This presentation contains certain forward-looking

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:

1 pricing and product initiatives of competitors;

2 legislative and regulatory developments and economic conditions;

3 delay or inability in obtaining regulatory approvals or bringing products to market;

4 fluctuations in currency exchange rates and general financial market conditions;

5 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;

6 increased government pricing pressures;

7 interruptions in production;

8 loss of or inability to obtain adequate protection for intellectual property rights;

9 litigation;

10 loss of key executives or other employees; and

11 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 SchwanChief Executive Officer

2020 performance

Outlook

5

2020: Targets fully achieved despite COVID-19 pandemic

6

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

CHFm (CER)

Group

Core OP

Group

Sales

CHFm (CER)

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

61,396 62,015

+ 4,739

-868

+ 1,800

- 5,051

- 5,919

+1%

2

2019 2020Diagnostics

Division

Pharma

New

Products1

Pharma

bx exposed2

& other

22,478

23,460 23,460

- 968

+ 1,812

- 803

- 40

+ 981

2019 2020CorporatePharma

lower profit

contribution

from lower

sales3

Pharma

additional

R&D spend

Diagnostics

growth &

efficiency

gains

+4%

Pharma

efficiency

gains &

other

At constant exchange rates (CER); 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi; 2 MabThera,

Herceptin & Avastin in Europe (Avastin: as of Jul 20) and MabThera, Herceptin & Avastin in U.S. and Japan; 3 Pharma sales decline minus proportional cost of sales 20207

Responding quickly and broadly to the pandemic

Collaboration with Regeneron on

casirivimab/imdevimab global supply

SARS-CoV-2 Rapid

Antigen Test launched

COVACTA

trial resultsREMDACTA trial

initiated

EMPACTA

trial resultsCOVACTA trial

initiated

Collaboration with Atea on

development of AT-527

cobas ® SARS-CoV-2

test receives FDA EUA

cobas® SARS-CoV-2 test & Flu

A/B Test receives FDA EUA

Elecsys® Anti-SARS-CoV-2 S

antibody test launched

Elecsys® Anti-SARS-CoV-2

antibody test receives FDA EUA

cobas®

6800/8800

cobas®

e411/601/602/801

Elecsys® IL-6 test

receives FDA EUA

SARS-CoV-2 Rapid

Antibody Test launched

Non-

instrumented

8

Lab SARS-COV-2

antigen test launched

FDA EUA granted in mild-

moderate adults and adolescents

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

Ph

arm

a

Dia

gn

osti

cs

REMAP-CAP

trial results

LightCycler®

480

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb

SARS-CoV-2 Rapid Antigen

Test Nasal launched

20 21

TIB MOLBIOL LightMix®

modular SARS-CoV-2 launched

casirivimab/imdevimab

AT-527

Potential use cases for COVID-19 portfolio

9

Use cases will continue to

persist with vaccine rollout

• People not yet vaccinated

• Vaccine ineffective/wore off

• Antibody testing

• Population surveillance

• Screening

• Flu/COVID-19 diagnosis

PCR=polymerase chain reaction test

Pre-exposure/asymptomatic

(screening and prophylaxis)

Symptomatic

(diagnosis and treatment)

Post-vaccination

(to confirm protection)

Diagnostics

PCR

Antigen test

IL-6 test

Antibody test

Pharma

Oral antiviral (DAA)

Neutralizing antibodies

Immunomodulators

HospitalizedLow risk MildHigh risk

2020: Sales growth due to Diagnostics Division

10CER=Constant Exchange Rates

2020 2019

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

Change in %

2020: Group sales growth impacted by COVID-19

11

2%

6%

4%

6%6%

4%

8%7%

5%

4%5%

6%

5%

7%

6%

4% 4%

6%

3%3%

4%

6% 6%

5%

6%7%7%

9%

8%

9%

13%

6%

7%

-4%

1%1%

-6%

-4%

-2%

0%

2%

4%

6%

8%

10%

12%

14%

16%

Q1

12

Q2

12

Q3

12

Q4

12

Q1

13

Q2

13

Q3

13

Q4

13

Q1

14

Q2

14

Q3

14

Q4

14

Q1

15

Q2

15

Q3

15

Q4

15

Q1

16

Q2

16

Q3

16

Q4

16

Q1

17

Q2

17

Q3

17

Q4

17

Q1

18

Q2

18

Q3

18

Q4

18

Q1

19

Q2

19

Q3

19

Q4

19

Q1

20

Q2

20

Q3

20

Q4

20

At constant exchange rates (CER)

+5%+2%

+18%

+28%

+7%

-6%-4%

-7%

+50%

+25%+32%

+24%

-10%

+0%

+10%

+20%

+30%

+40%

+50%

+60%

Q1'20 vs.

Q1'19

Q2'20 vs.

Q2'19

Q3'20 vs.

Q3'19

Q4'20 vs.

Q4'19

% CER

Diagnostics Pharma Pharma New Products

2020: Pandemic heavily impacting business dynamics

12Growth 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-19 testing overcompensating negative impact

on routine testing since June 2020

1st wave 2nd wave

15%

22%

31%

41%

0

3,000

6,000

9,000

12,000

15,000

18,000

21,000

FY 2017 FY 2018 FY 2019 FY 2020

Erivedge Perjeta Kadcyla Gazyva

Esbriet Cotellic Alecensa Tecentriq

Ocrevus Hemlibra Xofluza Polivy

Rozlytrek Phesgo Enspryng Evrysdi

Pharma: New products with strong momentum

Accelerated portfolio rejuvenation in Q4 2020

13All absolute values are presented in CHFm reported

Pharma sales mix

31%

29%

40%

2019

41%

30%

29%

2020

CHFm % of Pharma Sales

New products launched since 2012

Other products Herceptin + Rituxan + Avastin

36.1% 36.6% 36.9%

20.5

22.5

21.5

2018 2019 2020

+4% at CER

18.14

20.16

19.16

2018 2019 2020

+4% at CER

2020: Growth of profitability and Core EPS

% of sales

CHFCHFbn

Core operating profit Core EPS Operating free cash flow

1 at CER=Constant Exchange Rates

+4%1

+4%1 -21%1

+1.2%p1

-7.5%p1

33.0% 34.0%

25.4%

18.7

20.9

14.8

2018 2019 2020

-21% at CERCHFbn

14

2020 performance

Outlook

15

Continuing to invest in innovation

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

45

4

81

11

2

11

1

2

4

55

5

22

2

FY 2017 FY 2018 FY 2019 FY 2020

NM

Es

10

1413

19

Outlook FY

2021

Assets in Ph III & registration at all time high Diagnostics major systems launches ahead

8

3

3

6

2

221 cobas® pure2cobas® 58002

cobas® pro (high throughput)

Strong short- and mid-term news flow

Diversifying the late stage pipeline and setting new standards of care

17

tominersen Huntington’s 2022

gantenerumab Alzheimer’s 2022

SRP-9001 DMD latest 2023

etrolizumab Crohn’s 2022

PDSnAMD

DME

2020/21

2022

faricimabDME

nAMD2021

Product Indication Filing/Data Product Indication Filing/Data

Tecentriq

Adj SCCHN 2021

(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

Oncology/HematologyNeuroscience OphthalmologyImmunology

Actemra +/-

remdesivir

COVID-19 related

pneumonia2021

casirivimab/

imdevimab SARS-CoV-2 2021

AT-527 SARS-CoV-2 2021/22

Infectious diseases

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

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

crovalimab PNH 2022

Positive top-line announced

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

Aim to defend margins despite headwinds

18

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

Sales1 Expenses

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

Trends expected to continue:

Investing into the future while protecting

the margin

2021 outlook

Further growing top and bottom line

19

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

Pharmaceuticals Division

Bill AndersonCEO Roche Pharmaceuticals

2020: Pharmaceuticals Division sales

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


2020 2019

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

Change in %

CHFm % sales

Sales 44,532 100

Royalties & other op. inc. 1,959 4.4

Cost of sales -8,070 -18.2

M & D -6,633 -14.9

R & D -10,597 -23.8

G & A -1,714 -3.8

Core operating profit 19,477 43.7

-7% in CHF

2020 2020 vs. 2019

CER growth

-2%

-16%

-8%

8%

6%

0%

-7%

2020: Pharma Division

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


23

Reallocating resources into R&D

Providing more patient benefit at less cost to society

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

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

#12 #1 #15 #8 #7 #6 #2 #1undisclosed#19

launched

NMEs in clinical

development *

-34%

-31%

-25%

-16%

4%

2%

n/a

5%

21%

248%

40%

34%

18%

32%

24%

68%

55%

370%

n/a

n/a

-2,400 -2,000 -1,600 -1,200 -800 -400 0 400 800 1,200

HerceptinMabThera

AvastinLucentis

EnspryngPhesgoXofluzaEsbrietXolair

EvrysdiTNKase / Activase

GazyvaPolivy

AlecensaKadcylaPerjeta

Actemra / RoActemraOcrevus

HemlibraTecentriq

USEuropeJapanInternational

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

portfolio

24

CHFm

Absolute values and growth rates at Constant Exchange Rates (CER)

New products account for >47% of Pharma sales*

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

25* 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

Medicines; NME=new molecular entity

17%

24%

35%

47%

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000

Q4 17 Q4 18 Q4 19 Q4 20

Erivedge Perjeta Kadcyla Gazyva

Esbriet Cotellic Alecensa Tecentriq

Ocrevus Hemlibra Xofluza Polivy

Rozlytrek Phesgo Enspryng Evrysdi

CHFm % of Pharma Sales*

26

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

YoY CER growth

CHFbn

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;

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

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

Cotellic

-3%

-8% +3%

-35%

0

500

1,000

1,500

2,000

Q4 17 Q4 18 Q4 19 Q4 20

MabThera/Rituxan (Onc) Gazyva/Gazyvaro Polivy

Hematology franchise: Growth from Venclexta, Gazyva, and Polivy

27CER=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

YoY CER growthCHFmHematology 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

• CD20xCD3 program updates; Early filing potential in 3L+ FL/DLBCL

28

• 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

Hematology franchise: CD20 x CD3 program update

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

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

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

Ph I (GO29781): Mosunetuzumab in R/R FL

Investigator-assessed best objective response

(pooled data from 2.8mg to 13.5mg cohorts)

High response rates in heavily pre-treated DLBCL

Glofitamab step-up dosing* (2.5/10/16mg or 2.5/10/30mg)

Ph I (NP30179): Glofitamab in R/R DLBCL

High response rates in high risk subsets

+29%+44% +71%

+89%

+135%

+146%

+154%

+136%

+99% +54%

+49%+35%

0

100

200

300

400

500

600

700

800

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 overview: Growth driven by first-in-class indications

First adjuvant trials to read out in 2021

29

YoY CER growthCHFm

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

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

+99%

+69%+11%

+54%

0

50

100

150

200

250

300

350

Q4 17 Q4 18 Q4 19 Q4 20


30

YoY CER growthCHFm

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

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

Lung cancer franchise: Alecensa in ALK+ NSCLC

Strong 1L momentum continues in all markets

31

>500%

>500%

>500%

>500%

+313%

+146%+59%

+57%+45%

0

100

200

300

400

500

600

700

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


CHFm YoY CER growth

Hemophilia A franchise: Hemlibra growing strongly

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

CER=Constant Exchange Rates

Hemophilia Q4 update

• US/EU: Gaining market share in non-inhibitors

• Minor COVID-19 impact leading to delayed patient starts

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

• Hemlibra continues to penetrate across all patient types

Outlook 2021

• Further growth expected

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

+10%

+12% 0%

+2%

0

500

1,000

1,500

2,000

2,500

Q4 17 Q4 18 Q4 19 Q4 20

MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other

32

YoY CER growthCHFm

Immunology franchise: Stable sales driven by Actemra

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

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

+195%+104% +83%

+67%+59%

+48%+55%

+38%

+12%

+37%

+10%

0

250

500

750

1,000

1,250

1,500

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

33

YoY CER growthCHFmOcrevus 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)

MS franchise: Ocrevus with 25% total US market share

Market leadership momentum continues

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

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

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

H1 2021 Outlook

Access enabled by compelling value proposition

• Anticipated approvals in EMA, China, and Japan

• Primary analysis from Ph II (JEWELFISH) study in

previously treated patients

• 2-year data from pivotal Ph III trials SUNFISH and FIREFISH

• ~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

~2,500 patients treated worldwide between clinical

trials, commercial, and compassionate use program

Faricimab

(anti-VEGF/Ang-2 biMab)

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

Port delivery system

(PDS)

35

Ophthalmology franchise: Benefitting patients globally

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

• 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

• 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

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

37

2020: Key late-stage news flow*

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

• 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)

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

38

2021: Key late-stage news flow*

* Outcome studies are event-driven: timelines may change

Compound Indication Milestone

Regulatory

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

Phase III / pivotal

readouts

faricimab nAMD Ph III TENAYA/LUCERNE

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

casirivimab/imdevimab SARS-CoV-2 Post-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

Diagnostics Division

Thomas SchineckerCEO Roche Diagnostics

2020: Diagnostics Division sales

Strong growth driven by Molecular Diagnostics

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

2020 2019

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

Change in %

North America

+26%

~28% of divisional sales

Latin America

+14%


Japan

+5%

~4% of divisional salesEMEA1

+19%


2020: Diagnostics Division regional sales

Growth driven by COVID-19 testing

41

Asia Pacific

-3%


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

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0

Tissue

Diagnostics

Diabetes

Care

Molecular

Diagnostics

Centralised

and Point

of Care

Solutions

EMEA

North America

RoW

+90%

2020: Diagnostics Division highlights

Strong growth driven by COVID-19 testing

42

• 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%)+5%

-5%

-1%

CHFbn

1

YoY CER growth

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

2

CHFm % sales

Sales 13,791 100

Royalties & other op. inc. 61 0.4

Cost of sales -6,497 -47.0

M & D -2,728 -19.8

R & D -1,556 -11.3

G & A -507 -3.7

Core operating profit 2,564 18.6

+30% in CHF

2020 2020 vs. 2019

CER growth

14%

10%

0%

10%

50%

3%

-26%

-26%

2020: Diagnostics Division

Very strong core operating profit growth of +50%


Launched3,4

• 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

SARS-CoV-2 diagnostics portfolio1

Comprehensive portfolio of tests and digital solutions

44

Molecular

solutions

• TIB MOLBIOL LightMix® Modular SARS-CoV-2

• cobas® SARS-CoV-2

• cobas® SARS-CoV-2 & Influenza A/B

• cobas® SARS-CoV-2 & Influenza A/B

Launched

Launched

Launched3Launched

Launched

• Viewics LabOps COVID-19 for efficiency

improvements

• NAVIFY Remote Monitor5

• v-TAC6 digital algorithm for blood-gas

• iThemba Life COVID-19

• cobas® infinity POC COVID-19 Portal

Launched

Launched

Launched

Launched

Launched

Launched4

Launched

Launched3,4

Clinical Labs Near Patient

Immunology

solutions

Digital

solutions

• SARS-CoV-2 Rapid Antibody

• SARS-CoV-2 Rapid Antigen

• SARS-CoV-2 Rapid Antigen Test Nasal

• SARS-CoV-2 & Influenza A/B Rapid Antigen

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

In-development3

Launched

Recently launched

Launched

Investing CHFm >600 to increase supply chain capacities

Driving to unprecedented volume in record time!

