Novartis: Greifen Sie auf unser interaktives Foliendeck zu (PDF 12 MB)

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Q4 2020 Results

Investor presentation

1 Investor Relations │ Q4 2020 Results

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Oncology

Financial review

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Disclaimer

This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as "potential," "expected," "will," "planned," "pipeline," "outlook," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology and the Sandoz retail business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group's liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our not-for-profit portfolio of 15 medicines from the Sandoz division for symptomatic treatment of COVID-19 and our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID-19. 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. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of the COVID-19 pandemic on enrollment in, initiation and completion of our clinical trials in the future, and research and development timelines; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics by mid 2021; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this presentation; the potential that the strategic benefits, synergies or opportunities expected from the transactions described, including BeiGene, may not be realized or may be more difficult or take longer to realize than expected; the uncertainties 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; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; 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.

Enbrel® is a registered trademark of Amgen, Inc. Humira® and Skyrizi™ are registered trademarks of Abbvie Inc. Siliq® is a registered trademark Valeant Pharmaceuticals International, Inc. Taltz® is a registered trademark of Eli Lilly and Company. Stelara®, Tremfya® and Simponi® are registered trademarks of Janssen Biotech, Inc. Cimzia® is a registered trademark of UCB Group of Companies.

2 Investor Relations │ Q4 2020 Results

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Participants

Vas Narasimhan

John Tsai

Chief Executive Officer

Head of Global Drug Development and CMO

Harry Kirsch

Richard Saynor

Chief Financial Officer

CEO, Sandoz

Marie-France Tschudin

Shannon Thyme Klinger

President, Novartis Pharmaceuticals

Chief Legal Officer

Susanne Schaffert

President, Novartis Oncology

3 Investor Relations │ Q4 2020 Results

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Vas Narasimhan

Chief Executive Officer

Company overview

4 Investor Relations │ Q4 2020 Results

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We are transforming Novartis...

Strategy set out in 2018...

Our focus

Our five priorities

Focus our

Unleash the

Deliver

company

power of our

transformative

and capital

people

innovation

Accelerate

Embrace

Go big

certain

operational

on data

geographies

excellence

and digital

Strengthen

Build trust

our core

with society

...is transforming Novartis

100% focused as a medicines company

Leading pipeline, with 4 advanced therapy platforms

Achieved USD 2bn cost savings over 2017-2020

Establishing a leading digital and data science platform

Improving ESG scores, sector-leading across 4 key indices

Record-high engagement score

5 Investor Relations │ Q4 2020 Results

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...while delivering strong operational performance

Net sales +5% CAGR1

Core3 OpInc +10% CAGR1

Innovative Medicines

core3

margin up to 35%

Continuing operations2, USD bn

2017

2018

2019

2020

2017

2018

2019

2020

2017

2018

2019

2020

47.4

48.7

15.4

35.0%

14.1

33.5%

44.8

12.6

32.0%

42.3

11.7

31.0%

1. CAGR % 2017-20 in USD 2. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 3. Constant currencies (cc) and core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report

6 Investor Relations │ Q4 2020 Results

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Q4 sales growth and margin expansion driven by strong performance from key growth drivers

Operational performance

Continuing operations1, % cc vs. PY

Q4 2020 FY 2020

Net

sales

Core2

13%

OpInc

Key growth driver sales Q4 2020

Growth

Sales

Growth vs. PY

vs. PY

USD mn

716

198

35%

1,109

144

13%

471

23%

376

24%

254

33%

240

32%

408

13%

141

42%

335

184

18%

nm - not meaningful

Key growth drivers and launches, as % of Innovative Medicines sales

52%

Adakveo®

Beovu®

43%

Mayzent®

Piqray®

Xiidra®

34%

Lutathera®

Kymriah®

28%

Kisqali®

Ilaris®

Zolgensma®

Jakavi®

Tafinlar+Mekinist®

Promacta®

Entresto®

Cosentyx®

Other3

2017

2018

2019

2020

3. Includes Tasigna®, Xolair®, Aimovig®, Tabrecta ®, Kesimpta®, Luxturna® , Enerzair ® and Atectura®

1. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Core results are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report

7 Investor Relations │ Q4 2020 Results

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Zolgensma® sales of USD 920m in first full year since launch, now registered in 37 countries

Sales evolution

USD m

291

254

205

169

170

148

100

126

105

122

106

Q1'20

Q2'20

Q3'20

Q4'20

Ex-US

Performance highlights

Growth opportunities in existing indications

Clinical and pipeline

1. Newborn screening implementation may be impacted by COVID-related delays

8 Investor Relations │ Q4 2020 Results

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China: Rich pipeline, NRDL successes, expected to double sales by 2024

Second fastest growing pharmaceutical multinational company in China in 2020

Sales

Continuing operations1, USD bn, % cc

+16%

2.6

2.2

2019 FY

2020 FY

BTD - break through therapy designation 1. Refers to continuing operations as defined on page 43 of the Condensed Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Oncology strategic brands include: Strategic brands: Revolade®/ Jakavi®/ Tasigna®/ Exjade®/ Votrient®/ Sandostatin® LAR/ Zykadia®/ Tafinlar®+Mekinist® 3. Azarga® and Simbrinza® were also successfully listed in NRDL

9 Investor Relations │ Q4 2020 Results

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Sandoz sales met guidance with significant margin growth, despite pandemic impact

Sales stable, core margin increased by +3.3%pts in 2020

(vs. PY, in cc)

Q4 2020

FY 2020

Net sales

0% 0%

Core OpInc

15%

Core

20.8%

24.2%

margin:

+3.3%pts

Key 2020 performance drivers

Biopharmaceuticals1 growth +19%, increasing share in maturing European markets

Retail decline

driven by COVID-19 and US oral solids

Margin increase from product mix, productivity, favorable price effects; reduced spend

Driving growth

Biosimilars

Small molecules

Driving margin

(mid-to-high 20s in mid-to long term)

1. Biopharmaceuticals include biosimilars, biopharmaceutical contract manufacturing and Glatopa®

10 Investor Relations │ Q4 2020 Results

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Novartis focused on overcoming COVID-19 challenges

Select examples

Dermatology market declines with COVID-19

PsO market weekly patient visits Jan-Aug 2020

PsO market weekly NBRx Jan-Aug 2020

4.0

3.0

Volume (thousands)

Thousands

2.0

1.0

Visit

0.0

Jan

Mar

May

Aug

Oct

Dec

Jan

Mar

May

Aug

Oct

Dec

Sources: IQVIA Visits Data. IQVIA National Prescription Audit for Dermatology through December 2020

Oncology market declines with COVID-19

Biopsy and surgery rates

CDK4/6 market NBRx

Key areas impacted in 2020 expected to continue through H1 2021

Dynamic segment of

Several therapeutic areas,

market (new/switch

particularly dermatology and

patients): less patient

ophthalmology

traffic, less F2F

New launches

physician access

(e.g. Kesimpta®, Mayzent®)

Advanced breast cancer

(CDK4/6 market and Piqray®)

Hospital initiation (lab

Kymriah®

120

100

Breast

Lung

Melanoma

0Pre- Mar Apr

May

Jun

Jul

Aug

Sep

Oct

COVID

-20%

Pre-COVID baseline

Sep'20-Nov'20 Avg.

Q3'19-Q1'20 Avg.

work, diagnostics);

Lutathera®

immuno-suppression

concerns

Zolgensma®

Lower demand

Sandoz Retail

and anti-infectives

Source: IQVIA APLD, Novartis Analysis

Source: IQVIA projection

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Key innovation milestones in Q4

Approvals

Positive FDA

In-licensing deals

AdComm Opinion

Tislelizumab

BeiGene

EU for

HFpEF

(anti-PD-1)

Hyperlipidemia

Anti-COVID-19

Molecular

EU for Sickle cell

Positive readout

DARPins

Partners

disease

DME1

US for CRSwNP

LNP023 (iptacopan): FDA breakthrough designation (PNH), Rare Pediatric Disease Designation (C3G)

QGE031 (ligelizumab): FDA breakthrough designation (CSU) granted in December 2020

Leqvio® CRL update

All abbreviations onslidepage1444. . CRSwNP - Severe chronic rhinosinusitis with nasal polyps. 1. Ph3 KESTREL study 2. Third party site originally scheduled for inspection May 2020; underwent paper based review due to pandemic.

12 Investor Relations │ Q4 2020 Results

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2021 catalysts maintaining long-term momentum

Potential catalysts

Selected examples

Major approvals

Kesimpta® (EU/JP)

Entresto® (US)

Cosentyx® (US/JP/CN)

RMS

HFpEF

Pediatric psoriasis

Major submissions1

Alpelisib (BYL719)

Asciminib (ABL001)

Jakavi®

PROS

CML

Acute and chronic GvHD

Beovu®

Leqvio® (US)2

Kymriah®

DME

Hyperlipidemia

Major readouts

177Lu-PSMA-617

Sabatolimab (MBG453)

Canakinumab (ACZ885)3

Enabling submission 2021

mCRPC

MDS

NSCLC 1L + 2L

Kymriah®

Entresto®

r/r DLBCL 1st relapse

Post-AMI

Enabling submission 2022

Ligelizumab (QGE031)4

Cosentyx®

CSU

Iptacopan (LNP023)

Kisqali®

Others

IgAN, C3G (Ph2)

Breast cancer (MONALEESA-2 OS)

Pivotal study starts

Iptacopan (LNP023)

Ligelizumab (QGE031)

177Lu-PSMA-617

IgAN, C3G, aHUS

Food allergy, CINDU

pre-taxane

1. First submission in any market. 2. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021. 3. Depending on timing of final read-out submission may move to early 2022 4. Q4/2021-Q1/2022 potential COVID impact

13 Investor Relations │ Q4 2020 Results

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Moving forward a breadth of assets to drive long-term growth

Selected opportunities: selection of expected 2021 milestones and additional indications

Lifecycle management

Post-AMI: PARADISE

Entresto®

Ph3 readout H1 2021

HFpEF: FDA action date Q1 2021

HS: SUNRISE, SUNSHINE

Cosentyx®

Ph3 readout H2 2021

L. Planus, Peds PsO, jPsA/ER,

GCA, lupus nephritis

Kisqali®

aBC: MONALEESA-2 OS

readout H2 2021

PROS: submission H2 2021

BYL719

TNBC, ovarian cancer, HER2+

aBC, HNSCC 2/3L

Beovu®

DME: submission H1 2021

RVO, diabetic retinopathy

Pharmaceuticals

Iptacopan

IgAN, C3G: Ph2 readout H1 2021

(LNP023)

aHUS: Ph3 start. PNH, iMN

Iscalimab

Sjögren's, kidney Tx, liver Tx

(CFZ533)

Ligelizumab

CSU: PEARL 1, 2

(QGE031)

Ph3 readout H2 2021

CINDU, food allergy

Ph3 start H2 2021

Pelacarsen

CVRR-Lp(a)

(TQJ230)

Branaplam

HD: Ph2b start H2 2021

(LMI070)

SMA

Oncology

Canakinumab

NSCLC 1L/2L: CANOPY-1/2

(ACZ885)

Ph3 readout H1/2 2021

NSCLC adjuvant

177Lu-PSMA-617

mCRPC 3L:

VISION Ph3 readout H1 2021

mCRPC pre-taxane:

Ph3 start H1 2021

Sabatolimab

HR-MDS: STIMULUS

(MBG453)

Ph2 readout H2 2021

AML

TNO155

Solid tumors, multiple

combinations being explored

in on-going trials

LXH254

BRAF/NRASm melanoma,

mRAS/RAF NSCLC

'Wild Cards'

ECF843(Dry eye: Ph2 readout H2 2021),LNA043(Osteoarthritis: Ph2b start H1 2021),

CSJ117 (Asthma), QBW251 (COPD), NIS793 (Solid tumors)

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Financial review

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Marie-France Tschudin

President, Novartis Pharmaceuticals

15 Investor Relations │ Q4 2020 Results

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Pharmaceuticals portfolio continues to rejuvenate with 43% sales driven by recent launches and growth drivers

Pharmaceuticals net sales

FY 2020: Net sales up +5%

USD bn, growth in % cc

Growth drivers and launches growing +33%, despite pandemic conditions:

Recent launches1

now represent 43% of the pharmaceutical sales

Growth drivers2

Mature products3

Portfolio shift continues to lay foundation for future growth

+5%

Cosentyx® and Entresto® contributed USD 6.5bn, growing +23% cc YoY

23.3

24.3

Key approvals and launches in 2020 include:

0.7

1.9

- Kesimpta® in US

7.1

8.6

+33%

- Leqvio® in EU

15.5

13.8

-10%

- Cosentyx® nr-axSpA in US and EU

Launched new products or new major indications in all 5 franchises

FY 2019

FY 2020

1. Zolgensma®, Xiidra®, Beovu® , Mayzent®, Aimovig®, Luxturna®, Kesimpta® , Enerzair® and Atectura®. 2. Cosentyx®, Entresto®, Xolair® , Ilaris® 3. All other brands.

