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Novartis AG
TABLE OF CONTENTS
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Novartis AG
Company Overview
Company Overview
COMPANY OVERVIEW
Novartis AG (Novartis or ‘the company’) is one of the Big Pharma companies having strong presence in
diverse biopharmaceutical segments. It is involved in the research, development, and production of
medicines, eye care products and generic pharmaceuticals. In addition, it offers these products to treat
cardiovascular, cancer, neurological, dermatological, respiratory and infectious diseases, ophthalmic, and
immune disorders. It also conducts various research and development activities through its Novartis
Institutes for BioMedical Research (NIBR). The company is headquartered in Basel, Switzerland.
The company reported revenues of (US Dollars) US$50,135 million for the fiscal year ended December
2017 (FY2017), an increase of 1.5% over FY2016. In FY2017, the company’s operating margin was
17.2%, compared to an operating margin of 16.8% in FY2016. In FY2017, the company recorded a net
margin of 15.4%, compared to a net margin of 13.6% in FY2016.
The company reported revenues of US$13,121.0 million for the third quarter ended September 2018, a
decrease of 2.5% over the previous quarter.
Key Facts
KEY FACTS
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Novartis AG
Company Overview
Tickers
TICKERS
NOVN
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Novartis AG
Company Overview
Business Description
BUSINESS DESCRIPTION
Novartis AG (Novartis or ‘the company’) is one of the largest providers of healthcare products worldwide.
It develops and sells generic and biosimilar medicines, oncology and pharmaceuticals medicines and eye
care products.
The company classifies its business operations into three reportable segments: Sandoz, Innovative
Medicines and Alcon.
Under the Innovative Medicines (IM) segment, it offers 60 patented prescription medicines through
Novartis Pharmaceuticals and Novartis Oncology. Novartis Oncology business unit offers various drugs to
treat rare diseases and cancers and also focuses on neuroscience, cardio-metabolic, ophthalmology,
immunology, dermatology and respiratory. Novartis Pharmaceuticals business accounted for 62.8% of
segment’s total revenue and Novartis Oncology business accounted for 37.2% of segments total revenue.
In addition, Established Medicines accounted for 28.5% of Novartis Pharmaceuticals business, followed
by Ophthalmology therapeutic (25.9%), Immunology and Dermatology (19.5%), Neuroscience (15.8%),
Respiratory (7.8%) and Cardio-Metabolic (2.5%). In FY2017, the Innovative Medicines segment reported
revenues of US$33,025 million, accounting for 65.9% of the company’s total revenue.
Under the Sandoz segment, Novartis develops pharmaceutical and biotechnological active substances
and generic drugs through Anti-Infectives, Retail Generics and Biopharmaceuticals business units.
Sandoz offers 1,000 products in 150 countries and operates R&D centers in Kundl and Schaftenau,
Austria, Holzkirchen and Rudolstadt Germany and Ljubljana and Menges, Slovenia. It also operates
production hubs in Kundl and Schaftenau, Austria, Barleben, Holzkirchen and Rudolstadt, Germany and
Ljubljana, Slovenia and Strykow, Poland. Approximately 83.6% of the segment’s total revenue was
accounted from Retail generics division, followed by Biopharmaceuticals division (11.3%) and Anti-
Infectives division (5.1%). In FY2017, the Sandoz segment reported revenues of US$10,060 million,
accounting for 20.1% of the company’s total revenue.
Under the Alcon segment, Novartis provides eye care products through Vision Care and Surgical
businesses. Approximately 60.8% of the segment’s total revenue is accounted from Surgical business
and the remaining 39.2% is accounted from Vision Care business. It operates R&D centers in Teltow and
Grosswallstadt Germany, Berlin, Erlangen, Schaffhausen, Switzerland and Texas, Georgia,
Pennsylvania, West Virginia, and California, the US and production hubs in Cork, Ireland, Batam,
Indonesia, Grosswallstadt, Germany, Texas, the US and Johor, Malaysia. In FY2017, the Alcon segment
reported revenue of US$6,024 million, accounting for 12% of the company’s total revenue.
Its R&D afforts are focused on developing of innovative drugs and formulations for existing products and
development of new and innovative products based on changing market trends. As of December 31,
2017, it managed 500 clinical trials in progress and 200 projects in its clinical pipeline. It operates R&D
centers in Cambridge (Massachusetts), Basel, Switzerland, Fort Worth (Texas), the US, East Hanover
(New Jersey), Kundl and Schaftenau, Austria and Holzkirchen, Germany. It also collaborates with other
biotechnology and pharmaceutical companies for identifying cutting-edge technologies. In FY2017,
Novartis spent US$8,319 million for its R&D activities.
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Novartis AG
Company Overview
Geographically, the company classifies its operations into three regions: Europe (Switzerland, Germany,
France, the UK), Americas (including the US, Canada and Latin America) and Asia, Africa, and
Australasia. In FY2017, the Americas (including the US, Canada and Latin America) accounted for 42.6%
of the company’s total revenue, followed by Europe (Switzerland, Germany, France, the UK) (35.6%) and
Asia, Africa, Australasia (21.8%).
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Novartis AG
Company Overview
History
HISTORY
Ownership Changes
Year: 2018
In March, Novartis's 36.5% stake in consumer healthcare joint venture acquired by GlaxoSmithKline,
worth US$13 billion.
Regulatory Approval
Year: 2018
In May, Novartis secured approval from the US FDA for Gilenya to treat relapsing multiple sclerosis.
Contracts/Agreements
Year: 2018
In July, the company entered into a partnership with SHYFT, to support its digital transformation.
Regulatory Approval
Year: 2018
In July, Novartis secured an approval from the US Food and Drug Administration for its Kisqali to treat
advanced or metastatic breast cancer.
Contracts/Agreements
Year: 2018
In August, Novartis entered into an agreement with Albumedix to evaluate the development of several
first-in-class therapeutics using Albumedix’s Veltis technology platform and associated technologies.
Contracts/Agreements
Year: 2018
In August, the company and Invenergy announced a 100-megawatt virtual power purchase agreement for
environmental sustainability strategy and goals.
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Company Overview
Regulatory Approval
Year: 2018
In August, the company secured the EC approval for its Aimovig, a migraine drug.
Divestiture
Year: 2018
In September, Novartis signed an agreement to sell parts of its Sandoz US business to Aurobindo
Pharma USA, for US$900 million.
Contracts/Agreements
Year: 2018
In July, the company entered into a partnership with SHYFT, to support its digital transformation.
Financing Agreements
Year: 2018
In September, the company invested in Coda Biotherapeutics to raise US$19 million in Series A
Financing.
New Products/Services
Year: 2018
In October, Novartis' subsidiary, Alcon Laboratories introduced enhanced WaveLight Refractive Suite to
optimize the patient and surgeon LASIK experience.
Contracts/Agreements
Year: 2018
In September, the company partnered with Jordin Sparks and the Sickle Cell Disease Association of
America to introduce Generation S, an inspiring new sickle cell storytelling project.
Plans/Strategy
Year: 2018
In September, Novartis announced its plans to shut down its Grimsby manufacturing site.
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Company Overview
Acquisitions/Mergers/Takeovers
Year: 2018
In October, Novartis announced its plans to acquire Endocyte for US$2.1 billion.
Contracts/Agreements
Year: 2018
In September, the company, International healthcare organizations and Mundipharma entered into a
contract to market, sell and distribute Voltaren and Cataflam pain medicine brands in Malaysia, Thailand,
and the Philippines.
Contracts/Agreements
Year: 2018
In October, Novartis entered into an agreement with Pfizer to evaluate the combination of tropifexor
(LJN452) for the treatment of non-alcoholic steatohepatitis.
Contracts/Agreements
Year: 2018
In October, Novartis entered into a collaboration with Compact Imaging to develop a home-based monitor
to detect age-related macular degeneration and diabetic retinopathy.
Contracts/Agreements
Year: 2018
In October, the company and Foundation Medicine collaborated to develop companion diagnostic (CDx)
tests for Novartis targeted oncology and immuno-oncology therapeutic portfolio.
Contracts/Agreements
Year: 2018
In September, the company entered into partnership with the Global Antibiotic Research & Development
Partnership (GARDP) partnership to develop generic antibiotics and dispersible tablets to reduce child
deaths from drug-resistant infections.
Contracts/Agreements
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Company Overview
Year: 2018
In November, the company partnered with the Tufts Clinical and Translational Science Institute regarding
the foster innovative translational research.
Spin-off
Year: 2018
In July, the company announced its plans to spin-off eye care unit into stand-alone entity.
Contracts/Agreements
Year: 2018
In July, Novartis and Aveo Pharmaceuticals scrapped their US$326 million antibody licensing agreement
to develop and commercialize inhibitory antibody AV-380 and other antibodies.
Contracts/Agreements
Year: 2018
In December, the company collaborated with QIAGEN to develop companion diagnostic to guide
treatment for patients with PIK3CA-mutated advanced breast cancer.
Contracts/Agreements
Year: 2017
In March, PureTech entered into an agreement with Novartis for advancement of Clinical Stage mTORC1
Programs.
Contracts/Agreements
Year: 2018
In March, Novartis and Science 37 signed a strategic alliance to advance decentralized clinical trials.
Contracts/Agreements
Year: 2018
In March, Novartis paired up with Harvard University to innovate next generation biomaterial systems to
deliver immunotherapies.
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Company Overview
Contracts/Agreements
Year: 2018
In April, UMotif announced a partnership with Novartis and IQVIA on NHS Cancer Vanguard project.
Acquisitions/Mergers/Takeovers
Year: 2018
New Products/Services
Year: 2018
In March, Novartis and Pear Therapeutics announced to develop digital therapeutics to treat people with
schizophrenia and multiple sclerosis.
Contracts/Agreements
Year: 2018
In February, Novartis signed a partnership with Bill & Melinda Gates Foundation to strengthen expansion
of Novartis' drug candidate KDU731 for treating Diarrheal diseases .
Acquisitions/Mergers/Takeovers
Year: 2018
In February, the company's subsidiary, Novartis Groupe SA acquired Advanced Accelerator Applications
SA.
Regulatory Approval
Year: 2018
In February, the company received approval from the US Food and Drug Administration for its Glatopa
(glatiramer acetate injection) for relapsing forms of multiple sclerosis.
Regulatory Approval
Year: 2018
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Novartis AG
Company Overview
In January, the company received breakthrough therapy designation from the US FDA for its Kisqali for
the initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer.
Regulatory Approval
Year: 2018
In February, the company received approval from the US Food and Drug Administration for Cosentyx
label update, the first interleukin-17A (IL-17A) inhibitor to treat moderate-to-severe plaque psoriasis.
Regulatory Approval
Year: 2018
In January, the company received breakthrough therapy designation from the US Food and Drug
Administration for its Promacta to treat the patients with severe aplastic anemia.
Contracts/Agreements
Year: 2018
In January, the company entered into a long-term strategic alliance with TARGET PharmaSolutions, Inc,
to advance NASH research.
Regulatory Approval
Year: 2017
In December, the company received breakthrough therapy designation from the US Food and Drug
Administration for its Fingolimod to treat children and adolescents ten years of age or older with relapsing
multiple sclerosis.
Regulatory Approval
Year: 2017
In September, the company received approval from the European Commission for Rydapt (midostaurin)
for two indications in rare, hard-to-treat cancers.
