meet novartis management global drug development express or implied discussions regarding potential...

Meet Novartis Management

Global Drug Development

May 31, 2017

Global Drug Development

Disclaimer

| Meet Novartis Management | May 31, 2017 | Investor Presentation2

This presentation contains forward-looking statements that can be identified by terminology such as such as “potential,” “expected,” “will,” “planned,” or similar expressions, or

by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such

products; potential shareholder returns or credit ratings; or regarding the potential outcome of the announced review of options being undertaken to maximize shareholder

value of the Alcon Division; or regarding the potential financial or other impact on Novartis or any of our divisions of the significant reorganizations of recent years, including

the creation of the Pharmaceuticals and Oncology business units to form the Innovative Medicines Division, the creation of the Global Drug Development organization and

Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division

to the Innovative Medicines Division, the transfer of selected mature, non-promoted pharmaceutical products from the Innovative Medicines Division to the Sandoz Division,

and the transactions with GSK, Lilly and CSL; or regarding the potential impact of the share buyback plan; or regarding potential future sales or earnings of the Novartis Group

or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward looking

statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and

uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those

set forth in the forward looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be

approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any

particular revenue levels. Nor can there be any guarantee that the review of options being undertaken to maximize shareholder value of the Alcon Division will reach any

particular results, or at any particular time. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or

opportunities as a result of the significant reorganizations of recent years, including the creation of the Pharmaceuticals and Oncology business units to form the Innovative

Medicines Division, the creation of the Global Drug Development organization and Novartis Operations (including Novartis Technical Operations and Novartis Business

Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to the Innovative Medicines Division, the transfer of selected mature, non-promoted

pharmaceutical products from the Innovative Medicines Division to the Sandoz Division, and the transactions with GSK, Lilly and CSL. Neither can there be any guarantee

that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that the Group, or any of its divisions, will be commercially

successful in the future, or achieve any particular credit rating or financial results. In particular, management’s expectations could be affected by, among other things:

regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant

reorganizations of recent years, including the creation of the Pharmaceuticals and Oncology business units to form the Innovative Medicines Division, the creation of the

Global Drug Development organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic

Pharmaceuticals products of our Alcon Division to the Innovative Medicines Division, the transfer of selected mature, non-promoted pharmaceutical products from the

Innovative Medicines Division to the Sandoz Division, and the transactions with GSK, Lilly and CSL may not be realized or may take longer to realize than expected; the

inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in the research and development of new healthcare products,

including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate

extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; safety, quality or

manufacturing issues; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures, such as from increased publicity on

pharmaceuticals pricing, including in certain large markets; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product

liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes and government investigations generally; general

economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties

regarding future global exchange rates; uncertainties regarding future demand for our products; and uncertainties regarding potential significant breaches of data security or

data privacy, or disruptions of our information technology systems; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and

Exchange Commission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking

statements as a result of new information, future events or otherwise.

Broad, high value late stage pipeline with depth and quality assets in each

therapeutic area2

Focus on operational agility and productivity with goal to invest ~20% of

Innovative Medicines sales in R&D while driving dynamic growth1

Strong and diverse set of emerging Phase II assets from NIBR research as

well as from external deals3

Key Messages


Continued strong track record of R&D

excellence


1. Since the introduction of Breakthrough Designation pathway by the FDA, Novartis pipeline included a total of 16 breakthrough designations cumulatively of which 13 are currently actively under development or in approvedindications. Includes products in-licensed (with BTD granted prior to the acquisition of the asset) or out-licensed (with BTD granted to Novartis prior to divestment) 2. In number of new molecular entities (NMEs) approvedincluding fixed dose combinations 2007-2016

175+Projects in the

clinic

90+New molecular

entities in the

clinic

16Breakthrough

Therapy

designations1

#1In US/EU

approvals past

10 years2

40Potential filings

in US and EU

2017-2020

Progressing across 4 pillars of transformation

to achieve a step change in performance


Driving efficiency

and lowering our

cost base

Best-in-class

portfolio

prioritization

Leading

technology

Inspired

culture and

leaders

1

2 4

3

Rigorous disease area and portfolio

prioritization


• Evaluation of disease areas,

decision on future focus

• Examples: Prioritized liver diseases,

de-prioritized transplant

• Evaluation based on science,

risk, and valuation

• Funding consistent with priority

categories

• 70% of resources focused on

top projects

• Increasing number of

projects with blockbuster

potential

• Complementing portfolio

through deals and

alliances

ILLUSTRATIVE

Project prioritization

Race Go Pace Retire

Prioritizing bigger betsDisease/therapy area reviews

Un

me

t n

ee

d/a

ttra

cti

ve

ne

ss

Novartis strength

1

Driving operational performance across an

integrated organization


~10,000 associates

90+ NMEs in

clinic across 7

therapeutic areas

1 regulatory

submission

every 6 minutes

~175 programs

in clinic

Leveraging global

scale (3 major centers;

52 countries)

~500+ active trials with ~80,000+ patients

in ~70+ countries 300+ million observations

INTEGRATED

ORGANIZATION

2

Scaling digital development: Building

capabilities for data centered innovation


Digital TherapiesData and Trial Operations

Dramatically increase the speed and

quality of trials; with a step change

reduction in cost

Digital technologies as therapeutics

or to support the patient journey

Note: All trademarks are property of the respective owners

3

Progressing late stage development of

potential blockbusters1


Therapeutic area Molecule Indication MoAExp. pivotal

trial readout

Onco Oncology

LEE011 (Kisqali®) HR+ advanced or metastatic breast cancer CDK4/6 inhibitor ✓

CTL019 (CAR-T) r/r B-Cell ALL, DLBCL CAR-T Q2 20172

SEG101 (crizanlizumab) Sickle cell pain crises Anti-P-selectin 2018

CM Cardio-metabolicLCZ696 (Entresto®) Heart failure with preserved EF ARNI 2019

ACZ885 (canakinumab) CV risk reduction Anti-IL1β H2 2017

NS Neuroscience

OMB157 (ofatumumab) Relapsing multiple sclerosis CD20 2019

BAF312 (siponimod)3 Relapsing multiple sclerosis S1P receptor modulator ✓

AMG 334 (erenumab)4 Prophylaxis of migraine CGRP receptor antagonist ✓

I&DImmunology&

DermatologyAIN457 (Cosentyx®) Non-radiographic axial SpA Anti-IL17A 2018

Resp Respiratory

QVM149 (indacaterol, glycopyrronium,

mometasone)Asthma LABA + LAMA + ICS 2018

QAW039 (fevipiprant) Asthma CRTh2 antagonist 2019

Oph Ophthalmology RTH258 (brolucizumab) Neovascular AMD Anti-VEGF (scFv) H1 2017

Bios Biosimilars Multiple Multiple Multiple Ongoing

1. Blockbuster potential refers to specified indication 2. Ped. r/r B-cell ALL filed and priority review granted; Breakthrough Therapy designation granted for DLBCL 3. Next steps to be evaluated in consultations with health authorities 4. In collaboration with Amgen; Novartis has AMG 334 rights outside of Japan and co-commercialization in the US