Investor Relations │ Q4 2020 Results

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Cosentyx® Q4 sales up 13%, maintaining strong position in dermatology and outgrowing rheumatology market

Sales evolution

USD m, % cc

Ex-US

3.6bn

4.0bn (+13%)

1,109

858

937

965

930

944

1,012

791

354

330

372

423

336

354

317

324

474

534

601

611

576

614

640

686

2019

2020

Robust Q4 performance despite continued COVID-19 impact

Catalystsfor continued strong growth

JIA - Juvenile idiopathic arthritis HS - Hidradenitis suppurativa TRx - Total Prescriptions NBRx - New-to-Brand Prescriptions EMA - European Medicines Agency NRDL - National Reimbursement Drug List PsO - Psoriasis AS - ankylosing spondylitis SpA - spondyloarthritis TRx growth is calculated by comparing product volume across two time periods (YoY refers to Q4 2020 compared with Q4 2019). NBRx share calculated as product NBRx volume divided by market NBRx volume. 1. IQVIA Visits Data; 2. IQVIA National Prescription Audit for Dermatology through December 2020; PsO market includes Enbrel®, Humira®, Siliq®, Skyrizi™, Stelara®, Taltz®, Tremfya® 3. IQVIA National Prescription Audit for Rheumatology through December 2020; SpA market includes Cimzia®, Enbrel®, Humira®, Simponi®, Stelara®, Taltz®, Tremfya®

17 Investor Relations │ Q4 2020 Results

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Entresto® grows 44% in 2020 based on demand as an essential, first-choice treatment in heart failure

Sales evolution

USD m, % cc

Ex-US

2.5bn (+44%)

1.7bn

518

569

580

632

716

421

430

354

357

276

272

318

233

200

210

158

362

199

221

220

285

293

308

314

2019

2020

Strong momentum across geographies continues in Q4

Confidence in future growth

LCM

ACC - American College of Cardiology HFrEF - Heart failure with reduced ejection fraction. HFpEF - Heart failure with preserved ejection fraction. CHF - Congestive Heart Failure. Post-AMI - post Acute Myocardial Infarction 1. US NBRx - IMS New to Brand Q4 vs Q3. Weekly NBRx averaged ~4,000 for the Q4 period up to 25 Dec 2020 2. Eligible patients defined as prevalent HFrEF patients within each market's label. G7 = US, CA, JP, DE, FR, IT, UK 3. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway (ECDP) for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction (in publication). https://www.jacc.org/doi/10.1016/j.jacc.2020.11.022

18 Investor Relations │ Q4 2020 Results

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Positive FDA AdComm supports extending the use of Entresto® to more HF patients, building on leading position in rEF

Unmet need and value of Entresto® confirmed

Preparing for launch

1. LVEF pooled analysis PARADIGM/PARAGON. Solomon S et al. 2020 Circulation. 2. Dichotomous classification of HFrEF and HFpEF is not adequately capturing treatment effect as discussed by FDA AdComm on Entresto (15 Dec 2020) and spironolactone (16 Dec 2020), incl. CHARM study (Lund et al. European Journal of Heart Failure (2018) 20, 1230-1239); TOPCAT study (Solomon et al. European Heart Journal (2016) 37, 455-462)

19 Investor Relations │ Q4 2020 Results

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Company overview

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Financial review

Conclusion

Appendix

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Kesimpta® on track to become a 1st choice high efficacy DMT for patients, physicians and payers; preparing for RoW launches

Solid launch progress during pandemic

2021 priorities for acceleration

Broad payer

>150m (~73%) US commercial lives

Pull-through access, driving conversion

coverage

have unrestricted coverage or single step edit

to paid product with sales ramp up in H2

coverage including big 3 plans1

Comprehensive

100% target prescribers reached2,3

Drive breadth, depth of HCP adoption, increase

engagement

F2F engagement with pandemic recovery

Broad adoption

~1000 patients treated in 1st 4 months

Intensify patient activation through DTC and

of launch4, 17% naive5

omni-channel engagement

Positive customer

80% of free Rx filled within 1 week average6

Maintain and build

experience

Pandemic impact

Restricted F2F interactions, patient visits down

Impact expected to continue into H1

on MS Market

15-20%7, NBRx down 12%8

1. United Healthcare & OptumRx, CVS Caremark & Aetna, ESI Commercial, based on payer wins & associated lives covered 2. Internal target list having at least one contact through the hybrid F2F/ digital model 3. IQVIA BrandImpact. MS Promotional Activities Analysis. Neurology Panel. End Nov 2020. 4. IQVIA National Prescription Audit NBRx data through W/E 01/01 5. Based on start forms. 6. Novartis HUB and Direct to Specialty Pharmacy data 7. Symphony APLD Jan-Oct 2020 vs PY 8. Internal estimate; IQVIA Weekly NBRx w/e 20-Mar 2020 to 1-Jan 2021 vs PY

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Financial review

Conclusion

Appendix

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Leqvio®: Expect gradual ramp in Europe, building foundation to be stronger out of the gate upon approval in US

Progressing approvals

EC approval December 2020

Completed 10 additional filings in RoW

CRL response plan submission Q2/Q3 2021

Preparing launches

First prescriptions expected February with initial focus on population at high CV risk

On track for Q3 2021 launch in collaboration with NHS England

Advancing infrastructure building with healthcare systems

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Company overview

Pharmaceutiicals

Oncology

Financial review

Conclusion

Appendix

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Focus in 2021 will be launches and preparing for next big bets, building on the strong foundation

Maximize growth drivers

Cosentyx®: deliver nr-axSpA launch, LCM addressing 7m additional patients

Entresto®: drive penetration in CN, launch in JP, expansion into pEF and post-AMI

Deliver on new launches

Kesimpta®: enable broad HCP adoption, fast and simple access

Leqvio®: establish broad and affordable access, addressing adherence, system barriers

Beovu®: restore evidence-based confidence to treat, expansion into

DME/ RVO

Next wave of launches

Iptacopan: educate on complement- driven renal and hematologic diseases

Iscalimab: create awareness on unmet need

Ligelizumab: leverage dermatology / allergology footprint to expand use of biologics in CSU

Pelacarsen: drive Lp(a) awareness and standard protocol testing

Branaplam: drive biomarkers awareness and engage HD community on early treatment

Nr-axSpA - non-radiographic axial spondyloarthritis, pEF - preserved ejection fraction, post-AMI - post acute myocardial infarction, DME - diabetic macular edema, RVO - retinal vein occlusion, Lp(a) - lipoprotein (a)

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

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Susanne Schaffert

President, Novartis Oncology

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Continued momentum on growth drivers and launches more than offset generic erosion in Q4 and FY 2020

Oncology net sales

USD bn, % cc

Recent launches1

Growth drivers2

Base business4

Gx3

+3%

14.4

14.7

1.3

2.1

0.2

+29%

3.9

4.6

3.7

3.6

-1%

5.5

4.4

-19%

FY 2019

FY 2020

FY 2020: Net sales up +3%

Q4: Continued momentum of growth drivers and recent launches

Q4: Offset Gx erosion, COVID-19 impact

All growth rates in cc. 1. Recent launches include Kisqali®, Lutathera®,Kymriah®, Piqray®, Adakveo® , Tabrecta® 2.Growth drivers include Promacta®/Revolade®, Tafinlar®+ Mekinist®, Jakavi® (marketed by Novartis ex-US) 3. Gx include Afinitor®, Exjade®, Glivec® and Sandostatin® 4. Base business - other brands

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Oncology

Financial review

Conclusion

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Kisqali®: Strong growth as the only CDK4/6i proven to extend lives in two Ph3 trials

Sales evolution

USD m, % cc

Ex-US

+45%

687

480

369

230

250

318

FY 2019

FY 2020

1. Patient share, October YTD vs PY

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Kymriah®: Double-digit growth in all regions despite pandemic

Sales evolution

USD m, % cc

Ex-US

+68%

474

269

278

119

159

205

FY 2019

FY 2020

FBRI - Foundation for Biomedical Research and Innovation

26 Investor Relations │ Q4 2020 Results

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Asciminib: Superior efficacy and safety profile confirms potential to transform standard of care in CML

ASCEMBL is the 1st head-to-head pivotal trial vs. a 2nd generation TKI

Major Molecular Response rate at 24 weeks

25.5%

of patients

13.2%

1.9x1

n=1

n=7

Asciminib

Bosutinib

Complete Cytogenetic response at 24 weeks 40.8%

% of patients

24.2%

1.7x

Asciminib

Bosutinib

1. After adjusting for major cytogenetic response (MCyR) status at baseline. CML-CP, chronic myeloid leukemia-chronic phase; MMR, major molecular response; AE, adverse event;

27 Investor Relations │ Q4 2020 Results

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

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2021: Maximize momentum for our growth drivers and new launches, while preparing for next big bets

Maximize growth drivers

Kisqali®: Continue strong growth driven by M3 and M7 OS data

Kymriah®: Drive growth in pALL and DLBCL, leveraging a differentiated profile and increased manufacturing capacity and reliability

Lutathera®: Unlock potential in community setting and grow use in earlier lines of treatment

Promacta®/Revolade®: Growth in ITP and

uptake in 1L SAA in the US and Japan

Jakavi®: Continue strong growth in PV and MF, while launching GVHD

Tafinlar® + Mekinist®: leverage potential in adjuvant melanoma and NSCLC

Deliver on new launches

Piqray®: Maximize US launch momentum and expand further to EU markets

Adakveo®: Enable access in larger US accounts and continue global expansion

Tabrecta®: Maximize the first mover advantage as the first and only MET inhibitor available for patients in the US

Asciminib: Drive awareness of CML unmet need and the importance of STAMP and launch successfully in US

Next wave of launches

177Lu-PSMA: Further evolve commercial infrastructure for best-in-class launch

Canakinumab: Focus on medical education on pro-tumor inflammation

Sabatolimab: Build awareness of the dual mechanism of action of TIM-3 and its potential in MDS/AML

TNO155: Advance a first-in-class inhibitor of SHP2 across 5 combination trials in NSCLC and

CRC

LXH254: Advance potentially best-in-class B/C- RAF inhibitor in RAS/RAF mutant melanomas and lung cancers

28 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Expanding our pipeline with in-licensing of tislelizumab, a late-stagePD-1 inhibitor, from BeiGene1

Tislelizumab

Anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Strategic rationale

Accelerate IO market entry with backbone PD-1

Unlock combination potential with Novartis assets

Deal terms

1. Novartis signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China on January 11, 2021. Closing of the transaction is subject to receiving antitrust clearance. Until closing, BeiGene will continue to have control of tislelizumab 2. Ex-China regions include the US, Canada, Mexico, the EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan; BeiGene retains the rights to tislelizumab in China and other countries

29 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Harry Kirsch

Chief Financial Officer

Financial review and 2020 guidance

30 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

2020 financial results in line with guidance

As revised in Q3 investor call

Group full year guidance

FY 2020 vs. PY

In cc

in cc

"Sales expected to grow mid single digit assuming return to

normal prescription dynamics.3%ü 3 to 4% range in case of resurgence of COVID-19"

"Core operating income to grow low double digit to mid teens"

13% ü

31 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Solid FY performance on top and bottom line

Continuing operations

Change vs. PY

USD million

2020

% USD

% cc 2

Net Sales

12,770

Core Operating income

3,501

Operating income

2,644

Net Income

2,099

Core EPS (USD)

1.34

EPS (USD)