Regulatory Approval
Year: 2017
In October, the company's cancer combo Tafinlar and Mekinist secured FDA approval.
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Company Overview
Contracts/Agreements
Year: 2017
In November, the company and Amgen partnered with the Banner Alzheimer's Institute regarding the new
trial of the Alzheimer's Prevention Initiative (API) Generation Study 2.
Contracts/Agreements
Year: 2017
In November, Novartis enter into a partnership with Homology Medicines to establish and create
Treatments Using Homology’s Proprietary Gene Editing Technology.
Contracts/Agreements
Year: 2017
In September, Novartis entered into a new collaboration with the Max Foundation to support continued
access to treat the patients with chronic myeloid leukemia, gastrointestinal tumors and other rare cancers.
Contracts/Agreements
Year: 2017
In September, Novartis entered into a collaboration with University of California, Berkeley for the
development of new technologies to discover next-generation therapeutics.
Regulatory Approval
Year: 2017
In June, the company's division Sandoz’s Rixathon secured the EC approval to treat blood cancers and
immunological diseases in Europe.
New Products/Services
Year: 2017
In October, the company's division Alcon received CE-Mark for new preloaded intraocular lens (IOL)
delivery system.
Contracts/Agreements
Year: 2017
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Company Overview
In July, Novartis entered into an agreement with Cryoport for cryogenic logistics support of CTL019/CD19
CAR-T cell therapy.
Regulatory Approval
Year: 2017
In August, the company received approval from the European Commission for its Kisqali as a first-line
treatment for advanced breast cancer.
Regulatory Approval
Year: 2017
In August, the company received approval from the US Food and Drug Administration for its Kymriah
(tisagenlecleucel or CTL019) to treat children and young adults with B-cell precursor acute lymphoblastic
leukemia.
Regulatory Approval
Year: 2017
In April, the company received approval from the US Food and Drug Administration for its Rydapt to treat
acute myeloid leukemia and three types of systemic mastocytosis.
Contracts/Agreements
Year: 2017
In September, Novartis entered into a co-promotion agreement with HelsinnTherapeutics (US), Inc. for
Zykadia, a treatment for patients with ALK-positive metastatic non-small cell lung cancer.
Contracts/Agreements
Year: 2017
In September, Novartis entered into a partnership with NuvoAir to distribute NuvoAir's spirometry
technology to physicians globally.
Contracts/Agreements
Year: 2017
In July, the company and Oxford BioMedica signed an agreement for cell therapy treatment.
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Company Overview
Regulatory Approval
Year: 2017
In June, the company secured the FDA approval of Tafinlar in combination with Mekinist to treat patients
with metastatic non-small cell lung cancer.
Regulatory Approval
Year: 2017
In June, the company's Erelzi, the biosimilar of Amgen and Pfizer, secured the EC approval for its Enbrel,
for the treatment of multiple inflammatory diseases.
Regulatory Approval
Year: 2017
In June, the company secured the European Medicines Agency approval for its Marketing Authorization
Application for AMG 334 for the prevention of migraine.
Regulatory Approval
Year: 2017
In June, the company's division Sandoz’s Rixathon secured the EC approval to treat blood cancers and
immunological diseases in Europe.
Contracts/Agreements
Year: 2017
Contracts/Agreements
Year: 2017
In June, Novartis signed a collaboration agreement with IBM Watson Health regarding an initiative for
optimizing cancer care and to improve patient outcomes.
Contracts/Agreements
Year: 2017
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Company Overview
In June, Bristol-Myers Squibb collaborated with Novartis to investigate Opdivo (nivolumab) and Opdivo +
Yervoy (ipilimumab) in combination with Mekinist (trametinib) to treat metastatic colorectal cancer.
Contracts/Agreements
Year: 2017
In May, Novartis selected Biologics for the distribution of a new oral treatment, RYDAPT (midostaurin), for
acute myeloid leukemia (AML) adults who are FLT3 mutation-positive.
Regulatory Approval
Year: 2017
The EC approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of
patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).
Contracts/Agreements
Year: 2017
Novartis entered into a clinical trial agreement with Allergan to conduct a Phase IIb study, involving the
combination of a Novartis FXR agonist and Allergan's cenicriviroc (CVC) for the treatment of non-
alcoholic steatohepatitis (NASH). The company also expanded commercialization agreement with Amgen
for AMG 334 (erenumab), which is being investigated for the prevention of migraine.
Regulatory Approval
Year: 2017
The FDA approved Novartis’ Rydapt (midostaurin, formerly PKC412) in newly diagnosed FLT3-mutated
acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).
Regulatory Approval
Year: 2017
The FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients
with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase
(ALK)-positive, as detected by an FDA-approved test.
Others
Year: 2017
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Novartis AG
Company Overview
Novartis exercised exclusive option agreement with Conatus Pharmaceuticals for the treatment of NASH.
New Products/Services
Year: 2017
Alcon announced the EU launch of CyPass micro-stent, a micro invasive glaucoma surgical device, to
lower intraocular pressure (IOP) in patients with primary open-angle glaucoma.
Regulatory Approval
Year: 2017
The FDA granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen
receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r)
diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.
Others
Year: 2017
Novartis exercised an option to in-license ECF843 for ophthalmic indications worldwide (outside Europe).
Regulatory Approval
Year: 2017
The FDA approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase
inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone
receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or
metastatic breast cancer. Alcon received approval from the FDA for its AcrySof IQ ReSTOR +2.5
Multifocal Toric intraocular lens (IOL) with ACTIVEFOCUS(TM) optical design for patients undergoing
cataract surgery who choose to address their astigmatism and presbyopia at the same time. The FDA
also accepted the company's BLA filing and granted priority review for CTL019 (tisagenlecleucel-T), an
investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric
and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Regulatory Approval
Year: 2017
The FDA accepted Novartis’ sNDA for filing, and granted priority review for the expanded use of Zykadia
(ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
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Company Overview
Contracts/Agreements
Year: 2017
Novartis signed memorandum of understanding with the Ministry of National Health Services, Regulations
and Coordination of Pakistan for providing free medicine to treat the people with chronic diseases.
Acquisitions/Mergers/Takeovers
Year: 2017
Contracts/Agreements
Year: 2017
The company announced a collaboration and option agreement with Ionis Pharmaceuticals and its
affiliate Akcea Therapeutics, to license two novel treatments with the potential to significantly reduce
cardiovascular risk in patients suffering from high levels of lipoproteins known as Lp(a) and ApoCIII.
New Products/Services
Year: 2017
Alcon launched AcrySof IQ PanOptix Toric presbyopia- and astigmatism-correcting intraocular lens (IOL)
for patients with pre-existing corneal astigmatism undergoing cataract surgery.
Regulatory Approval
Year: 2017
The company also announced that the EC approved Votubia (everolimus) dispersible tablets as an
adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or
without secondary generalization, are associated with tuberous sclerosis complex (TSC).
Plans/Strategy
Year: 2016
In October, the company plans to expand its global research headquarters on Massachusetts Avenue in
Cambridge, Massachusetts.
Contracts/Agreements
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Company Overview
Year: 2016
Novartis announced a collaboration with Qualcomm through its subsidiary, Qualcomm Life, in digital
innovation with the Breezhaler inhaler device to treat COPD. The company also entered into a strategic
alliance and licensing agreement with Surface Oncology.
Regulatory Approval
Year: 2016
Novartis received the FDA approval for its Cosentyx (secukinumab) for the treatment of two new
indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA), in the US.
Regulatory Approval
Year: 2016
Sandoz announced that the EMA accepted its marketing authorization application (MAA) for its biosimilar
to Amgen's EU-licensed Neulasta (pegfilgrastim) - a long-acting recombinant human granulocyte colony-
stimulating factor (G-CSF).
Acquisitions/Mergers/Takeovers
Year: 2016
Sandoz acquired the rights for the development and commercialization of PF-06438179 (biosimilar
infliximab) from Pfizer in the 28 countries that form the European Economic Area (EEA).
Contracts/Agreements
Year: 2016
Alcon entered into an agreement to acquire Transcend Medical, a privately-held, US-based company
focused on developing minimally-invasive surgical devices to treat glaucoma.
Regulatory Approval
Year: 2016
Novartis announced that the FDA granted breakthrough therapy designation to PKC412 (midostaurin).
The company announced that the FDA approved its Afinitor (everolimus) tablets for the treatment of adult
patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of
gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.
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Company Overview
Regulatory Approval
Year: 2016
Novartis received the EC’s approval for its Revolade (eltrombopag), for the treatment of pediatric (aged 1
year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory
to other treatments (e.g. corticosteroids, immunoglobulins). In addition, Sandoz announced that the EC
approved a type 2 variation for the addition of a subcutaneous (sc) route of administration in Binocrit's
(epoetin alfa) nephrology indication. The FDA also granted three breakthrough therapy designations for
Ilaris (canakinumab) to treat three rare types of periodic fever syndromes, also known as hereditary
periodic fevers.
Regulatory Approval
Year: 2016
Sandoz announced that the EMA accepted its MAA for a biosimilar to Roche's EU-licensed MabThera
(rituximab).
Regulatory Approval
Year: 2016
Novartis announced that the EC approved Afinitor (everolimus) tablets for the treatment of unresectable
or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of
gastrointestinal (GI) or lung origin in adults with progressive disease.
Contracts/Agreements
Year: 2016
The company announced the extension of its partnership with Medicines for Malaria Venture (MMV). The
company also entered into a collaboration and licensing agreement with Xencor for the development of
bispecific antibodies for treating cancer.
New Products/Services
Year: 2016
Alcon launched Dailies Total1 Multifocal contact lenses for people with presbyopia.
Regulatory Approval
Year: 2016
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Company Overview
Alcon achieved the FDA approval for the CyPass Micro-Stent, a micro invasive glaucoma surgical (MIGS)
device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract
surgery. The company announced that the FDA granted breakthrough therapy designation to LEE011
(ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal
growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. The FDA also
approved Sandoz’s Erelzi (etanercept-szzs) for all indications included in the reference product label,
including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis
(AS) and polyarticular juvenile idiopathic arthritis (JIA).
New Products/Services
Year: 2016
Alcon launched the NGENUITY 3D Visualization System, a platform for Digitally Assisted Vitreoretinal
Surgery (DAVS).
Regulatory Approval
Year: 2016
The FDA granted three simultaneous approvals for the expanded use of Novartis’ Ilaris (canakinumab) to
treat three rare and distinct types of periodic fever syndromes.
New Products/Services
Year: 2016
Alcon announced the US launch of the CyPass Micro-Stent, a prescription medical device that is
indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to
moderate primary open-angle glaucoma.
Regulatory Approval
Year: 2016
The FDA accepted the company's NDA for filing and granted priority review for LEE011 (ribociclib) as
first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth
factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with
letrozole. The FDA also granted priority review to the PKC412 (midostaurin) NDA for the treatment of
acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3)
mutation, as well as for the treatment of advanced systemic mastocytosis (SM).
Acquisitions/Mergers/Takeovers
Year: 2016
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Company Overview
Regulatory Approval
Year: 2016
The EC granted an additional indication for the company’s Lucentis (ranibizumab) to treat patients with
visual impairment due to choroidal neovascularization (CNV) associated with causes other than
neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM).