Phase 2 pipeline deep with mix of internal and

external assets


Therapeutic area Molecule Indication Externally sourced

Onco

Oncology 18 IO assets incl. combos Multiple Co-stim; Others

ABL001 CML

BYL719 Breast Cancer

INC280 NSCLC Incyte

Jakavi® steroid refractory acute GVHD Incyte

CM

Cardio-metabolic APO(a)-LRx1 High risk CVRR Ionis Pharmaceuticals / Akcea

TherapeuticsAPOCIII-LRx1 High risk CVRR

LHW090 Resistant hypertension

LIK066 Weight loss Advinus

MAA868 Stroke prevention

NS

Neuroscience BYM338 Sarcopenia hip fracture

CNP520 Alzheimer’s

LMI070 Spinal muscular atrophy

EMA401 Neuropathic Pain Spinifex Pharmaceuticals, Inc.

I&D

Immunology-

Dermatology

CJM112 Multiple immune disorders

VAY7852 NASH/Cirrhosis Conatus Pharmaceuticals

LJN452 Non-Alcoholic Steatohepatitis

QGE031 Chronic spontaneous urticaria Tanox/Genentech

VAY736 Sjoegren’s syndrome / AIH

ZPL389 Atopic dermatitis Ziarco

Resp

Respiratory ACZ885 Sarcoidosis

CJM112 Asthma

QBW251 Cystic fibrosis/COPD

OphOphthalmology UNR844 Presbyopia Encore Vision

ECF843 (Lubricin) Dry eye Lubris Biopharma

1. Option to license 2 Emricasan

Trial Indication Opportunity Status

Planned next

milestone

MONALEESA-3 1st & 2nd line in combination

with Fulvestrant

CDK 4/6i in Phase 3

study with Fulvestrant

Fully enrolled;

readout H2 2017

Filing in H1

2018 if positive

MONALEESA-7 Pre-menopausal women 1st line

in combination with goserelin +

ET2

CDK 4/6i in Pre-

menopausal setting

Fully enrolled;

readout H2 2017

Filing in H1

2018 if positive

Adjuvant Trials

EarLEE-1

EarLEE-2

High risk of recurrence trial

Intermediate risk of recurrence

trial

Focus on populations

with higher risk of relapse

Trial initiation Trials to start

Q2-Q3 2017

Kisqali®1

: clinical trial programs advancing across

indications for HR+/HER2- advanced breast cancer


Onco

CM

NS

I&D

Resp

Oph

Bios

1. Formerly known as LEE011 2. Endocrine therapy

FDA approved Rydapt®1

in newly diagnosed

FLT3+ AML2

and advanced SM3


1. Formerly known as midostaurin (PKC412) 2. Acute Myeloid Leukemia 3. Systemic Mastocytosis 4. R. Stone et al. presented at American Society of Hematology (ASH) Annual Meeting, December 6th 2015, Orlando, FL, USA (Plenary Presentation, Abstract #5) 5. RYDAPT US Prescribing Information April 28, 2017 6. Swissmedic Rydapt Prescribing Information May 05, 2017 7.USA: as detected by an FDA approved test. FDA approved FLT3 mutation testing as a companion diagnostic for Rydapt is performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc. 8. Kantar Health EPI G7 (US, DE, FR, IT, UK, SP, JP); 9. Patel JP, Gönen M, Figueroa ME, et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012; 22;366(12):1079-1089;

Onco

CM

NS

I&D

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Bios

• Targeted therapy approved for newly

diagnosed FLT3 mutated AML in combination

with standard chemotherapy5,6,7

• About 34k8 patients in G7. ~ 1/3 of patients

have a FLT3 gene mutation9 and ~60% are fit

for chemotherapy, translating to ~6000

Rydapt®-eligible patients in the G7

• Worldwide regulatory submissions and HA

reviews ongoing

High unmet need Differentiated label

• First new treatment in more than 25 years for

AML patients eligible for standard therapy

• Rydapt® treatment regimen in FLT3-mutated

AML demonstrated a significant improvement

in overall survival with a 23% reduction in the

risk of death4

• Rydapt® is the first and only approved therapy

for three types of SM collectively known as

advanced SM, a group of ultra-rare, life-

threatening conditions

Progressing our Immuno-Oncology strategy


Advancing CAR-T PD-1 update Ready for IO 2nd Gen

18 second generation agents in

mono or combo progressing in

early studies

• Manufacturing optimization

• Filed in pediatric/young adult r/r ALL

in US, priority review granted, filing

in Europe targeted for H2 2017

• Breakthrough Therapy designation

awarded for DLBCL, planned filing in

US and EU in H2 2017

• CLL and Multiple Myeloma

progressing

• Solid tumors in FIH trials

Onco

CM

NS

I&D

Resp

Oph

Bios

Tumor Type PDR001 (PD-1 Antagonist)

Melanoma Phase 3 trial in combination with

Tafinlar®+Mekinist®: FPFV

achieved for run-in

NET Pivotal Phase 2 FPFV achieved

HCC Phase 1b in combination with

sorafenib FPFV achieved

NSCLC Phase 1b FPFV achieved

CRC Phase 1b FPFV Q3 2017

SEG101 (crizanlizumab) – planned filing in 2018


1. SEG101 (formerly SelG1) 5mg/kg monthly Source: Ataga et al, NEJM Dec 3, 2016 (online)

SUSTAIN trial (Phase 2)SEG1011 significantly (p=.010) reduced Sickle Cell Pain Crises (SCPC) and generally well tolerated

• Planning FDA submission in 2018;

assuming successful PK/PD

comparability study to final

manufacturing process

• Discussions progressing in Europe

• Additional long term safety and

efficacy data expected to be

generated in adult and pediatric

studies after submission

SEG101

Onco

CM

NS

I&D

Resp

Oph

Bios

11.0

6.9

2.95.1

1.43.0

24.0

4.0

1.1

10.3

4.1

1.6

Median

annual rate of

uncomplicated

pain crisis

+2.9x

Number of

patients with

SCPC rate

of zero at

end of study

+2.2x

Median annual

rate of days

hospitalized

+2.0x

-63%

-42%

-45%

Median time to

first pain crisis

(months)

Median

annual rate

of pain crises

Median time to

second pain

crisis (months)

Placebo (N=67)

