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Globe and Mail
a day ago
- Business
- Globe and Mail
AZN Q2 Earnings Meet Estimates, Sales Beat as Key Drugs Outperform
AstraZeneca 's AZN second-quarter 2025 core earnings of $1.09 per American depositary share (ADS) came in line with the Zacks Consensus Estimate. Core earnings of $2.17 per share rose 10% year over year on a reported basis and 12% on a constant exchange rate (CER). Total revenues of $14.46 billion rose 12% on a reported basis and 11% at CER, driven by higher product sales and alliance revenues from partnered medicines. Revenues beat the Zacks Consensus Estimate of $14.03 billion. All growth rates mentioned below are on a year-over-year basis and at CER. AZN's Product Sales & Alliance Revenues Among AstraZeneca's various therapeutic areas, Oncology revenues were up 18%, while Cardiovascular, Renal and Metabolism ('CVRM') product sales rose 3%. The Respiratory & Immunology (R&I) segment's sales rose 12%. While Rare disease revenues rose 7%, sales of Vaccines & Immune (V&I) Therapies rose 54%. Sales of other medicines were down 9%. Product sales rose 10% to $13.8 billion, as strong underlying demand trends for its products were partially offset by new manufacturer discounts under Medicare Part D redesign in the United States. Alliance revenues include royalties and profit share from partnered medicines, such as Enhertu and Tezspire, in geographies where its partner books product sales. Alliance revenues rose 35% to $654 million, driven by continued revenue growth from partnered medicines. Alliance revenues included $436 million from Daiichi Sankyo for Enhertu and $155 million of AstraZeneca's share of gross profits in the United States from partner Amgen AMGN for Tezspire. Alliance revenues also included $10 million from partner Daiichi Sankyo for Datroway and $27 million for Beyfortus. AZN records a 50% share of gross profits from Beyfortus' sales in major ex-U.S. markets and 25% of brand revenues from the rest of the world markets received from partner Sanofi SNY. The company also records Beyfortus product sales from products supplied to partner Sanofi under the V&I Therapies segment. AstraZeneca's Key Oncology Drugs Beat Estimates Here, we have discussed the total revenues of its drugs by including Alliance revenues and Collaboration revenues within each revenue figure. In Oncology, Tagrisso recorded revenues of $1.81 billion, up 12% year over year, on strong demand for all indications and in all regions, which more than offset the impact of Medicare Part D redesign and pricing pressure in some European markets. Tagrisso sales beat the Zacks Consensus Estimate as well as our model estimate of $1.75 billion. Lynparza's total revenues rose 11% to $838 million, driven by increased market share/demand growth for all approved indications. The drug's sales beat the Zacks Consensus Estimate of $810 million and our estimate of $788.7 million. AstraZeneca markets Lynparza in partnership with Merck MRK. During the quarter, the company did not record any milestone payment from partner Merck related to the drug. Imfinzi generated sales of $1.46 billion in the quarter, up 26%, driven by strong growth from launch in bladder and lung cancer indications, partially offset by mandatory price reductions in Japan. Imfinzi sales beat the Zacks Consensus Estimate of $1.37 billion and our estimate of $1.3 billion. Sales of Calquence rose 10% to $872 million in the quarter. New breast cancer drug Truqap recorded $170 million in revenues in the second quarter of 2025 compared with $132 million in the previous quarter. Newly approved drug Datroway, for which it has a partnership with Daiichi Sankyo, recorded revenues of $11 million in the quarter compared with $4 million in the first quarter, driven by encouraging initial launch uptake in the United States. The FDA approved the expanded use of Datroway for a second indication — non-small cell lung cancer in June. AZN's CVRM Segment Performance In CVRM, Farxiga recorded product sales of $2.15 billion, up 10%, driven by continued demand growth across chronic kidney disease and heart failure. Farxiga sales beat the Zacks Consensus Estimate of $2.05 billion and our model estimate of $2.06 billion. Brilinta/Brilique sales totaled $215 million in the reported quarter, down 38%, due to the generic launch in Europe and the United States in the second quarter. New drug Wainua recorded $44 million in product sales during the quarter compared with $39 million in the previous quarter, driven by strong launch momentum in the United States and