• 60 new manufacturing lines

• 17 locations with 5 new partners


• 1 new biotech facility

CONSUMABLES REAGENTS

RAW MATERIALS INSTRUMENTS


• 4 major facility expansions

• 1 new manufacturing space

• CHFm >600 investment

• >1200 new employees

45

• 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-2 Extraction Solution: virus inactivation time of 2 minutes

46

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

High performing test to detect SARS-CoV-2

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

exposure/screening individuals; 3 cobas® e: cobas e 801, cobas® e 602, cobas® e 601, cobas® e 411

Elecsys® In-solution

double-antibody sandwich

Ru

Ru

Ru

Ru

9 min

Streptavidin-coated paramagnetic

microparticleRu Ruthenylated monoclonal

antibody against N

Biotinylated monoclonal

antibody against N

SARS-CoV-2 nucleocapsid (N) in

the sample

Phase 1

Phase 2

Phase 3

9 min

47

• 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)

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

In clinical studies with major vaccine developers

1 Includes: CE-IVD FDA-EUA, India, Indonesia, Singapore, Thailand, Taiwan, Philippines, Vietnam, Argentina; 2 n=1423 positive samples, 14 days or later after diagnosis with PCR;3 cobas® e: cobas® e 801, cobas® e 602, cobas® e 601, cobas® e 411

Elecsys® In-solution

double-antigen sandwich

Biotin-labelled

complementary

antigen

Ruthenylated

antigenRu

Immature IgG

Immature IgM

Matur

e IgG

Mature IgM

Streptavidin-coated

paramagnetic microparticles

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

Enables clinicians to make fast targeted treatment decisions

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

• 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)

PIK3CA pathways in cancer

PI3 KINASE

(PIK3CA)

Growth Factor Receptor

(FGFR and EGFR family

members

PTEN

AKT 1

mTOR

Cell membrane

Cell proliferation, cell survival,

invasion & metastasis tumour-

induced angiogenesis

Extracellular Growth Factor

• Three next-generation CE-IVD algorithms launched in 2020

utilizing whole slide analysis for medical decision support to

critical cancer diagnosis

• Cloud based clinical workflow software and algorithms on

the NAVIFY platform

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

Powerful pipeline utilising latest advances in AI technology

49

HER2 (4B5)

PD-L1 HER2 Dual

ISH

SCANNING PATHOLOGIST

WORKFLOW

IMAGE

ANALYSIS

VENTANA DP 200 NAVIFY Digital

Pathology

uPath Image Analysis

Algorithms

NAVIFY Tumor Board

Outlook on 2021 new systems launches

Enabling comparable results in different size laboratories

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

Low

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

cobas® 5800* cobas® 6800 cobas® 8800

Medium HighThroughput

Molecular

solutions

SWA**

solutions

Roche Diagnostics Investors Day 2021

Innovating Diagnostics, Shaping Healthcare, Changing lives

51

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/

Devices

Workflow cobas® prime Next generation pre-analytical platform to support cobas® 6800/8800 Systems CE

Diabetes

Care

Accu-Chek Solo Diabetes

ManagerIntegration of the Accu-Chek Guide test strip technology into the Accu-Chek

Solo Diabetes Manager (remote control)CE

Tests/

Assays

Infectious

Diseases

Elecsys® EBV EBNA IgGEBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV) CEElecsys® EBV VCA IgG

Elecsys® EBV IgM

cobas® HIV-1&2 Qual Qualitative detection and confirmation of HIV-1 & HIV-2 US

cobas® EBV Monitoring tests for transplant patients to aid in the management of EBV and BKV infections US

cobas® BKV

Cervical

Cancer

cobas® HPV (6800/8800)The world’s leading cobas® HPV assay for use on the fully automated cobas®

6800/8800 Systems US

CINtec PLUS CytologyNext generation “Pap” test which leverages p16/Ki-67 dual-stain biomarker technology on cervical cytology samples US

Tissue DxVENTANA HER2 Dual ISH

Fully automated, brightfield ISH assay to determine eligibility for HER2 targeted

therapyUS

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

Software

Sequencing NAVIFY Mutation ProfilerSoftware as a medical device for annotating, variant classification, clinical interpretation and reporting from comprehensive genomic profile testing US

Diabetes

Care

RocheDiabetes InsulinStartA messaging service designed for people with type 2 diabetes to ease the

transition from oral antidiabetics to a complimentary insulin therapyCE

mySugr app Enabling control of the Accu-Chek Insight insulin pump from the mySugr app WW

RocheDiabetes Care Platform New releases with improved features focusing on device connectivity, integration

of 3rd parties, and healthcare professionals’ workflow optimisationWW

1CE: European Conformity, US: FDA approval, WW: Worldwide; EBV=Epstein-Barr virus; BKV=BK virus 52

Key launches 2021

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 53

Area Product Description Market1

Instruments

Core Labcobas® pure integrated solutions Low-to-medium volume SWA CE

cobas® pro integrated solutions New high throughput configurations of the cobas pro instrument CE

Point of Care cobas® pulse Successor of Accu-Chek® Inform II CE

Molecular Labcobas® 5800 Fully automated low throughput PCR system CE

AVENIO Edge System Automated sequencing library preparation and target enrichment instrument WW

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

Tests

Core Lab

Elecsys® SARS-CoV-2 Antigen Automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection US

Elecsys® NT-proBNP IU

• extensions in Heart Failure

• extension for Atrial FibrillationElecsys® TnT–hs 3 claim extensions in Coronary Arterial Disease

A set of 5 intended use extensions in the Coronary Arterial Disease, Atrial Fibrillation and

Heart Failure Space CE

Molecular LabAVENIO FoundationOne kit (RUO) Decentralized kit of the FoundationOne test WW

KAPA HyperPETE kit New targeted sequencing portfolio using primer extension for small targets WW

Digital

Solutions

Pathology LabuPath 2.0

First IVD release and version of Open API of the clinical pathologist workflow module for NAVIFY Digital Pathology & on-premise uPath

WW

RUO Algorithms Whole slide image analysis algorithms (ER (SP1), Ki-67 (30-9), and PR (1E2)) WW

InsightsNAVIFY Oncology 1.0 Modular Oncology decision support solution WW³

NAVIFY Pass 1.0 Solution for providers to communicate SARS-CoV-2 rapid antigen test results to a mobile app US & CE³

Core Lab Elecsys® GAAD Algorithm Algorithm for early detection of HCC in patients with chronic liver disease. CE

Diabetes CareRemote Patient Monitoring

Module within RDCP that enables remote Health Care Professional - Patient with Diabetes

interaction, including a patient dashboard, check-in and chat functionalityWW³

Accu-Chek SugarView Meter-free blood glucose testing using a smartphone and app OUS³

Finance

Alan HippeChief Financial Officer

2020 results

Focus on Cash

Outlook

55

• 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

2020: Highlights

56

Business

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)

• 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)

Cash flow

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

by the Board of Directors; FCF=free cash flow

2020: Successfully managing the transition in volatile environment

CHFm (CER)

Group

Core OP

Group

Sales

CHFm (CER)

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

61,396 62,015

+ 4,739

-868

+ 1,800

- 5,051

- 5,919

+1%

2

2019 2020Diagnostics

Division

Pharma

New

Products1

Pharma

bx exposed2

& other

22,478

23,460 23,460

- 968

+ 1,812

- 803

- 40

+ 981

2019 2020CorporatePharma

lower profit

contribution

from lower

sales3

Pharma

additional

R&D spend

Diagnostics

growth &

efficiency

gains

+4%

Pharma

efficiency

gains &

other

At constant exchange rates (CER); 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi; 2 MabThera,

Herceptin & Avastin in Europe (Avastin: as of Jul 20) and MabThera, Herceptin & Avastin in U.S. and Japan; 3 Pharma sales decline minus proportional cost of sales 202057

2020: Group performance

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


2020 2019

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

Change in %

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

+14%

1

+620

-1,689

-3,143+89 +661

-241

+1,800

-3,763

United States Europe Intl. Chugai

(Japan)

Dia Division Group Fx Group

CHF

Pharma Division Dia Division

PY: +62

-6% +1% +7% -6% +1% -5%

-2% +14%

1

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

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

20.3521.20

+0.3 p +0.9 p

+4.9 p

-1.1 p -0.1 p -0.7 p

FY 2019 Gains

product…

ROOI Gains equity securities Bond redemption Resolution tax disputes Other, mainly sales FY 2020

CHF+4.2%

Income from

disposal of

products

Other

ROOI

Gains equity

securities

Bond

redemptionOperationsFY 2019 FY 2020

Resolution tax

disputes

CHFm abs. CER

Sales 58,323 620

Royalties & other op. inc. 2,020 -175

Cost of sales -14,567 1,015

M & D -9,361 631

R & D -12,153 -953

G & A -2,726 -157

Core operating profit 21,536 981

-4% in CHF

2020

CER growth

2020 vs. 2019

1%

-6%

-6%

8%

4%

6%

-8%

2020: Group operating performance

Core operating profit growth ahead of sales growth


2,285

2,020

-57-27

+70

-251

1 2 3 4 5 6

2020: Royalties and other operating income

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

Out-licensingincome

Income fromdisp. of products

62

CHFm

2020

Royalties and other operating income decreased by -8% at CER

CER = Constant Exchange Rates

Royalty income Other operatingincome2019

Major transformation ongoing across the Group

Example: Cost of Sales

63Variances at constant exchange rates (CER)

• Manufacturing cost of goods sold and period costs:

Product mix, productivity improvements, and lower

inventory write-offs

• Collaboration and profit sharing agreements: Decrease

driven by lower MabThera/Rituxan sales (US)

• Royalty expenses: Decrease related to expired Cabilly

patent, partially offset by increased sales for certain

royalty-bearing products (Ocrevus, etc.)

Cost of Sales 2019 2020 abs. CER % CER

Pharma Division 10,180 8,070 +1,652 -16%

Manufacturing cost 6,086 5,021 +787 -13%

Dia Division 6,183 6,497 -637 +10%

Manufacturing cost 6,079 6,395 -638 +11%

Group 16,363 14,567 +1,015 -6%

Manufacturing Cost 12,165 11,416 +149 -1%

20,50518,942

2,046

22,47921,015

1,966

21,53619,477

2,564

Roche Group Pharma Division Diagnostics Division

2018 2019 2020

36.1% 36.6% 36.9%

43.1% 43.3% 43.7%

15.9% 15.2%18.6%

+4%¹0%¹

+50%¹

+1.2%p¹

+1.1%p¹

+4.8%p¹

2020: Core operating profit and margin

64

CHFm

1 At CER=Constant Exchange Rates

% of sales

2020: Core net financial result

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

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

-903

-87 -15

+182+58

-1

+202

2019 2020

CHFm

• Net financial expenses decreased by +34% at CER

• Interest expenses1 decreased by +26% at CER

Equity

securities

Net interest

incomeFX G/L

Interest

expenses1 Other

-564

G/L on debt

redemption

2020: Group Core tax rate

Tax rate relatively stable excluding resolution of several tax disputes

66

16.3

18.4 18.6

17.1

+0.2p

+2.1p

-1.5p

2019 2020

As reported

%

Resolution of

Tax Disputes

2020

Tax development

(excluding

Resolution of

Tax Disputes)

2020

-3,880

Before

Resolution of

Tax Disputes

Resolution of

Tax Disputes

2019

As reported

2019

Before

Resolution of

Tax Disputes

2020: Non-core and IFRS income

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

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

2019 2020

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 assets1

-1,756 -672 1,084

M&A and alliance transactions 43 -9 -52

Legal & Environmental2

-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

Change in %

2020 results

Focus on Cash

Outlook

68

2020: Operating Free Cash Flow

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

69CER=Constant Exchange Rates; OP=Operating Profit; NWC=Net Working Capital; PP&E=Property, Plant & Equipment incl. change of lease liability paid; IA=Intangible Assets

CHFm

20,921

14,815

-74 -2,307

-216 -1,838

-1,671

2019 2020Investmentsin IA

NWC movement

Investmentsin PP&E

OP, net of cash adjustments

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

Foreignexchange

2020: Group net debt lower vs. YE 2019

70

-2.5

+14.8

-1.9

-3.9

Taxes -3.2

Treasury -0.7

CHFbn

Free Cash Flow CHF 10.9bn

vs. 16.8bn in 2019

Dividends paid

Trans. own eq. instr.

M&A & All. trans.

Curr. Transl. & Other

[PY: +20.9]

-8.0

-2.1

-1.2

+1.0

-10.3

Net debt

31 Dec 2019

Operating

Free

Cash Flow

Dividends, M&A and Alliance

transactions and other

Net debt

31 Dec 2020

Non-OperatingFree

Cash Flow

Thereof investments in

Innovation

Intangible Asset

-3.2M&A-1.2

Total

-4.8Equity-0.4

-1.4 -4.8 -6.20.02019:

2020:

Balance sheet 31 December 2020

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

71CER = Constant Exchange Rates

2%

Net debt/

total assets:

Equity & liabilities

51.8 53.2

35.9 39.8

19.4 20.6

23.120.9

11.9 12.3

24.1 25.4

31 Dec

2019

31 Dec

2020

31 Dec

2019

31 Dec

2020

86.1 86.1+9%

+7%

+13%

+9%

Current

liabilities

Non-

current

liabilities

Equity

(Net assets)

14%14%

23%

63%

24%

43% 46%

83.1 83.1

62%

29%

28%

29%

25%

+12%

% change in CER

vs 31 Dec 2019

+9%

-5%

+17%

Cash and

marketable

securities

Other

current

assets

Non-

current

assets

CHFbn

% change in CER

vs 31 Dec 2019

2020 results

Focus on Cash

Outlook

72

1 On group growth rates

High currency impact in 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

0.97 0.97

0.950.94

1.001.00 1.00 0.99

1.08 1.07 1.06 1.06 1.06 1.07 1.07 1.08 1.08 1.07 1.08 1.08

1.07 1.06 1.07 1.07

1.13 1.13 1.12 1.11

In 2020 impact1 is (%p):

CHF / USD

CHF / EUR

-3% -3% -4% -5%

-6% -6% -5% -4%

Average YTD 2020

Monthly avg fx rates 2020

Q1 HY Sep

YTD

FY

Sales -5 -5 -6 -6

Core operating

profit-7 -8

Core EPS -8 -9

Average

YTD 2019

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

73

19.16 19.35

+0.19

Core EPS 2020 as

reported

2020 foreign

exchange losses:

Core EPS impact

Core EPS 2020 basis

for Outlook Core EPS

growth 2021 at CER

2020: Core EPS

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

74

CHF

CER = Constant Exchange Rates

2021 outlook

Further growing top and bottom line

75

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

Changes to the development pipeline

Q4 2020 update

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

Removed from phase I Removed from phase II Removed from phase III Approvals

1 NME:

RG6321 PDS with ranibizumab - wAMD

2 AIs:

RG6062 Esbriet - UILD

RG7446 Tecentriq+nab-paclitaxel - TNBC

neoadjuvant

2 NMEs:

RG6149 ST2 MAb - asthma

RG7845 fenebrutinib - RA

2 NMEs:

RG6359 SPK-3006 - Pompe disease

RG6422 AT-527 - adult non-hospitalised SARS-

CoV-2

2 AIs:

RG6058 tiragolumab+T+chemo - 1L non-

squamous NSCLC

RG6171 giredestrant - ER+/HER2- 2/3L mBC

7 NMEs:

RG6006 Abx MCP - bacterial infections

RG6007 HLA-A2-WT1 x CD3 - AML

RG6120 VEGF-Ang2 DutaFab - nAMD

RG6182 NME - neurodegenerative diseases

RG6232 TYRP1 x CD3 - metastatic melanoma

RG6234 NME - multiple myeloma

RG6312 NME - geographic atrophy

3 NMEs:

RG7845 fenebrutinib – PPMS

RG6026 glofitamab – 2L+ DLBCL*

RG7828 mosunetuzumab – 2L+ FL*

4 AIs:

RG1594 Ocrevus high dose - RMS & PPMS

RG6413+RG6412 casivirimab+imdevimab –

SARS-CoV-2 adult - ambulatory

RG7446 Tecentriq - SC NSCLC

3 AIs:

RG6152 Xofluza - influenza hospitalized

patients

RG7440 ipatasertib+chemo - 1L TNBC/HR+ BC

RG7440 ipatasertib+Tecentriq+taxane - 1L

TNBC

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

1 NME:

RG7461 simlukafusp alfa combos - solid tumors

2 AIs:

RG7446 Tecentriq+Avastin+Cotellic - 2/3L CRC

RG7446 Tecentriq + K/HP - HER2+ BC

Status as of February 04, 2021

77

* phI safety run-in ongoing

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

RG7440

ipatasertib + Taxane + T TNBC

ipatasertib + rucaparib mCRPC, solid tumors

ipatasertib .prostate cancer, pretreated

RG7446

Morpheus platform solid tumors

T + CD47 MAb r/r AML

T + Venclexta maintenance 1L ES-SCLC

RG7601

Venclexta + AMG176 AML

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

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

RG6171giredestrant (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

RG6058

tiragolumab + T NSCLC

tiragolumab + T + chemo 1L non-squamous NSCLC

tiragolumab + T cervical cancer

RG7601Venclexta + fulvestrant 2L HR+BC

Venclexta + carfilzomib r/r MM t(11:14)

CHU Oncolytic Type 5 adenovirus esophageal cancer

RG6173 anti-tryptase asthma

RG6354rhPTX-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-2 adult-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

Phase I (49 NMEs + 14 AIs) Phase II (22 NMEs + 12 AIs)

1Individualized Neoantigen Specific Immunotherapy2RG6149 NME status, RG7880 AI status3combination contributing as two entities

Roche Group development pipeline

New Molecular Entity (NME) Metabolism

Additional Indication (AI) Neuroscience

Oncology / Hematology Ophthalmology

Immunology Other

Infectious Diseases RG-No - Roche/Genentech

CHU - Chugai managed

IONIS – IONIS managed

SQZ - SQZ Biotechnology managed

NOV - Novimmune managed

4DMT - 4DMT managed

78

Status as of February 04, 2021

T=Tecentriq

Roche Group development pipeline

RG6013 Hemlibra mild to moderate hemophilia A

RG6026** glofitamab + chemo 2L+ DLBCL

RG6058

tiragolumab + T + chemo 1L SCLC

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

RG7440ipatasertib + abiraterone 1L CRPC

ipatasertib + fulvestrant + palbociclib 1L HR+ mBC

RG7596 Polivy 1L DLBCL

RG7446

Tecentriq NSCLC adj

Tecentriq NMIBC, high risk

Tecentriq RCC adj

Tecentriq + cabozantinib advanced RCC

Tecentriq + cabozantinib 2L NSCLC

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

RG7601Venclexta 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

RG6152

Xofluza influenza, pediatric (0-1 year)

Xofluza influenza, pediatric (1-12 years)

Xofluza influenza direct transmission

RG6413+

RG6412*

casivirimab+imdevimab SARS-CoV-2 adult prophylaxis

casivirimab+imdevimab SARS-CoV-2 adult ambulatory

RG1450 gantenerumab Alzheimer’s

RG1594 Ocrevus high dose RMS & PPMS

RG6042 tominersen Huntington’s

RG7845 fenebrutinib PPMS

RG6321port delivery system with ranibizumab . DME

port delivery system with ranibizumab DR

RG7716faricimab DME

faricimab wAMD

RG6396Gavreto (pralsetinib) 1 RET+ NSCLC

Gavreto (pralsetinib) 3 RET+ MTC

RG7446Tecentriq Dx+ 1 1L sq + non-sq NSCLC

T + nab-paclitaxel 4 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

Phase III (14 NMEs + 34 AIs) Registration (4 NMEs + 7 AIs)