SEG101 (N=65)

Advancing ABL001, a potent, allosteric

inhibitor of BCR-ABL1


• Effective and overall well-tolerated in

Phase 1 in heavily treated CML patients

resistant to or intolerant of prior TKIs

‒ Pivotal study in ≥3rd CML-CP patients planned to

start in 2017

‒ Phase 1 study ongoing to test other regimens and

TKI combination treatments

• Combination treatments: in vitro data of

ABL001 with nilotinib, imatinib and

dasatinib suggest synergistic effects for

BCR-ABL inhibition2

a. Patients had ≥ 6 months of treatment exposure or achieved response within 6 months b. BCR-ABL1IS reduction achieved c. Patients had ≥ 12 months of treatment exposure or achieved

response within 12 months 1. B. Sellers: AACR 2016 2. T. Hughes and D. White et al; ASH 2016; Abstract 1121 Abbreviations: CCyR = complete cytogenetic response; CHR = complete

hematologic response; CML-CP = chronic myeloid leukemia - chronic phase; MR = molecular response; Ph+ CML = Philadelphia chromosome positive chronic myeloid leukemia; TKI = tyrosine

kinase inhibitor

Responses in CML-CP patients treated

with ABL001 with ≥3 months exposure

on study

ABL001

Onco

CM

NS

I&D

Resp

Oph

Bios

0

10

20

30

40

50

60

70

80

90

100

Hematologic relapse

(n = 16)

Cytogenetic relapse

(> 35% Ph+; n = 12)

Pati

en

ts W

ith

Resp

on

se (

%)

CHR:

88% (14/16) CCyR:

75% (9/12)MR:

42% (16/38)

Molecular relapse

(no MMR; n = 38)

Hematologic Response

Within 6 Months

Cytogenetic Response

Within 6 Monthsa

Status at Baseline

Molecular Response

Within 12 Monthsb,c

BYL719 shows promising data in PIK3CAmut

breast

cancer patients in combination with Fulvestrant


• Pre-clinical data demonstrated

synergistic impact of alpelisib +

fulvestrant compared to fulvestrant

alone1

• Pivotal clinical trials currently enrolling

for alpelisib combination in advanced

breast cancer (BC) patients harboring

the PIK3CA mutation

• PI3K/mTOR pathway is most

frequently altered pathway in breast

cancer with PIK3CA mutations present

in approx. 35% of hormone-receptor

positive (HR+) breast cancer patients2

• FDA filing planned in 2019

Onco

CM

NS

I&D

Resp

Oph

Bios

BYL719

Source: 1. Bosch et al. Sci Transl Med. 2015 Apr 15;7(283):283ra51; 2. The Cancer Genome Atlas Network. Nature. 2012;490:61–70

INC280 (capmatinib): Multiple potential first-

in-class indications

| Meet Novartis Management | May 31, 2017 | Investor Presentation 16

Lung

• cMET amplified and/or mutation

− 5-7% of lung cancer

− Potentially 1st in class

• EGFR mutations

- 16% of lung cancer (up to 40% in Asia)

- 1L in combination with EGF816 to prevent

T790/cMET resistance

- 2L in combination with erlotinib to treat cMET

resistance

- Potentially 1st cMET/EGFR combination

• Combinations with immuno-oncology (IO) being

explored

- INC280 enhances dendritic cell activity, thereby

potentially enhancing IO treatments when used in

combination

Hepatocellular Carcinoma (HCC)

• Accounts for 70-90% of liver cancers worldwide.

Approx. 745,500 deaths caused by liver cancer

globally in 20121

• 2L HCC in combination with PDR001 (IO)

1. American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015

Onco

CM

NS

I&D

Resp

Oph

Bios

Entresto®

- investigating potential treatment for

~9m chronic HF patients without effective therapy


1. Potential patients are defined by the indications studied in the ongoing / planned trials in HFpEF and post acute MI. Potentially eligible population dependent on trial results and label. Estimate for

US+EU5 is ~4.2m Current estimates based on Decision Resources; Diller et al. Archives of Family Medicine. 1999; 8(5):414-420; Novartis analyses;

Abbreviations: HF-rEF=heart failure-reduced ejection fraction; HF-pEF=heart failure-preserved ejection fraction; AMI=acute myocardial infarction

Onco

CM

NS

I&D

Resp

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Bios

HF-rEFApproved

HF-pEF Post-AMI

Potentially

eligible patients1

~8.5m ~8.5m ~0.3m

Pivotal trials PARADIGM PARAGON PARADISE

Key supportive

trials

TRANSITION

PIONEER HF

Chronic Heart Failure

Trial Indication Status

Next expected

milestone

HF-pEF1 Fully enrolled 4 months

ahead of plan

Interim analysis 2018

Filing in 2019

Post-AMI2 EnrollingCompletion 2019

Filing in 2020

Pre- vs. post-discharge

following ADHF (HF-rEF)Enrollment on track Completion 2018

In hospital initiation vs.

Enalapril following ADHF3 Enrollment on track Completion 2018

Entresto®

expansion studies all on track


1. HF-pEF: heart failure with preserved ejection fraction 2. AMI: acute myocardial infarction 3. ADHF: acute decompensated heart failure

Onco

CM

NS

I&D

Resp

Oph

Bios

Entresto®

- new evidence could enhance standard

of care status in HF patients with diabetes


Onco

CM

NS

I&D

Resp

Oph

Bios

• PARADIGM-HF post-hoc analysis1

suggests that Entresto® has favorable

metabolic benefits in HF patients with

diabetes:

- New use of Insulin was reduced by 29%, vs.

enalapril (p=.005)

- HbA1c reduction of -0.26% vs. -0.16% at 1

year vs. enalapril (p=.002)

• Engagement with health authorities for

potential label enabling studies initiated

1. JP Seferovic et al. www.thelancet.com/diabetes-endocrinology. Online Mar 18, 2017

http://www.thelancet.com/diabetes-endocrinology

On track for readout mid-2017

• CANTOS Phase 3 trial of ACZ885 in

cardiovascular risk reduction

• 1,400 events reached as agreed with

regulatory authorities, LPLV reached

• Study has passed 3 futility analyses

and 22 DMC safety reviews

• Potentially addressing ~4m patients in

G7 with MI history with high

inflammation burden

Population

• History of MI

• hsCRP≥2mg/L

• On SoC treatment

Primary

endpoint• Composite of CV death, MI or Stroke

Key

secondary

endpoints

• Primary + unplanned revascularization

• New onset of Type 2 Diabetes

Sample size

• 1,400 primary events provides ~90% power to detect 20% RRR vs. placebo

• 10,065 patients randomized

CANTOS trial design

CANTOS has reached the protocol defined

number of events, on track for mid-2017 readout


ACZ885

Onco

CM

NS

I&D

Resp

Oph

Bios

Ionis/Akcea Option Deal: Targeting two highly

validated CV targets in Phase 2b studies


Source: Novartis Qualitative Research Note: option deal subject to customary closing conditions and regulatory approval

