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January 26, 2021 at 04:06 am

Participants	Company overview	Pharmaceuticals	Oncology	Financial review	Conclusion	Appendix	Back	Next

Q4 2020 Results

Investor presentation

1 Investor Relations │ Q4 2020 Results

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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.

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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

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Vas Narasimhan

Chief Executive Officer

Company overview

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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

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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

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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	3%
sales
	1%
Core2	13%
OpInc
	2%

Key growth driver sales Q4 2020		Growth

Sales	Growth vs. PY		vs. PY
USD mn	USD mn		cc

716		198	35%
1,109	144		13%
471	91		23%
376	83		24%

254	68		33%

240	62		32%
408	52		13%

141	45		42%

57	40		nm

34	33		nm

335	32		8%

184	29		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®

	Q4		Q4	Q4	Q4
				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

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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

44	100

126	105	122		106


Q1'20	Q2'20	Q3'20	Q4'20
		Ex-US				US

Performance highlights

Delivered significant growth in 2020 despite COVID-19 delaying new starts and switches; impact expected to continue through H1 2021
Treatment of choice for newly diagnosed patients
>800 patients have received Zolgensma®; now registered in 37 countries
Shift toward broader labeling (e.g. EU, Canada) and use globally - In EU, 15% of patients >2 years old and 2% over 13.5kg
Access pathways in 9 EU countries (~25% of the population)

Growth opportunities in existing indications

Approvals expected H1 2021: Switzerland, Australia, Argentina, South Korea
Formal reimbursement expected in 15 countries by 2022 (.e.g UK, Spain, Canada, Brazil, Argentina)
Expected increase in newborn screening: >80% in US and 20% in EU by end 20211

Clinical and pipeline

Confirmatory data in 2021: cumulative IV safety, final STR1VE-EU & STR1VE-US results
IT partial clinical hold: preclinical studies on track; FDA recommends a pivotal confirmatory study to be initiated after partial clinical hold is lifted
10+ early-stage programs with two INDs planned in 2021

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

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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

China net sales grew +16% despite COVID-19impact
Key growth drivers continued momentum, FY sales growth YoY: Entresto®, Cosentyx®, Oncology strategic brands2
NRDL achievements in 2020:
- Successfully listed: Cosentyx® (PsO & AS), Gilenya®, Mayzent®, Tafinlar® & Mekinist®3
- Renewed listing: Tasigna®, Votrient®, Sandostatin® LAR, Zykadia®
Rich pipeline:
- 2020 NDA approvals: Cosentyx® AS, Mayzent®, Pataday®, Tafinlar®+Mekinist® adj, Zykadia® 1L
- 7 approvals expected in 2021 (NDA submitted in 2020)
- Kesimpta® granted China priority review, TQJ230 obtained 1st BTD
- New launches planned by 2023: Kisqali®, ACZ885
- New indications by 2023: Afinitor® (ER+ 2/3L BC), Tafinlar®+Mekinist® (BRAF+ NSCLC), Revolade® (SAA 2L/1L)

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

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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%

	3%
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

15+ pipeline assets, many entering clinical phase soon
Sales of up to USD 3.5bn expected by 2025

Small molecules

High LoE coverage (EU: >80%, US: >50%) with approximately 40 US first-to-files until 2024

Driving margin

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

Manufacturing optimization
Product mix from higher biosimilar share
Operational excellence including use of digital

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

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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
80
60
40
20
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

CRL due to unresolved facility inspection-related conditions at
3rd party manufacturer in Europe2
No concerns raised in CRL regarding efficacy or safety of Leqvio®
Response to CRL based on 3rd party readiness to be submitted Q2-Q3 2021
Need for FDA inspection under discretion of FDA
Concurrently working on technology transfer to add Novartis own facility

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.

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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	FL
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	HS

	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

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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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Marie-France Tschudin

President, Novartis Pharmaceuticals

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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.
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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

		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


	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4
			2019			2020

Robust Q4 performance despite continued COVID-19 impact

COVID-19market impact: patient visits at 70%-80% vs. pre-COVID-191
Demand driven by clinical profile, strong access, execution excellence
Q4 YoY TRx grew faster than the market in US for PsO and SpA:
- PsO: +10% vs. market +7%, maintaining strong NBRx share~16%2
- SpA: +18% vs. market +9%, leading NBRx share ~30%3