Immunology Other

Infectious Diseases

1 Approved in US, filed in EU2 Filed in US3 Approved in US4 Filed in EU5 US rolling submission initiated

79Status as of February 04, 2021

T=Tecentriq

*combination contributing as two entities ** phI safety run-in ongoing

NME submissions and their additional indications

Projects in phase II and III

RG6026glofitamab + chemo

2L DLBCL

RG6058

tiragolumab + Tecentriq (T)

1L PD-L1+ cervical ca

RG6058tiragolumab + T1L PD-L1+ NSCLC

RG6058

tiragolumab + Tlocally adv esophageal

cancer

RG6058

tiragolumab + TStage III unresectable 1L

NSCLC

RG6058tiragolumab + T1L non-sq NSCLC

RG6114

inavolisib(mPI3K alpha inh)

1L HR+ BC

RG6171giredestrant (SERD)

ER+/HER2- mBC

RG6171giredestrant (SERD)2L/3L ER+/HER2- mBC

RG7907+

RG7854

TLR7 ago (3) + CpAM (2)

HBV

RG7906ralmitaront

schizophrenia

RG6356

microdystrophinSRP-9001

DMD

RG6100

semorinemab(Tau MAb )Alzheimer’s

RG7845fenebrutinib

PPMS

RG7935prasinezumab

Parkinson’s

RG6180

autogene cevumeran(iNeST3)

1L melanoma

RG7440

ipatasertib + fulv +

palbociclib

1L HR+ mBC

RG7828

mosunetuzumab +

lenalidomide

2L FL

RG7992FGFR1 x KLB MAb

NASH

RG6354

rhPTX-2 (PRM-151)

IPF

RG6354

rhPTX-2 (PRM-151)myelofibrosis

RG6149ST2 MAb

COVID-19 pneumonia

RG6173Anti-tryptase

asthma

RG7880efmarodocokin alfa

(IL22-Fc)inflammatory diseases

RG6321

Port Delivery System with ranibizumab

DME

RG6321


DR

20212020 2023 and beyond2022

✓ Indicates submission to health authorities has occurred

Unless stated otherwise submissions are planned to occur in US and EU1 US rolling submission initiated2 US only3 Individualized Neoantigen Specific Immunotherapy




Immunology Other

Infectious Diseases

RG6321


wAMD✓1

RG7916Evrysdi (risdiplam)

SMA (EU) ✓

RG6396

Gavreto(pralsetinib) ✓

RET+ NSCLC

RG6396

Gavreto(pralsetinib) ✓2

RET+ MTC

RG6413+

RG6412

casivirimab+imdevimab

SARS-CoV-2

adult-prophylaxis

RG6413+

RG6412


SARS-CoV-2

adult-ambulatory

RG6413+

RG6412


SARS-CoV-2

adult-hospitalised

RG6321


wAMD (EU)

RG7716faricimab

DME

RG7716faricimab

wAMD

RG6042tominersenHuntington’s

RG1450gantenerumab

Alzheimer‘s

RG7413etrolizumab

Crohn’s

RG6058

tiragolumab + Tecentriq1L SCLC

RG6107crovalimab

PNH

RG7440

ipatasertib + abiraterone

1L CRPC


RG7446Tecentriq + Avastin

HCC adj

RG7446TecentriqSC NSCLC

RG7446Tecentriq

HER2+ BC neoadj

RG7446 Tecentriq + paclitaxel

TNBC adj

RG7446Tecentriq

High risk NMIBC

RG7446 Tecentriq + chemo

SCCHN adj

RG7446

Tecentriq + capecitabineor carbo/gem

TNBC

RG7446Tecentriq + cabozantinib

adv RCC

RG7446Tecentriq + cabozantinib

2L NSCLC

✓ Indicates submission to health authorities has occurred

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

20212020 2023 and beyond2022

New Molecular Entity (NME) Immunology Neuroscience

Additional Indication (AI) Infectious Diseases Ophthalmology

Oncology / Hematology Metabolism Other

RG7159Gazyva

lupus nephritis

RG1594Ocrevus

high dose RMS & PPMS

RG7601Venclexta

r/r MM t(11:14)

RG7601Venclexta + azacitidine

1L MDS

RG7601Venclexta + fulvestrant

2L HR+BC

RG7853Alecensa

ALK+ NSCLC adj

RG6152

Xofluzainfluenza, pediatric

(1-12 yrs)

RG1569Actemra +/- remdesivir

COVID-19 pneumonia

RG6062Esbriet ✓

UILD (EU)

RG6013Hemlibra

Mild to moderate

hemophilia A (EU)

RG6268Rozlytrek (BFAST)1L NSCLC ROS1+

RG7596 Polivy

1L DLBCL

AI submissions for existing products

Projects in phase II and III

RG3648Xolair ✓

Asthma home use

RG6062Esbriet ✓

UILD (US)

RG7421

Cotellic + Tecentriq + Zelboraf ✓

1L+ BRAFm melanoma

RG7446Tecentriq + nab-paclitaxel

TNBC neoadj ✓ EU

RG7446 Tecentriq + Avastin ✓

1L HCC

RG7601Venclexta +azacitidine ✓

1L AML

RG7853Alecensa (BFAST) ✓

1L NSCLC ALK+


RG6152Xofluza

direct transmission

RG6152

Xofluzainfluenza, pediatric

(0-1 year)

RG3648Xolair

Food allergy

RG7446TecentriqNSCLC adj

RG7446TecentriqRCC adj

RG7446Tecentriq ± chemo

1L mUC

Major pending approvals 2020-YTD 2021

EU Japan-ChugaiUS

RG6168

Enspryng (satralizumab)

NMOSD

Filed Aug 2019

RG7446

Tecentriq1L non-sq + sq NSCLC Dx+

Filed Nov 2019

RG7916

Evrysdi (risdiplam)

SMA

Filed July 2020

RG7601

Venclexta+ azacitidine1L AML

Filed May 2020

RG6396

Gavreto (pralsetinib)RET+ NSCLCFiled May 2020

RG7446

Tecentriq + nab-paclitaxelTNBC neoadj

Filed Dec 2020

RG6062

EsbrietUILD

Filed Jan 2021




Immunology Other

Infectious Diseases

RG6062

EsbrietUILD

Filed Nov 2020

RG7853

Alecensa (BFAST)1L NSCLC ALK+

Filed Jan 2020

RG7596

Polivyr/r DLBCL

Filed June 2020

RG7916

Evrysdi (risdiplam)SMA

Filed Oct 2020

RG7916


Filed March 2020

RG6168


NMOSD

Filed April 2020

RG6152

Xofluzainfluenza

Filed May 2020

RG6152

Xofluzainfluenza, high risk

Filed May 2020

RG6013

HemlibraHemophilia A

Filed June 2020

RG7159

Gazyva

1L FL and r/r FL

Sept 2020

RG7446


Filed Sept 2020

RG7446

Tecentriq + pemetrexed1L non-sq NSCLC

Filed Sept 2020

China


EU Japan-ChugaiUS




Immunology Other

Infectious Diseases

RG7596

Polivyr/r DLBCL

January 2020

RG7601

Venclexta+Gazyva

1L CLL

Mar 2020

RG1594

Ocrevus

Short infusion RMS & PPMS

May 2020

RG6268

Rozlytrek (entrectinib)

ROS1+ NSCLC

Aug 2020

RG6268


NTRK+ tumor-agnostic

Aug 2020

RG7446

Tecentriq +Avastin1L HCC

Nov 2020

RG6264

Phesgo FDC SCHer2+BC

Dec 2020

RG6152

Xofluza

influenza

Jan 2021

RG6152

Xofluza

influenza, high risk

Jan 2021

RG6152

Xofluza

post exposure prophylaxis

Jan 2021

RG6268


ROS1+ NSCLC

Feb 2020

China

RG3502

Kadcyla

HER2+ eBC

Jan 2020

RG7446

Tecentriq+chemo1L extensive stage SCLC

Feb 2020

RG405

Avastin

1L/2L glioblastoma

Sept 2020

RG7446

Tecentriq +Avastin1L HCC

Oct 2020

RG7853

Alecensa

r/r ALK+ ALCL

Feb 2020

RG105

Rituxan

thrombocytopenic purpura

Feb 2020

RG6168


NMOSD

June 2020

RG3502

Kadcyla

HER2+ eBC adj

Aug 2020

RG7446

Tecentriq+AvastinHCC

Sept 2020

RG7446

Tecentriq +Avastin1L non-sq NSCLC Dx+

Dec 2020

Major granted approvals 2020 and YTD 2021

RG7601

Venclexta+Gazyva1L CLL

Mar 2020

RG7446

Tecentriq+Avastin1L HCC

May 2020

RG7446


May 2020

RG7421

Cotellic+Zelboraf+Tecentriq1L+ BRAFm melanoma

May 2020

RG6264

Phesgo(Perjeta+Herceptin) FDC SC

Her2+BC June 2020

RG7916


Aug 2020

RG6168


NMOSD

Aug 2020

RG6396

Gavreto (pralsetinib)RET+ NSCLC

Sept 2020

RG7601

Venclexta+azacitidine1L AML Oct 2020


FDC = fixed-dose combination

RG6152

Xofluza

post exposure prophylaxis

Nov 2020

RG6413+

RG6412


SARS-CoV-2 (EUA*)

Nov 2020

RG6396

Gavreto (pralsetinib)RET+ MTCDec 2020

RG1594

Ocrevus

Short infusion RMS & PPMS

Dec 2020

RG3648

Xolairnasal polyps

Dec 2020

*Emergency Use Authorisation

84

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

85

He

mo

ph

ilia

In collaboration with Chugai

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

IndicationHemophilia A patients

with inhibitors to factor VIII

Hemophilia A pediatric patients

with inhibitors to factor VIII

Phase/studyPhase III

HAVEN 1

Phase III

HAVEN 2

# of patients N=118 N=88

Design

Patients on episodic treatment prior to study entry:

ARM A: Hemlibra prophylaxis

ARM B: Episodic treatment (no prophylaxis)

Patients on prophylaxis prior to study entry:

ARM C: Hemlibra prophylaxis

Patients on episodic treatment previously on non-interventional study:

ARM D: Hemlibra prophylaxis

Patients on prophylactic or episodic treatment prior to study entry:

Cohort A: Hemlibra prophylaxis qw

Cohort B: Hemlibra prophylaxis q2w

Cohort C: Hemlibra prophylaxis q4w

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

Status

FPI Q4 2015, recruitment completed in arms A and B Q2 2016

Primary and all secondary endpoints met Q4 2016

Data published in NEJM 2017; 377:809-818

FPI Q3 2016, recruitment completed Q2 2017

Positive interim data in Q2 2017

FPI cohorts B/C Q4 2017

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

IndicationHemophilia A patients

without inhibitors to factor VIII

Hemophilia A patients with and without inhibitors to Factor VIII,

dosing every 4 weeks


HAVEN 3

Phase III

HAVEN 4


Design

Patients on FVIII episodic treatment prior to study entry:

ARM A: Hemlibra prophylaxis qw

ARM B: Hemlibra prophylaxis q2w

ARM C: Episodic FVIII treatment; switch to Hemlibra prophylaxis

possible after 24 weeks

Patients on FVIII prophylaxis prior to study entry:

ARM D: Hemlibra prophylaxis qw

Multicenter, open-label, non-randomized study to assess the efficacy,

safety, pharmacokinetics, and pharmacodynamics of Hemlibra

administered every 4 weeks.

Part 1: Pharmacokinetic (PK) run-in part (N=6)

Part 2: Expansion part (N=40)

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

Status


Study met primary and key secondary endpoints Q4 2017

FDA granted Breakthrough Therapy Designation April 2018

Data presented at WFH 2018

Filed in US (priority review) and EU in Q2 2018

Data published in NEJM 2018; 379: 811-822


PK run-in data at ASH 2017

Positive interim analysis outcome reported Q4 2017

Data presented at WFH 2018

Interim data filed in US and EU in Q2 2018

Data published in Lancet Haematology 2019 Jun;6(6):e295-e305

•Approved in US Q4 2018 and EU Q1 2019


Hemlibra


86

He

mo

ph

ilia


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

Hemlibra


87

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

VIII


HAVEN 5

Phase III

HAVEN 6


Design

Patients with Hemophilia regardless of FVIII inhibitor status on

prophylactic or episodic treatment prior to study entry:

• Arm A: emicizumab prophylaxis qw

• Arm B: emicizumab prophylaxis q4w

• Arm C: No prophylaxis (control arm)

Multicenter, open-label study to evaluate the safety, efficacy,

pharmacokinetics, and pharmacodynamics of Hemlibra in patients with

mild or moderate Hemophilia A without FVIII inhibitors

Primary endpoint Number of bleeds over 24 weeks Safety and efficacy

Status

FPI Q2 2018

Recruitment completed Q1 2019

Filed in China Q2 2020

FPI Q1 2020



He

mo

ph

ilia

Alecensa

New CNS-active inhibitor of anaplastic lymphoma kinase

88In collaboration with Chugai

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

On

co

log

y

IndicationTreatment-naïve

ALK+ advanced NSCLCAdjuvant ALK+ NSCLC


ALEX

Phase III

ALINA


Design ARM A: Alecensa 600mg BID

ARM B: Crizotinib 250mg BID

ARM A: Alecensa 600 mg BID

ARM B: Platinum-based chemotherapy

Primary endpoint Progression-free survival Disease-free survival

Status


Primary endpoint met Q1 2017

Data presented at ASCO 2017, 2018, ESMO 2017, 2018


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

FPI Q3 2018


Kadcyla

First ADC for HER2-positive breast cancer

89

On

co

log

y

IndicationHER2-positive early breast cancer

high-risk patients


KATHERINE

# of patients N=1,484

Design

ARM A: Kadcyla 3.6mg/kg q3w

ARM B: Herceptin

Primary endpoint Invasive disease-free survival

Status


• 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

CT Identifier NCT01772472

In collaboration with ImmunoGen, Inc.

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

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


APHINITY

Phase III

IMpassion050

# of patients N=4,803 N=453

Design

ARM A: Perjeta (840mg loading, 420 q3w) + Herceptin for 52 weeks

plus chemotherapy (6-8 cycles)

ARM B: Placebo + Herceptin (52 weeks) plus chemotherapy (6-8

cycles)

ARM A: ddAC Herceptin/Perjeta + paclitaxel followed by surgery and

chemotherapy

ARM B: ddAC Herceptin/Perjeta + chemotherapy +Tecentriq followed

by surgery and chemotherapy +Tecentriq

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

Status


Data presented at ASCO 2017 and published in NEJM 2017; 377:122-131

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

FPI Q4 2018



ddAC=dose-dense doxorubicin plus cyclophosphamide; FEC=fluorouracil, epirubicin and cyclophosphamide; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medcine;

SABCS=San Antonio Breast Cancer Symposium

On

co

log

y

Perjeta

First-in-class HER2 dimerization inhibitor

90

On

co

log

y

Perjeta

First-in-class HER2 dimerization inhibitor

Indication HER2-positive early breast cancer subcutaneous co-formulation


FeDeriCa

Phase II

PHranceSCa


Design

Fixed-dose combination (FDC) of Perjeta (P) and Herceptin (H) for

subcutaneous administration in combination with chemotherapy in the

neoadjuvant/adjuvant setting

ARM A: P IV+H IV+chemotherapy

ARM B: FDC of PH SC+chemotherapy

ARM A: PH IV followed by FDC SC

ARM B: PH FDC SC followed by IV

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

Status



Data presented at SABCS 2019

FPI Q4 2018

Final analysis completed, 85% patients preferred FDC SC

Data presented at ESMO 2020

Filed in US Q4 2019 & in EU Jan 2020



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

Indication 1L non-squamous NSCLC1L non-squamous and squamous NSCLC

PD-L1-selected patients


IMpower132

Phase III

IMpower110


Design

ARM A: Tecentriq plus carboplatin or cisplatin plus pemetrexed

ARM B: Carboplatin or cisplatin plus pemetrexed

ARM A: Tecentriq monotherapy

ARM B: NSq: carboplatin or cisplatin plus pemetrexed

Sq: carboplatin or cisplatin plus gemcitabine

Primary endpoint Progression-free survival and overall survival Overall survival

Status

FPI Q2 2016


Study met co-primary endpoint of PFS in Q2 2018

Data presented at WCLC 2018

Final OS presented at ESMO Asia 2020

IMpower111 consolidated into IMpower110 Q3 2016


Study met primary endpoint in PD-L1 high (IC3/TC3) Q3 2019

Data presented at ESMO, ESMO-IO 2019 and final OS at WCLC 2021

Filed in EU and US (priority review) Q4 2019

Approved in US Q2 2020


Tecentriq

Anti-PD-L1 cancer immunotherapy – lung cancer

92

On

co

log

y

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

Lung Cancer

Indication 1L extensive-stage SCLC


IMpower133Phase Ib


Design

ARM A: Tecentriq plus carboplatin plus etoposide

ARM B: Placebo plus carboplatin plus etoposide

Carboplatin and etoposide +/- Tecentriq followed by maintenance

Tecentriq plus Venclexta

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

Status

FPI Q2 2016

Orphan drug designation granted by FDA Q3 2016

Study met endpoints of OS and PFS in Q2 2018

Primary data presented at WCLC 2018


Filed with the US and EU Q3 2018


FPI Q3 2020


Tecentriq


93

On

co

log

y

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

Indication Adjuvant NSCLC Neoadjuvant NSCLC


IMpower010

Phase III

IMpower030


Design

Following adjuvant cisplatin-based chemotherapy

ARM A: Tecentriq

ARM B: Best supportive care

ARM A: Tecentriq + platinum-based chemotherapy

ARM B: Platinum-based chemotherapy

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

Status

FPI Q3 2015

Trial amended from PD-L1+ selected patients to all-comers

FPI for all-comer population Q4 2016


FPI Q2 2018


Tecentriq


94

On

co

log

y

NSCLC=non-small cell lung cancer

*SC with Halozyme’s rHuPH20/ Halozyme’s human hyaluronidase

NSCLC=non-small cell lung cancer; ESMO=European Society for Medical Oncology

On

co

log

y

Indication 1L NSCLC Stage IV NSCLC2L NSCLC previously treated with an immune

checkpoint inhibitor

Phase/studyPhase II/III

B-FAST

Phase Ib/III

IMscin001*

Phase III

CONTACT-01

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

Design

Cohort A: ALK+ (Alecensa)