Lp(a)

>50mg/dl

Patients on optimized LDL-C therapy at high risk

Routine or Post Event Testing of Residual Risk Factors

Lp(a)-LRX

• Genetically validated

• Established biomarker

• Phase 2b ongoing

• End of Phase 2 ~2018

APOCIII-LRx

• Genetically validated

• Established biomarker

• Phase 2 planned

• End of Phase 2 2019

ApoCIII

>20mg/dl

and/or TGs

>200mg/dl

CVRR

Onco

CM

NS

I&D

Resp

Oph

Bios

LIK066, an SGLT1/2 inhibitor, with potential

for best-in-class weight loss


• Inhibition of both SGLT11

and SGLT21

– Blocks reabsorption of filtered

glucose in the kidney

– Reduces intestinal glucose

absorption

• Aim to achieve weight loss

through dual mechanism of

action

• Proof-of-concept data projected

more than 10% placebo-adjusted

weight loss at 52 weeks

• Additional expected benefits

include improved glycemic control,

lipid profile, blood pressure

• Phase 2b trial planned to start in

H1 2017

SGLT1/2 dual mode of action

1. SGLT = sodium-glucose co-transporter

LIK066 development

LIK066

Onco

CM

NS

I&D

Resp

Oph

Bios

BAF312 filing planned in US H1 2018 in relapsing

MS; labeling of population studied a review issue


RRMS SPMS

FREEDOMS I

N=1272

DECIDE

N=1841

EXPAND

N=1651

Fingolimod Daclizumab Siponimod

Age, years (mean) 37.0 36.3 48.0

Time since onset, years (mean) 8.2 / 6.7 7.0* 16.8

Time since (R)MS diagnosis, years (mean) 5.1 4.2 12.6

% relapse-free prior 2 years 0% 0% 63.9%

EDSS (mean) 2.4 2.5* 5.4

EDSS (% pts ≥6.0) 0% 0% 55.6%

Acute MRI lesions (T1 Gd+, % of patients) 61.9% 44%* 21.3%

MRI disease burden [T2 lesion vol (mean)] 6.4 cm3 9.7 cm3 15.3 cm3

Primary Endpoint ARR ARR 3m Disability

progression

FREEDOMS I: Novartis, data on file; DECIDE: Kappos et al 2015; EXPAND: Kappos, et al. AAN 2016

*daclizumab arm only

• Filing based on EXPAND study in

SPMS and Phase 2 study in RRMS

• Novartis to propose labeling to

describe unique population studied

• Timing driven by collection of

additional safety data and finalizing

manufacturing submission

• Safety profile is in line with other

compounds in this class

BAF312

Onco

CM

NS

I&D

Resp

Oph

Bios

0

2

4

6

8

10

12

Placebo OMB157

99.8%

(p<0.001)

OMB157 (ofatumumab) demonstrated strong

efficacy in Phase 2 studies in RRMS


• Two parallel Phase 3 studies vs.

oral teriflunomide (Aubagio®2) in

relapsing MS started 3Q16

• Planned filing 2019

OMB157 suppressed >90% of new MS

lesions in the brain as measured by MRI1

Me

an

Nu

mb

er

cu

mu

lati

ve

Ga

d le

sio

ns

we

ek

s 8

-24

OMB157

1. Sorensen PS et al., Neurology 2014;82(7):573-81; MRI = Magnetic Resonance Imaging; Pooled analysis of all doses levels in the Sorensen study (Ph IIa); 100 mg, 300 mg, 700 mg - i.v.

2. Aubagio® is a registered trademark of Sanofi

Onco

CM

NS

I&D

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Oph

Bios

AMG 3341: first-in-class submitted in the US

and in the EU


1. Development in collaboration with Amgen, Companies to co-commercialize in the US, Novartis to have exclusive rights in rest of world excluding Japan 2. Global Burden of Disease Study 2015

Collaborators. Lancet. 2016

Onco

CM

NS

I&D

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Oph

Bios

AMG 334

• Migraine in the TOP TEN world

leading of all causes of years lived

with disability2

• 9.4 million episodic and 4.2 million

chronic migraine patients in EU-5

• Fully human, potent, selective

CGRP antagonist targeting

receptor

• Consistent data in phase 2 and 3

clinical studies

AMG 334 with unique profile Robust market access strategy

• Filing activities on track for first-in-class

submission in Q2 2017

• Encouraging subpopulation efficacy data,

recently presented at AAN

• Access strategy focuses on subpopulation

with high unmet medical need. Dedicated

LIBERTY clinical trial underway

EMA401: Novel treatment option for refractory

peripheral neuropathic pain (PNP)


1. Lancet (2014), Rice et al.

• PNP is excruciating, appearing e.g. after

herpetic infection, in diabetic patients or in

patients treated with chemotherapy

• SoC medications partially effective with CNS

adverse effects.

• EMA401 is a novel, peripherally acting AT-II

antagonist

• Phase 2 proof-of-concept (PHN): strong

efficacy already seen at 4 weeks

- Efficacy potentially increasing over longer time

period (plateau not reached at 4 weeks) or with

higher dosing

• Phase 2 dose-finding to begin in 2017

EMA401 improved pain significant

in patients with post-herpetic

neuralgia

Time course of mean change in pain intensity from baseline by week of treatment

Data are mean change from baseline in average weekly numerical rating scale pain score

per week of treatment (last observation carried forward imputation). Error bars are standard

error of the mean. *EMA401 vs placebo p=0.0184. †EMA401 vs placebo p=0.0066

Onco

CM

NS

I&D

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Oph

Bios

EMA401

CNP5201

program focused on genetically

identified population at risk of Alzheimer’s


• BACE inhibitor

• Clinical program aims to

prevent onset of AD symptoms

in healthy subjects with strong

genetic pre-disposition 2, 3

• Second pivotal study being

initiated in 2H2017

• Completion expected >2022

• FDA Fast Track designation

received

1. CNP520: co-developed with Amgen 2. In collaboration with Banner Alzheimer’s Institute; includes Novartis investigational immunotherapy CAD106 3. APOE4 Homozygotes and amyloid-

positive APOE4 Heterozygotes, 60-75 years old

CNP520Cognitively normal

Preclinical ADMild Cognitive Impairment /

Prodromal AD

Dementia / Mild-moderate-severe AD

Aβ

Tau-meditated neuronal injury

and dysfunction

Clinical function

- 20 years 0Dementia diagnosis

Years

AD

bio

mark

ers

Norm

al

Ab

no

rmal

Most competitors

CNP520

Onco

CM

NS

I&D

Resp

Oph

Bios

Strengthening leadership by targeting new frontiers

in dermatology, rheumatology and hepatology


Onco

CM

NS

I&D

Resp

Oph

Bios

Now 2019-22 2022-23 >2024

Rheumatology

Hepatology

& Transplant

Dermatology

nrAxSpA,

superiority H2H vs.