Contracts/Agreements
Year: 2016
Novartis entered into a definitive agreement for the acquisition of Ziarco Group Limited, a privately held
company focused on the development of novel treatments in dermatology. The company also signed
collaboration and license agreement with Conatus Pharmaceuticals, a biotechnology company, to
develop new oral treatments for chronic liver diseases.
Contracts/Agreements
Year: 2016
Novartis entered into a definitive agreement for the acquisition of Encore Vision, a privately-held company
in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia.
Divestiture
Year: 2015
Novartis completed the divestment of its animal health division to Eli Lilly and Company (Lilly) for
approximately $5.4 billion.
Contracts/Agreements
Year: 2015
The company signed collaboration and licensing agreements with Intellia Therapeutics for the discovery
and development of new medicines using CRISPR genome editing technology and Caribou Biosciences
for the development of drug discovery tools.
Regulatory Approval
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Company Overview
Year: 2015
Sandoz announced that the FDA Oncologic Drugs Advisory Committee (ODAC) has recommended
approval of its investigational biosimilar filgrastim in the US.
Corporate Changes/Expansions
Year: 2015
Novartis Pharmaceuticals announced its plans to establish of a joint investment company with Qualcomm
Ventures, the investment arm of Qualcomm.
Regulatory Approval
Year: 2015
Novartis announced that the EC has approved Cosentyx (secukinumab, formerly known as AIN457) as a
first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for
systemic therapy. The company received the FDA approval for Cosent (secukinumab) for the treatment of
moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug
that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light
therapy). The FDA also granted accelerated approval of Bexsero (Meningococcal Group B Vaccine
[recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by
serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25
years of age.
Regulatory Approval
Year: 2015
Alcon received approval from the FDA of Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for
the treatment of ocular itching associated with allergic conjunctivitis. The FDA also granted priority review
designation to the company's LCZ696, an investigational medicine for the treatment of heart failure with
reduced ejection fraction (HFrEF). The FDA approved Farydak (panobinostat, previously known as
LBH589) capsules in combination with bortezomib and dexamethasone for the treatment of patients with
multiple myeloma who have received at least two prior regimens, including bortezomib and an
immunomodulatory (IMiD) agent.
Corporate Changes/Expansions
Year: 2015
Novartis completed a series of transactions with GlaxoSmithKline (GSK), including the acquisition of
certain oncology products and pipeline compounds from GSK, the creation of a consumer healthcare
business through a joint venture that combines the two companies' consumer divisions, and the
divestiture of the Novartis non-influenza vaccines business to GSK.
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Company Overview
Regulatory Approval
Year: 2015
The company announced the FDA approval of its Zarxio (filgrastim-sndz) for all indications included in the
reference product's label.
Regulatory Approval
Year: 2015
The EC approved the company's Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia
vera (PV) who are resistant to or intolerant of hydroxyurea.
Contracts/Agreements
Year: 2015
Novartis entered into a major multiyear alliance with Aduro Biotech that is focused on the discovery and
development of next generation cancer immunotherapies targeting the STING (Stimulator of Interferon
Genes) pathway and launched a new immuno-oncology research group.
Regulatory Approval
Year: 2015
The FDA approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for
oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients two years
of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT)
in patients 10 years of age and older.
Regulatory Approval
Year: 2015
Alcon received approval from the FDA for its AcrySof IQ ReSTOR +2.5 Diopter (D) Intraocular Lens (IOL),
for patients undergoing cataract eye surgery who choose to address their near, intermediate, and
distance vision needs at the same time. Sandoz received the FDA approval of Glatopa, the first generic
version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis
therapy.
Regulatory Approval
Year: 2015
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Company Overview
Novartis received the EC's approval for Zykadia (ceritinib) to treat adult patients with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with
crizotinib. Novartis also received the FDA approval for its Promacta (eltrombopag) for the treatment of
children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient
response to corticosteroids, immunoglobulins or splenectomy. Subsequently, the company received
European CE Mark for its AcrySof IQ PanOptix trifocal intraocular lens (IOL) for patients undergoing
cataract surgery who elect to address their near, intermediate, and distance vision needs with a single
lens.
New Products/Services
Year: 2015
Sandoz announced the US launch of Glatopa, the first generic version of Teva's Copaxone (glatiramer
acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy.
Contracts/Agreements
Year: 2015
Regulatory Approval
Year: 2015
Alcon received European CE Mark for its AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery
System for patients undergoing cataract surgery. The company received the FDA approval for its Entresto
(sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced
ejection fraction. Novartis antimalarial medicine Coartem 80/480mg received World Health Organization
(WHO) prequalification, making it the first and only high strength (80/480mg) Artemisinin-based
Combination Therapy (ACT) antimalarial treatment available for public sector procurement.
Regulatory Approval
Year: 2015
CHMP of the European Medicines Agency (EMA) adopted a positive opinion for the combination of
Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or
metastatic melanoma with a BRAF V600 mutation. The company also announced that the FDA granted
priority review for the same patient population. The FDA also approved Odomzo (sonidegib, formerly
LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma
(laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for
surgery or radiation therapy.
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Company Overview
Divestiture
Year: 2015
Regulatory Approval
Year: 2015
The EC approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult
patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or
radiation therapy.
Contracts/Agreements
Year: 2015
Novartis entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline
(GSK).
Regulatory Approval
Year: 2015
Novartis announced that the EC has approved the combination of Tafinlar (dabrafenib) and Mekinist
(trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF
V600 mutation.
Contracts/Agreements
Year: 2015
The company entered into a global collaboration with Amgen to commercialize and develop pioneering
neuroscience treatments.
New Products/Services
Year: 2015
Regulatory Approval
Year: 2015
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Company Overview
The EC approved Revolade (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA)
who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable
for hematopoietic stem cell transplant.
Regulatory Approval
Year: 2015
The EC approved Farydak (panobinostat, previously known as LBH589) capsules, in combination with
bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory
multiple myeloma. Swissmedic approved Entresto (sacubitril/valsartan), previously known as LCZ696, to
reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced
ejection fraction (HFrEF).
Regulatory Approval
Year: 2015
The FDA accepted Novartis' Biologics License Application (BLA) under the 351 (k) pathway for its
proposed biosimilar to Amgen's US-licensed Enbrel (etanercept) - a tumor necrosis factor alpha (TNF-
alpha) inhibitor. Alcon received the FDA approval for its AcrySof IQ Aspheric IOL with the UltraSert Pre-
loaded Delivery System for patients undergoing cataract surgery.
Acquisitions/Mergers/Takeovers
Year: 2015
Novartis acquired Admune Therapeutics and signed licensing agreements with Palobiofarma and XOMA
Corporation.
Regulatory Approval
Year: 2015
Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k)
pathway for its proposed biosimilar to Amgen's US-licensed Neulasta (pegfilgrastim) - a recombinant
human granulocyte colony-stimulating factor (G-CSF). The EC approved Cosentyx (secukinumab) for the
treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA).
Regulatory Approval
Year: 2015
The EC approved Entresto (sacubitril/valsartan) for the treatment of adult patients with symptomatic
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Company Overview
Contracts/Agreements
Year: 2014
In January, Novartis and Foundation Medicine expanded collaboration to offer genomic profiling and
molecular information for clinical oncology programs.
Acquisitions/Mergers/Takeovers
Year: 2014
Contracts/Agreements
Year: 2014
In July, Novartis collaborated with Banner Alzheimer's Institute for a pioneering clinical study to prevent
Alzheimer's disease.
Divestiture
Year: 2014
Novartis divested its blood transfusion diagnostics unit to Grifols, a Spain-based developer of blood
plasma-based products, for $1,675 million in cash.
Regulatory Approval
Year: 2014
The FDA granted US marketing approvals for Novartis's Xolair (omalizumab) for the treatment of chronic
idiopathic urticaria (CIU), an unpredictable and debilitating skin disease that is known as chronic
spontaneous urticaria (CSU) outside of the US; and also for the company's Zykadia (ceritinib, previously
known as LDK378) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+)
metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Corporate Changes/Expansions
Year: 2014
Novartis announced portfolio transformation to increase its focus on pharmaceuticals, eye care and
generics.
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Company Overview
Contracts/Agreements
Year: 2014
The company signed agreements with GlaxoSmithKline (GSK) to acquire GSK's oncology products, to
combine Novartis's OTC business with GSK's consumer business in a joint venture, and to divest its
Vaccines (excluding flu) to GSK.
Contracts/Agreements
Year: 2014
Novartis signed an agreement to divest its animal health business to Eli Lilly for approximately $5.4
billion.
Contracts/Agreements
Year: 2014
Novartis signed a licensing and commercialization agreement with Ophthotech Corporation (Ophthotech)
for the exclusive rights to market Fovista (anti-PDGF aptamer) outside the US.
Litigation
Year: 2014
Novartis settled its litigation with a subsidiary of Sun Pharmaceutical Industries relating to Novartis
patents covering the use of certain polymorphic forms of Gleevec (imatinib mesylate), which would expire
in 2019 (including pediatric exclusivity).
Corporate Changes/Expansions
Year: 2014
FDA issued a Complete Response Letter regarding the company's BLA for RLX030 (serelaxin) for the
treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 would be
required for a US license to be granted. The Committee for Medicinal Products for Human Use also
adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF)
indicating that further evidence is required for a license to be granted in the EU. Alcon received positive
CHMP opinion for Simbrinza, a new fixed-dose combination medicine to treat patients with glaucoma.
Regulatory Approval
Year: 2014
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Company Overview
Novartis submitted an application to the FDA for meningitis B vaccine candidate, Bexsero. The FDA
granted Breakthrough Therapy status to Novartis's CTL019, an investigational chimeric antigen receptor
(CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute
lymphoblastic leukemia (r/r ALL).
Contracts/Agreements
Year: 2014
Alcon, entered into an agreement with a division of Google Inc. to in-license its "smart lens" technology
for all ocular medical uses.
Regulatory Approval
Year: 2014
The FDA accepted Sandoz's biologics license application for filgrastim, which was filed under the new
biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The
EC granted marketing authorization for Alcon's Simbrinza eye drops suspension (brinzolamide 10mg/mL
and brimonidine tartrate 2mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.
Corporate Changes/Expansions
Year: 2014
Novartis stated that LCZ696, its investigational heart failure medicine, was superior to ACE-inhibitor
enalapril on key endpoints in the PARADIGM-HF trial. The company also announced its plans to file the
marketing authorization application for LCZ696, a twice-a-day tablet being investigated for heart failure, in
the US by the end of 2014 and in the EU in early 2015.
Contracts/Agreements
Year: 2014
Novartis entered into a definitive agreement to divest its influenza vaccines business to CSL Limited for
an agreed price of $275 million.
Regulatory Approval
Year: 2014
The FDA Advisory Committee recommended approval of Novartis's AIN457 (secukinumab) for patients
with moderate-to-severe plaque psoriasis.
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Company Overview
Contracts/Agreements
Year: 2014
Novartis also formed a clinical collaboration with Bristol-Myers Squibb Company (BMS) to evaluate the
safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with
BMS's investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), in Phase I/II trials of
patients with non-small cell lung cancer.
