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Pictured: Sanofi building in Germany with blue sign at night/iStock, Panama7 Sanofi on Thursday released its fourth-quarter and full-year 2023 results revealing an International Financial Reporting Standards net income loss of approximately $600 million, driven mainly by a weak U.S. dollar, high expenses and rising generic competition. The French pharma’s business operating and net incomes took a hit, dropping 5.2% and 2.7% in the fourth quarter versus the same period the prior year. Operating expenses, meanwhile, grew 7.1% to around $5.19 billion. Contributing strongly to the decline was Sanofi’s multiple sclerosis therapy Aubagio (teriflunomide), the sales of which dropped 74% to just over $130 million in the fourth quarter after its loss of exclusivity, according to the company’s presentation. Still, the pharma posted positive growth for its net sales in the fourth quarter, raking in more than $11.8 billion, which represents 9.3% growth at constant exchange rates compared with the same period the prior year. Its full-year 2023 sales, which came in at around $46.6 billion, posted 5.3% growth from the previous year. The blockbuster anti-inflammatory drug Dupixent (dupilumab) was once again Sanofi’s top-selling asset, netting approximately $3.23 billion in the fourth quarterwith 31.3% revenue growth. Despite sustaining a 4% drop in sales, Sanofi’s portfolio of influenza vaccines brought in a combined $741 million and remains one of the company’s best-performing product categories. Other high-performance assets in the fourth quarter of 2023 included Sanofi’s polio, pertussis and Hib vaccines, as well as its preventive antibody for respiratory syncytial virus Beyfortus (nirsevimab). Looking forward to 2024, Sanofi and partner Regeneron are looking to boost Dupixent’s earnings further with a potential approval in chronic obstructive pulmonary disease (COPD). The companies posted data from the Phase III BOREAS trial in March 2023 and the Phase III NOTUS study in November 2023, showing that Dupixent could significantly reduce episodes of exacerbations in COPD patients. Dupixent is also in Phase III studies for bullous pemphigoid, chronic pruritus of unknown origin, chronic spontaneous urticaria and eosinophilic gastritis, submissions for which are planned for 2025 and beyond. Sanofi is also preparing to make a handful of regulatory submissions this year, including for tolebrutinib in relapsing multiple sclerosis and non-relapsing secondary progressive multiple sclerosis, fitusiran in hemophilia A and B and rilzabrutinib in immune thrombocytopenia. On Thursday, Sanofi named François-Xavier Roger as its new chief financial officer, replacing Jean-Baptiste Chasseloup de Chatillon who will move on to lead a charity for children. Roger was most recently the financial head of Nestle, where he served for over eight years and drove the company’s “sustainable value creation,” according to the announcement. Roger was also previously the CFO of Takeda and Danone Asia, and had worked for other pharma companies including Aventis, Roussel and Hoechst. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

The clinical trial conducted in seven large Israeli dairy farms, in collaboration with Strauss Health (partially owned by Groupe Danone), demonstrated that Mileutis can effectively substitute the major use of antibiotics in the dairy industry. Milk derived from cows treated with Mileutis' Imilac™ non-antibiotic, non-hormonal therapy exhibited a 7.2% increase in protein content, 4% increase in fat content, and an increase of 957 kg (8.6%) in energy corrected milk yield per cow over 305 days. The trial paves the way for superior milk production performance for dairy farmers while improving the well-being of the dairy cows. David Javier Iscovich, CEO and co-founder of Mileutis: "Consumers can anticipate a future where they will enjoy better milk, produced by healthier cows, and with superior nutritional values". NESS ZIONA, Israel, Aug. 8, 2023 /PRNewswire/ -- Mileutis, an Israeli-based biopharmaceutical company that is leading the dairy industry and animal health into a sustainable future, has completed a rigorous, randomized, case-controlled, multi-center, clinical field trial. The trial was conducted at seven different commercial dairy farms and involved over 500 dairy cows. The results of this trial provide further conclusive evidence of the ability of Imilac™, therapy to completely substitute the routine use of antibiotics at dry-off in the dairy industry. Continue Reading Imilac infographic. Credit - Mileutis In addition, the study revealed that Imilac ™ is further impacting milk nutritional characteristics – a breakthrough that was patented by Mileutis. The trial was carried out in dairy farms providing milk to Israel's two largest dairy product providers – Yotvata Dairy, part of the Strauss Health Group, partially owned by Danone, and Tnuva, Israel's largest dairy company. Antibiotics have traditionally been used to treat and manage udder inflammation in dairy cows (mastitis), the primary issue faced by the dairy industry at the beginning of the dry-off period. However, this approach, applied for too long, presents farming challenges and human health risks related to antimicrobial resistance (AMR). Mileutis has developed a revolutionary, safe and residue-free biological therapy named Imilac™, helping to address this critical health issue without using antibiotics. Designed to replace the routine use of antibiotics administered at dry-off once a year, Imilac™ has exhibited game-changing results in the clinical trials, paving the way for a transformation in the dairy sector and leading the dairy industry into a sustainable future. Mileutis conducted a comprehensive trial, including a follow-up period of one full year, to analyze the quantity and quality of milk from cows undergoing the Imilac™ therapy compared to the traditional treatment of antibiotics. The trial was conducted at seven prominent dairy farms across Israel, spanning from Yotvata and Yahel in the south to the Hama'ayanot Valley in the north-east and Kfar Vitkin on the coastal plain. The trial produced significant findings that support the company's goal of reducing antibiotic use and enhancing the welfare of dairy cows. The research also provided evidence that when using Imilac™, the "dry period" can be shortened while extending the number of milking days. This breakthrough resulted in an approximate increase of 236 kg of milk yield per cow without use of antibiotics. In addition, the applied Mileutis' therapy during the trials improved cow well-being and reduces suffering among cows in the first days after dry-off by accelerating the involution process. Further, Imilac™ demonstrated a remarkable ability to significantly increase energy-corrected milk yield (ECM) during the subsequent milking cycle of 305-days following treatment. This increase totaled to 957 kg (8.6%) of milk yield per cow and was achieved through natural biological means without the use of exogenous hormones. Milk yield refers to the quantity of milk produced by a cow over a specific period, while energy equivalent milk yield considers not only the quantity of milk produced but also the energy content or the total energy value of the milk. The product proved to be highly effective in enhancing the level of solids (fat and protein) in milk, the direct result of which improves financial returns for dairy farmers. Milk derived from cows treated with Imilac™ exhibited an impressive 7.2% increase in protein content and a remarkable 4% increase in fat content. Mileutis was established in 2004 and is headed by David Javier Iscovich. The R&D effort is being led by Dr. Jose Iscovich, president and co-founder of the company. "Dairy farmers can now look forward to a future where the milk they produce will contain higher nutritional characteristics for consumers, will be more profitable for the farmers themselves, and environmentally friendly, thanks to the advancements pioneered by Mileutis," says David Javier Iscovich, CEO and co-founder of Mileutis. "Beyond an increase in the yield and welfare of cows, the improved profitability of dairy farmers can impact milk prices and benefit the broader consumer market while meeting growing global demand." Iscovich added: "The impact of this scientific breakthrough for the dairy industry, consumers, and the environment cannot be overstated. Improved milk quality and yield will not only promote high quality consumption for individuals but also contribute to a more environmentally efficient milk production process. Consumers can anticipate a future where they will enjoy better milk, produced by healthier cows, and with superior nutritional values. At Mileutis, our goal remains steadfast in our commitment to ensuring the welfare of cows while maintaining the integrity of the milk production process." Ram Srugo, CEO of Yotvata Dairy said, "In recent years, we have been implementing the Sustainable Dairy Program in our dairy farms—a project that closely examines the sustainability and welfare aspects of milk production. This includes evaluating the cow's living conditions, proximity to its natural behavior, overall health, treatment procedures, food quality, environmental impact, and efforts to reduce Greenhouse emissions, among other factors. Our association with Mileutis, with its breakthrough development of antibiotic substitutes, allows us to further enhance the welfare of our cows and align with our sustainability goals in the dairy farms". The reports from the participating dairy farms indicate a high level of satisfaction across various parameters concerning the cow's welfare and Mileutis' product's positive impact to the environment. Dairy farmers have even expressed a desire to start using Mileutis' product. We firmly believe that by acting responsibly in the milk production process, we can offer consumers peace of mind and confidence in our dairy products. This assurance stems from our commitment to the well-being of our cows, minimizing our environmental impact, and maintaining transparency throughout the journey of milk production, from the field to the plate." The significant strides made by Mileutis extend beyond the immediate benefits of Imilac™, and the company is actively in the process of developing an additional product line to address indications beyond mastitis, with an estimated potential to reduce antibiotic usage in the dairy industry by up to 90%. Images can be downloaded here. You can watch a video on Mileutis here. Photo - SOURCE Mileutis Ltd.