initial launch in ex-U.S. markets. AZN's R&I Segment Performance In R&I, Symbicort sales declined 1% to $715 million due to generic erosion in Europe and competition from triple therapy on the ICS/LABA class of medicines like Symbicort in China. The drug's sales missed the Zacks Consensus Estimate and our model estimate of $726 million and $732.9 million, respectively. Fasenra recorded sales of $502 million in the quarter, up 18% year over year, driven by strong demand growth and market share gains. The recent launch for the EGPA indication also benefited sales in some countries. The drug's sales beat the Zacks Consensus Estimate as well as our model estimate of$467 million. Breztri recorded sales of $283 million, up 20% year over year. Pulmicort sales declined 32% to $106 million. Tezspire recorded total revenues of $261.0 million, up 65% year over year, driven by demand growth and launch uptake in multiple markets. Amgen records product sales in the United States, and AstraZeneca records its share of U.S. gross profits as Alliance revenues. AstraZeneca books product sales in markets outside the United States. New product Airsupra generated $42 million in product sales in the second quarter, compared with $28 million in the previous quarter. New lupus drug, Saphnelo, recorded sales of $167 million, up 48% year over year. AZN's Rare Disease, V&I and Other Segment In the Rare Disease portfolio, Soliris sales fell 22% to $530 million due to conversion to Ultomiris and biosimilar erosion in Europe. Ultomiris revenues amounted to $1.18 billion, up 23%, driven by patient demand, growth in neurology indications, geographic expansions in new markets and continued conversion from Soliris. The impact of Medicare Part D redesign was minimal in the second quarter. In Other Medicines, sales of Nexium declined 11% to $201 million. In V&I Therapies, AstraZeneca recorded $126 million in revenues from Beyfortus, which included alliance revenues mentioned earlier as well as sales of manufactured Beyfortus product to Sanofi. AZN Maintains 2025 Guidance AstraZeneca maintained its financial guidance for 2025. It expects total revenues to grow by a high single-digit percentage at CER. Core EPS is expected to increase by a low double-digit percentage. Our Take on AZN's Results AstraZeneca reported decent second-quarter results, as its earnings matched estimates and revenues beat the same. Sales of almost all key drugs, including Tagrisso, Lynparza, Imfinzi, Farxiga and Fasenra beat estimates. All these drugs have been driving AstraZeneca's top-line growth over the past several quarters, backed by increasing demand trends. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap also contributed to top-line growth in the second quarter. AstraZeneca also announced an increase in its interim dividend by 3% to $1.03 per share. Shares of the British drugmaker rose around 4% in pre-market trading on Tuesday in response to the strong top-line performance. Year to date, the stock has risen 11.1% compared with the industry 's 3.1% increase. AZN reaffirmed its 2025 guidance. Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. Growth momentum in the Oncology and CVRM segments is expected to continue in 2025. However, in Rare Disease, though AstraZeneca expects growth in 2025, it will be at a slower pace than in 2024. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate$80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with almost half of these already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026 Earlier this month, AZN announced plans to invest $50 billion by 2030 to boost manufacturing and R&D in the United States to expand domestic production in response to ongoing tariff pressures under President Donald Trump. AZN's Zacks Rank Currently, AstraZeneca has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Higher. Faster. Sooner. Buy These Stocks Now A small number of stocks are primed for a breakout, and you have a chance to get in before they take off. At any given time, there are only 220 Zacks Rank #1 Strong Buys. On average, this list more than doubles the S&P 500. We've combed through the latest Strong Buys and selected 7 compelling companies likely to jump sooner and climb higher than any other stock you could buy this month. You'll learn everything you need to know about these exciting trades in our brand-new Special Report, 7 Best Stocks for the Next 30 Days. Download the report free now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report
Medscape
5 days ago
- Health
- Medscape
Why Are RSV Vaccine Rates so Shockingly Low?