Catalystsfor continued strong growth

Increased biologics penetration in existing indications (all regions)
China NRDL listing for PsO and AS
300mg auto-injector & pre-filled syringe approved by EMA
Clinical data readout (ULTIMATE): significant reduction in synovitis
Expansion to up to 10 indications/label expansions planned (e.g. HS, JIA)

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®

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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
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

Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4
	2019			2020

Strong momentum across geographies continues in Q4

US demand driven growth (+27% YoY) 1
China (>200% YoY) fueled ex-US growth
Europe delivered strong double-digit growth (+32% YoY)

Confidence in future growth

Increasing penetration in HFrEF: only 25% currently treated2
A direct-to-ARNI approach is now recommended in de novo patients by ACC in the 2021 ECDP3

LCM

Extended use in the treatment of HFpEF (US, Q1 2021)
PARADISE-MItrial on track for read-out in Q2 2021

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

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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

Recognition of highest effect in ejection fraction below normal1
12:1 vote in favor of extending use
Understanding of HF is evolving putting dichotomous classification in question2
Confirms strong unmet need
Regulatory decision expected Q1 2021

Preparing for launch

Disease burden significant with frequent HF hospitalizations, emergency rooms and urgent office visits
Depending on label, US addressable population could be 1.5m to 3m
Strong experience and footprint in cardiology
Expect to maintain leading access position
Uptake likely gradual due to lack of consensus guidelines

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)

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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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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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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)

22 Investor Relations │ Q4 2020 Results

Participants	Company overview	Pharmaceuticals	Oncology	Financial review	Conclusion	Appendix	Back	Next

Susanne Schaffert

President, Novartis Oncology

23 Investor Relations │ Q4 2020 Results

Participants	Company overview	Pharmaceuticals	Oncology	Financial review	Conclusion	Appendix	Back	Next

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	.2	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%

Growth drivers and launches up +29%, despite pandemic conditions
Embarked on virtual launches with Adakveo® and Tabrecta®

Q4: Continued momentum of growth drivers and recent launches

Promacta® / Revolade® (USD 471m, +23%)
Jakavi® (USD 376m, +24%)
Tafinlar® + Mekinist® (USD 408m, +13%)
Kymriah® (USD 141m, +42%)
Kisqali® (USD 184m, +18%)

Q4: Offset Gx erosion, COVID-19 impact

Generic impact mainly from Afinitor®, Exjade®
Lutathera® (USD 109m, +1% cc) continued impact from COVID-19

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

24 Investor Relations │ Q4 2020 Results

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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
US
+45%
	687
480	369

230
250	318

FY 2019	FY 2020

Delivered strong growth (+45% cc) and market share gains (+4.8%1) in 2020, driven by unprecedented overall survival (OS) benefit from 2 pivotal Ph3 trials
CDK4/6i market still depressed due to COVID-19 (NBRx down -15% vs. PY)
Longest median OS among all Ph3 trials in aBC: nearly 5 years in pre- menopausal patients
Pooled data from MONALEESA studies presented at SABCS confirmed efficacy across luminal and ET resistant HER2-E patient subtypes
Ability to selectively and preferentially inhibit CDK4 may restore endocrine sensitivity in these more aggressive tumors
NATALEE adjuvant study in intermediate and high risk populations (70% of adjuvant patients) final readout expected 2022

1. Patient share, October YTD vs PY

25 Investor Relations │ Q4 2020 Results

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

Sales evolution

USD m, % cc

		Ex-US

		US	+68%



				474
				269
278

119
159	205


		FY 2019	FY 2020

Sales grew +68% cc in 2020, despite COVID-19 impact on healthcare systems
Continued to expand our global footprint:
- 27 countries covering at least 1 indication
- 290+ qualified treatment centers
- FBRI approved for commercial supply (previous approvals: Stein, Les Ulis)
Increased manufacturing capacity ~70% vs. PY, improved process robustness
New data at ASH:
- ELARA interim analysis showed Kymriah® is effective in extensively pre-treated patients with r/r FL: CR 65%, ORR 83%; submission expected 2021
- JULIET updated efficacy results showed continued durable responses for patients with r/r DLBCL: 2-yearprogression-free survival rate 33%
Advanced our CAR-T pipeline (new indications) and CAR-T manufacturing platform

FBRI - Foundation for Biomedical Research and Innovation

26 Investor Relations │ Q4 2020 Results

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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