0.92

Free Cash Flow

3,342

-4

Change vs. PY

2020

% USD

% cc 2

48,659

15,416

10,152

8,071

5.78

3.55

11,691 -10

32 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Core margin expansion of +2.8% points FY

Innovative Medicines core margin at 35.0%

Continuing operations1,2

Q4 2020

FY 2020

Core operating

Net sales

income

Core margin

Net sales

income

Core margin

change vs. PY

Core margin

change vs. PY

Core margin

change vs. PY

(in % cc)

(%)

(%pts cc)

(in % cc)

(%)

(%pts cc)

Innovative Medicines

31.4

0.7

35.0

2.2

Sandoz

20.8

0.8

24.2

3.3

Continuing Operations

27.4

0.4

31.7

2.8

33 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

FY 2020 free cash flow decreased to USD 11.7bn

Continuing operations1 free cash flow2

USD billion

-10%

Key drivers vs. PY:

+ Higher operating income

12.9

11.7

(adjusted for non-cash items)

− Payments for legal matters − Lower divestment proceeds

FY 2019

FY 2020

34 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

2021 Novartis full year guidance

Barring unforeseen events; growth vs. PY in cc

Continuing operations | full year guidance1

vs. PY (cc)

Sales expected to grow low to mid single digit

Core operating income expected to grow mid single digit, ahead of sales

1. Key assumptions:

35 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Q1 2021 Sales expected to decline due to PY COVID-19 forward purchasing of approximately +0.4bn

Sales growth vs. PY

%pts, cc

2020

Actuals

Q1FY

Low to mid single digit

2021

Illustrative

Low to mid single digit

Q1 2020

0.4bn Forward purchasing (approximately 3%pts of Q1 growth)

Q1 2021

Broadly in line vs. PY excluding PY forward purchasing impact

Key assumption:

Return to normal prescription dynamics of healthcare systems by mid 2021

36 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Expecting margin expansion with Core OpInc growth magnitude lower in 2021 driven by increased launch investments

2021 pushes and pulls

Growth drivers and Kesimpta® launch

Increased investments

uptake benefiting from return to normal

in launches and pre-launches, including

global healthcare systems by early H2

Kesimpta® and Leqvio®

Productivity programs

Increased development costs

Continue new ways of working

tislelizumab1

Increased investments into growth drivers

assuming physician access normalizes as of

mid year

37 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

FY 2021 Guidance on other financial KPIs

Barring unforeseen events; growth vs. PY in cc

Continuing operations1 | full year guidance

vs. PY (cc)

Core Net

Expenses expected to be broadly in line vs. 2020

Financial Result

Core Tax Rate 2021 Core tax rate expected to be around 16%

38 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Novartis proposes 24th consecutive dividend increase to the AGM: 3.00 CHF / share1

3.5

3.0

CHF dividend

USD dividend

2.5

.8%in

2.0

CAGR

1.5

1.0

0.5

0.0

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

2020 dividend yield 3.6%2

2020 dividend growth 1.7%3

CHF

CHF2.95 USD3.12 CHF3.00 USD 3.40

USD

.1% in

and

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

Proposal to shareholders at the 2021 Annual General Meeting, taking place on March 2, 2021 2. Based on closing share price of CHF 83.65 at end of business year 2020 (December 30, 2020) 3. In CHF

Converted at historic exchange rates at the dividend payment dates as per Bloomberg for 2020, assumes an exchange rate of USD/CHF of 0.88106 as of December 31, 2020

39 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial reviewi

Conclusion

Appendix

Back

Expected currency impact for full year 2021

Currency impact vs. PY

%pts, assuming late-January exchange rates prevail in 2021

FX impact on Net sales

3 to 4

Q4 FY Q1 FY

20202021

Actual Simulation

FX impact on Core operating income

2 3

-1

-4

Q4 FY Q1 FY

20202021

40 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Vas Narasimhan

Chief Executive Officer

41 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Made significant strides in building trust with society and in integrating ESG across every aspect of our company

Key ESG developments over the past 12 months and selected aspirations

Ethical

Pricing

Global Health

Corporate

Governance &

Standards

& Access

Challenges

Citizenship

Transparency

Resolved material legacy

Introduced 100+

Expanded our Africa sickle

Strong COVID-19 response

ESG indexlaunched

compliance issues

Emerging Market Brands

cell disease program

Integrating D&I efforts

Reporting in line with TCFD

Launched Code of Ethics

Issued sustainability-

Advancing pipeline of

across our operations

Working towards integrated

linked bond

novel malaria treatments

reporting

Select 200% increase in SITs

50% increase in our

Full carbon, plastic and

ESG targets embedded into

commitments patient reach by 20251

Flagship Programs' reach

water neutrality by 2030

executive remuneration

by 20251

Significant improvements recognized by third party ESG rating agencies.

SIT - Strategic innovative therapies 1. As defined in ESG bond prospectus More details in Novartis in Society Report: www.novartis.com/nisreport2020

42 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Confident that we will grow top and bottom line every year to 2025 and meet external expectations

Analyst consensus sales

USD billion

+4% CAGR

2020

Growth Drivers1

Launches2

Other/Pipeline

Sandoz

Gx Brands3

2025

Actual

Consensus

IM margin

External expectations based

35.0%

on analyst consensus

37.6%

1. Cosentyx®, Entresto®, Zolgensma®, Kisqali®, Mayzent®, Tafinlar+Mekinist®, Jakavi®, Beovu®, Xiidra®, Aimovig®, Xolair®. 2. Lutathera®, Kymriah®, Piqray®, Adakveo®, Kesimpta®, Leqvio®, Tabrecta®, Asciminib. 3. Brands with 2024

consensus sales lower than 2019 actual sales (Glivec®, Tasigna®, Afinitor®, Votrient®, Promacta®, Exjade®, Sandostatin®, Galvus®, Gilenya®, Lucentis®).

Source: Novartis Investor Relations in-house consensus as of November 12, 2020.

Investor Relations

│ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Conclusion

Delivered on our strategic and operational commitment in 2020

Third successive year of increases in sales, core operating income and margin

Progressing the pipeline and key approvals in 2020: Kesimpta® in US, Leqvio®, Zolgensma® in EU, Tabrecta® in US, new indications for Cosentyx®

Expecting top and bottom line growth every year through 2025

44 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

Appendix

45 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

FinancialFi i performanceance

Innovation: Pipeline overview

Innovation: Clinical trials

Strong FY operational performance from growth drivers

Key growth driver sales FY 2020

Sales

Growth vs. PY

USD Million

2,497

771

44%

920

559

151%

3,995

444

13%

1,738

322

23%

1,339

225

20%

687

207

45%

1,542

204

16%

320

204

176%

873

202

31%

474

196

68%

376

184

95%

190

155

nm - not meaningful

Key growth drivers and launches, as % of Innovative Medicines sales

49%

Adakveo®

40%

Mayzent®

Beovu®

Piqray®

32%

Xiidra®

Lutathera®

26%

Kymriah®

Kisqali®

Ilaris®

Zolgensma®

Jakavi®

Tafinlar+Mekinist®

Promacta®

Entresto®

Cosentyx®

FY 2017 FY 2018 FY 2019

FY 2020

Other1

1. Includes Tasigna®, Xolair®, Aimovig®, Tabrecta®, Luxturna® , Kesimpta®, Enerzair ® and Atectura®

46 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

FinancialFi i performanceance

Innovation: Pipeline overview

Innovation: Clinical trials

Net debt increased by USD 8.6bn mainly due to

The Medicines Company acquisition

-8.6

-15.9

-7.0

-2.1

-1.2

-24.5

-10.0

11.7

Dec. 31, 2019

Dividends

M&A

Free Cash Flow2

Treasury share

Others

Dec. 31, 2020

transactions1

transactions, net

1. Mainly the acquisition of The Medicines Company for USD 9.6bn. 2. Free cash flow is a non-IFRS measure. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report.

47 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

FinancialFi i performanceance

Innovation: Pipeline overview

Innovation: Clinical trials

Advancing our innovation agenda over the last 3 years

Major

approvals1

Major

submissions2

Major

readouts (pivotal)

2018

2019

2020

DLBCL

SPMS

HR+ BC

Sickle cell

Relapsing MS

NSCLC

Hyperlipidemia

Migraine

Lutathera®

Adj Melanoma

NET

SMA

nAMD

Asthma

Nr-axSpA

1st line SAA

SPMS

HR+ BC

nAMD

NSCLC

asthma

HFpEF

Hyperlipidemia

SMA

1st line SAA

Sickle cell

Relapsng MS

Nr-axSpa

Asciminib

Advanced BC

HR+ BC

nr-axSpA

Relapsing MS

HFpEF

Chronic GvHD

CML 3L

DME

Fevipiprant

NSCLC

SMA presymptomatic

Asthma

Follicular lymphoma

1. First approval in any market. 2. First submission in any market.

48 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

2020 pipeline milestones

H1 2020

H2 2020

✓ Achieved

✕ Missed

Regulatory

Beovu®

nAMD (EU/JP)

✓

Adakveo®

Sickle cell disease (EU)

✓

Cosentyx®

nr-axSpA (EU/US)

✓

Tabrecta® (capmatinib)

NSCLC (US/JP)

✓

decisions and

Cosentyx®

AS (CN)

✓

Cosentyx®

Pediatric psoriasis (EU)

✓

opinions

Kesimpta®

Relapsing MS (US)

✓

Cosentyx®

nr-axSpA (JP)

✓

(H2 2020)

Piqray®

HR+/HER2- aBC with PIK3CA

✓

Entresto®

HFpEF (US)

Q1 20212

mutation (EU)

Enerzair®

Asthma (EU/JP)

✓

Leqvio (inclisiran)

Hyperlipidemia (US)

✕4

Tafinlar® & Mekinist®

Adjuvant melanoma (CN)

✓

Hyperlipidemia (EU)

✓

Xiidra®

DED (EU)

Xolair®

Nasal Polyposis (US/EU)

✓

Zolgensma® IV

SMA (EU/JP)

✓

Major

Entresto®

HFpEF (US)

✓

Alpelisib (BYL719)

PROS (US)

H2 2021

Inclisiran (KJX839)

Hyperlipidemia (EU)

✓

AVXS-101 IT

SMA (US)

✕3

expected

Cosentyx®

Juvenile PsA / enthesitis-related

submissions

Q2 2021

arthritis (US/EU)

Spartalizumab (PDR001)

Metastatic melanoma (US/EU)

Negative

and Tafinlar® & Mekinist®

read-out

177Lu-PSMA-617

mCRPC (US)

Q4 2021

Major

Entresto®

Post-acute MI1

✓

Asciminib (ABL001)

CML 3L

✓

expected trial

Tropifexor (LJN452)

NASH

Beovu

DME

UNR844

Presbyopia

✓

Jakavi®

chronic GVHD

✓

readouts*

Kisqali®

aBC (MONALEESA-2 OS)

Q4 2021

177Lu-PSMA-617

mCRPC

H1 2021

*Achieved = on-time readout of data, irrespective of trial outcome

1. Planned study readout 2021; preplanned DMC interim analysis readout completed in March 2.Received positive FDA Advisory Committee recommendation for use in

patients with HFpEF Dec 2020 3. FDA recommended pivotal confirmatory study to supplement existing STRONG data

4. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party

manufacturing facility in Europe. FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021

49 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

2021 key pipeline milestones1

H1 2021

H2 2021

✓ Achieved ✕ Missed

Regulatory decisions and opinions

Major expected submissions

Major expected trial readouts*

Entresto®

HFpEF (US)

Cosentyx®

Pediatric psoriasis (US / CN / JP)

Kesimpta®

Relapsing MS (EU / JP)

Leqvio®

Hyperlipidemia (US)2

Asciminib (ABL001)

CML 3L (JP)

Jakavi®

Acute and chronic GvHD (EU, JP)

Beovu®

DME (JP)

Tabrecta®

NSCLC (EU)

Alpelisib (BYL719)

PROS (US)

Beovu®

DME (US / EU)

Kymriah®

r/r Follicular lymphoma (US / EU / JP)

Asciminib (ABL001)

CML 3L (US /EU)

Iptacopan (LNP023)

Ph2 - IgAN

Canakinumab (ACZ885)

Ph3 - NSCLC 1L

Iptacopan (LNP023)