Cohort B: RET+ (Alecensa)

Cohort C: bTMB-high (Tecentriq)

Cohort D: ROS1+ (Rozlytrek)

Cohort E: BRAF+ (Zelboraf plus Cotellic plus

Tecentriq)

Phase Ib

Dose finding, Tecentriq SC followed by

Tecentriq IV

Phase III

2L NSCLC non inferiority of Tecentriq SC vs

Tecentriq IV

ARM A: Tecentriq plus cabozantinib

ARM B: Docetaxel

Primary endpoint Cohort A/B: Objective response rate

Cohort C: Progression-free survival

Observed concentration of Tecentriq in serum

at cycle 1

Overall survival

Status

FPI Q3 2017

Recruitment completed for cohort A Q3 2018

and cohort C Q3 2019

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

FPI Q4 2018

FPI in phase III part Q4 2020

FPI Q3 2020

CT Identifier NCT03178552 NCT03735121 NCT04471428

Tecentriq


95

IndicationAdjuvant squamous cell carcinoma of the

head and neckRelapsed or refractory AML

First-line BRAFv600 mutation-positive

metastatic or unresectable locally advanced

melanoma


IMvoke010Phase I

Phase III

IMspire150 TRILOGY1


Design

ARM A: Tecentriq 1200mg q3w

ARM B: Placebo

Tecentriq plus anti-CD47 Double-blind, randomized, placebo-controlled

study

ARM A: Tecentriq plus Cotellic plus Zelboraf2

ARM B: Placebo plus Cotellic plus Zelboraf2

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

Status

FPI Q1 2018


FPI Q4 2019 FPI Q1 2017



Data presented at AACR 2020

Data published in Lancet;395(10240):1835-

1844

Filed in US Q2 2020 under Project Orbis3



On

co

log

y

Tecentriq

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

96SCCHN=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; 3 Project Orbis=FDA framework for concurrent submission and review of oncology products among international partners; AACR=American Association for Cancer Research

UC=urothelial carcinoma; BCG=Bacille Calmette-Guérin

Tecentriq

Anti-PD-L1 cancer immunotherapy – UC

97

On

co

log

y

Indication 1L metastatic urothelial carcinomaHigh-risk non-muscle-invasive

bladder cancer


IMvigor130

Phase III

ALBAN


Design

ARM A: Tecentriq plus gemcitabine and carboplatin or cisplatin

ARM B: Tecentriq monotherapy

ARM C: Placebo plus gemcitabine and carboplatin or cisplatin

ARM A: BCG induction and maintenance

ARM B: Tecentriq+ BCG induction and maintenance

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

Status

FPI Q3 2016

FPI for arm B (amended study) Q1 2017


Study met co-primary endpoint of PFS Q3 2019


FPI Q4 2018


Indication Adjuvant renal cell carcinomaAdvanced renal cell carcinoma after immune checkpoint inhibitor

treatment


IMmotion010

Phase III

Contact-031


Design

ARM A: Tecentriq monotherapy

ARM B: Observation

ARM A: Tecentriq plus cabozantinib

ARM B: cabozantinib

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

Status

FPI Q1 2017


FPI Q3 2020


Tecentriq

Anti-PD-L1 cancer immunotherapy – renal cell cancer

98

On

co

log

y

1In collaboration with Exelixis

Indication 1L hepatocellular carcinoma Adjuvant hepatocellular carcinoma


IMbrave150

Phase III

IMbrave050


Design

ARM A: Tecentriq plus Avastin

ARM B: Sorafenib

ARM A: Tecentriq plus Avastin

ARM B: Active surveillance

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

Status

FPI Q1 2018; recruitment completed Q1 2019

Data presented at ESMO Asia 2019

US filing completed under RTOR Q1 2020; filed in EU Q1 2020

Data published in NEJM 2020;382:1894-1905


FPI Q4 2019


Tecentriq

Anti-PD-L1 cancer immunotherapy – CRC and HCC

99

On

co

log

y

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

100

On

co

log

y

IndicationPreviously untreated metastatic

triple negative breast cancer


IMpassion130

Phase III

IMpassion132


Design

ARM A: Tecentriq plus nab-paclitaxel

ARM B: Placebo plus nab-paclitaxel

ARM A: Tecentriq plus capecitabine or carbo/gem

ARM B: Placebo plus capecitabine or carbo/gem

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

Status


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

2019


US accelerated approval Q1 2019

Approved in EU Q3 2019

Final OS presented at ESMO Asia 2020

FPI Q1 2018


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

Tecentriq

Anti-PD-L1 cancer immunotherapy – breast cancer

101

On

co

log

y

Indication Neoadjuvant triple negative breast cancer Adjuvant triple negative breast cancer


IMpassion031

Phase III

IMpassion030

# of patients N=324 N=2,300

Design

ARM A: Tecentriq plus nab-paclitaxel

ARM B: Placebo plus nab-paclitaxel

ARM A: Tecentriq + paclitaxel followed by AC followed by Tecentriq

+ AC, followed by Tecentriq maintenance

ARM B: Placebo + paclitaxel followed by AC followed by placebo

Primary endpoint Percentage of participants with pathologic complete response (pCR) Invasive Disease Free Survival

Status

FPI Q3 2017


Study met primary endpoint Q2 2020


Data published in Lancet 2020;396 (10257):1090-1100

Filed in EU Q4 2020

FPI Q3 2018


IDMC=Independent data monitoring committee; ESMO=European Society for Medical Oncology

Venclexta

Novel small molecule Bcl-2 selective inhibitor – CLL

102Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute

CLL=chronic lymphocytic leukemia; ASH=American Society of Hematology; ASCO=American Society of Clinical Oncology; RTOR=Real time oncology review;

NEJM=New England Journal of Medicine; MRD=Minimal Residual Disease

On

co

log

y

IndicationUntreated CLL patients with

coexisting medical conditionsRelapsed or refractory CLL Untreated fit CLL patients


CLL14

Phase III

MURANO

Phase III

CristaLLo


Design

ARM A: Venclexta plus Gazyva

ARM B: Chlorambucil plus Gazyva

ARM A: Venclexta plus Rituxan

ARM B: Rituxan plus bendamustine

ARM A: Venclexta plus Gazyva

ARM B: Fludarabine + cyclophosphamide

+ Rituxan or bendamustine + Rituxan

Primary endpoint Progression-free survival Progression-free survival MRD negativity rate in peripheral blood at

15 months

Status

Study met primary endpoint at pre-specified

interim analysis Q4 2018

BTD granted by FDA Q1 2019

US filing completed under RTOR Q1 2019

Filed in EU Q2 2019

Data presented at ASCO 2019, ASH 2019 and

ASH 2020


Approved US Q2 2019 and EU Q1 2020

Study met primary endpoint at interim analysis

Data presented at ASH 2017

Filed in US Q4 2017 and EU Q1 2018

Data published in NEJM 2018; 378:1107–20

Updated data presented at ASCO 2018, ASH 2019

and ASH 2020

Approved in US Q2 2018 (priority review)

EU approval Q4 2018

FPI Q2 2020


Indication Relapsed or refractory multiple myeloma

Phase/study Phase I Phase Ib/IIPhase III

CANOVA


Design

Dose escalation cohort:

Venclexta dose escalation

Safety expansion cohort (t11:14):

Venclexta expansion

Combination:

Venclexta plus dexamethasone

Venclexta plus carfilzomib plus dexamethasone in

t(11;14) positive r/r MM

Venclexta plus dexamethazone vs pomalidomide

plus dexamethasone in t(11;14) positive r/r MM

Primary endpoint Safety and maximum tolerated dose Safety, objective response rate, PK, PD Progression-free survival

Status

FPI Q4 2012

Data presented at ASCO 2015

Updated data presented at ASCO 2016

and ASH 2016

FPI Q1 2017 FPI Q4 2018


Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;

MM=multiple myeloma; ASCO=American Society of Clinical Oncology; ASH=American Society of Hematology

Venclexta

Novel small molecule Bcl-2 selective inhibitor – MM

103

On

co

log

y

Indication Treatment-naïve AML not eligible for standard induction therapy


Viale-A

Phase III

Viale-C


Design

• ARM A: Venclexta plus azacitidine

• ARM B: Azacitidine

ARM A: Venclexta plus low-dose cytarabine

• ARM B: Low-dose cytarabine

Primary endpoint Overall survival and percentage of participants with complete

remission

Overall survival

Status

FPI Q1 2017

Study met dual primary endpoints Q1 2020

Data presented at EHA 2020

Data published NEJM 2020 Aug 13;383(7):617-629

FPI Q2 2017

Study did not meet primary endpoint Q1 2020

Primary and additional 6 month overall survival data presented at ASCO

2020

Data published in Blood 2020;135(24):2137-2145

Filed in US and EU Q2 2020



Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute

AML=acute myeloid leukemia; EHA=European Hematology Association; NEJM=New England Journal of Medicine

Venclexta

Novel small molecule Bcl-2 selective inhibitor – AML

104

On

co

log

y

Indication Relapsed or refractory AML Relapsed or refractory hematological malignancies

Phase/study Phase I Phase I


Design

Venclexta in combination with gilteritinib Venclexta plus AMG176 dose escalation

Dose expansion phase to confirm safety and preliminary RPTD

Primary endpoint Dose and composite complete remission (CRc) Rate Maximum tolerated dose and safety

Status

FPI Q4 2018

Initial data presented at ASH 2019

Updated data presented at ASH 2020

FPI Q2 2019

Study on clinical hold


Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;

AML=acute myeloid leukemia; ASH=American Society of Hematology; RPTD =recommended phase II dose

Venclexta

Novel small molecule Bcl-2 selective inhibitor – AML

105

On

co

log

y

IndicationRelapsed or refractory myelodysplastic

syndromesTreatment-naive myelodysplastic syndromes

Newly diagnosed higher-risk

myelodysplatic syndrome

Phase/study Phase Ib Phase IIPhase III

VERONA


Design

Cohort 1:

ARM A: Venclexta 400 mg

ARM B: Venclexta 800 mg

Cohort 2:

ARM A: Venclexta plus azacitidine

Study expansion:

Venclexta or Venclexta plus azacitidine

ARM A: Venclexta 400 mg plus azacitidine

ARM B: Venclexta 800 mg plus azacitidine

ARM C: Azacitidine

ARM A: Venclexta plus azacitidine

ARM B: Placebo plus azacitidine

Primary endpoint Safety, efficacy, PK and PD Overall response rate Complete remission rate and overall survival

Status

FPI Q1 2017 FPI Q1 2017


Updated data presented at ASH 2020

FPI Q4 2020



MDS=myelodysplastic syndromes; ASH=American Society of Hematology

Venclexta

Novel small molecule Bcl-2 selective inhibitor – MDS

106

On

co

log

y


Venclexta

Novel small molecule Bcl-2 selective inhibitor – breast cancer

107

On

co

log

y

Indication ≥2L HR+ breast cancer

Phase/studyPhase II

VERONICA

# of patients N=103

Design

ARM A: Venclexta plus fulvestrant

ARM B: Fulvestrant

Primary endpoint Clinical benefit lasting equal or more than 24 weeks

Status

FPI Q3 2018


IndicationRelapsed or refractory

FL and DLBCL1L DLBCL

Phase/study Phase Ib/IIPhase III

POLARIX


Design

PIb: Dose escalation

PhII: Polatuzumab vedotin plus BR vs. BR

PhII expansion: Polatuzumab vedotin plus Gazyva (non-randomized)

ARM A: Polatuzumab vedotin plus R-CHP

ARM B: R-CHOP

Primary endpoint Safety and response by PET/CT Progression-free survival

Status

FPI Q4 2014

PRIME Designation (Q2 2017) and Breakthrough Therapy Designation

(Q3 2017) granted for r/r DLBCL

Pivotal randomized Ph2 in r/r DLBCL presented at ASH 2017 and ASH

2020

Filed in US and EU Q4 2018; US priority review granted Q1 2019

Approved in US Q2 2019 and in EU Jan 2020

Published in J Clin Oncol. 2020 Jan 10;38(2):155-165

FPI Q4 2017



In collaboration with Seagen Inc.

ADC=antibody–drug conjugate; DLBCL=diffuse large B cell lymphoma; FL=follicular lymphoma; r/r=relapsed or refractory; ASH=American Society of Hematology; BR=bendamustine

and Rituxan; R-CHP=Rituxan, cyclophosphamide, hydroxydoxorubicin, prednisone; R-CHOP=Rituxan, cyclophosphamide, doxorubicin, vincristine, and prednisone

Polivy (polatuzumab vedotin)

ADC targeting CD79b to treat B cell malignancies

108

On

co

log

y

Indication Relapsed or refractory FL or DLBCL

Phase/study Phase I/II Phase I/II


Design

• Dose escalation cohort:

Polatuzumab vedotin plus Gazyva plus Venclexta1

• Expansion cohort DLBCL:

Polatuzumab vedotin plus Rituxan plus Venclexta1

• Expansion cohort FL:

Polatuzumab vedotin plus Gazyva plus Venclexta1

Dose escalation cohort:

Polatuzumab vedotin plus Gazyva plus lenalidomide

Expansion cohort DLBCL:

Polatuzumab vedotin plus Rituxan plus lenalidomide

Expansion cohort FL:

Polatuzumab vedotin plus Gazyva plus lenalidomide

Primary endpoint Percentage of participants with CR Percentage of participants with CR

Status

FPI Q1 2016

FL not developed further due to portfolio priorities


FPI Q1 2016

Interim data in FL presented at ASCO, EHA and ICML 2019

Primary data presented at ASH 2019


In collaboration with Seagen Inc.; 1Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute

ADC=antibody–drug conjugate; FL=follicular lymphoma; DLBCL=diffuse large B cell lymphoma; CR=complete response; ASH=American Society of Hematology; EHA=European

Hematology Association; ICML=International Conference on Malignant Lymphoma

Polivy (polatuzumab vedotin)

ADC targeting CD79b to treat B cell malignancies

109

On

co

log

y

IndicationLocally Advanced or Metastatic tumors with

ROS1 gene rearrangement

Locally Advanced or Metastatic tumors with

NTRK1/2/3 gene rearrangement

Pediatric tumors with NTRK 1/2/3, ROS-1

or ALK rearrangement

Phase/studyPhase II

STARTRK2

Phase II

STARTRK2

Phase I/Ib

STARTRK - NG

# of patients N~300 total N~300 total N~80

Design

Single arm with Baskets based on tumor type

and genomic alteration status





Primary endpoint Objective response rate Objective response rate Maximum tolerated dose (MTD) and

recommended phase II dose (RP2D)

Status

FPI Q1 2016

Data presented at WCLC 2018

FPI Q1 2016


FPI Q2 2016

Initial data presented at ASCO 2019

Breakthrough Therapy Designation granted by FDA (Q2 2017), PRIME designation granted by EMA (Q1 2018) and Sakigake Designation granted by

MHLW (Q4 2017) for NTRK fusion-positive, locally advanced or metastatic solid tumors

Filed in US Q4 2018 and EU Q1 2019


Published in Lancet Oncol. 2020 Feb;21(2):261-271 and 271-282



CNS-active and selective inhibitor of NTRK/ROS1

110WCLC=World Conference on Lung Cancer; ESMO=European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; NTRK=neurotrophic receptor tyrosine kinase;

PRIME= priority medicines

On

co

log

y

IndicationRET+ NSCLC, thyroid cancer and

other advanced solid tumors1L RET fusion-positive, metastatic NSCLC

Phase/studyPhase I/II

ARROW

Phase III

AcceleRET Lung


Design

Part 1: Gavreto 30-600mg dose-escalation

Part 2: Gavreto 400mg dose expansion

Arm A: Gavreto 400mg

Arm B: Platinum-based chemotherapy +/- pembrolizumab

Primary endpoint Safety and efficacy Progression-free survival

Status

Data presented at ASCO (NSCLC) and ESMO (medullary thyroid cancer)

2020

Filed in US and EU for RET fusion-positive NSCLC and US for RET-

mutant medullary thyroid cancer and RET fusion-positive thyroid cancer

Approved in US Q3 2020 in RET fusion-positive NSCLC, in Q4 2020 in

RET-mutant medullary thyroid cancer and RET fusion-positive thyroid

cancer

Study initiated in Q1 2020


In collaboration with Blueprint Medicines

NSCLC=non-small cell lung cancer; ASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology

Gavreto (pralsetinib, RG6396)

Highly selective RET inhibitor

111

On

co

log

y

Indication Relapsing multiple sclerosis (RMS) Primary-progressive

multiple sclerosis (PPMS)


OPERA I

Phase III

OPERA II

Phase III

ORATORIO


Design

96-week treatment period:

ARM A: Ocrelizumab 2x300 mg iv

followed by 600 mg iv every 24 weeks

ARM B: Interferon -1a


ARM A: Ocrelizumab 2x300 mg iv

followed by 600 mg iv every 24 weeks

ARM B: Interferon -1a


ARM A: Ocrelizumab 2x300 mg iv every 24 weeks

ARM B: Placebo

Primary endpoint Annualized relapse rate at 96 weeks

versus Rebif

Annualized relapse rate at 96 weeks

versus Rebif

Sustained disability progression versus placebo by Expanded

Disability Status Scale (EDSS)

Status

Primary endpoint met Q2 2015, OLE ongoing

Primary data presented at ECTRIMS 2015

Updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018


Data published on COVID-19 in Mult Scler Relat Disord on Ocrevus treated people

with MS, doi.org/10.1016/j.msard.2020.102725


Primary data presented at ECTRIMS 2015, updated data

presented at AAN and ECTRIMS 2017, AAN and EAN 2018




Ocrevus (ocrelizumab, RG1594)

Humanized mAb selectively targeting CD20+ B cells

112OLE=Open label extension; ECTRIMS=European Committee for Treatment and Research in Multiple Sclerosis; AAN=Annual Meeting of the American Academy of Neurology; EAN=European

Academy of Neurology; NEJM=New England Journal of Medicine

Ne

uro

sc

ien

ce



113

IndicationRelapsing and primary progressive multiple sclerosis (RMS &

PPMS)Primary progressive multiple sclerosis (PPMS)

Phase/studyPhase IIIb

ENSEMBLE PLUS

Phase IIIb

ORATORIO-HAND

# of patients N=1225 N ~ 1000

Design

• Substudy of ongoing phase IIIb, open-label, single-arm ENSEMBLE

study

• Shorter two-hour infusion time


ARM A: Ocrelizumab 600mg IV every 24 weeks

ARM B: Placebo

Primary endpoint

Safety, measured by the proportion of patients with IRRs following the

first randomised 600 mg infusion (frequency/severity assessed during

and 24-hours post infusion)

Time to upper limb disability progression confirmed for at least 12 weeks

Status

• Filed in US and EU Q1 2020

• Approved in EU Q2 2020 and US Q4 2020

• Data published Neurol, Neuroimmunol and Neuroinflamm Sept 2020;

7(5), e807

FPI Q3 2019


Ne

uro

sc

ien

ce



114

Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS)

Phase/studyPhase IIIb

GAVOTTE

Phase IIIb

MUSETTE

# of patients N ~ 699 N ~ 786

Design



ARM B: Ocrelizumab 1200mg if body weight <75kg or 1800mg if body

weight > or equal to 75kg every 24 weeks



ARM B: Ocrelizumab 1200mg if body weight <75kg or 1800mg if body

weight > or equal to 75kg every 24 weeks

Primary endpoint Superiority of Ocrelizumab higher dose versus approved dose on

composite confirmed disability progression (cCDP)

Superiority of Ocrelizumab higher dose versus approved dose on

composite confirmed disability progression (cCDP)

Status

FPI Q4 2020 FPI Q4 2020


Ne

uro

sc

ien

ce

Indication Spinal muscular atrophy


FIREFISH

Phase II/III

SUNFISH

Phase II

JEWELFISH

# of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) N=174

Design

Open-label study in infants with type 1 spinal

muscular atrophy:

Part 1 (dose-finding): At least 4 weeks

Part 2 (confirmatory): 24 months

Randomized, double-blind, placebo-controlled

study in adult and pediatric patients with type 2

or type 3 spinal muscular atrophy:

Part 1 (dose-finding): At least 12 weeks

Part 2 (confirmatory): 24 months

Open-label single arm study in adult and

pediatric patients with previously treated SMA

type 1, 2 and 3

Primary endpoint Safety, tolerability, PK, PD and efficacy Safety, tolerability, PK, PD and efficacy Safety, tolerability and PK/PD

Status

Recruitment completed for part 2 Q4 2018

12 month data from Part 1 presented at AAN,

CureSMA and EAN 2019; 16 month data

presented at WMS 2019

Study met primary endpoint in part 2 Jan 2020

Part 2 1-year data presented at AAN 2020 and

part 1 2-year data at WMS 2020

Recruitment completed for part 2 Q3 2018

12 month data from Part 1 presented at AAN,

CureSMA and EAN 2019; 16 month data

presented at WMS 2019

Study met primary endpoint in part 2 Q4 2019

Part 2 Data presented at SMA Europe 2020

FPI Q1 2017 Data presented at WMS 2017, AAN 2018, WMS

2018, CureSMA 2019, WMS 2019 and

CureSMA2020 Recruitment completed Q1 2020

Orphan drug designation granted by FDA Q1 2017 and EU Q1 2019, PRIME designation in Q4 2018; filed in US Q4 2019; approved in US Q3 2020


Evrysdi (risdiplam, RG7916)

Oral SMN2 splicing modifier

115In collaboration with PTC Therapeutics and SMA Foundation

SMN=survival motor neuron; AAN=American Academy of Neurology; WMS=World Muscle Society; EAN=European Academy of Neurology; PRIME=priority medicines

Ne

uro

sc

ien

ce

Indication Spinal muscular atrophy

Phase/studyPhase II

RAINBOWFISH

# of patients N=25

Design

Open-label, single-arm, multicenter study in infants aged from birth to 6 weeks who have been genetically diagnosed with SMA but are not yet

presenting with symptoms

Primary endpoint Proportion of participants with two copies of the SMN2 gene (excluding the known SMN2 gene modifier mutation c.859G>C) and baseline

CMAP>=1.5 millivolt who are sitting without support

Status FPI Q3 2019


Evrysdi (risdiplam, RG7916)

Oral SMN2 splicing modifier

116In collaboration with PTC Therapeutics and SMA Foundation

SMN=survival motor neuron; CMAP=compound muscle action potential

Ne

uro

sc

ien

ce

Indication Neuromyelitis optica spectrum disorder (NMOSD)


Sakura Star

Phase III

Sakura Sky

# of patients N=95 N=70 (adults); N=6 (adolescents)

Design

Satralizumab as monotherapy:

• Group A: Satralizumab 120mg SC monthly

• Group B: Placebo SC monthly

Add-on therapy of satralizumab:

• Group A: Satralizumab 120mg SC monthly

• Group B: Placebo SC

Both arms on top of baseline therapies: azathioprine, mycophenolate

mofetil or oral corticosteroids

Primary endpoint •Efficacy (time to first relapse) and safety, PD, PK Efficacy (time to first relapse) and safety, PD, PK

Status


Data presented at ECTRIMS 2019

Published in Lancet Neurology 2020; 19(5): 402-412

FPI Q3 2017


Data presented at ECTRIMS 2018 and AAN 2019

Published in NEJM 2019; 381:2114-2124

BTD granted Q4 2018

Filed in EU Q3 2019; US acceptance of filing Q4 2019,



Enspryng (satralizumab, RG6168, SA237)

Anti-IL-6 receptor humanized monoclonal antibody

117*Trials managed by Chugai (Roche opted-in)

ECTRIMS=European Committee for Treatment and Research in Multiple Sclerosis; AAN=American Academy of Neurology; NEJM=New England Journal of Medicine

Ne

uro

sc

ien

ce

Indication Lupus nephritis

Phase/studyPhase II

NOBILITY

Phase III

REGENCY


Design

ARM A: Obinutuzumab 1000mg IV plus mycophenolate mofetil /

mycophenolic acid

ARM B: Placebo IV plus mycophenolate mofetil / mycophenolic acid

ARM A: Obinutuzumab 1000 mg IV (six doses through Week 52) plus

mycophenolate mofetil

ARM B: Obinutuzumab 1000 mg IV (five doses through Week 52) plus

mycophenolate mofetil

ARM C: Placebo IV plus mycophenolate mofetil

Primary endpoint Percentage of participants who achieve complete renal response (CRR) Percentage of participants who achieve complete renal response (CRR)

Status



Breakthrough therapy designation granted by the FDA Q3 2019

Data presented at ASN and ACR 2019

FPI Q3 2020


Gazyva (obinutuzumab)

Immunology development program

118In collaboration with Biogen

ASN=American Society of Nephrology; ACR=American College of Rheumatology

Imm

un

olo

gy

Indication Adult hospitalised with severe COVID-19 pneumonia


COVACTA1

Phase III

REMDACTA2


Design

Arm A: tocilizumab plus standard of care

Arm B: placebo plus standard of care

Arm A: remdesivir plus tocilizumab

Arm B: remdesivir plus placebo

Primary endpoint Clinical status assessed using 7-Category Ordinal Scale (Day 28)

Primary endpoint not met Q3 2020

Time to hospital discharge or ready for discharge

Status FPI Q1 2020

LPI Q2 2020

FPI Q2 2020

LPI Jan 2021


Actemra/RoActemra (RG-1569)

Interleukin 6 receptor inhibitor

119

1In collaboration with US Biomedical Advanced Research and Development Authority (BARDA); 2In collaboration with Gilead Sciences, Inc.

Imm

un

olo

gy

Indication Adult hospitalised with severe COVID-19 pneumonia

Phase/studyPhase II

MARIPOSA

Phase III

EMPACTA


Design

Arm A: 8 mg/kg tocilizumab plus standard of care

Arm B: 4mg/kg tocilizumab plus standard of care

Conducted in sites known to provide critical care to underserved and

minority populations that often do not have access to clinical trials

Arm A: tocilizumab plus standard of care

Arm B: placebo plus standard of care

Primary endpoint Pharmacodynamics and pharmacokinetics Cumulative proportion of participants requiring mechanical ventilation

by day 28

Status

FPI Q2 2020

LPI Q2 2020

FPI Q2 2020


Published in NEJM 2021 Jan 7;384(1):20-30


Actemra/RoActemra (RG-1569)

Interleukin 6 receptor inhibitor

120

Imm

un

olo

gy

NEJM=New England Journal of Medicine

Indication Chronic rhinosinusitis with nasal polyps Food allergy


POLYP 1

Phase III

POLYP 2

Phase III

OUtMATCH1


Design

Adult patients with chronic rhinosinusitis

with nasal polyps (CRSwNP) who have had

an inadequate response to SOC:

• ARM A: Xolair every 2 wks or every 4 wks

• ARM B: Placebo

Adult patients with chronic rhinosinusitis with

nasal polyps (CRSwNP) who have had an

inadequate response to SOC:

• ARM A: Xolair every 2 wks or every 4 wks

• ARM B: Placebo

• Xolair by subcutaneous injection either every 2

weeks or every 4 weeks for 16 to 20 weeks

Primary endpoint

Change from baseline in average daily

nasal congestion score (NCS) at week 24

Change from baseline in nasal polyp score

(NPS) to week 24

Change from baseline in average daily nasal

congestion score (NCS) at week 24

Change from baseline in nasal polyp score (NPS)

to week 24

• Number of participants who successfully

consume ≥600 mg of peanut protein without

dose-limiting symptoms

Status

FPI Q4 2017


Co-primary endpoints met Q2 2019

FPI Q4 2017


Co-primary endpoints met Q2 2019

• FPI July 2019

Filed in US Q4 2019

Approved in the EU Q3 2020 and US Q4 2020

Data published in J Allergy Clin Immunol 2020;146(3):595-605


Xolair

Humanized mAb that selectively binds to IgE

121In collaboration with Novartis; 1 Sponsor of the study is the National Institute of Allergy and Infectious Diseases (NIAID)

Imm

un

olo

gy

Xofluza (baloxavir marboxil, RG6152, S-033188 )

Small molecule, novel CAP-dependent endonuclease inhibitor

122

Infe

cti

ou

sD

ise

ase

s

In collaboration with Shionogi & Co., Ltd.

NEJM=New England Journal of Medicine

Indication Influenza


CAPSTONE-1

Phase III

CAPSTONE-2

# of patients N=1,436 N=2,184

Design

Randomized, double-blind study of a single dose of Xofluza

compared with placebo or Tamiflu 75 mg twice daily for 5 days in

otherwise healthy patients with influenza

Randomized, double-blind study of a single dose of Xofluza compared with

placebo or Tamiflu 75 mg twice daily for 5 days in patients with influenza at

high risk of influenza complications

Primary endpoint Time to alleviation of symptoms Time to improvement of influenza symptoms

Status



Filed in US Q2 2018 (priority review), approval Q4 2018


Filed in EU Q4 2019

Approved in EU Jan 2021



Data presented at IDweek 2018

Filed in US Q1 2019, approval Q4 2019

Filed in EU Q4 2019

Data published in Lancet Infectious Diseases 2020 Jun 8;S1473-

3099(20)30004-9

Approved in EU Jan 2021


Xofluza (baloxavir marboxil, RG6152, S-033188 )


123

Infe

cti

ou

s D

ise

ase

s




FLAGSTONE (hospitalised patients)

Phase III

miniSTONE 1 (0-1 year old)

Phase III

miniSTONE 2 (1-12 years old )


Design

• Xofluza + neuraminidase inhibitor vs placebo

+ neuraminidase inhibitor in hospitalised

patients with influenza

• Xofluza on Day 1 (based on body weight and age)

in healthy pediatric patients from birth to <1 year

with influenza-like symptoms

• Xofluza vs Tamiflu in healthy pediatric

patients 1 to <12 years of age with influenza-

like symptoms

Primary endpoint Time to clinical improvement Safety Safety

Status

FPI Jan 2019


Study did not meet primary endpoint Q2 2020

• FPI Q1 2019 • FPI Q4 2018

• Recruitment completed Q1 2019

• Primary endpoint met Q2 2019

• Data presented at OPTIONS X 2019

• Filed in US Q1 2020

• Data published in Pediatric Infectious

Disease 2020 Aug;39(8):700-705

• Not approved in the US, determining path

forward with the FDA


Xofluza (baloxavir marboxil, RG6152, S-033188)


124

Infe

cti

ou

s D

ise

ase

s


PCR=Polymerase chain reaction; NEJM=New England Journal of Medicine



BLOCKSTONE

Phase IIIb

CENTERSTONE

# of patientsN=752 N=3,160

Design

Post exposure prophylaxis to prevent disease onset in household

contacts. Used after known exposure to infected person.

Household contacts treated with Xofluza vs placebo

Reduction of direct transmission of influenza from otherwise healthy

patients to household contacts

Patients treated with Xofluza vs placebo

Primary endpoint Percentage of household contacts who developed clinical influenza Percentage of household contacts who are PCR-positive for influenza by

day 5 post randomization of index patients

Status


Data presented at OPTIONS X 2019

Filed in US Q1 2020

Data published in NEJM 2020 Jul 8. doi:10.1056/NEJMoa1915341

Approved in US Q4 2020 and EU Jan 2021

FPI Q4 2019

CT Identifier JapicCTI-184180 NCT03969212

125

Pipeline summary





Spark


Diagnostics


Indication 1L castration-resistant prostate cancer Advanced prostate cancer and solid tumorsProstate cancer previously treated with

androgen receptor-targeted therapy


IPATential150Phase Ib Phase Ib

# of patients N=1,100 N=54 N=50

Design

ARM A: Ipatasertib plus abiraterone

ARM B: Placebo plus abiraterone

Ipatasertib plus rucaparib

Stage 1: Dose escalation in advanced breast,

ovarian and prostate cancer

Stage 2: Dose expansion in prostate cancer

Ipatasertib plus Tecentriq plus docetaxel

Primary endpoint

Radiographic progression-free survival (rPFS)

in patients with PTEN loss tumors and overall

population

• Safety and efficacy • Safety and efficacy

Status

FPI Q2 2017

Recruitment completed Jan 2019

Study met co-primary endpoint in rPFS in

patients with PTEN loss tumors Q2 2020


• FPI Q2 2019 • FPI Q3 2020


On

co

log

y

In collaboration with Array BioPharma

ESMO=European Society for Medical Oncology

Ipatasertib (RG7440, GDC-0068)

Highly selective small molecule inhibitor of Akt

126

On

co

log

y

Indication 1L TNBC and HR+ breast cancer TNBC 1L HR+ mBC


IPATunity130Phase Ib

Phase Ib/III

IPATunity150


Design

Cohort A: Dx+ 1L TNBC (N=249):

ARM A: Ipatasertib+paclitaxel

ARM B: Placebo+paclitaxel

Cohort B: Dx+ HR+ mBC (N=201):

ARM A: Ipatasertib+paclitaxel

ARM B: Placebo+paclitaxel

ARM A: Ipatasertib+Tecentriq +paclitaxel

ARM B: Ipatasertib+Tecentriq+nab-paclitaxel

ARM A: Ipatasertib plus fulvestrant and

palbociclib

ARM B: Placebo plus fulvestrant and

palbociclib

Primary endpoint Progression-free survival Safety and efficacy Progression free survival in ITT and in patients

with PIK3CA/AKT1/PTEN altered tumors

Status

FPI Q1 2018

Recruitment cohort B completed Q1 2019 and

cohort A Q1 2020

Cohort B (HR+) primary endpoint not met,

data presented at ESMO 2020

Cohort A (TNBC) primary endpoint not met Q3

2020, data presented at SABCS 2020

FPI Q1 2018

Data presented at AACR 2019 and SABCS

2020

FPI Q4 2019 in Phase Ib part


In collaboration with Array BioPharma

TNBC=triple-negative breast cancer; ASCO=American Society of Clinical Oncology; AACR=American Association for Cancer Research; ESMO=European Society for Medical Oncology;