Regulatory Approval
Year: 2014
The European Commission (EC) granted approval for Signifor (pasireotide) as a new long acting release
formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom
surgery is not an option or has not been curative and who are inadequately controlled on treatment with a
first-generation somatostatin analogue (SSA). Novartis announced that the CHMP granted accelerated
assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection
fraction (HFrEF).
Regulatory Approval
Year: 2014
The company announced that the FDA has approved Signifor long-acting release (LAR) (pasireotide) for
injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had
an inadequate response to surgery and/or for whom surgery is not an option. Alcon announced that its
treatment for patients with glaucoma, Travatan (40µg/mL travoprost) Eye Drops Solution, has been
granted an additional indication by the EC to decrease elevated intraocular pressure (IOP) in pediatric
patients, aged two months to less than 18 years, with ocular hypertension or pediatric glaucoma. The
Japanese Ministry of Health, Labor and Welfare (MHLW) approved the company's Cosentyx
(secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic
arthritis (PsA) in adults who are not adequately responding to systemic therapies (except for biologics).
Regulatory Approval
Year: 2013
The FDA approved Novartis's Exjade (deferasirox) for the treatment of chronic iron overload in patients
with non-transfusion-dependent thalassemia. The EC approved Bexsero (Meningococcal Group B
Vaccine [rDNA, component, adsorbed]), the first vaccine to prevent the leading cause of life-threatening
meningitis across Europe for use in individuals from two months of age and older.
Regulatory Approval
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Company Overview
Year: 2013
Novartis received FDA approval for Zortress (everolimus) for the prophylaxis of organ rejection in adult
patients receiving a liver transplant. Zortress is the first mammalian target of rapamycin (mTOR) inhibitor
approved for use following liver transplantation. The FDA also granted US marketing approvals for
Alcon's Simbrinza suspension, indicated for the reduction of elevated intraocular pressure (IOP) in
patients with primary open-angle glaucoma or ocular hypertension, and for Novartis's Ilaris
(canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two
years and older.
Regulatory Approval
Year: 2013
European Commission granted the marketing authorization for a new indication for Lucentis to treat
patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic
myopia (myopic CNV).
Contracts/Agreements
Year: 2013
Novartis entered into a global licensing and research collaboration agreement with Regenerex a
biopharmaceutical company, for use of the company's novel Facilitating Cell Therapy (FCRx) platform.
Regulatory Approval
Year: 2013
The EC approved the use of Novartis's Ilaris (canakinumab) for the treatment of active systemic juvenile
idiopathic arthritis in patients aged two years and older, who have responded inadequately to previous
therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids.
Regulatory Approval
Year: 2013
Novartis received the European Commission approval for once-daily Ultibro Breezhaler (indacaterol 85
mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult
patients with chronic obstructive pulmonary disease (COPD). The company received Japanese marketing
approval for once-daily Ultibro Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg),
delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in
COPD.
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Company Overview
Regulatory Approval
Year: 2013
Sandoz received Danish marketing authorization for its AirFluSal Forspiro, an innovative new inhaler for
patients with asthma and/or chronic obstructive pulmonary disease (COPD).
Regulatory Approval
Year: 2012
Novartis received regulatory approval in China for Lucentis (ranibizumab) to treat wet (neovascular) age-
related macular degeneration. Alcon, a Novartis company, gained exclusive rights to commercialize
ocriplasmin outside the US for the treatment of symptomatic vitreomacular adhesion (VMA). The FDA
approved the company's Afinitor (everolimus) tablets for the treatment of adult patients with kidney tumors
known as renal angiomyolipomas and tuberous sclerosis complex In the same year, the EU approved
Signifor (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an
option. Signifor is the first medicine to be approved in the EU targeting Cushing's disease.
Acquisitions/Mergers/Takeovers
Year: 2012
Novartis acquired Fougera Pharmaceuticals (formerly Nycomed US), a US-based specialty dermatology
generics company, for $1.5 billion in an all-cash transaction.
Regulatory Approval
Year: 2012
Afinitor tablets received marketing approvals in the US and Europe for the treatment of postmenopausal
women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast
cancer) in combination with exemestane.
Regulatory Approval
Year: 2012
The company received EU approval for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor, for the
treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also
known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential
thrombocythemia myelofibrosis.
Contracts/Agreements
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Company Overview
Year: 2011
In April, Novartis entered into a research collaboration with Biovista to identify new indications for a
number of undisclosed Novartis compounds utilizing Biovista’s Clinical Outcome Search Space
technology
Regulatory Approval
Year: 2011
Novartis's Lucentis received European marketing approval for a new indication to treat patients with visual
impairment due to diabetic macular edema (DME). The FDA granted approval for the use of Menveo
[Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] for
active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis
serogroups A, C, Y and W-135 in individuals two to 10 years of age.
Contracts/Agreements
Year: 2011
Novartis entered into a definitive agreement for the acquisition of Genoptix, a specialized laboratory
providing personalized diagnostic services to community-based hematologists and oncologists, for $25
per share in cash.
Acquisitions/Mergers/Takeovers
Year: 2011
Novartis acquired 85% stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., a developer, producer and
distributor of bio-pharmaceutical products and vaccines in China.
Regulatory Approval
Year: 2011
Novartis's Rasilamlo, a single-pill combination of aliskiren and amlodipine, received European marketing
authorization for the treatment of high blood pressure patients not controlled by either aliskiren or
amlodipine alone. The FDA granted US marketing approval for Novartis's Afinitor (everolimus) tablets for
the treatment of progressive neuroendocrine tumors of pancreatic origin in patients with unresectable,
locally advanced or metastatic disease. In addition, Novartis received regulatory approval in Japan for
Onbrez Inhalation Capsules (indacaterol) 150 mcg once-daily for the treatment of chronic obstructive
pulmonary disease (COPD). also, the FDA approved once-daily Arcapta Neohaler (indacaterol inhalation
powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients
with COPD including chronic bronchitis and/or emphysema.
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Company Overview
Regulatory Approval
Year: 2011
Novartis's Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a
single pill received approval from the EC for the treatment of high blood pressure.
Contracts/Agreements
Year: 2010
In February, Novartis entered into an agreement with NasVax for the joint development of NasVax's
VaxiSome adjuvant technology for improved flu vaccines, including swine flu.
Contracts/Agreements
Year: 2010
In January, Novartis AG entered into an agreement with Prometheus Laboratories to acquire exclusive
rights to distribute, promote and sell Proleukin in the US.
Acquisitions/Mergers/Takeovers
Year: 2010
Novartis acquired Corthera, a privately-held US biopharmaceutical company, for $120 million. Sandoz
acquired Oriel Therapeutics, a privately-held US pharmaceuticals company.
Regulatory Approval
Year: 2010
The FDA approved Novartis's Zortress (everolimus) oral tablets for the prevention of organ rejection of
kidney transplants in adult patients at low-to-moderate immunologic risk.
Regulatory Approval
Year: 2010
Tasigna received Japanese and European marketing approvals as a treatment for adult patients with
newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic
phase.
Contracts/Agreements
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Company Overview
Year: 2009
In March, Novartis and UK's Epistem entered into a two year stem cell drug discovery collaboration.
Contracts/Agreements
Year: 2009
Acquisitions/Mergers/Takeovers
Year: 2009
Contracts/Agreements
Year: 2009
The company entered into royalty agreement with Regeneron Pharmaceuticals regarding the sale of
canakinumab.
New Products/Services
Year: 2009
Contracts/Agreements
Year: 2009
The company entered the Japan vaccines market through an agreement with Takeda Pharmaceutical
Company for the distribution of Novartis Vaxem-Hib vaccine for the prevention of infection caused by
Haemophilus influenza type B.
Regulatory Approval
Year: 2009
The EC granted marketing approval for Afinitor (everolimus) tablets for the treatment of patients with
advanced renal cell carcinoma.
Acquisitions/Mergers/Takeovers
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Company Overview
Year: 2009
Sandoz completed the acquisition of the specialty generic injectables business of EBEWE Pharma for
$1.2 billion to further develop generic oncology injectables business unit.
Acquisitions/Mergers/Takeovers
Year: 2008
Regulatory Approval
Year: 2008
the FDA granted US marketing approvals for Tekturna HCT (aliskiren and hydrochlorothiazide) as a
single-tablet combination of two high blood pressure medicines - Tekturna (aliskiren) and the diuretic
hydrochlorothiazide; Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and
valsartan) as first-line treatments for high blood pressure; Glivec (imatinib) for the post-surgery treatment
of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal
tumors (GIST).
Regulatory Approval
Year: 2008
Novartis received EU marketing authorizations for the following products: Galvus and Eucreas, as new
oral treatments for type 2 diabetes patients; Extavia (interferon beta-1b) for the treatment of early and
relapsing forms of multiple sclerosis (MS); Aclasta (zoledronic acid 5 mg) for the treatment of
osteoporosis in men who are at increased risk of fractures, and broadened the Aclasta label to include
reduction of new clinical fractures in both men and postmenopausal women with osteoporosis who have
recently suffered a hip fracture.
Acquisitions/Mergers/Takeovers
Year: 2008
Novartis acquired a 25% stake in Alcon, a leading provider of eye care products, from Nestle for $10.4
billion. Novartis also obtained rights to acquire the remaining 52% stake held by Nestle for a price not
exceeding approximately $28 billion. Novartis completed the agreement with Nestle by acquiring a 77%
majority stake in Alcon for $28.3 billion, and subsequently entered into an all-share direct merger with
Alcon for the remaining 23% minority stake. Nestle fully acquired Alcon in 2011.
Acquisitions/Mergers/Takeovers
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Company Overview
Year: 2008
Contracts/Agreements
Year: 2007
In March, Novartis and Euroscreen SA, entered into a research collaboration for the identification of the
natural ligands of orphan receptors.
Regulatory Approval
Year: 2007
Novartis received approval from the European Commission to market Exforge, a single-pill treatment for
patients with high blood pressure and Lucentis. The company obtained FDA approval for Tekturna, a
medicine for the treatment of high blood pressure as monotherapy; and Reclast (zoledronic acid) for the
treatment of patients with a bone condition known as Paget's disease. Further in the same period, the
company suspended US marketing and sales of Zelnorm (tegaserod maleate), a treatment for irritable
bowel syndrome (IBS) with constipation and chronic constipation, as per a request by the FDA.
Regulatory Approval
Year: 2007
Novartis received European Commission's marketing authorizations for Focetria, a human vaccine for use
in an influenza pandemic; Exelon patch (rivastigmine transdermal patch), a skin patch therapy to treat
Alzheimer's disease; Galvus (vildagliptin), a once-daily oral treatment for patients with type 2 diabetes;
and for Aclasta, as the once-yearly treatment for postmenopausal osteoporosis.
Divestiture
Year: 2007
Novartis consolidated its businesses by selling its medical nutrition business for $2.5 billion and Gerber
baby foods business to Nestle.
Divestiture
Year: 2006
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Company Overview
The company divested its nutrition and Sante unit, and acquired Chiron and created a new division
focused on vaccines and diagnostics.
Contracts/Agreements
Year: 2005
In April, Vectura Group plc, Arakis Ltd and Novartis entered into an agreement for product NVA237, a.
antimuscarinic agent for the treatment of chronic obstructive pulmonary disease (COPD).
