Roche : Full-Year 2020 Presentation with appendix

February 04, 2021 at 08:54 am

This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:

pricing and product initiatives of competitors;
legislative and regulatory developments and economic conditions;
delay or inability in obtaining regulatory approvals or bringing products to market;
fluctuations in currency exchange rates and general financial market conditions;
uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;
increased government pricing pressures;
interruptions in production;
loss of or inability to obtain adequate protection for intellectual property rights;
litigation;
loss of key executives or other employees; and
adverse publicity and news coverage.

Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche's earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com

All mentioned trademarks are legally protected.

Roche

2020 results

Basel, 4 February 2021

Group

Severin Schwan

Chief Executive Officer

2020 performance

Outlook

2020: Targets fully achieved despite COVID-19 pandemic

Targets for 2020	FY 2020

Group sales growth1 Low- to mid-single digit	+1%

Core EPS growth1

Broadly in line with sales growth

+4%

Dividend outlook	Further increase dividend in Swiss francs2	CHF 9.10

1 At constant exchange rates (CER); 2 2020 dividend as proposed by the Board of Directors

2020: Successfully managing the transition in volatile environment

	Compensated for biosimilar & COVID-19		Efficiency gains & investment into future

Group		Group
Sales		Core OP
CHFm (CER)	+ 4,739	CHFm (CER)

		- 5,051 2
			+ 1,800
		-868
		- 5,919
61,396				62,015

		+1%
2019	Pharma	Pharma	Diagnostics	2020
	New	bx exposed2	Division
	Products1	& other

At constant exchange rates (CER); 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Herceptin & Avastin in Europe (Avastin: as of Jul 20) and MabThera, Herceptin & Avastin in U.S. and Japan; 3

	+ 1,812	+ 981
	- 40

		- 803
		23,460	23,460
22,478	- 968

		+4%

2019	Pharma	Pharma	Pharma	Diagnostics Corporate	2020
	lower profit	efficiency	additional	growth &
	contribution	gains &	R&D spend	efficiency
	from lower	other		gains

sales3
Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi; 2 MabThera,	7
Pharma sales decline minus proportional cost of sales 2020

Responding quickly and broadly to the pandemic

Pharma

AT-527

Collaboration with Atea on

development of AT-527

casirivimab/imdevimab

Collaboration with Regeneron on

FDA EUA granted in mild-

casirivimab/imdevimab global supply

moderate adults and adolescents

COVACTA trial

REMDACTA trial

COVACTA

EMPACTA

REMAP-CAP

initiated

trial results

Jan 20

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jan 21 Feb

LightCycler®

TIB MOLBIOL LightMix®

480 modular SARS-CoV-2 launched

cobas®

cobas ® SARS-CoV-2

cobas® SARS-CoV-2 test & Flu

Diagnostics

6800/8800

test receives FDA EUA

A/B Test receives FDA EUA

cobas®

Elecsys® Anti-SARS-CoV-2

Elecsys® IL-6 test

Elecsys® Anti-SARS-CoV-2 S

Lab SARS-COV-2

e411/601/602/801

antibody test receives FDA EUA

receives FDA EUA

antibody test launched

antigen test launched

Non-

SARS-CoV-2 Rapid

SARS-CoV-2 Rapid Antigen

instrumented

Antibody Test launched

Antigen Test launched

Test Nasal launched

Overview - not all COVID-19 related developments captured; EUA=emergency use authorization

Potential use cases for COVID-19 portfolio

Pre-exposure/asymptomatic	Symptomatic	Post-vaccination
(screening and prophylaxis)	(diagnosis and treatment)	(to confirm protection)

PCR				Use cases will continue to
Antigen test				persist with vaccine rollout

Diagnostics			•	People not yet vaccinated

IL-6 test
			•	Vaccine ineffective/wore off
	Antibody test
		•	Antibody testing

Oral antiviral (DAA)			•	Population surveillance

		Neutralizing antibodies	•	Screening
		•	Flu/COVID-19 diagnosis
Pharma

			Immunomodulators
Low risk	High risk	Mild	Hospitalized

PCR=polymerase chain reaction test

2020: Sales growth due to Diagnostics Division

	2020	2019	Change in %
	CHFbn	CHFbn	CHF	CER

Pharmaceuticals Division	44.5	48.5	-8	-2
Diagnostics Division	13.8	12.9	6	14

Roche Group	58.3	61.5	-5	1

CER=Constant Exchange Rates	10

2020: Group sales growth impacted by COVID-19

16%
14%																														13%
12%
10%							8%																				9% 9%
8%							7%					7%											7%7%						7%
	6%		6%6%				6%				6%		6%
6%					5%				6%				6% 6%				8%		6%


4%											5%	5%			4%			4%		5%
		4%		4%			4%		4%													1% 1%
2%										3%	3%
2%
0%

-2%
-4%																																	-4%
-6%

	Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
	12	12	12	12	13	13	13	13	14	14	14	14	15	15	15	15	16	16	16	16	17	17	17	17	18	18	18	18	19	19	19	19	20	20	20	20
At constant exchange rates (CER)																																11

2020: Pandemic heavily impacting business dynamics

% CER		1st wave		2nd wave
+60%
+50%	+50%

+40%			+32%
		+25%	+28%
+30%
+20%			+18%	+24%

+10%	+7%	+2%
	+5%
+0%
	-6%		-7%
		-4%
-10%

	Q1'20 vs.	Q2'20 vs.	Q3'20 vs.	Q4'20 vs.
	Q1'19	Q2'19	Q3'19	Q4'19

Diagnostics

Pharma

Pharma New Products

Growth rates at CER (Constant Exchange Rates)

Pharmaceuticals

Severe impact from biosimilars and COVID-19
Q4 carry over effect (Ocrevus administration)

Diagnostics

Routine diagnostics impacted by COVID-19, gradual recovery since June 2020
COVID-19testing overcompensating negative impact on routine testing since June 2020

Pharma: New products with strong momentum

Accelerated portfolio rejuvenation in Q4 2020

Pharma sales mix

CHFm

% of Pharma Sales

21,000

41%

18,000

15,000

31%

12,000

22%

9,000

15%

6,000

3,000

FY 2017

FY 2018

FY 2019

FY 2020

Erivedge

Perjeta

Kadcyla

Gazyva

Esbriet

Cotellic

Alecensa

Tecentriq

Ocrevus

Hemlibra

Xofluza

Polivy

Rozlytrek

Phesgo

Enspryng

Evrysdi

All absolute values are presented in CHFm reported

2019

40% 31%

29%

2020

29%

41%

30%

New products launched since 2012

Other products Herceptin + Rituxan + Avastin

2020: Growth of profitability and Core EPS

			Core operating profit		Core EPS		Operating free cash flow

	36.1%	36.6%	36.9%						33.0%	34.0%
% of sales

														25.4%
						+1.2%p1

						+4%1
CHFbn							CHF	+4%1			CHFbn		-21% at CER


						21.5

				22.5				20.16	19.16				20.9


	20.5											18.7

								18.14					14.8

2018	2019	2020	2018	2019	2020	2018	2019	2020
1 at CER=Constant Exchange Rates								14

2020 performance

Outlook

Continuing to invest in innovation

Assets in Ph III & registration at all time high

Diagnostics major systems launches ahead

NMEs

			19
			2
	14	13	5

	2	2
10		2


	5	5	2
4


	1
1	1	1
1		1	8

4	5	4

FY 2017	FY 2018	FY 2019	FY 2020

221

Outlook FY

2021

cobas® 58002

cobas® pure2

cobas® pro (high throughput)

NME=new molecular entity; 1	Ph III in SRP-9001 DMD, Ph III in AT-527COVID-19, Ph III in rh-PTX-2 in IPF; 2	currently in development and not commercially available	16

Strong short- and mid-term news flow

Diversifying the late stage pipeline and setting new standards of care

Product	Indication		Filing/Data

tominersen	Huntington's		2022
gantenerumab	Alzheimer's		2022
SRP-9001	DMD		latest 2023

etrolizumab	Crohn's		2022
PDS	nAMD		2020/21
DME		2022

faricimab	DME		2021
nAMD

Actemra +/-	COVID-19 related	2021
remdesivir	pneumonia

casirivimab/	SARS-CoV-2		2021
imdevimab

AT-527	SARS-CoV-2		2021/22
crovalimab	PNH		2022
Positive top-line announced	Neuroscience	Immunology

Product		Indication	Filing/Data
		Adj SCCHN	2021
Tecentriq		(Neo)Adj NSCLC	2021/22
	Adj RCC	2022

		Adj HCC	2022
ipatasertib		1L mCRPC	2022
Polivy		1L DLBCL	2021
tiragolumab + T	1L SCLC	2022
mosunetuzumab	R/R FL	2021
glofitamab		R/R DLBCL	2022
Venclexta		R/R MM t(11;14)	2022
giredestrant		2L/3L mBC	2022
inavolisib		1L HR+ BC	2022/23
Ophthalmology	Infectious diseases	Oncology/Hematology

Source: DMD=duchenne muscular dystrophy; nAMD=neovascular age-related macular degeneration; DME=diabetic macular edema; PNH=paroxysmal nocturnal hemoglobinuria; SCCHN=squamous cell carcinoma of the head and neck; RCC=renal	17
cell carcinoma; NSCLC=non-small cell lung cancer; HCC=hepatocellular carcinoma; mCRPC=metastatic castration resistant prostate cancer; DLBCL=diffuse large B-cell lymphoma; SCLC=small cell lung cancer; FL=follicular lymphoma;

MM=multiple myeloma

Outlook 2021: Growing sales & profit and investing in the future

Aim to defend margins despite headwinds

Sales1

Expenses

Pharma: New Products growth to continue overcompensating for the biosimilar impact

Diagnostics: Strong sales growth expected in particular in H1 21

Pharma: AHR erosion additional impact of roughly CHF

-4.6 bn

Trends expected to continue:

Investing into the future while protecting the margin

1	based on assumption of general normalization in 2H '21; 2	at CER=Constant Exchange Rates; AHR=Avastin, Herceptin, MabThera/Rituxan	18

2021 outlook

Further growing top and bottom line

Group sales growth1		• Low- to mid-single digit

Core EPS growth1		• Broadly in line with sales growth

Dividend outlook		• Further increase dividend in Swiss francs

1	At Constant Exchange Rates (CER); based on the current assessment of the COVID-19 impact	19

Pharmaceuticals Division

Bill Anderson

CEO Roche Pharmaceuticals

2020: Pharmaceuticals Division sales

New products growing strongly - sales impacted by COVID-19 pandemic

	2020	2019	Change in %
	CHFm	CHFm	CHF	CER

Pharmaceuticals Division	44,532	48,516	-8	-2
United States	23,647	26,711	-11	-6
Europe	8,198	8,453	-3	1
Japan	3,765	4,143	-9	-6
International	8,922	9,209	-3	7

CER=Constant Exchange Rates

2020: Pharma Division

Core operating profit stable vs. prior year and significant reallocation of resources into R&D

	2020		2020 vs. 2019
	CHFm % sales	CER growth

Sales	44,532			100	-2%

Royalties & other op. inc.	1,959			4.4	-7%
Cost of sales	-8,070			-18.2	-16%
M & D	-6,633			-14.9	-8%
R & D	-10,597			-23.8		8%
G & A	-1,714			-3.8		6%

Core operating profit	19,477			43.7		0%

					-7% in CHF

CER=Constant Exchange Rates

Reallocating resources into R&D

Providing more patient benefit at less cost to society

launched
NMEs in clinical	#12	#1	#19	undisclosed	#15	#8	#7	#6	#2	#1
development *

1	First approval of a new molecule in a new indication; * Molecule classification for NMEs in clinical development where details have been disclosed - there are 20 additional undisclosed NMEs in	23

clinical development; PHC=personalized healthcare; NME=new molecular entity.