SABCS=San Antonio Breast Cancer Symposium

Ipatasertib (RG7440, GDC-0068)

Highly selective small molecule inhibitor of Akt

127

Tiragolumab (anti-TIGIT, RG6058, MTIG7192A)

Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT

128

Indication 1L NSCLC PD-L1 TPS>50% 1L ES-SCLC


SKYSCRAPER-01

Phase III

SKYSCRAPER-02

# of patients N=500-560 N=470

Design

Arm A: Tiragolumab plus Tecentriq

Arm B: Placebo plus Tecentriq

Arm A: Tiragolumab plus Tecentriq, carboplatin and etoposide

Arm B: Placebo plus Tecentriq, carboplatin and etoposide

Primary endpoint Overall survival and progression free survival Overall survival and progression free survival

Status FPI Q1 2020 FPI Q1 2020


NSCLC=Non-small cell lung cancer; ES-SCLC=Extensive stage small cell lung cancer

On

co

log

y



129

Indication Stage III unresectable 1L NSCLCMetastatic and/or recurrent PD-L1+

cervical cancer


SKYSCRAPER-03

Phase II

SKYSCRAPER-04


Design

Arm A: Tiragolumab plus Tecentriq for up to 12 months

Arm B: Durvalumab for up to 12 months


Arm B: Tecentriq

Primary endpoint Progression-free survival Objective Response Rate (ORR)



NSCLC=Non-small cell lung cancer

On

co

log

y



130

Indication 1L non-squamous NSCLC Locally advanced esophageal cancer 1L esophageal cancer

Phase/studyPhase II

SKYSCRAPER-06

Phase III

SKYSCRAPER-07

Phase III

SKYSCRAPER-08


Design

Arm A: Tiragolumab plus Tecentriq plus

pemetrexed plus chemo followed by

maintenance tiragolumab plus Tecentriq plus

pemetrexed

Arm B: Placebo plus pembrolizumab plus

pemetrexed plus chemo followed by

maintenance placebo plus pembrolizumab

plus pemetrexed


Arm B: Tecentriq plus placebo

Arm C: Placebo plus placebo

Arm A: Tiragolumab plus Tecentriq plus

cisplatin and paclitaxel

Arm B: Placebo plus placebo plus cisplatin

and paclitaxel

Primary endpoint

Objective response rate (ORR) and

progression-free survival

Progression-free survival (A vs C)

Overall survival (A vs C, hierarchical, B vs C

hierarchical)

Overall survival and progression-free survival

Status FPI Q4 2020 FPI Q3 2020 FPI Q4 2020


NSCLC=Non-small cell lung cancer

On

co

log

y



131

Indication Solid tumors NSCLCR/R Multiple Myeloma (MM) or R/R B-cell

NHL

Phase/study Phase IPhase II

CITYSCAPEPhase l


Design

Phase Ia: Dose escalation and

expansion of tiragolumab

Phase Ib: Dose escalation and

expansion Tecentriq plus tiragolumab

Phase Ib: Chemo combinations with

tiragolumab (cis, carbo, pem, pac,

etoposide)

Arm A: Tecentriq plus tiragolumab

Arm B: Tecentriq monotherapy

Phase Ia: Tiragolumab monotherapy

Phase Ib: Tiragolumab plus daratumumab (r/r

MM) or rituximab (r/r NHL)

Primary endpoint Safety, tolerability, PK variability and

preliminary efficacy

Overall response rate and progression-free

survival

Safety, tolerability, PK/PD and preliminary

efficacy

Status

FPI Q2 2016

Data presented at AACR 2020

FPI Q3 2018


Data presented at ASCO 2020 and WCLC 2021

Breakthrough therapy designation granted by

FDA Dec 2020

FPI Q2 2019


NSCLC=Non-small cell lung cancer; r/r=Relapsed refractory; NHL=Non-Hodgkin's lymphoma; ASCO=American Society of Clinical Oncology; AACR=American Association for Cancer Research

On

co

log

y

Glofitamab (CD20-TCB, RG6026)

Bispecific anti-CD20/CD3 antibody engaging T and B cells simultanously

132

Indication Relapsed or refractory Non-Hodgkin’s lymphoma Non-Hodgkin’s lymphoma

Phase/study Phase I Phase Ib Phase Ib

# of patients N=700 N=140Part I: 15-60

Part II: ~66-104

Design

Cohort 1: Single-agent dose escalation

study

Initial dose escalation

Expansion cohort in r/r DLBCL

Expansion cohort in r/r FL

All patients will receive pretreatment with a

single dose of Gazyva (1000mg)

Cohort 2: glofitamab + Gazyva (i.e.

continuous treatment with Gazyva)

Dose escalation and expansion

Arm A: glofitamab plus Tecentriq

Arm B: glofitamab plus Polivy

Part I: Dose-finding for the combination of

glofitamab plus G/R CHOP in r/r indolent NHL

Part II: Dose expansion glofitamab plus G/R-

CHOP or R-CHOP in 1L DLBCL

Part III: glofitamab + R-CHP+Pola

Primary endpoint Safety Safety Safety

Status

FPI Q1 2017

Data presented at ASH 2018, ICML and

ASH 2019, EHA 2020 and ASH 2020

FPI Q2 2018


FPI Q1 2018


On

co

log

y

DLBCL=diffuse large B cell lymphoma; FL=Follicular lymphoma; ASH=American Society of Hematology; EHA=European Hematology Association; ICML=International Conference on Malignant

Lymphoma; CHOP=cyclophosphamide, doxorubicin, vincristine and prednisone; R=Rituxan/MabThera; G=Gazyva

IndicationRelapsed/refractory DLBCL and High-Grade Large B-Cell

Lymphoma2L+ SCT-ineligible DLBCL

Phase/study Phase IbPhase III

STARGLO


Design

Glofitamab plus gemcitabine and oxaliplatin, followed by up to 4 cycles

of glofitamab monotherapy

A single dose of obinutuzumab will be administered 7 days prior to the

first dose of glofitamab

Arm A: glofitamab plus gemcitabine and oxaliplatin, followed by up to 4

cycles of glofitamab monotherapy

Arm B: Rituxan in combination with gemcitabine and oxaliplatin

A single dose of obinutuzumab will be administered 7 days prior to the

first dose of glofitamab

Primary endpoint Safety Overall survival

Status FPI Q2 2020 FPI expected early 2021


On

co

log

y

Glofitamab (CD20-TCB, RG6026)


133DLBCL=diffuse large B cell lymphoma; SCT=stem cell transplant

Indication 3L+ FL, 3L+ DLBCL & other R/R NHL 1L DLBCL R/R DLBCL

Phase/study Phase I Phase Ib/II Phase Ib


Design

Dose escalation study of mosunetuzumab as

single agent and in combination with

Tecentriq

Expansion cohorts for r/r FL, r/r DLBCL and

subcutaneous in r/r NHL

Mosunetuzumab plus CHOP

Mosunetuzumab plus CHP plus polatuzumab

vedotin

Mosunetuzumab+CHP-polatuzumab vedotin

vs R+CHP-polatuzumab vedotin

Mosunetuzumab plus polatuzumab vedotin

Primary endpoint Safety, tolerability, dose/schedule, PK, and

response rates

Safety/tolerability and response Safety/tolerability and response

Status

FPI Q3 2015

Data in r/r NHL presented at ASH 2018 and

2019, and in r/r FL at ASH 2020

BTD granted by FDA Q2 2020

FPI Q1 2019

Data for M+CHOP presented at ASH 2020

FPI Q3 2018


On

co

log

y

Mosunetuzumab (CD20/CD3, RG7828)


134FL=follicular lymphoma; DLBCL=diffuse large B cell lymphoma; r/r=relapsed/refractory; NHL=non-Hodgkin’s lymphoma; CHOP=cyclophosphamide, doxorubicin, vincristine, and

prednisone; CHP=cyclophosphamide, doxorubicin, and prednisone); ASH=American Society of Hematology; R=Rituximab

Indication 1L DLBCL & 2L DLBCL following 1L induction R/R 2L+ FL

Phase/study Phase I Phase Ib

# of patients N=92 + 80 (cohort C) N=27

Design

Cohort A: Mosunetuzumab monotherapy (after a response to prior

systemic chemotherapy)

Cohort B: Mosunetuzumab monotherapy (1L treatment in elderly/frail)

Cohort C: Mosunetuzumab (subcutanous) plus polatuzumab vedotin

in 1L elderly/unfit

Mosunetuzumab plus lenalidomide safety run-in for phase III

Primary endpoint Safety/tolerability and response Safety/tolerability and response

Status

FPI Q2 2019 – Cohort B

FPI Q3 2019 – Cohort A

Initial data presented at ASH 2020 (cohort B)

Cohort C: FPI expected Q1 2021

FPI Q3 2020


On

co

log

y

Mosunetuzumab (CD20/CD3, RG7828)


135FL=follicular lymphoma; DLBCL=diffuse large B cell lymphoma; r/r=relapsed/refractory

Indication PIK3CA-mutant HR+ mBCPIK3CA mutant solid tumors and metastatic

ER+ HER2-neg breast cancer


INAVO120Phase I


Design

Arm A: GDC-0077 plus palbociclib plus fulvestrant

Arm B: Placebo plus palbociclib plus fulvestrant

Monotherapy and in combination with SoC (letrozole; letrozole plus

palbociclib; fulvestrant)

• Stage 1: Dose escalation

• Stage 2: Expansion

Primary endpoint Progression-free survival • Safety, tolerability and PK

Status FPI Q1 2020 • FPI Q4 2016

• Preclinical/molecule discovery data presented at AACR 2017

• Data presented at SABCS 2019 and 2020


On

co

log

y

Inavolisib (RG6114, GDC-0077)

A potent, orally available, and selective PI3Kα inhibitor

136AACR=American Association for Cancer Research; SABCS=San Antonio Breast Cancer Symposium

Indication Metastatic ER+ HER2-neg breast cancer ER+ HER2-neg Stage I-III operable breast cancer

Phase/study Phase I Phase I


Design

Dose escalation and expansion at recommended phase II dose (RP2D)

Single agent and in combination with palbociclib and/or luteinizing

hormone−releasing hormone (LHRH) agonist

Open-label, pre-operative administration

Dose escalation

Primary endpoint Safety Safety, tolerability and PK/PD

Status FPI Q4 2017

Data presented at SABCS 2019

FPI Q3 2019


On

co

log

y

Giredestrant (SERD (3),RG6171, GDC-9545)

A selective estrogen receptor degrader or downregulator

137SABCS=San Antonio Breast Cancer Symposium

Indication Neoadjuvant ER+ BC 1L ER+ metastatic breast cancer2L/3L ER+/HER2-negative

metastatic breast cancer

Phase/study Phase II Phase III Phase II


Design

• ARM A: Single agent followed by combo with

palbociclib

• ARM B: anastrazole followed by anastrazole

plus palbociclib

Arm A: giredestrant plus palbociclib

Arm B: letrozole plus palbociclib

Arm A: giredestrant monotherapy

Arm B: endocrine monotherapy (fulvestrant

or aromatase inhibitor)

Primary endpoint Safety, tolerability and PK/PD Progression-free survival Progression-free survival

Status FPI Q3 2020 FPI Q4 2020 FPI Q4 2020


On

co

log

y

Giredestrant (SERD (3), RG6171, GDC-9545)

A selective estrogen receptor degrader or downregulator

138

Indication Alzheimer’s Prevention Initiative (API) Colombia

Phase/studyPhase II

Cognition study

# of patients N=252

Design

ARM A: PSEN1 E280A mutation carriers receive crenezumab SC

ARM B: PSEN1 E280A mutation carriers receive placebo

ARM C: non-mutation carriers receive placebo

Primary endpoint Change on Alzheimer’s Prevention Initiative (API) Composite Cognitive Test total score at 260 weeks treatment

Status

FPI Q4 2013



In collaboration with AC Immune

A=amyloid-beta

Crenezumab (RG7412)

Humanized mAb targeting all forms of A

139

Ne

uro

sc

ien

ce

Indication Prodromal to mild Alzheimer’s disease


GRADUATE 1

Phase III

GRADUATE 2

# of patients N=1,016 N=1,016

Design

104-week subcutaneous treatment period:

ARM A: Gantenerumab

ARM B: Placebo


ARM A: Gantenerumab

ARM B: Placebo

Primary endpoint Change in CDR-SOB at 27 months Change in CDR-SOB at 27 months

Status

FPI Q2 2018


FPI Q3 2018



In collaboration with MorphoSys AG

A=amyloid-beta; CDR-SOB=Clinical Dementia Rating Scale Sum of Boxes

Ne

uro

sc

ien

ce

Gantenerumab (RG1450)

Fully human mAb binding aggregated forms of A

140

Indication Prodromal Alzheimer’s disease Mild Alzheimer’s disease


SCarlet RoAD

Phase III

Marguerite RoAD


Design


ARM A: Gantenerumab (225 mg)

ARM B: Gantenerumab (105 mg)

ARM C: Placebo


ARM A: Gantenerumab

ARM B: Placebo

Primary endpoint Change in CDR-SOB at 2 years

Sub-study: change in brain amyloid by PET at 2 years

Change in ADAS-Cog and CDR-SOB at 2 years (co-primary)

Status

Phase I PET data: Archives of Neurology, 2012 Feb;69(2):198-207


Dosing stopped due to futility Q4 2014

FPI in open label extension study Q4 2015

OLE data presented at CTAD 2017, AD/PD and AAN 2018 and 2019

FPI Q1 2014

Recruitment stopped Q4 2015

FPI Q1 2016 for open label extension

OLE data (MRI) presented at CTAD 2017, AD/PD, AAIC 2018 and AAN

2018 and 2019


Gantenerumab (RG1450)

Fully human mAb binding aggregated forms of A

141In collaboration with MorphoSys AG

A=amyloid-beta; CDR-SOB=Clinical Dementia Rating Scale Sum of Boxes; PET= positron emission tomography; ADAS-cog=Alzheimer’s Disease Assessment Scale cognitive subscale;

AAIC=Alzheimer’s Association International Conference; CTAD=Clinical Trials on Alzheimer's Disease; AD/PD=Alzheimer’s & Parkinson’s Diseases Congress; AAN=American Academy of Neurology;

MRI=Magnetic resonance imaging

Ne

uro

sc

ien

ce

Indication Huntington’s disease

Phase/study Phase I/IIaPhase II

OLE


Design

Multiple ascending doses of RG6042 administered intrathecally to adult

patients with early manifest Huntington's Disease

Patients from phase I are enrolled into OLE

Primary endpoint Safety, tolerability, PK and PD Longer term safety, tolerability, PK, PD.

Status

FPI Q3 2015

Data presented at CHDI 2018 and AAN 2018

PRIME designation granted 2018

Published in NEJM 2019; 380:2307-2316

FPI Q1 2018

PK/PD data presented at AAN 2019

Update presented at CHDI 2020

Study completed, patients moved to GEN-EXTEND OLE


Tominersen (RG6042, HTT ASO )

Antisense oligonucleotide (ASO) targeting human HTT mRNA

142

Ne

uro

sc

ien

ce

In collaboration with Ionis Pharmaceuticals

AAN=American Academy of Neurology; NEJM=New England Journal of Medicine

Indication Huntington’s disease


Generation HD1

Phase III

GEN-EXTEND


Design

ARM A: RG6042 120mg bimonthly

ARM B: RG6042 120mg every four months

ARM C: Placebo bimonthly

Open-Label Extension study in patients participating in prior Roche and

Genentech sponsored studies

• Arm A: RG6042 120mg bimonthly

• Arm B: RG6042 120mg every four months

Primary endpoint cUHDRS globally

TFC USA only

Long term safety, tolerability

Status

FPI Jan 2019

Q1 2019 protocol modified to allow for bi-monthly vs four-monthly dosing,

FPI for new protocol July 2019


• FPI April 2019


Tominersen (RG6042, HTT ASO )

Antisense oligonucleotide (ASO) targeting human HTT mRNA

143

Ne

uro

sc

ien

ce

In collaboration with Ionis Pharmaceuticals

cUHDRS=composite Unified Huntington's Disease Rating Scale; TFC=total function capacity

Fenebrutinib (RG7845, GCD-0853)

Highly selective and reversible (noncovalent) bruton tyrosine kinase inhibitor (BTKi)

144

Imm

un

olo

gy

IndicationPrimary progressive multiple sclerosis

(PPMS)Relapsing multiple sclerosis (RMS)


FENtrepid

Phase III

FENhance 1

Phase III

FENhance 2


Design

ARM A: Fenebrutinib twice daily oral

Arm B: Ocrelizumab 2x300 mg IV every 24

weeks

Arm A: Fenebrutinib twice daily oral

Arm B: Teriflunomide once daily oral

Arm A: Fenebrutinib twice daily oral

Arm B: Teriflunomide once daily oral

Primary endpoint

Time to onset of composite 12-week

confirmed disability progression (cCDP12)



and annualized relapse rate



and annualized relapse rate

Status FPI Q4 2020 FPI expected Q1 2021 FPI expected Q1 2021


Etrolizumab (RG7413)

Humanized mAb against beta 7 integrin

145

Imm

un

olo

gy

Indication Moderately to severely active Crohn’s disease Moderately to severely active Crohn’s disease