57		6
%
	Asciminib	Bosutinib

Complete Cytogenetic response at 24 weeks 40.8%

% of patients	24.2%	1.7x


Asciminib	Bosutinib

Ph3 ASCEMBL study in 3L+ CML-CP: demonstrated statistically significant superiority in efficacy vs. bosutinib and a favorable safety profile
MMR rate at 24 weeks: 25.5% vs. 13.2% with bosutinib, meeting primary endpoint; consistent across most major demographic and prognostic subgroups
AEs leading to dose adjustment or interruption with asciminib vs. bosutinib were 37.8% (n=156) and 60.5% (n=76), respectively; AEs leading to discontinuation were 5.8% and 21.1%, respectively
Global regulatory submissions planned in H1 2021; further plans to expand into earlier lines underway

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

Participants	Company overview	Pharmaceuticals	Oncology	Financial review	Conclusion	Appendix	Back	Next

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

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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

PD-1market expected to reach USD 63bn by 2026
Tislelizumab already approved in China; 15 potentially registration-enabling clinical trials currently ongoing, with first ex-China filing expected in 2021
Key indications include NSCLC, HCC, esophageal and gastric cancer

Unlock combination potential with Novartis assets

Multiple combination opportunities identified with Novartis portfolio, across all 4 therapeutic platforms
Open the door to potential broader strategic collaboration with BeiGene

Deal terms

Upfront payment of USD 650m plus royalties and milestone payments
Novartis obtains development and commercialization rights in ex-China regions2
Closing expected H1 2021, deal subject to normal closing conditions1

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

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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	Next

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

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Solid FY performance on top and bottom line

Continuing operations	1	Q4	Change vs. PY
USD million			2020	% USD	% cc 2
Net Sales			12,770	3	1

Core Operating income	2	3,501	1	2
Operating income		2,644	45	51

Net Income			2,099	86	93

Core EPS (USD)	2		1.34	2	3
EPS (USD)			0.92	84	93

Free Cash Flow	2		3,342	-4

FY	Change vs. PY

2020	% USD	% cc 2

48,659	3	3

15,416	9	13
10,152	12	19

8,071	13	20

5.78	9	13
3.55	14	21

11,691 -10

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
Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report

32 Investor Relations │ Q4 2020 Results

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Core margin expansion of +2.8% points FY

Innovative Medicines core margin at 35.0%

Continuing operations1,2

		Q4 2020				FY 2020

		Core operating					Core operating
	Net sales	income		Core margin		Net sales	income		Core margin
	change vs. PY	change vs. PY	Core margin	change vs. PY		change vs. PY	change vs. PY	Core margin	change vs. PY
	(in % cc)	(in % cc)	(%)	(%pts cc)		(in % cc)	(in % cc)	(%)	(%pts cc)
Innovative Medicines	1	3	31.4	0.7	4	11	35.0	2.2
Sandoz	0	3	20.8	0.8	0	15	24.2	3.3

Continuing Operations	1	2	27.4	0.4		3	13	31.7	2.8

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
Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report

33 Investor Relations │ Q4 2020 Results

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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

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
Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55 of the Condensed Financial Report

34 Investor Relations │ Q4 2020 Results

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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

IM Division expected to grow mid single digit
Sandoz expected to be broadly in line with prior year

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

1. Key assumptions:

Our guidance assumes that we see a return to normal global healthcare systems including prescription dynamics by mid 2021
In addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2021 in the US

35 Investor Relations │ Q4 2020 Results

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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

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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

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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

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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	7


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
				4
CHF					CHF2.95 USD3.12 CHF3.00 USD 3.40
			4	USD
		.1% in
	and	10

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

1.	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
4.	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

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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
2	4	3 to 4
0

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

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Vas Narasimhan

Chief Executive Officer

41 Investor Relations │ Q4 2020 Results

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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

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

	Analyst consensus sales
	USD billion
					+4% CAGR
								60
		49
		2020	Growth Drivers1	Launches2	Other/Pipeline	Sandoz	Gx Brands3	2025
		Actual						Consensus
							IM margin
		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.
43	Investor Relations	│ Q4 2020 Results

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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		Growth vs. PY
USD Million	USD Million		cc
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

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

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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

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Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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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:

COSSET (COVID-19Site Surveillance Tool): predictive tool for proactively adapting to dynamic COVID-19 impacts at site level
> 35k remote monitoring visits since March
> 2k direct-to-patient medical delivery shipments
< 24 hours to detect / respond to site level actions
Active home nursing and virtual safety assessments
Novartis Digital Recruitment (NDR) implemented for new trial starts

1. As of end of December 2020

51 Investor Relations │ Q4 2020 Results

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Oncology

Financial review

Conclusion

Appendix

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Innovation:Innovati Pipelinei overviewerview

