A replay will be available after the live webcast by visitinghttps://www.novartis.com/investors/event-calendar. Novartis remains committed to its strong investment-grade credit rating and capital allocation priorities, including our growing (CHF) annual dividend. Study update to be provided following assessment, Integrated Ph1/3 clinical trial ROSALIA met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis, Interim analysis of the Ph2b dose ranging study evaluating safety and efficacy in patients aged 45-55 years with presbyopia did not meet its primary endpoint of demonstrating a statistically significant dose response at Month 3. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Ir acompanhar as regulaes da Anvisa e precisar manter a empresa atualizada constantemente sobre as novas normas. Nor can there be any guarantee that the proposed spin-off of Sandoz will maximize value for shareholders, or that Novartis or any of its divisions, or a separate Sandoz business, will be commercially successful in the future, or achieve any particular credit rating or financial results. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. Basel, March 14, 2019 - Novartis announced today that Richard Francis will be stepping down as CEO of Sandoz, a Novartis division, and as a member of the Executive Committee of Novartis on March 31, 2019. Sandoz is expected to deliver its next wave of growth based on the existing biosimilars pipeline of 15+ molecules, a strong and experienced management team and organization. About 108,000 people of more than 140 nationalities work at Novartis around the world. Sandoz would be headquartered in Switzerland and . . In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Pricing had a negative impact of 6 percentage points. 2A table showing the Q3 2022 and 9M 2022 key figures excluding Roche can be found on page 8 and a reconciliation of 2021 IFRS results and non-IFRS measures core results to exclude the impacts of the 2021 divestment of our Roche investment can be found on page 57 of the Condensed Interim Financial Report. Novartis revealed in its third-quarter results statement that it was weighing options for Sandoz to "maximise shareholder value," adding that could include retaining the business or a. Geographically, we are focused on growing in ourpriority geographies- the US, China, Germany and Japan. Basel, April 4, 2022 Novartis today announced the introduction of a new organizational structure and operating model designed to support the company's innovation, growth, and productivity ambitions as a focused medicines company in the coming decade. Basel, November 7, 2022 Sandoz, a global leader in generic and biosimilar medicines, today announced an additional investment of EUR 50 million to support increased European manufacturing capacity for finished dosage form (FDF) penicillins, the leading class of antibiotics worldwide. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Sales in Europe were USD 3.6 billion (-7%, +5% cc), in the US USD 1.3 billion (-1%) and in the rest of the world USD 2.0 billion (+6%, +12% cc). By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions2. The subsidiary, which runs the business of biosimilars and off-patent drugs, will become entirely independent, creating one of Europe's largest generics companies in the process. The increase was mainly due to the USD 7.5 billion annual dividend payment and net cash outflow for treasury share transactions of USD 7.9 billion, partially offset by USD 8.4 billion free cash flow during the first nine months of 2022. Core operating income margin was 33.4% of net sales, increasing by 0.1 percentage points (+0.5 percentage points cc). Excluding the impact of Roche income, net income declined -12% (cc). The spin-off aims to maximize shareholder value by creating the #1 European generics company1 and a global leader in biosimilars, allowing Novartis shareholders to participate fully in the potential future upside for both Sandoz and Novartis Innovative Medicines. Novartis Access Launched in September 2015, Novartis Access is an unprecedented new Novartis-wide initiative to drive patient access to our medicines in lower-income countries. A spin-off would allow our shareholders to benefit from the potential future successes of a more focused Novartis and a standalone Sandoz, and would offer differentiated and clear investment theses for the individual businesses. The expansion will support a double-digit increase in our future output capacity for penicillins. Completion of the transaction is subject to certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval in line with Swiss corporate law. Sandoz on social media:LinkedIn: https://www.linkedin.com/company/sandozTwitter: https://twitter.com/sandoz_globalFacebook: https://www.facebook.com/sandozglobal/Instagram: https://www.instagram.com/sandozglobal, CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/, This site is intended for a global audience, Sandoz announces further investment in key manufacturing facility in Austria, to support increased global