Phase/study

Phase III

BERGAMOT

Induction and maintenance study

Phase III

JUNIPER

Open label extension study for BERGAMOT


Design

ARM A: Etrolizumab SC 210 mg (induction only)

ARM B: Etrolizumab SC 105 mg and maintenance

ARM C: Placebo

Etrolizumab SC 105mg q4w

Primary endpoint Induction and maintenance of clinical remission Safety

Status FPI Q1 2015

Cohort 1 data presented at UEGW 2017

FPI Q2 2015


UEGW=United European Gastroenterology Week

Crovalimab (RG6107; SKY59)

A humanized monoclonal antibody against complement C5

146

Imm

un

olo

gy

Indication Paroxysmal nocturnal hemoglobinuria (PNH)


COMPOSER

# of patients N=59

Design

Healthy volunteers and treatment naïve and pretreated patients with PNH:

Part 1: single ascending dose study in healthy subjects

Part 2: intra-patient single ascending dose study in PNH patients

Part 3: Multiple-dose study in PNH patients

Part 4: Dose confirmation in PNH patients

Primary endpoint Safety, PK, PD

Status

Part 1: FPI Q4 2016

Part 2/3: FPI Q2 2017

Part 4: FPI Q2 2019

Nonclinical data published in Scientific Reports 2017 Apr; 7(1):1080

Data presented for Part 2 and 3 at ASH 2018 and 2019



ASH=American Society of Hematology

Crovalimab (RG6107; SKY59)

A humanized monoclonal antibody against complement C5

147

Imm

un

olo

gy

IndicationParoxysmal Nocturnal Hemoglobinuria

(PNH) patients switching from a C5

inhibitor

Paroxysmal Nocturnal Hemoglobinuria

(PNH)

C5 inhibitor naive patients

Paroxysmal Nocturnal Hemoglobinuria

(PNH)

C5 inhibitor naive patients (China only)


COMMODORE 1

Phase III

COMMODORE 2

Phase III

COMMODORE 3


Design

Arm A: Crovalimab

Arm B: Eculizumab

Arm C: Patients switching to crovalimab from

ravulizumab, higher than labelled doses of

eculizumab & C5 SNP patients (descriptive-

arm)

Arm A: Crovalimab

Arm B: Eculizumab

Crovalimab loading dose IV on Day 1, followed

by weekly crovalimab subcutaneous doses for

4 weeks

Primary endpoint

Non-inferiority of crovalimab compared to

eculizumab - mean % change in LDH level

(measure of haemolysis) from baseline to week

25

Non-inferiority of crovalimab compared to

eculizumab:

- % pts with transfusion avoidance from

baseline through week 25

- % pts with haemolysis control, as measured

by LDH <=1.5ULN from week 5-25

Percentage of patients with transfusion

avoidance from baseline through week 25

Mean percentage of participants with

hemolysis control (week 5 through week 25)

Status FPI Q3 2020 FPI Q4 2020 FPI expected Q1 2021



LDH=Lactate Dehydrogenase

rhPTX-2 (RG6354)

Recombinant human innate immunity protein pentraxin-2

148

Imm

un

olo

gy

Indication Idiopathic pulmonary fibrosis (IPF) Myelofibrosis

Phase/study Phase II Phase II


Design

• Randomized, double-blind, placebo-controlled trial: 4-week screening

period, 24-week randomized treatment period, 4-week follow-up visit

(week 28)

• RG6354 at days 1, 3 and 5 then every 4 weeks vs placebo

• Multiple dose study of RG6354

Primary endpoint• Least-squares mean change in forced vital capacity (FVC) percentage of

predicted value from baseline to week 28

• Bone marrow response rate

Status• Study met primary endpoint

• Data published in JAMA 2018;319(22):2299-2307

Ongoing


JAMA=Journal of the American Medical Association

Indication Neovascular age related macular degeneration (nAMD)Center-involving diabetic macular edema

(CI-DME)

Phase/studyPhase II

AVENUE

Phase II

STAIRWAY

Phase II

BOULEVARD


Design

ARM A: SoC (Lucentis), q4w

ARM B: 1.5 mg faricimab, q4w

ARM C: 6mg faricimab, q4w

ARM D: 6mg faricimab, q4w / q8w

ARM E: SoC q4w x 3 doses, switch group to 6

mg faricimab q4w

ARM A: SoC (Lucentis), q4w

ARM B: 6mg faricimab, q>8w (short interval

duration)

ARM C: 6mg faricimab, q>8w (long interval

duration)

ARM A: SoC (Lucentis), 0.3 mg q4w

ARM B: 1.5mg faricimab, q4w

ARM C: 6mg faricimab, q4w

Primary endpoint Change from baseline BCVA after 32 weeks Change from baseline BCVA at Week 40 Mean change from baseline BCVA at week 24

Status

FPI Q3 2015


Data presented at Retina Society 2018

Data published JAMA Ophthalmol 2020;

138(9):955-963

FPI Q1 2017


Data presented at Retina Society 2018 (24

week data) and AAO 2018 (full data)

Data published JAMA Ophthalmol 2020;

138(9):964-972

FPI Q2 2016


Data presented at Angiogenesis 2018 and

Retina Society 2018

Data published in Ophthalmology 2019

Aug;126(8):1155-1170


Faricimab (RG7716)

Bispecific antibody to simultaneously bind Ang-2 and VEGF-A

149

Op

hth

alm

olo

gy

BCVA=best corrected visual acuity; SoC=standard of care; AAO=American Academy of Ophthalmology

Faricimab (RG7716)


150

Op

hth

alm

olo

gy

PTI=Personalized Treatment Interval; BCVA=best corrected visual acuity

Indication Center-involving diabetic macular edema (CI-DME)


YOSEMITE

Phase III

RHINE


Design

ARM A: Faricimab q8w

ARM B: Faricimab (RG7716) q8w/PTI

ARM C: Aflibercept, q8w

ARM A: Faricimab q8w

ARM B: Faricimab (RG7716) q8w/PTI

ARM C: Aflibercept, q8w

Primary endpoint Change from baseline in BCVA at 1 year Change from baseline in BCVA at 1 year

Status

FPI Q3 2018



FPI Q4 2018




Faricimab (RG7716)


151

Op

hth

alm

olo

gy

BCVA=best corrected visual acuity

Indication Neovascular age related macular degeneration (nAMD)


TENAYA

Phase III

LUCERNE


Design

ARM A: Faricimab 6.0mg Q16 flex after 4 initiating doses (IDs)

ARM B: Aflibercept 2.0mg Q8 after 3 IDs

ARM A: Faricimab 6.0mg Q16 flex after 4 initiating doses (IDs)

ARM B: Aflibercept 2.0mg Q8 after 3 IDs

Primary endpoint Change from baseline in BCVA Week 40, 44 & 48 Change from baseline in BCVA Week 40, 44 & 48

Status

FPI Q1 2019


Study met primary endpoint Jan 2021

FPI Q1 2019


Study met primary endpoint Jan 2021


Indication wAMD


Archway

Phase II+III extension

Portal


Design

ARM A: PDS with ranibizumab every 24 weeks

ARM B: Intravitreal ranibizumab every 4 weeks

Patients from LADDER or Archway will receive refills of 100 mg/mL

ranibizumab q24w (patients without the PDS will receive the PDS and

subsequent refills)

Primary endpoint Change in BCVA from baseline at the average of week 36 and week 40 Safety and long term efficacy

Status

FPI Q3 2018



Data presented at ASRS 2020

FPI Q3 2018



First eye implant to achieve sustained delivery of a biologic medicine

152BCVA=best corrected visual acuity; wAMD=wet age-related macular degeneration; ASRS=American Society of Retinal Specialists

Op

hth

alm

olo

gy

Indication DMEDiabetic retinopathy without

center-involved diabetic macular edema


Pagoda

Phase III

Pavilion


Design

ARM A: PDS with ranibizumab every 24 weeks

ARM B: Intravitreal ranibizumab every 4 weeks

Arm A: Intravitreal ranibizumab (X2) followed by PDS implant (refill

every 36 weeks)

Arm B: Q4W comprehensive clinical monitoring until participants

receive PDS (refill every 36 weeks)

Primary endpoint Change in BCVA from baseline at the average of week 48 and week 52 Percentage of participants with a ≥2-step improvement from baseline on

the ETDRS-DRSS at Week 52




First eye implant to achieve sustained delivery of a biologic medicine

153

Op

hth

alm

olo

gy

DME=diabetic macular edema; BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; DRSS=Diabetic Retinopathy Severity Scale

154

Pipeline summary





Spark


Diagnostics


Molecule Indication Phase # of patients Status CT Identifier

Oncology

TYRP1 x CD3 (RG6232) Melanoma I 210 FPI Q4 2020 NCT04551352

FAP-4-1BBL (RG7827) Solid tumors I 200FPI Q2 2018


CD19-4-1BBL (RG6076)R/R B cell non-Hodgkin’s

lymphomaI 207 Part I: FPI Q3 2019; Part II: FPI Q3 2020 NCT04077723

PD1-IL2v (RG6279) Solid tumors I 440 FPI Q2 2020 NCT04303858

cibisatamab

(CEA x CD3, RG7802)

CEA-positive solid tumors

Ia 149FPI Q4 2014

Data presented at ASCO 2017NCT02324257

Ib 228FPI Q1 2016

Data presented at ASCO 2017NCT02650713

3L+ MSS mCRC Ib 46 FPI Q1 2019 NCT03866239

PD1-TIM3 (RG7769) Solid tumors Ia/b 280 FPI Q4 2018 NCT03708328

PD1-LAG3 (RG6139) Solid tumors I 320 FPI Q4 2019 NCT04140500

selicrelumab (RG7876) Solid tumors Ib 170 FPI Q1 2016; Part II FPI Q2 2018 NCT02665416

Anti-CD25 (RG6292)

Solid tumors I 110 FPI Q4 2019 NCT04158583

Advanced and metastatic

solid tumorsI 160 FPI Jan 2021 NCT04642365

TLR7 agonist (4) (RG6115) Hepatocellular carcinoma I 100 FPI July 2020 NCT04338685

NME (RG6234) Multiple myeloma I 240 FPI Q4 2020 NCT04557150

HLA-A2-WT1 x CD3 (RG6344) AML I 160 FPI Q4 2020 NCT04580121

pRED oncology development programs

155


Neuroscience

Brain Shuttle gantenerumab (RG6102) Alzheimer's disease I ~60 FPI Q3 2019 NCT04023994

ralmitaront

(partial TAAR1 agonist, RG7906)Schizophrenia

II 36 FPI Q4 2018; LPI Q3 2019

II 345 FPI Q4 2019 NCT03669640

II 308 FPI Q3 2020

prasinezumab1

(anti-αSynuclein, RG7935, PRX002)Parkinson’s disease II 316

Study did not meet its primary objective,

but showed signals of efficacy on core

motor signs in PD. Key study data

presented at MDS Sep 2020. The 52-week

blinded extension (Part 2) is ongoing;

Ph2b study under preparation

NCT03100149

(PASADENA)

GABA-Aa5 PAM (RG7816) AutismI 105 FPI Q4 2017

I 15 FPI Q2 2018 NCT03507569

NME (RG7637)Neurodevelopmental

disordersI 80 FPI July 2020 NCT04475848

UBE3A LNA Angelman syndrome I 66 FPI Q3 2020 NCT04428281

NME (RG6182)Neurodegenerative

disorderI 30 FPI Q4 2020

Immunology

IgG-IL2 FP (RG7835) Ulcerative Colitis Ib 65 FPI Q2 2019 NCT03943550

pRED neuroscience and immunology development programs

Partner: 1Prothena

156


Infectious Diseases

TLR7 agonist (3) (RG7854) Chronic hepatitis B I 150FPI Q4 2016

Data presented at APASL 2019NCT02956850

CpAM (RG7907) Chronic hepatitis B I/II 192

FPI Q4 2016

Data presented at EASL 2018, 2019 &

2020

Part 1 (healthy volunteers) published in

Antimicrob Agents Chemother DOI:

10.1128/AAC.01323-20

NCT02952924

TLR7 agonist (3) + CpAM

(RG7854 + RG7907)Chronic hepatitis B II 65 FPI July 2020

NCT04225715

(PIRANGA)

PDL1 LNA (RG6084) Chronic hepatitis B I 27 FPI Q1 2019

Abx MCP (RG6006) A. baumannii I 168 FPI Q4 2020 NCT04605718

Ophthalmology

NME (RG6179)1 DME I 50 FPI July 2019

VEGF-Ang2 DutaFab (RG6120) nAMD I 50 FPI Q4 2020 NCT04567303

NME (RG7774) Retinal disease II 180 FPI Q2 2020NCT04265261

(CANBERRA)

pRED infectious diseases and ophthalmology development programs

157Partner: 1Sesen Bio

Abx MCP=antibiotic macrocyclic peptide

158

Pipeline summary





Spark


Diagnostics



Oncology

KRAS G12C (RG6330)Metastatic solid tumors with

KRAS G12C mutationI 108 FPI Q3 2020 NCT04449874

cevostamab

(anti-FcRH5 x CD3; RG6160)R/R multiple myeloma I 300 FPI Q3 2017 NCT03275103

HER2 x CD3 (RG6194)Metastatic HER2-expressing

cancersI 440 FPI Q2 2018 NCT03448042

BCMA x CD16a (RG6296)1 R/R multiple myeloma I 55 FPI Q3 2020 NCT04434469

NME (RG6286)Locally advanced or

metastatic colorectal cancerI 67 FPI Q3 2020 NCT04468607

IL15/IL15Ra-Fc (RG6323)2 Solid tumors I/II 250 FPI Q1 2020 NCT04250155

autogene cevumeran

(Individualized Neoantigen-Specific

Therapy (iNeST); RG6180)3

Solid tumors Ia/IIb 770FPI Q4 2017

Data presented at AACR 2020NCT03289962

1L advanced melanoma II 132 FPI Q1 2019NCT03815058

(IMcode001)

gRED oncology development programs

159Partner: 1Affimed, 2Xencor, 3BioNTech


Immunology

efmarodocokin alfa

(IL-22Fc, RG7880)

Inflammatory diseases Ib 90 FPI Q2 2016 NCT02749630

Inflammatory bowel disease II 270 FPI Q4 2018 NCT03558152

aGVHD lb FPI Q4 2020 NCT04539470

NME (RG6287, GDC-8264) Inflammatory bowel disease I 114 FPI Jan 2020

NME (RG6151, GDC-0214) Asthma I 84FPI Q4 2017


ACTRN1261700

1227381p

NME (RG6244, GDC-4379) Asthma I 84 FPI Q2 2019ACTRN1261900

0227190p

Anti-tryptase

(RG6173, MTPS9579A)

Asthma I 70 FPI Q1 2018

Asthma IIa 160 FPI Q4 2019 NCT04092582

ST2 MAb (RG6149, AMG 282,

MSTT1041A) or IL-22Fc (RG7880)2

Adult hospitalised with severe

COVID-19 pneumoniaII 390 FPI Q2 2020

NCT04386616

(COVASTIL)

NME (RG6315, MTBT1466A) Immunologic disorders I ~24 FPI Q3 2020

gRED immunology development programs

160Partner: 1Amgen, 2Amgen for ST2 MAb


Neuroscience

Semorinemab (RG6100)1

Prodromal to mild

Alzheimer’s diseaseII 457

FPI Q4 2017

Primary endpoint not met Q3 2020

Data at CTAD 2020

NCT03289143

(TAURIEL)

Moderate Alzheimer’s disease II 260 FPI Q1 2019NCT03828747

(LAURIET)

gRED neuroscience, ophthalmology and metabolic diseases

development programs

161Partner: 1AC Immune

Ophthalmology

NME (RG6147) Geographic atrophy II 285 FPI Q2 2019NCT03972709

(GALLEGO)

NME (RG6312) Geographic atrophy la 63 FPI Q4 2020 NCT04615325

Metabolic Diseases

FGFR1 X KLB (RG7992)

Metabolic diseases Ia 79FPI Q4 2015

Recruitment completed Q1 2017NCT02593331

Metabolic diseases Ib 140FPI Q1 2017

Recruitment completed Q2 2019NCT03060538

NASH II 260 FPI Q3 2020 NCT04171765

162

Pipeline summary





Spark


Diagnostics


MoleculeSPK-8011

(RG6357)

SPK-8016

(RG6358)

Indication Hemophilia A Hemophilia A with inhibitors to Factor VIII

Phase/study Phase I Phase I/II Phase I/II


Design

Long term follow up study of patients who

have received SPK-8011 in any prior

Spark-sponsored SPK-8011 study

Gene transfer, dose-finding safety, tolerability,

and efficacy study of SPK-8011

Gene transfer, dose-finding safety, tolerability, and

efficacy study of SPK-8016 in individuals with FVIII

inhibitors

Primary endpoint

Safety Safety and changes from baseline in FVIII

activity levels at week 52

Updated data presented at ISTH 2020

Safety; peak and steady state FVIII activity levels at

week 52

Status Ongoing Ongoing Ongoing

CT IdentifierNCT03432520 NCT03003533 NCT03734588

Hemophilia A

Unique gene therapy platform

163

He

mo

ph

ilia

MoleculeSPK-7001

(RG6367)

Indication Choroideremia

Phase/study Phase I/II

# of patients N=15

Design

Safety study in subjects with CHM (choroideremia) gene mutations

Primary endpoint Safety and tolerability

Status FPI Q1 2015


CT IdentifierNCT02341807

Choroideremia


164

Op

hth

alm

olo

gy

MoleculeSPK-3006

(RG6359)