2020: Strong growth for new products leading to a more diversified portfolio

Tecentriq

55%

Hemlibra

68%

Ocrevus

24%

Actemra / RoActemra

32%

Perjeta

18%

Kadcyla

34%

Alecensa

40%

Polivy

248%

Gazyva

21%

TNKase / Activase

Evrysdi

n/a

Xolair

Esbriet

Xofluza

370%

Phesgo

n/a

Enspryng

n/a

Lucentis

-16%

Europe

Avastin

-25%

Japan

MabThera

-31%

Herceptin

-34%

International

-2,400-2,000-1,600-1,200-800	-400	0	400	800	1,200
CHFm
Absolute values and growth rates at Constant Exchange Rates (CER)					24

New products account for >47% of Pharma sales*

4 NMEs launched in 2020: ENSPRYNG, PHESGO, GAVRETO & EVRYSDI

CHFm

5,000 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 0

% of Pharma Sales*

47%

35%

24%

17%

Q4 17	Q4 18	Q4 19	Q4 20
Erivedge	Perjeta	Kadcyla	Gazyva
Esbriet	Cotellic	Alecensa	Tecentriq
Ocrevus	Hemlibra	Xofluza	Polivy
Rozlytrek	Phesgo	Enspryng	Evrysdi

* Venclexta sales are booked by partner AbbVie and therefore not included (Q4: USDm 365); Gavreto sales are initially booked by partner Blueprint Medicines and therefore not included, Gavreto discovered by Blueprint	25

Medicines; NME=new molecular entity

2020: Oncology -10% due to biosimilars & COVID-19

YoY CER growth

Cotellic

CHFbn

HER2 franchise

Kadcyla and Perjeta with strong global uptake in adjuvant BC
Phesgo launched in US and EU

Avastin franchise

Biosimilar erosion in all regions

Hematology franchise*

Venclexta: Strong growth in 1L CLL and 1L AML
Gazyva: Growth in 1L CLL and 1L FL
Polivy: Strong US/EU launch in R/R DLBCL

Tecentriq

Growth driven by 1L SCLC, 1L TNBC and 1L HCC

Alecensa

Strong performance in all regions

CER=Constant Exchange Rates; 2020 Oncology sales: CHF 23.3bn; CER growth -10%; * Venclexta sales booked by AbbVie and therefore not included (FY-2020 sales of USD 1,337m); Polivy in collaboration with Seagen;	26

BC=breast cancer; AML=acute myeloid leukemia; CLL=chronic lymphocytic leukemia; FL=follicular lymphoma; R/R DLBCL=relapsed/refractory diffuse large B cell lymphoma; SCLC=small cell lung cancer; TNBC=triple
negative breast cancer; HCC=hepatocellular carcinoma

Hematology franchise: Growth from Venclexta, Gazyva, and Polivy

CHFm	YoY CER growth

2,000

1,500 -3% -8% +3%

1,000

-35%

500

Q4 17

Q4 18

Q4 19

Q4 20

Hematology franchise Q4 update

CD20 franchise

MabThera/Rituxan onc (-43%): Biosimilar and COVID-19 impact
Gazyva (+6%): Growth in 1L CLL and 1L FL; some COVID-19 impact

Venclexta*

Strong growth driven by 1L CLL and 1L unfit AML
Ph III (Viale-A) in 1L unfit AML approved in US; filed in EU
Updated NCCN guidelines in CLL & AML to «category 1»

Polivy

US/EU: strong uptake in R/R DLBCL

Outlook 2021

Ph III (POLARIX) results for Polivy in 1L DLBCL expected

	MabThera/Rituxan (Onc)	Gazyva/Gazyvaro		Polivy	• CD20xCD3 program updates; Early filing potential in 3L+ FL/DLBCL
			27

CER=Constant Exchange Rates; * Venclexta sales are booked by AbbVie (FY-2020 sales of USDm 1,337); Gazyva in collaboration with Biogen; Polivy in collaboration with Seagen; CLL=chronic lymphocytic leukemia;

FL=follicular lymphoma; AML=acute myeloid leukemia; NCCN=national comprehensive cancer network; R/R DLBCL=relapsed/refractory diffuse large B cell lymphoma; SC=subcutaneous

Hematology franchise: CD20 x CD3 program update

Potential for early filings in 3L+ FL and 3L+ DLBCL

Ph I (GO29781): Mosunetuzumab in R/R FL		Ph I (NP30179): Glofitamab in R/R DLBCL

High response rates in high risk subsets		High response rates in heavily pre-treated DLBCL
	Glofitamab step-up dosing* (2.5/10/16mg or 2.5/10/30mg)

Mosunetuzumab in R/R FL: High and durable responses with low grade 2 and no grade ≥3 CRS (no protocol-required hospitalization)
Glofitamab in R/R DLBCL: Off-the-shelf option with high CR rates in heavily pre-treated patients and manageable CRS (mostly grade 1-2)
Ph I mosunetuzumab SC: Less frequent grade 2 CRS than IV at 7-fold higher dose; SC step up dosing to be further explored
Ph III safety run-in for mosunetuzumab + lenalidomide in 2L+ FL ongoing
Ph III safety run-in for glofitamab + GemOx in 2L+ DLBCL ongoing

Assouline et al, ASH 2020; FL = follicular lymphoma; R/R = relapsed/refractory; CR=complete response; CRS=cytokine release syndrome; Hutchings et al, ASH 2020; *Patients with missing or no response assessment are	28

included as non-responders. Two aNHL and six iNHL patients did not have a response assessment reported at time of CCOD; DLBCL=Diffuse large B-cell lymphoma; GemOx=gemcitabine+oxaliplatin

Tecentriq overview: Growth driven by first-in-class indications

First adjuvant trials to read out in 2021

CHFm

YoY CER growth

800

+35%

+49%

700

+54%

+99%

600

+136%

+154%

500

+146%

400

+135%

+44% +71%+89%

+29%

100

Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20

US Europe International Japan

Tecentriq Q4 update

Lung franchise (NSCLC, SCLC)

US/EU/Japan: Growth driven by 1L SCLC and 1L NSCLC
BTD for tiragolumab + Tecentriq in PDL1+ NSCLC

Breast franchise (TNBC)

US/EU: Growth driven by 1L PDL1+ TNBC

GI franchise (HCC)

US: 1L HCC reaching 50% market share after 7 months
EU/China: 1L HCC first-in-class approvals achieved

Outlook 2021

Ph III (IMpower010) Tecentriq in adj NSCLC
Ph III (IMvoke010) Tecentriq in adj SCCHN

CER=Constant Exchange Rates; HCC=hepatocellular cancer; NSCLC=non small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple negative breast cancer	29

Lung cancer franchise: Alecensa in ALK+ NSCLC

Strong 1L momentum continues in all markets

CHFm	YoY CER growth
350	+54%

300
250	+11%

200	+69%

150 +99%

100 50 0

Q4 17	Q4 18	Q4 19	Q4 20
US	Europe	International	Japan

Alecensa Q4 update

US (-4%): 1L New patient share > 70%
EU (+22%): 1L New patient share EU-5 >80%
Japan (+29%): 1L New patient share > 70%
International (>500%): Driven by China NRDL listing
FoundationOne Liquid CDx (FMI's blood-based NGS test) approved as companion diagnostic for Alecensa

Outlook 2021

Strong growth, especially in International to continue

CER=Constant Exchange Rates; NSCLCL=non-small cell lung cancer; NRDL=national drug reimbursement list; FMI=Foundation medicine; NGS=next generation sequencing

Hemophilia A franchise: Hemlibra growing strongly

28% total US patient share and 22% total EU-5 patient share reached

CHFm			YoY CER growth
700

					+45%

600				+57%



	+146%


		+59%
500	+313%

Hemophilia Q4 update

•	US/EU: Gaining market share in non-inhibitors
•	Minor COVID-19 impact leading to delayed patient starts

400

>500%

• Around 9,500 patients treated globally, thereof 5,000 in the US

>500%

300

>500%

200

>500%

100

Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20

US Europe International Japan

• Hemlibra continues to penetrate across all patient types

Outlook 2021

Further growth expected
US/EU: Further patient share gains in non-inhibitors expected

CER=Constant Exchange Rates

Immunology franchise: Stable sales driven by Actemra

CHFm

2,500

2,000

1,500

1,000

500

YoY CER growth


		+12%
	0%
+10%

			+2%

Q4 17	Q4 18	Q4 19	Q4 20
MabThera/Rituxan (RA)		Actemra IV


Actemra SC			Xolair


CellCept			Pulmozyme


Esbriet			Other

Immunology Q4 update

Esbriet (-9%)

Growth in mild/moderate segments
BTD in unclassifiable interstitial lung disease (uILD)

Actemra (+29%)

Remains leading RA monotherapy in EU-5
Sales driven by COVID-19; Positive study results (REMAP-CAP)

Xolair (+3%)

Remains leader in biologics asthma market; growth in CIU
Self-injection(home use) approval in the US expected in H1

Outlook 2021

Ph III (REMDACTA) results for Actemra+remdesivir in COVID-19
Ph III (STARSCAPE) rhPTX-2+SOC in IPF first-patient-in in Q1
Ph III (MAJESTY) Gazyva in MN first-patient-in in Q1

CER=Constant Exchange Rates; RA=rheumatoid arthritis; CIU=chronic idiopathic urticaria; SOC=standard of care; IPF=idiopathic pulmonary fibrosis; MN=membranous nephropathy

MS franchise: Ocrevus with 25% total US market share

Market leadership momentum continues

CHFm

YoY CER growth

1,500

1,250

+37%

+38%

+55%

+10%

1,000

+48%

+12%

+59%

+67%

750

+83%

+104%

+195%

500

250

Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20

Europe

International

Ocrevus Q4 update

US new patient share remains ~40%
Q4 growth despite COVID-19 and carry over from Q2 (1st wave)
Shorter infusion approved in US
Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III (GAVOTTE) in PPMS first-patient-in
Fenebrutinib (BTKi): Ph III program PPMS (FENtrepid) first- patient-in

Outlook 2021

Continued growth expected
Ongoing launches in EU and International
Fenebrutinib (BTKi): Ph III program in RMS (FENhance)

CER=Constant Exchange Rates; MS=multiple sclerosis; RMS=relapsing MS; PPMS=primary progressive MS

SMA franchise: Successful virtual US launch of Evrysdi

>1,000 US patients treated (>10% total share) after less than 5 months

Broad uptake across all patient types

Patients treated with all SMA types Pattern mirrors disease prevalence: 25% type 1, 50% type 2, 25% type 3

Naive (~1/3) and previously treated (~2/3)

Pts switching from both Spinraza & Zolgensma

Broad range of ages

2 month old infants to 70+ year old adults ~50% of patients are adults

>350 HCPs have prescribed Evrysdi

~2,500 patients treated worldwide between clinical trials, commercial, and compassionate use program

* SMA=spinal muscular atrophy; HCP=health care professional

Access enabled by compelling value proposition

~55% of lives covered due to active payer engagement
Rapid payer coverage by Commercial and Medicaid plans
Most payer policies fully aligned to the FDA label

H1 2021 Outlook

Anticipated approvals in EMA, China, and Japan
Primary analysis from Ph II (JEWELFISH) study in previously treated patients
2-yeardata from pivotal Ph III trials SUNFISH and FIREFISH

Ophthalmology franchise: Benefitting patients globally

Faricimab: Positive results in DME & nAMD; PDS: launch on track

Faricimab	Port delivery system
(anti-VEGF/Ang-2 biMab)	(PDS)

Ph III (YOSEMITE & RHINE) results in DME positive with >50% of patients being able to extend time between treatments to 16 weeks
Ph III (LUCERNE & TENAYA) results in nAMD positive with nearly half (45%) of patients being treated every 16 weeks
First time this level of durability has been achieved in Ph III
Filing on track for 2021; Data to be presented at Angiogenesis

Ph III (ARCHWAY) data in nAMD show more than 98% of patients were able to go six months between treatments
Generally well tolerated with favorable benefit-risk profile
Ph III trials in DME (PAGODA) and DR (PAVILION) enrolling rapidly; Ex-US studies to be initiated
Additional Ph III (ARCHWAY) data to be presented at Angiogenesis
US approval expected in 2021

nAMD=neovascular age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy

Infectious diseases: SARS-CoV-2 development program

Positive read-outs for nAb cocktail - first shipments

Casirivimab + imdevimab (nAb cocktail):

