Key Takeaways SNY is trading below its 50- and 200-day moving averages, raising investor concerns about stock direction. Dupixent drives SNY revenues with approvals in eight diseases. Estimates for SNY's 2025 and 2026 earnings have risen, supported by new launches and pipeline momentum.Sanofi’s (SNY) stock has been trading below its 200-day and 50-day moving averages since early June. On June 23, the stock’s closing price of $48.18 was below its 50-day moving average of $50.32 and the 200-day moving avera ...

Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]

Core Insights - The FDA approved Merck's Enflonsia to protect infants from respiratory syncytial virus (RSV), competing with Sanofi and AstraZeneca's Beyfortus [1][4] - Merck plans to launch Enflonsia ahead of the RSV season, with orders expected to start in July [2] - The approval provides a new treatment option for RSV, which causes significant mortality and hospitalization among infants [3] Company Developments - Merck aims to ensure availability of Enflonsia in the U.S. before the RSV season to alleviate the burden on families and healthcare systems [4] - Enflonsia is a preventative monoclonal antibody that can be administered to infants regardless of weight, offering dosing convenience [5] - Sanofi is increasing the supply of Beyfortus, which generated €1.7 billion ($1.8 billion) in sales last year [6] Industry Context - Other companies, including Pfizer, GSK, and Moderna, offer RSV vaccines, but these are limited to adults and pregnant women [6] - A meeting of CDC vaccine advisors is scheduled for June 25 to 27 to discuss recommendations for RSV shots and other immunizations [7] - In clinical trials, Enflonsia reduced RSV-related hospitalizations by over 84% and lower respiratory infections requiring medical attention by more than 60% compared to a placebo [8]

Core Earnings and Revenue Performance - AstraZeneca's first-quarter 2025 core earnings were $1.24 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.10, with core earnings of $2.49 per share reflecting a 21% year-over-year increase at constant exchange rates (CER) [1][2] - Total revenues reached $13.59 billion, a 7% increase on a reported basis and 10% at CER, although this figure fell short of the Zacks Consensus Estimate of $13.68 billion [2] Product Sales and Therapeutic Areas - Product sales increased by 9% to $12.88 billion, driven by strong demand for marketed products [3] - Oncology product sales rose 13%, while Cardiovascular, Renal and Metabolism (CVRM) product sales increased by 12%, and Respiratory & Immunology (R&I) segment sales grew by 11%. However, sales in the Rare Disease segment remained flat, and Vaccines & Immune (V&I) Therapies saw a decline of 30% [4] Collaboration Revenues - Collaboration revenues totaled $74 million, a 64% increase attributed to a sales milestone for Farxiga in Japan, while alliance revenues rose 42% to $639 million, driven by growth from partnered medicines [5][6] Key Drug Performance - Tagrisso sales reached $1.68 billion, up 8%, surpassing estimates [7] - Lynparza sales increased by 5% to $726 million but missed estimates due to soft performance in emerging markets and U.S. headwinds [8][9] - Imfinzi generated $1.26 billion in sales, up 16%, but also missed estimates [9] - Calquence sales rose 8% to $762 million, beating estimates [10] - New drug Truqap recorded $132 million in revenues, down from the previous quarter due to Medicare Part D redesign impacts [11] Segment Performance - In the CVRM segment, Farxiga sales were $2.06 billion, up 16%, benefiting from label expansions [12] - Brilinta/Brilique sales decreased by 4% to $305 million, while new drug Wainua added $39 million in sales [13] - In the R&I segment, Symbicort sales declined by 3% to $723 million, and Pulmicort sales fell by 26% [14] - Fasenra recorded a 19% increase in sales to $418 million, exceeding estimates [15] - In the Rare Disease portfolio, Soliris sales fell 38% to $444 million, while Ultomiris revenues rose 25% to $1.05 billion [17] Cost and Guidance - Core selling, general and administrative expenses increased by 4% to $3.46 billion, while core research and development expenses rose 16% to $3.09 billion [19] - AstraZeneca maintained its 2025 guidance, expecting total revenues to grow by a high single-digit percentage at CER and core EPS to increase by a low double-digit percentage [20] Strategic Updates - AstraZeneca announced the discontinuation of the CAPItello-280 study for Truqap in metastatic castration-resistant prostate cancer [22] - The company received a positive recommendation for a label expansion involving Calquence for CLL treatment [23] - AstraZeneca plans to launch 20 new medicines by 2030, targeting $80 billion in total annual revenues by the end of the decade [29]