Ph2 - C3G

ECF843

Ph2 - Dry eye

Entresto®

Ph3 - Post-AMI

Ligelizumab (QGE031)

Ph3 - CSU3

Canakinumab (ACZ885)

Ph3 - NSCLC 2L

Kisqali®

aBC (MONALEESA-2 OS)

177Lu-PSMA-617

Ph3 - mCRPC

Remibrutinib (LOU064)

Ph2 - CSU

Cosentyx®

Ph3 - Juvenile PsA

Cosentyx®

Ph3 - HS

Sabatolimab (MBG453)

Ph2, MDS

Kymriah®

Ph3, r/r DLBCL 1st relapse

*Achieved = on-time readout of data, irrespective of trial outcome

1. 2021 Key milestone table may evolve based on read-out outcomes as well as BD&L activities 2. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021 3. Q4/2021-Q1/2022 potential COVID impact

50 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

COVID-19 outlook for 2021

Therapeutic areas with highest potential for ongoing COVID-19 impact in 2021

Ophthamology

Respiratory Diseases

Kidney Disease /

TransplantDermatology

To date, minimal impact (<3 months) expected for majority of regulatory submissions through 20251

Uncertainty remains about FDA's ability to conduct foreign manufacturing inspections

Robust mitigations in place for clinical trial execution:

1. As of end of December 2020

51 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Our pipeline projects at a glance

Phase 1/2

Phase 3

Registration

Total

ONCOLOGY

PHARMACEUTICALS

Cardiovascular, Renal, Metabolism

Immunology, Hepatology, Dermatology

Neuroscience

Ophthalmology

Respiratory

Global Health

BIOSIMILARS

Total

118

167

52 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis submission schedule

New Medical Entities: Lead and supplementary indications

2021

2022

2023

2024

≥2025

177Lu-PSMA-617

Lead

ligelizumab

Lead

ECF843

Lead

Icenticaftor

Lead

177Lu-NeoB

Lead

iscalimab

Lead

NIS793

Lead

AAA617

QGE031

Dry eye

QBW251

AAA603

CFZ533

Solid tumors

mCRPC 3L

CSU

COPD

Multiple Solid Tumors

Renal Tx

LEAD INDICATIONS

asciminib

Lead

iptacopan

ABL001

LNP023

CML 3L

PNH

sabatolimab

Lead

MBG453

HR-MDS

Lead

SAF312

Lead

177Lu-PSMA-R2

Lead

ianalumab

Lead

OAV201

Lead

COSP

AAA602

VAY736

AVXS-201

Prostate cancer

Sjögren's syndrome

Rett syndrome

CEE321

LMI070

pelacarsen

UNR844

Lead

Presbyopia

Atopic Dermatitis

Huntington's disease

TQJ230

CVRR-Lp(a)

cipargamin

Lead

LNA043

Lead

remibrutinib

KAE609

Osteoarthritis

LOU064

Malaria severe

CSU

CPK850

Lead

LXE408

Lead

spartalizumab

Lead

Visceral leishmaniasis

PDR001

Malignant melanoma (combo)

CSJ117

Lead

LXH254

Lead

TNO155

Lead

Asthma

Solid tumors

ganaplacide

Lead

mavoglurant

Lead

tropifexor&cenicriviroc

Lead

KAF156

AFQ056

LJC242

NASH

Malaria uncomplicated

Cocaine use disorder

gevokizumab

Lead

MIJ821

Lead

VPM087

Depression

1st line CRC / 1st line RCC

INDICATIONS

canakinumab

LCM

177Lu-PSMA-617

ACZ885

AAA617

NSCLC 2L

Pre-taxane

canakinumab

canakinumab1)

LCM

ACZ885

NSCLC 1L

Adjuvant NSCLC

iptacopan

LNP023

C3G

NEW

iptacopan

LNP023

IgAN

1. Depending on timing of final read-out submission may move to early 2022.

LCM

crizanlizumab

LCM

cipargamin

LCM

iptacopan

LCM

LMI070

LCM

SEG101

KAE609

LNP023

SMA

Sickle cell anaemia with crisis ped

Malaria uncomplicated

aHUS

LCM

ligelizumab

LCM

iscalimab

LCM

ianalumab

LCM

remibrutinib

LCM

QGE031

CFZ533

VAY736

LOU064

CINDU

Liver Tx

AIH

Sjögren's syndrome

LCM

sabatolimab

LCM

iscalimab

LCM

ligelizumab

LCM

tropifexor&licogliflozin LCM

MBG453

CFZ533

QGE031

LJN452

Unfit AML

Sjögren's syndrome

Food allergy

NASH (combos)

LCM

iptacopan

LCM

LNP023

iMN

53 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis submission schedule

Supplementary indications for existing brands

20211)

2022

2023

2024

≥2025

alpelisib, BYL719

LCM

Cosentyx

LCM

Cosentyx

LCM

Coartem

LCM

Aimovig

LCM

Jakavi

LCM

Mayzent

LCM

PROS

secukinumab, AIN457

artemether + lumefantrine, CCA566

erenumab, AMG334

ruxolitinib, INC424

siponimod, BAF312

PsA IVIV

AS IVIV

Malaria uncompl., formula for <5kg

Pediatric Migraine

Myelofibrosis (combination)

Pediatric MS

Beovu

LCM

Cosentyx

LCM

Beovu

LCM

Cosentyx

LCM

Cosentyx

LCM

Jakavi

LCM

Piqray

LCM

brolucizumab, RTH258

secukinumab, AIN457

brolucizumab, RTH258

secukinumab, AIN457

ruxolitinib, INC424

alpelisib, BYL719

DME

AS H2H

Diabetic retinopathy

GCA

Lichen Planus

Pediatrics Chronic GVHD

HNSCC 2/3L

Cosentyx

LCM

Cosentyx

LCM

Beovu

LCM

Jakavi

LCM

Cosentyx

LCM

Kymriah

LCM

Piqray

LCM

secukinumab, AIN457

brolucizumab, RTH258

ruxolitinib, INC424

secukinumab, AIN457

tisagenlecleucel, CTL019

alpelisib, BYL719

Juvenile idiopathic arthritis

Hidradenitis suppurativa

RVO

Pediatrics Acute GVHD

Lupus Nephritis

1L high risk ALL, pediatrics & young adults

HER2+ adv BC

Entresto

LCM

Entresto EU3)

LCM

denosumab

BioS

Tafinlar + Mekinist

LCM

leqvio

LCM

sacubitril/valsartan, LCZ696

GP2411

dabrafenib + trametinib, DRB436

KJX839

Post-AMI

Pediatric HF

anti RANKL mAb

Thyroid cancer

CVRR-LDLC

Jakavi

LCM

Promacta

LCM

Kisqali

LCM

Tabrecta

LCM

ruxolitinib, INC424

eltrombopag, ETB115

ribociclib, LEE011

capmatinib, INC280

Chronic GVHD

Radiation sickness syndrome

HR+/HER2- BC (adj)

Solid tumors

Jakavi

LCM

Promacta

LCM

Lutathera

LCM

ruxolitinib, INC424

eltrombopag, ETB115

177Lu-oxodotreotide2)

Acute GVHD

Food effect free formulation

GEP-NET 1L G3

Kymriah

LCM

Tafinlar + Mekinist

LCM

Piqray

LCM

tisagenlecleucel, CTL019

dabrafenib + trametinib, DRB436

alpelisib, BYL719

r/r DLBCL 1st relapse

HGG/LGG - Pediatrics

TNBC

Kymriah

LCM

Xolair

LCM

Piqray

LCM

tisagenlecleucel, CTL019

omalizumab, IGE025

alpelisib, BYL719

r/r Follicular lymphoma

Food allergy

Ovarian cancer

Xolair

LCM

omalizumab, IGE025

Auto-injector

1. OAV101 (AVXS-101) IT filing timelines TBC based on HA feedback, preclinical studies to address partial clinical hold are on track 2. 177Lu-dotatate in US 3. Approved in US

54 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis pipeline in registration

1 lead indications

Lead indication

Immunology, Hepatology, Dermatology

Code

Name

Mechanism

Indication(s)

AIN457

Cosentyx®

IL17A inhibitor

300 mg AI

Neuroscience

Code

Name

Mechanism

Indication(s)

OMB157

ofatumumab

CD20 antagonist

r MS1)

Cardiovascular, Renal, Metabolism

Code

Name

Mechanism

Indication(s)

KJX839

Leqvio®

siRNA (regulation of LDL-C)

Hyperlipidemia2)

LCZ696

Entresto®

Angiotensin receptor/neprilysin

HFpEF

inhibitor

Global Health

Code

Name

Mechanism

Indication(s)

LAM320

Lamprene®

SMPD1 inhibitor

Tuberculosis3)

1. Approved in US as Kesimpta® 2. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe, FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021. 3. WHO Pre-Qualification

55 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis pipeline in Phase 3

Oncology

Code

Name

Mechanism

Indication(s)

AAA617

177Lu-PSMA-617

Targeted radioligand therapy

mCRPC

mCRPC pre-taxane

AAA6011)

Lutathera®

Targeted radioligand therapy

GEP-NET 1L G3

ABL001

asciminib

BCR-ABL inhibitor

CML 3L

ACZ885

canakinumab

IL-1b inhibitor

NSCLC 1L

NSCLC 2L

Adjuvant

NSCLC

BYL719

Piqray®

PI3Kα inhibitor

HER2+ adv BC

TNBC

HNSCC 2/3L

Ovarian cancer

CTL019

Kymriah®

CD19 CART

r/r Follicular

1L high risk

r/r DLBCL 1st

lymphoma

ALL, pediatrics

relapse

and young

adults

DRB436

Tafinlar® +

BRAF inhibitor + MEK inhibitor

Thyroid cancer

Mekinist®

ETB115

Promacta®

Thrombopoietin receptor (TPO-R)

Radiation sickness syndrome

Food effect free formulation

agonist

INC280

capmatinib

Met inhibitor

NSCLC EU2)

INC424

Jakavi®

JAK1/2 inhibitor

Acute GVHD

Chronic GVHD

LEE011

Kisqali®

CDK4 Inhibitor

HR+/HER2- BC (adj)

MBG453

sabatolimab

TIM3 antagonist

HR-MDS

Immunology, Hepatology, Dermatology

Code

Name

Mechanism

Indication(s)

AIN457

Cosentyx®

IL17A Inhibitor

Lupus Nephritis

Juvenile idiopathic arthritis

AS H2H

IV regimen in PsA

IV regimen in AS

QGE031

ligelizumab

IgE Inhibitor

CSU

CINDU

Food allergy

Ophthalmology

Code

Name

Mechanism

Indication(s)

RTH258

Beovu®

VEGF Inhibitor

Diabetic retinopathy

RVO

DME

6 lead indications

Lead indication

Neuroscience

Code

Name

Mechanism

Indication(s)

AMG334

Aimovig®

CGRPR antagonist

Ped Migraine

BAF312

Mayzent®

S1P1,5 receptor modulator

Ped MS

Respiratory Disease

Code

Name

Mechanism

Indication(s)

IGE025

Xolair®

IgE inhibitor

Food allergy

Auto-injector

Cardiovascular, Renal, Metabolism

Code

Name

Mechanism

Indication(s)

KJX839

Leqvio®

siRNA (regulation of LDL-C)

CVRR-LDLC

LCZ696

Entresto®

Angiotensin receptor/neprilysin

Post-AMI

Pediatric HF3)

inhibitor

TQJ230

pelarcasen

ASO targeting Lp(a)

CVRR-Lp(a)

Global Health

Code

Name

Mechanism

Indication(s)

COA566

Coartem®

Malaria uncomplicated, new formulation <5kg patients

Biosimilars

Code

Name

Mechanism

Indication(s)

GP2411

denosumab

anti RANKL mAb

Denosumab BioS

1. 177Lu-dotatate in US 2. Approved in US & JP 3. Approved in US

56 Investor Relations │ Q4 2020 Results

Participants

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Financial review

Conclusion

Appendix

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Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis pipeline in Phase 2

Oncology

Code

Name

Mechanism

Indication(s)

BYL719

alpelisib

PI3Kα inhibitor

PROS

BLZ945

CSF-1 Inhibitor

Solid tumors

DRB436

Tafinlar® + Mekinist®

BRAF inhibitor + MEK inhibitor

HGG/LGG - Pediatrics

INC280

capmatinib

Met inhibitor

Solid tumors

NSCLC

(Combo)