Innovation: Clinical trials

Our pipeline projects at a glance

	Phase 1/2	Phase 3	Registration	Total
ONCOLOGY	51	22	0	73


PHARMACEUTICALS	67	21	5	93

Cardiovascular, Renal, Metabolism	12	4	2	18
Immunology, Hepatology, Dermatology	27	9	1	37
Neuroscience	7	2	1	10
Ophthalmology	6	3	0	9
Respiratory	9	2	0	11
Global Health	6	1	1	8

BIOSIMILARS	0	1	0	1
Total	118	44	5	167

52 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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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	Lead		Lead		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
		RP			Visceral leishmaniasis		PDR001
							Malignant melanoma (combo)

		CSJ117	Lead		LXH254	Lead	TNO155	Lead
		Asthma			Solid tumors		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		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

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Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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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

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Financial review

Conclusion

Appendix

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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

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Financial review

Conclusion

Appendix

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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	HS
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

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Innovation: Clinical trials

Novartis pipeline in Phase 2

Oncology

Code	Name	Mechanism	Indication(s)
BYL719	alpelisib	PI3Kα inhibitor	PROS
BLZ945	BLZ945	CSF-1 Inhibitor	Solid tumors
DRB436	Tafinlar® + Mekinist®	BRAF inhibitor + MEK inhibitor	HGG/LGG - Pediatrics
INC280	capmatinib	Met inhibitor	Solid tumors	NSCLC		NSCLC
					(Combo)		(Combo)
INC424	Jakavi®	JAK1/2 inhibitor	Myelofibrosis (combination)		Pediatrics acute	Pediatrics
								GVHD	chronic GVHD
LXH254	LXH254	cRAF inhibitor	Melanoma (combo)
MBG453	sabatolimab	TIM3 antagonist	Unfit AML
NIR178	NIR178, spartalizumab	Ad2AR inhibitor, PD1 inhibitor	Cancers
NIS793	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	ADPT02	-	NASH (Combos)
AIN457	Cosentyx®	IL17A inhibitor	GCA	Lichen planus
CFZ533	iscalimab	CD40 inhibitor	Renal Tx	Sjögren's	HS	Liver Tx
LJC242	tropifexor & cenicriviroc	FXR agonist, CCR2 inhibitor	NASH (combos)
LJN452	tropifexor & licogliflozin	FXR agonist	NASH (combos)
LNA043	LNA043	ANGPTL3 agonist	Osteoarthritis
LOU064	remibrutinib	BTK inhibitor	CSU	Sjögren's
LRX712	LRX712	-	Osteoarthritis
LYS006	LYS006	Anti-inflammatory	Acne	Colitis ulcerative	HS
MAS825	MAS825	-	NLRC4-GOF indications
VAY736	ianalumab	BAFF-R inhibitor	Sjögrens	AIH	SLE

Ophthalmology

Code	Name	Mechanism	Indication(s)
CPK850	CPK850	RLBP1 AAV	RP
ECF843	ECF843	rh-Lubricin	Dry eye
LKA651	LKA651	EPO inhibitor	DME
SAF312	SAF312	TRPV1 antagonist	COSP
UNR844	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	BLZ945	CSF-1 Inhibitor	ALS
LMI070	branaplam	mRNA splicing modulator	SMA
MIJ821	MIJ821	NR2B Inhibitor	Depression
OAV101	AVXS-101	Survival motor neuron (SMN)	SMA IT1)
		gene therapy

Respiratory Disease
Code	Name	Mechanism	Indication(s)
CMK389	CMK389	IL-18 inhibitor	Pulmonary sarcoidosis
CSJ117	CSJ117	TSLP inhibitor	Asthma
DFV890	DFV890	-	COVID-19 related pneumonia
LOU064	remibrutinib	BTK inhibitor	Asthma
MAS825	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	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	LTW980	-	Hypertriglyceridemia

Global Health
Code	Name	Mechanism	Indication(s)
AFQ056	AFQ056	mGluR5 Antagonist	Cocaine use disorder
KAE609	cipargamin	PfATP4 inhibitor	Malaria severe	Malaria uncomplicated
KAF156	ganaplacide	-	Malaria uncomplicated
LXE408	LXE408	Protozoan inhibitor	Visceral leishmaniasis