Ph II (Study 2067) in outpatient setting: Primary endpoint of viral load reduction met; FDA EUA granted on Nov 20; First governmental orders from US and Europe received
Ph II (Study 2066) in hospitalized patients: Futility analysis passed in sero-negative patients for lower risk of mechanical ventilation and/or death, supporting additional investigation in this population
Ph III (Study 2069) post-exposure prophylaxis: Positive interim results showing reduction in overall infections within the first week and 100% prevention of symptomatic infections

Actemra for COVID-19 pneumonia:

• REMAP-CAP study with positive data release by the Imperial College London

nAb=neutralizing antibodies; DAA=direct acting antiviral; EUA=emegency use authorization	36

2020: Key late-stage news flow*

Additional 2020 news flow:

casirivimab/imdevimab: Positive Ph II results in outpatients; US EUA granted
Actemra: Positive Ph III (EMPACTA) in severe COVID-19 related pneumonia
Actemra: Ph III (COVACTA) did not meet primary endpoint; potentially clinically meaningful benefits in time to hospital discharge and duration of ICU stay

Gavreto: US approval in RET fusion-positive mNSCLC
Gavreto: US approval in metastatic RET+ thyroid cancer
Xolair: US filing of prefilled syringe for self-administration across all indications
Evrysdi: Positive Ph III (FIREFISH part 2) results in type 1 SMA
Esbriet: US priority review granted in unclassifiable interstitial lung disease (UILD)

* Outcome studies are event-driven: timelines may change; EUA=emergency use authorization; ICU=intensive care unit

2021: Key late-stage news flow*

Compound

Indication

Milestone

Regulatory

Phase III / pivotal

readouts

Evrysdi	SMA type 1/2/3	EU approval

PDS ranibizumab	nAMD (continuous delivery)	US/EU filing; US approval

faricimab	DME/nAMD	US/EU joint filing (DME+AMD)

casirivimab/imdevimab	SARS-CoV-2	EU approval

Venclexta + azacitidine	1L unfit AML	EU approval

Tecentriq	1L PDL1+ NSCLC	EU approval

Xofluza	Healthy patients; High risk patients; Post exposure	EU approval

faricimab	nAMD	Ph III TENAYA/LUCERNE

casirivimab/imdevimab	SARS-CoV-2 Outpatient	Ph III Study 2067

casirivimab/imdevimab	SARS-CoV-2Post-exposure prophylaxis	Ph III Study 2069

Tecentriq	Adjuvant NSCLC	Ph III IMpower010

Evrysdi	SMA type 1/2/3 switching study	Ph II JEWELFISH

Polivy + R-CHP	1L DLBCL	Ph III POLARIX

Tecentriq + chemo	Adjuvant SCCHN	Ph III IMvoke010

mosunetuzumab	3L+ FL	Ph Ib GO29781

glofitamab	3L+ DLBCL	Ph Ib NP30179

* Outcome studies are event-driven: timelines may change

Diagnostics Division

Thomas Schinecker CEO Roche Diagnostics

2020: Diagnostics Division sales

Strong growth driven by Molecular Diagnostics

	2020	2019	Change in %
	CHFm	CHFm	CHF	CER

Diagnostics Division	13,791	12,950	6	14
Centralised and Point of Care Solutions	7,273	7,819	-7	-1
Molecular Diagnostics	3,760	2,109	78	90
Diabetes Care	1,670	1,918	-13	-5
Tissue Diagnostics	1,088	1,104	-1	5

CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding sequencing business: +102%	40

2020: Diagnostics Division regional sales

Growth driven by COVID-19 testing

		Japan
North America		+5%
+26%	EMEA1	~4% of divisionalsales
~28% of divisional sales	+19%
	~40% of divisional sales

		Asia Pacific
Latin America
	-3%
+14%
	~23% of divisional sales
~6% of divisional sales

All growth rates at Constant Exchange Rates (CER); 1 Europe, Middle East and Africa

2020: Diagnostics Division highlights

Strong growth driven by COVID-19 testing

YoY CER growth

Centralised

and Point

of Care

Solutions

Molecular Diagnostics1

Diabetes

Care

Tissue Diagnostics

-1%

+90%

-5%

+5%	EMEA2
North America

	RoW

Immunodiagnostics (-6%)
Clinical Chemistry (-11%)
POC3 Immunodiagnostics (+667%)
Virology (+180%)
LightMix Systems (+189%)
POC3 Molecular (+152%)
Blood glucose monitoring (-4%)
Insulin delivery systems (-15%)
Advanced staining (+5%)
Companion diagnostics (+8%)

CHFbn

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

CER=Constant Exchange Rates; 1 Underlying growth of Molecular Diagnostics excluding sequencing business: +102%; 2 EMEA=Europe, Middle East and Africa; 3	POC=point of care	42

2020: Diagnostics Division

Very strong core operating profit growth of +50%

	2020		2020 vs. 2019
	CHFm % sales	CER growth

Sales	13,791			100		14%
					-26%

Royalties & other op. inc.	61			0.4	-26%
Cost of sales	-6,497			-47.0		10%
M & D	-2,728			-19.8	0%
R & D	-1,556			-11.3		10%
G & A	-507			-3.7		3%

Core operating profit	2,564			18.6		50%
						+30% in CHF

CER=Constant Exchange Rates	43

SARS-CoV-2 diagnostics portfolio1

Comprehensive portfolio of tests and digital solutions

		Clinical Labs		Near Patient



Molecular	• TIB MOLBIOL LightMix® Modular SARS-CoV-2	Launched
		• cobas® SARS-CoV-2 & Influenza A/B
•	cobas® SARS-CoV-2	Launched	Launched
solutions
•	cobas® SARS-CoV-2 & Influenza A/B
Launched

Immunology

solutions

Elecsys® Anti-SARS-CoV-2
Elecsys® Anti-SARS-CoV-2 S2
Elecsys® SARS-CoV-2 antigen
Elecsys® IL-6 Test to diagnose cytokine release syndrome

Launched
	• SARS-CoV-2	Rapid Antibody	Launched3


Launched		•	SARS-CoV-2 Rapid Antigen	Launched3,4


Launched4		• SARS-CoV-2	Rapid Antigen Test Nasal
Launched3,4
		•	SARS-CoV-2	& Influenza A/B Rapid Antigen
Launched	In-development3



	Digital				•	NAVIFY Remote Monitor5	Launched
				•	v-TAC6 digital algorithm for blood-gas
			Launched
• Viewics LabOps COVID-19 for efficiency	Launched
	solutions	improvements			•	iThemba Life COVID-19
		Launched

						• cobas® infinity POC COVID-19 Portal
						Launched


	Recently launched
1 Not all products are available in all countries; 2 S=spike protein; 3 external distribution partnership; 4 not yet approved in the U.S.; 5 US only; 6 v-TAC=venous to arterial conversion	44

Investing CHFm >600 to increase supply chain capacities

Driving to unprecedented volume in record time!

CONSUMABLES	REAGENTS

•	60 new manufacturing lines	•	20 new manufacturing lines
•	17 locations with 5 new partners	•	4 major facility expansions

	•	CHFm >600 investment
	•	>1200 new employees
•	8 new manufacturing lines	• 1 new manufacturing space
•	1 new biotech facility

RAW MATERIALS

INSTRUMENTS

Launch of Elecsys® SARS-CoV-2 Antigen Test in CE mark countries

High performing test to detect SARS-CoV-2

				Elecsys® In-solution
				double-antibody sandwich

				Ru
		Phase 1

			9 min
			Ru
		Phase 2

			9 min
			Ru
		Phase 3

Ru	Biotinylated monoclonal	SARS-CoV-2 nucleocapsid (N) in
			antibody against N	the sample
		Ru	Ruthenylated monoclonal	Streptavidin-coated paramagnetic
			antibody against N	microparticle

Test to detect active SARS-CoV-2 infections
Excellent performance:
- Sensitivity 94.5% (n=200 positive samples1)
- Specificity 99.9% (n=2,747 negative samples2)
Potential to scale up to double-digit million tests/month
Available for all cobas® e3 immunoanalyzers (installed base > 40,000)
SARS-CoV-2Extraction Solution: virus inactivation time of 2 minutes

1 Based on samples from 200 symptomatic individuals and cobas® SARS-CoV-2 Target 2 Ct value < 30; 2 Based on samples from 548 symptomatic individuals and 2199 known/suspected	46
exposure/screening individuals; 3 cobas® e: cobas e 801, cobas® e 602, cobas® e 601, cobas® e 411

FDA grants EUA for Elecsys® Anti-SARS-CoV-2 S immunoassay

In clinical studies with major vaccine developers

Elecsys® In-solution

double-antigen sandwich

	Matur		Biotin-labelled
Immature IgG		complementary
	e IgG		antigen

Immature IgM	Mature IgM	Ru	Ruthenylated
antigen

Streptavidin-coated
paramagnetic microparticles

FDA Emergency use authorization1 on December 2nd
Quantitative immunoassay detecting antibodies to the receptor binding domain (RBD) of the spike protein (anti-S)
Excellent performance:
- Sensitivity 98.8% (n=1423 positive samples2)
- Specificity 99.98% (n=5991negative samples)
Excellent correlation of the Elecsys® Anti-SARS-CoV-2 S units with the new WHO International Standard
Potential to scale up to double-digit million tests/month
Available on all cobas® e3 immunoanalyzers (installed base >40,000)

1	Includes: CE-IVDFDA-EUA, India, Indonesia, Singapore, Thailand, Taiwan, Philippines, Vietnam, Argentina; 2 n=1423 positive samples, 14 days or later after diagnosis with PCR;	47

3 cobas® e: cobas® e 801, cobas® e 602, cobas® e 601, cobas® e 411

Launch of cobas® PIK3CA Mutation Test (CE-IVD)

Enables clinicians to make fast targeted treatment decisions

PIK3CA pathways in cancer

Extracellular Growth Factor

Cell membrane

Growth Factor Receptor (FGFR and EGFR family members

PI3 KINASE

(PIK3CA)

PTEN

AKT 1

mTOR

Cell proliferation, cell survival, invasion & metastasis tumour- induced angiogenesis

PCR test for detection of 17 PIK3CA mutations in advanced or metastatic breast cancer
Up to 40% of patients with HR+/HER2- harbor a PIK3CA mutation 1
High analytical sensitivity for 0.7 to 3.5% mutation level (variant dependent)
Clinical reproducibility > 99%; 100% concordance vs NGS
Runs on cobas® z 4800 (installed base>2000)

1 cobas® PIK3CA Mutation Test CE-IVD package insert 1. Vasan N et al., Annals of Onco 2019

End-to-end Digital Pathology solution with IVD image analysis

Powerful pipeline utilising latest advances in AI technology

SCANNING	PATHOLOGIST	IMAGE
	WORKFLOW	ANALYSIS
VENTANA DP 200	NAVIFY Digital	uPath Image Analysis
	Pathology	Algorithms	• Three next-generationCE-IVD algorithms launched in 2020

				utilizing whole slide analysis for medical decision support to
		PD-L1	HER2 Dual	critical cancer diagnosis

ISH

• Cloud based clinical workflow software and algorithms on

HER2 (4B5)	the NAVIFY platform

NAVIFY Tumor Board

Outlook on 2021 new systems launches

Enabling comparable results in different size laboratories

Throughput	Low	Medium	High

	cobas® pure*	cobas® pro	cobas® pro (high throughput)

SWA**

solutions

cobas® 5800*

cobas® 6800

cobas® 8800

Molecular

solutions

* Currently in development and not commercially available; ** Serum Work Area	50

Roche Diagnostics Investors Day 2021

Innovating Diagnostics, Shaping Healthcare, Changing lives

23rd March 2021, 14:00-16:00 CEST (virtual set up)

Presenters:

