at longer intervals without any additional safety issues. The two trials included treatment of patients with wet AMD and diabetic macular edema (DME). An estimated 1.1 million people in the U.S. have wet AMD, while 1.2 million are estimated to have DME, according to Regeneron.

Persons: Vabysmo, Regeneron, Eylea, Raghav Mahobe, Krishna Chandra Eluri, Maju Samuel, Sriraj Organizations: Regeneron Pharmaceuticals, Drug Administration, FDA, AMD, biosimilars, Thomson Locations: U.S, Bengaluru

☆ Regeneron shares fall after FDA rejects high-dose eye disease treatment
▼ + stars: | 2023-06-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York. Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment. Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler." That suggests the drug could potentially win approval down the road. But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings ' eye drug, Vabysmo.

Persons: Regeneron Organizations: Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Roche Holdings Locations: Tarrytown , New York, U.S

☆ Regeneron's Eylea drug misses sales estimates as competition heats up
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +1 min

The drug recorded sales of $2.28 billion in the quarter, missing expectations of $2.43 billion, according to an average of six analysts' estimates polled by Refinitiv. The company has also been leaning on its anti-inflammatory drug Dupixent - a treatment currently approved for five indications including asthma and atopic dermatitis, or eczema. Quarterly sales of Dupixent, recorded by Regeneron's partner Sanofi (SASY.PA), rose about 37% to $2.49 billion, above expectations of $2.38 billion. Regeneron's total revenue of $3.16 billion beat estimates of $3 billion. Excluding items, the company reported a profit of $10.09 per share, above estimates of $9.56.

☆ Roche Q1 sales decline tempered by swift uptake of new eye drug
▼ + stars: | 2023-04-26 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

[1/2] The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. Quarterly group revenue fell to 15.3 billion Swiss francs ($17.2 billion), the company reported on Wednesday, beating market expectations of 14.8 billion francs. The company, which does not report earnings for its first and third quarter, reiterated that pandemic-related sales - mainly lab testing, antibody treatment Ronapreve and repurposed arthritis drug Actemra - would drop by 5 billion francs this year. "We are very happy with the very rapid and significant uptake in the different markets around the world," he said on a media call. Sales and core earnings per share were still expected to decrease at a "low single-digit" percentage in 2023, the pharmaceuticals and diagnostics company added.

☆ Cowen says buy Regeneron, success of drugs could help pharmaceutical stock
▼ + stars: | 2023-01-30 | by ( Alex Harring | ) www.cnbc.com time to read: +2 min

Regeneron 's stock could get a boost as one of its major drugs gains a competitive edge and another continues dominating, according to Cowen. Analyst Tyler Van Buren on Monday upgraded the pharmaceutical stock to outperform from market perform. Van Buren said Eylea has an "incremental improvement" over competing drug Vabysmo after previously being considered equal. "The HD Eylea data has altered the trajectory of Regeneron," Van Buren said in a note to clients. Van Buren said Regeneron's cancer portfolio continues to post little to no value, but there's potential opportunity in Odronextamab and Fianlimab specifically.

☆ JPMorgan upgrades Regeneron, says eye drug launch could help boost shares nearly 20%
▼ + stars: | 2023-01-20 | by ( Samantha Subin | ) www.cnbc.com time to read: +1 min

Approval of Regeneron 's eye drug treating age-related macular degeneration could serve as the next big catalyst for shares of the pharmaceutical giant, according to JPMorgan. Analyst Chris Schott upgraded shares of Regeneron to overweight from neutral, calling the pharmaceutical company's Eylea drug a "best in class therapy" slated to broaden its AMD segment. The positivity from Schott comes even after the company noted that a shift to an off-label competitor negatively impacted drug sales in the final quarter of 2022. Despite a crowded and increasingly competitive market, Schott also views Regeneron's drug treating atopic dermatitis, or eczema, as another potential growth driver for the stock going forward. Regeneron outperformed in 2022, rising 14% as the broader market fell.

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