INC424

Jakavi®

JAK1/2 inhibitor

Myelofibrosis (combination)

Pediatrics acute

Pediatrics

GVHD

chronic GVHD

LXH254

cRAF inhibitor

Melanoma (combo)

MBG453

sabatolimab

TIM3 antagonist

Unfit AML

NIR178

NIR178, spartalizumab

Ad2AR inhibitor, PD1 inhibitor

Cancers

NIS793

TGFB1 inhibitor

Pancreatic cancer

PDR001

spartalizumab

PD1 inhibitor

Metastatic melanoma (combo)

SEG101

crizanlizumab

P-selectin Inhibitor

Ped sickle cell anaemia with crisis

Immunology, Hepatology, Dermatology

Code

Name

Mechanism

Indication(s)

ADPT02

NASH (Combos)

AIN457

Cosentyx®

IL17A inhibitor

GCA

Lichen planus

CFZ533

iscalimab

CD40 inhibitor

Renal Tx

Sjögren's

Liver Tx

LJC242

tropifexor & cenicriviroc

FXR agonist, CCR2 inhibitor

NASH (combos)

LJN452

tropifexor & licogliflozin

FXR agonist

NASH (combos)

LNA043

ANGPTL3 agonist

Osteoarthritis

LOU064

remibrutinib

BTK inhibitor

CSU

Sjögren's

LRX712

Osteoarthritis

LYS006

Anti-inflammatory

Acne

Colitis ulcerative

MAS825

NLRC4-GOF indications

VAY736

ianalumab

BAFF-R inhibitor

Sjögrens

AIH

SLE

Ophthalmology

Code

Name

Mechanism

Indication(s)

CPK850

RLBP1 AAV

ECF843

rh-Lubricin

Dry eye

LKA651

EPO inhibitor

DME

SAF312

TRPV1 antagonist

COSP

UNR844

Disulfide bonds modulator

Presbyopia

1. Preclinical studies to address partial clinical hold are on track

31 lead indications

Lead indication

Neuroscience

Code

Name

Mechanism

Indication(s)

BAF312

Mayzent®

S1P1,5 receptor modulator

Stroke

BLZ945

CSF-1 Inhibitor

ALS

LMI070

branaplam

mRNA splicing modulator

SMA

MIJ821

NR2B Inhibitor

Depression

OAV101

AVXS-101

Survival motor neuron (SMN)

SMA IT1)

gene therapy

Respiratory Disease

Code

Name

Mechanism

Indication(s)

CMK389

IL-18 inhibitor

Pulmonary sarcoidosis

CSJ117

TSLP inhibitor

Asthma

DFV890

COVID-19 related pneumonia

LOU064

remibrutinib

BTK inhibitor

Asthma

MAS825

COVID-19 related pneumonia

QBW251

icenticaftor

CFTR potentiator

COPD

VAY736

ianalumab

BAFF-R inhibitor

IPF

Cardiovascular, Renal, Metabolism

Code

Name

Mechanism

Indication(s)

CFZ533

iscalimab

CD40 inhibitor

Lupus nephritis

T1DM

HSY244

Atrial fibrillation

LCZ696

Entresto®

Angiotensin receptor/neprilysin

nHCM

inhibitor

LMB763

nidufexor

FXR agonist

Diabetic nephropathy

LNP023

iptacopan

CFB inhibitor

PNH

IgAN

C3G

iMN

aHUS

LTW980

Hypertriglyceridemia

Global Health

Code

Name

Mechanism

Indication(s)

AFQ056

mGluR5 Antagonist

Cocaine use disorder

KAE609

cipargamin

PfATP4 inhibitor

Malaria severe

Malaria uncomplicated

KAF156

ganaplacide

Malaria uncomplicated

LXE408

Protozoan inhibitor

Visceral leishmaniasis

57 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis pipeline in Phase 1 (1 of 2)

36 lead indications

Lead indication

Oncology

Code

Name

Mechanism

Indication(s)

AAA603

177Lu-NeoB

Radioligand therapy target GRPR

Multiple solid tumors

AAA602

177Lu-PSMA-R2

Radioligand therapy target PSMA

Prostate cancer

ADPT01

TNBC (combos)

Colorectal cancer (combos)

ADPT03

BCL11A

Sickle cell anemia

CSJ137

Growth factor inhibitor

Anaemia

CTL019

Kymriah®

CD19 CART

Lymphoma

DKY709

DKY709 + spartalizumab

Novel immunomodulatory agent

Cancers

EGF816

nazartinib + LXH254, ribociclib, capmatinib, opdivo, mekinist

EGFR inhibitor

NSCLC (combo)

HDM201

HDM201 + MBG453, venetoclax

MDM2 inhibitor

Haematological malignancy

JBH492

Haematological malignancy

JEZ567

CD123 CART

AML

KAZ954

Solid tumors

LHC165

LHC165 + spartalizumab

TLR7 agonist

Solid tumors

LXF821

EGFR CART

Glioblastoma multiforme

LXH254

LXH254 (combos)

cRAF inhibitor

Solid tumors

MAK683

EED inhibitor

Cancers

MCM998

MCM998, LXG250

BCMA CART, CD19 CART

Multiple myeloma

MIK665

MCL1 inhibitor

AML (combo)

NIS793

NIS793, spartalizumab

TGFB1 inhibitor

Solid tumors

NIZ985

NIZ985, spartalizumab

IL-15 agonist

Solid tumors

NZV930

NZV930, spartalizumab, NIR178

CD73 antagonist

Solid tumors

PDR001

spartalizumab (combos)

PD1 inhibitor

AML

Solid tumors (combo)

PHE885

BCMA cell therapy

Multiple myeloma

SQZ622

CD123xCD3 modulator

AML

TNO155

SHP2 inhibitor

Solid tumors (single agent)

Solid tumors (combo)

VAY736

ianalumab + ibrutinib

BAFF-R inhibitor

Haematological malignancy

VOB560

Cancers

VPM087

gevokizumab

IL1B Antagonist

CRC 1st line

WNT974

WNT974 + spartalizumab

Porcupine Inhibitor

Solid tumors

WVT078

Multiple myeloma

YTB323

YTB323 ± ibrutinib

CD19 CART

Haematological malignancy

58 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Novartis pipeline in Phase 1 (2 of 2)

36 lead indications

Lead indication

Immunology, Hepatology, Dermatology

Code

Name

Mechanism

Indication(s)

CEE321

Pan JAK Inhibitor

DFV890

Anti-inflammatory therapy

FIA586

NASH

MHS552

Autoimmune indications

MHV370

Sjögren's

SLE

NGI226

Tendinopathy

Neuroscience

Code

Name

Mechanism

Indication(s)

OAV201

OAV201 (AVXS-201)

MECP2 gene therapy

Rett syndrome

LMI070

branaplam

mRNA splicing modulator

Huntington

Respiratory Disease

Code

Name

Mechanism

Indication(s)

LTP001

Respiratory diseases

NCJ424

Respiratory diseases

Cardiovascular, Renal, Metabolism

Code

Name

Mechanism

Indication(s)

MBL949

Obesity related diseases

Ophthalmology

Global Health

Code

Name

Mechanism

Indication(s)

Code

Name

Mechanism

Indication(s)

MHU650

Diabetic eye diseases

KAF156

ganaplacide

Malaria prophylaxis

59 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

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 2b or later).

For further information on all Novartis clinical trials, please visit: www.novartisclinicaltrials.com

60 Investor Relations │ Q4 2020 Results

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Financial review

Conclusion

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cardiovascular, Renal

and Metabolic

61 Investor Relations │ Q4 2020 Results

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Financial review

Conclusion

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Entresto® - Angiotensin II Receptor Neprilysin Inhibitor (ARNI)

Study

NCT02678312 PANORAMA HF (CLCZ696B2319)

NCT03785405 (CLCZ696B2319E1 - extension study)

Indication

Heart failure in pediatric patients

Phase

Phase 2

Phase 3

Patients

360

240

Primary Outcome

Part 1: Pharmacodynamics and pharmacokinetics of

Number of participants with Adverse Events (AEs) and

Measures

sacubitril/valsartan LCZ696 analytes

Serious Adverse Events (SAEs)

Part 2: Efficacy and safety compared with enalapril

Arms/Intervention

• Part 1: Sacubitril/valsartan 0.8 mg/kg or 3.1 mg/kg or both;

• Single arm, open label sacubitril/valsartan (pediatric

0.4 mg/kg or 1.6 mg/kg or both (single doses).

formulation granules (12.5, 31.25 mg in capsules); liquid

• Part 2: enalapril/placebo 0.2 mg/kg bid (ped. formulation

formulation (1mg/ml and 4mg/ml concentration) and

1mg/ml) and adult formulation (2.5, 5, 10 mg bid);

adult formulation (50, 100, 200 mg bid))

Sacubitril/valsartan (LCZ696)/placebo: Ped. formulation

granules (12.5, 31.25 mg in capsules); liquid formulation

(1mg/ml and 4mg/ml concentration) and adult formulation (50,

100, 200 mg bid)

Target Patients

Pediatric patients from 1 month to < 18 years of age with heart

Pediatric patients with heart failure due to systemic left

failure due to systemic left ventricle systolic dysfunction

ventricle systolic dysfunction who have completed study

CLCZ696B2319

Read-out Milestone(s)

2022; (Analysis of 110 pts from Part 2 formed the basis for

2022

pediatric submission in Apr-2019 and approval by the US FDA in

Oct-2019 for the treatment of symptomatic HF with systemic left

ventricular systolic dysfunction in children aged 1 year and older)

Publication

TBD

62 Investor Relations │ Q4 2020 Results

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Conclusion

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Entresto® - Angiotensin II Receptor Neprilysin Inhibitor (ARNI)

Study

NCT02884206 PERSPECTIVE (CLCZ696B2320)

NCT02468232 PARALLEL-HF (CLCZ696B1301)

Indication

Heart failure

Heart failure, reduced ejection fraction

Phase

Phase 3

Patients

592

225

Primary Outcome

Change from baseline in the CogState Global Cognitive

Time to the first occurrence of the composite endpoint - either

Measures

Composite Score (GCCS)

cardiovascular (CV) death or heart failure (HF) hospitalization

• Sacubitril/valsartan 50, 100, and 200 mg bid with placebo

• Sacubitril/valsartan 50 mg, 100 mg, 200 mg bid/placebo of

Arms/Intervention

of valsartan

enalapril

• Valsartan 40, 80, and 160 mg bid tablets with placebo for

• Enalapril 2.5 mg, 5 mg, 10 mg bid / placebo of

sacubitril/valsartan

Target Patients

Patients with chronic heart failure with preserved ejection

Japanese heart failure patients (NYHA Class II-IV) with

fraction

reduced ejection fraction

Read-out Milestone(s)

2022

Primary: Q1-2019(actual); Extension (open-label):H1-2021

Publication

TBD

Submitted for Q4-2020: Primary manuscript in Circ J

63 Investor Relations │ Q4 2020 Results

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Entresto® - Angiotensin II Receptor Neprilysin Inhibitor (ARNI)

Study

NCT01920711 PARAGON-HF (CLCZ696D2301)

NCT03066804 PARALLAX (CLCZ696D2302)

Indication

Heart failure, preserved ejection fraction

Phase

Phase 3

Patients

4,822

2,572

Primary Outcome

Cumulative number of primary composite events of

Change in NT-proBNP from baseline to week 12

cardiovascular (CV) death and total (first and recurrent) HF

and change in 6 minute walk distance (6MWD) from baseline

Measures

hospitalizations

to Week 24

•

Sacubitril/valsartan or placebo 50 mg, 100 mg, and 200 mg

•

Sacubitril/valsartan 50 mg, 100 mg and 200 mg bid and

Arms/Intervention

matching placebo

bid

•

Enalapril 2.5 mg, 5 mg and 10 mg bid and matching placebo

•

Valsartan or placebo 40 mg, 80 mg, and 160 mg bid

•

Valsartan 40 mg, 80 mg, 160 mg bid and matching placebo

Target Patients

Heart failure patients (NYHA Class II-IV) with preserved

ejection fraction

Read-out Milestone(s)

2019 (actual)