Thomas Schinecker, CEO Diagnostics

Ann Costello, Global Head Roche Diagnostics Solutions

Palani Kumaresan, Head of Research & Development

Benjamin Lilienfield, Life Cycle Leader Systems

Andre Ziegler, Global Clinical Leader Cardiology

Michael Hombach, Global Clinical Leader Infectious disease

Jill German, Global Head of Pathology Lab

Key launches 2020

	Area	Product	Description	Market1
Instruments/	Workflow	cobas	®	prime	Next generation pre-analytical platform to support cobas® 6800/8800 Systems	CE

Devices	Diabetes	Accu-Chek Solo Diabetes	Integration of the Accu-Chek Guide test strip technology into the Accu-Chek	CE
Care	Manager	Solo Diabetes Manager (remote control)



		Elecsys® EBV EBNA IgG	EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA
		Elecsys® EBV VCA IgG	CE
					IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
	Infectious	Elecsys® EBV IgM
	Diseases	cobas® HIV-1&2 Qual	Qualitative detection and confirmation of HIV-1 & HIV-2	US
Tests/		cobas® EBV	Monitoring tests for transplant patients to aid in the management of EBV and	US

	cobas® BKV	BKV infections
Assays
	Cervical	cobas	®	HPV (6800/8800)	The world's leading cobas® HPV assay for use on the fully automated cobas®	US
		6800/8800 Systems
	Cancer	CINtec PLUS Cytology	Next generation "Pap" test which leverages p16/Ki-67dual-stain biomarker	US

					technology on cervical cytology samples
		VENTANA HER2 Dual ISH	Fully automated, brightfield ISH assay to determine eligibility for HER2 targeted	US
	Tissue Dx	therapy

	Algorithm - HER2 (4B5)	Whole slide image analysis algorithm for HER2 (4B5)	CE


	Sequencing	NAVIFY Mutation Profiler	Software as a medical device for annotating, variant classification, clinical	US
	interpretation and reporting from comprehensive genomic profile testing
		RocheDiabetes InsulinStart	A messaging service designed for people with type 2 diabetes to ease the	CE
Software		transition from oral antidiabetics to a complimentary insulin therapy
Diabetes
mySugr app	Enabling control of the Accu-Chek Insight insulin pump from the mySugr app	WW
	Care
	RocheDiabetes Care Platform	New releases with improved features focusing on device connectivity, integration	WW

		of 3rd parties, and healthcare professionals' workflow optimisation
1CE: European Conformity, US: FDA approval, WW: Worldwide; EBV=Epstein-Barr virus; BKV=BK virus	52

Key launches 2021

Area

Product

Description

Market1

Instruments

Tests

Digital

Solutions

Core Lab	cobas® pure integrated solutions	Low-to-medium volume SWA
cobas® pro integrated solutions	New high throughput configurations of the cobas pro instrument

Point of Care	cobas® pulse	Successor of Accu-Chek® Inform II
Molecular Lab	cobas® 5800	Fully automated low throughput PCR system
AVENIO Edge System	Automated sequencing library preparation and target enrichment instrument


Diabetes Care	Accu-Chek Instant Forward	New features for the Instant meter to increase performance and user experience

	Elecsys® SARS-CoV-2 Antigen	Automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection
Core Lab	Elecsys® NT-proBNP IU
• extensions in Heart Failure	A set of 5 intended use extensions in the Coronary Arterial Disease, Atrial Fibrillation and
	• extension for Atrial Fibrillation	Heart Failure Space
	Elecsys® TnT-hs 3 claim extensions
	in Coronary Arterial Disease
Molecular Lab	AVENIO FoundationOne kit (RUO)	Decentralized kit of the FoundationOne test
	KAPA HyperPETE kit	New targeted sequencing portfolio using primer extension for small targets

	uPath 2.0	First IVD release and version of Open API of the clinical pathologist workflow module for
Pathology Lab	NAVIFY Digital Pathology & on-premise uPath
RUO Algorithms	Whole slide image analysis algorithms (ER (SP1), Ki-67(30-9), and PR (1E2))


Insights	NAVIFY Oncology 1.0	Modular Oncology decision support solution
NAVIFY Pass 1.0	Solution for providers to communicate SARS-CoV-2 rapid antigen test results to a mobile app


Core Lab	Elecsys® GAAD Algorithm	Algorithm for early detection of HCC in patients with chronic liver disease.
	Remote Patient Monitoring	Module within RDCP that enables remote Health Care Professional - Patient with Diabetes
Diabetes Care	interaction, including a patient dashboard, check-in and chat functionality
	Accu-Chek SugarView	Meter-free blood glucose testing using a smartphone and app

WW³

US & CE³

WW³

OUS³

RDCP: Roche Diabetes Care Platform; 1 CE: European Conformity, US: FDA approval, WW: Worldwide, OUS: Outside the US; 2 Reasearch Use Only; 3 Only a few selected countries

Finance

Alan Hippe

Chief Financial Officer

2020 results

Focus on Cash

Outlook

2020: Highlights

Business

Sales growth of +1%1 despite biosimilars impact of CHF -5.1bn2
Core operating profit up +4%1 and Core EPS growth of +4%1
Dividend3 in Swiss francs further increased

Cash flow

Operating Free Cash Flow of CHF 14.8bn despite higher investments in in-licensing and higher inventories
Net debt lower by CHF 0.6bn vs. YE 2019, now at CHF -1.9bn, as FCF of CHF 10.9bn offsets dividends paid (CHF -8.0bn)

Net financial result

Core net financial expenses decreased by +34%1 due to lower interest expenses (CHFm 182) mainly driven by early debt redemption in 2019 (loss of CHFm 202)

IFRS

Net income increased by +17%1 driven by lower impairments of intangible assets and goodwill and the release of the Accutane US litigation provision

1 At Constant Exchange Rates (CER); 2	MabThera, Herceptin & Avastin in Europe (Avastin: as of Jul 20) and US & Japan Herceptin, Avastin & MabThera; 3	based on 2020 dividend as proposed	56

by the Board of Directors; FCF=free cash flow

2020: Successfully managing the transition in volatile environment

	Compensated for biosimilar & COVID-19		Efficiency gains & investment into future

Group		Group
Sales		Core OP
CHFm (CER)	+ 4,739	CHFm (CER)

		- 5,051 2
			+ 1,800
		-868
		- 5,919
61,396				62,015

		+1%
2019	Pharma	Pharma	Diagnostics	2020
	New	bx exposed2	Division
	Products1	& other

	+ 1,812	+ 981
	- 40

		- 803
		23,460	23,460
22,478	- 968

		+4%

2019	Pharma	Pharma	Pharma	Diagnostics Corporate	2020
	lower profit	efficiency	additional	growth &
	contribution	gains &	R&D spend	efficiency
	from lower	other		gains

sales3
Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi; 2 MabThera,	57
Pharma sales decline minus proportional cost of sales 2020

2020: Group performance

Core operating profit up +4 & Core EPS growth of +4%

		2020	2019	Change in %
		CHFm	CHFm	CHF	CER

	Sales	58,323	61,466	-5	1
	Core operating profit	21,536	22,479	-4	4
	as % of sales	36.9	36.6
	Core net income	17,378	18,062	-4	5
	as % of sales	29.8	29.4
	Core EPS (CHF)	19.16	20.16	-5	4
	IFRS net income	15,068	14,108	7	17
	Operating free cash flow	14,815	20,921	-29	-21
	as % of sales	25.4	34.0
	Free cash flow	10,943	16,764	-35	-26
	as % of sales	18.8	27.3
CER=Constant Exchange Rates					58

2020: Group sales

CER sales increase of +1%, driven by Diagnostics and International, partly offset by a decrease in the US; Fx impact of -6%p

-6%	+1%	+7%	-6%	+1%	-5%
	Pharma Division		Dia Division
		-2%		+14%

	+1,800	+620
-1,689	-241
+661	-3,763
+89
		-3,143

United States	Europe	Intl.	Chugai	Dia Division	Group	Fx 1	Group
			(Japan)				CHF
Absolute values in CHFm at Constant Exchange Rates (avg full year 2019); 1 avg full year 2019 to avg full year 2020 fx			59

2020: Core EPS development

Operations growth is main driver for Core EPS growth

CHF

+4.2%

+4.9 p

	+0.3 p	+0.9 p

-1.1 p	-0.1 p	-0.7 p

21.20

20.35

FY 2019	Income from	Other	Gains equity	Bond	Resolution tax	FY 2020
disposal of	Operations
ROOI	securities	redemption		disputes
	products

All at CER (Constant Exchange Rates, average FY 2019); ROOI=Royalties and other operating income excl. Gains on product disposals			60

2020: Group operating performance

Core operating profit growth ahead of sales growth

		2020	2020 vs. 2019
		CHFm	abs. CER	CER growth
	Sales	58,323	620
		1%
	Royalties & other op. inc.	2,020	-175	-8%
	Cost of sales	-14,567	1,015	-6%
	M & D	-9,361	631	-6%
	R & D	-12,153	-953		8%
	G & A	-2,726	-157		6%
	Core operating profit	21,536	981		4%

					-4% in CHF
CER=Constant Exchange Rates			61

2020: Royalties and other operating income

Lower income on product disposals, partially offset by higher other operating income from Venclexta profit share

CHFm

			+70
	-57	-27

2,285
				-251
	Royalties and other operating income decreased by -8% at CER	2,020
1	2	3	4	5	6
2019	Royalty income	Out-licensing	Other operating	Income from	2020
	income	income	disp. of products

CER = Constant Exchange Rates

Major transformation ongoing across the Group

Example: Cost of Sales

Cost of Sales	2019	2020	abs. CER	% CER
Pharma Division	10,180	8,070	+1,652	-16%	• Manufacturing cost of goods sold and period costs:
Manufacturing cost	6,086	5,021	+787	-13%	Product mix, productivity improvements, and lower
inventory write-offs

Dia Division	6,183	6,497	-637	+10%	• Collaboration and profit sharing agreements: Decrease
Manufacturing cost	6,079	6,395	-638	+11%	driven by lower MabThera/Rituxan sales (US)

					• Royalty expenses: Decrease related to expired Cabilly
Group	16,363	14,567	+1,015	-6%	patent, partially offset by increased sales for certain
Manufacturing Cost	12,165	11,416	+149	-1%	royalty-bearing products (Ocrevus, etc.)

Variances at constant exchange rates (CER)

2020: Core operating profit and margin

% of sales				43.1%	43.3%	43.7%
36.6%	36.9%
36.1%
					+1.1%p¹

						+1.2%p¹
CHFm				+4%¹				0%¹	18.6%
22,479							15.9%
20,505	21,536			21,015	15.2%

		19,477
								+4.8%p¹
			18,942

+50%¹

2,046 1,966 2,564

2018 2019 2020

1 At CER=Constant Exchange Rates

Roche Group

Pharma Division

Diagnostics Division

2020: Core net financial result

Improvement driven by net loss on debt redemption in 2019 and lower interest expenses

CHFm
	• Net financial expenses decreased by +34% at CER
	•	Interest expenses1 decreased by +26% at CER
							-564
-903						+58
					+182

				+202
	-87	-15	-1

2019	Net interest	Equity	FX G/L	G/L on debt	Interest	Other	2020
income	securities	redemption	expenses1

CER=Constant Exchange Rates; 1	incl. amortisation of debt discount and net gains on interest rate derivatives	65

2020: Group Core tax rate

Tax rate relatively stable excluding resolution of several tax disputes

			+0.2p		-1.5p

	+2.1p
		18.4		18.6
16.3						17.1

					-3,880
2019		2019		2020		2020
As reported	Resolution of	Before	Tax development	Before	Resolution of	As reported
	Tax Disputes	Resolution of	(excluding	Resolution of	Tax Disputes
	2019	Tax Disputes	Resolution of	Tax Disputes	2020
			Tax Disputes)

2020: Non-core and IFRS income

Total non-core operating items decreasing due to lower IA impairments and Legal & Environmental income

			2019	2020		Change in %
			CHFm	CHFm	CHFm	CHF	CER
Core operating profit			22,479	21,536	-943	-4	+4
Global restructuring plans		-1,206	-909	297
Amortisation of intangible assets	-1,532	-1,750	-218
Impairment of intangible assets	1	-1,756	-672	1,084

M&A and alliance transactions		43	-9	-52
Legal & Environmental	2		-480	347	827

Total non-core operating items		-4,931	-2,993	1,938
IFRS Operating profit			17,548	18,543	995	+6	+16
Total financial result & taxes		-3,440	-3,475	-35
IFRS net income			14,108	15,068	960	+7	+17

CER=Constant Exchange Rates; IA=intangible assets; 1 incl. goodwill; 2 incl. pension plan settlements	67

2020 results

Focus on Cash

Outlook

2020: Operating Free Cash Flow

OFCF down by -21% driven by Net Working Capital movement and higher investments in Intangible Assets

CHFm

-74-2,307

-216-1,838

-1,671

20,921

OFCF lower by -21% /-4,435m at CER

2019	OP, net of cash	NWC	Investments	Investments	Foreign
	adjustments	movement	in PP&E	in IA	exchange

CER=Constant Exchange Rates; OP=Operating Profit; NWC=Net Working Capital; PP&E=Property, Plant & Equipment incl. change of lease liability paid; IA=Intangible Assets

14,815

2020

2020: Group net debt lower vs. YE 2019

Free Cash Flow CHF 10.9bn

CHFbn

vs. 16.8bn in 2019

-3.9

+14.8

-10.3

[PY: +20.9]

-2.5

-1.9

Taxes

-3.2

Dividends paid

-8.0

Treasury

-0.7

Trans. own eq. instr.