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and children younger than 2 years. The most severe and life-threatening cases typically affect infants younger than 6 months. However, older toddlers, adults with chronic illnesses or multiple comorbidities, and older adults are also at an elevated risk. Immunization Progress Research on both active and passive RSV immunization has advanced significantly in recent years. Following the approval of the first prophylactic antibody in 2022 and two vaccines in 2023, the prevention of severe RSV illnesses has become increasingly effective. Current strategies include maternal vaccination to protect newborns, immunization of older adults, and passive immunization of infants using the monoclonal antibody nirsevimab. In June, the FDA approved a second monoclonal antibody: clesrovimab. Nirsevimab Nirsevimab (Beyfortus) has been available in the European Union since November 2022. It is indicated for RSV prophylaxis in all infants during their first RSV season and in children up to 2 years of age who are at increased risk during their second season. Nirsevimab is a human monoclonal immunoglobulin G1 (IgG1) kappa antibody produced using recombinant DNA technology. It binds to a highly conserved site on the RSV fusion (F) glycoprotein, which is present only in the prefusion form of the viral surface protein. Nirsevimab has a markedly longer serum half-life than earlier antibodies. The drug is administered as a single intramuscular dose adjusted according to the child's weight. Germany's Standing Committee on Vaccination recommends that infants born between April and September receive antibodies in autumn before their first RSV season. Those born between October and March should receive the vaccine as soon as possible after birth. Clesrovimab Clesrovimab (Enflonsia) is a human monoclonal IgG1 kappa antibody. Unlike nirsevimab, it binds to two sites in both the pre- and post-fusion conformations of the F protein. It is administered as a single intramuscular injection and does not require weight-based dosing. The manufacturer has applied for approval from the European Medicines Agency, and the decision is pending. RSV Vaccines Three RSV vaccines, each targeting a different group, are currently authorized for use in Germany. Arexvy: A monovalent recombinant protein vaccine that includes the RSV F protein and the AS01E adjuvant. It is approved for adults aged 60 years or older. Abrysvo: A bivalent recombinant protein vaccine containing prefusion F antigens from RSV subtypes A and B. It is authorized for use in pregnant women to protect their infants up to 6 months of age and in adults aged 60 years or older. mResvia: Approved in mid-2024, this is the only mRNA RSV vaccine currently available. It is indicated for adults aged 60 years or older and was recently approved in the US for high-risk adults aged 18-59 years. Real-World Data Although clinical trials have demonstrated the strong efficacy of RSV vaccines and antibodies in preventing severe illnesses, data from real-world immunization programs are limited. A new systematic review by UK researchers addressed this gap. Between December 2024 and February 2025, they conducted monthly searches across the Ovid, Embase, MEDLINE, and global health databases. The review included 43 studies that evaluated nirsevimab, maternal RSV vaccination, and adult RSV vaccination. The goal was to assess uptake across countries and demographic groups. Data from more than 1.38 million individuals in Spain, France, Italy, Luxembourg, and the US were analyzed. One study combined records from Catalonia and Andorra. Most data (86%) were drawn from electronic health records and medical registries, and vaccine data were solely from the US. Nirsevimab Uptake In Spain, the uptake of nirsevimab during the 2023-2024 RSV season reached 90.1% (95% CI, 86.4-92.9), the highest of any country reviewed. Infants born during the RSV season and Spanish nationals had higher immunization rates. In the US, 51.2% of eligible infants received nirsevimab in 2023-2024. Uptake was greater among preterm infants, those with at least one comorbidity, and those from Hispanic backgrounds. France recorded 76.5% coverage, with higher rates in infants younger than 3 months than in