adalimumab

primary Sjoegren's

syndrome

(VAY736 etc)

Early pipeline

Next generation

Bx in CSU

QGE031

(ligelizumab

Atopic dermatitis

(ZPL389)

Hidradenitis suppurativa

Early pipeline

vitiligo etc

Psoriasis

PsA , AS

Orphan

Early pipeline

Combo NASH

treatments

Auto-immune hepatitis

(VAY736)

NASH (LJN452)

(VAY785)

CSU

Tx portfolio

Cosentyx®

continues to deliver strong data

across indications


Psoriasis AS & PsA Future Indications

• New analysis shows 21%

of patients did not relapse

more than one year after

treatment discontinuation1

• Early treatment correlated

with lower relapse rate1

• STEPIn trial evaluating

disease modification

potential

1. Lebwohl M et al. Long-term psoriasis control following secukinumab discontinuation indicated disease modification of moderate to severe psoriasis. Presented as a poster presentation at the 13th

Annual Maui Derm for Dermatologists 2017. 20-24th March 2017 2. In physical function, quality of life, and inflammation 3. Marzo-Ortega H, et al. Arthritis Care Res 2017. doi:

10.1002/acr.23233 4. Humira® is a registered trademark of AbbVie Ltd.

• MEASURE 2 data supports

sustained 2 year

improvements in signs and

symptoms2 of AS3

• H2H study in PsA enrolling

versus Humira®4

• Non-radiographic Axial

Spondyloarthritis Phase 3

trial on track for 2019 filing

Onco

CM

NS

I&D

Resp

Oph

Bios

ZPL389 once daily oral for atopic dermatitis

with strong Phase 2 data


• Significant unmet need and lack of treatment

options

• ~17 m patients with mod-to severe AD in G73

– ~2/3 pediatric patients with ~20% mod-severe

– ~1/3 adult patients with ~70% mod-severe

• Potential first in class H4 receptor antagonist

• Blockbuster opportunity for pre-Biologics oral

with pediatric-suitable safety profile

• Compelling 8-week PoC data

– ZPL389 strong efficacy already at week 4 1,2

– Efficacy plateau not reached by week 8

ZPL389

Please note that figure above does not show intervals equidistantly

1. Werfel T. et al, Late breaking oral abstract (1346), EAACI 2016; 2. Beck LA et al, NEJM, 2014; 371; 130-139 3. Decision Resources report and internal analysis, Herd RM et al, 1996 and internal analysis

Onco

CM

NS

I&D

Resp

Oph

Bios

Novartis continues to lead the charge in

chronic spontaneous urticaria (CSU)


• CSU: under-diagnosed & under-treated

• Xolair®1: building CSU market from zero

– Estimated 3 million patients in G72

– Prolonged itchy hives & angioedema with

QoL impact

• ~1/3 of patients with poor response to anti-

histamines

– Anti-IgE mAb (Xolair®) only approved

therapy

• Next generation mAb QGE031 with increased

potency

– Potential to deliver faster and more

complete remission in more patients

– Phase 2b data in 2017

– Phase 3 start in 2018

1. Novartis co-promotes Xolair® with Genentech in the US and shares a portion of operating income, but we do not record any US sales. Novartis records all sales of Xolair® outside the US 2.

Decision Resource Group

Onco

CM

NS

I&D

Resp

Oph

Bios

CSU

New Allergan collaboration strengthens

Novartis portfolio in NASH


• LJN452 in Phase 2 in NASH (FLIGHT-FXR1)

• VAY7852 progressing in four Phase 2 studies

including NASH Fibrosis and NASH Cirrhosis

with collaborator Conatus

• Combining Allergan’s CVC with a Novartis

FXR agonist in Phase 2 studies

• Multiple assets in Phase 2 studies for other

liver indications

1. NCT02855164 2. Emricasan 3. Collaboration with Allergan

LJN452FXR

LIK066SGLT-1/2

VAY7852

Pan-caspase

CVC3

CCR2/5

Multimodal

Clinical

Pre-clinical

Early phase research on

anti-fibrotic mechanisms

Building a pipeline of NASH

combination therapies

Several assets progressing

NASH

Onco

CM

NS

I&D

Resp

Oph

Bios

Developing leading portfolio in moderate to

severe asthma


Primary Care

Specialist Care

QMF149

QVM149

Xolair®

QAW039

QVM1491: inhaled combination therapy

• Once-daily triple combination for Ex-US

• Pivotal Phase 3 trials ongoing; planned filing 2019

Moderate/severe asthma portfolio

QAW039: potential first-in-class oral treatment for severe asthma

• CRTh2 antagonist; add-on to ICS/LABA or ICS/LABA/LAMA2

• Pivotal Phase 3 trials ongoing; planned filing 2019

Xolair® : first choice biologic for allergic asthma

• Xolair® with US3 approval for pediatric moderate to severe persistent allergic asthma

1. Fixed-dose combination of indacaterol, glycopyrronium and mometasone 2. LABA = long-acting β2-agonist; ICS = inhaled corticosteroid; LAMA = long-acting muscarinic antagonist

3. Novartis co-promotes Xolair® with Genentech in the US and share a portion of operating income, but we do not record any US sales. Novartis records all sales of Xolair® outside the US

Source: Novartis; Decision Resources, Epidemiology Database

Asthma

Potentially

eligible patients

7.0m (EU5+JP)

4.0m (G7)

2.2m (G7)

Onco

CM

NS

I&D

Resp

Oph

Bios

QAW039 - Phase 3 ongoing based on supportive

Phase 2 data; readout expected in 2019


Fold reduction from baseline in eosinophil count

Geometric mean (95% CI); LOCF

0 6 12 18

0.5

1

2

4

8

Time (weeks)

QAW039Placebo

2.6xp=0.008

3.5xp=0.001

1.0xp =0.918

Treatment Wash out

Source: S Gonem, R Berair et al, Phase 2a randomized placebo-controlled trial of the oral prostaglandin D2 receptor (PD2/CRTH2) antagonist QAW039 in eosinophilic asthma, ERS congress 2014

Abbreviations: BID=twice daily; LOCF=last observation carried forward; QoL=quality of life

• Pre-clinical data demonstrate potential for

high potency

• QAW039 (225 mg BID) induced significant

suppression of sputum eosinophilia at week

12 and significant improved QoL

• Phase 3 pivotal trials ongoing; expected

readout 2019

QAW039

Onco

CM

NS

I&D

Resp

Oph

Bios

Ongoing Phase 3 studies to assess q12w/q8w

RTH258 vs. q8w aflibercept1

to readout in H1 2017


Source: Holz F, EURetina 2015 oral presentation; NCT02307682; NCT02434328

1. In Phase 3 program, brolucizumab patients are selected for q12 week or q8 week maintenance dosing based on investigator masked assessment of disease activity. Aflibercept patients receive

q8 week maintenance dosing per the Eylea® label 2. Predicated by Phase 2 data (OSPREY trial) and designed to confirm in HAWK and HARRIER trials

nAMD Phase 3 trial designTrials designed to show differentiation vs. aflibercept

Brolucizumab 3 mg (q12w or q8w)*


Aflibercept 2 mg (q8w)

92 weeks

(both trials)


Aflibercept 2 mg (q8w)

N=1082

N=741

Potential differentiators / clinical

endpoints

• High proportion of patients successfully

maintained on q12w dosing regimen2

• Greater anatomical efficacy: greater

proportion of retinal fluid resolution, higher

central retinal fluid (CRT) reduction and

better CRT stability2

• Individualized treatment regimen assigned as

early as week 16 based on disease activity

assessment

• On track for read-out in H1 2017

Onco

CM

NS

I&D

Resp

Oph

Bios

RTH258

UNR844 (EV06) for potential treatment of

presbyopia


82% of patients achieved DCNVA* of 20/40 with EV06

* DCNVA= distance corrected near visual acuity Encore Vision, Inc. press release, May 2016

UNR844

• UNR844 improved lens flexibility

through twice daily drops for 3

months

• Effects sustained over 6 months

• UNR844 was well tolerated, no

sight-related AEs or other safety

concerns

• Phase 2 dose finding now in

planning

Onco

CM

NS

I&D

Resp

Oph

Bios

Recently licensed ECF843 could be first-in-

class treatment for Dry Eye patients


• ECF843, a recombinant form of human Lubricin, a naturally

occurring component of normal tears

• Potential first-in-class therapeutic to provide relief of dry eye

signs and symptoms within 4 weeks

• Phase 2 trial showed significant improvement in both signs

and symptoms of dry eye1

• Along with recent acquisition of UNR844 in presbyopia,

expands Front of the Eye pipeline

1. The Ocular Surface, Vol. 15, Issue 1, p77–87

Activity across all three layers of tear film

ECF843

Onco

CM

NS

I&D

Resp

Oph

Bios

Biosimilars: Two CHMP positive opinions in

April


1. Launch delay due to litigation 2. As measured by ORR (Overall Response Rate) 3. MabThera® is a registered trademark of Roche

• CHMP positive opinion

• Confirmatory study

demonstrated equivalent

efficacy2 /safety to

MabThera®3

• Erelzi® approved in US1

• CHMP positive opinion

Etanercept Rituximab

Onco

CM

NS

I&D

Resp

Oph

Bios

Molecule Indication1 Originator2 Agency Filing

Etanercept Rheumatoid Arthritis FDA2015(approved)

✓

Etanercept Rheumatoid Arthritis EMA2015(CHMP positive opinion)

✓

Epoetin

subcutaneousAnemia EMA

2015(approved)

✓

Rituximab Non-Hodgkin’s Lymphoma EMA2016(CHMP positive opinion)

✓

Adalimumab Rheumatoid Arthritis FDA 2017

Adalimumab Rheumatoid Arthritis EMA2017(EU file accepted)

✓

Rituximab Non-Hodgkin’s Lymphoma FDA 2017

Infliximab Inflammatory Bowel Disease EMA2017(EU file accepted)

✓

Pegfilgrastim Neutropenia EMA 20173

Pegfilgrastim Neutropenia FDA 20183

Biosimilars filing milestones through 2018


1. Main indication only 2. All trademarks are the property of the respective originator companies 3. Reflects re-filing as communicated in Q1

Onco

CM

NS

I&D

Resp

Oph

Bios

H1 2017 H2 2017

Regulatory

decisions

and opinions

Kisqali® (LEE011) HR+/HER2- adv. BC (US) ✓ LEE011 HR+/HER2- adv. BC (EU) =

Rydapt® (PKC412) AML and ASM (US) ✓ PKC412 AML and ASM (EU) =

Tafinlar®+Mekinist® BRAF+ NSCLC (EU) ✓ Tafinlar®+

Mekinist®BRAF+ NSCLC1 (US) =

GP2015 Etanercept BS2,3 (EU) ✓ GP2013 Rituximab BS2,3 (EU) ✓

Zykadia® ALK+ NSCLC (US) ✓ Zykadia® ALK+ NSCLC2 (EU) ✓

Submissions AMG 334 Migraine4 = GP2013 Non-Hodgkin’s Lymphoma (US) =

CTL019 Pediatric/young adult ALL

(US)1

✓ RLX030 Acute heart failure ✕

GP2017 Adalimumab BS3 (EU) ✓ ACZ885 CV risk reduction5 =

GP1111 Infliximab BS3 (EU) ✓ CTL019 DLBCL5 (US) =

GP2017 Adalimumab BS3 (US) =

LA-EP2006 Pegfilgrastim BS3 (EU) =

Major trial

readouts

RLX030 RELAX-AHF-2 (AHF) ✕ CTL019 JULIET (DLBCL) =

ACZ885 CANTOS (CVRR) =

RTH258 HARRIER, HAWK (nAMD) =

Strong progress on key 2017 milestones


✓ Achieved ✕ Missed = On track

1. FDA Priority Review 2. Positive CHMP opinion, final EMA approval pending 3. Biosimilar 4. Submitted in the US and EU, Novartis has US co-commercialization rights

5. If results from Phase 3 trials are supportive

Summary


• Focus on operational excellence and productivity with goal to achieve R&D

spend of approximately 20% of Innovative Medicines sales in the near

term. Digital development also a top priority

• Seven development franchises with broad, high value late stage pipeline

portfolio and expanding therapeutic breadth and depth

• Strong and diverse set of emerging Phase 2 assets from internal research

and recent external deals

Appendix

1. Secondary prevention of cardiovascular events

2. Diffuse large B-cell lymphoma

3. Multiple sclerosis

4. Severe aplastic anemia

5. Chronic myeloid leukemia

6. Long-acting release

7. Relapsing multiple sclerosis

8. Non-small cell lung cancer

9. Neovascular age-related macular degeneration

10. Multi-drug resistant

11. Breast cancer

12. Retinopathy of prematurity

13. Non-Hodgkin’s lymphoma

14. Non-radiographic axial spondyloarthritis

15. Preserved ejection fraction

16. Graft-versus-host disease

17. Neuroendocrine tumors

18. Chronic spontaneous urticaria / chronic idiopathic urticaria

19. Psoriatic arthritis head-to-head study versus adalimumab

20. Diabetic macular edema

21. Non-alcoholic steatohepatitis

22. Ankylosing spondylitis head-to-head study versus adalimumab

23. Acute myeloid leukemia

Planned filings 2017 to 2021


a) In collaboration with Amgen; companies to co-commercialize in the

US, Novartis to have AMG 334 exclusive rights in rest of world

excluding Japan

b) EU filing, submitted in US

c) US filing, submitted in EU

d) US re-filing following withdrawal in Q1 2017, submitted in EU

e) US filing, submitted in EU with positive CHMP opinion

f) Lubris LLC transaction announced in April 2017

New molecule

New indication

New formulation

Biosimilars

Combination abbreviations:

fulv fulvestrant

tmx tamoxifen

gsn goserelin

NSAI Non-steroidal aromatase inhibitor

Taf Tafinlar® (dabrafenib)

Mek Mekinist® (trametinib)

LA-EP2006 (pegfilgrastim, EU)

Chemotherapy-induced neutropenia and others (same as originator)

KAE609Malaria

CAD106Alzheimer’s disease

LIK066Weight loss

CJM112Immune disorders

ABL001CML5 3rd line

EMA401Neuropathic pain

CNP520Alzheimer’s disease

BYM338Hip fracture

QGE031CSU/CIU18

BYM338Sarcopenia

PIM447Hematologic tumors

VAY736Primary Sjoegren’s syndrome

Entresto®

Post-acute myocardial infarction

QAW039Atopic dermatitis

RTH258DME20

CTL019b

Pediatric/young adult acute lymphoblastic leukemia

Tasigna®c

CML5 treatment free remission

LCI699Cushing’s disease

BAF312RMS7

QAW039Asthma

Entresto®

Heart failure (PEF)15

Lucentis®

ROP12

INC280 NSCLC8

KAF156 Malaria

QVM149Asthma

QMF149Asthma

Kisqali® + fulvHR+, HER2 (-) postmenopausal

adv. BC11 1st/2nd line

Kisqali® + tmx + gsn/or NSAI + gsnHR+, HER2 (-) premenopausal

adv. BC11 1st line

Zykadia®

ALK+ adv. NSCLC8

(Brain metastases)

Cosentyx®

nrAxSpA14

BYL719 + fulvHR+, HER2 (-) postmenopausal

adv. BC11 2nd line

OMB157RMS7

ACZ885Sec. prev. CV events1

CTL019DLBCL2

Arzerra®

NHL13 (refractory)

Tafinlar® + Mekinist®BRAF V600+ melanoma (adjuvant)

RTH258nAMD9

2021201920182017 2020

Jakavi®Acute GVHD16

FTY720Pediatric MS3

LJN452NASH21

GP2017 (adalimumab, US/EU)

Arthritides, plaque psoriasis and others (same as originator)

GP1111 (infliximab, EU)Autoimmune diseases (same as

originator)

GP2013e (rituximab, US)Follicular lymphoma, DLBCL2 and

others (same as originator)

QBW251Cystic fibrosis

AMG 334a

Migraine

Kisqali®

HR+, HER2 (-) BC11 (adjuvant, intermediate risk)

Cosentyx®

PsA H2H19

Cosentyx®

AS H2H22

LAM320MDR10 tuberculosis

Promacta®/Revolade®

SAA4 1st line

ZPL389Atopic dermatitis

PKC412AML23 (FLT3 wild type)

UNR844Presbyopia

SEG101Sickle cell disease

LA-EP2006 (pegfilgrastim, US)


GP2018 (infliximab, US)Autoimmune diseases (same as

originator)

INC280NSCLC8 (EGFRm)

Jakavi®Chronic GVHD16

Kisqali®HR+, HER2 (-) BC11 (adjuvant,

high risk)

Signifor® LAR6,d

Cushing’s diseasePDR001 + Taf/Mek

Metastatic BRAF V600+ melanoma

ECF843f

Dry eye

PDR001NET17

Pipeline of key projects in confirmatory

development


a) Lubris LLC transaction announced in April 2017.

b) In collaboration with Amgen; companies to co-commercialize in the US,

Novartis to have AMG 334 exclusive rights in rest of world excluding Japan.

c) Submitted in US.

d) Approved in US, submitted in EU.

e) Approved in EU, submitted in US.

f) Submitted in EU.

g) Submitted in EU, US filing withdrawal in Q1 2017 with refiling in 2017.

h) Positive CHMP opinion.

New molecule

New indication

New formulation

Biosimilars

1. Chronic myeloid leukemia

2. Non-small cell lung cancer

3. Non-alcoholic steatohepatitis

4. Chronic spontaneous urticaria / chronic idiopathic urticaria

5. Neuroendocrine tumors

6. Relapsing multiple sclerosis

7. Breast cancer

8. Neovascular age-related macular degeneration

9. Secondary prevention of cardiovascular events

10. Non-Hodgkin’s lymphoma

11. Non-radiographic axial spondyloarthritis

12. Psoriatic arthritis head-to-head study versus adalimumab

13. Ankylosing spondylitis head-to-head study versus adalimumab

14. Diffuse large B-cell lymphoma

15. Preserved ejection fraction

16. Multiple sclerosis

17. Graft-versus-host disease

18. Multi-drug resistant

19. Retinopathy of prematurity

20. Acute myeloid leukemia

21. Severe aplastic anemia

22. Diabetic macular edema

23. Acute lymphoblastic leukemia

24. Advanced systemic mastocytosis

25. Long-acting release

PDR001NET5

SEG101Sickle cell disease

Post-PoC Phase III / Pivotal In Registration

ACZ885Sec. prev. CV events9

BAF312 RMS6

FTY720 Pediatric MS16

Lucentis®

ROP19

QAW039Asthma

RTH258nAMD8

Cosentyx®

nrAxSpA11

QMF149Asthma

QVM149Asthma

AMG 334b

MigraineOMB157

RMS6

Entresto®

Heart failure (PEF)15

RTH258DME22

LCI699Cushing’s disease

Kisqali® + ltzd

HR+, HER2(-) postmenopausal adv. BC7 1st line

PKC412AML20

Tafinlar® + Mekinist®e

BRAF V600+ NSCLC2

Arzerra®

NHL10 (refractory)

Kisqali® + tmx + gsn/or NSAI +

gsnHR+, HER2(-) premenopausal

adv. BC7 1st line

Kisqali® + fulvHR+, HER2(-) postmenopausal

adv. BC7 1st/2nd line

Tafinlar® + Mekinist®BRAF V600+ melanoma (adjuvant)