-2.1

M&A & All. trans.

-1.2

Curr. Transl. & Other

+1.0

Net debt

Operating

Non-Operating

Dividends, M&A

Net debt

31 Dec 2019

Free

and Alliance

31 Dec 2020

Cash Flow

transactions and

other

Intangible Asset

Equity

M&A

Total

Thereof investments in

2020:

-3.2

-0.4

-1.2

-4.8

Innovation

2019:

-1.4

0.0

-4.8

-6.2

Balance sheet 31 December 2020

Equity ratio at 46% (31 Dec 2019: 43%)

	% change in CER	% change in CER
CHFbn	vs 31 Dec 2019	vs 31 Dec 2019

Cash and	83.1	86.1	+9%		83.1	86.1	+9%
11.9	12.3
marketable	+7%
14%			25.4
14%		24.1
securities		Current	+12%
		29%
	19.4	20.6	+13%	liabilities	29%
Other

current	23%	24%		Non-		20.9
assets				23.1	-5%
			current	25%
				28%
				liabilities
						Net debt/
	51.8	53.2	+9%
Non-				total assets:
					39.8

current	63%	62%		Equity	35.9	2%

assets				43%	46%	+17%
			(Net assets)
	31 Dec	31 Dec			31 Dec	31 Dec
	2019	2020			2019	2020

CER = Constant Exchange Rates

2020 results

Focus on Cash

Outlook

High currency impact in 2020

CHF / USD
Average	-3%			-3%			-4%			-5%
YTD 2019				1.00			1.00			0.99
		1.00

								0.95			0.94
		0.97			0.97

				Average YTD 2020
0.97	0.97	0.96	0.97	0.97	0.95	0.94	0.91	0.91	0.91	0.91	0.89
				Monthly avg fx rates 2020

CHF / EUR
		-6%			-6%			-5%			-4%
		1.13			1.13			1.12			1.11
		1.07			1.06			1.07			1.07
1.08	1.07	1.06	1.06	1.06	1.07	1.07	1.08	1.08	1.07	1.08	1.08

1 On group growth rates

In 2020 impact1 is (%p):

	Q1	HY	Sep	FY
			YTD

Sales	-5	-5	-6	-6

Core operating		-7		-8
profit


Core EPS		-8		-9

2021 currency impact1 expected (based on 31 Dec 2020 FX rates):

For FY around -3%p to -5%p FX impact on Sales, Core
OP & Core EPS

2020: Core EPS

Core EPS 2020 of CHF 19.35 is basis for Core EPS outlook 2021 at CER

CHF	+0.19

	19.16	19.35

Core EPS 2020 as	2020 foreign	Core EPS 2020 basis
reported	exchange losses:	for Outlook Core EPS
	Core EPS impact	growth 2021 at CER
CER = Constant Exchange Rates		74

2021 outlook

Further growing top and bottom line

Group sales growth1		• Low- to mid-single digit

Core EPS growth1		• Broadly in line with sales growth

Dividend outlook		• Further increase dividend in Swiss francs

1	At Constant Exchange Rates (CER); based on the current assessment of the COVID-19 impact	75

Changes to the development pipeline

Q4 2020 update

New to phase I	New to phase II		New to phase III		New to registration

7 NMEs:	2 NMEs:	3 NMEs:		1 NME:
RG6006 Abx MCP - bacterial infections	RG6359 SPK-3006 - Pompe disease	RG7845 fenebrutinib - PPMS		RG6321 PDS with ranibizumab - wAMD
RG6007 HLA-A2-WT1 x CD3 - AML	RG6422 AT-527 - adult non-hospitalised SARS-	RG6026 glofitamab - 2L+ DLBCL*
RG6120 VEGF-Ang2 DutaFab - nAMD	CoV-2	RG7828 mosunetuzumab - 2L+ FL*		2 AIs:
RG6182 NME - neurodegenerative diseases					RG6062 Esbriet - UILD
RG6232 TYRP1 x CD3 - metastatic melanoma		4 AIs:		RG7446 Tecentriq+nab-paclitaxel - TNBC
RG6234 NME - multiple myeloma	2 AIs:	RG1594 Ocrevus high dose - RMS & PPMS		neoadjuvant
RG6312 NME - geographic atrophy	RG6058 tiragolumab+T+chemo - 1L non-	RG6413+RG6412 casivirimab+imdevimab -
	squamous NSCLC	SARS-CoV-2 adult - ambulatory
	RG6171 giredestrant - ER+/HER2- 2/3L mBC	RG7446 Tecentriq - SC NSCLC

Removed from phase I

Removed from phase II

Removed from phase III

Approvals

1 NME:	2 NMEs:	3 AIs:
RG7461 simlukafusp alfa combos - solid tumors	RG6149 ST2 MAb - asthma	RG6152 Xofluza - influenza hospitalized
	RG7845 fenebrutinib - RA	patients
2 AIs:		RG7440 ipatasertib+chemo - 1L TNBC/HR+ BC
RG7446 Tecentriq+Avastin+Cotellic - 2/3L CRC		RG7440 ipatasertib+Tecentriq+taxane - 1L
RG7446 Tecentriq + K/HP - HER2+ BC		TNBC

phI safety run-in ongoing

2 NMEs approved in EU: RG6152 Xofluza - influenza RG6264 Phesgo - HER2+ BC

5 AIs approved in US:

RG1594 Ocrevus short infusion - RMS & PPMS RG3648 Xolair - nasal polyps

RG6152 Xofluza - post exposure prophylaxis RG6396 Gavreto - RET-mutant thyroid cancer RG7601 Venclexta+azacitdine - 1L AML

3 AIs approved in EU:

RG6152 Xofluza - influenza high risk & post exposure prophylaxis

RG7446 Tecentriq+Avastin - 1L HCC

Status as of February 04, 2021

Roche Group development pipeline

Phase I (49 NMEs + 14 AIs)

Phase II (22 NMEs + 12 AIs)

RG6007	HLA-A2-WT1 x CD3			AML
RG6026	glofitamab monotherapy and combos	heme tumors
RG6058	tiragolumab combos		heme & solid tumors
RG6076	CD19-4-1BBL			heme tumors
RG6115	TLR7 agonist (4)			HCC
RG6139	PD1 x LAG3			solid tumors
RG6160	cevostamab (FcRH5 x CD3)			r/r MM
RG6171	giredestrant (SERD)			ER+/HER2- BC

RG6180	autogene cevumeran±T (iNeST1)	solid tumors
RG6185	belvarafenib (pan-RAF inh)+Cotellic	solid tumors
RG6194	HER2 x CD3			BC

RG6232	TYRP1 x CD3		metastatic melanoma

RG6234	-		multiple myeloma
RG6279	PD1-IL2v			solid tumors
RG6286	-			colorectal cancer

RG6290	MAGE-A4 ImmTAC			solid tumors

RG6292	anti-CD25 MAb ± T			solid tumors
RG6296	BCMA x CD16a			r/r MM
RG6323	IL15/IL15Ra-Fc			solid tumors

RG6330	KRAS G12C			solid tumors
	ipatasertib + Taxane + T			TNBC
RG7440	ipatasertib + rucaparib		mCRPC, solid tumors
	ipatasertib	.prostate cancer, pretreated

	Morpheus platform			solid tumors


RG7446	T + CD47 MAb			r/r AML
	T + Venclexta		maintenance 1L ES-SCLC
	Venclexta + AMG176			AML

RG7601	Venclexta ± azacitidine			r/r MDS
	Venclexta + gilteritinib			r/r AML
RG7769	PD1 x TIM3			solid tumors
RG7802	cibisatamab ± T			solid tumors
RG7827	FAP-4-1BBL + T			solid tumors
RG7828	mosunetuzumab monotherapy + combos	heme tumors
RG7876	selicrelumab combos			solid tumors

Status as of February 04, 2021


CHU	FIXa x FX				hemophilia
CHU	glypican-3 x CD3				solid tumors
CHU	codrituzumab				HCC
CHU	CD137 switch antibody			solid tumors
CHU	-	..	solid tumors & endometriosis
SQZ	PBMC vaccine				solid tumors
RG6151	-				asthma
RG6244	-				asthma
RG6287	-				IBD
RG6418	NLRP3 inh				inflammation
RG6315	-				immunologic disorders
RG7835	IgG-IL2				autoimmune diseases
RG6006	Abx MCP				bacterial infections
RG6084	PD-L1 LNA				HBV
RG6346	HBV siRNA				HBV
RG6091	UBE3A LNA				Angelman syndrome
RG6102	brain shuttle gantenerumab		Alzheimer's
RG6182	-			neurodegenerative diseases
RG6237	-			neuromuscular disorders
RG7637	-	.	neurodevelopmental disorders
RG7816	GABA Aa5 PAM				autism
RG6120	VEGF-Ang2 DutaFab			nAMD
RG6179	-				DME
RG6247	4D-110				choroideremia
RG6312	-				geographic atrophy
RG7921	-				nAMD
4DMT	4D-125		X-linked retinitis pigmentosa
CHU	PTH1 recep. ago				hypoparathyroidism
CHU	-				hyperphosphatemia
	New Molecular Entity (NME)				Metabolism

	Additional Indication (AI)				Neuroscience
	Oncology / Hematology				Ophthalmology
	Immunology				Other
	Infectious Diseases
1Individualized Neoantigen Specific Immunotherapy	T=Tecentriq
2RG6149 NME status, RG7880 AI status
3combination contributing as two entities

RG6171	giredestrant (SERD)			neoadjuvant ER+ BC
giredestrant (SERD)			2/3L ER+/HER2- mBC

RG6180	autogene cevumeran + pembrolizumab	1L melanoma
RG6357	SPK-8011					hemophilia A
RG6358	SPK-8016	hemophilia A with inhibitors to factor VIII
	tiragolumab + T					NSCLC
RG6058	tiragolumab + T + chemo		1L non-squamous NSCLC
	tiragolumab + T					cervical cancer
RG7601	Venclexta + fulvestrant				2L HR+BC
Venclexta + carfilzomib				r/r MM t(11:14)

CHU	Oncolytic Type 5 adenovirus			esophageal cancer
RG6173	anti-tryptase					asthma
RG6354	rhPTX-2(PRM-151)				myelofibrosis
rhPTX-2(PRM-151)	.	idiopathic pulmonary fibrosis