Contracts/Agreements
Year: 2005
In June, the company signed a research collaboration and license agreements with Hybridon.
Acquisitions/Mergers/Takeovers
Year: 2005
Novartis acquired Hexal and Eon Labs which were integrated into its Sandoz division. This provided
Novartis with a strong base in the global generic pharmaceutical industry.
Divestiture
Year: 2005
The company sold its dietary food business to the private equity group ABN Amro Capital France for
$258.6 million.
Contracts/Agreements
Year: 2004
In May, the company entered into an agreement with MorphoSys AG to discover and develop antibody-
based biopharmaceuticals as therapeutic agents.
Acquisitions/Mergers/Takeovers
Year: 2004
Others
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Company Overview
Year: 2003
The company sold the US rights to market tension headache products Fioricet and Fiorinal to Watson
Pharmaceuticals (now, Actavis Inc.), a US-based pharmaceutical company, for $178 million.
Corporate Changes/Expansions
Year: 2003
Novartis united its 14 generic company brands under a single global umbrella name, Sandoz. In a bid to
expand its antiviral portfolio, Novartis acquired a 51% stake in Idenix, a Cambridge, Massachusetts-
based biotech company. Novartis further increased its investment in Roche by $120 million by acquiring
an additional 0.6% of the company's shares.
Acquisitions/Mergers/Takeovers
Year: 2002
Novartis's animal health business unit acquired two US farm animal vaccine companies, Grand
Laboratories of Iowa, and ImmTech Biologies of Kansas, for a combined minimum purchase price of $99
million. These acquisitions provided Novartis with immediate entry into the world's largest farm animal
vaccine market, the US. Novartis's Sandoz business unit acquired Lek Pharmaceuticals, a Slovenian
generics company. The consumer health division divested its food and beverage business to Associated
British Foods, a UK-based food, ingredients and retail group, for $270 million in cash. After this
transaction was completed, the remaining health food and slimming and sports nutrition businesses were
reorganized as a stand-alone unit, nutrition and Sante, which for external reporting purposes were
consolidated into the medical nutrition business unit.
Acquisitions/Mergers/Takeovers
Year: 2001
Novartis acquired a 20% interest in Roche Holding, a Switzerland-based healthcare company, for
approximately $3.1 billion. Over the course of the following year, Novartis increased its investment in
Roche by $1.8 billion by acquiring a further 11.4% of the company's shares.
Corporate Changes/Expansions
Year: 1999
Novartis initiated a plan to sell off several business units in order to focus efforts on its healthcare
business. This plan culminated with the spinoff of the company's agribusiness unit with AstraZeneca to
form a new company, Syngenta.
Incorporation/Establishment
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Company Overview
Year: 1996
Novartis AG (Novartis or ‘the company’) was formed by the merger of two Swiss companies, Sandoz and
Ciba-Geigy.
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Company Overview
Key Employees
KEY EMPLOYEES
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Company Overview
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Company Overview
Mr. Houten serves as the Director of Novartis since 2017. Prior to this, he served as the Chief Executive
Officer and chairman of the executive committee and the board of management of Royal Philips, a
position he has held since 2011. In May 2016, he also became vice chairman and a member of the
supervisory board of Philips Lighting. He joined Philips in 1986 and held various global senior leadership
positions. Mr. Houten also served as the consultant of boards of companies including ING Group NV and
ASM International NV. Earlier, he also served as the Chief Executive Officer of NXP Semiconductors (a
Philips spinoff) from 2004 to 2009.
Joerg Reinhardt
Mr. Reinhardt serves as the Chairman of the company since 2013. Prior to this, he served in the
Executive Committee of Bayer HealthCare from 2010 to 2013, the Chief Operating Officer of Novartis
from 2008 to 2010 and as the Head of the Diagnostics and Vaccines Division of Novartis from 2006 to
2008. Earlier, he also served as the member of the supervisory board of MorphoSys AG in Germany from
2001 to 2004. Mr. Reinhardt was member of the board of directors of Lonza Group AG from 2012 to 2013
and also served as the Chairman of Genomics Institute of the Novartis Research Foundation in the US
from 2000 to 2010.
Bertrand Bodson
Board:Senior Management
Job Title:Chief Digital Officer
Since:2017
Bertrand Bodson will assume the position of Chief Digital Officer of the company from January 1, 2018.
Elizabeth Barrett
Board:Senior Management
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Company Overview
Mr. Barrett serves as the Chief Executive Officer of its Oncology since 2018. She also served as the
Global President of Oncology in Pfizer Inc and worked with Johnson & Johnson and Cephalon Inc in
2009. She started her career in 1984 in Kraft Foods Group Inc.
Board:Senior Management
Job Title:Chief Executive Officer-Alcon
Since:2016
Age:63
Mr. Ball serves as the Chief Executive Officer of Novartis since 2016. He also served as the Chief
Executive Officer of Hospira from 2011 to 2015 and held various leadership positions in Syntex
Corporation, Allergan and Eli Lilly.
Paul Hudson
Board:Senior Management
Job Title:Chief Executive Officer-Novartis Pharmaceuticals
Since:2016
Age:51
Mr. Hudson serves as the Chief Executive Officer of the company since 2016. He also worked as the
Executive Vice President of North America and President of AstraZeneca-US. Mr. Hudson also served as
the President and Representative Director of AstraZeneca K.K. (Japan and Spain) and at Sanofi-
Synthelabo UK and GlaxoSmithKline UK.
Richard Francis
Board:Senior Management
Job Title:Chief Executive Officer-Sandoz
Since:2014
Age:50
Mr. Francis serves as the Chief Executive Officer of the Sandoz, since 2014. He also worked with Sanofi
UK; Biogen Idec; and held various leadership positions in Wyeth and Lorex Synthelabo. Earlier, he also
served as the Senior Vice President of the company’s US commercial organization.
Harry Kirsch
Board:Senior Management
Job Title:Chief Financial Officer
Since:2013
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Age:53
Mr. Kirsch serves as the Chief Financial Officer of Novartis since 2013. He also served as the the Chief
Financial Officer of Pharma Europe, Chief Financial Officer of Novartis's pharmaceuticals division and
Head of financial operations and business planning & analysis of the Pharmaceuticals division. Earlier, he
also served as the Chief Financial Officer of P&G's global pharmaceuticals business and held various
roles in P&G's consumer goods business, technical operations, and Global Business Services
organization. He joined the company in 2003.
Vasant Narasimhan
Board:Senior Management
Job Title:Chief Executive Officer
Since:2018
Age:42
Mr. Narasimhan serves as the Chief Executive Officer of Novartis since 2018. Prior to this, he served as
the company's Chief Medical Officer and Global Head of Drug Development and is also a member of the
Executive Committee of Novartis. During his career, he held various leadership roles in commercial and
the development functions. Earlier, Dr. Narasimhan also served as Global Development Head of Novartis
Vaccines and Global Head of Development of Novartis Pharmaceuticals. He joined the company in 2005.
Nancy C. Andrews
Ms. Andrews serves as the Director of Novartis since 2015. She is Dean of the Duke University School of
Medicine, Vice Chancellor for academic affairs for Duke University and also a Professor of pediatrics,
pharmacology and cancer biology at Duke University in the US and was elected as a fellow of the
American Association for the Advancement of Science and to membership in the US National Academy
of Sciences, the National Academy of Medicine, and the American Academy of Arts and Sciences. Prior
to joining Duke, Dr. Andrews was director of the Harvard/MIT M.D.-Ph.D. Program, and dean of basic
sciences and graduate studies as well as professor of pediatrics at Harvard Medical School. From 1993
to 2006, she was a biomedical research investigator at the Howard Hughes Medical Institute in the US.
Ms. Andrews is a former president of the American Society for Clinical Investigation. Currently, she
serves as the Chairman of the board of directors of the American Academy of Arts and Sciences and of
the Burroughs Wellcome Fund, a member of the Massachusetts Institute of Technology (MIT)
Corporation. She also serves on the council of the National Academy of Medicine and on the Scientific
Management Review Board of the US National Institutes of Health.
Dimitri Azar
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Job Title:Director
Since:2012
Age:59
Mr. Azar serves as the Director of Novartis since 2012. He is Dean of the University of Illinois at Chicago
(UIC) College of Medicine in the United States since 2011, and as professor of ophthalmology,
bioengineering and pharmacology at UIC since 2006. From 2006 to 2011, he served as the head of the
Department of Ophthalmology and Visual Sciences at UIC. He is a member of the American
Ophthalmological Society, former president of the Chicago Ophthalmological Society, and president-elect
of the Chicago Medical Society. Additionally, he is on the board of the Tear Film and Ocular Surface
Society, the board of Verb Surgical Inc., and the scientific board of Verily – all based in the US. Mr. Azar
also serves as the senior director of ophthalmological innovation at Verily Life Sciences.
Ton Buechner
Mr. Buechner serves as the Director of Novartis since 2016. Prior to this, he served as the Chief
Executive Officer and Chairman of the Executive Board of Dutch multinational AkzoNobel from 2012 to
2017. Prior to joining AkzoNobel, Mr. Buechner spent almost two decades at the Sulzer Corporation in
Switzerland, where he was appointed divisional president in 2001 and served as the president and Chief
Executive Officer from 2007 to 2011. He also worked with the oil and gas construction industry, and held
various leadership roles in Allseas Engineering in the Netherlands and AkerKvaerner in Singapore, before
he joined Sulzer in 1994. He is a member of the supervisory board of Voith GmbH in Germany.
Srikant Datar
Mr. Datar serves as the Director of Novartis since 2003. He has been the Arthur Lowes Dickinson
professor of business administration at Harvard Business School in the US Since 1996 and has been
faculty chair of the Harvard Innovation Lab and senior associate dean for university affairs at Harvard
Business School since 2015. Mr. Datar also serves as the member of the boards of directors of ICF
International Inc., Stryker Corp. and T-Mobile US. Earlier, he also served on the boards of HCL
Technologies Ltd from 2012 to 2014 and for KPIT Cummins Infosystems Ltd from 2007 to 2012.
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Since:2016
Age:61
Ms. Doherty serves as the Director of Novartis since 2016. Prior to this, she serves as the Non-Executive
Director and Chairman of the Audit Committee at Dunelm Group PLC in the UK and as the member of the
supervisory board and audit committee of Corbion NV in the Netherlands. She is a fellow of the Chartered
Institute of Management Accountants and served as a board member of the UK Ministry of Justice and
Her Majesty’s Courts and Tribunals Service in the UK. Ms. Doherty also served as an advisor of GBfoods
and Affinity Petcare SA, subsidiaries of Agrolimen SA. Earlier, she also served as the non-executive
director and audit committee member of Delhaize Group in Belgium and Nokia Corp in Finland. She also
served as the non-executive director of SABMiller PLC in the UK. She began her career as an auditor and
has held various senior finance and accounting roles in Unilever PLC and Tesco PLC. These include
interim Chief Financial Officer of Cognita Schools Ltd. from 2014 to 2015, Chief Financial Officer and
board member of Reckitt Benckiser Group PLC from 2011 to 2013, interim Chief Financial Officer of City
Inn in 2010, and Chief Financial Officer of Brambles Ltd. from 2007 to 2009.
