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[1/2] Paul Hudson, chief executive officer of Sanofi, speaks during the annual results news conference at the company's headquarters in Paris, France, February 4, 2022. The market's shock reaction, compounded by a lack of details of the spending push, overshadowed Sanofi's plan to list its consumer unit, in line with an industry trend. David Song, a portfolio manager and investment partner at Tema ETF, said: "The narrative of Sanofi has been a margin expansion, earnings-driven story for a lot of investors." "Shouldn't investors give credit to managements who care about long-term shareholder value creation?," said Song. ($1 = 0.9206 euros)Reporting by Ludwig Burger; Editing by Josephine Mason and Emelia Sithole-MatariseOur Standards: The Thomson Reuters Trust Principles.
Persons: Paul Hudson, Sanofi, Benoit Tessier, Hudson, Dan Lyons, Janus Henderson, Markus Manns, David Song, Fabian Wenner, Julius Baer, Union's Manns, Janus Henderson's Lyons, Johnson, Song, Ludwig Burger, Josephine Mason, Emelia Organizations: REUTERS, Reuters, Janus Henderson Investors, Germany's Union Investment, Tema, Thomson Locations: Paris, France, British, Hudson, Denver, Swiss, Tema
The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File photo Acquire Licensing RightsNov 27 (Reuters) - Sanofi (SASY.PA) plans to seek U.S. approval for it best-selling anti-inflammatory drug Dupixent to be used in the treatment of "smoker's lung", also known as COPD, after a second large trial showed significant benefits. The company had embarked on a second trial to bolster the statistical reliability of the read-outs. Details of the second trial would be presented at an as yet undisclosed medical conference, Sanofi added. The company has been discussing with major watchdogs across the world whether the BOREAS results were substantial enough to support a regulatory review and what role the second trial would play in reviews.
Persons: Sanofi, Gonzalo Fuentes, BOREAS, Ludwig Burger, Tassilo Hummel, Edwina Gibbs Organizations: Sanofi, Polyclonals, REUTERS, Food and Drug Administration, Thomson Locations: Lyon, France
Under a push to spend more on immunology and inflammation drug development, the company abandoned a target for a 32% operating profit margin for 2025 to focus on "long-term profitability". EPS would see a strong rebound in 2025 but not enough to sustain the previous margin target. CONSUMER STAND-ALONECEO Hudson said the core innovative drugs business had improved enough to soon do without the more predictable cash flows from consumer products. The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. The timing of the potential consumer listing, which Sanofi said would be in the fourth quarter of 2024 or later, would be set to maximize shareholder value.
Persons: Hudson, Sanofi, drugmaker, Paul Hudson, Terence McManus, Johnson, we've, Gonzalo Fuentes, Roche, Dupixent, Ludwig Burger, Sherry Jacob, Phillips, Mark Potter, Sharon Singleton Organizations: Sanofi, Bellevue Asset Management, Reuters, Barclays, Johnson, GSK, Pfizer, Bayer, Polyclonals, REUTERS, Provention, Merck & Co, Thomson Locations: France, Bellevue, Lyon, Paris
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
May 22 (Reuters) - The benefits of Sanofi (SASY.PA) and Regeneron's (REGN.O) anti-inflammatory drug Dupixent set in quickly during a trial to treat "smoker's lung" and lasted for the duration of the 1-year study, French drugmaker Sanofi said late on Sunday. The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial. Sanofi presented details on the successful study at the American Thoracic Society congress in Washington over the weekend. "Within two weeks we saw improvement in lung function and improvement in quality of life," said Naimish Patel, Sanofi head of global development for immunology and inflammation. "We will take these results to regulators and have a discussion about what can be done ahead of the read-out of the second trial," Patel said.
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.