57 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

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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 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	ADPT01	-	TNBC (combos)	Colorectal cancer (combos)
ADPT03	ADPT03	BCL11A	Sickle cell anemia
CSJ137	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	JBH492	-	Haematological malignancy
JEZ567	JEZ567	CD123 CART	AML
KAZ954	KAZ954	-	Solid tumors
LHC165	LHC165 + spartalizumab	TLR7 agonist	Solid tumors
LXF821	LXF821	EGFR CART	Glioblastoma multiforme
LXH254	LXH254 (combos)	cRAF inhibitor	Solid tumors	Solid tumors
MAK683	MAK683	EED inhibitor	Cancers
MCM998	MCM998, LXG250	BCMA CART, CD19 CART	Multiple myeloma
MIK665	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	PHE885	BCMA cell therapy	Multiple myeloma
SQZ622	SQZ622	CD123xCD3 modulator	AML
TNO155	TNO155	SHP2 inhibitor	Solid tumors (single agent)	Solid tumors (combo)	Solid tumors (combo)
VAY736	ianalumab + ibrutinib	BAFF-R inhibitor	Haematological malignancy
VOB560	VOB560	-	Cancers
VPM087	gevokizumab	IL1B Antagonist	CRC 1st line
WNT974	WNT974 + spartalizumab	Porcupine Inhibitor	Solid tumors
WVT078	WVT078	-	Multiple myeloma
YTB323	YTB323 ± ibrutinib	CD19 CART	Haematological malignancy

58 Investor Relations │ Q4 2020 Results

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Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

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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	CEE321	Pan JAK Inhibitor	AD
DFV890	DFV890	-	Anti-inflammatory therapy
FIA586	FIA586	-	NASH
MHS552	MHS552	-	Autoimmune indications
MHV370	MHV370	-	Sjögren's	SLE
NGI226	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	LTP001	-	Respiratory diseases
NCJ424	NCJ424	-	Respiratory diseases

Cardiovascular, Renal, Metabolism

Code	Name	Mechanism	Indication(s)
MBL949	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

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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

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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Appendix

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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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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	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	TBD

62 Investor Relations │ Q4 2020 Results

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Oncology

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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	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	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

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Abbreviations

Entresto® - Angiotensin II Receptor Neprilysin Inhibitor (ARNI)

Study	NCT01920711 PARAGON-HF (CLCZ696D2301)	NCT03066804 PARALLAX (CLCZ696D2302)
Indication	Heart failure, preserved ejection fraction	Heart failure, preserved ejection fraction
Phase	Phase 3	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	Heart failure patients (NYHA Class II-IV) with preserved
ejection fraction	ejection fraction

Read-out Milestone(s)	2019 (actual)	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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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

Q4-2020- Planned: PARADISE-MI study design / baseline characteristics
Planned primary data presentation and publication in H2- 2021

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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	TBD

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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)
	Hypercholesterolemia (HoFH)

Phase
Phase 3	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	TBD

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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	Phase 2
Patients	112	72
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	TBD

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Abbreviations

LNP023 - Factor B inhibition of the complement alternative pathway

Study	NCT03832114 (CLNP023X2202)	NCT03955445 (CLNP023B12001B)
Indication	C3 glomerulopathy (C3G)	C3 glomerulopathy (C3G)
Phase	Phase 2	Phase 2 (open-label extension)

Patients		27 patients from ongoing Ph2 (sample size from Ph3 pending
27	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	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)

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Abbreviations

LNP023 - Factor B inhibition of the complement alternative pathway

Study	NCT03439839 (CLNP023X2201)	NCT03896152 (CLNP023X2204)
Indication	Paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH)
Phase	Phase 2	Phase 2
Patients	16	13
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	13
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)	Primary: Q2-2020(actual)
Extension: 2023	Extension: 2022

Publication	Antonio M. Risitano, MD, PhD1 et al. Presented at EBMT	TBD
2020 congress

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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

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Abbreviations

Immunology,

Hepatology &

Dermatology

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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	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	2022

Publication	TBD	TBD

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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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT03504852 (CAIN457A2324)	NCT03589885 MATURE (CAIN457A2325)
Indication	Psoriasis	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	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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT02471144 (CAIN457A2310)	NCT03668613 (CAIN457A2311)
Indication	Psoriasis	Psoriasis
Phase	Phase 3	Phase 3
Patients	162	84
Primary Outcome	Psoriasis Area and Severity Index (PASI) 75 response and	Psoriasis Area and Severity Index (PASI) 75 response and
Investigators' Global Assessment (IGA) 0 or 1 response at	Investigators' Global Assessment (IGA) 0 or 1 response at
Measures
week 12	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	2023
Publication	Published Q4 2020 JEADV	Publication planned in H1-2021

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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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT03031782 (CAIN457F2304)	NCT03769168 (CAIN457F2304E1 - extension study)
Indication	Psoriatic arthritis	Psoriatic arthritis
Phase	Phase 3	Phase 3
Patients	80	64
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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT02696031 PREVENT (CAIN457H2315)	NCT03259074 SURPASS (CAIN457K2340)
Indication	Non-radiographic axial spondyloarthritis	Ankylosing spondylitis
Phase	Phase 3	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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT03713619 SUNSHINE (CAIN457M2301)	NCT04179175 (CAIN457M2301E1)
Indication	Hidradenitis Suppurativa (HS)	Hidradenitis Suppurativa (HS)
Phase	Phase 3	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	• 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

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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

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Abbreviations

Cosentyx® - Anti IL-17

Study	NCT04156620 INVIGORATE-1 (CAIN457P12301)	NCT04209205 INVIGORATE-2 (CAIN457P12302)
Indication	Axial spondyloarthritis	Psoriatic Arthritis (PsA)
Phase	Phase 3	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	• Secukinumab intravenous (i.v.) regimen
• Placebo 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	TBD

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Company overview

Pharmaceuticals

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Financial review

Conclusion

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Innovation: Clinical trials

CRM

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Neuroscience

Oncology

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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.	• Secukinumab 300 mg s.c.
• Placebo 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	TBD

83 Investor Relations │ Q4 2020 Results

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Company overview

Pharmaceuticals

Oncology

Financial review

Conclusion

Appendix

Back

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Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

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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

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

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

Back

Financial performance

Innovation: Pipeline overview

Innovation: Clinical trials

CRM

IHD

Neuroscience

Oncology

Ophthalmology

Respiratory

Sandoz Biopharmaceuticals

Global Health

Abbreviations

LOU064 - Bruton's tyrosine kinase (BTK) inhibitor

Study	NCT03926611 (CLOU064A2201)	NCT04109313 (CLOU064A2201E1)
Indication	Chronic spontaneous urticaria (CSU)	Chronic spontaneous urticaria (CSU)
Phase	Phase 2	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

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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	NCT02477332 (CQGE031C2201)	NCT02649218 (CQGE031C2201E1)
Indication	Chronic spontaneous urticaria	Chronic spontaneous urticaria
Phase	Phase 2	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	Adult patients with chronic spontaneous urticaria inadequately
Target Patients	controlled with H1-antihistamines at approved or increased	controlled with H1-antihistamines at approved or increased
doses, alone or in combination with H2-antihistamines or	doses, alone or in combination with H2-antihistamines or

	leukotriene receptor antagonists.	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

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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	NCT03437278 (CQGE031C2202)	NCT04210843 (CQGE031C2302E1)
Indication	Chronic spontaneous urticaria	Chronic spontaneous urticaria
Phase	Phase 2	Phase 3
Patients	48	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

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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	NCT03580369 Pearl 1 (CQGE031C2302)	NCT03580356 Pearl 2 (CQGE031C2303)
Indication	Chronic spontaneous urticarial / Chronic idiopathic urticaria	Chronic spontaneous urticarial / Chronic idiopathic urticaria
Phase	Phase 3	Phase 3
Patients	1,050	1,050
Primary Outcome	Absolute change from baseline in UAS7 (Urticaria Activity	Absolute change from baseline in UAS7 (Urticaria Activity
Measures	Score) at week 12	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	• 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	dose B from wk24 to wk52
Target Patients	Adolescents and adults with chronic spontaneous urticaria	Adolescents and adults with chronic spontaneous urticaria
inadequately controlled with H1-antihistamines	inadequately controlled with H1-antihistamines

Read-out Milestone(s)	H2-2021	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	Phase 2
Patients	180	80
Primary Outcome	Safety and efficacy of VAY736 in primary Sjögren's syndrome	Alanine aminotransferase (ALT) normalization
Measures	(pSS)


Arms/Intervention	• VAY736	• 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	Migraine
Phase	Phase 3	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

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Company overview

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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

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
39
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

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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	60	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	Type 1 spinal muscular atrophy
Phase	Phase 3	Phase 3
Patients	33	22
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	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

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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	Phase 3
Patients	30	2
	•	[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	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	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
51
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

FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal study

98 Investor Relations │ Q4 2020 Results

Participants

Company overview

Pharmaceuticals

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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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Novartis AG published this content on 26 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 January 2021 09:05:01 UTC

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