Ann Fudge
Ms. Fudge serves as the Director of Novartis since 2008. Prior to this, she served as the vice chairwomen
and senior independent director of Unilever NV, London and Rotterdam. She also serves as the
Chairwomen of the United States Program Advisory Panel of the Bill & Melinda Gates Foundation,
Director of Northrop Grumman Corporation in the US, a trustee of Boston-based WGBH public media and
a member of the visiting committee of Harvard Business School in the US. Ms. Fudge also served on the
board of General Electric Co. in the US from 1999 to 2015.
Pierre Landolt
Mr. Landolt serves as the Director of Novartis since 1996. He also serves as the chairman of the Sandoz
Family Foundation and as the chairman of the Swiss private bank Landolt & Cie SA. Mr. Landolt also
serves as the chairman of Emasan AG and Vaucher Manufacture Fleurier SA, and vice chairman of
Parmigiani Fleurier SA. He also serves as the vice chairman of the Montreux Jazz Festival Foundation
and a board member of Amazentis SA, Switzerland, and the Eneas Fund, Cayman Islands. In Brazil, Mr.
Landolt is president of AxialPar Ltda. and Moco Agropecuaria Ltda., the Instituto Fazenda Tamandua and
the Instituto Estrela de Fomento ao Microcredito. From 1974 to 1976, he worked for Sandoz Brazil. In
1977, he acquired an agricultural estate in the semi-arid Northeast Region of
Brazil, and within several years he converted it into a model farm in organic and biodynamic production.
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Since 1997, Mr. Landolt has been associate and chairman of AxialPar Ltda., Brazil. In 2007, he co-
founded Amazentis SA, a startup company active in the convergence space of medication and nutrition.
In 2011, Mr. Landolt received the title of Docteur des Sciences Economiques Honoris Causa from the
University of Lausanne in Switzerland.
Mr. Planta serves as the Director of Novartis since 2006. Prior to this, he served as the counsel to the law
firm Lenz & Staehelin AG, where he was a partner from 1988
to 2017. He is also a board member of Helvetia Holding AG in Switzerland, and also serves on the boards
of various Swiss subsidiaries of foreign companies and other non-listed Swiss companies, including
Burberry (Suisse) SA, Lenz & Staehelin, A.P. Moller Finance SA, HSBC Private Bank (Suisse) SA,
Socotab Frana SA and Raymond Weil SA. Mr. Planta also serves as the chairman of the regulatory board
of the SIX Swiss Exchange AG. He previously served as chairman of Clinique Generale-Beaulieu SA
from 2011 to 2016, and as
the Director from 2008 to 2016. Additionally, he was chairman of Swiss National Insurance Company Ltd.
(Nationale Suisse) from 2011 to 2015, as a Director of Nationale Suisse from 1997 to 2015, and as a
Director of Holcim Ltd. from 2003 to 2014.
Charles L. Sawyers
Mr. Sawyers serves as the Director of Novartis since 2013. In the US, he is Chairman of the Human
Oncology and Pathogenesis Program for Memorial Sloan-Kettering Cancer Center, Professor of medicine
and of cell and developmental biology at the Weill Cornell Graduate School of Medical Sciences and an
investigator of the Howard Hughes Medical Institute. He also serves on the US President Barack
Obama's National Cancer Advisory Board, and is President-elect of the American Association of Cancer
Research. Mr. Sawyers is the former president of the American Society for Clinical Investigation and is
also a member of the US National Academy of Sciences and Institute of Medicine. He also worked with
the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles for nearly 18
years before joining Memorial Sloan-Kettering in 2006.
William T. Winters
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Age:57
Mr. Winters serves as the Director of Novartis since 2013. Prior to this, he served as the Chief Executive
Officer and a board member of Standard Chartered, in London. He previously managed Renshaw Bay,
an alternative asset management firm, and served as the co- Chief Executive Officer of JPMorgan's
investment bank from 2003 to 2010. Mr. Winters also served as a commissioner on the UK Independent
Commission on Banking in 2010 and 2011. He joined JPMorgan in 1983 and held various management
roles across several market areas and in corporate finance. He is a board member of Colgate University,
International Rescue Committee, the Young Vic theater and the Print Room theater in the UK.
Steven Baert
Board:Senior Management
Job Title:Head-Human Resources
Since:2014
Age:44
Mr. Baert serves as the Head of Human Resources in Novartis since 2014. He joined the company in
2006 and held various senior HR roles, including Head of Human Resources for Emerging Growth
Markets, and Global Head of Human Resources, Oncology. Mr. Baert also served as Head of Human
Resources, US and Canada, for Novartis Pharmaceuticals Corporation. Prior to joining Novartis, he held
various Human Resources positions at Bristol-Myers Squibb Co. and Unilever.
Board:Senior Management
Job Title:President-Novartis Institutes for BioMedical Research (NIBR)
Since:2016
Age:46
Mr. Bradner serves as the President of Novartis Institutes for BioMedical Research (NIBR) since 2016.
Prior to joining the company, he was on the Faculty of Harvard Medical School in the Department of
Medical Oncology at the Dana-Farber Cancer Institute in the US from 2005 to 2015. He is a Co-Founder
of five biotechnology companies.
Andre Wyss
Board:Senior Management
Job Title:President-Novartis Operations; Country President, Switzerland, President-Switzerland
Since:2016
Age:51
Mr. Wyss serves as the President of Switzerland and President of Novartis Operations since 2016. He
joined the company in 1984 as a Chemistry Apprentice in manufacturing and held various positions since
then. Mr. Wyss is a member of the board of economiesuisse.
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Enrico Vanni
Board:Executive Board
Job Title:Vice Chairman
Age:67
Mr. Vanni serves as the Vice Chairman of Novartis. He has also been the Director of Novartis since 2011.
He retired as a Director of McKinsey & Company in 2007 and served as a board member of several
companies in industries from healthcare to private banking, including Advanced Oncotherapy PLC in the
UK and other non-listed companies such as Lombard Odier SA, Banque Privée BCP (Suisse) SA, and
Denzler & Partners SA, in Switzerland. Earlier, he also served on the boards of Eclosion2 in Switzerland
from 2009 to 2017, board of Alcon Inc. in Switzerland from 2010 to 2011, and board of Actavis PLC in
Ireland in 2010. He began his career as a research engineer at the International
Business Machines Corp. (IBM) in California, US, and later joined in McKinsey in Zurich in 1980. He
managed the Geneva office for McKinsey from 1988 to 2004, and consulted for companies in the
pharmaceutical, consumer and finance sectors. Mr. Vanni also served as the independent consultant,
supporting leaders of pharmaceutical and biotechnology companies on core strategic challenges facing
the healthcare industry.
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Products:
Brands:
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Trileptal (oxcarbazepine)
Tegretol (carbamazepine)
Afinitor/Votubia (everolimus)
Exjade (deferasirox)
Gleevec/Glivec (imatinib mesylate/imatinib)
Zometa (zoledronic acid)
Jakavi (ruxolitinib)
Femara (letrozole tablets/letrozole)
Signifor (pasireotide)
Tasigna (nilotinib)
Sandostatin LAR & Sandostatin SC (octreotide acetate for injectable suspension & octreotide acetate)
Lucentis (ranibizumab)
Foradil (formoterol)
Arcapta Neohaler / Onbrez Breezhaler (indacaterol)
Seebri Breezhaler (glycopyrronium)
Ultibro Breezhaler (indacaterol / glycopyrronium)
TOBI/TOBI Podhaler (tobramycin)
Xolair (omalizumab)
Ilaris (canakinumab)
Myfortic (mycophenolic acid/mycophenolate sodium, USP)
Neoral/Sandimmune (cyclosporine, USP Modified)
Simulect (basiliximab)
Zortress/Certican (everolimus)
Coartem/Riamet (artemether and lumefantrine)
Lescol/Lescol XL (fluvastatin sodium)
Miacalcin/Miacalcic (salmon calcitonin)
Lamisil (terbinafine)
Reclast/Aclasta (zoledronic acid 5 mg)
Vivelle Dot/Estradot (estradiol hemihydrate)
Voltaren/Cataflam (diclofenac sodium/potassium/resinate/free acid)
Alcon
Sandoz
Enoxaparin sodium injection (Lovenox)
Valsartan HCT (authorized generic of Novartis’s Diovan HCT)
Somatropin (Genotropin)
Votrient
Acetylcysteine (Fluimucil)
Amoxicillin / clavulanic acid (Augmentin)
Omeprazole (Prilosec)
Lactobacillus (Linex)
Fentanyl (Duragesic)
Tafinlar + Mekinist
Tacrolimus (Prograf)
Atorvastatin (Lipitor)
AIR OPTIX
NIGHT & DAY / AIR OPTIX NIGHT & DAY
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SWOT Analysis
SWOT ANALYSIS
Novartis AG (Novartis or ‘the company’) is one of the Big Pharma companies having strong presence in
diverse biopharmaceutical segments. It is engaged in the research, development, manufacture and
marketing of branded drugs, generic pharmaceutical products, preventive vaccines, diagnostic tools and
consumer health products. Novartis's diverse product portfolio compiled with research and development
activities has enabled it to record a robust revenue growth rate. However, the company is facing
competition from generic manufacturers as a result of losing patent exclusivity.
Strength Weakness
Diversified portfolio across high-growth segments of Product discontinuations and failures hampers the
the healthcare sector helped Novartis record brand image
consistent growth
Strong R&D program helping Novartis to strengthen its
product pipeline
Opportunity Threat
Strategic acquisitions creates a dominant market Heightened regulatory and safety hurdles
position Generic competition may put pressure on the
Agreements to enhance Novartis’ product portfolio company's profit margins
Healthcare cost containment measures leading to drug
pricing controls
Strength
Diversified portfolio across high-growth segments of the healthcare sector helped Novartis record
consistent growth
A well-diversified healthcare product portfolio has enabled Novartis to deliver significantly high top-line
growth. In FY2017, the company recorded 65.9% of its net sales from innovative medicines, 20.1% from
generic pharmaceuticals and biosimilars (Sandoz), and 12% from surgical and vision care products
(Alcon). Among the Big Pharma companies, no other company has such a diversified offering in terms of
prescription pharmaceutical focus.
Novartis has positioned itself to capture significant marketplace opportunities across geographies.
Approximately 43% of its total sales are accounted from other countries, 34% from the US, 8% from
Germany, 6% from Japan, 5% from France, 2% from the UK and 2% from Switzerland. As a result,
Novartis is not dependent for growth on any one product, region, or market. The company's growth is
sustained by its strong position in diverse market segments.
Thus, the diversity of Novartis’ business and product portfolio allows it to capture opportunities across the
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global healthcare market, while balancing the company's risk and exposure to macroeconomic effects.
Novartis conducts research and early-stage development through the Novartis Institutes for BioMedical
Research (NIBR), which is primarily focused on developing new and innovative medicines. It has
approximately 23,000 scientists, physicians and business professionals involved in R&D, of which more
than 6,000 scientists and associates at NIBR conduct research in various disease areas such as such as
cardiovascular and metabolic diseases, neuroscience, oncology, muscle disorders, ophthalmology,
autoimmune diseases, and respiratory diseases. in the US, Switzerland, Singapore and China.