SummarySummary Companies Adj EPS still seen up by "low single digit" percentage in 2023Q1 operating profit, Dupixent sales beat consensusEstablished MS pill Aubagio hit by U.S. generic competitionApril 27 (Reuters) - French drugmaker Sanofi (SASY.PA) on Thursday posted better-than-expected earnings for the first quarter as continued gains from anti-inflammatory drug Dupixent more than offset declining sales from an established multiple sclerosis drug. It reported an 8.7% rise in quarterly business operating income, or adjusted earnings before interest and tax, to 3.33 billion euros ($3.7 billion), ahead of an average analyst estimate of 3.14 billion posted on the company's website. Revenue from eczema and asthma drug Dupixent, jointly developed with Regeneron (REGN.O), surged more than 43% to 2.32 billion euros, above a consensus of 2.27 billion euros. Finance chief Jean-Baptiste de Chatillon said in a media call that, for now, there would be no new annual peak sales estimate for the product, which Sanofi has put at more than 13 billion euros. ($1 = 0.9049 euros)Reporting by Ludwig Burger; Editing by Jacqueline WongOur Standards: The Thomson Reuters Trust Principles.
Regeneron and Sanofi Look for Billions From COPD Drug
  + stars: | 2023-03-25 | by ( David Wainer | ) www.wsj.com   time to read: 1 min
Dupixent was approved for eczema in 2017. Chronic obstructive pulmonary disease is the third-highest cause of death globally. Yet, despite its high death toll, it lacks great treatment options, and no new approaches have been approved in more than a decade. That is partly because it is a complex disease with different clinical characteristics that vary by patient, making it harder for companies to succeed in clinical trials. But there is a huge opportunity for drug companies that do come along with demonstrably good results.
Regeneron 's Dupixent drug could serve as the next big catalyst for shares of the pharmaceutical company, according to Jefferies. REGN YTD mountain Regeneron shares so far this year A study released Thursday indicated that Dupixent, created with Sanofi, showed promise as a treatment for patients with COPD. Broken down, the data showed Dupixent reduced some moderate or severe acute exacerbations of COPD by 30%, compared with a placebo over a 52-week period. Tewari also views Eylea as another upside driver for shares as Wall Street gains more clarity on the drug. Shares of Regeneron have been on a tear in 2023, up 11% after gaining 14% during 2022's market rout.
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Bank of America (BAC.N) and UBS (UBS.N) now see the Fed funds rate target peaking at 5-5.25% in May compared to earlier forecasts of 5.25-5.5%. Nvidia Corp (NVDA.O) rose 1.9% after Needham raised its price target on the chipmaker on likely benefit from near-term data center strength. ET is expected to show a rise in jobless claims last week, hinting at some cooling in labor demand. Regeneron Pharmaceuticals Inc (REGN.O) jumped 8.6% on promising results on its blockbuster asthma drug Dupixent from a lung disease trial. Reporting by Amruta Khandekar and Ankika Biswas in Bengaluru; Editing by Savio D'Souza and Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
Sanofi and Regeneron said in a statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and COPD respiratory symptoms. JP Morgan analyst Richard Vosser said the trial update had "blow-out data" in store for investors, and that market consensus for 2027 Dupixent sales of 15.7 billion euros would likely be topped-up by between 1 and 2 billion euros. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19% of the French group's overall sales of 43 billion euros, last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Sanofi and Regeneron on Tuesday announced the European Commission had approved Dupixent to treat severe atopic dermatitis in young children.
Shares of Sanofi and Regeneron both jumped by more than 6% on Thursday after the pharmaceutical companies released promising data showing their jointly developed asthma drug Dupixent also shows promise in treating COPD patients. New data from a phase three clinical trial shows Dupixent reduced bad bouts of chronic obstructive pulmonary disease, or COPD, by 30% compared with a placebo over 52 weeks. The trial enrolled COPD patients with type 2 inflammation — an allergic response that can result in decreased lung function. The companies said a second phase three trial of Dupixent in COPD is ongoing, with data expected in 2024. He added that J.P. Morgan expects to see new COPD patients adding $1.5 billion to $2 billion in new sales for Dupixent.