RG7880	efmarodocokin alfa (IL22-Fc)	inflammatory diseases
RG6149/RG78802	ST2 MAb or efmarodocokin alfa	COVID-19 pneumonia
NOV	TLR4 MAb				autoimmune diseases
IONIS	ASO factor B					IgA nephropathy
RG6413+RG64123	casivirimab+imdevimab		SARS-CoV-2adult-hospitalised
RG6422	AT-527					SARS-CoV-2
RG7854+RG79073	TLR7 ago(3) + CpAM (2)				HBV
RG6359	SPK-3006					Pompe disease
RG7992	FGFR1 x KLB MAb				NASH
RG6100	semorinemab					Alzheimer's
RG6356	microdystrophin (SRP-9001)			DMD
RG7412	crenezumab			familial Alzheimer's healthy pts
RG7906	ralmitaront					schizophrenia
RG7935	prasinezumab					Parkinson's
RG6147	-					geographic atrophy
RG6367	SPK-7001					choroideremia
RG7774	-					retinal disease
IONIS	ASO factor B					geographic atrophy

RG-No - Roche/Genentech	SQZ - SQZ Biotechnology managed	78

CHU - Chugai managed	NOV - Novimmune managed
IONIS - IONIS managed	4DMT - 4DMT managed

Roche Group development pipeline

Phase III (14 NMEs + 34 AIs)

Registration (4 NMEs + 7 AIs)

RG6013	Hemlibra	mild to moderate hemophilia A
RG6026**	glofitamab + chemo			2L+ DLBCL
	tiragolumab + T + chemo		1L SCLC
RG6058	tiragolumab + T		1L PD-L1+ NSCLC

tiragolumab + T	locally advanced esophageal cancer

	tiragolumab + T	.stage III unresectable 1L NSCLC
RG6107	crovalimab			PNH

RG6114	inavolisib (mPI3K alpha inh)		1L HR+ mBC

RG6171	giredestrant (SERD)			ER+/HER2- mBC
RG7440	ipatasertib + abiraterone		1L CRPC
ipatasertib + fulvestrant + palbociclib	1L HR+ mBC

RG7596	Polivy			1L DLBCL


	Tecentriq			NSCLC adj
	Tecentriq			NMIBC, high risk
	Tecentriq			RCC adj
	Tecentriq + cabozantinib		advanced RCC

	Tecentriq + cabozantinib		2L NSCLC
RG7446	T ± chemo			SCCHN adj
Tecentriq			HER2+ BC neoadj


	T + capecitabine or carbo/gem		1L TNBC

	T + paclitaxel			TNBC adj
	T + Avastin			HCC adj
	T ± chemo			1L mUC

	Tecentriq			SC NSCLC

RG6268	Rozlytrek ROS1+			1L NSCLC
RG7601	Venclexta			r/r MM t(11:14)
Venclexta + azacitidine			1L MDS

RG7828**	mosunetuzumab + lenalidomide		2L+ FL
RG7853	Alecensa		ALK+ NSCLC adj
RG1569	Actemra ± remdesivir	COVID-19 pneumonia
RG3648	Xolair			food allergy
RG7159	Gazyva			lupus nephritis
RG7413	etrolizumab			Crohn's
	Xofluza	influenza, pediatric (0-1 year)
RG6152	Xofluza	influenza, pediatric (1-12 years)
	Xofluza	influenza direct transmission
RG6413+	casivirimab+imdevimab	SARS-CoV-2 adult prophylaxis
RG6412*	casivirimab+imdevimab	SARS-CoV-2 adult ambulatory
RG1450	gantenerumab			Alzheimer's
RG1594	Ocrevus high dose			RMS & PPMS
RG6042	tominersen			Huntington's
RG7845	fenebrutinib			PPMS
RG6321	port delivery system with ranibizumab	.	DME
port delivery system with ranibizumab		DR

RG7716	faricimab			DME
faricimab			wAMD

RG6396	Gavreto (pralsetinib) 1		RET+ NSCLC
Gavreto (pralsetinib) 3		RET+ MTC

RG7446	Tecentriq Dx+ 1	1L sq + non-sq NSCLC
T + nab-paclitaxel4		TNBC neoadj

RG7601	Venclexta + azacitidine 1		1L AML
RG7853	Alecensa		1LNSCLC Dx+
RG3648	Xolair 2	asthma home use
RG6062	Esbriet		UILD
RG6168	Enspryng (satralizumab) 1		NMOSD
RG7916	Evrysdi (risdiplam) 1		SMA
RG6321	port delivery system with ranibizumab 5	wAMD

Approved in US, filed in EU
Filed in US
Approved in US
Filed in EU
US rolling submission initiated

New Molecular Entity (NME)		Metabolism
Additional Indication (AI)		Neuroscience
Oncology / Hematology		Ophthalmology

T=Tecentriq

*combination contributing as two entities

phI safety run-in ongoing

Immunology		Other
Infectious Diseases

Status as of February 04, 2021

NME submissions and their additional indications

Projects in phase II and III

						RG6026	glofitamab + chemo
						2L DLBCL

							tiragolumab +
						RG6058	Tecentriq (T)
							1L PD-L1+ cervical ca
						RG6058	tiragolumab + T
						1L PD-L1+ NSCLC

		RG6413+	casivirimab+imdevimab		tominersen		tiragolumab + T
		RG6412	SARS-CoV-2	RG6042	Huntington's	RG6058	locally adv esophageal
		adult-prophylaxis			cancer

		RG6413+	casivirimab+imdevimab	RG1450	gantenerumab	RG6058	tiragolumab + T
		RG6412	SARS-CoV-2	Alzheimer's	Stage III unresectable 1L
		adult-ambulatory			NSCLC

RG6321	Port Delivery System	RG6413+ casivirimab+imdevimab	RG7413	etrolizumab	RG6058	tiragolumab + T
with ranibizumab	RG6412	SARS-CoV-2	Crohn's	1L non-sq NSCLC
	wAMD✓1	adult-hospitalised

	Evrysdi (risdiplam)		Port Delivery System		tiragolumab +		inavolisib
RG7916	RG6321	with ranibizumab	RG6058	Tecentriq	RG6114	(mPI3K alpha inh)
SMA (EU) ✓
		wAMD (EU)		1L SCLC		1L HR+ BC

	Gavreto		faricimab		crovalimab	giredestrant (SERD)
RG6396	(pralsetinib) ✓	RG7716	RG6107	RG6171
DME	PNH	ER+/HER2- mBC
	RET+ NSCLC


	Gavreto		faricimab		ipatasertib +	giredestrant (SERD)
RG6396	(pralsetinib) ✓2	RG7716	RG7440	abiraterone	RG6171
wAMD	2L/3L ER+/HER2- mBC
	RET+ MTC			1L CRPC

RG7907+	TLR7 ago (3)
+ CpAM (2)
RG7854
HBV

RG7906	ralmitaront
schizophrenia

	microdystrophin
RG6356	SRP-9001
	DMD
	semorinemab
RG6100	(Tau MAb )
	Alzheimer's
RG7845	fenebrutinib
PPMS

RG7935	prasinezumab
Parkinson's

	autogene cevumeran
RG6180	(iNeST3)
	1L melanoma
	ipatasertib + fulv +
RG7440	palbociclib
	1L HR+ mBC
	mosunetuzumab +
RG7828	lenalidomide
	2L FL

RG7992	FGFR1 x KLB MAb
NASH

	rhPTX-2
RG6354	(PRM-151)
	IPF
	rhPTX-2
RG6354	(PRM-151)
	myelofibrosis
RG6149	ST2 MAb
COVID-19 pneumonia

RG6173	Anti-tryptase
asthma

RG7880	efmarodocokin alfa
(IL22-Fc)

	inflammatory diseases
	Port Delivery System
RG6321	with ranibizumab
	DME
	Port Delivery System
RG6321	with ranibizumab
	DR

2020	2021	2022	2023 and beyond

Indicates submission to health authorities has occurred

Unless stated otherwise submissions are planned to occur in US and EU

US rolling submission initiated
US only
Individualized Neoantigen Specific Immunotherapy

Status as of February 04, 2021

New Molecular Entity (NME)		Metabolism
Additional Indication (AI)		Neuroscience
Oncology / Hematology		Ophthalmology
Immunology		Other
Infectious Diseases	80

AI submissions for existing products

Projects in phase II and III

New Molecular Entity (NME)	Immunology	Neuroscience
Additional Indication (AI)	Infectious Diseases	Ophthalmology
Oncology / Hematology	Metabolism	Other

RG3648	Xolair ✓
Asthma home use

RG6062	Esbriet ✓
UILD (US)

	Cotellic + Tecentriq +

RG7421	Zelboraf ✓
	1L+ BRAFm melanoma
RG7446	Tecentriq + nab-paclitaxel
TNBC neoadj ✓ EU

RG7446	Tecentriq + Avastin ✓
1L HCC

RG7601	Venclexta +azacitidine ✓
1L AML

RG7853	Alecensa (BFAST) ✓
1L NSCLC ALK+

		Xofluza
RG6152		influenza, pediatric
		(1-12 yrs)
RG1569		Actemra +/- remdesivir
	COVID-19 pneumonia

RG6062		Esbriet ✓
	UILD (EU)

RG6013		Hemlibra

	Mild to moderate
		hemophilia A (EU)
RG6268		Rozlytrek (BFAST)
	1L NSCLC ROS1+

RG7596		Polivy
	1L DLBCL

RG6152		Xofluza
	direct transmission

		Xofluza
RG6152		influenza, pediatric
		(0-1 year)
RG3648		Xolair
	Food allergy

RG7446		Tecentriq

	NSCLC adj

RG7446		Tecentriq
	RCC adj

RG7446		Tecentriq ± chemo
	1L mUC

RG7446	Tecentriq + Avastin
HCC adj

RG7446	Tecentriq
SC NSCLC

RG7446	Tecentriq
HER2+ BC neoadj


RG7446	Tecentriq + paclitaxel
TNBC adj

RG7446	Tecentriq
High risk NMIBC

RG7446	Tecentriq + chemo
SCCHN adj

	Tecentriq + capecitabine
RG7446	or carbo/gem
	TNBC
RG7446	Tecentriq + cabozantinib
adv RCC

RG7446	Tecentriq + cabozantinib
2L NSCLC

RG7159	Gazyva
lupus nephritis

	Ocrevus
RG1594
high dose RMS & PPMS

	Venclexta
RG7601
r/r MM t(11:14)

RG7601	Venclexta + azacitidine
1L MDS

RG7601	Venclexta + fulvestrant
2L HR+BC

RG7853	Alecensa
ALK+ NSCLC adj

2020	2021	2022	2023 and beyond

Status as of February 04, 2021	✓ Indicates submission to health authorities has occurred		81

Unless stated otherwise submissions are planned to occur in US and EU

Major pending approvals 2020-YTD 2021

	US			EU		China		Japan-Chugai

	Esbriet		Enspryng (satralizumab)		Evrysdi (risdiplam)		Polivy
RG6062	UILD	RG6168	NMOSD		RG7916	SMA	RG7596	r/r DLBCL
	Filed Nov 2020		Filed Aug 2019			Filed March 2020		Filed June 2020
	Alecensa (BFAST)		Tecentriq			Enspryng (satralizumab)		Evrysdi (risdiplam)
RG7853	1L NSCLC ALK+	RG7446	1L non-sq + sq NSCLC Dx+		RG6168	NMOSD	RG7916	SMA
	Filed Jan 2020		Filed Nov 2019			Filed April 2020		Filed Oct 2020
				Evrysdi (risdiplam)			Xofluza
			RG7916	SMA		RG6152	influenza
				Filed July 2020			Filed May 2020
				Venclexta+ azacitidine			Xofluza
			RG7601	1L AML		RG6152	influenza, high risk
				Filed May 2020			Filed May 2020
							Hemlibra
				Gavreto (pralsetinib)
			RG6396	RET+ NSCLC		RG6013	Hemophilia A
				Filed May 2020			Filed June 2020
				Tecentriq + nab-paclitaxel			Gazyva
			RG7446	TNBC neoadj		RG7159	1L FL and r/r FL
				Filed Dec 2020			Sept 2020
				Esbriet			Tecentriq
			RG6062	UILD		RG7446	1L non-sq + sq NSCLC Dx+
				Filed Jan 2021			Filed Sept 2020
							Tecentriq + pemetrexed
						RG7446	1L non-sq NSCLC
							Filed Sept 2020

New Molecular Entity (NME)	Metabolism
Additional Indication (AI)	Neuroscience
Oncology / Hematology	Ophthalmology
Immunology	Other
Infectious Diseases

Status as of February 04, 2021

Major granted approvals 2020 and YTD 2021

	US		EU	China	Japan-Chugai

	Venclexta+Gazyva
RG7601	1L CLL
	Mar 2020
	Tecentriq+Avastin
RG7446	1L HCC
	May 2020
	Tecentriq
RG7446 1L non-sq + sq NSCLC Dx+
	May 2020
	Cotellic+Zelboraf+Tecentriq
RG7421	1L+ BRAFm melanoma
	May 2020
	Phesgo
RG6264	(Perjeta+Herceptin) FDC SC
	Her2+BC June 2020
	Evrysdi (risdiplam)
RG7916	SMA
	Aug 2020
	Enspryng (satralizumab)
RG6168	NMOSD
	Aug 2020
	Gavreto (pralsetinib)
RG6396	RET+ NSCLC
	Sept 2020
	Venclexta+azacitidine

	Xofluza
RG6152	post exposure prophylaxis
	Nov 2020
RG6413+	casivirimab+imdevimab
SARS-CoV-2 (EUA*)
RG6412
Nov 2020

	Gavreto (pralsetinib)
RG6396	RET+ MTC
	Dec 2020
	Ocrevus
RG1594 Short infusion RMS & PPMS
	Dec 2020
	Xolair
RG3648	nasal polyps
	Dec 2020

	Polivy
RG7596	r/r DLBCL
	January 2020
	Venclexta+Gazyva
RG7601	1L CLL
	Mar 2020
	Ocrevus
RG1594	Short infusion RMS & PPMS
	May 2020
	Rozlytrek (entrectinib)
RG6268	ROS1+ NSCLC
	Aug 2020
	Rozlytrek (entrectinib)
RG6268	NTRK+ tumor-agnostic
	Aug 2020

	Tecentriq +Avastin
RG7446	1L HCC
	Nov 2020
	Phesgo FDC SC
RG6264	Her2+BC
	Dec 2020
	Xofluza
RG6152	influenza
	Jan 2021
	Xofluza

	Kadcyla
RG3502	HER2+ eBC
	Jan 2020
	Tecentriq+chemo
RG7446	1L extensive stage SCLC
	Feb 2020
	Avastin
RG405	1L/2L glioblastoma
	Sept 2020
	Tecentriq +Avastin
RG7446	1L HCC
	Oct 2020

	Rozlytrek (entrectinib)
RG6268	ROS1+ NSCLC
	Feb 2020
	Alecensa
RG7853	r/r ALK+ ALCL
	Feb 2020
	Rituxan
RG105	thrombocytopenic purpura
	Feb 2020
	Enspryng (satralizumab)
RG6168	NMOSD
	June 2020
	Kadcyla
RG3502	HER2+ eBC adj
	Aug 2020
	Tecentriq+Avastin
RG7446	HCC
	Sept 2020
	Tecentriq +Avastin
RG7446	1L non-sq NSCLC Dx+
	Dec 2020

RG7601	1L AML
	Oct 2020

RG6152	influenza, high risk
	Jan 2021
	Xofluza

New Molecular Entity (NME)	Metabolism
Additional Indication (AI)	Neuroscience

*Emergency Use Authorisation

RG6152	post exposure prophylaxis
	Jan 2021

Oncology / Hematology	Ophthalmology
Immunology	Other
Infectious Diseases

Status as of February 04, 2021

FDC = fixed-dose combination

Pipeline summary

Marketed products additional indications

Global Development late-stage trials

pRED (Roche Pharma Research & Early Development)

gRED (Genentech Research & Early Development)

Spark

Roche Group 2020 results

Diagnostics

Foreign exchange rate information

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

Indication	Hemophilia A patients	Hemophilia A pediatric patients
with inhibitors to factor VIII	with inhibitors to factor VIII


Phase/study	Phase III	Phase III
HAVEN 1	HAVEN 2

# of patients
N=118	N=88

	Patients on episodic treatment prior to study entry:	Patients on prophylactic or episodic treatment prior to study entry:
	 ARM A: Hemlibra prophylaxis	 Cohort A: Hemlibra prophylaxis qw
	 ARM B: Episodic treatment (no prophylaxis)	 Cohort B: Hemlibra prophylaxis q2w	Hemophilia
Design	Patients on prophylaxis prior to study entry:	 Cohort C: Hemlibra prophylaxis q4w

	 ARM C: Hemlibra prophylaxis
	Patients on episodic treatment previously on non-interventional study:
	 ARM D: Hemlibra prophylaxis

Primary endpoint	 Number of bleeds over 24 weeks	 Number of bleeds over 52 weeks

	 FPI Q4 2015, recruitment completed in arms A and B Q2 2016	 FPI Q3 2016, recruitment completed Q2 2017
	 Primary and all secondary endpoints met Q4 2016	 Positive interim data in Q2 2017
	 Data published in NEJM 2017; 377:809-818	 FPI cohorts B/C Q4 2017
Status		 Full primary data at ASH 2018
	
		Data published in Blood 2019;134(24):2127-2138
	 Data presented at ISTH 2017, updated data presented at ASH 2017
	 Filed in US and EU in Q2 2017; granted accelerated assessment (EMA) and priority review (FDA)
	 Approved in US Q4 2017 and EU Q1 2018

CT Identifier	NCT02622321	NCT02795767

In collaboration with Chugai

ASH=American Society of Hematology; ISTH=International Society on Thrombosis and Haemostasis; NEJM=New England Journal of Medicine

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

Indication	Hemophilia A patients	Hemophilia A patients with and without inhibitors to Factor VIII,
without inhibitors to factor VIII	dosing every 4 weeks

Phase/study

of patients
Design
Primary endpoint
Status

Phase III	Phase III
HAVEN 3	HAVEN 4

N=135	N=46

Patients on FVIII episodic treatment prior to study entry:	Multicenter, open-label,non-randomized study to assess the efficacy,
 ARM A: Hemlibra prophylaxis qw	safety, pharmacokinetics, and pharmacodynamics of Hemlibra
 ARM B: Hemlibra prophylaxis q2w	administered every 4 weeks.
 ARM C: Episodic FVIII treatment; switch to Hemlibra prophylaxis	 Part 1: Pharmacokinetic (PK) run-in part (N=6)
possible after 24 weeks	 Part 2: Expansion part (N=40)
Patients on FVIII prophylaxis prior to study entry:
 ARM D: Hemlibra prophylaxis qw

 Number of bleeds over 24 weeks	 Number of bleeds over 24 weeks
 FPI Q3 2016, recruitment completed Q2 2017	 FPI Q1 2017, recruitment completed Q2 2017
 Study met primary and key secondary endpoints Q4 2017	 PK run-in data at ASH 2017
 FDA granted Breakthrough Therapy Designation April 2018	 Positive interim analysis outcome reported Q4 2017
 Data presented at WFH 2018	 Data presented at WFH 2018
 Filed in US (priority review) and EU in Q2 2018	 Interim data filed in US and EU in Q2 2018
 Data published in NEJM 2018; 379: 811-822	 Data published in Lancet Haematology 2019 Jun;6(6):e295-e305

•Approved in US Q4 2018 and EU Q1 2019

Hemophilia

CT Identifier

NCT02847637

NCT03020160

In collaboration with Chugai

ASH=American Society of Hematology; WFH=World Federation of Hemophilia; NEJM=New England Journal of Medicine

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

Indication	Hemophilia A patients with and without inhibitors to Factor VIII	Hemophilia A mild to moderate patients without inhibitors to Factor
VIII


Phase/study	Phase III	Phase III
HAVEN 5	HAVEN 6

# of patients
N=85	N=70

	Patients with Hemophilia regardless of FVIII inhibitor status on	Multicenter, open-label study to evaluate the safety, efficacy,
	prophylactic or episodic treatment prior to study entry:	pharmacokinetics, and pharmacodynamics of Hemlibra in patients with	Hemophilia
Design	• Arm A: emicizumab prophylaxis qw	mild or moderate Hemophilia A without FVIII inhibitors
	• Arm B: emicizumab prophylaxis q4w
	• Arm C: No prophylaxis (control arm)

Primary endpoint	 Number of bleeds over 24 weeks	 Safety and efficacy

	 FPI Q2 2018	 FPI Q1 2020
	 Recruitment completed Q1 2019
Status	 Filed in China Q2 2020

CT Identifier	NCT03315455	NCT04158648

In collaboration with Chugai

Alecensa

New CNS-active inhibitor of anaplastic lymphoma kinase

Indication	Treatment-naïve	Adjuvant ALK+ NSCLC
ALK+ advanced NSCLC


Phase/study	Phase III	Phase III
ALEX	ALINA

# of patients
N=286	N=255

Design	 ARM A: Alecensa 600mg BID	 ARM A: Alecensa 600 mg BID	Oncology
 ARM B: Crizotinib 250mg BID	 ARM B: Platinum-based chemotherapy


Primary endpoint
 Progression-free survival	 Disease-free survival

	 Recruitment completed Q3 2015	 FPI Q3 2018
	 Primary endpoint met Q1 2017
	 Data presented at ASCO 2017, 2018, ESMO 2017, 2018
Status	 Data published in NEJM 2017; 377:829-838
	 CNS data presented at ESMO 2017
	 Final PFS and updated OS presented at ESMO 2019
	 Approved in US Q4 2017 (priority review) and in EU Q4 2017
CT Identifier	NCT02075840	NCT03456076

In collaboration with Chugai	88
NSCLC=non-small cell lung cancer; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medicine; ESMO=European Society for Medical Oncology

Kadcyla

First ADC for HER2-positive breast cancer

Indication	HER2-positive early breast cancer
high-risk patients

Phase/study

of patients
Design
Primary endpoint

Status

CT Identifier

Phase III

KATHERINE

N=1,484

ARM A: Kadcyla 3.6mg/kg q3w
ARM B: Herceptin
Invasive disease-free survival
Recruitment completed Q4 2015

Stopped at pre-planned interim data analysis for efficacy Q4 2018
Data presented at SABCS 2018
BTD granted by FDA in Q1 2019
US filling completed under RTOR Q1 2019 and filed in EU Q1 2019
Approved in US Q2 2019 and in EU Q4 2019
Data published in NEJM 2019; 380:617-628

NCT01772472

Oncology

In collaboration with ImmunoGen, Inc.	89

ADC=antibody drug conjugate; SABCS=San Antonio Breast Cancer Symposium; RTOR=Real time oncology review; ORR=Objective Response Rate; NEJM=New England Journal of Medicine

Perjeta

First-in-class HER2 dimerization inhibitor

Indication	Adjuvant HER2-positive breast cancer	Neoadjuvant HER2-positive breast cancer

Phase/study	Phase III	Phase III
APHINITY	IMpassion050

# of patients
N=4,803	N=453

	 ARM A: Perjeta (840mg loading, 420 q3w) + Herceptin for 52 weeks	 ARM A: ddAC Herceptin/Perjeta + paclitaxel followed by surgery and
	plus chemotherapy (6-8 cycles)	chemotherapy
	 ARM B: Placebo + Herceptin (52 weeks) plus chemotherapy (6-8	 ARM B: ddAC Herceptin/Perjeta + chemotherapy +Tecentriq followed	Oncology
Design	cycles)	by surgery and chemotherapy +Tecentriq



Primary endpoint	 Invasive disease-free survival (IDFS)	 Pathologic complete response (pCR)

	 Primary endpoint met Q1 2017	 FPI Q4 2018
	 Data presented at ASCO 2017 and published in NEJM 2017; 377:122-131	 Recruitment completed Q3 2020
Status	 Filed in US and EU Q3 2017
	 Approved in US Q4 2017 (priority review) and EU Q2 2018
	 Six year IDFS data presented at SABCS 2019