those aged 3-12 months. Luxembourg reported 83.8%, Italy 68.7%, and Catalonia-Andorra combined 60.2%. Subgroup analyses revealed that children who experienced RSV or other acute respiratory infections were less likely to receive nirsevimab. Maternal Vaccination Maternal RSV vaccine coverage during pregnancy was 30.5% (95% CI, 20.6-42.6). Uptake was significantly lower among women without health insurance or with statutory coverage than among those with private insurance. Black and Hispanic women had lower rates than non-Hispanic White women. Older Adult Vaccination Four population-based studies assessed RSV vaccine uptake in adults aged 60 years or older, showing an average rate of 18.2% (95% CI, 10.8-28.9) in 2023-2024. Uptake was higher among adults older than 75 years, those with comorbidities, and immunocompromised individuals. As with maternal vaccination, the rates were lower among the Black and Hispanic populations. The researchers highlighted the concerningly low uptake among pregnant women and older adults despite the availability of effective prevention tools. They called for coordinated national, clinical, and public health efforts to improve immunization rates in high-risk populations. World Health Organization (WHO) Guidance In May, the WHO published its first position paper on RSV immunization in infants and young children, underscoring global urgency. RSV is the leading cause of pediatric morbidity and mortality. In 2019, an estimated 100,000 children younger than 5 years died from RSV-related lower respiratory tract infections, representing about 2% of all deaths in this age group. Approximately half of these deaths occur in infants younger than 5 months, with 97% occurring in low- and middle-income countries. Globally, RSV accounts for an estimated 3.6 million hospitalizations annually in children younger than 5 years. The WHO recommends that all countries implement immunization programs to prevent severe RSV disease in vulnerable groups. The choice between maternal vaccination and the use of long-acting monoclonal antibodies, such as nirsevimab, should be based on local factors, including health system integration, cost, and overall feasibility. Germany's Robert Koch Institute provides additional guidance in its fact sheets on RSV immunization, including details on nirsevimab and adult vaccinations.
Mint
23-07-2025
- Business
- Mint
Dr Reddy's Labs Q1 Results: Net profit rises just 1.4% YoY to ₹1,409 crore; revenue surges 11%
Dr Reddy's Labs Q1 Results: Leading pharmaceutical company Dr Reddy's Laboratories announced earnings for the April to June quarter of the financial year 2025-26 on Wednesday, July 23. The company reported a consolidated net profit growth of 1.4 per cent to ₹ 1,409 crore in Q1FY26 compared to ₹ 1,392 crore posted in the year-ago period. The pharma major's revenue from operations in the June-ended quarter stood at ₹ 8,572 crore, up 11.3 per cent from ₹ 7,696 crore in the corresponding quarter of the last financial year. In terms of segment-wise performance, revenue from Global Generics, which constitutes nearly 90 per cent of the total revenue, stood at ₹ 7,562 crore compared to ₹ 6,885crore. The company posted ₹ 970 crore revenue from Pharmaceutical Services and Active Ingredients in Q1FY26, compared to ₹ 1,030 crore. The total expenses rose 15.8 per cent at ₹ 6,957 crore in the April to June quarter for the fiscal year 2025-26 from ₹ 6,006 crore in the same quarter previous year. The pharma company's EBITDA was ₹ 2,278 crore, accounting for approximately 26.7% of total revenues. Partnership with Alvotech to co-develop, manufacture and co-commercialise pembrolizumab, a biosimilar candidate to Keytruda. Collaboration with Sanofi to launch Beyfortus (Nirsevimab), a drug for preventing Respiratory Syncytial Virus (RSV) in India. • Launched Sensimune in India, an immunotherapy product for house dust mite-induced allergies in partnership with ALK-Abell6. Speaking on the results and the upcoming course of action, Co-Chairman & MD, G V Prasad said, 'the pricing pressure on Lenalidomide is expected to intensify in the U.S. generics market. We remain focused on strengthening our base business by delivery of our pipeline assets, improving overall productivity and business development.'