Major pipeline products include ABL001 for chronic myeloid leukemia, ACZ885 for secondary prevention
of cardiovascular events, AMG 334 for migraine and Arzerra for refractory non-Hodgkin’s lymphoma. It
also include BAF312 for secondary progressive multiple sclerosis, BYL719 for advanced breast cancer,
BYM338 for hip fracture and sarcopenia, EMA401 for peripheral neuropathic pain, Entresto for chronic
heart failure and INC280 for non-small cell lung cancer. Furthermore, it also develops Jakavi for graft-
versus-host disease and early myelofibrosis, OMB157 for relapsing multiple sclerosis, LAM320 for
multidrug-resistant tuberculosis, QAW039 for asthma, ZPL389 for atopic dermatitis, RTH258 for
neovascular age-related macular degeneration and GP1111 for inflammatory bowel disease, rheumatoid
arthritis and plaque psoriasis.
It operates and manages major R&D facilities in Basel, Switzerland, Cambridge (Massachusetts), East
Hanover (New Jersey) and Fort Worth (Texas), the US, Holzkirchen, Germany, Kundl and Schaftenau,
Austria and Shanghai, China. Novartis has collaborative arrangements, with other pharmaceutical and
biotechnology companies, to develop and commercialize product candidates. It also has over 300
academic and 100 industry alliances focused on areas of mutual scientific interest. It has collaboration
with Ionis Pharmaceuticals, Akcea Therapeutics, Cota Healthcare, MorphoSys, Perthera, PureTech,
Parvus Therapeutics, Bristol-Myers Squibb and others and also owns numerous US and foreign patents
covering processes for manufacturing a product, and particular uses of that product.
In FY2017, Novartis invested US$8.3 billion for its R&D activities, significantly advancing its promising
pipeline projects and securing major FDA and European approvals across its portfolio. As of December
2017, Novartis had more than 200 projects under clinical development and 500 clinical trails in progress.
It received 16 major approvals and six FDA breakthrough therapy designations and applied for 16 major
submissions in FY2017.
Innovation based strategies enables the company to stay abreast of the changes in the industry and
provides it with ‘first mover’ advantage by launching products ahead of competition and also delivers
advanced products to its customers.
Weakness
In 2017, Novartis discontinued the development of various products that include trametinib dimethyl
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sulfoxide and dabrafenib mesylate in Phase II stage, bimagrumab in Phase III trials for the treatment of
sporadic inclusion body myositis (sIBM), Fevipiprant (QAW-039) in Phase II stage for atopic dermatitis,
CJM-112 in Phase I/II stage for chronic plaque-type psoriasis, buparlisib hydrochloride in Phase II for
metastatic breast cancer, and Infigratinib (BGJ-398) for solid tumors. It also discontinued the
development of alpelisib and EGF-816 for solid tumors, Gilenya in EU, the US and Japan, QBW-251 in
Phase II stage for cystic fibrosis, afuresertib hydrochloride for solid tumors and hematological cancers
and FCR-001 for stem cell therapy. Such recalls could hamper the brand image of the company.
Opportunity
Novartis has been acquiring various complementary businesses that are likely to broaden its pipeline and
strengthen its leadership position in the biopharmaceutical industry. For instance, Novartis acquired
AveXis, Inc in May 2018 and Advanced Accelerator Applications S.A. (AAA) in February 2018 to further
enhance its presence in the market. Earlier, it also acquired Encore Vision, Inc. (Encore) in January 2017.
These acquisitions are part of the company’s strategic priority of becoming a leader in the pharmaceutical
industry and also allows it to expand its presence across various emerging markets. It also offer strong
growth opportunities for the company especially while entering new markets or launching new products
and services.
The company has entered into various collaboration and license agreements in the recent past. These
agreements would help the company to add new therapies to its existing portfolio. For instance, in
February 2018, the company signed a partnership with Bill & Melinda Gates Foundation to strengthen
expansion of Novartis' drug candidate KDU731 for treating Diarrheal diseases. In April 2018, UMotif
announced a partnership with Novartis and IQVIA on NHS Cancer Vanguard project. In March 2018, the
company and Science 37 signed a strategic alliance to advance decentralized clinical trials. In the same
month, Novartis paired up with Wyss Institute at Harvard University to innovate next generation
biomaterial systems to deliver immunotherapies. In January 2018, the company entered into a long-term
strategic alliance with TARGET PharmaSolutions, Inc, to advance NASH research capabilities.
In June 2017, Bristol-Myers Squibb collaborated with Novartis to investigate Opdivo (nivolumab) and
Opdivo + Yervoy (ipilimumab) in combination with Mekinist (trametinib) to treat metastatic colorectal
cancer. In June 2017, Novartis signed a collaboration agreement with IBM Watson Health regarding an
initiative for optimizing cancer care and to improve patient outcomes. In March 2017, Biologics entered
into an agreement with Novartis, to provide KISQALI for treatment of breast cancer. In January 2017,
Novartis announced a collaboration and option agreement with Ionis Pharmaceuticals and its affiliate
Akcea Therapeutics, to license two novel treatments with the potential to significantly reduce
cardiovascular risk in patients suffering from high levels of lipoproteins known as Lp(a) and ApoCIII. The
two investigational antisense therapies developed by Ionis-called AKCEA-APO(a)-LRx and AKCEA-
APOCIII-LRx-have the potential to lower both lipoproteins up to 90% and significantly reduce
cardiovascular risk in high-risk patient populations. This agreement would help the company in building a
robust cardiovascular portfolio of targeted therapies to address unmet medical need of high-risk patients.
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Thus, the strategic collaborations and license agreements would enhance Novartis’ product portfolio and
also enhances its market presence compared to its peers.
Threat
Following a series of widely publicized issues in recent years, health regulators are increasingly focusing
on product safety. In addition, government authorities around the world have paid increased attention to
the risk/benefit profile of pharmaceutical products with an emphasis on product safety and on incremental
improvement over older products in the same therapeutic class.
The post-approval regulatory burden on healthcare companies has also been growing. Approved drugs
have increasingly been subject to requirements such as Risk Evaluation and Mitigation Strategies
(REMS), risk management plans, comparative effectiveness studies, health technology assessments and
requirements to conduct post-approval Phase IV clinical trials to gather far more detailed safety and other
data on products. These requirements make the maintenance of regulatory approvals and achievement of
reimbursement for the company's products increasingly expensive and further heighten the risk of recalls,
product withdrawals, or loss of market share. Like its industry peers, Novartis has been required by health
authorities to conduct additional clinical trials, and to submit additional analyses of its data in order to
obtain product approvals or reimbursement by government or private payors. Novartis has had REMS
and other such requirements imposed as a condition for approval of its new drugs.
By increasing the costs of and causing delays in obtaining approvals, and by creating an increased risk
that products either will not be approved, or will be removed from the market after previously having been
approved, these regulatory developments have had, and can be expected to continue to have, a material
adverse effect on the company's business operations and growth margins.
In the recent past, some of the Novartis best-selling products have begun to face significant competition
due to the end of market exclusivity resulting from the expiry of patent protection. For instance, in
FY2017, the impact of generic competition on the company’s sales amounted to approximately US$2.0
billion. In FY2018, Novartis expects decrease in its net sales of about US$1.5 billion due to the loss of
intellectual property protection for its products. The company’s formerly best-selling product,
Gleevec/Glivec, is facing continued and increasing generic competition in the US, EU and Japan. Some
of its best selling products including Gilenya, Afinitor/Votubia, Certican/Zortress, Exjade/Jadenu and
Lucentis could face generic competition in one or more major markets during the next three years. Diovan
and Co-Diovan/Diovan HCT (high blood pressure) has generic competitors in the US, EU and Japan.
The loss of exclusivity of important products due to generic challenges, patent expiry, competition from
newly patented products, or changes in regulatory status could have a negative impact on the company’s
results of operations.
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In the recent years, there have been cutbacks in health care spending in major economies. The ongoing
financial crisis and its resultant drag on economic growth continue to impact the debt burden of many
economies, most notably in Europe. With budgets under pressure and a fragile global economy, stringent
cost-containment measures have been implemented in countries around the world. In recent years, some
governments and payers have introduced price reductions and/or rebate increases for patented and
generic medicines, as well as other healthcare products and services. Other initiatives to contain
healthcare costs include mandatory pricing systems, reference pricing initiatives, an increase in imports of
drugs from lower-cost countries to higher-cost countries, shifting of the payment burden to patients
through higher co-payments, limiting physicians' ability to choose among competing medicines,
mandatory substitution of generic drugs, and growing pressure on physicians to reduce the prescribing of
patented prescription medicines.
These ongoing pressures are expected to affect Novartis' businesses operations and its brand image.
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Top Competitors
TOP COMPETITORS
The following companies are the major competitors of Novartis AG
AstraZeneca PLC
Bristol-Myers Squibb Company
Eli Lilly and Company
F. Hoffmann-La Roche Ltd
Johnson & Johnson
Merck KGaA
Pfizer Inc.
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Company View
COMPANY VIEW
A statement by Mr. Joerg Reinhardt, the Chairman of Novartis AG, is given below. The statement has
been taken from the company's annual report for the financial year ending December 31, 2017.
Dear shareholder,
Novartis made substantial progress in 2017. We returned Alcon to growth, launched important new
products, and benefited from efficiency gains delivered by Novartis Business Services and the recently
established global drug development and production organizations. These accomplishments have helped
us to deliver solid performance. We increased sales by 2% in constant currencies, improved net income
by 12% in constant currencies, and were able to strengthen our cash flow and core earnings per share
with the objective of continuing to create value for our shareholders.
We believe innovation will become increasingly important in view of the persistent challenges in the
healthcare environment. To remain at the forefront of innovation, we have continued to strengthen our
leadership. We have also enhanced our ability to develop breakthrough therapies by accelerating internal
and external collaboration, pursuing bolt-on acquisitions and digitizing our operations. The creation of the
Chief Digital Officer position is set to add further impetus to the transformation of Novartis.
With the appointment of Vasant Narasimhan as Chief Executive Officer starting February 1, the Board of
Directors is confident Novartis is well placed to begin a new phase of growth and strengthen its global
market position. As we move forward, our leadership team is focused on driving innovation and is
cultivating a company culture aimed at helping us become one of the most trusted partners in the
healthcare industry. On behalf of the Board of Directors, I would also like to express my gratitude to our
outgoing CEO, Joseph Jimenez, who has successfully led Novartis for eight years through a challenging
period of major patent expirations and laid the foundation for a strong future.
We will continue to make substantial investments in research and development and to concentrate on ex
- ploring new therapeutic pathways that help improve and extend people’s lives. We are currently
investigating more than 70 new molecules in areas of high unmet medical need such as cancer,
respiratory disease and heart disease.
The healthcare industry is going through a transformative period marked by diverging trends. On the one
hand, digital technologies and new biotechnological discoveries allow for the development of
breakthrough therapies that can help substantially improve the individual treatment of patients. At the
same time, aging populations are set to lead to an increase in the cost of care due to the rise in
noncommunicable diseases.
Novartis is committed to enhancing healthcare innovation to address high unmet medical needs and is
prepared to leverage breakthrough technologies in the interest of patients. We are also collaborating with
healthcare providers on new pricing solutions such as outcomesbased payment models that can help
ease the burden on healthcare systems while at the same time supporting patients’ access to quality
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care.