CT Identifier	NCT01358877	NCT03726879

ddAC=dose-dense doxorubicin plus cyclophosphamide; FEC=fluorouracil, epirubicin and cyclophosphamide; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medcine;	90
SABCS=San Antonio Breast Cancer Symposium

Perjeta

First-in-class HER2 dimerization inhibitor

Indication	HER2-positive early breast cancer subcutaneous co-formulation

Phase/study	Phase III	Phase II
FeDeriCa	PHranceSCa


# of patients	N=500	N=160

	Fixed-dose combination (FDC) of Perjeta (P) and Herceptin (H) for	 ARM A: PH IV followed by FDC SC
	subcutaneous administration in combination with chemotherapy in the	 ARM B: PH FDC SC followed by IV
	neoadjuvant/adjuvant setting			Oncology
Design	 ARM A: P IV+H IV+chemotherapy

 ARM B: FDC of PH SC+chemotherapy


Primary endpoint	 Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7	 Percentage who preferred PH FDC SC

	 Recruitment completed Q4 2018	 FPI Q4 2018
	 Primary endpoint met Q3 2019	 Final analysis completed, 85% patients preferred FDC SC
Status	 Data presented at SABCS 2019	 Data presented at ESMO 2020

	 Filed in US Q4 2019 & in EU Jan 2020

	 Approved in US Q2 2020 and EU Q4 2020
CT Identifier	NCT03493854	NCT03674112	91

SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase; SABCS=San Antonio Breast Cancer Symposium

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	1L non-squamous NSCLC	1L non-squamous and squamous NSCLC
PD-L1-selected patients


Phase/study	Phase III	Phase III
IMpower132	IMpower110

# of patients
N=568	N=570

	 ARM A: Tecentriq plus carboplatin or cisplatin plus pemetrexed	 ARM A: Tecentriq monotherapy
Design	 ARM B: Carboplatin or cisplatin plus pemetrexed	 ARM B: NSq: carboplatin or cisplatin plus pemetrexed
	Sq: carboplatin or cisplatin plus gemcitabine	Oncology


Primary endpoint	 Progression-free survival and overall survival	 Overall survival


	 FPI Q2 2016	 IMpower111 consolidated into IMpower110 Q3 2016
	 Recruitment completed Q2 2017	 Recruitment completed Q1 2018
Status	 Study met co-primary endpoint of PFS in Q2 2018	 Study met primary endpoint in PD-L1 high (IC3/TC3) Q3 2019
 Data presented at WCLC 2018	 Data presented at ESMO, ESMO-IO 2019 and final OS at WCLC 2021
	 Final OS presented at ESMO Asia 2020	 Filed in EU and US (priority review) Q4 2019
		 Approved in US Q2 2020
CT Identifier	NCT02657434	NCT02409342

NSCLC=non-small cell lung cancer; NSq=non-squamous; Sq=squamous; ESMO=European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; WCLC=World Conference on	92
Lung Cancer

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication		1L extensive-stage SCLC

Phase/study	Phase III	Phase Ib
IMpower133

# of patients
N=400	N=62

	 ARM A: Tecentriq plus carboplatin plus etoposide	 Carboplatin and etoposide +/- Tecentriq followed by maintenance
Design	 ARM B: Placebo plus carboplatin plus etoposide	Tecentriq plus Venclexta
		Oncology

Primary endpoint	 Progression-free survival and overall survival	 Safety and efficacy


	 FPI Q2 2016	 FPI Q3 2020
	 Orphan drug designation granted by FDA Q3 2016
	 Study met endpoints of OS and PFS in Q2 2018
Status	 Primary data presented at WCLC 2018
	 Data published in NEJM 2018; 379:2220-2229
	 Filed with the US and EU Q3 2018
	 Approved in US Q1 2019 and EU Q3 2019

CT Identifier	NCT02763579	NCT04422210

SCLC=small cell lung cancer; WCLC=World Conference on Lung Cancer; NEJM=New England Journal of Medicine

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	Adjuvant NSCLC	Neoadjuvant NSCLC

Phase/study	Phase III	Phase III
IMpower010	IMpower030

# of patients
N=1,280	N=450

	Following adjuvant cisplatin-based chemotherapy	 ARM A: Tecentriq + platinum-based chemotherapy
Design	 ARM A: Tecentriq	 ARM B: Platinum-based chemotherapy
 ARM B: Best supportive care		Oncology


Primary endpoint	 Disease-free survival	 Major pathological response and event free survival


	 FPI Q3 2015	 FPI Q2 2018
Status	 Trial amended from PD-L1+ selected patients to all-comers
 FPI for all-comer population Q4 2016

	 Recruitment completed Q3 2018
CT Identifier	NCT02486718	NCT03456063

NSCLC=non-small cell lung cancer

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	1L NSCLC	Stage IV NSCLC	2L NSCLC previously treated with an immune
checkpoint inhibitor


Phase/study	Phase II/III	Phase Ib/III	Phase III
B-FAST	IMscin001*	CONTACT-01

# of patients
N=660	N=375	N=350

	 Cohort A: ALK+ (Alecensa)	Phase Ib	 ARM A: Tecentriq plus cabozantinib
	 Cohort B: RET+ (Alecensa)	 Dose finding, Tecentriq SC followed by	 ARM B: Docetaxel
Design	 Cohort C: bTMB-high (Tecentriq)	Tecentriq IV		Oncology
 Cohort D: ROS1+ (Rozlytrek)	Phase III


	 Cohort E: BRAF+ (Zelboraf plus Cotellic plus	 2L NSCLC non inferiority of Tecentriq SC vs
	Tecentriq)	Tecentriq IV

Primary endpoint	 Cohort A/B: Objective response rate	 Observed concentration of Tecentriq in serum	 Overall survival
	 Cohort C: Progression-free survival	at cycle 1
	 FPI Q3 2017	 FPI Q4 2018	 FPI Q3 2020
	 Recruitment completed for cohort A Q3 2018	 FPI in phase III part Q4 2020
	and cohort C Q3 2019
Status	 Study met primary endpoint in cohort A
(ALK+) Q3 2019; presented at ESMO 2019

	 ALK+ Alecensa (cohort A) filed in US Q1 2020
	 Cohort C did not show statistical significance
	for primary endpoint
CT Identifier	NCT03178552	NCT03735121	NCT04471428

*SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase	95
NSCLC=non-small cell lung cancer; ESMO=European Society for Medical Oncology

Tecentriq

Anti-PD-L1 cancer immunotherapy - SCCHN/hematology/melanoma

Indication	Adjuvant squamous cell carcinoma of the		First-line BRAFv600 mutation-positive
Relapsed or refractory AML	metastatic or unresectable locally advanced
head and neck
		melanoma


Phase/study	Phase III	Phase I	Phase III
IMvoke010	IMspire150 TRILOGY1

# of patients
N=400	N=21	N=500

	 ARM A: Tecentriq 1200mg q3w	 Tecentriq plus anti-CD47	Double-blind, randomized, placebo-controlled
	 ARM B: Placebo		study
Design			 ARM A: Tecentriq plus Cotellic plus Zelboraf2	Oncology
			 ARM B: Placebo plus Cotellic plus Zelboraf2


Primary endpoint	 Event-free survival and overall survival	 Safety and efficacy	 Progression-free survival

	 FPI Q1 2018	 FPI Q4 2019	 FPI Q1 2017
	 Recruitment completed Q1 2020		 Recruitment completed Q2 2018
			 Primary endpoint met Q4 2019
Status			 Data presented at AACR 2020
		 Data published in Lancet;395(10240):1835-

			1844
			 Filed in US Q2 2020 under Project Orbis3
			 Approved in US Q3 2020
CT Identifier	NCT03452137	NCT03922477	NCT02908672

SCCHN=squamous cell carcinoma of the head and neck; AML=acute myeloid leukemia; 1In collaboration with Exelixis; 2Zelboraf in collaboration with Plexxikon, a member of Daiichi Sankyo Group;	96

3 Project Orbis=FDA framework for concurrent submission and review of oncology products among international partners; AACR=American Association for Cancer Research

Tecentriq

Anti-PD-L1 cancer immunotherapy - UC

Indication	1L metastatic urothelial carcinoma	High-risknon-muscle-invasive
bladder cancer


Phase/study	Phase III	Phase III
IMvigor130	ALBAN


# of patients	N=1,200	N=614

	 ARM A: Tecentriq plus gemcitabine and carboplatin or cisplatin	 ARM A: BCG induction and maintenance
Design	 ARM B: Tecentriq monotherapy	 ARM B: Tecentriq+ BCG induction and maintenance
 ARM C: Placebo plus gemcitabine and carboplatin or cisplatin		Oncology

Primary endpoint	 Progression-free survival, overall survival and safety	 Recurrence-free survival

	 FPI Q3 2016	 FPI Q4 2018
	 FPI for arm B (amended study) Q1 2017
Status	 Recruitment completed Q3 2018
	 Study met co-primary endpoint of PFS Q3 2019
	 Data presented at ESMO 2019
CT Identifier	NCT02807636	NCT03799835

UC=urothelial carcinoma; BCG=Bacille Calmette-Guérin

Tecentriq

Anti-PD-L1 cancer immunotherapy - renal cell cancer

Indication	Adjuvant renal cell carcinoma	Advanced renal cell carcinoma after immune checkpoint inhibitor
treatment


Phase/study	Phase III	Phase III
IMmotion010	Contact-031

# of patients	N=778	N=500

	 ARM A: Tecentriq monotherapy	 ARM A: Tecentriq plus cabozantinib
Design	 ARM B: Observation	 ARM B: cabozantinib
		Oncology

Primary endpoint	 Disease-free survival	 Progression-free survival and overall survival

	 FPI Q1 2017	 FPI Q3 2020
Status	 Recruitment completed Q1 2019
CT Identifier	NCT03024996	NCT04338269

1In collaboration with Exelixis

Tecentriq

Anti-PD-L1 cancer immunotherapy - CRC and HCC

Indication	1L hepatocellular carcinoma	Adjuvant hepatocellular carcinoma

Phase/study	Phase III	Phase III
IMbrave150	IMbrave050

# of patients
N=501	N=662

	 ARM A: Tecentriq plus Avastin	 ARM A: Tecentriq plus Avastin
	 ARM B: Sorafenib	 ARM B: Active surveillance	Oncology
Design


Primary endpoint	 Overall survival and progression free survival	 Recurrence-Free Survival (RFS)

	 FPI Q1 2018; recruitment completed Q1 2019	 FPI Q4 2019
	 Data presented at ESMO Asia 2019
Status	 US filing completed under RTOR Q1 2020; filed in EU Q1 2020
	 Data published in NEJM 2020;382:1894-1905
	 Approved in US Q2 2020 and EU Q4 2020
CT Identifier	NCT03434379	NCT04102098

Cotellic in collaboration with Exelixis; ESMO=European Society for Medical Oncology; NEJM=New England Journal of Medicine; RTOR=Real time oncology review

Tecentriq

Anti-PD-L1 cancer immunotherapy - breast cancer

Indication	Previously untreated metastatic
triple negative breast cancer


Phase/study	Phase III	Phase III
IMpassion130	IMpassion132

# of patients
N=900	N=572

	 ARM A: Tecentriq plus nab-paclitaxel	 ARM A: Tecentriq plus capecitabine or carbo/gem
Design	 ARM B: Placebo plus nab-paclitaxel	 ARM B: Placebo plus capecitabine or carbo/gem
		Oncology

Primary endpoint	 Progression-free survival and overall survival (co-primary endpoint)	 Overall survival

	 Recruitment completed Q2 2017	 FPI Q1 2018
	 Study met co-primary endpoint of PFS in both PDL1+ and ITT
	populations Jul 2018
	 Primary PFS and interim OS data presented at ESMO 2018 and ASCO
Status	2019
	 Data published in NEJM 2018; 379:2108-2121
	 US accelerated approval Q1 2019
	 Approved in EU Q3 2019
	 Final OS presented at ESMO Asia 2020
CT Identifier	NCT02425891	NCT03371017

ESMO=European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medicine

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