Picornaviridae Infections

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

The promise of a one-and-done CRISPR infusion is beginning to look more real than ever. On Thursday, Intellia Therapeutics announced that an experimental gene editing therapy reduced dangerous and unpredictable swelling attacks caused by the disease hereditary angioedema. Hereditary angioedema can cause disfiguring or even fatal symptoms. But in the 27-person, Phase 2 study, patients who received the gene editing treatment saw the mean rate of monthly attacks fall by about 80%. And eight of 11 patients who got the mid-level dose of the drug have had zero attacks during a median follow-up of nine months since the infusion. “I was overwhelmed by the clinical response,” Danny Cohn, a doctor at Amsterdam University Medical Center who led the Phase 2 study, told Endpoints News in an interview. Cohn said the 10 patients treated at his hospital have all reported dramatic improvements. “These swellings can be disfiguring when the face is swollen, extremely painful when the intestines are swollen, or even fatal when the upper airways are involved,” he said. “So this has really been a game-changer.” The results, published in the New England Journal of Medicine , provide the first detailed look at a mid-stage study of a CRISPR therapy delivered to the liver using an infusion of lipid nanoparticles. Intellia is already recruiting for a larger 60-person Phase 3 study and aims to file for FDA approval in 2026. “Unless something changes, this will be the first in vivo CRISPR drug that’s approved,” Intellia CEO John Leonard told Endpoints News . So far, the CRISPR treatment seems safe. Intellia said that headache, fatigue and a common cold were the most frequent side effects. While the data are impressive, the roughly 80% reduction in attacks doesn’t look quite as high as the near-perfect results from a Phase 1 study which showed a remarkable 98% reduction through the latest data cutoff, with patients followed a median of 20 months. Cohn and Leonard both told Endpoints separately that they believe the lower response in the new Phase 2 study is likely due to patients not knowing if they got the CRISPR treatment or the placebo. Patients are taught to report signs of a potential swelling episode — which might manifest as a cramp, an itch, or a tingling sensation — and immediately take a drug to prevent a full-blown attack. In the earlier study, where everyone knew they got the treatment, patients may have been more likely to hold off on treating a potential attack. “What’s clear is the drug actively works. I mean, there’s no doubt about that,” Leonard said. Full relief from attacks, as the group of eight patients experienced, is not a result for patients that has been thought possible before, he said. Most people with hereditary angioedema have mutations in a gene for an enzyme called C1 esterase inhibitor. Proper functioning of that enzyme is needed to control another blood protein called kallikrein that kick-starts a process that causes inflammation, swelling and constriction of airways. Intellia’s therapy breaks the gene for kallikrein to prevent runaway swelling. The low dose reduced kallikrein levels in the blood by 55% and the medium dose reduced the protein by 86% at 16 weeks. “We are not targeting the gene that is causing the disease,” Cohn said. “But we are rebalancing the system by decreasing plasma kallikrein.” If the drug passes its next clinical trial, it will face competition from other therapies. Takeda’s commercial antibody Takhzyro also targets kallikrein. And Ionis is developing its own genetic medicine for the disease, a gene-silencing antisense oligonucleotide that reduced swelling attacks by 81% when taken every four weeks in a Phase 3 study. Ionis said in August that it was preparing to submit the drug to regulators. Leonard believes that Intellia’s one-and-done treatment will be an attractive alternative. “We think very quickly people will understand what’s possible and be very enthusiastic,” he said.

MISSION, Kan., Oct. 21, 2024 /PRNewswire/ -- (Family Features) Cold and flu season is here. The best way to battle cold and flu season is to prevent coming down with anything at all. While it's impossible to stay entirely safe from germs, sniffles and coughs, there are a few healthy habits you can incorporate for extra protection this year. Along with the guidance you receive from your health care provider, consider these dietary and lifestyle recommendations to support your immune system naturally. Continue Reading Grape and Brussels Sprout Slaw Commit to a Healthier Diet: Essential for optimizing your immune system, eating a healthy diet consisting of more foods like fruits, vegetables, nuts, seeds, legumes and whole grains is recommended by experts. These foods contain beneficial plant compounds linked to health benefits in humans. Case in point: fresh grapes. Natural grape compounds, including antioxidants and other polyphenols, may help protect the health and function of cells. At the most basic level, healthy cells are the foundation of good health. Making simple swaps such as choosing fresh California grapes instead of processed snacks or adding grapes into favorite recipes for a healthy boost are tasty ways to add these beneficial compounds. Studies suggest some grape compounds may positively influence immune function, including resveratrol and certain flavonoids. Additional studies show adding heart-healthy grapes to your daily diet can help support brain, colon and skin health. Grapes are also a good source of vitamin K, which may help support lung health. Incorporate the health benefits of grapes into your diet with an easy, convenient recipe like Grape and Brussels Sprout Slaw, perfect for eating on its own or pairing with a favorite protein such as grilled chicken breast. Prioritize Basic Hygiene: Preventive practices can help you avoid germs, protecting yourself and others at the same time. Frequently wash your hands using soap and water, limit contact with others who may be sick and cover your nose and mouth with a tissue or elbow while coughing or sneezing. Stay Active: Cold and flu season lines up with brisk temperatures, often making it more difficult to get outside for exercise. Find an activity you enjoy like moderate-intensity walking, jogging, biking or playing an aerobic sport. The "Journal of Sport and Health Science" reports exercise can help improve immune response and reduce inflammation, making it a key way to prepare your body to fight back. Hydrate, Hydrate, Hydrate: Staying hydrated helps your immune system by keeping the body's defenses functioning properly. In addition to drinking water, you can increase hydration by eating foods with high water content like grapes, which contain about 82% water. Manage Stress: You can help control stress – which has a negative impact on overall health and wellness – in a number of ways. Practice deep breathing or meditation, engage in activities and hobbies that bring joy and develop nighttime habits that promote good sleep. If snacking in the evening, choose foods such as grapes that are a natural source of melatonin, a compound which helps regulate sleep cycles. Talk with someone you trust, like a friend, family member or mental health professional, to help relieve stress. Visit GrapesFromCalifornia.com to find more ways to support your immune health. Grape and Brussels Sprout Slaw Servings: 6 1 bag (12 ounces) shredded Brussels sprouts 2/3 cup finely shredded red cabbage 2 cups red Grapes from California, halved lengthwise 1/2 cup finely diced red onion 3 scallions, trimmed and thinly sliced 2 tablespoons rice vinegar 1 1/2 tablespoons honey 1 teaspoon fresh lemon or lime juice 1 teaspoon low-sodium soy sauce 2 tablespoons olive oil 1 tablespoon toasted (dark) sesame oil freshly ground black pepper, to taste 3 tablespoons toasted sesame seeds In large mixing bowl, combine shredded sprouts, cabbage, grapes, onion and scallions. In small bowl, whisk vinegar, honey, lemon or lime juice and soy sauce. Drizzle in olive and sesame oils while whisking. Toss well with slaw mixture. Chill 45 minutes to incorporate flavors. Season with pepper and sprinkle sesame seeds on top. Nutritional information per serving: 170 calories; 4 g protein; 22 g carbohydrates; 9 g fat (48% calories from fat); 1.5 g saturated fat (8% calories from saturated fat); 0 mg cholesterol; 60 mg sodium; 4 g fiber. Michael French [email protected] 1-888-824-3337 editors.familyfeatures.com About Family Features Editorial Syndicate A leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com. SOURCE Family Features Editorial Syndicate WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED