Novartis Q2 2017 IR Presentation

Novartis AG
Investor Relations
Q2 2017 Results
Investor Presentation | July 18, 2017
Disclaimer
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organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to
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organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to
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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
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in Novartis AGs 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.
2 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Agenda
1. Group review Joseph Jimenez, Chief Executive Officer
2. Financial review Harry Kirsch, Chief Financial Officer
3. Development Vas Narasimhan, Global Head Drug Development & CMO
4. Closing Joseph Jimenez, Chief Executive Officer
5. Q&A session Executive team

Novartis delivered strong innovation and
operational performance in Q2
Net sales in line with PY (cc)

as growth drivers offset Glivec LOE impact
Core operating income in line with PY (cc)

as gross margin expansion and productivity compensated for Glivec LOE and growth investments
Surge of innovation milestones

14 key approvals and positive opinions1, 5 major submissions and 9 positive trial readouts
1. Does not include positive ODAC recommendation for CTL019 for pediatric and young adult r/r B-cell ALL
Growth rates in constant currencies (cc) vs. prior year (PY). Constant currencies, core results and free cash flow are non-IFRS measures. An explanation of these measures can be found on page 43 of the Condensed Interim Financial Report.

Strong innovation newsflow in Q2
Selected news:
Approvals & Opinions Filings Data
AMG 334 RTH258
Gx Advair Diskus1 ACZ885
Infliximab CTL019
Adalimumab
1. Advair, Advair Diskus, and Diskus are registered trademarks of the GSK group of companies

Positive pivotal trial readouts in Pharmaceuticals
RTH258
Two Phase 3 studies showed non-inferiority to aflibercept in neovascular
AMD1; majority of patients maintained on quarterly dosing
Safety comparable to aflibercept
ACZ885
CANTOS study met primary endpoint, lowering CV risk post MI2
No treatment currently available for patients with high inflammation

burden post MI2
1. AMD age-related macular degeneration 2. MI myocardial infarction

Strong progress on our cell therapy platform,
a key pillar of our IO strategy
FDA advisory committee recommended

CTL019 for approval in pediatric ALL1
CTL019 pivotal study showed durable

responses up to 6 months in DLBCL2
1. ALL acute lymphoblastic leukemia 2. DLBCL diffuse large B-cell lymphoma

Sandoz biosimilars pipeline is on its way...
Approved and
launched in EU
etanercept rituximab
Filed in EU Adalimumab Infliximab
Leading portfolio with 5

biosimilars now on market

Key growth drivers are on track
Q2 2017 Net Sales Growth vs. PY
Selected Growth Drivers Therapeutic Area (USD m) (% cc)
Immunology & Dermatology 490 90%
Cardio-Metabolic 110 240%

1
Oncology 210 35%
Oncology 186 32%
Oncology 2162 28%2
Oncology 463 7%
Neuroscience 837 5%
Immunology & Dermatology, Respiratory 226 12%
Oncology 8 nm3
Biopharmaceuticals Multiple 260 6%
1. Approved as Promacta in the US 2. Net sales and growth of Tafinlar + Mekinist 3. nm not meaningful as Kisqali was launched in US in March 2017

Entresto growth momentum continued;
on track for FY sales of USD 500m
US Weekly NBRx1 US Weekly TRx1

2,500
WW Q2 sales of USD 110m 16,000
(vs. USD 84m in Q1) 2,000 14,000
12,000
US benefitting from improved 1,500 10,000
access and field force 8,000

1,000
6,000
Ex-US benefitting from 500 4,000
2,000
improvements in reimbursement
0 0
Sep-15
Nov-15
Sep-16
Nov-16
Nov-15
Nov-16
Jan-16
May-16
Jan-17
May-17
Mar-16
Mar-17
Sep-15
Sep-16
Jan-16
May-16
Jan-17
May-17
Jul-15
Jul-16
Jul-15
Mar-16
Jul-16
Mar-17
1. US data, NBRx and TRx across specialties from week ending 10-Jul 2015 to 30-Jun 2017 (Source: IMS)

Cosentyx delivered strong growth
Quarterly net sales

USD m
>1.1bn 490
Ex-US
US 410
391
WW Q2 sales of USD 490m
301
260
Strong growth in both psoriasis and
261m 176 spondyloarthropathy (SpA) indications vs.
121 Q1, in both US and ex-US
88
22 30
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
2015 2016 2017

Alcon net sales grew +3% (cc), driven by both
franchises
Surgical Vision Care

Net sales +3% cc Net sales +2% cc
Growth in key segments, including IOLs Contact lenses grew for 5th consecutive quarter
Continued strengthening of operations and Dailies Total1 continued strong performance in

customer service all regions

Novartis Group seeing benefits of new
organizational structure and focus
Integrated Drug Development Centralized Operations
More transitions from NIBR to Development Novartis Business Services reducing costs while
improving quality
Earlier deal-making to strengthen pipeline New capabilities, e.g. advanced analytics
platform for Drug Development IT
Speed of progress on cell therapy platform
Novartis Technical Operations contributing to
Biosimilars pipeline delivery gross margin improvement

Agenda

Summary of Q2 2017 financial results
Group1 Q2 Change vs. PY

USD million 2017 % USD % cc
Net Sales 12,242 -2 0
Core Operating income 3,235 -3 0
Operating income 2,280 9 13
Net Income 1,979 10 14
Core EPS (USD) 1.22 -1 2
EPS (USD) 0.84 11 15
Free Cash Flow 3,243 28
1. Core results, constant currencies and free cash flow are non-IFRS measures. Further details regarding non-IFRS measures can be found starting on page 43 of the Condensed Interim Financial Report

Sales volume offset by generics and price impact
Group Q2 2017
(growth vs. PY in %)
Net sales Core operating income
Volume before Gx 6 21
Generics impact -3 -10
Price1 -3 -11
CC Growth 0 0
Currency -2 -3
USD Growth -2 -3
1. Includes the price impact of Generic entries

Group Core margin 26.4% in line with PY (cc)
Q2 2017
Core operating
Net sales income Core margin
change vs. PY change vs. PY Core ROS change vs. PY
(in % cc) (in % cc) (%) (% pts cc)
Innovative Medicines 1 1 31.1 -0.2
Sandoz -4 -7 20.3 -0.7
Alcon 3 -7 13.9 -1.5

1
Group 0 0 26.4 0.0
1. Division weighted average decline of -0.4% was offset by lower net corporate expense (+0.4%)

H1 free cash flow grew 26% to USD 4.9bn
Group free cash flow

(USD bn)
+26%
4.9
Key drivers vs. PY:
3.9
+ Working Capital
+ OTC JV Dividend
Lower OpInc
H1 2016 H1 2017

Net debt increased mainly due to the annual
dividend payment and share repurchases
(USD bn)
-6.1
-16.0 4.9
-6.5
-2.9
-0.7
-0.9 -22.1
Dec 31, 2016 Free Cash Flow Dividends Treasury share M&A related Others Jun 30, 2017
transactions, net payments

Expected currency impact for H2 and FY 2017
Assuming mid-July exchange rates prevail

Currency impact vs. PY (in % pts)
FX impact on FX impact on
Net sales Core operating income
2 1
-2 -2 -1 -1 -2
-3 -4 -3 -3 -3
FY Q1 Q2 Q3 Q4 FY FY Q1 Q2 Q3 Q4 FY
2016 2017 2016 2017

Actual Simulation

Re-confirming 2017 full year Group guidance
Barring unforeseen events (in cc)
Group net sales expected to be broadly in line with PY

Innovative Medicines broadly in line with prior year, to a slight increase
Sandoz broadly in line with prior year
Alcon revised upward to low single digit growth versus prior year
Group core operating income expected to be broadly in line with PY to

low single digit decline

Agenda

A strong quarter for innovation at Novartis
9 5 2 5 9
major approvals positive CHMP FDA major positive major
in US and EU opinions Breakthrough submissions in trial and trial
+ positive ODAC
Therapy US and EU extension
recommendation for designations readouts
CTL019

Progressing late stage development of potential
blockbusters1
Exp. pivotal
Therapeutic area Molecule Indication MoA Current status
trial readout

HR+/HER2- advanced or metastatic breast Approved in US and positive
LEE011 (Kisqali) CDK4/6 inhibitor
cancer CHMP opinion
Onco Oncology CTL019 (CAR-T) r/r B-Cell ALL, DLBCL CAR-T 2 Filed in US
SEG101 (crizanlizumab) Sickle cell pain crises Anti-P-selectin 3 On track for submission in 2018
LCZ696 (Entresto) Heart failure with preserved EF ARNI 2019 On track
CM Cardio-metabolic
ACZ885 (canakinumab) CV risk reduction Anti-IL1 Positive pivotal trial read out
OMB157 (ofatumumab) Relapsing multiple sclerosis CD20 2019 On track
NS Neuroscience BAF312 (siponimod) Relapsing multiple sclerosis5 S1P receptor modulator Path forward agreed with FDA
AMG 334 (erenumab)4 Prophylaxis of migraine CGRP receptor antagonist Filed in US and EU
Immunology&
I&D AIN457 (Cosentyx) Non-radiographic axial SpA Anti-IL17A 2018 On track
Dermatology
QVM149 (indacaterol, Asthma LABA + LAMA + ICS 2018 On track
glycopyrronium, mometasone)
Resp Respiratory
QAW039 (fevipiprant) Asthma CRTh2 antagonist 2019 On track
Oph Ophthalmology RTH258 (brolucizumab) Neovascular AMD Anti-VEGF (scFv) Positive pivotal read out
Bios Biosimilars Multiple Multiple Multiple Ongoing Varying
1. Blockbuster potential refers to specified indication 2. Ped and young adult r/r B-cell ALL filed in US and priority review granted; Breakthrough Therapy designation granted for DLBCL 3. Refers to phase 2 readout 4. In collaboration
with Amgen; Novartis has AMG 334 rights outside of Japan and co-commercialization in the US 5. with advanced disease features, as agreed with FDA, based on EXPAND study

Advancing our Immuno-Oncology strategy
Focus for today
Onco Advancing CAR-T PD-1 update Ready for IO 2nd Gen
CM
NS
Tumor Type PDR001 (PD-1 Antagonist)

I&D FDA AdCom unanimously 18 agents in mono or combination
endorses pediatric and young Melanoma Ph 3 trial in combination with Tafinlar progressing in early studies
adult r/r ALL for approvability + Mekinist : FPFV achieved
Resp NET Orphan Drug designation; Ph 2
DLBCL primary analysis confirms
fully enrolled
interim analysis; filing expected in
Oph Q4 2017 in US and EU HCC Ph 1b in combination with sorafenib
FPFV achieved
CLL and Multiple Myeloma
progressing NSCLC Ph 1b FPFV achieved
Bios
Solid tumors in FIH trials CRC Ph 1b FPFV achieved

CTL019
FDA AdCom unanimously supports profile of CTL019
for licensure in pediatric and young adult r/r ALL1
Proportion of patients relapse free since onset CTL019 demonstrates consistent results in
Onco
of remission children and young adults with r/r ALL1 in
100 an updated analysis
CM
83% of patients achieved CR2 or CR2 with
Probability of relapse-free, %
80 incomplete blood count recovery in 3 months

NS Relapse-free survival 75% at 6 months; overall
60 survival 89% at 6 months
CTL019 safety profile well-characterized and
I&D
40 manageable without CRS3 deaths or cerebral
edema
Resp 20 Number of patients: 52
Number of events: 11 Novartis manufacturing process is robust
Median: not reached (95% CI: 7.5, NE)
with the ability to use cryopreservation,
Oph 0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 establishing global scale
Patients at risk Time (months)
52 52 48 45 36 23 15 14 11 7 7 5 1 1 1 0 Scheduling flexibility, global reach, durability in
Bios transport, and preserved cell quality
1. r/r ALL relapsed/refractory acute lymphoblastic leukemia 2. CR complete remission 3. CRS cytokine release syndrome

CTL019
CTL019 JULIET updated analysis of patients at
3 and 6 months confirms interim analysis
Onco
Primary efficacy analysis of ~80 DLBCL1 patients at 3 months and 46
CM DLBCL1 patients at 6 months confirms interim analysis and statistically
significant overall response rate
NS
No new safety signals detected
I&D
Full results to be presented at a major medical congress in H2
Resp Planned filing in Q4 2017 in US and EU
Oph
Potentially eligible patients 2nd line ~33,0002 / 3rd line ~16,0002
Bios
1. DLBCL Diffuse large B-cell lymphoma; 2. Incidence: Based on 2017 incidence rate in US, EU-14, Israel, Japan and Canada -Surveillance, Epidemiology, and End Results Program (SEER); Decision Resources; Novartis analysis
Relapsed/Refractory %: Internal Novartis discussions

CTL119
CTL119 humanized CAR-T shows promising
results in CLL1 in combination with ibrutinib
Onco High unmet medical need for new therapies for refractory CLL 1
Early clinical data in CLL1 presented at ASCO 2017
CM
8 of 9 evaluable patients tested had no signs of CLL1 in their bone marrow at three
months
NS
All patients in pilot study had been taking ibrutinib for at least 6 months and were not in
complete remission
I&D
10 patients experienced CRS2, 2 of which were grade 3. However, no patients required
treatment with tocilizumab and all patients recovered from CRS2
Resp
Goal of CTL119/ibrutinib combination is to deepen responses to CR/MRD 3 negative disease

Oph and ultimately be able to discontinue ibrutinib testing ongoing in current study
Bios
CTL119 is being developed in collaboration with the University of Pennsylvania
1. CLL chronic lymphocytic leukemia 2. CRS cytokine release syndrome 3. MRD Minimal residual disease; CR complete remission

Other key pipeline achievements in Oncology
during Q2
Onco HR+/HER2- locally advanced or metastatic BC1: Positive CHMP
opinion
CM
BRAF V600+ metastatic NSCLC2: US Approval
NS BRAF V600+ locally advanced or metastatic ATC3: Breakthrough
Therapy designation granted
I&D
CML-TFR4: Positive EC decision to update the Tasigna (nilotinib)

Resp SmPC5 with regard to TFR
Oph
ALK+ advanced NSCLC2: US and EU approval for 1st line use
Bios
1. BC Breast Cancer 2. NSCLC Non-small Cell Lung Cancer 3. ATC anaplastic thyroid cancer 4. CML-TFR Treatment-free remission 5. SmPC Summary of product characteristics

ACZ885
CANTOS study met its primary endpoint, full
results will be presented at ESC1
Onco Spontaneous MI at least 30 days prior to randomization
on standard therapies and elevated hsCRP ( 2 mg/L)
CM
NS Randomized Randomized Randomized Randomized

Canakinumab 50 mg Canakinumab 150 mg Canakinumab 300 mg Placebo
SC q3 months SC q3 months SC q3 months SC q3 months
I&D
Resp
Primary Endpoint: Time to first major cardiovascular event (MACE: CV death, non-fatal MI, or non-fatal stroke)
Secondary Endpoints: Time to first event of MACE or hospitalization for unstable angina requiring unplanned
Oph revascularization; time to new onset diabetes among those with pre-diabetes at randomization; all cause mortality; time
to first occurrence of all cause mortality, non-fatal stroke, or non-fatal MI
Bios
Key Exploratory Endpoints: DVT/PE, stent thrombosis, hospitalizations for CHF, PCI/CABG and biomarkers
1. ESC European Society of Cardiology, Barcelona, August 26 30, 2017; presentation on August 27

ACZ885
CANTOS study provides opportunity to look at
specific sub-groups; analysis ongoing
Onco Biomarker data on hsCRP, IL-6, and additional inflammatory cytokines
CM Estimated 10% of patients in study with peripheral artery disease
NS
~70% of patients current or former smokers
~8% of patients with prior stroke or TIA1
I&D
Resp
Patients well treated with contemporary secondary prevention therapies
Oph (statins, beta blockers, anti-platelet agents, and RAAS blockers)
Bios
1. TIA transitory ischemic attack

AMG 334
AMG 334 (erenumab), first-in-class therapy
submitted in the US and in the EU
Onco
Fully human, potent, selective CGRP antagonist targeting receptor
CM
Efficacy and safety profile in >2,600 patients treated:
Rapid onset, sustained efficacy; 2 out of 3 patients had 50% response and 26%
NS
were completely migraine free at month 15 (ongoing extension trial)2
I&D High efficacy in difficult to treat patients (chronic migraine with previous
prophylactic treatment failure or recent medication overuse)
Resp
Placebo-like safety profile; longest established safety profile (5 years extension
Oph ongoing trial)
Bios
Regulatory files submitted to FDA, submitted and accepted by EMA
1. Development in collaboration with Amgen; Amgen has exclusive commercialization rights in Japan and Novartis in the rest of the world and Amgen will co-commercialize AMG 334 in the US
2. Ashina N. et al. Maintenance of Clinical Response to erenumab (AMG 334) in Episodic Migraine: Complete One-Year Results From an Ongoing Open-Label Extension Study. 70mg data. P003, EHMTIC 2016

AMG 334
AMG 334 (erenumab) subgroup analysis shows
efficacy in previously treated patients1
Previous prophylactic Tx failure subgroup1 Recent medication overuse subgroup2
Onco
Monthly Migraine Days (MMD) reduction vs. baseline Days using acute pain medication (triptans and ergot derivatives)
Baseline: ~18 days
CM Baseline Month 1 Month 2 Month 3 Baseline Month 1 Month 2 Month 3
0.0 0.0
NS
-1.0
-2.0
-2.1
-2.68 -2.0
I&D -3.0
- 3.3 and
-4.0 - 2.71 and - 2.8 days
-5.38 - 4.28 days -4.0
Resp -5.0
placebo * reduction* -4.9 *
reduction*
placebo
-6.0 70 mg
70 mg
-6.96
Oph -7.0
140 mg
* -6.0 140 mg -5.4 *
Patients with 2 prior treatment failures: Placebo (N=142); Patients with recent medication overuse: Placebo (N=113);
erenumab 70 mg (N=93); erenumab 140 mg (N=92) erenumab 70 mg (N=78); erenumab 140 mg (N=77)
* p<0.001
Bios AMG 334 (erenumab) subgroup analyses shows efficacy in difficult-to-treat chronic migraine patients 1. Ashina et al, Pre-specified subgroup analysis of the phase 2. randomized, double-blind, placebo-controlled study. PR1046 presented at
EAN. The erenumab Chronic Migraine pivotal study was published in Lancet Neurology Volume 16, Issue 6, June 2017, Pages 425434. 2. Diener H et al, Efficacy of erenumab for the Treatment of Patients with Chronic Migraine in Presence of
Medication Overuse. PR1048 presented at EAN

Cosentyx rheumatology profile further
strengthened
Onco
3 year data in AS from MEASURE 11
Up to 80% sustained improvements in AS over 3 years1
CM
100 Rapid & sustained pain relief shown in PsA2
H2H3 superiority to Stelara4 at 52 weeks5 added to EU
Percentage responders
NS
80
label in psoriasis (PsO)6
60
I&D
5 year data reinforces sustained efficacy and safety
40 profile in PsO
Resp 20 SEC IV-150 mg ASAS 20
Multiple ongoing trials:
SEC IV-150 mg ASAS 40 Non-radiographic axial spondyloarthritis7
0 H2H3 superiority studies vs. adalimumab in AS8 and PsA9
Oph 0
0 1
52 2
104 3
156
Years New-onset PsO10
1. Baraliakos X, et al. Clin Exp Rheumatol 2017;[epub ahead of print] 2. McInnes IB, et al. Ann Rheum Dis 2017;76(suppl 2):675; 3. H2H head-to-head 4. Stelara is a registered trademark of Janssen Biotech, Inc 5. Blauvelt A, et al. J
Bios Am Acad Dermatol 2017;76:6069 6. Cosentyx Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003729/WC500183129.pdf [accessed 10 July
2017] 7. https://clinicaltrials.gov/ct2/show/NCT02696031 [accessed 10 July 2017] 8. Novartis data on file 9. https://clinicaltrials.gov/ct2/show/NCT02745080 [accessed 10 July 2017] 10. https://clinicaltrials.gov/ct2/show/NCT03020199
[accessed 10 July 2017]

RTH258
HAWK and HARRIER designed to assess efficacy and safety of
q12w dosing of RTH258 vs. q8w dosing of Eylea1
Two-year, randomized, double-masked, multicenter studies comparing the efficacy and safety of brolucizumab
Onco versus aflibercept in subjects with nAMD
CM
NS
I&D
Resp
Oph
patient dosed with brolucizumab Disease Activity assessment Primary Analysis
Bios patient dosed with aflibercept Final analysis

1. Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.

RTH258
RTH258 met primary endpoint with majority of patients on
q12w dosing; DME and RVO studies planned
Onco
Primary Efficacy Endpoint
Change in BCVA2 from Baseline to week 48
CM Secondary endpoints
Change in BCVA2 from baseline averaged over the period Week 36 to Week 48
NS
Proportion of q12w subjects up to week 48 in the brolucizumab treatment arms 52%, 57%
I&D Proportion of patients on q12w regimen at week 12 remaining on q12w regimen at
week 48
To be
Resp Anatomical parameters of disease activity (retinal fluid, retinal thickness)
presented at
Disease activity assessment AAO1
Oph
Visual function-related subject-reported outcomes
To assess the safety and tolerability of brolucizumab relative to aflibercept
Bios
1. AAO American Academy of Ophtalmology meeting in November 2017 2. BCVA best-corrected visual acuity

Biosimilars: two marketing authorizations and
two submissions in Europe in Q2
Onco
CM
Biosimilar etanercept Biosimilar rituximab

NS
EU approval and launch EU approval and launch
I&D
Resp
Oph
Biosimilar infliximab Biosimilar adalimumab

Bios
submitted in EU submitted in EU
Biosimilars filing milestones
Molecule Indication1 Originator2 Agency Filing

Onco
Etanercept Rheumatoid Arthritis FDA
2015
(approved)
2015
CM Etanercept Rheumatoid Arthritis EMA (approved)
2015
Epoetin subcutaneous Anemia EMA (approved)
NS 2016
Rituximab Non-Hodgkins Lymphoma EMA (approved)
I&D Adalimumab Rheumatoid Arthritis FDA 2017

2017
Adalimumab Rheumatoid Arthritis EMA (filed)
Resp
Rituximab Non-Hodgkins Lymphoma FDA 2017
2017
Oph
Infliximab Inflammatory Bowel Disease EMA (filed)
Pegfilgrastim Neutropenia EMA 2017
Bios Pegfilgrastim Neutropenia FDA 20193

1. Main indication only 2. All trademarks are the property of the respective originator companies 3. Reflects re-filing as communicated in Q1, now scheduled for H1 2019

Strong progress on key 2017 milestones in H1
H1 2017 H2 2017
Regulatory Kisqali HR+/HER2- adv. BC (US) Kisqali HR+/HER2- adv. BC (EU)2
decisions Rydapt AML and adv. SM (US) Rydapt AML and adv. SM (EU) =
and opinions Tafinlar + Mekinist BRAF+ NSCLC (US, EU) Rixathon Rituximab BS (EU)
Erelzi Etanercept BS (EU) CTL019 Ped. and young adult r/r ALL (US)1 =
Zykadia ALK+ NSCLC (US, EU)
Submissions AMG 334 Migraine (US, EU) GP2013 Rituximab BS (US) =
Ped. and young adult r/r
CTL019 RLX030 Acute heart failure
ALL (US)1
GP2017 Adalimumab BS (EU) ACZ885 CV risk reduction =
DLBCL (US, EU), ped. and young
GP1111 Infliximab BS (EU) CTL019 =
adult r/r ALL (EU)
GP2017 Adalimumab BS3 (US) =
LA-EP2006 Peg-filgrastim BS3 (EU) =
Major trial RLX030 RELAX-AHF-2 (AHF) CTL019 JULIET (DLBCL)
readouts ACZ885 CANTOS (CVRR) RTH258 HARRIER, HAWK (nAMD)
Achieved Missed = On track
1. FDA priority review granted 2. Positive CHMP opinion, final EMA approval pending 3. BS Biosimilar

Summary
Strong momentum in the pipeline
Key growth drivers on track
A stronger, more integrated company

Appendix
Planned filings 2017 to 2021
2017 2018 2019 2020 2021
CTL019a Tafinlar + Mekinist BAF312 BYL719 + fulv ABL001 BYM338 PIM447
Pediatric/young adult acute HR+, HER2 (-) postmenopausal
BRAF V600+ melanoma (adjuvant) Relapsing multiple sclerosis CML4 3rd line Hip fracture recovery Hematologic cancers
lymphoblastic leukemia adv. BC9 2nd line
ACZ885 Tasigna b INC280 PDR001 + Taf/Mek QGE031 CAD106 QBW251

Sec. prev. CV events1 CML4 treatment free remission NSCLC6 Metastatic BRAF V600+ melanoma CSU/CIU16 Alzheimers disease Cystic fibrosis
CTL019 Signifor LAR5,c LCI699 QAW039 Entresto CJM112 UNR844

DLBCL2 Cushings disease Cushings disease Asthma Post-acute myocardial infarction Immune disorders Presbyopia
GP2013b (rituximab, US) RTH258 Arzerra Cosentyx CNP520 VAY736

FTY720 Follicular lymphoma, DLBCL2 and
Pediatric multiple sclerosis others (same as originator) nAMD7 NHL11 (refractory) PsA H2H17 Alzheimers disease Primary Sjoegrens syndrome
GP2017c (adalimumab, US)
Promacta/Revolade Arthritides, plaque psoriasis and others SEG101 Cosentyx Jakavi ECF843d VAY785e
SAA3 1st line (same as originator) Sickle cell disease nrAxSpA12 Chronic GVHD14 Dry eye NASH18
LA-EP2006 (pegfilgrastim, EU) Entresto RTH258 EMA401 ZPL389

Chemotherapy-induced neutropenia LAM320
and others (same as originator) MDR8 tuberculosis Heart failure (PEF)13 Diabetic macular edema Peripheral neuropathic pain Atopic dermatitis
1. Secondary prevention of cardiovascular events Kisqali + fulv Jakavi KAE609 BYM338

2. Diffuse large B-cell lymphoma HR+, HER2 (-) postmenopausal Acute GVHD14 Malaria Sarcopenia
3. Severe aplastic anemia adv. BC9 1st/2nd line
4. Chronic myeloid leukemia Kisqali + tmx + gsn/or NSAI + gsn
5. Long-acting release HR+, HER2 (-) premenopausal
OMB157 KAF156 Cosentyx
Relapsing multiple sclerosis Malaria AS H2H19
6. Non-small cell lung cancer adv. BC9 1st line
7. Neovascular age-related macular degeneration
8. Multi-drug resistant Lucentis PDR001 LIK066 INC280
9. Breast cancer ROP10 NET15 Weight loss NSCLC6 (EGFRm)
10. Retinopathy of prematurity
LJN452 Kisqali
11. Non-Hodgkins lymphoma QMF149 HR+, HER2 (-) BC9 (adjuvant,
12. Non-radiographic axial spondyloarthritis Asthma NASH18 intermediate risk)
13. Preserved ejection fraction
14. Graft-versus-host disease QVM149 LMI070 Kisqali
15. Neuroendocrine tumors HR+, HER2 (-) BC9 (adjuvant,
Asthma Spinal muscular atrophy high risk)
16. Chronic spontaneous urticaria / chronic idiopathic urticaria
17. Psoriatic arthritis head-to-head study versus adalimumab Zykadia MAA868 Rydapt
18. Non-alcoholic steatohepatitis ALK+ adv. NSCLC6
(Brain metastases) Stroke prevention in atrial fibrillation AML20 (FLT3 wild type)
19. Ankylosing spondylitis head-to-head study versus adalimumab
20. Acute myeloid leukemia LA-EP2006 (pegfilgrastim, US)
Combination abbreviations: Chemotherapy-induced neutropenia New molecule
a) EU filing, submitted in US. fulv fulvestrant and others (same as originator)
b) US filing, approved in EU. tmx tamoxifen New indication
c) US filing, submitted in EU. gsn goserelin
d) Lubris LLC transaction announced in April 2017. NSAI Non-steroidal aromatase inhibitor New formulation
e) Conatus transaction for exclusive global license for Taf Tafinlar (dabrafenib)
emricasan announced in May 2017. Mek Mekinist (trametinib) Biosimilars

Pipeline of key projects in confirmatory development
Post-PoC Phase III / Pivotal In Registration
ABL001 KAE609 QGE031 BAF312 CTL019 OMB157 AMG 334c
CML1 3rd line Malaria CSU/CIU3 Relapsing multiple sclerosis DLBCL12 Relapsing multiple sclerosis Migraine prophylaxis
BYM338 KAF156 UNR844 BYL719 + fulv Entresto Promacta/Revolade CTL019d

Hip fracture recovery Malaria Presbyopia HR+, HER2 (-) postmenopausal Heart failure (PEF)13 Pediatric/young adult ALL19
adv. BC5 2nd line SAA17 1st line
CAD106 LIK066 VAY736 LCI699 Entresto QMF149 Kisqali + ltze,f

Alzheimers disease Weight loss Primary Sjoegrens syndrome Cushings disease Post-acute myocardial infarction Asthma HR+, HER2(-) postmenopausal
adv. BC5 1st line
CJM112 LJN452 VAY785b PDR001 + Taf/Mek FTY720 QVM149 Rydapte

Immune disorders Non-alcoholic steatohepatitis Non-alcoholic steatohepatitis Metastatic BRAF V600+ melanoma Pediatric multiple sclerosis Asthma AML18
CNP520 LMI070 ZPL389 QAW039 Jakavi RTH258 Rydapte

Alzheimers disease Spinal muscular atrophy Atopic dermatitis Asthma Acute GVHD14 Diabetic macular edema ASM20
ECF843a MAA868 BYM338 RTH258 Jakavi Rydapt Signifor LAR21,g

Dry eye Stroke prevention in atrial fibrillation Sarcopenia nAMD6 Chronic GVHD14 AML18 (FLT3 wild type) Cushings disease
EMA401 PIM447 INC280 SEG101 LAM320 Tafinlar + Mekinist GP1111 (infliximab, EU)
Autoimmune diseases (same as
Peripheral neuropathic pain Hematologic cancers NSCLC2 (EGFRm) Sickle cell disease MDR15 tuberculosis BRAF V600+ melanoma (adjuvant)
originator)
INC280 QBW251 PDR001 ACZ885 Kisqali + fulv Zykadia GP2017 (adalimumab, EU)
Arthritides, plaque psoriasis and others
NSCLC2 Cystic fibrosis NET4 HR+, HER2(-) postmenopausal ALK+ adv. NSCLC2
Sec. prev. CV events7 (same as originator)
adv. BC5 1st/2nd line (Brain metastases)
Arzerra Kisqali + tmx + gsn/or NSAI + gsn GP2013 (rituximab, US)

1. Chronic myeloid leukemia 12. Diffuse large B-cell lymphoma HR+, HER2(-) premenopausal Follicular lymphoma, DLBCL12 and
NHL8 (refractory) others (same as originator)
2. Non-small cell lung cancer 13. Preserved ejection fraction adv. BC5 1st line
3. Chronic spontaneous urticaria / chronic idiopathic urticaria 14. Graft-versus-host disease
Cosentyx Kisqali GP2017 (adalimumab, US)
4. Neuroendocrine tumors 15. Multi-drug resistant HR+, HER2(-) BC5 (adjuvant, Arthritides, plaque psoriasis and others
5. Breast cancer 16. Retinopathy of prematurity nrAxSpA9 intermediate risk) (same as originator)
6. Neovascular age-related macular degeneration 17. Severe aplastic anemia
LA-EP2006 (pegfilgrastim, US/EU)
7. Secondary prevention of cardiovascular events 18. Acute myeloid leukemia Cosentyx Kisqali Chemotherapy-induced neutropenia and
8. Non-Hodgkins lymphoma 19. Acute lymphoblastic leukemia PsA H2H10 HR+, HER2(-) BC5 (adjuvant, high risk) others (same as originator)
9. Non-radiographic axial spondyloarthritis 20. Advanced systemic mastocytosis New molecule
10. Psoriatic arthritis head-to-head study versus adalimumab 21. Long-acting release Cosentyx Lucentis New indication
11. Ankylosing spondylitis head-to-head study versus adalimumab ROP16
AS H2H11
New formulation
Combination abbreviations: a) Lubris LLC transaction announced in April 2017. d) Submitted in US.
fulv fulvestrant NSAI Non-steroidal aromatase inhibitor b) Conatus transaction for exclusive global license for e) Approved in US, submitted in EU. Biosimilars
ltz letrozole Taf Tafinlar (dabrafenib) emricasan announced in May 2017. f) Positive CHMP opinion.
tmx tamoxifen Mek Mekinist (trametinib) c) In collaboration with Amgen; companies to co- g) Submitted in EU.
gsn goserelin commercialize in the US, Novartis to have AMG 334
exclusive rights in rest of world excluding Japan.

Clinical Trials Update
Includes selected ongoing or recently concluded global trials of Novartis development programs/products
which are in confirmatory development or marketed (typically Phase 2 or later).
For further information on all Novartis clinical trials, please visit: www.novartisclinicaltrials.com
Key changes vs. April presentation
New additions
Study Indication Phase Patients
NCT03096834 [LIBERTY] (CAMG334A2301) Migraine Phase 3 220
NCT02745080 [EXCEED 1] (CAIN457F2366) Psoriatic Arthritis Phase 3 850
NCT03031782 (CAIN457F2304) Psoriatic Arthropathy Phase 3 80
NCT03094195 EMPHENE (CEMA401A2201) Treatment of Peripheral Neuropathic Pain Phase 2 360
NCT03078751 EarLEE-1 (CLEE011G2301) Adjuvant Breast cancer, High Risk Phase 3 2,000
NCT02892019 (CQMF149G2202) Asthma Phase 2 80
NCT03100500 (CQVM149B1305) Asthma Phase 3 66
NCT02712983 iBEST-1 (CTBM100G2202) Bronchiectasis Phase 2 180
Trials taken out (operational milestones achieved)

Study Indication Phase Patients
NCT01922102 BRILLIANCE (CRFB002F2302) Choroidal neovascularization secondary to Phase 3 475
pathologic myopia
NCT02487446 (CQVA149A2349) COPD Phase 3B 354
NCT02487498 (CQVA149A2350) COPD Phase 3B 354
NCT02007720 RELAX-AHF-ASIA (CRLX030A2302) Acute heart failure Phase 3 1,520
NCT01870778 RELAX-AHF-2 (CRLX030A2301) Acute heart failure Phase 3 6,600
NCT01979614 (CRLX030A2203) Acute heart failure Phase 2 62
NCT01597908 COMBI-V (CDRB436B2302) Melanoma Phase 3B 694
NCT01153763 BREAK-2 (CDRB436A2201) Melanoma Phase 2A 30
NCT01584648 COMBI-d (CDRB436B2301) Melanoma Phase 3A 340
NCT00782067 (CPKC412D2201) Advanced Mastocytosis Phase 2 116

Cardio-Metabolic
Entresto - Angiotensin receptor neprilysin inhibitor (ARNI)
Study NCT02678312 PANORAMA HF (CLCZ696B2319) NCT02661217 TRANSITION (CLCZ696B2401)

Indication Heart failure in pediatric patients Heart failure
Phase Phase 2/3 Phase 4
Patients 360 1,000

Part 1: Pharmacodynamics and pharmacokinetics of Assessing the percentage of patients who achieve the target
Primary Outcome Measures LCZ696 analytes dose of 200 mg bid LCZ696 at 10 weeks after
Part 2: Efficacy and safety compared with enalapril randomization
Part 1: LCZ696 0.8 mg/kg or 3.1 mg/kg or both

Pre-discharge treatment initiation - LCZ696
Arms/Intervention Part 2: Enalapril is 0.2 mg/kg; LCZ696: 3.125 mg
Post-discharge treatment initiation - LCZ696
granules and adult formulation (50, 100, 200 mg)
Pediatric patients from1 month to < 18 years of age with

Heart failure patients with reduced ejection-fraction
Target Patients heart failure due to systemic left ventricle systolic
hospitalized for an acute decompensation event
dysfunction
Expected Completion 2021 H2-2018
Publication TBD TBD

Study NCT02884206 PERSPECTIVE (CLCZ696B2320) NCT02468232 PARALLEL-HF (CLCZ696B1301)

Indication Heart failure Heart failure, reduced ejection fraction
Phase Phase 3 Phase 3
Patients 520 220

Time to the first occurrence of the composite endpoint -
Change from baseline in the CogState Global Cognitive
Primary Outcome Measures either cardiovascular (CV) death or heart failure (HF)
Composite Score (GCCS)
hospitalization
LCZ696 50, 100, and 200 mg with placebo of valsartan

LCZ696 50 mg, 100 mg, 200 mg/placebo of Enalapril
Arms/Intervention Valsartan 40, 80, and 160 mg tablets with placebo for
Enalapril 2.5 mg, 5 mg, 10 mg / placebo of LCZ696
LCZ696
Patients with chronic heart failure with preserved ejection Japanese heart failure patients (NYHA Class II-IV) with
Target Patients
fraction reduced ejection fraction
Expected Completion 2021 2019
Publication TBD TBD

Study NCT01920711 PARAGON (CLCZ696D2301) NCT02924727 PARADISE-MI (CLCZ696G2301)

Indication Heart failure, preserved ejection fraction Acute myocardial infarction
Patients 4,800 4,650
Cumulative number of primary composite events of Time to the first occurrence of a confirmed composite
Primary Outcome Measures cardiovascular (CV) death and total (first and recurrent) HF endpoint (cardiovascular (CV) death, heart failure (HF)
hospitalizations hospitalization, or outpatient heart failure)
LCZ696 24/26 mg, 49/51 mg and 97/103 mg/ placebo of

LCZ696 50 mg, 100 mg and 200 mg ramipril/valsartan
Arms/Intervention
Valsartan 40 mg, 80 mg and 160 mg Ramipril 1.25 mg, 2.5 mg, and 5 mg/ placebo of LCZ696/
placebo for valsartan
Post-AMI patients with evidence of LV systolic dysfunction

Heart failure patients (NYHA Class II-IV) with preserved
Target Patients and/or pulmonary congestion, with no known prior history of
ejection fraction
chronic HF

Publication TBD TBD

Ilaris - Anti IL-1
Study NCT01327846 CANTOS (CACZ885M2301)

Indication Cardiovascular risk reduction
Phase Phase 3
Patients 10,064
Time to first occurrence of major adverse cardiovascular

Primary Outcome Measures event, which is a composite of CV death, non-fatal MI, and
stroke
Canakinumab 50 mg + standard care therapy

Arms/Intervention
Placebo + standard care therapy
Post-myocardial infarction patients on standard of care with

Target Patients
elevated hsCRP
Core portion of study completed June 2017; Open-label
Expected Completion
extension continues till Jan 2020
Press release issued 22 Jun 2017;
Publication Primary endpoint results ESC 2017;
Publication in Q3-2017

Immunology &
Dermatology
Certican - Inhibition of mTOR
Study NCT01888432 (CRAD001H2307) NCT01698918 BOLERO-4 (CRAD001Y24135)

Indication Transplantation liver ER+ breast cancer 2nd / 3rd line
Phase Phase 3B Phase 2
Patients 286 200
Composite efficacy failure of treated biopsy proven acute

Percentage of patients progression-free after completion of
Primary Outcome Measures rejection, graft loss or death in everolimus with reduced
1st line treatment (everolimus + letrozole)
tacrolimus group compared to standard tacrolimus
Everolimus (3-8 ng/mL) + reduced tacrolimus (3-5

Everolimus + letrozole (10mg daily)
Arms/Intervention ng/mL) corticosteroids
Everolimus + exemestane (2.5mg daily)
Standard tacrolimus (~5-15 ng/mL) corticosteroids
Postmenopausal women with estrogen receptor positive

Target Patients Recipients of living donor liver transplants
HER2 negative metastatic or locally advanced breast cancer
Expected Completion Q4-2017 H2-2018

Abstracts submitted to congresses (ILTS, ESOT,
AASLD) in Q1, Q2-2017 with month 12 results
Publication Congress/journal TBD in Q1/Q3-2017
Manuscript submission to American Journal of
Transplantation in Q2-2017

Cosentyx - Anti IL-17
Study NCT01636687 JUNCTURE (CAIN457A2309) NCT02404350 FUTURE 5 (CAIN457F2342)

Indication Psoriasis Psoriatic arthritis
Patients 171 990
Psoriasis Area and Severity Index (PASI) 75 score and American College of Rheumatology 20 (ACR20)
Primary Outcome Measures
Investigators' Global Assessment (IGA) with 0 or 1 response response at Week 16
Secukinumab 150 mg load

Secukinumab 150 mg
Secukinumab 150 mg no load
Arms/Intervention Secukinumab 300 mg
Secukinumab 300 mg load
Placebo
Placebo
Target Patients Patients with chronic plaque-type psoriasis Patients with active psoriatic arthritis
Expected Completion Q1-2017 2019
52-week results: J Eur Acad Dermatol Venereol. 2017 Jan 23

Publication 24 week results; planned for ACR in Nov-2017
4-year results: Congress in Q1-2018

Study NCT01863732 (CAIN457F2305E1 extension study) NCT02896127 MEASURE 5 (CAIN457F2308)
Indication Ankylosing spondylitis Ankylosing spondylitis
Patients 300 450
Assessment of spondyloarthritis international society criteria The proportion of participants who achieve an ASAS 20
/ ASAS 20 response response
Secukinumab 75 mg in PFS Secukinumab 150 mg s.c. in FFS

Arms/Intervention
Secukinumab 150 mg in PFS Placebo s.c. in PFS
Target Patients Patients with active ankylosing spondylitis Patients with active ankylosing spondylitis
3-year results: Manuscript published in Clinical and

Publication Experimental Rheumatology in May-2017 TBD
4-year results: planned for ACR in Nov-2017

Study NCT01649375 (CAIN457F2310) NCT02008916 (CAIN457F2314)

Indication Ankylosing spondylitis Ankylosing spondylitis
Patients 222 222
Assessment of SpondyloArthritis International Society / Assessment of Spondyloarthritis International Society

ASAS 20 response criteria / ASAS 20 response
Secukinumab 75 mg Secukinumab 10 mg/kg / 300 mg

Arms/Intervention Secukinumab 150 mg Secukinumab 10 mg/kg / 150 mg
Placebo Placebo
Target Patients Patients with active ankylosing spondylitis Patients with active ankylosing spondylitis
Expected Completion 2019 Q1-2018
Primary 52 week results: Baeten D & Sieper J, et al. N
Engl J Med 2015;373:253448 16 weeks results: PANLAS congress in Apr-2016
2 year results: Marzo-Ortega, et al. Arthritis Care Res 52 weeks results: Manucript in Arthritis Research &
Publication
2017 Feb 24. doi: - 10.1002/acr.23233 Therapy in Q2-2017
3 year results: presented at EULAR in June-2017. 2 year results: Planned for ACR in Nov-2017
Manuscript to be submitted in Q3-2017

Study NCT02159053 (CAIN457F2320) NCT01989468 (CAIN457F2318)
Indication Ankylosing spondylitis Psoriatic arthritis
Patients 350 405
Assessment of Spondyloarthritis International Society American College of Rheumatology 20 (ACR20) response in

criteria / ASAS 20 at week 16 subjects treated with secukinumab vs. placebo
Secukinumab 150 mg s.c. with loading Secukinumab (AIN457) 150 mg s.c.

Arms/Intervention Secukinumab 150 mg s.c. without loading Secukinumab (AIN457) 300 mg s.c.
Placebo Placebo
Target Patients Patients with active ankylosing spondylitis Patients with active psoriatic arthritis
Expected Completion Q2-2018 Q2-2018
Publication TBD 52 week results: Manuscript to be submitted in Q3-2017

Study NCT01752634 (CAIN457F2312) NCT01892436 FUTURE 1 extension (CAIN457F2306E1)

Indication Psoriatic arthritis Psoriatic arthritis
Patients 400 500
Proportion of subjects that have a positive clinical response

Proportion of subjects achieving American College of
Primary Outcome Measures to treatment (individual improvement) in disease activity
Rheumatology 20 (ACR20) response criteria
according to ACR20 (or ACR50 or ACR 70)
Secukinumab (AIN457) 150 mg s.c.

Secukinumab (AIN457) 75 mg s.c. Secukinumab 75 mg
Arms/Intervention
Secukinumab (AIN457) 300 mg s.c. Secukinumab 150 mg
Placebo s.c.
Target Patients Patients with active psoriatic arthritis Patients with active psoriatic arthritis
Primary results: McInnes IB, et al. Lancet. 3 year results: ACR 2016; Mease PJ et al. Arthritis
Publication 2015;386:113746 Rheumatol. 2016; 68 (suppl 10)
2 years results: Submitted to Rheumatology in Q1-2017 3 years results: Manuscript to be submitted in Q4-2017

Study NCT03031782 (CAIN457F2304) NCT02745080 [EXCEED 1] (CAIN457F2366)

Indication Psoriatic Arthropathy Psoriatic Arthritis
Patients 80 850
Primary Outcome Measures Time to flare in treatment period 2 American College of Rheumatology 20 (ACR20) response
Secukinumab (AIN457 - pre-filled syringe) Secukinumab 300 mg s.c.

Arms/Intervention
Placebo Adalimumab 40 mg s.c.
Juvenile Idiopathic Arthritis subtypes of Psoriatic and

Target Patients Asthma patients
Enthesitis-related Arthritis
Publication TBD TBD

Study NCT02294227 FUTURE 4 (CAIN457F2336) NCT02471144 (CAIN457A2310)

Indication Psoriatic arthritis Psoriasis
Patients 318 160
Assessment of American College of The percentage of Participants achieving a 75% Improvement from
Rheumatology 20 (ACR20) Baseline in PASI Score at week 12
Secukinumab low dose

Secukinumab 150 mg with loading
Secukinumab high dose
Arms/Intervention Secukinumab 150 mg without loading
Placebo
Placebo
Etanercept (comparator)
Target Patients Patients with active psoriatic arthritis Patients from 6 to less than 18 years of age with severe chronic plaque
Marzo-Ortega, et al. Arthritis Care Res 2017 Feb 24. doi:

Publication TBD
10.1002/acr.23233

Study NCT01555125 FEATURE (CAIN457A2308) NCT01640951 (CAIN457A2304E1 extension study)

Indication Psoriasis Psoriasis
Patients 171 740
Psoriasis Area and Severity Index (PASI) 75 score and
Primary Outcome Measures Investigators' Global Assessment (IGA) with 0 or 1 The number and percentage of subjects having any AE
response
Fixed-time interval regimen secukinumab 150 mg
Secukinumab 150 mg Retreatment at start of relapse secukinumab 150 mg
Arms/Intervention Secukinumab 300 mg Fixed-time interval regimen secukinumab 300 mg
Placebo Retreatment at start of relapse secukinumab 300 mg
Open label secukinumab 300 mg
Patients with moderate to severe chronic plaque-type psoriasis
Target Patients Patients with chronic plaque-type psoriasis treated with either a fixed dose regimen or on a retreatment at
start of relapse regimen
3-years results: Planned submission in BJD in Q3-2017

52-weeks results: J Drugs Dermatol. 2016 Oct
Publication 5-years results: Planned submission in JEADV in Q3-2017
1;15(10):1226-1234
Planend submission to EADV 2017 (late-breaker)

Study NCT02748863 ALLURE (CAIN457A2323) NCT01544595 (CAIN457A2302E1 extension study)

Indication Psoriasis Psoriasis
Patients 210 1,144
Percentage of patients who achieve 75% reduction in Cumulative rate of subjects with loss of psoriasis area and
Primary Outcome Measures PASI and achieve IGA mod 2011 0 or 1 and improved by at severity index (PASI) 75 response; demonstrate long-term
least 2 points on the IGA scale compared to baseline efficacy, safety, and tolerability
Secukinumab 2 mL form
Secukinumab 150 mg or 300 mg
Arms/Intervention Secukinumab 1 mL form
Placebo
Placebo
Patients with moderate to severe chronic plaque-type

Target Patients Adult subjects with moderate to severe plaque psoriasis psoriasis completing preceding psoriasis phase III studies
with secukinumab
Expected Completion H2-2018 Q4-2017

2-years results: Br J Dermatol. 2017 May 12. doi:
Publication TBD 10.1111/bjd.15656
5-years results: TBD

Study NCT02696031 (CAIN457H2315) NCT02826603 CLARITY (CAIN457A2326)

Indication Non-radiographic Axial Spondyloarthritis Psoriasis
Phase Phase 3 Phase 3B
Patients 555 1,100
The proportion of participants who achieved an ASAS 40

response (Assessment of SpondyloArthritis International Psoriasis Area and Severity Index (PASI) will be
Society criteria); Evaluate the safety, tolerability and efficacy assessed/calculated as per usual standard
up to 2 years
Secukinumab 150 mg
Secukinumab 300 mg
Arms/Intervention Secukinumab 150 mg no load
Ustekinumab 45 mg/ 90 mg
Placebo
Target Patients Patients with non-radiographic axial spondyloarthritis Patients with moderate to severe plaque psoriasis
Publication TBD TBD

Ilaris - Anti IL-1
Study NCT02059291 CLUSTER (CACZ885N2301)

Indication Hereditary periodic fevers
Phase Phase 3
Patients 203
To demonstrate significant reduction of disease activity with canakinumab
vs. placebo
Canakinumab
Arms/Intervention
Placebo
Patients with, 3 separate disease cohorts TRAPS, HIDS, and colchicine
Target Patients
resistant FMF (Hereditary periodic fevers )
Expected Completion Q3-2017
Planned for presentation at PRES (Sep-2017) and ACR (Nov-2017)

congresses
Interim safety & efficacy in NEJM in Q4 2017
Publication
Quality-of-life manuscript publication submission target Q4-2017
(journal TBD)
Additional manuscripts in 2018

Ilaris - Anti IL-1
Study NCT02296424 (CACZ885G2306)
Indication SJIA - Systemic Juvenile Idiopathic Arthritis
Phase Phase 3B/4
Patients 182
Proportion of patients in clinical remission on canakinumab

Primary Outcome Measures who are able to remain at an initial reduced canakinumab
dose or prolonged canakinumab dose interval
Canakinumab dose reduction

Arms/Intervention
Canakinumab dose interval prolongation
Patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

Target Patients
(Pediatric)
Publication Manuscript to be submitted in Q3-2017

LJN452 - FXR Agonist
Study NCT02855164 (CLJN452A2202)
Indication Non-alcoholic steatohepatitis
Phase Phase 2
Patients 250
Adverse event profile of different doses; determine the dose
relationship of LJN42 on markers of hepatic inflammation in
Primary Outcome Measures NASH (ALT and AST); determine dose-response
relationship of LJN42 on liver fat content by changes in
quantitative MRI
Arms/Intervention Multiple LJN452 doses and placebo
Target Patients Patients with non-alcoholic steatohepatitis (NASH)
Publication TBD

QGE031 - Anti-IgE
Study NCT02649218 (CQGE031C2201)
Indication Chronic spontaneous urticaria
Phase Phase 2B
Patients 360
Long-term safety; number of participants with treatment-

emergent adverse events (AEs)
Arms/Intervention Multiple doses of QGE031
Target Patients Patients with Chronic Spontaneous Urticaria (CSU)
Publication TBD

Neuroscience
AMG334 CGRP Receptor Antagonist
Study NCT03096834 [LIBERTY] (CAMG334A2301)

Indication Migraine
Phase Phase 3
Patients 220
Percentage of patients with a 50% response in the reduction

of Monthly Migraine Days (MMD)
Subcutaneous injection of AMG334

Arms/Intervention
Subcutaneous injection of placebo
Adult episodic migraine patients who have failed prophylactic

Target Patients
migraine treatments
Expected Completion H1-2019
Publication TBD

CAD106 active Beta-amyloid immunotherapy
CNP520 BACE Inhibitor
Study NCT02565511 GENERATION S1 (CAPI015A2201J)

Indication Alzheimers disease
Phase Phase 2B/3
Patients 1,340
Time to diagnosis of MCI due to Alzheimer's disease or
dementia due to Alzheimer's disease
Change in the Alzheimer's Prevention Initiative Composite
Cognitive (APCC) Test Score
CAD106 450 g + Alum 450 g i.m.
Placebo to CAD106 + Alum 450 g i.m.
Arms/Intervention
CNP520 50 mg oral
Placebo to CNP520 oral
Cognitively unimpaired participants aged 60 to 75 years,

Target Patients
with two APOE4 allele (Homozygotes ).
Expected Completion 2023
Publication TBD

CNP520 BACE Inhibitor
Study NCT03131453 GENERATION S2 (CCNP520A2202J)

Indication Alzheimers disease
Phase Phase 2B/3
Patients 2,000
Time to diagnosis of MCI due to Alzheimer's disease or
dementia due to Alzheimer's disease
Change in the Alzheimer's Prevention Initiative Composite
Cognitive (APCC) Test Score
CNP520 15 mg oral
Arms/Intervention CNP520 50 mg oral
Placebo to CNP520 oral
Cognitively unimpaired participants aged 60 to 75 years,

with at least one APOE4 allele (Homozygotes or
Target Patients
Heterozygotes) and, if Heterozygotes, with evidence of
elevated brain amyloid.
Publication TBD

BAF312 - S1P-R modulator
Study NCT01185821 BOLD (CBAF312A2201E1) NCT01665144 -EXPAND (CBAF312A2304)

Indication Secondary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
Patients 297 1,530
Long-term safety and tolerability (emphasis on cardiovascular

The delay in time to confirmed disability progression as
Primary Outcome Measures events, viral infections, macular edema and dermatologic
measured by EDSS
alterations)
BAF312 10 mg
BAF312 2 mg BAF312 0.25 to 2 mg
Arms/Intervention
BAF312 0.5 mg Placebo
BAF312 dose between 0.1- 8 mg blinded
Patients (with relapsing-remitting Multiple Sclerosis)

Target Patients Patients with secondary progressive multiple sclerosis
completed the core study BAF312A2201
Expected Completion Q1-2017 Core in 2016/Extension in 2023
Krzysztof Selmaj et al, Siponimod for patients with relapsing-

Presentations at ECTRIMS and AAN 2017
Publication remitting multiplesclerosis (BOLD): an adaptive, dose-ranging,
Journal (TBD) by Q4-2017.
randomised, phase 2 study, Lancet, 2013

BYM338 - Activin receptor II B
Study NCT02333331 InvestiGAIT (CBYM338E2202) NCT02152761 (CBYM338D2201)
Indication Sarcopenia Hip fracture recovery
Phase Phase 2B Phase 2B
Patients 280 245

Evaluate improvement in physical performance (Change
Change from baseline in total lean body mass measured by
Primary Outcome Measures from baseline at week 24 in Short Physical Performance
DXA at week 24
Battery)
Bimagrumab low dose Bimagrumab low dose
Bimagrumab moderate dose Bimagrumab moderate dose
Arms/Intervention
Bimagrumab high dose Bimagrumab high dose
Placebo Placebo
Target Patients Older adults with sarcopenia Patients after surgical treatment of hip fracture
Publication TBD TBD

EMA401 - Angiotensin II type 2 receptor antagonist
Study NCT03094195 EMPHENE (CEMA401A2201)

Indication Treatment of Peripheral Neuropathic Pain
Phase Phase 2
Patients 360
Dose-response in change in weekly mean of the 24-hour

average pain score from Baseline to Week 12
EMA401 25mg BID, 100mg BID, 300mg BID

Arms/Intervention
Placebo
Target Patients Post-herpetic neuralgia patients
Publication TBD

Gilenya - S1P-R modulator
Study NCT01892722 PARADIGMS (CFTY720D2311) NCT01201356 (CFTY720D2399)
Indication Pediatric Multiple Sclerosis Relapsing Multiple Sclerosis (RMS)
Phase Phase 3B Phase 3B/4
Patients 190 4,133
Frequency of relapses in patients treated for up to 24

Primary Outcome Measures Long-term safety and tolerability
months (using ARR)
Interferon beta-1a i.m.

Arms/Intervention Single-arm study of Fingolimod 0.5 mg/day
Fingolimod 0.5 mg/ 0.25 mg
Pediatric patients with multiple sclerosis with five-year

Target Patients Patients with relapsing multiple sclerosis
fingolimod Extension Phase
Publication TBD TBD

Gilenya - S1P-R modulator
Study NCT01633112 ASSESS (CFTY720D2312)
Indication Relapsing Remitting Multiple Sclerosis (RRMS)
Phase Phase 3B
Patients 1,960
Comparison of 2 doses (0.25 mg and .5 mg) of fingolimod to

Primary Outcome Measures glatiramer acetate (20 mg) in reducing the annualized
relapse rate up to 12 months
Fingolimod 0.5 mg orally

Arms/Intervention Fingolimod 0.25mg orally
Copaxone 20 mg s.c.
Target Patients Patients with relapsing-remitting multiple sclerosis
Publication TBD

OMB157 - Anti-CD20
Study NCT02792218 Asclepios I (COMB157G2301) NCT02792231 Asclepios II (COMB157G2302)

Indication Multiple Sclerosis Multiple Sclerosis
Patients 900 900
Annualized Relapse Rate (ARR) - number of confirmed Annualized Relapse Rate (ARR) - number of confirmed
Primary Outcome Measures relapses in a year calculated based on cumulative number relapses in a year calculated based on cumulative number
of relapses by patient adjusted for time-in-study by patient of relapses by patient adjusted for time-in-study by patient
Ofatumumab subcutaneous Ofatumumab subcutaneous

Arms/Intervention
Teriflunomide oral Teriflunomide oral
Target Patients Patients with relapsing forms of multiple sclerosis Patients with relapsing forms of multiple sclerosis
Publication TBD TBD

Oncology
Afinitor - Inhibition of mTOR
Study NCT01524783 RADIANT-4 (CRAD001T2302) NCT01713946 EXIST-3 (CRAD001M2304)

Indication Non-functional carcinoid tumors Tuberous sclerosis complex (TSC)
Patients 302 355
PFS is defined as the time from randomization to the date of

the first documented tumor progression as per modified
Percentage reduction from baseline in partial onset seizure
Primary Outcome Measures RECIST 1.0 or death from any cause, whichever comes first.
frequency during maintenance period of the core phase
Progression is assessed by cat scan (CT) and/or magnetic
resonance imaging (MRI)
Everolimus (titrated to 3-7 ng/mL)

Everolimus + BSC (10mg daily)
Arms/Intervention Everolimus (titrated to 9-15 ng/mL)
Everolimus placebo + BSC
Placebo
Patients with tuberous sclerosis complex (TSC) who have

Target Patients Patients with advanced NET of GI or lung origin
refractory partial-onset seizures

Publication Yao JC, et al. Lancet. 2016;387:968-977 French JA, et al. Lancet. 2016;388:2153-2163

Afinitor - Inhibition of mTOR
Study NCT01783444 BOLERO-6 (CRAD001Y2201)

Indication ER+ breast cancer 2nd / 3rd line
Phase Phase 2
Patients 300
To estimate the hazard ratio of PFS for everolimus plus

exemestane versus everolimus alone. Progression Free
Survival (PFS) Time Frame: 28 months after first patient
randomized or once 150 PFS have occurred.
Capecitabine monotherapy (1250mg/m2 twice daily)

Arms/Intervention Everolimus monotherapy (10mg daily)
Everolimus (10mg daily) with exemestane (25mg daily)
Postmenopausal women with estrogen resceptor position,

Target Patients locally advanced, recurrent, or metastatic breast cancer after
recurrence or progression on prior letrozole or anastrozole
Publication Q2-2018

Arzerra - CD20
Study NCT01077518 COMPLEMENT A+B (COMB157E2301)
Indication Refractory iNHL (3rd Line)
Phase Phase 3A
Patients 346
Progression-free-survival following ofatumumab and

bendamustine combination therapy
Ofatumumab and Bendamustine infusions

Arms/Intervention
Bendamustine infusion
Patients with indolent B-cell non-Hodgkin's lymphoma

Target Patients unresponsive to rituximab or a rituximab-containing regimen
during or within six months of treatment
Publication Targeting congress in Q2-2018 (tbc)

BYL719 - Alpha-specific PI3K inhibitor
Study NCT02437318 SOLAR-1 (CBYL719C2301)

Indication HR + mBC
Phase Phase 3
Patients 560
Progression-free survival (PFS) for patients with PIK3CA

mutant status
Fulvestrant 500 mg + alpelisib 300 mg

Arms/Intervention
Fulvestrant 500 mg + placebo
Men and postmenopausal women with hormone receptor

Target Patients positive, HER2-negative advanced breast cancer which
progressed on or after aromatase inhibitor treatment

Publication TBD

CTL019 CAR-T therapy
Study NCT02445248 JULIET (CCTL019C2201) NCT02435849 ELIANA (CCTL019B2202)

Indication Relapsed / refractory DLBCL Relapsed/ refractory ALL
Patients 114 100
Overall remission rate (ORR) - overall remission rate during

the 6 months after CTL019 administration, which includes
Primary Outcome Measures Overall response rate; efficacy and safety of CTL019
CR and CR with incomplete blood count recovery (CRi) as
determined by IRC assessment
Arms/Intervention Single-arm study of CTL019 Single-arm study of single dose of CTL019
Adult patients with relapsed or refractory diffuse large B-cell Pediatric and young adult patients with relapsed and
Target Patients
lymphoma (DLBCL) refractory B-cell acute lymphoblastic leukemia
Schuster et al. at ICML 2017; Bishop et al update at ASH Grupp et al. Presented at ASH 2016; Buchner et al
Publication 2017; Interim Analysis update at EHA 2017;
Journal TBD in Q4-2017 Publication submission in Q3 2017

Exjade - Iron chelation of bis-hydroxy-phenyl triazole type
Study NCT00940602 TELESTO (CICL670A2302)
Indication Iron Overload
Phase Phase 2
Patients 224
To compare deferasirox to placebo with regard to event-free

Primary Outcome Measures survival in low and int-1 risk MDS patient with transfusional
iron overload
Deferasirox, iron chelator

Arms/Intervention
Placebo
Patients with myelodysplastic syndromes (low/int-1 risk) and

Target Patients
transfusional iron overload (TELESTO)
Publication Congress in Q4-2018, Journal TBD

Farydak - Histone Deacetylase (HDAC) inhibitor
Study NCT02654990 PANORAMA-3 (CLBH589D2222)

Indication Multiple myeloma
Phase Phase 2
Patients 240
Primary Outcome Measures Overall response rate (ORR) up to 8 cycles
20mg panobinostat three times a week

Arms/Intervention 20mg panobinostat twice a week
10mg panobinostat three times a week
Patients with relapsed or relapsed/refractory multiple

Target Patients myeloma who have been previously exposed to
immunomodulatory agents
Publication TBD

INC280 - cMET Inhibitor
Study NCT02468661 (CINC280B2201) NCT02414139 (CINC280A2201)

EGFR mutated advanced/metastatic Non-small Cell EGFR Wild-type, ALK negative advanced Non-small Cell Lung
Indication
Lung Cancer (NSCLC) Cancer (NSCLC)
Phase Phase 1B/2 Phase 2
Patients 135 318
Phase Ib: Frequency and characteristics of Dose
Limiting Toxicity (DLTs) to the INC280 and erlotinib
Primary Outcome Measures Overall Response Rate (ORR)
combination;
Phase II: Progression-free Survival (PFS
Pre-treated pts. with cMET GCN 6
INC280 single agent
Pre-treated pts. with cMET GCN 4 and < 6
INC280 in combination with erlotinib
Arms/Intervention Pre-treated pts. with cMET GCN < 4
Platinum in combination with pemetrexed
Pre-treated pts. with cMET mutations regardless of cMET GCN
(comparator)
Treatment-nave pts. with cMET dysregulation
Adult patients with EGFR wild-type (wt), ALK-negative advanced non-
Adult patients with EGFR mutation (L858R and /or
small cell lung cancer (NSCLC) with either cMET amplification or
ex19del), cMET-amplified, locally
Target Patients cMET mutations and are either pretreated with 1 or 2 prior lines of
advanced/metastatic nonsmall cell lung cancer
systemic therapy or are treatment-nave for the advanced stage of
(NSCLC) with acquired resistance to EGFR TKI
disease
Publication Congress presentation in Q2-Q3 2018 Congress presentation in Q2-Q3 2018

Jakavi - JAK1/2 inhibitor
Study NCT02913261 REACH2 (CINC424C2301)

Indication Steroid-Refractory Acute Graft vs. Host Disease (SR aGVHD)
Phase Phase 3
Patients 308
Primary Outcome Measures Overall Response Rate (ORR) at 28 Days
Ruxolitinib 10mg BID

Arms/Intervention
Best Available Therapy (BAT)
Target Patients Patients with Steroid-refractory Acute GVHD (SR aGVHD)
Publication TBD

Kisqali - CDK 4/6 inhibitor
Study NCT01958021 MONALEESA-2 (CLEE011A2301) NCT02278120 MONALEESA-7 (CLEE011E2301)

Indication Advanced breast cancer - 1st line (with letrozole) Advanced breast cancer - 1st line (pre-menopausal)
Patients 668 672
Progression Free Survival (PFS) - time from the date of

randomization to the date of the first documented
Primary Outcome Measures randomization to the date of the first documented
progression or death due to any cause and assessed
progression or death due to any cause
according to RECIST 1.1
LEE011 600 mg + letrozole 2.5 mg LEE011 600 mg + NSAI/tamoxifen + goserelin 3.6 mg

Arms/Intervention
Placebo + letrozole 2.5 mg Placebo of LEE011 + NSAI/tamoxifen + goserelin 3.6 mg
Postmenopausal women with hormone receptor positive,

Premenopausal women with hormone receptor positive,
Target Patients HER2 negative, advanced breast cancer who received no
HER2-negative, advanced breast cancer
prior hormonal therapy for advanced disease

Publication Hortobagyi et al. N Engl J Med. 2016;375(18):1738-1748 H1-2018

Kisqali - CDK 4/6 inhibitor
Study NCT02422615 MONALEESA-3 (CLEE011F2301) NCT03078751 EarLEE-1 (CLEE011G2301)

Indication Advanced breast cancer 1st / 2nd line (with fulvestrant) Adjuvant Breast cancer, High Risk
Patients 727 2,000

To compare invasive disease-free survival (iDFS) using
Primary Outcome Measures randomization to the date of the first documented
STEEP criteria
progression or death due to any cause
Riblociclib 600mg + fulvestrant 500mg Ribociclib 600 mg + Endocrine Therapy

Arms/Intervention
Placebo of Riblociclib + fulvestrant 500mg Placebo + Endocrine Therapy
Postmenopausal women with hormone receptor positive,

Patients with hormone receptor-positive, HER2-negative,
Target Patients HER2-negative, advanced breast cancer who have received
high risk early breast cancer
no or only one line of prior endocrine treatment

Publication Q2-2018 TBD

LCI699 - Hydroxylase inhibitor
Study NCT02697734 LINC-4 (CLCI699C2302) NCT02180217 LINC-3 (CLCI699C2301)
Indication Cushing's disease Cushing's disease
Patients 69 132
Demonstrate the superiority of osilodrostat compared to

Compare the complete response rate at the end of the 8-
Primary Outcome Measures placebo in achieving a complete response mean urine free
week period
cortisol upper limit of normal (mUFC ULN) at Week 12
Osilodrostat
Arms/Intervention Single-arm LCI699
Placebo
Target Patients Patients with Cushing's disease Patients with Cushing's disease
Publication TBD TBD

Mekinist - MEK-inhibitor
Study NCT01245062 METRIC (CTMT212A2301)

Indication Melanoma
Phase Phase 3A
Patients 297
Progression-free Survival in BRAF V600E mutation-positive

Primary Outcome Measures participants without a history of brain metastases as
assessed by the investigator and independent review
MEK inhibitor
Arms/Intervention Chemotherapy
Crossover
Patients with advanced or metastatic BRAF V600E/K

Target Patients
mutation-positive melanoma
Flaherty KT, et al. Improved survival with MEK inhibition in

Publication BRAF-mutated melanoma. N Engl J Med. 2012 Jul
12;367(2):107-14

PDR001 PD-1 inhibitor
Study NCT02955069 (CPDR001E2201) NCT02967692 (CPDR001F2301)

Neuroendocrine tumors of pancreatic,
Indication Metastatic melanoma
gastrointestinal or thoracic origin
Patients 90 538
Incidence of dose limiting toxicities (DLTs) , immune
Primary Outcome Measures Overall response rate microenvironment and biomarker modulation and Progression-Free
Survival (PFS)
PDR001 + Tafinlar + Mekinist

Arms/Intervention Single arm
Placebo + Tafinlar + Mekinist
Patients with advanced or metastatic non-functional Previously untreated patients with unresectable or metastatic BRAF
Target Patients neuroendocrine tumors of pancreatic, gastrointestinal V600 mutant melanoma
(GI), or thoracic origin

Publication TBD TBD

PKC412 - Multi-targeted kinase inhibitor
Study NCT00651261 RATIFY (CPKC412A2301)

Indication AML
Phase Phase 3
Patients 717
Primary Outcome Measures Overall survival
Induction and consolidation chemotherapy plus

Arms/Intervention midostaurin
Induction and consolidation chemotherapy plus placebo
Newly diagnosed patients < 60 years of age with FLT3

Target Patients
mutated acute myeloid leukemia (AML)
R. Stone et al, ASH2015, Abstract No 6

Publication
Manuscript published NEJM Online First, June 23, 2017

SIGNIFOR - Somatostatin Analogue
Study NCT01915303 CAPACITY (CSOM230B2411) NCT02354508 SWITCH (CSOM230C2413)

Indication Cushing's disease Acromegaly
Patients 64 112
Proportion of patients who attain mUFC 1.0 ULN at week Proportion of patients who achieve biochemical control
35 with pasireotide alone or in combination with cabergoline defined as GH <1g/L and IGF-1 <ULN at week 36.
Pasireotide +/- Cabergoline Pasireotide LAR (40 mg)

Arms/Intervention
Pasireotide alone or with Cabergoline Pasireotide LAR (up-titrated 60 mg)
Patients with persistent or recurrent Cushings disease or

Target Patients patients with de novo Cushings disease that are not Patients with inadequately controlled acromegaly
considered candidates for pituitary surgery

Feelders R, et al., ENDO2017 Late Breaker Abstract 57
Publication TBD
Publication submission Q4-2017

Tafinlar+Mekinist - BRAF inhibitor and MEK inhibitor
Study NCT01978236 GSK116521 (CDRB436B2202) NCT01072175 Study 220 (CDRB436B2201)
Indication Melanoma and Brain Metastases Melanoma
Phase Phase 2B Phase 2B
Patients 30 430
Safety, pharmacokinetics, pharmacodynamics and clinical activity of the
Concentrations and tissue distribution of
Primary Outcome Measures BRAF inhibitor dabrafenibin combination with the MEK inhibitor
dabrafenib and its metabolites
trametinib
Dabrafenib 75 mg
Dabrafenib 150 mg Trametinib 2 mg
Arms/Intervention
Trametinib 2 mg Dabrafenib 75 mg + trametinib 2mg
+ dose escalation
Patients with BRAF mutation-positive metastatic

Target Patients Patients with BRAF mutant metastatic melanoma
melanoma to the brain
Expected Completion Q3-2017 H2-2018
Publication TBD Flaherty KT, et al. N Engl J Med. 2012 Nov;367(18):1694-703

Study NCT01227889 BREAK-3 (CDRB436A2301) NCT01336634 (CDRB436E2201)
Indication Melanoma NCSLC
Phase Phase 3A Phase 2A
Patients 200 124
Progression-free Survival (PFS) as assessed by the

Primary Outcome Measures Overall response rate (ORR)
investigator
Dabrafenib150 mg
Dabrafenib 150 mg
Arms/Intervention Intravenous dacarbazine (DTIC) 1000 mg/m2
Dabrafenib 150 mg + trametinib 2 mg
Crossover dabrafenib150 mg
Previously untreated subjects with BRAF mutation positive Subjects with BRAF V600E mutation positive metastatic
Target Patients
advanced (Stage III) or metastatic (Stage IV) melanoma (stage IV) non-small cell lung cancer
Publication Hauschild A, et al. Lancet. 2012 Jul 28;380(9839):358-65 Congress in Q3-2017

Study NCT01682083 (CDRB436F2301)
Indication Adjuvant Melanoma
Phase Phase 3A
Patients 852
Primary Outcome Measures Relapse-free survival (RFS)
Dabrafenib 150 mg + trametinib 2 mg

Arms/Intervention
Placebo
Subjects with high-risk BRAF V600 mutation-positive

Target Patients
melanoma after surgical resection
Publication Congress in Q3-2017

Study NCT01677741 (CDRB436A2102)
Indication Melanoma
Phase Phase 1
Patients 60
Primary Outcome Measures Safety, tolerability and pharmacokinetics
Arms/Intervention Single-arm study of oral dabrafenib
Pediatric Subjects Aged 1 Month to <18 Years with

Target Patients
Advanced BRAF V600-Mutation Positive Solid Tumors
Publication TBD

Study NCT02039947 COMBI-MB (CDRB436B2204)
Indication Melanoma
Phase Phase 2B
Patients 120
Primary Outcome Measures Intracranial response (IR) rate
Arms/Intervention Dabrafenib 150 mg + trametinib 2 mg
Patients with BRAF mutation-positive melanoma that has

Target Patients
metastasized to the brain
Publication Davies M et al. ASCO 2017

Tasigna - Bcr-Abl, c-Kit and PDGF-R tyrosine kinase inhibitor
Study NCT01698905 ENESTop (CAMN107A2408) NCT01784068 ENEST Freedom (CAMN107I2201)

Indication Newly Diagnosed CML/CML-TFR CML-TFR
Patients 117 175
Percentage of patients who are in MMR (major molecular

No documented confirmed loss of MR4, no documented
Primary Outcome Measures response) at 48 weeks after starting the treatment-free
loss of MMR and no re-starting of nilotinib therapy
remission (TFR) phase
Arms/Intervention Single-arm study of nilotinib Single-arm study of nilotinib followed by treatment-free
Adult CML-CP patients who received a minimum of 3 years

of TKI therapy, started off with imatinib treatment for > 4 Patients with BCR-ABL1 positive Chronic Myelogenous
weeks, then switched to nilotinib for at least 2 years prior to Leukemia in chronic phase who have achieved durable
Target Patients
study entry and achieved MR4.5 on nilotinib, but did not minimal residual disease (MRD) status on first line nilotinib
have documented MR4.5 at the time of switch from imatinib treatment
to nilotinib

Publication Hughes TP, et al. J Clin Oncol. 2016;34 [abstract 7054] Hochhaus A, et al. Leukemia. 2016 Jan; 30(1): 5764

Tasigna - Bcr-Abl, c-Kit and PDGF-R tyrosine kinase inhibitor
Study NCT01844765 DIALOG (CAMN107A2203)

Indication Newly diag. CML and CML res/intol to imatinib/dasatinib
Phase Phase 2
Patients 70
Rate of Major Molecular Responder (MMR) by BCR-ABL RQ-PCR

analysis from peripheral blood by 12 cycles
Newly diagnosed and untreated Ph+ CML in first chronic phase

Arms/Intervention Resistant/intolerant Ph+ CML in chronic phase
Resistant/intolerant Ph+ CML in accelerated phase
Pediatric patients with newly diagnosed Ph+ chronic myelogenous

leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or
Target Patients
accelerated phase (AP) resistant or intolerant to either imatinib or
dasatinib

Publication Congress/journal TBD in Q3-2017
Tykerb - HER2 inhibitor
Study NCT01160211 ALTERNATIVE (CLAP016A2307)

Indication HER2+ breast cancer
Phase Phase 3A
Patients 369
Progression free survival (PFS) of lapatinib/ trastuzumab/

Primary Outcome Measures aromatase inhibitor (AI) combination vs. trastuzumab/ AI
combination
Lapatinib plus trastuzumab plus aromatase inhibitor

Arms/Intervention Trastuzmab plus aromatase inhibitor
Lapatinib plus aromatase inhibitor
Patients with hormone receptor positive, HER2-positive

Target Patients metastatic breast cancer (MBC) who have received prior
trastuzumab and endocrine therapies

ASCO 2017. Gradishar et al. J Clin Oncol. 2017; 35: suppl;
Publication Abs 1004.
Primary Manuscript H2-2017
Votrient - Inhibition of VEGFR, PDGFR
Study NCT00720941 COMPARZ (CPZP034A2301) NCT01235962 PROTECT (CPZP034D2301)

Indication RCC RCC adjuvant
Phase Phase 3B Phase 3A
Patients 876 1,500
Progression-free Survival (PFS) - interval between the date

of randomization and the earliest date of progressive
Primary Outcome Measures Disease-free survival
disease (PD), as defined by the Independent Review
Committee (IRC) or death due to any cause
Pazopanib 800 mg Pazopanib 600 mg/800 mg

Arms/Intervention
Sunitinib 50 mg Placebo
Patients with locally advanced and/or metastatic renal cell Subjects with localized or locally advanced RCC following
Target Patients
carcinoma nephrectomy
Expected Completion H2-2018 2019
Motzer RJ, et al. Pazopanib vs. sunitinib in metastatic renal- Motzer R, et al, J Clin Oncol. 2017;35:suppl; Abstract 4507.;
Publication
cell carcinoma. N Engl J Med. 2013;369:722731 Journal TBD in Q3-2017
Votrient - Inhibition of VEGFR, PDGFR
Study NCT01147822 COMPARZ (CPZP034A2201) NCT02014636 (CPZP034A2101)

Indication RCC RCC
Phase Phase 2B Phase 1
Patients 175 228
Progression-free Survival (PFS) - interval between the date

of randomization and the earliest date of progressive Incidence and severity of adverse events (AEs) and serious
disease (PD), as defined by the Independent Review adverse events (SAEs ); Progression-free survival (PFS)
Committee (IRC), or death due to any cause
Dose escalation phase: pazopanib and MK 3475

Pazopanib 800 mg
Arms/Intervention Randomized phase: pazopanib monotherapy
Sunitinib 50 mg
pazopanib+MK-3475 MK-3475 monotherapy
Target Patients Advanced RCC patients from Asian Patients with advanced renal cell carcinoma
Publication Journal TBD in Q3-2017 Congress presentation Q4-2017
Zykadia - ALK inhibitor
Study NCT02040870 ASCEND-6 (CLDK378A2109) NCT02336451 ASCEND-7 (CLDK378A2205)
Indication ALK activated NSCLC after crizotinib failure ALK activated NSCLC metastatic to the brain
Patients 103 160
Overall response rate (ORR)- the proportion of patients with

Pharmacokinetics of LDK378 after daily oral dose; safety
Primary Outcome Measures a best overall confirmed response of CR or PR in the whole
and tolerability
body as assessed per RECIST 1.1 by the investigator
Arms/Intervention Single-arm study of LDK378 750 mg Five-arm study of LDK378 (ceritinib) 750 mg
Adult Chinese patients with ALK-rearranged

Patients with ALK-activated non-small cell lung cancer
Target Patients (ALK-positive) advanced non-small cell lung cancer
(NSCLC) metastatic to the brain and/or to leptomeninges
(NSCLC) previously treated with Crizotinib
Zhang L, et al. Presented at ESMO-Asia 2016; abstract

Publication 1035 Congress presentation Q3-Q4 2018
Journal TBD in Q3-2017
Study NCT01828099 ASCEND-4 (CLDK378A2301) NCT02465528 (CLDK378A2407)
Indication ALK activated 1st line NSCLC ALK activated rare tumors
Patients 376 106
Progression Free Survival (PFS) - time from date of

Primary Outcome Measures randomization to date of first documented disease or date of Disease Control Rate (DCR) based on local assessments
death due to any cause
LDK378 750 mg
Arms/Intervention Multi-arm study of ceritinib (LDK378)
Pemetrexed + cisplatin or pemetrexed + carboplatin
Patients with advanced solid tumors and hematological

1st line adult patients with ALK rearranged (ALK-positive),
Target Patients malignancies characterized by genetic abnormalities of
stage IIIB or IV, non-squamous non-small cell lung cancer
anaplastic lymphoma kinase
Publication Soria JC, et al. Lancet. 2017 Jan. 389(10072):917-929 TBD
Study NCT01685138 ASCEND-3 (CLDK378A2203) NCT01828112 ASCEND-5 (CLDK378A2303)
Indication ALK activated NSCLC crizotinib naive + post chemotherapy ALK activated NSCLC after crizotinib failure
Patients 126 231

Overall response rate (ORR) to LDK378 by investigator
Primary Outcome Measures randomization to the date of the first radiologically
assessment
documented disease progression or death due to any cause
Oral LDK378 750 mg once daily

Arms/Intervention Single-arm study of oral LDK378 750 mg
Pemetrexed/ docetaxel
Adult patients with ALK-rearranged (ALK-positive) advanced

Crizotinib naive adult patients with ALK-activated non-small non-small cell lung cancer who have been treated
Target Patients
cell lung cancer post chemotherapy previously with chemotherapy (platinum doublet) and
crizotinib
Felip E, et al. Presented at ESMO 2016; abstract 1208O Shaw AT, et al. Lancet Oncology. 2017 Jun (epub ahead
Publication
Journal TBD in Q2-2018 of print)
Ophthalmology
Lucentis - Anti-VEGF
Study NCT02375971 RAINBOW (CRFB002H2301)

Indication Retinopathy of Prematurity (ROP)
Phase Phase 3
Patients 180
To achieve absence of active Retinopathy of Prematurity

(ROP) and unfavorable structural outcome, patients must
Primary Outcome Measures fulfill all the following criteria, 1) survival, 2) no intervention
with a second modality for ROP, 3) absence of active ROP
and 4) absence of unfavorable structural outcome
Ranibizumab 0.2 mg
Arms/Intervention Ranibizumab 0.1 mg
Laser therapy
Male and female preterm infants with bilateral retinopathy of

Target Patients
prematurity (ROP) who require treatment.
Publication 2019
108| Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation
RTH258 - Anti-VEGF
Study NCT02434328 HARRIER (CRTH258A2302) NCT02307682 HAWK (CRTH258A2301)

Indication nAMD nAMD
Patients 860 990
Change in Best Corrected Visual Acuity (BCVA) from Change in Best Corrected Visual Acuity (BCVA) from
baseline at week 48 baseline at week 48
RTH258 (3 mg/50 L)
RTH258 (6 mg/50 L)
Arms/Intervention RTH258 (6 mg/50 L)
Aflibercept (2 mg/50 L)
Aflibercept
Target Patients Subjects with exudative age-related macular degeneration Subjects with exudative age-related macular degeneration
Publication Abstract/presentation at AAO meeting in November 2017 Abstract/presentation at AAO meeting in November 2017
Respiratory
QAW039 - CRTh2 antagonist
Study NCT02555683 (CQAW039A2307) NCT02563067 (CQAW039A2314)
Indication Asthma Asthma
Patients 846 846
Reduction in the rate of moderate-to-severe asthma Reduction in the rate of moderate-to-severe asthma
exacerbations exacerbations
QAW039 Dose 1 QAW039 Dose 1

Arms/Intervention QAW039 Dose 2 QAW039 Dose 2
Placebo Placebo
Target Patients Patients with uncontrolled severe asthma Patients with uncontrolled severe asthma
Publication TBD TBD
QAW039 - CRTh2 antagonist
Study NCT03052517 (CQAW039A2315)

Indication Asthma
Phase Phase 3
Patients ~2300
Long term safety: treatment emergent adverse event (AE),

Primary Outcome Measures SAE and AE leading to discontinuation from study (52 wks
and 160 wks)
QAW039 Dose 1
Arms/Intervention QAW039 Dose 2
Placebo
Target Patients Patients with Moderate to Severe asthma
Publication TBD
QVM149 - LA beta2 agonist, LA muscarinic antagonist, ICS
Study NCT02554786 (CQVM149B2301) NCT02571777 (CQVM149B2302)

Patients 2,800 3,155
Primary Outcome Measures Trough FEV1 Trough FEV1
QMF149 150/160 g QVM149 150/50/160 g

QMF149 150/320 g QVM149 150/50/80 g
Arms/Intervention MF 400 g QMF149 150/160 g
MF 400 g QMF149 150/320 g
Salmeterol 50 g /fluticasone 500 g Salmeterol 50 g /fluticasone 500 g
Adult and adolescent patients with uncontrolled asthma despite Adult patients with uncontrolled asthma despite med/high-
Target Patients
med-/high-dose ICS or low-dose ICS/LABA(GINA step 3) dose ICS/LABA (GINA 4)
Publication TBD TBD
QMF149G - Long-acting beta2 agonist and inhaled corticosteroid
Study NCT02892019 (CQMF149G2202)

Indication Asthma
Phase Phase 2
Patients 80
Primary Outcome Measures Trough FEV1
Indacaterol acetate 75 g (via Concept1 inhaler)

Arms/Intervention
Indacaterol acetate 150 g (via Concept1 inhaler)
Children greater or equal to 6 and less than 12 years of age

Target Patients
with asthma
Publication TBD
Study NCT03100500 (CQVM149B1305) NCT03137784 (CQVM149B2204)

Patients 66 144
Number of patients who reported treatment emergent Evaluate the bronchodilator effects of NVA237 (25 ug and
adverse events during the 52 weeks of the study 50 ug) compared to placebo in terms of trough FEV1
NVA237 (glycopyrronium bromide) 25/50 g

Arms/Intervention Single Arm: QMF149 150/320 g once daily
Placebo
Target Patients Japanese patients with Asthma Asthma patients
Expected Completion H1-2019 Q2-2018
Publication TBD TBD
Study NCT03100825 (CQVM149B1304)

Indication Asthma
Phase Phase 3
Patients 100
Number of patients who reported treatment emergent

adverse events during the 52 weeks of the study
Single Arm: QVM149 150/50/160 g once daily

Arms/Intervention
(Concept1 inhaler)
Target Patients Japanese patients with Asthma
Publication TBD
Seebri - LA muscarinic receptor antagonist
Study NCT02371629 (CNVA237A2320)
Indication COPD
Phase Phase 3B/4
Patients 752
Trough Forced Expiratory Volume in 1 Second (FEV1) at
week 12
NVA237 once daily

Arms/Intervention
NVA237 twice daily
Patients with moderate and severe chronic obstructive

Target Patients
pulmonary disease
Publication TBD
Sandoz
Biopharmaceuticals
Erelzi - Biosimilar etanercept
Study NCT02638259 (GP15 301)

Indication Immunology
Phase Phase 3
Patients 366
Primary Outcome Change in DAS28-CRP score from baseline to week 24 in

Measures patients treated with GP2015 and patients treated with Enbrel
GP2015 50 mg
Arms/Intervention
EU-authorized Enbrel 50mg
Target Patients Patients with moderate to severe, active rheumatoid arthritis
Publication Presentation/poster at ACR Q4-2017
Rixathon - Biosimilar rituximab
Study NCT02514772 (GP13 302) NCT01419665 (GP13 301)
Indication Immunology Oncology
Patients 107 629
Incidence of adverse events and serious adverse events,

Primary Outcome Measures Overall response rate in patients with FL
anaphylactic reactions, hypersensitivity; immunogenicity
GP2013 10 mg/mL GP2013

Arms/Intervention
Rituxan or MabThera 10 mg/mL MabThera
Patients with active Rheumatoid Arthritis, previously treated Patients with previously untreated, advanced stage follicular
Target Patients
with Rituxan or MabThera (ASSIST-RT) lymphoma (ASSIST-FL)

ASH Poster 2016, Manuscript accepted in Lancet
Publication ACR Q4-2017 Poster; Manuscript planned Q4-2017
Hematology (Jun-2017)
Rixathon - Biosimilar rituximab
Study NCT01274182 (GP13 201)
Indication Immunology
Phase Phase 2
Patients 312
Compare pharmacokinetics (PK) of GP2013 and rituximab

following IV infusion in patients with RA
GP2013 1000 mg
Arms/Intervention
Rituxan and MabThera 1000 mg
Patients with rheumatoid arthritis refractory or intolerant to

Target Patients standard DMARDs and one or up to three anti-TNF
therapies
Published in Annals of Rheumatic Disease (doi:10.1136/
Publication annrheumdis-2017-211281); ACR Poster 2016;
ACR Poster 2016
GP2017 - Biosimilar adalimumab
Study NCT02016105 ADACCESS (GP17-301) NCT02744755 ADMYRA (GP17-302)

Indication Immunology Immunology
Patients 465 353
PASI 75 response rate at week 16 in patients treated with Change in DAS28-CRP score from baseline to week 12 in
Primary Outcome
GP2017 and patients treated with Humira patients treated with GP2017 and patients treated with
Measures
Humira
GP2017 GP2017
Arms/Intervention
Humira Adalimumab US licensed Humira Adalimumab
Patients with moderate to severe chronic plaque-type
Target Patients Patients with moderate to severe active rheumatoid arthritis
psoriasis
Abstract and poster at AAD 2017, EADV 2017, ACG 2017,

Publication UEGw 2017, ACR 2017, EULAR 2018 TBD
Manuscript with study results journal TBD in 2017/2018
Established Medicines
and Anti-infectives
Tobramycin An aminoglycoside antibiotic derived from
Streptomyces tenebrarius
Study NCT02712983 iBEST-1 (CTBM100G2202)

Indication Bronchiectasis
Phase Phase 2
Patients 180
Primary Outcome Measures P. aeruginosa density in sputum
Three dose regimens, each of them having 3 treatment

arms:
Arms/Intervention Tobramycin inhalation powder
Tobramycin inhalation powder and placebo
Placebo
Patients with non-cystic fibrosis bronchiectasis and

Target Patients
pulmonary P. aeruginosa infection
Publication TBD
Key definitions and trademarks
This presentation contains several important words or phrases that we define as below:
ADHF: Acute decompensated heart failure HR+/HER2- mBC: Hormone Receptor positive / Human Epidermal growth factor receptor 2 negative
AE: Adverse Event metastatic breast cancer
ALK: Anaplastic lymphoma kinase LoE: Loss of exclusivity
ALL: Acute lymphatic leukemia MI: Myocardial infarction
AMD: Age-Related Macular Degeneration MS: Multiple sclerosis
AMI: Acute myocardial infection NASH: Non-Alcoholic Steatohepatitis
AML: Acute myeloid leukemia NET: Neuroendocrine tumor
Approval: In Pharmaceuticals and Alcon in US and EU; each indication and regulator combination counts New assets: Assets acquired in the GSK transaction which closed on March 2, 2015
as approval; excludes label updates, CHMP opinions alone and minor approvals NSAI: Nonsteroidal aromatase inhibitor
aRCC: advanced renal cell cancer NSCLC: Non-small cell lung cancer
ARNI: Antiogensin receptor neprilysin inhibitor NTD: New Therapeutic Drug
AS: Ankylosing Spondylitis ORR: Overall response rate
ASM: Aggressive systemic mastocytosis OS: Overall survival
ATC: Anaplastic thyroid cancer PA: Prior authorization
BCVA: best corrected visual acuity PASI 90: 90% reduction in Psoriasis Area Severity Index from baseline
BTD: Breakthrough therapy designation PFS: Progression free survival
CGRP: Calcitonin gene-related peptide PsA: Psoriatic arthritis
CLL: Chronic lymphoccytic leukemia PsO: Psoriasis
cITP: Chronic immune thrombocytopenia PV: Polycythemia vera
CM: Chronic migraine PY: Prior year
CML: Chronic myeloid leukemia QoL: Quality of Life
COPD: Chronic Obstructive Pulmonary Disease RCC: Renal cell cancer
CR: complete remission ROP: Retinopathy of prematurity
CRC: Colorectal Cancer r/r ALL: relapsed/refractory acute lymphoblastic leukemia
CRi: Complete remission with incomplete blood count recovery RRMS: relapsing-remitting multiple sclerosis
CSU / CIU: Chronic spontaneous urticaria / Chronic idiopathic urticaria SAA: Severe aplastic anemia
CVRR: Cardiovascular risk reduction scFv: Single chain variable fragment
DLBCL: Diffuse large B-cell lymphoma SCPC: Sickle cell pain crisis
DMC: Data monitoring committee SpA: Spondyloarthropathy
EDSS: Expanded Disability Status Scale SPMS: Secondary progressive multiple sclerosis
EF: ejection fraction TFR: Treatment-free Remission
EM: Episodic migraine
FPFV: First patient first visit Trademarks
GvHD: graft vs. host disease Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.
HbA1C: Glycated hemoglobin Enbrel, Epogen and Neulasta are a registered trademark of Amgen Inc.
HCC: Hepatocellular carcinoma
Humira is a registered trademark of AbbVie Ltd.
HF: Heart failure
HF-pEF: Heart failure with preserved ejection fraction MabThera is a registered trademark of Roche, Ltd.
HFrEF: Heart failure with reduced ejection fraction Procrit is a registered trademark of Janssen Products, LP.
MF: Myelofibrosis Remicade and Stelara are registered trademarks of Janssen Biotech, Inc.
Rituxan is a registered trademark of Biogen Inc

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Novartis AG

2 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

1. Group review Joseph Jimenez, Chief Executive Officer

2. Financial review Harry Kirsch, Chief Financial Officer

3. Development Vas Narasimhan, Global Head Drug Development & CMO

4. Closing Joseph Jimenez, Chief Executive Officer

5. Q&A session Executive team

Net sales in line with PY (cc)

Core operating income in line with PY (cc)

Surge of innovation milestones

4 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Approvals & Opinions Filings Data

AMG 334 RTH258

Gx Advair Diskus1 ACZ885

5 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Safety comparable to aflibercept

No treatment currently available for patients with high inflammation

6 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

FDA advisory committee recommended

CTL019 pivotal study showed durable

1. ALL acute lymphoblastic leukemia 2. DLBCL diffuse large B-cell lymphoma

7 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Filed in EU Adalimumab Infliximab

Leading portfolio with 5

8 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Immunology & Dermatology 490 90%

Cardio-Metabolic 110 240%

Oncology 186 32%

Oncology 2162 28%2

Immunology & Dermatology, Respiratory 226 12%

Biopharmaceuticals Multiple 260 6%

9 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

US Weekly NBRx1 US Weekly TRx1

access and field force 8,000

10 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Quarterly net sales

11 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Surgical Vision Care

Continued strengthening of operations and Dailies Total1 continued strong performance in

12 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Integrated Drug Development Centralized Operations

13 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

1. Group review Joseph Jimenez, Chief Executive Officer

2. Financial review Harry Kirsch, Chief Financial Officer

3. Development Vas Narasimhan, Global Head Drug Development & CMO

4. Closing Joseph Jimenez, Chief Executive Officer

5. Q&A session Executive team

Group1 Q2 Change vs. PY

15 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

16 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Sandoz -4 -7 20.3 -0.7

Alcon 3 -7 13.9 -1.5

17 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Group free cash flow

18 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

19 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Assuming mid-July exchange rates prevail

2016 2017 2016 2017

20 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

Barring unforeseen events (in cc)

Group net sales expected to be broadly in line with PY

Group core operating income expected to be broadly in line with PY to

21 | Novartis Q2 2017 Results | July 18, 2017 | Novartis Investor Presentation

1. Group review Joseph Jimenez, Chief Executive Officer