•

Sep-2019: Primary manuscript (ARNI in HFpEF. Solomon S

•

Study design (Wachter et al; ESC-HF),May-2020

et al; NEJM. DOI: 10.1056/NEJMoa1908655)

•

Mar-2020: Published (NTproBNP, putative placebo analysis)

•

Primary data presented at ESC latebreaker, Aug-2020

Publication

•

Jun-2020: Submitted (renal outcomes, cognitive function)

•

Baseline data publication in EJHF (expected publication Q4-

•

Q4-2020 Planned: Urgent HF visits, regional differences,

2020), accepted Sep-2020

win ratio, adjudicated vs reported endpts; Subgroups (mode

•

Planned Primary Publication High Tier Journal in H1-2021

of death, MRA, age, gender)

64 Investor Relations │ Q4 2020 Results

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Company overview

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Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Entresto® - Angiotensin II Receptor Neprilysin Inhibitor (ARNI)

Study

NCT02924727 PARADISE-MI (CLCZ696G2301)

Indication

Post-acute myocardial infarction

Phase

Phase 3

Patients

5,670

Primary Outcome

Time to the first occurrence of a confirmed composite

Measures

endpoint (cardiovascular (CV) death, heart failure (HF)

hospitalization, or outpatient heart failure)

• Sacubitril/valsartan 50 mg, 100 mg, 200 mg bid; placebo

Arms/Intervention

for ramipril ; placebo for valsartan

• Ramipril 1.25 mg, 2.5 mg, and 5 mg bid; placebo for

sacubitril/valsartan; placebo for valsartan

Target Patients

Read-out Milestone(s)

Publication

Post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF

H1-2021

65 Investor Relations │ Q4 2020 Results

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

KJX839 - siRNA (regulation of LDL-C)

Study

NCT03060577 ORION-3 (CKJX839A12201E1)

NCT03705234 ORION-4 (CKJX839B12301)

Indication

Hypercholesterolemia inc. Atherosclerotic Cardiovascular

Hypercholesterolemia inc. Heterozygous Familial

Disease (ASCVD) and ASCVD risk equivalents Heterozygous

Hypercholesterolaemia (HeFH)

Familial Hypercholesterolaemia (HeFH)

Phase

Phase 2

Phase 3

Patients

490

~15,000

LDL-C reduction at Day 210 for Group 1 subjects

A composite of major adverse cardiovascular events, defined as:

Primary Outcome

•

Coronary heart disease (CHD) death;

Changes in other lipids and lipoproteins and reduction of LDL-

•

Myocardial infarction;

Measures

C of more than 50% for patients that are above LDL-C goal ;

•

Fatal or non-fatal ischaemic stroke; or

longer term exposure and safety.

•

Urgent coronary revascularization procedure

•

Group 1 - inclisiran 300mg sc on Day 1 and every 180 days

Arm 1: every 6 month treatment KJX839 300mg (given by

subcutaneous injection on the day of randomization, at 3 months

thereafter for up to 4 years.

and then every 6-months) for a planned median duration of

•

Group 2- Evolocumab 140mg s.c. injection on Day 1 and

Arms/Intervention

about 5 years

every 2 weeks until Day 336, followed by inclisiran 300mg

Arm 2: matching placebo (given bysubcutaneous injection on the

on Day 360, Day 450 and then every 6 months for a

day of randomization, at 3 months and then every 6-

planned duration of 4 years.

months) for a planned median duration of about 5 years.

Target Patients

Patients with HeFH or pre-existing atherosclerotic

Patient population with mean baseline LDL-C ≥ 100mg/dL

cardiovascular disease (ASCVD) on background statin +/-

ezetimibe therapy

Read-out Milestone(s)

2022

2025

Publication

TBD

66 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

KJX839 - siRNA (regulation of LDL-C)

Study

NCT03851705 ORION-5 (CKJX839A12302)

NCT03814187 ORION-8 (CKJX839A12305B)

Indication

Hypercholesterolemia inc. Homozygous Familial

Hypercholesterolemia inc. Heterozygous Familial

Hypercholesterolaemia (HeFH) and Homozygous Familial

Hypercholesterolemia (HoFH)

Phase

Phase 3

Patients

56 randomized 2:1 (inclisiran: placebo)

2,991 entered the study

Primary Outcome

•

LDL-C reduction at Day 150

•

Proportion of subjects achieving prespecified low density

lipoprotein cholesterol (LDL-C) targets at end of study

Measures

•

Changes in PCSK9, other lipids and lipoproteins

•

Safety and tolerability profile of long term use of inclisiran

• Part 1: inclisiran 300mg on Day 1 and Day 90 or placebo

Inclisiran 300mg on day 1 (placebo patients entered into study

on Day 1 and Day 90

from ORION 9, 10 & 11) or placebo on Day 1 (inclisiran

Arms/Intervention

• Part 2: inclisiran on Day 180 for patients who were

patients entered into study from ORION 9, 10 & 11) then

randomized to the placebo group only, inclisiran on Day

inclisiran 300mg on Day 90 and every 6 months for a planned

270 and then every 6 months for a planned duration of 2

duation of 3 years

years for all patients

Patients with HoFH with background statin +/- ezetimibe

Patients with HeFH or pre-existing atherosclerotic

Target Patients

cardiovascular disease (ASCVD) on background statin +/-

therapy

ezetimibe therapy and risk equivalents (patients from ORION

9, 10 & 11 studies)

Read-out Milestone(s)

Primary: Q3-2020(actual); Final: H2-2021

2023

Publication

TBD

67 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

LNP023 - Factor B inhibition of the complement alternative pathway

Study

NCT03373461 (CLNP023X2203)

NCT04154787 (CLNP023D12201)

Indication

IgA nephropathy (IgAN)

Idiopathic membranous nephropathy (iMN)

Phase

Phase 2

Patients

112

Primary Outcome

Change from baseline of log transformed UPCR derived from

Change from baseline of UPCR derived from 24hr urine

Measures

the 24h urine collections at Baseline and Day 90

collections at Baseline and Week 24

• Placebo

• LNP023 Dose - 200mg bid

• LNP023 Dose 1 - 10mg bid

Arms/Intervention

• LNP023 Dose 2 - 50mg bid

• LNP023 Dose - 50mg bid

• LNP023 Dose 3 - 200mg bid

• Rituximab

• LNP023 Dose 4 - 100mg bid (Part 2 only)

Target Patients

Patients with biopsy-verified IgA nephropathy

Patients with biopsy proven iMN who are at high risk of

disease progression defined on the basis of antibody anti-

PLA2R titre and proteinuria

Read-out Milestone(s)

H1-2021 (IA)

2022

Publication

TBD

68 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

LNP023 - Factor B inhibition of the complement alternative pathway

Study

NCT03832114 (CLNP023X2202)

NCT03955445 (CLNP023B12001B)

Indication

C3 glomerulopathy (C3G)

Phase

Phase 2

Phase 2 (open-label extension)

Patients

27 patients from ongoing Ph2 (sample size from Ph3 pending

HA discussions Q1 2021), total patients for this study will

increase

Cohort A: Ratio to Baseline of UPCR to Week 12 derived from

Characterize the effect of LNP023 treatment on a composite

Primary Outcome

24hr urine collection

renal response endpoint at 9 months (1. a stable or improved

Cohort B: Change from Baseline in C3 Deposit Score (based

Measures

eGFR and, 2. a reduction in proteinuria and 3. an increase in

on immunofluorescence microscopy) at Week 12

C3 compared to the CLNP023X2202 baseline visit)

Arms/Intervention

Increasing doses of LNP023 up to 200mg bid:

• Open-label LNP023 200mg bid

• Cohort A: Native kidney patients

• Cohort B: Kidney transplanted patients

Target Patients

Patients with C3 glomerulopathy

Read-out Milestone(s)

H1-2021

2024

Publication

Interim analysis data from Cohort-A presented at American

TBD

Society of Nephrology (ASN 2020)

69 Investor Relations │ Q4 2020 Results

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Innovation: Clinical trials

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IHD

Neuroscience

Oncology

Ophthalmology

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Abbreviations

LNP023 - Factor B inhibition of the complement alternative pathway

Study

NCT03439839 (CLNP023X2201)

NCT03896152 (CLNP023X2204)

Indication

Paroxysmal nocturnal hemoglobinuria (PNH)

Phase

Phase 2

Patients

Primary Outcome

Reduction of chronic hemolysis, based on LDH level at Week

Reduction of PNH associated hemolysis, based on

percentage of patients with 60% reduction in LDH or LDH

Measures

below upper limit of normal up to 12 weeks of treatment.

•

Cohort 1: 10 patients receiving LNP023 200mg bid, in

•

Arm 1: 4wks treatment LNP023 25mg bid followed by 8wk

addition to SoC, for 13 weeks with 3yr treatment extension

period

treatment LNP023 100mg bid and 2yr extension LNP023

Arms/Intervention

•

Cohort 2: 5 patients receiving LNP023 50mg bid, in addition

100mg bid

to SoC, for minimum 2 weeks with 3yr treatment extension

•

Arm 2: 4wks treatment LNP023 50mg bid followed by 8wk

period. Dose may be increased D15 onwards to 200mg bid

treatment LNP023 200mg bid and 2yr extension LNP023

if LDH not within limit of normal or reduced by at least 60%

200mg bid

compared to Baseline.

Target Patients

Patients with PNH, showing signs of active hemolysis despite

Patients with PNH, showing signs of active hemolysis, not

treatment with SoC (defined as an antibody with anti C5

treated with any other complement inhibitor less than 3

activity).

months prior to study start Day 1

Read-out Milestone(s)

Primary: Q2-2020(actual)

Extension: 2023

Extension: 2022

Publication

Antonio M. Risitano, MD, PhD1 et al. Presented at EBMT

TBD

2020 congress

70 Investor Relations │ Q4 2020 Results

Participants

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

TQJ230 - Antisense oligonucleotide targeting apolipoprotein(a) mRNA

Study

NCT04023552 Lp(a)HORIZON (CTQJ230A12301)

Indication

Cardiovascular risk reduction

Phase

Phase 3

Patients

7,680

Primary Outcome

Time to the first occurrence of MACE (cardiovascular death,

non-fatal MI, non-fatal stroke and urgent coronary re-

Measures

vascularization)

Arms/Intervention

TQJ230 80 mg injected monthly subcutaneously or matched

placebo

Target Patients

Patients with a history of Myocardial infarction or Ischemic

Stroke, or a clinically significant symptomatic Peripheral Artery

Disease, and Lp(a) ≥ 70 mg/dL

Read-out Milestone(s)

2024

Publication

TBD

71 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Immunology,

Hepatology &

Dermatology

72 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

CFZ533 - Blocking, non-depleting,Fc-silent,anti-CD40 monoclonal antibody

Study

NCT03663335 CIRRUS I (CCFZ533A2201)

NCT03905525 TWINSS (CCFZ533B2201)

Indication

Kidney transplantation

Sjögren's syndrome

Phase

Phase 2

Patients

681

260

Primary Outcome

Cohorts 1 and 2-mean iBox risk prediction score at 12 months.