demand for essential antibiotics, Diversity & Inclusion Governance and Community, Novartis Commitment to Patients and Caregivers, Novartis Gene Therapies Managed Access Program, Healthcare Professional Resources by Country, Novartis Institutes for BioMedical Research, Cardiovascular and metabolic disease research at Novartis, Autoimmunity, transplantation and inflammatory disease research at Novartis, Musculoskeletal Disease Research at Novartis, DAx: exploratory disease research at Novartis, Community Exploration & Learning Lab (CELL), Sandoz Announces Further Investment Key Manufacturing Facility Austria Support Increased Global Demand Essential Antibiotics, https://www.linkedin.com/in/richard-saynor/. Core operating income was USD 12.6 billion (-1%, +6% cc), mainly driven by higher sales, partly offset by higher R&D and M&S investments. Nor can there be any guarantee that such products will be commercially successful in the future. Global sales of Biopharmaceuticals grew to USD 533 million (+1%, +14% cc) partly benefiting from a one-time revenue deduction adjustment. As a standalone company, Sandoz would focus on its vision to deliver access to patients, leveraging the business strengths and purpose-driven workforce. Sales in the US were USD 4.1 billion (+8%) and in the rest of the world USD 6.2 billion (-9%, +2% cc). The application includes all indications of the reference medicine Tysabri (natalizumab), FDA accepted for review sBLA for high concentration formulation of biosimilar, FDA granted Fast Track Designation and Orphan Drug Designation for ganaplacide and lumefantrine (combination), which is being co-developed with Medicines for Malaria Venture, for acute, uncomplicated malaria, In October, Ph3 APPLY-PNH trial met its two primary endpoints for superiority vs anti-C5 treatment in adult paroxysmal nocturnal hemoglobinuria (PNH) patients with residual anemia despite prior anti-C5 treatment, Positive results from two parallel, pivotal Ph3 trials (SUNSHINE and SUNRISE) demonstrated, New large pooled exploratory analysis from MONALEESA-2, -3 and -7 reinforces OS benefit (median OS of 63.4 months) with, Ph3 RATIONALE 301 trial demonstrated non-inferior OS for tislelizumab vs sorafenib (median OS: 15.9 months vs 14.1 months) in patients with previously untreated unresectable hepatocellular carcinoma. Excluding the impact of Roche income, net income declined -27% (cc). Latest News Oct 25, 2022 Novartis maintains growth momentum and confirms FY'22 Group guidance Sep 19, 2022 Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial Aug 25, 2022 Sandoz net sales were USD 9.6 billion in 2021, decreasing by 2% 1 (cc) from the previous year, as volume growth in our Biopharmaceuticals and contract manufacturing businesses was offset by the effects of price competition and continued headwinds for our Retail Generics business in the US. Sales growth benefited from a strong cough and cold season and a return towards normal business dynamics in the first half of the year. Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development. About SandozSandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. 53 LR. Automation, state-of-the-art technology for API manufacturing and simplified processing will allow Sandoz to integrate all production steps into a single process in one location, resulting in increased capacity and supply reliability. Conference callNovartis will hold an investor and analyst webcast today at 16:00 CET, 1 Based on IQVIA gross sales for combined Generics and Biosimilars market, referring to March 2022. Novartis has announced it is to divest its generics division Sandoz. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. It anticipates Sandoz's sales to total around $2.5 billion and operating income to decline in the low-to-mid-single-digit percentage range. Aug 25, 2022 Media Release English | German Investors Watch the webcast 16:00 CEST | 15:00 BST | 10:00 EDT Download the presentation (PDF 1.1 MB) Video Additional resources Sandoz.com Novartis concluded the strategic review of Sandoz, announcing a proposed 100% spin-off of Sandoz, its generics and biosimilars division into a new publicly traded standalone company. Find out more athttps://www.novartis.com. Any Sandoz dividends would be incremental to Novartis dividends. Global sales of Biopharmaceuticals grew to USD 1.6 billion (+1%, +11% cc). Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and noSandostatinLAR generics enter in the US. Sandoz: #1 European Generics Company and a Global Leader in BiosimilarsSandoz generated USD 9.6bn sales in 2021 sales and served 100+ markets globally with a strong presence in Europe as well as in the United States and Rest of World. Novartis unveiled a new focused strategy with our transformation into a pure-play Innovative Medicines business. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. Sandoz biosimilars help patients, in areas including immunology, oncology, nephrology, supportive care and endocrinology, access critical and potentially life-changing medicines sustainably and affordably. The results come soon after Sandoz confirmed acceptance of license applications for two other proposed biosimilars. Novartis maintains growth momentum and confirms FY'22 Group guidance . We urgently need to change the operating framework, to introduce basic concepts such as inflation-linked pricing and tenders with criteria that go beyond price.. The standalone Sandoz would be headquartered in Switzerland and listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US. Ad-hoc-Mitteilung gemss Art. 53 LR Sandoz strategic review concludes that a separation of Sandoz by way of a 100% spin-off is in the best interest of shareholders, creating the #1 European generics company and a global leader in biosimilars, and a more focused Novartis Our ambition is to be the worlds leading and most valued generics company. Language & Country Selector for Desktop. It tried to divest. Robert Way/iStock Editorial via Getty Images Novartis ( NYSE: NVS) on Monday said that Sandoz is planning a 50M to support increased European manufacturing capacity for finished dosage form. Net income was USD 1.6 billion (-43%, -33% cc), mainly due to lower operating income. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Pricing had a negative impact of 4 percentage points. Core net income was USD 3.4 billion (-11%, -2% cc), as growth in core operating income was more than offset by the loss of Roche core income. Our six in-market growth drivers with multi-billion sales potential (Cosentyx,Entresto,Zolgensma,Kisqali,Kesimpta,Leqvio) grew 23% in the quarter and now represent 33% of total IM sales. Novartis plans to petition the U.S. Supreme Court to uphold validity of the Gilenya (fingolimod) dosing regimen patent Media Release Sep 19, 2022 Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial Media Release Sep 15, 2022 Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference products label. Tislelizumab demonstrated a favorable safety profile with fewer grade 3 adverse events (AEs) and fewer AEs leading to discontinuation. In addition, both companies would be able to focus on maximizing value creation for their shareholders by prioritizing capital and resource allocation, employing separate capital structure policies, and increasing management focus on their respective business needs.. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can be found athttps://www.novartis.com/investors/event-calendar. Francesco Balestrieri, currently Region Head Europe, Sandoz, has been appointed ad-interim CEO Sandoz. Latest News Oct 25, 2022. Novartis concluded the strategic review of Sandoz, announcing a proposed 100% spin-off of Sandoz, its generics and biosimilars division into a new publicly traded standalone company. The transaction is expected to be tax neutral to Novartis.Sandoz CEO designate announcement. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Global | en . In particular, our expectations could be affected by, among other things: an unexpected failure to complete, or unexpected delays in completing, the necessary actions for the proposed spin-off, or to obtain the necessary approvals to complete these actions; the potential strategic benefits, synergies or opportunities expected from the proposed spin-off may not be realized or may take longer to realize than expected; regulatory actions or delays or government regulation generally; the inherent uncertainty in predicting shareholder returns; the successful separation of Sandoz from Novartis and the timing of such separation; potential adverse reactions to the proposed spin-off by customers, suppliers, strategic partners or key Sandoz personnel and potential difficulties in maintaining relationships with such persons; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Innovative Medicines (IM) sales grew +4% cc (-3% USD), driven by key growth brands including: Sandoz sales grew +4% cc (-7% USD) driven by continued growth in biopharmaceuticals, Innovative Medicines sales grew +5% cc (-1% USD) and core operating income +6% cc (-1% USD), Sandoz sales grew +6% cc (-3% USD) and core operating income +5% cc (-2% USD). 25! 1.Constant currencies (cc), core results and free cash flow are non-IFRS measures. Sales in Europe declined -4% (cc), while sales in the US declined -17%. 2.A reconciliation of 2021 IFRS results and non-IFRS measures core results to exclude the impacts of the 2021 divestment of our Roche investment can be found on page 57 of the Condensed Interim Financial Report. Credit: Novartis AG. Sandoz also announced last year that it was investing an additional EUR 50 million for sterile API production at Palafolls, Spain. Free Whitepaper. Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. It tried to divest. Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority. Therefore, this important milestone means that we are one step closer to giving individuals living with osteoporosis access to a more affordable, biosimilar version of this critical medicine, which may help to change the course of their disease.. 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