We are prepared to take calculated risks across the research portfolio and work toward translating
scientific advances in fields such as genetics and immunology into pharmaceutical products. As part of
these efforts, we launched three cancer therapies in 2017: Kisqali, Rydapt and Kymriah. Kymriah,
developed with the University of Pennsylvania in the US, is the first approved chimeric antigen receptor T-
cell (CAR-T) therapy, an innovative cell therapy that is available in the US on an industrial scale and
takes personalized medicine to a new level.
Reflecting our ambition to deliver our treatments to as many patients as possible, we are also
accelerating our activities to improve access to healthcare in developing countries. As part of these
efforts, we expanded the reach of our Novartis Access program, which aims to help address the rise in
chronic diseases in lower-income countries in Africa, Asia and South America.
We constantly seek ways to improve our corporate governance, strengthen our commitment to integrity
and ethical behavior, and continue cultivating an open and transparent dialogue with our many
stakeholders. We pursue engagement with patient groups, customers, shareholders and society as a
whole. We are convinced that this exchange benefits our company in the long term and can also
contribute to strengthening healthcare systems.
I thank you for the confidence you have placed in our company and am pleased to be able to propose a
dividend increase of 2% to CHF 2.80 at the next Annual General Meeting.
Novartis AG Page 62
© MarketLine
Novartis AG
Company Overview
Head Office
Novartis AG
Lichtstrasse 35
Basel
Basel-Stadt
Basel
Basel-Stadt
CHE
Phone:41 61 3241111
Fax:41 61 3247826
www.novartis.com
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Novartis AG
Company Overview
Phone:39 2 96541
Fax:39 2 96542910
www.novartis.it
Novartis Healthcare A/S Novartis International Pharmaceutical Ltd
131 Front Street
Edvard Thomsen Road 14, 3 Hamilton
Copenhagen Hamilton
Copenhagen BMU
DNK Phone:1-441 2968025
Phone:45 39 168400 Fax:1-441 2965083
Fax:45 39 168401 www.novartis.bm
www.novartis.dk
Novartis Pharma (Pakistan) Ltd Novartis Pharma SAS
15 West Wharf, Dockyard Road
Karachi 2-4 rue Lionel Terray, B.P. 308
Sindh Rueil-Malmaison cedex
Karachi Paris
Sindh Ile-de-France
PAK Paris
Phone:92 21 32313386 Ile-de-France
Fax:92 21 32310072 FRA
www.novartis.pk Phone:33 1 55476000
www.novartis.fr
Novartis UK Ltd
Frimley Business Park
Frimley
Camberley
Surrey
Camberley
Surrey
GBR
Novartis AG Page 64
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Novartis AG
Company Overview
Financial Overview
FINANCIAL OVERVIEW
Summarized Statement
*Note: Eliminations not included, all figures in Million except per share data.
Detailed Statement
*Note: Eliminations not included, all figures in Million except per share data.
Novartis AG Page 65
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Novartis AG
Company Overview
Expenses, Total
Research & Development USD 9,071.00 9,086.00 8,738.00 8,402.00 8,313.00
Depreciation/ Amortization USD 0.00 0.00 43.00 43.00 197.00
Unusual Expense (Income) USD 14.00 0.00 1,158.00 911.00 611.00
Other Operating Expenses, USD 842.00 1,121.00 332.00 306.00 415.00
Total
Total Operating Expense USD 41,747.00 42,545.00 41,514.00 41,111.00 41,494.00
Operating Income USD 10,969.00 11,089.00 8,845.00 8,275.00 8,641.00
Other, Net USD -71.00 -89.00 -81.00 -18.00 -44.00
Net Income Before Taxes USD 10,807.00 12,272.00 8,134.00 7,817.00 8,999.00
Provision for Income Taxes USD 1,498.00 1,545.00 1,106.00 1,119.00 1,357.00
Net Income After Taxes USD 9,309.00 10,727.00 7,028.00 6,698.00 7,642.00
Minority Interest USD -117.00 -70.00 -11.00 14.00 0.00
Net Income Before Extra. USD 9,192.00 10,657.00 7,017.00 6,712.00 7,642.00
Items
Total Extraordinary Items USD -17.00 -447.00 10,766.00 0.00 61.00
Net Income USD 9,175.00 10,210.00 17,783.00 6,712.00 7,703.00
Income Available to Com USD 9,192.00 10,657.00 7,017.00 6,712.00 7,642.00
Excl ExtraOrd
Income Available to Com Incl USD 9,175.00 10,210.00 17,783.00 6,712.00 7,703.00
ExtraOrd
Dilution Adjustment USD 0.00 0.00 0.00 0.00 0.00
Diluted Net Income USD 9,175.00 10,210.00 17,783.00 6,712.00 7,703.00
Diluted Weighted Average USD 2,479.00 2,470.00 2,438.00 2,400.00 2,371.00
Shares
Diluted EPS Excluding USD 3.71 4.31 2.88 2.80 3.22
ExtraOrd Items
Diluted Normalized EPS USD 3.93 4.68 3.29 3.12 3.44
DPS - Common Stock USD 2.76 2.62 2.70 2.70 2.87
Primary Issue
Balance Sheet
Cash USD 3,995.00 3,607.00 3,074.00 1,912.00 2,970.00
Cash & Equivalents USD 2,692.00 9,416.00 1,600.00 5,095.00 5,890.00
Short Term Investments USD 2,409.00 480.00 628.00 539.00 487.00
Cash and Short Term USD 9,096.00 13,503.00 5,302.00 7,546.00 9,347.00
Investments
Accounts Receivable - USD 9,907.00 8,278.00 8,182.00 8,203.00 8,601.00
Trade, Net
Total Receivables, Net USD 12,628.00 10,258.00 10,553.00 10,208.00 11,101.00
Total Inventory USD 7,267.00 6,093.00 6,226.00 6,255.00 6,867.00
Prepaid Expenses USD 671.00 550.00 621.00 692.00 756.00
Novartis AG Page 66
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Novartis AG
Company Overview
Other Current Assets, Total USD 880.00 7,157.00 143.00 230.00 137.00
Total Current Assets USD 30,542.00 37,561.00 22,845.00 24,931.00 28,208.00
Property/ Plant/ Equipment, USD 35,301.00 31,428.00 31,448.00 31,296.00 34,010.00
Total - Gross
Accumulated Depreciation, USD -17,104.00 -15,445.00 -15,466.00 -15,655.00 -17,546.00
Total
Property/ Plant/ Equipment, USD 18,197.00 15,983.00 15,982.00 15,641.00 16,464.00
Total - Net
Goodwill, Net USD 31,026.00 29,311.00 31,174.00 30,980.00 31,750.00
Intangibles, Net USD 27,841.00 23,832.00 34,217.00 31,340.00 29,997.00
Long Term Investments USD 10,101.00 9,440.00 16,577.00 15,400.00 16,645.00
Note Receivable - Long USD 647.00 712.00 1,203.00 1,100.00 968.00
Term
Other Long Term Assets, USD 7,900.00 8,548.00 9,558.00 10,732.00 9,047.00
Total
Total Assets USD 126,254.00 125,387.00 131,556.00 130,124.00 133,079.00
Accounts Payable USD 6,148.00 5,419.00 5,668.00 4,873.00 5,169.00
Accrued Expenses USD 4,286.00 4,402.00 4,366.00 4,169.00 4,811.00
Notes Payable/ Short Term USD 4,083.00 3,571.00 3,915.00 5,611.00 4,842.00
Debt
Current Port. of LT Debt/ USD 2,590.00 2,989.00 1,659.00 178.00 359.00
Capital Leases
Other Current liabilities, Total USD 9,261.00 10,592.00 8,100.00 7,378.00 8,222.00
Total Current Liabilities USD 26,368.00 26,973.00 23,708.00 22,209.00 23,403.00
Long Term Debt USD 11,242.00 13,799.00 16,327.00 17,897.00 23,224.00
Total Long Term Debt USD 11,242.00 13,799.00 16,327.00 17,897.00 23,224.00
Total Debt USD 17,915.00 20,359.00 21,901.00 23,686.00 28,425.00
Deferred Income Tax USD 6,904.00 6,099.00 6,355.00 6,657.00 5,168.00
Minority Interest USD 129.00 78.00 76.00 59.00 59.00
Other Liabilities, Total USD 7,268.00 7,672.00 8,044.00 8,470.00 7,057.00
Total Liabilities USD 51,911.00 54,621.00 54,510.00 55,292.00 58,911.00
Common Stock, Total USD 1,001.00 1,001.00 991.00 972.00 969.00
Retained Earnings USD 73,431.00 69,868.00 80,379.00 81,148.00 77,639.00
(Accumulated Deficit)
Treasury Stock - Common USD -89.00 -103.00 -101.00 -76.00 -100.00
Unrealized Gain (Loss) USD 0.00 0.00 461.00 348.00 386.00
Other Equity, Total USD 0.00 0.00 -4,684.00 -7,560.00 -4,726.00
Total Equity USD 74,343.00 70,766.00 77,046.00 74,832.00 74,168.00
Total Liabilities & USD 126,254.00 125,387.00 131,556.00 130,124.00 133,079.00
Shareholders' Equity
Total Common Shares USD 2,426.08 2,398.63 2,373.89 2,374.06 2,317.46
Novartis AG Page 67
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Novartis AG
Company Overview
Outstanding
Cash Flow
Net Income/ Starting Line USD 9,309.00 10,727.00 7,028.00 6,698.00 7,703.00
Depreciation/ Depletion USD 1,601.00 1,630.00 1,550.00 1,591.00 1,677.00
Amortization USD 2,804.00 3,052.00 3,921.00 4,452.00 4,399.00
Non-Cash Items USD 3,364.00 2,571.00 4,102.00 2,239.00 710.00
Changes in Working Capital USD -3,904.00 -4,083.00 -4,704.00 -3,505.00 -1,868.00
Cash from Operating USD 13,174.00 13,897.00 11,897.00 11,475.00 12,621.00
Activities
Capital Expenditures USD -3,378.00 -3,404.00 -3,505.00 -2,879.00 -2,746.00
Other Investing Cash Flow USD 26.00 4,285.00 -7,279.00 -562.00 -373.00
Items, Total
Cash from Investing USD -3,352.00 881.00 -10,784.00 -3,441.00 -3,119.00
Activities
Financing Cash Flow Items USD -99.00 -140.00 -4.00 1.00 10.00
Total Cash Dividends Paid USD -6,100.00 -6,810.00 -6,643.00 -6,475.00 -6,495.00
Issuance (Retirement) of USD -1,237.00 -4,515.00 -4,490.00 -895.00 -5,238.00
Stock, Net
Issuance (Retirement) of USD -1,333.00 3,318.00 1,961.00 2,055.00 3,990.00
Debt, Net
Cash from Financing USD -8,769.00 -8,147.00 -9,176.00 -5,314.00 -7,733.00
Activities
Foreign Exchange Effects USD 82.00 -295.00 -286.00 -387.00 84.00
Net Change in Cash USD 1,135.00 6,336.00 -8,349.00 2,333.00 1,853.00
Cash Interest Paid USD 609.00 668.00 646.00 723.00 708.00
Cash Taxes Paid USD 2,054.00 2,179.00 2,454.00 2,111.00 1,611.00
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Company Overview
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Company Overview
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Company Overview
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Company Overview
Interim Ratios
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