Change in EULAR Sjögren's syndrome Disease Activity Index

Integrative score that will provide a prediction of graft survival

(ESSDAI) score and EULAR Sjögren's syndrome Patient

Measures

at year 5

Reported Index (ESSPRI) score

Arms/Intervention

•

Two cohorts: de novo TX and maintenance

•

Three dose arms of CFZ533

•

Test Arms: CFZ533 + MMF + corticosteroids

•

Placebo

•

Standard of Care: TAC + MMF + corticosteroids

Target Patients

Kidney transplant recipients

Patients with Sjögren's syndrome

Read-out Milestone(s)

2022

Publication

TBD

73 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

CFZ533 - Blocking, non-depleting,Fc-silent,anti-CD40 monoclonal antibody

Study

NCT03781414 CONTRAIL I (CCFZ533A2202)

Indication

Liver transplantation

Phase

Phase 2

Patients

128

Primary Outcome

Proportion of patients with composite event (BPAR, Graft Loss

Measures

or Death) over 12 months

Arms/Intervention

•

Control/Standard of Care: TAC + MMF + Corticosteroids

•

CFZ533 dose A + MMF + Corticosteroids

•

CFZ533 dose B + MMF + Corticosteroids

Target Patients

Read-out Milestone(s)

Publication

Liver transplant recipients

2023

TBD

74 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT03504852 (CAIN457A2324)

NCT03589885 MATURE (CAIN457A2325)

Indication

Psoriasis

Phase

Phase 3B

Phase 3

Patients

331

122

Primary Outcome

PASI 90 response and IGA mod 2011 0 or 1 response after 16

PASI 75 response and IGA mod 2011 0 or 1 response after 12

Measures

weeks of treatment

•

Secukinumab 300 mg every 2 weeks after weekly doses till

•

Secukinumab 2 mL (300 mg) auto-injector

Arms/Intervention

Week 4

•

Secukinumab 2 x 1 mL (150 mg each) prefilled syringe

•

Secukinumab 300 mg every 4 weeks after weekly doses till

•

Placebo 2 mL auto-injector

Week 4

•

Placebo 2 x 1 mL prefilled syringe

Target Patients

Subjects (≥90kg) with moderate to severe plaque psoriasis

Subjects with moderate to severe plaque psoriasis

Read-out Milestone(s)

Q3-2020(actual)

Final: Q4-2020(actual)

Publication

Publication (primary efficacy) planned in H1-2021

Publication (16 week primary results) planned in H1-2021

75 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT02471144 (CAIN457A2310)

NCT03668613 (CAIN457A2311)

Indication

Psoriasis

Phase

Phase 3

Patients

162

Primary Outcome

Psoriasis Area and Severity Index (PASI) 75 response and

Investigators' Global Assessment (IGA) 0 or 1 response at

Measures

week 12

•

Secukinumab low dose

•

Secukinumab low dose

Arms/Intervention

•

Secukinumab high dose

•

Placebo

•

Secukinumab high dose

•

Etanercept (comparator)

Target Patients

Patients from 6 to less than 18 years of age with severe

Pediatric patients of age 6 to <18 years, with moderate to

chronic plaque psoriasis

severe plaque psoriasis

Read-out Milestone(s)

2023

Publication

Published Q4 2020 JEADV

Publication planned in H1-2021

76 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT03066609 (CAIN457A2318)

Indication

Psoriasis

Phase

Phase 3

Patients

543

Primary Outcome

Psoriasis Area and Severity Index (PASI) 75 response and

Investigators' Global Assessment (IGA) 0 or 1 response at

Measures

week 12

Arms/Intervention

• Secukinumab 300 mg

• Secukinumab 150 mg

•

Placebo

Target Patients

Patients with moderate to severe chronic plaque-type

psoriasis with or without psoriatic arthritis comorbidity

Read-out Milestone(s)

Q1-2019(actual)

•

Week 16 results: Poster presented at: 2019 American

Academy of Dermatology (AAD) Annual Meeting,

Publication

•

March 1-5, 2019, Washington, D.C.

•

52-week results: Poster at EADV 2019, Madrid 9-13

October, 2019

•

Manuscript publication H1-2021

77 Investor Relations │ Q4 2020 Results

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Innovation: Clinical trials

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IHD

Neuroscience

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Ophthalmology

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Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT03031782 (CAIN457F2304)

NCT03769168 (CAIN457F2304E1 - extension study)

Indication

Psoriatic arthritis

Phase

Phase 3

Patients

Primary Outcome

Time to 33 flares

Number of participants with JIA ACR30 response

Measures

Arms/Intervention

• Secukinumab (pre-filled syringe) 75 mg

• Secukinumab 75 mg/0.5 ml

• Placebo

• Secukinumab 150 mg/1.0 ml

Target Patients

Juvenile idiopathic arthritis subtypes of psoriatic and enthesitis-

Patients with juvenile idiopathic arthritis subtypes of juvenile

related arthritis

psoriatic arthritis and enthesitis related arthritis

Read-out Milestone(s)

H1-2021

2025

Publication

Planned publication in 2021

TBD

78 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT02696031 PREVENT (CAIN457H2315)

NCT03259074 SURPASS (CAIN457K2340)

Indication

Non-radiographic axial spondyloarthritis

Ankylosing spondylitis

Phase

Phase 3

Patients

555

837

Primary Outcome

The proportion of participants who achieved an ASAS 40

No radiographic structural progression as measured by

response (Assessment of SpondyloArthritis International

Measures

modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)

Society criteria);

Arms/Intervention

• Secukinumab 150 mg load

• Secukinumab 150/300 mg

• Secukinumab 150 mg no load

• Adalimumab biosimilar 40 mg

•

Placebo

Target Patients

Patients with non-radiographic axial spondyloarthritis

Patients with active ankylosing spondylitis

Read-out Milestone(s)

Week 52: Q3-2019(actual); Final: H1-2021

2022

•

Abstract (16 week results) presented at ACR 2019

•

Abstract (52 week results) presented at EULAR 2020

• Study design manuscript published. Baraliakos et al. Clinical

Publication

•

Manuscript published in Aug 2020 in Arthritis and

Drug Investigation (2020) 40:269-278.

Rheumatology

•

Further publications planned

79 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

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Financial review

Conclusion

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT03713619 SUNSHINE (CAIN457M2301)

NCT04179175 (CAIN457M2301E1)

Indication

Hidradenitis Suppurativa (HS)

Phase

Phase 3

Patients

471

745

Primary Outcome

Proportion of participants with Hidradenitis Suppurativa clinical

Proportion of patients with Hidradenitis Suppurativa Clinical

Measures

response (HiSCR)

Response (HiSCR)

• Secukinumab 300 mg every 2 weeks

Arms/Intervention

• Secukinumab 300 mg every 4 weeks

•

Placebo (every 2 weeks)

• Secukinumab 300 mg every 4 weeks

•

Placebo (every 4 weeks)

Target Patients

Patients with moderate to severe Hidradenitis Suppurativa

Patients with moderate to severe hidradenitis suppurativa

completing either of the core trials AIN457M2301 (NCT

0313632) or AIN567M2302 (NCT03713619)

Read-out Milestone(s)

Primary (week 16): H2-2021; Final: 2022

2025

Publication

Study design SHSA 2020; Primary 2022

Study design SHSA 2020

80 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

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Financial review

Conclusion

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Innovation: Clinical trials

CRM

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Neuroscience

Oncology

Ophthalmology

Respiratory

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Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT03713632 SUNRISE (CAIN457M2302)

Indication

Hidradenitis Suppurativa (HS)

Phase

Phase 3

Patients

471

Primary Outcome

Proportion of patients with Hidradenitis Suppurativa Clinical

Measures

Response (HiSCR)

• Secukinumab 300 mg every 2 weeks

Arms/Intervention

• Secukinumab 300 mg every 4 weeks

• Placebo (every 2 weeks)

• Placebo (every 4 weeks)

Target Patients

Read-out Milestone(s)

Publication

Subjects with moderate to severe Hidradenitis Suppurativa

Primary (week 16): H2-2021; Final: 2022

StudStudy design SHSA 2020; Primary 2022

81 Investor Relations │ Q4 2020 Results

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Company overview

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Financial review

Conclusion

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Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT04156620 INVIGORATE-1 (CAIN457P12301)

NCT04209205 INVIGORATE-2 (CAIN457P12302)

Indication

Axial spondyloarthritis

Psoriatic Arthritis (PsA)

Phase

Phase 3

Patients

500

380

Primary Outcome

The proportion of subjects achieving an ASAS40 (Assessment

The proportion of subjects achieving American College of

Measures

of SpondyloArthritis International Society criteria) response

Rheumatology 50 (ACR50) response criteria

Arms/Intervention

• Secukinumab intravenous (i.v.) regimen

• Placebo intravenous (i.v.) regimen

Target Patients

Patients with active axial spondyloarthritis

Patients with active psoriatic arthritis (PsA) despite current or

previous NSAID, DMARD and/or anti-TNF therapy

Read-out Milestone(s)

Primary (week 16): 2022; Final: 2023

2022

Publication

TBD

82 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Cosentyx® - Anti IL-17

Study

NCT04181762 SELUNE (CAIN457Q12301)

NCT04300296 PRELUDE (CAIN457S12201)

Indication

Lupus Nephritis

Lichen Planus

Phase

Phase 3

Phase 2

Patients

460

108

Primary Outcome

Proportion of subjects achieving protocol-defined CRR

Proportion of patients achieving Investigator's Global

Assessment (IGA 0/1) score at 16 weeks +30% delta vs

Measures

placebo

Arms/Intervention

• Secukinumab 300 mg s.c.

• Placebo s.c.

Target Patients

Patients with active lupus nephritis (ISN/RPS Class III or IV,

Adult patients with biopsy-proven lichen planus not adequately

with or without co-existing class V features)

controlled by topical therapies

Read-out Milestone(s)

2026

2022

Publication

TBD

83 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

LJC242 - FXR agonist + CCR2/CCR5 inhibitor

Study

NCT03517540 TANDEM (CLJC242A2201J)

Indication

Non-alcoholic steatohepatitis

Phase

Phase 2

Patients

193

Primary Outcome

Evaluation of safety and tolerability of combination therapy

(tropifexor + cenicriviroc) by monitoring adverse event profile,

Measures

vital signs and laboratory parameters

•

Arm A: tropifexor (LJN452) dose 1

Arms/Intervention

•

Arm B: cenicriviroc (CVC)

• Arm C: LJN452 dose 1 + CVC

• Arm D: LJN452 dose 2 + CVC

Target Patients

Read-out Milestone(s)

Publication

Adult patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis

Q4-2020

Abstract planned in H1-2021

84 Investor Relations │ Q4 2020 Results

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Company overview

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Financial review

Conclusion

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Neuroscience

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Ophthalmology

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Abbreviations

LJN452 - FXR Agonist

Study

NCT04065841 ELIVATE (CLJN452D12201C)

Indication

Non-alcoholic steatohepatitis (NASH)

Phase

Phase 2

Patients

380

Primary Outcome

Proportion of patients with resolution of NASH and no

worsening of fibrosis OR improvement in fibrosis by at least

Measures

one stage without worsening of NASH at Week 48 compared

with baseline

•

Arm A: combination therapy tropifexor + licogliflozin

•

Arm B: tropifexor monotherapytropifexor + licogliflozin

Arms/Intervention

placebo

•

Arm C: licogliflozin monotherapylicogliflozin + tropifexor

placebo

•

Arm D: licogliflozin placebo + tropifexor placebo

Target Patients

Adult patients with biopsy based non-alcoholic steatohepatitis

(NASH) and liver fibrosis

Read-out Milestone(s)

2022

Publication

Planned in H1-2023

85 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

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Sandoz Biopharmaceuticals

Global Health

Abbreviations

LOU064 - Bruton's tyrosine kinase (BTK) inhibitor

Study

NCT03926611 (CLOU064A2201)

NCT04109313 (CLOU064A2201E1)

Indication

Chronic spontaneous urticaria (CSU)

Phase

Phase 2

Patients

308

250

Primary Outcome

Change from baseline in weekly Urticaria Activity Score (UAS7) at Week 4

•

Long-term safety and tolerability

Measures

•

Arm 1 Low dose of LOU064 orally in the morning (once daily) and matching

placebo in the evening from Day 1 to 85

•

Arm 2 Medium dose of LOU064 orally in the morning (once daily) and

matching placebo in the evening from Day 1 to 85

•

Selected dose of LOU064 taken orally twice

Arms/Intervention

•

Arm 3 High dose of LOU064 orally in the morning (once daily) and matching

a day (morning and evening) from day 1 to

placebo in the evening from Day 1 to 85

week 52

•

Arm 4 Low dose of LOU064 orally, twice daily from Day 1 to 85

•

Arm 5 Medium dose of LOU064 orally, twice daily from Day 1 to 85

•

Arm 6 High dose of LOU064 orally, twice daily from Day 1 to 85

•

Placebo arm Matching placebo, orally, twice daily from Day 1 to 85

Target Patients

Adults with CSU inadequately controlled by H1-antihistamines

Patients with CSU who have participated in

preceding studies with LOU064

Read-out Milestone(s)

H2-2021

2022

Publication

Primary resuls: EADV2021 synchronized with manuscript (NEJM), ACAAI2021

TBD

Secondary results: AAAAI, AAD 2022

86 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

QGE031 - Anti-IgE

Study

NCT02477332 (CQGE031C2201)

NCT02649218 (CQGE031C2201E1)

Indication

Chronic spontaneous urticaria

Phase

Phase 2

Patients

382

226

Primary Outcome

Establish dose-response relationship of QGE031 with respect

Long-term safety; number of participants with treatment-

Measures

to achievement of complete hives response at week 12

emergent adverse events

•

Ligelizumab 24mg q4wks for 20 weeks

•

Ligelizumab 72mg q4wks for 20 weeks

Arms/Intervention

•

Ligelizumab 240mg q4wks for 20 weeks

Ligelizumab 240 mg q4wks open label for 52 weeks

•

Ligelizumab 120mg single dose

• Omalizumab 300mg q4wks for 20 weeks

•

Placebo q 4wks for 20 weeks

Adult patients with chronic spontaneous urticaria inadequately

Target Patients

controlled with H1-antihistamines at approved or increased

doses, alone or in combination with H2-antihistamines or

leukotriene receptor antagonists.