Pharma delivers, for others
  + stars: | 2023-03-23 | by ( ) www.reuters.com   time to read: +2 min
The progressive lung disease, which commonly crops up in heavy smokers, is the third biggest cause of death globally. A 30% reduction in exacerbations and significant lung function improvement means the drug should spin more profit. Deloitte estimates projected returns on drug development for the biggest pharma firms were 1.2% last year. Writ large, the world might be getting too good of a bargain. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.
In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Sanofi previously forecast Dupixent would generate up to 13 billion euros ($14.2 billion) in sales in its best year as it seeks to widen its use across several inflammatory conditions. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19%, of the French group's overall sales of 43 billion euros last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Dupixent was also approved by the EC to treat eosinophilic esophagitis, a condition that damages the esophagus, in January.
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Regeneron's Dupixent shows promise as COPD treatment
  + stars: | 2023-03-23 | by ( ) www.cnbc.com   time to read: 1 min
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailRegeneron's Dupixent shows promise as COPD treatmentCNBC's Meg Tirrell joins 'Closing Bell' to report that Regeneron's drug Dupixent has shown promise in treating COPD during phase 3 results.
March 13 (Reuters) - France's Sanofi SA (SASY.PA) on Monday agreed to acquire Provention Bio Inc <PRVB.O> for $2.9 billion to bolster its work on a U.S.-approved type 1 diabetes therapy and strengthen its drug pipeline following development setbacks. The deal builds on an existing co-promotion agreement between the two companies, and would give the French drugmaker full ownership of the drug, Tzield, Sanofi said, adding it expects to complete the acquisition in the second quarter of 2023. While growth in asthma and eczema drug Dupixent is boosting Sanofi's sales, investors have criticised its drug development pipeline as weak. Sanofi, the maker of long acting insulin products Toujeo and Lantus for type 2 diabetes, in 2019 quit further type 2 diabetes drug development. Chief Executive Officer Paul Hudson said last month the company saw great promise in type 1 diabetes drug development and reaffirmed his commitment to steer clear of further work on type 2 diabetes and obesity.
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Sanofi’s ailments are more than skin deep
  + stars: | 2023-02-03 | by ( ) www.reuters.com   time to read: +2 min
LONDON, Feb 3 (Reuters Breakingviews) - Sanofi (SASY.PA) is battling multiple ailments. The $115 billion French pharma group on Friday forecast “low single digit” growth in earnings per share for 2023, disappointing analysts. Hence it’s more reliant on the star asthma and eczema drug Dupixent, which contributed nearly a fifth of Sanofi’s 43 billion euros of sales in 2022. Last August, $36 billion was wiped off Sanofi, GSK (GSK.L) and spinoff Haleon (HLN.L) shares on U.S. litigation fears. It currently trades on 10 times its forecast 2023 earnings, while Novartis (NOVN.S) trades on 13 times.
Feb 3 (Reuters) - Sanofi (SASY.PA) on Friday forecast moderate earnings growth this year, saying higher demand for bestselling asthma and eczema drug Dupixent would be partly offset by competition for its multiple sclerosis pill Aubagio and product launch costs. Aubagio, with 2 billion euros in sales last year, will face competition from cheaper products over the next few months after losing patent protection, Sanofi said. The company reaffirmed its target to achieve sales of Dupixent, jointly developed with Regeneron (REGN.O), of 10 billion euros this year, up more than 20% from 8.29 billion euros in 2022. Sanofi reported a 20.7% rise in fourth-quarter business operating income, or adjusted earnings before interest and tax, to 2.72 billion euros ($2.96 billion), edging past an average analyst estimate of 2.69 billion euros posted on the company's website. Revenue from Dupixent surged 42% to 2.4 billion euros during the quarter ended Dec. 31, slightly above a consensus of 2.37 billion euros.
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.
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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