Business Times
22-07-2025
- Business
- Business Times
Sanofi to buy Vicebio for up to US$1.6 billion in vaccine push
[PARIS] Sanofi agreed to buy UK biotech Vicebio for as much as US$1.6 billion, gaining experimental vaccines and a technology to streamline their development. The French drugmaker will pay US$1.15 billion upfront with a commitment for potential milestones worth as much as US$450 million, it said in a statement on Tuesday (Jul 22). Chief executive officer Paul Hudson is looking for innovation that fits with Sanofi's existing offerings, and Vicebio's experimental shots are intended to prevent several respiratory illnesses including RSV, the target of its new therapy Beyfortus. The deal is expected to close in the fourth quarter, and won't have a significant impact on Sanofi's financial guidance for the year, the company said. The transaction helps Sanofi get closer to making next-generation vaccines that offer protection against multiple respiratory viruses in a single shot that isn't mRNA – the technology behind the blockbuster Covid-19 immunisations. Vicebio's technology allows quicker development of liquid combination vaccines that can be stored at fridge temperatures, simplifying manufacturing and distribution by eliminating the need for freezing. The company is working on a single shot against RSV and human metapneumovirus, or hMPV, which is in an exploratory early-stage study. Like several rivals, Sanofi is focusing on cutting-edge therapies while divesting older medicines and its consumer-health division. BLOOMBERG
UPI
17-07-2025
- Health
- UPI
Few babies getting RSV antibody shot, study says
Only about a third of babies eligible for nirsevimab got the injection during the 2023-24 RSV season, researchers reported Thursday in the journal Pediatrics. Photo by BaLL LunLa/Adobe Stock/HealthDay July 17 (UPI)-- A new antibody shot that protects babies against RSV infection could be struggling to gain traction, researchers report. Only about a third (35%) of babies eligible for nirsevimab got the injection during the 2023-24 RSV season, researchers reported Thursday in the journal Pediatrics. That was the first season that the monoclonal antibody jab was available to babies following its approval by the U.S. Food and Drug Administration, researchers said. "Notably, patients who were publicly insured, Black, or living in areas with lower childhood opportunity were significantly less likely to receive nirsevimab," wrote the research team led by Mahaa Ahmed, a clinical research project manager at Children's Hospital of Philadelphia. Respiratory syncytial virus is a common germ that usually causes mild, cold-like symptoms, according to the U.S. Centers for Disease Control and Prevention. But RSV can be dangerous for infants. It's the most common cause of pneumonia in children younger than 1 year of age, frequently leading to hospitalization, the CDC says. To combat this threat, the FDA in 2023 approved nirsevimab, a lab-created antibody that provides babies with protection against RSV. The drug is marketed under the name Beyfortus by its manufacturer, Sanofi Pharmaceuticals. Nirsevimab is recommended for all babies younger than 8 months, and for children 8 through 19 months who are at increased risk for severe RSV, the CDC says. It's one of two options that parents now have to protect their newborns. Another is an RSV vaccine that a mother can take while pregnant, with the protection she gains passing to her unborn child. For the new study, researchers tracked nirsevimab use throughout the Children's Hospital of Philadelphia Primary Care Network, a set of 32 practices across Pennsylvania and New Jersey that serves more than 300,000 children. The team identified more than 7,200 babies eligible to have received nirsevimab during its inaugural 2023-24 RSV season. But only about 2,500 got the vaccination, researchers found. Uptake ranged from 20% to 65% across practices. It wasn't because parents were vaccine-averse - 84% of the babies were fully vaccinated against a range of other infectious diseases by 9 months old, researchers said. Overall, 39% of fully vaccinated babies and 22% of partially vaccinated babies received nirsevimab, results show. Older babies born from April through July were 40% less likely to have gotten the shot compared with those born in August and September, researchers found. "We hypothesize this is because younger infants have more frequent visits to the pediatrician and have a higher risk of complications from RSV," researchers wrote. "However, infants aged 6-12 months remain at high risk for RSV hospitalization, and opportunities to receive nirsevimab outside well child visits, including acute care visits and nurse visits, may be particularly important for older children." Likewise, Black babies were 47% less likely to have gotten nirsevimab compared to white children, poor children were 30% less likely, and those on Medicaid or CHIP were 21% less likely. "Notably, these disparities occurred despite the presence of a clinical decision support system, which reminded clinicians of all eligible patients," researchers wrote. Several factors could have contributed to the low uptake of nirsevimab, researchers said. For example, since the shot had just been approved, parents and doctors might not have been certain that health insurance would cover it, researchers said. "This early uncertainty might have led some families to decline nirsevimab and thus contributed to disparities in uptake," researchers wrote. Further study is needed to see whether this same lack of acceptance occurred in other health networks, and to determine the reasons why some babies are more likely to get nirsevimab than others, researchers said. More information The U.S. Centers for Disease Control and Prevention has more on RSV. Copyright © 2025 HealthDay. All rights reserved.
