Novartis

Novartis AG is a holding company, which engages in the development, manufacture, and marketing of healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment researches, develops, manufactures, distributes and sells patented pharmaceuticals, and is composed of two business units: Novartis Oncology and Novartis Pharmaceuticals. The Sandoz segment develops, manufactures and markets finished dosage form medicines as well as intermediary products, including active pharmaceutical ingredients. The Corporate segment refers to group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

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Novartis AG is a holding company, which engages in the business of developing, manufacturing, and marketing healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment includes researching, distributing and selling patented pharmaceuticals. The Sandoz segment focuses on marketing finished dosage form medicines and intermediary products including active pharmaceutical ingredients. The Corporate segment is involved in group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

Novartis AG and Molecular Partners AG on Monday reported positive topline data from their antiviral Covid-19 treatment ensovibep, and will seek expedited regulatory authorizations globally.

Dow Jones Newswires: Novartis to seek FDA approval for COVID-19 treatment after positive data

Molecular Partners AG

Basel, January 10, 2022 — Novartis and Molecular Partners today announced that Part A of the EMPATHY clinical trial1 that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo – (1) composite endpoint of hospitalization and/or Emergency Room (ER) visits or death, and (2) time to sustained clinical recovery. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDA's EUA process.

Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19

Alnylam Pharmaceuticals

Novartis (NVS) partners with Alnylam (ALNY) to collaborate on the discovery and the development of siRNA-based targeted therapy to restore functional liver cells.

Novartis (NVS) Partners With Alnylam for Liver-Targeted Therapies

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Novartis AG said on Tuesday a U.S. court of appeals upheld the validity of a dosage regimen patent for its multiple sclerosis treatment Gilenya, allowing a permanent injunction against Chinese generic drugmaker HEC Pharma to stay in place until the patent expires in 2027.

Novartis says U.S. court upholds Gilenya patent

Basel, January 4, 2022 — Today, Novartis announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No. 9,187,405 covering a dosing regimen for Gilenya. In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining Abbreviated New Drug Application (ANDA) filer challenging this patent. This decision confirms the validity of the patent and allows that injunction to remain in place.

Novartis announces U.S. Court of Appeals for the Federal Circuit (CAFC) upholds validity of Gilenya® (fingolimod) dosage regimen patent

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These stocks could rebound nicely in the new year.

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The FDA approves Novartis' (NVS) Cosentyx for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis.

Novartis (NVS) Gets FDA Nod for Cosentyx's Label Expansion

The FDA has approved Novartis AG's (NYSE: NVS) Cosentyx (secukinumab) for active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older.  Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for ERA and PsA in pediatric patients in the U.S.

Novartis' Cosentyx Scores FDA Approval For Arthritis In Children, Adolescents

The FDA has approved Alnylam Pharmaceuticals Inc's (NASDAQ: ALNY) Leqvio (inclisiran) to lower low-density lipoprotein cholesterol (LDL-C).  Leqvio is indicated in the U.S. as an adjunct to diet and maximally tolerated statin therapy to treat clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia, requiring additional LDL-C lowering.

FDA Approves Alnylam - Novartis' Leqvio As the First siRNA To Reduce Bad Cholesterol

Novartis AG (NYSE: NVS) announced it is buying Gyroscope. These are the details.

Why Novartis (NVS) Is Buying Gyroscope For $1.5 Billion

The prize Novartis has its eyes on is, well, eyes. The Swiss healthcare giant announced Wednesday it's buying British biotech Gyroscope.

Novartis Eyes Up to $1.5 Billion for Gene Therapy Firm

Basel, December 22 , 2021 — Novartis, a leader in rheumatology and immuno-dermatology, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older1. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology1.

Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis

Novartis (NVS) is set to acquire ocular gene therapy company Gyroscope Therapeutic. Generic arm Sandoz submits a marketing authorization application for a proposed biosimilar of Herceptin.

Novartis (NVS) to Buy Gyroscope, Submits Herceptin Biosimilar to EMA

Syncona Limited (LSE:SYNC) has seen its shares jump after selling one of its portfolio companies to Novartis for up to £1.1bn. Syncona co-founded the business, Gyroscope, in 2016 and has seen it grow into a global leader in ocular gene therapies.

Syncona sells portfolio company Gyroscope to Novartis for £1.1bn

Basel, December 22, 2021 — Novartis announced today that it entered into a definitive agreement to acquire all of the outstanding share capital of the UK-based ocular gene therapy company Gyroscope Therapeutics.

Novartis to acquire Gyroscope Therapeutics, adding a one-time gene therapy that could transform care for geographic atrophy, a leading cause of blindness

BeiGene

Novartis (NVS) signs collaboration and license agreement with BeiGene for ociperlimab (BGB-A1217), expanding research and development activities in immuno-oncology.

Novartis (NVS) Collaborates With BeiGene for Oncology Drug

BeiGene Ltd (NASDAQ: BGNE) announced an option, collaboration, and license agreement with Novartis AG (NYSE: NVS) to develop, manufacture, and commercialize BeiGene's ociperlimab in North America, Europe, and Japan.  Ociperlimab is currently being investigated in two global Phase 3 trials, the AdvanTIG-301 and AdvanTIG-302 trials, combined with tislelizumab in lung cancer.

Novartis Inks Option Agreement For BeiGene Anti-Cancer Therapy For Over $1 Billion

Novartis AG (NYSE: NVS) said that its ligelizumab antibody treatment against recurring hives did not meet the goal of superiority to standard treatment Xolair (omalizumab) in a late-stage study. Novartis' PEARL 1 and PEARL 2 Phase 3 studies met the goal for ligelizumab to show higher efficacy against chronic spontaneous urticaria (CSU) compared to placebo at week 12, but not compared to omalizumab.

Novartis' Ligelizumab Suffers Setback In Late-Stage Skin Disorder Studies

BeiGene Ltd. BGNE, +0.25% said Monday it had entered an agreement with Swiss drug company Novartis Pharma AG NVS, -0.20% to develop its investigational TIGIT inhibitor ociperlimab in North America, Europe, and Japan and to market five Novartis oncology treatments in China.

BeiGene to receive up to $1 billion in oncology deal with Novartis

Basel, December 20, 2021 — Novartis announced today the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company's research and development activities in immuno-oncology. Ociperlimab is a late-stage TIGIT inhibitor, a novel class of anti-cancer therapies that blocks the TIGIT protein receptor. Ociperlimab is currently being evaluated in two Phase III lung cancer trials and additional studies are ongoing in a wide range of solid tumors.

Novartis strengthens immunotherapy pipeline with option, collaboration and license agreement with BeiGene for TIGIT inhibitor ociperlimab

Ad hoc announcement pursuant to Art. 53 LR

Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU)

Roche Holding AG

Novartis says it will buy back up to $15 billion of its stock, signaling confidence in its growth prospects and its pipeline.

Novartis to Spend Bulk of Roche Windfall on Buying Back Stock, Not M&A

The stock price of Novartis AG (NYSE: NVS) increased by over 3% pre-market today. This is why it happened.

Novartis Stock (NVS): Why The Price Increased Today

News for Novartis Stock (NVS)