Read-out Milestone(s)

2017 (actual)

2019 (actual)

•

H1-2021 3 Manuscripts: Angioedema, Sleep/DLQI

•

H1-2021 manuscript: primary results extension trial (NEJM)

Publication

(including also ext. data), Data visualization

•

2021 Congresses: exploratory data AAAAI, AAD, EAACI,

•

2021 Congresses: exploratory data EAACI, EADV, ACAAI,

EADV, ACAAI, encores at GUF

encores at GUF

87 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

QGE031 - Anti-IgE

Study

NCT03437278 (CQGE031C2202)

NCT04210843 (CQGE031C2302E1)

Indication

Chronic spontaneous urticaria

Phase

Phase 2

Phase 3

Patients

800

Primary Outcome

Change in the 7 day Urticaria Activity Score (UAS7)

The proportion of subjects with well-controlled disease

Measures

(UAS7 ≤ 6) at week 12

Arms/Intervention

•

Ligelizumab high dose q4wks for 24 weeks

•

Ligelizumab Dose 1 and 3

•

Ligelizumab low dose q4wks for 24 weeks

•

Ligelizumab Dose 2 and 3

•

Placebo / ligelizumab high dose q4wks for 8 / 16 weeks

Target Patients

Adolescents from 12 to <18 years of age, with chronic

Patients who completed studies CQGE031C2302,

spontaneous urticaria

CQGE031C2303, CQGE031C2202 or CQGE031C1301

Read-out Milestone(s)

H2-2021

2026

•

Study design was presented at PAAM (Peds Allergy &

Asthma Meeting) and at UCARE meeting 2019

Publication

•

Baseline characteristics 2020/21

Study design presented at 2020 EAACI

•

Primary results to be presented in late 2021/2022 (e.g.

EAACI, PAAM, EADV)

•

Manuscript to be submitted in 2022

88 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

QGE031 - Anti-IgE

Study

NCT03580369 Pearl 1 (CQGE031C2302)

NCT03580356 Pearl 2 (CQGE031C2303)

Indication

Chronic spontaneous urticarial / Chronic idiopathic urticaria

Phase

Phase 3

Patients

1,050

Primary Outcome

Absolute change from baseline in UAS7 (Urticaria Activity

Measures

Score) at week 12

•

Ligelizumab dose A q4w for 52 weeks

• Ligelizumab dose A q4w for 52 weeks

•

Ligelizumab dose B q4w for 52 weeks

• Ligelizumab dose B q4w for 52 weeks

Arms/Intervention

• Omalizumab 300 mg q4w for 52 weeks

•

Placebo q4w from randomization to wk20, then ligelizumab

• Placebo q4w from randomization to wk20, then ligelizumab

dose B from wk24 to wk52

Target Patients

Adolescents and adults with chronic spontaneous urticaria

inadequately controlled with H1-antihistamines

Read-out Milestone(s)

H2-2021

Publication

• Study design presented at UCARE 2018

• Primary results to be presented in 2022 (e.g. EAACI, PAAM, EADV)

• Manuscript to be submitted in 2022

89 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

VAY736 - Fully human IgG1/κ anti-BAFF-R mAb

Study

NCT02962895 (CVAY736A2201)

NCT03217422 AMBER (CVAY736B2201)

Indication

Primary Sjögren's syndrome

Autoimmune hepatitis

Phase

Phase 2

Patients

180

Primary Outcome

Safety and efficacy of VAY736 in primary Sjögren's syndrome

Alanine aminotransferase (ALT) normalization

Measures

(pSS)

Arms/Intervention

• VAY736

• Placebo

• Placebo control with conversion to active VAY736

Target Patients

Patients with moderate to severe primary Sjögren's syndrome

Autoimmune hepatitis patients with incomplete response or

(pSS)

intolerant to standard treatment of care

Read-out Milestone(s)

Q2-2020(actual)

2026

Publication

• Manuscript Q4-2020

TBD

90 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Neuroscience

91 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Aimovig® - CGRP receptor antagonist

Study

NCT03096834 LIBERTY (CAMG334A2301)

NCT03333109 EMPOWER (CAMG334A2302)

Indication

Migraine

Phase

Phase 3

Patients

246

900

Primary Outcome

Percentage of patients with a 50% response in the reduction

Change from baseline in monthly migraine days at the last

Measures

of Monthly Migraine Days (MMD)

month (Month 3) of the double-blind treatment period

Arms/Intervention

•

Subcutaneous injection of AMG334 (erenumab)

• AMG334 (erenumab) Dose 1

• AMG334 (erenumab) Dose 2

•

Subcutaneous injection of placebo

•

Placebo

Target Patients

Adult episodic migraine patients who have failed prophylactic

Adult episodic migraine patients

migraine treatments

Read-out Milestone(s)

Double-blind: 2017 (actual);

Q1-2020(actual)

Extension (open-label):H1-2021

•

PROs and prespecified subgroup analysis (Double-blind

•

Primary analysis manuscript submitted end 2020

phase) submitted to JNNP accepted Aug-2020

Publication

•

Submitted May 28, 2020 1 year Open-label extension to

•

Abstracts accepted for MTIS in 2020

Neurology

•

Secondary analysis to be submitted to multiple congresses

•

Planned for Q4-2020: 2Y Open-label extension Abstracts

in 2021

completed for EAN, AHS, EHF and MTIS in 2020

92 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Aimovig® - CGRP receptor antagonist

Study

NCT03867201 DRAGON (CAMG334A2304)

Indication

Migraine

Phase

Phase 3

Patients

550

Primary Outcome

Change from baseline in monthly migraine days during the last

Measures

4 weeks of the 12-week treatment period

Arms/Intervention

•

Subcutaneous injection of AMG334 (erenumab) 70 mg

•

Subcutaneous injection of placebo

Target Patients

Adult chronic migraine patients

Read-out Milestone(s)

Double-blind:2021;

Extension (open-label): 2024

Publication

Planned in H2-2022 for double-blind phase and H1-2025 for

open-label extension phase

93 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

LMI070 - SMN2 RNA splice modulator

Study

NCT02268552 (CLMI070X2201)

Indication

Type 1 spinal muscular atrophy

Phase

Phase 1/2

Patients

Primary Outcome

Number of participants with adverse events (AEs), serious

Measures

adverse events (SAEs) and deaths

Branaplam oral, once weekly:

•

Part 1: 5 ascending doses

Arms/Intervention

•

Part 2: 2 different dose levels

•

Part 3: patients continue on initial dose assigned in Part 1 or

Part 2

Target Patients

Read-out Milestone(s)

Publication

Patients with type 1 spinal muscular atrophy

Study Part 2: Q3-2020(actual)

Study Part 3: 2023

TBD

94 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

OMB157 - Anti-CD20

Study

NCT03249714 APOLITOS (COMB157G1301)

NCT03650114 ALITHIOS (COMB157G2399)

Indication

Multiple sclerosis

Multiple Sclerosis

Phase

Phase 2

Phase 3

Patients

2010

Primary Outcome

Reduced cumulative number of Gd-enhanced T1 lesions

Evaluate the long-term safety and tolerability of ofatumumab

across 4 MRI scans at week 12, 16, 20 and 24 (ofatumumab

20 mg subcutaneous (sc) once every 4 (q4) weeks in subjects

Measures

vs placebo)

with RMS from the first dose of ofatumumab

Arms/Intervention

•

Ofatumumab 20 mg subcutaneous injections

• Ofatumumab 20 mg every 4 weeks

•

Placebo

Target Patients

Patients with relapsing forms of multiple sclerosis

Patients with relapsing MS

Read-out Milestone(s)

Q1-2020(actual)

2028

Publication

Publication planned for H1-2021

TBD

95 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Zolgensma® - SMN1 gene replacement therapy

Study

NCT03461289 STRIVE-EU(CL-302)

NCT03306277 STRIVE (CL-303)

Indication

Type 1 spinal muscular atrophy

Phase

Phase 3

Patients

Primary Outcome

Proportion of participants sitting without support

•

Achievement of independent sitting for at least 30 seconds

Measures

•

Event-free survival

Arms/Intervention

Open-label,single-arm,single-dose, intravenous

Target Patients

Patients with spinal muscular atrophy Type 1

Patients with Spinal Muscular Atrophy Type 1

Read-out Milestone(s)

Q4-2020(actual)

Q4-2019(actual)

Publication

Final results at the 2021 annual meeting of the

Publication of full results in top-tier neurology journal in

European Academy of Neurology (EAN, June 19‒22)

February 2021

96 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Zolgensma® - SMN1 gene replacement therapy

Study

NCT03505099 SPR1NT (CL-304)

NCT03837184 STR1VE Asia Pacific (CL-306)

Indication

Spinal muscular atrophy

Type 1 spinal muscular atrophy

Phase

Phase 3

Patients

•

[2 copies of SMN2] Percentage of participants achieving

functional independent sitting for at least 30 seconds at any

Primary Outcome

visit

Proportion of participants sitting without support

Measures

•

[3 copies of SMN2] Percentage of participants achieving the

ability to stand without support for at least 3 seconds at any

visit

Arms/Intervention

Open-label,single-arm,single-dose, intravenous

Target Patients

Pre-symptomatic patients with spinal muscular atrophy and

Patients with spinal muscular atrophy Type 1

multiple copies SMN2

Read-out Milestone(s)

H2-2021

Publication

(Muscular Dystrophy Association) MDA 2021 (March 15‒18)

and (American Academy of Neurology) AAN 2021

TBD

(April 17‒22)

97 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Zolgensma® - SMN1 gene replacement therapy

Study

NCT03381729 STRONG (CL-102)

Indication

Type 2 spinal muscular atrophy

Phase

Phase 1

Patients

Primary Outcome

•

Safety and tolerability, incidence of adverse events

•

Proportion of patients achieving Standing Milestone

Measures

•

Change in Hammersmith Functional Motor Scale

Arms/Intervention

Open-label,single-arm,single-dose, intrathecal

Target Patients

Patients with spinal muscular atrophy with 3 copies of SMN2

Read-out Milestone(s)

Cohort B: Q4-2019(actual); Cohort C1: TBC

Publication

TBD

98 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

Oncology

CRM

IHD

Neuroscience

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

Oncology

99 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

Oncology

CRM

IHD

Neuroscience

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

ABL001 - Specific, allosteric Bcr-Abl kinase inhibitor

Study

NCT03106779 ASCEMBL (CABL001A2301)

Indication

Chronic myeloid leukaemia (CML)

Phase

Phase 3

Patients

233

Primary Outcome

Major Molecular Response (MMR) rate at 24 weeks

Measures

Arms/Intervention

• ABL001 40 mg bid

•

Bosutinib 500 mg

Target Patients

Patients with chronic myelogenous leukemia in chronic phase,

previously treated with 2 or more tyrosine kinase inhibitors

Read-out Milestone(s)

Q3-2020(actual)

•

Hochhaus A., et al. [Efficacy and Safety Results from

ASCEMBL, a Multicenter, Open-Label, Phase 3 Study of

Asciminib, a First-in-Class STAMP Inhibitor, vs Bosutinib

Publication

(BOS) in Patients (Pts) with Chronic Myeloid Leukemia in

Chronic Phase (CML-CP) Previously Treated with ≥2

Tyrosine Kinase Inhibitors (TKIs), LBA-4] ASH 2020

•

Manuscript submission Q4-2020

100 Investor Relations │ Q4 2020 Results

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