PKC412ASM24

Signifor® LAR25,g

Cushing’s disease

Zykadia®

ALK+ adv. NSCLC2

(Brain metastases)

Zykadia®

ALK+ adv. NSCLC2

(1st line, treatment naïve)

BYL719 + fulvHR+, HER2 (-) postmenopausal

adv. BC7 2nd line

Entresto®

Post-acute myocardial infarction

CTL019c

Pediatric/young adult ALL23

CTL019DLBCL14

GP2013 (rituximab, US)Follicular lymphoma, DLBCL14 and


GP2017 (adalimumab, US/EU)

Arthritides, plaque psoriasis and others (same as originator)

GP1111 (infliximab, EU)Autoimmune diseases (same as

originator)

Tasigna®f

CML1 treatment free remission

GP2015h (etanercept, EU)Arthritides, plaque psoriasis and


GP2013h (rituximab, EU)Follicular lymphoma, DLBCL14 and


VAY736Primary Sjoegren’s syndrome

KAF156Malaria

QAW039Atopic dermatitis

CAD106Alzheimer’s disease

KAE609Malaria

BYM338 Hip fracture

LJN452NASH3

BYM338 Sarcopenia

EMA401Neuropathic pain

QGE031CSU/CIU4

INC280 NSCLC2

ABL001CML1 3rd line

PIM447Hematologic tumors

Jakavi®Acute GVHD17

CJM112Immune disorders

CNP520Alzheimer’s disease

LIK066Weight loss

QBW251Cystic fibrosis

Cosentyx®

PsA H2H12

Cosentyx®

AS H2H13

ZPL389Atopic dermatitis

LAM320MDR18 tuberculosis

Kisqali®

HR+, HER2(-) BC7 (adjuvant, intermediate risk)

Promacta®/Revolade®

SAA21 1st line

PKC412AML20 (FLT3 wild type)

UNR844Presbyopia

LA-EP2006 (pegfilgrastim, US/EU)


GP2018 (infliximab, US)Autoimmune diseases (same as

originator)

INC280NSCLC2 (EGFRm)

Jakavi®Chronic GVHD17

Kisqali®

HR+, HER2(-) BC7 (adjuvant, high risk)

PDR001 + Taf/MekMetastatic BRAF V600+ melanoma

ECF843a

Dry eye

Combination abbreviations:

fulv fulvestrant

ltz letrozole

tmx tamoxifen

gsn goserelin

NSAI Non-steroidal aromatase inhibitor

Taf Tafinlar® (dabrafenib)

Mek Mekinist® (trametinib)

http://deis.novartis.intra/deis.asp?SEB001X

http://deis.novartis.intra/deis.asp?LBS834A


http://deis.novartis.intra/deis.asp?AHT956A

http://deis.novartis.intra/deis.asp?FTY720D

http://deis.novartis.intra/deis.asp?RFB002D



http://deis.novartis.intra/deis.asp?DNK333B






http://deis.novartis.intra/deis.asp?VAK694A


http://deis.novartis.intra/deis.asp?CAD106A

http://deis.novartis.intra/deis.asp?VAK694A


http://deis.novartis.intra/deis.asp?ATI355A


http://deis.novartis.intra/deis.asp?VAM627A








Key definitions and trademarks


This presentation contains several important words or phrases that we define as follows:

ADHF: Acute decompensated heart failure

AE: Adverse Event

ALK: Anaplastic lymphoma kinase

ALL: Acute lymphatic leukemia

AMD: Age-Related Macular Degeneration

AMI: Acute myocardial infection

AML: Acute myeloid leukemia

Approval: In Pharmaceuticals and Alcon in US and EU; each indication and regulator combination

counts as approval; excludes label updates, CHMP opinions alone and minor approvals

aRCC: advanced renal cell cancer

ARNI: Antiogensin receptor neprilysin inhibitor

AS: Ankylosing Spondylitis

BTD: Breakthrough therapy designation

CGRP: Calcitonin gene-related peptide

cITP: Chronic immune thrombocytopenia

CM: Chronic migraine

CML: Chronic myeloid leukemia

COPD: Chronic Obstructive Pulmonary Disease

CR: complete remission

CRC: Colorectal Cancer

CRi: Complete remission with incomplete blood count recovery

CSU / CIU: Chronic spontaneous urticaria / Chronic idiopathic urticaria

CVRR: Cardiovascular risk reduction

DLBCL: Diffuse large B-cell lymphoma

DMC: Data monitoring committee

EDSS: Expanded Disability Status Scale

EF: ejection fraction

EM: Episodic migraine

GvHD: graft vs. host disease

HbA1C: Glycated hemoglobin

HCC: Hepatocellular carcinoma

HF: Heart failure

HF-pEF: Heart failure with preserved ejection fraction

HFrEF: Heart failure with reduced ejection fraction

HR+/HER2- mBC: Hormone Receptor positive / Human Epidermal growth factor receptor 2 negative

metastatic breast cancer

LoE: Loss of exclusivity

MF: Myelofibrosis

MI: Myocardial infarction

MS: Multiple sclerosis

NASH: Non-Alcoholic Steatohepatitis

NET: Neuroendocrine tumor

New assets: Assets acquired in the GSK transaction which closed on March 2, 2015

NSAI: Nonsteroidal aromatase inhibitor

NSCLC: Non-small cell lung cancer

NTD: New Therapeutic Drug

ORR: Overall response rate

OS: Overall survival

PA: Prior authorization

PASI 90: 90% reduction in Psoriasis Area Severity Index from baseline

PFS: Progression free survival

PsA: Psoriatic arthritis

PsO: Psoriasis

PV: Polycythemia vera

PY: Prior year

QoL: Quality of Life

RCC: Renal cell cancer

ROP: Retinopathy of prematurity

r/r ALL: relapsed/refractory acute lymphoblastic leukemia

RRMS: relapsing-remitting multiple sclerosis

SAA: Severe aplastic anemia

scFv: Single chain variable fragment

SCPC: Sickle cell pain crisis

SM: Systemic mastocytosis

SpA: Spondyloarthritis

SPMS: Secondary progressive multiple sclerosis

Trademarks

Aubagio® and Lemtrada® are registered trademarks of Genzyme Corporation

Enbrel® is a registered trademark of Amgen Inc.

Humira® is a registered trademark of AbbVie Ltd.

MabThera® is a registered trademark of Roche, Ltd.

Remicade® and Stelara® are registered trademarks of Janssen Biotech, Inc.

and Simponi® are registered trademarks of Johnson & Johnson

meet novartis management global drug development express or implied discussions regarding potential...

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