Indication Pompe disease


RESOLUTE

# of patients N=20

Design

Gene transfer study for late-onset Pompe disease

Primary endpoint Safety

Status FPI Q4 2020

CT IdentifierNCT04093349

Pompe disease


165

Me

tab

olic

dis

ea

se

s

166

Pipeline summary





Spark


Diagnostics


2020: Geographical sales split by Divisions and Group*

167

CHFm 2019 2020 % change CER

Pharmaceuticals Division 48,516 44,532 -2

United States 26,711 23,647 -6

Europe 8,453 8,198 +1

Japan 4,143 3,765 -6

International 9,209 8,922 +7

Diagnostics Division 12,950 13,791 +14

United States 2,932 3,522 +27

Europe 3,938 4,519 +20

Japan 509 517 +5


Group 61,466 58,323 +1

United States 29,643 27,169 -3

Europe 12,391 12,717 +7

Japan 4,652 4,282 -5


CER=Constant Exchange Rates; *Geographical sales split shown here does not represent operational organization

Pharma Division sales 2020

New products

168CER = Constant Exchange Rates (avg full year 2019); * over 500%

CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER

Erivedge 278 7 186 6 61 3 - - 31 18Perjeta 3,883 18 1,476 2 1,150 10 294 9 963 75Kadcyla 1,745 34 807 34 560 35 90 13 288 37Gazyva 632 21 293 25 211 26 69 8 59 6Esbriet 1,108 4 788 3 266 6 - - 54 5Cotellic 51 -3 12 16 21 -29 - - 18 39Alecensa 1,160 40 343 10 264 29 240 15 313 189Tecentriq 2,738 55 1,566 40 576 72 330 82 266 93Ocrevus 4,326 24 3,408 18 674 41 - - 244 68Hemlibra 2,190 68 1,388 56 373 135 313 40 116 233Xofluza 43 370 37 399 - - - - 6 227

Polivy 169 248 104 117 62 * - - 3 *

Rozlytrek 24 267 19 198 1 * 4 * - -

Phesgo 23 - 23 - - - - - - -

Enspryng 18 - 6 - - - 12 - - -

Evrysdi 55 - 55 - - - - - - -

Total 18,443 32 10,511 24 4,219 34 1,352 32 2,361 76

Global US Europe Japan International

Pharma Division sales 2020

Top 20 products

CER = Constant Exchange Rates (avg full year 2019); * over 500% 169

CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER

Avastin 4,992 -25 1,795 -37 1,252 -27 717 -15 1,228 -2

Ocrevus 4,326 24 3,408 18 674 41 - - 244 68

MabThera 4,223 -31 2,864 -32 379 -33 64 -39 916 -22

Perjeta 3,883 18 1,476 2 1,150 10 294 9 963 75

Herceptin 3,732 -34 1,356 -47 665 -32 140 -40 1,571 -17

Actemra / RoActemra 2,858 32 1,212 36 783 16 366 -5 497 116

Tecentriq 2,738 55 1,566 40 576 72 330 82 266 93

Hemlibra 2,190 68 1,388 56 373 135 313 40 116 233

Xolair 1,904 2 1,904 2 - - - - - -

Kadcyla 1,745 34 807 34 560 35 90 13 288 37

Lucentis 1,444 -16 1,444 -16 - - - - - -

TNKase / Activase 1,321 5 1,268 5 - - - - 53 6

Alecensa 1,160 40 343 10 264 29 240 15 313 189

Esbriet 1,108 4 788 3 266 6 - - 54 5

Pulmozyme 642 -9 437 -12 133 5 1 19 71 -6

Gazyva 632 21 293 25 211 26 69 8 59 6

CellCept 606 -2 62 -21 157 -6 80 -2 307 5

Mircera 470 -17 - - 58 -9 154 -21 258 -15

Madopar 361 8 - - 109 0 - - 252 11

Xeloda 301 -21 7 -68 16 -3 32 -55 246 -10

Pharma Division 44,532 -2 23,647 -6 8,198 1 3,765 -6 8,922 7

Global US Europe Japan International

170

Pharma Division CER sales growth1 in %

Global top 20 products

CER = Constant Exchange Rates; * over 500% 1 Q1-Q4/19 vs Q1-Q4/18; Q1-Q4/20 vs. Q1-Q4/19;

Q1/19 Q2/19 Q3/19 Q4/19 Q1/20 Q2/20 Q3/20 Q4/20

Avastin 9 6 8 -6 -13 -24 -30 -35

Ocrevus 67 59 48 55 38 12 37 10

MabThera -3 -5 -1 -6 -15 -32 -33 -43

Perjeta 41 29 33 16 22 12 17 20

Herceptin -6 -12 -7 -24 -24 -33 -38 -43

Actemra / RoActemra 6 10 9 5 30 40 27 29

Tecentriq 135 146 154 136 99 54 49 35

Hemlibra * * * 313 146 59 57 45

Xolair 1 2 3 0 3 1 3 3

Kadcyla 24 42 54 57 55 26 33 26

Lucentis 11 9 7 7 -13 -25 -5 -22

TNKase / Activase 7 -3 5 0 11 -3 1 11

Alecensa 61 41 50 11 43 27 37 54

Esbriet 10 13 6 9 22 2 5 -9

Pulmozyme 6 0 7 -5 10 -10 -16 -17

Gazyva 35 38 45 51 49 23 15 6

CellCept 4 -4 3 -3 7 -2 -11 -1

Mircera 16 10 11 5 -8 -7 -26 -24

Madopar 16 -1 22 9 5 23 2 4

Xeloda 5 -2 -4 -13 -16 -12 -20 -42

171

Pharma Division CER sales growth1 in %

Top 20 products by region

CER = Constant Exchange Rates; * over 500% 1 Q1-Q4/20 vs. Q1-Q4/19

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Avastin -27 -39 -37 -47 -3 -13 -33 -61 -5 -19 -25 -7 5 -6 -14 8

Ocrevus 29 9 32 5 79 26 56 20 - - - - 119 43 74 55

MabThera -14 -33 -35 -49 -24 -44 -29 -36 -39 -45 -38 -34 -9 -25 -30 -24

Perjeta -1 4 7 0 21 1 13 4 49 11 -9 0 83 50 52 135

Herceptin -38 -46 -49 -59 -32 -33 -30 -31 -26 -45 -46 -43 4 -14 -28 -29

Actemra / RoActemra 44 65 15 19 27 2 10 24 6 -8 -15 1 27 123 209 114

Tecentriq 79 31 37 27 169 90 72 18 111 94 62 75 101 120 74 86

Hemlibra 119 51 50 30 216 92 171 99 207 36 13 15 * 319 58 325

Xolair 3 1 3 3 - - - - - - - - - - - -

Kadcyla 68 36 34 11 43 26 39 34 3 3 7 41 63 12 30 50

Lucentis -13 -25 -5 -22 - - - - - - - - - - - -

TNKase / Activase 10 -3 1 11 - - - - - - - - 27 4 -5 1

Alecensa 29 7 17 -4 51 27 22 22 15 8 8 29 97 107 141 *

Esbriet 20 4 8 -12 28 -3 -2 2 - - - - 23 3 5 -9

Pulmozyme 10 -10 -22 -24 12 0 3 4 - 13 40 -15 8 -25 -6 -7

Gazyva 48 23 29 5 57 13 26 15 95 65 -36 -9 7 16 5 -1

CellCept -15 -31 -29 -6 15 -20 -8 -10 0 -6 -3 1 11 18 -10 4

Mircera - - - - 6 -13 -14 -17 -17 -29 -20 -18 -6 13 -31 -30

Madopar - - - - 13 -11 2 -2 - - - - 2 40 2 6

Xeloda -71 - -15 -51 25 4 -18 -18 -54 -60 -56 -50 1 8 -13 -41

2020

International

20202020 2020

US Europe Japan

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Pharmaceuticals Division 10 11 15 8 7 -6 -4 -7

United States 14 13 14 11 3 -10 -5 -13

Europe -6 -2 5 6 14 -3 2 -8

Japan 7 12 14 3 3 -7 -13 -5

International 17 16 27 2 16 5 -2 11

Diagnostics Division 1 4 6 1 5 2 18 28

Roche Group 8 9 13 6 7 -4 1 1

2019 vs. 2018 2020 vs. 2019

CER sales growth (%)

Quarterly development

CER=Constant Exchange Rates 172

1,836

604

819

163

251

1,645

613

733

114

185

1,171

480

433

97

161

991

322

390

103

176

795

234

314

104

143

935

227

408

166

136

815

235

345

114

122

785

303

274

97

112

714

178

274

127

135

0 500 1,000 1,500 2,000

Southern

European

Countries

Spain

Italy

Portugal

GreeceDec 2020

Dec 2019

Dec 2018

Dec 2017

Dec 2016

Dec 2015

Dec 2014

Dec 2013

Dec 2012

2020: Accounts receivable in Southern Europe decreased

by -61% since Dec 2012

173Sovereign country ratings from Standard & Poor’s, as of 7 January 2021

B+

BBB

BBB

A-

CHFm

-61%

5.78.4

2.58.8

1.9

18.8 19.614.4 15.0 14.2

78.5 80.283.1

80.486.1

31 Dec 2018 30 Jun 2019 31 Dec 2019 30 Jun 2020 31 Dec 2020

7%

10%

3%

11%

2%

Balance sheet: Net debt, gross debt, and total assets

174

Gross debt

(CHFbn)

Total assets

(CHFbn)

Net debt /

total assets

Net debt

(CHFbn)

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

-25%

CER growth

US -37%

Europe -27%

Japan -15%

International -2%

Regional sales CER growth

Avastin


2020 sales of CHF 4,992m

• US: Decline due to biosimilars

• EU: Decline due to biosimilars

• Japan: Decline due to biosimilars

• International: Stable due to volume growth in China compensating for decline in other regions

175

0.0

1.0

2.0

3.0

4.0

5.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+24%

CER growth

US +18%

Europe +41%

International +68%


Ocrevus



• US: Moving into earlier lines displacing orals; gaining market shares in all MS indications and segments;

COVID-19 impact in Q2 with carry-over effect into Q4

• EU: Uptake dynamics in EU5 countries overall similar to the US

176

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

-31%

CER growth

US -32%

Europe -33%

Japan -39%

International -22%


MabThera / Rituxan



• US: Decline due to biosimlars and some COVID-19 impact

• EU: Decline due to biosimlars and some COVID-19 impact

• Japan: Decline due to biosimilars and some COVID-19 impact

• International: Some COVID-19, NRDL price decline and biosimilar impact in China

177

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+18%

CER growth

US +2%

Europe +10%

Japan +9%

International +75%




• US: Increased DoT in eBC compensates for patients with residual disease being switched to Kadcyla

• EU: Growth driven by eBC adjuvant setting; switching of patients with residual disease to Kadcyla

• International: Accelerated growth in all regions, especially in China after NRDL was achieved

• Japan: Growth driven by eBC and mBC

178

Perjeta

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

-34%

CER growth

US -47%

Europe -32%

Japan -40%

International -17%


Herceptin


• US: Biosimilar erosion and switching of patients with residual disease to Kadcyla

• EU: Decline due to biosimilars and switching

• Japan: Decline due to biosimilars

• International: NRDL price decline in China and some biosimilar impact

CER=Constant Exchange Rates 179

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+32%

CER growth

US +36%

Europe +16%

Japan -5%

International +116%


Actemra / RoActemra



• US: Increased demand for SC formulation (home administration) and due to COVID-19 related pneumonia

• EU: Market leadership in 1L RA monotherapy maintained; Growth driven by new RA, GCA and due to

COVID-19 related pneumonia

• International: Strong growth driven by all regions and due to COVID-19 related pneumonia

180

0.0

0.5

1.0

1.5

2.0

2.5

3.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+55%

CER growth

US +40%

Europe +72%

Japan +82%

International +93%


Tecentriq



• US: Growth driven by first-in-class launches in 1L SCLC, 1L TNBC and 1L HCC

• EU: Growth driven by first-in-class launches in 1L SCLC and 1L TNBC and by share gains in 2L NSCLC

• Japan: Growth driven by first-in-class launches in 1L SCLC and 1L TNBC

181

0.0

0.5

1.0

1.5

2.0

2.5

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+68%

CER growth

US +56%

Europe +135%

Japan +40%

International +233%


Hemlibra



• US: Continued share gains in non-inhibitors; Some COVID-19 impact in Q2, but strong recovery in H2

• EU: Growth driven by strong non-inhibitor launches in EU5

• Japan: Very strong uptake in non-inhibitors

182

0.0

0.5

1.0

1.5

2.0

2.5

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+2%

CER growth

US +2%


Xolair



• Xolair remains market leader in a growing biologics asthma market; patients are eager to stay on their

treatments in face of COVID-19

• Growth due to chronic idiopathic urticaria (CIU)

183

0.0

0.4

0.8

1.2

1.6

2.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+34%

CER growth

US +34%

Europe +35%

Japan +13%

International +37%


Kadcyla



• US: Strong uptake in adjuvant eBC in patients with residual disease after neoadjuvant treatment

• EU: Strong uptake in adjuvant eBC in EU-5

• International: Growth driven by all regions

184

0.0

0.4

0.8

1.2

1.6

2.0

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

-16%

CER growth

US -16%


Lucentis



• Decline due to pronounced COVID-19 impact

• Overall market shares stable

185

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+5%

CER growth

US +5%

International +6%


TNKase / Activase



• Growth driven by demand

186

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+40%

CER growth

US +10%

Europe +29%

Japan +15%

International +189%


Alecensa



• US: Growth driven by 1L; new patient share reaching >70%

• EU: Growth driven by 1L; EU-5 new patient share reaching >80%

• Japan: Growth due to 1L new patient share reaching >70%

• International: Growth driven by launch in China following NRDL listing

187

0.0

0.2

0.4

0.6

0.8

1.0

1.2

FY 17 FY 18 FY 19 FY 20

CHFbnGlobal sales

+4%

CER growth

US +3%

Europe +6%

International +5%


Esbriet



• US: Growth driven by continued penetration in moderate and mild patients; improved patient compliance;

patients are eager to stay on their treatments in face of COVID-19

• EU: Growth driven by continued penetration in moderate and mild patients

188

189

Pipeline summary





Spark


Diagnostics


2020: Diagnostics Division CER growth

By Region and Business Area (vs. 2019)

190CER=Constant Exchange Rates; ¹ Europe, Middle East and Africa; * incl. Sequencing business

% CER % CER % CER % CER

CHFm growth CHFm growth CHFm growth CHFm growth

Centralised and Point of Care Solutions 7,273 -1 2,846 11 1,463 2 2,964 -10

Molecular Diagnostics* 3,760 90 1,423 93 1,522 100 815 70

Diabetes Care 1,670 -5 945 -11 288 -1 437 4

Tissue Diagnostics 1,088 5 277 4 594 2 217 11

Diagnostics Division 13,791 14 5,491 19 3,867 26 4,433 1

Global North AmericaEMEA RoW1

Diagnostics Division quarterly sales and CER growth1

191CER=Constant Exchange Rates; ¹ Versus same period of prior year

Centralised and Point 1,681 -1 2,081 5 2,004 9 2,053 -2 1,572 -1 1,609 -17 1,847 -1 2,245 16

of Care Solutions

Molecular 502 7 527 6 518 8 562 4 614 29 944 91 1,020 109 1,182 125

Diagnostics

Diabetes 465 1 493 0 437 -8 523 9 425 -2 407 -9 429 6 409 -14

Care

Tissue 251 -1 275 -4 273 6 305 -1 270 12 238 -8 287 12 293 3

Diagnostics

Diagnostics Division 2,899 1 3,376 4 3,232 6 3,443 1 2,881 5 3,198 2 3,583 18 4,129 28

Q3 20CHFm % CER

Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q4 20CHFm % CERCHFm % CER CHFm % CER CHFm % CERCHFm % CER CHFm % CER

Q2 20CHFm % CER


Growth driven by EMEA and North America, partially offset by Asia Pacific

192CER=Constant Exchange Rates; 1 Europe, Middle East and Africa

CER sales growthCHF 13,791

14%

19%

26%

-3%

14%

5%

Diagnostics

Division

EMEA¹

North

America

Asia

Pacific

Latin

America

Japan

North America

Japan

EMEA1

Asia Pacific

Latin America

28.4%

5.7%

22.7%

3.7%

39.5%

5,491

3,867 3,128

788

517


Growth driven by Molecular Diagnostics, partially offset by Diabetes Care


CHF 13,791CER sales growth

14%

-1%

90%

-5%

5%

Diagnostics

Division

Centralised and

Point of Care

Solutions

Molecular

Diagnostics

Diabetes

Care

Tissue

Diagnostics

Molecular Diagnostics

Centralised and Point of

Care Solutions

Diabetes Care

Tissue Diagnostics

27%

8%

12%

53%

7,273

3,760

1,670

1,088

Centralised and Point of Care Solutions


0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

FY 2018 FY 2019 FY 2020

CHFbn

Immunodiagnostics Clinical Chemistry POC products Other

-6%

-11%

+54%

2020 vs. 2019

CER growth

-1%

+1%

Molecular Diagnostics


0.0

0.4

0.8

1.2

1.6

2.0

2.4

2.8

3.2

3.6

4.0

4.4

FY 2018 FY 2019 FY 2020

CHFbn

Virology LightMix Systems

Blood Screening Cervical Cancer & Microbiology

Other

+90%

+180%

-8%

+189%

2020 vs. 2019

CER growth

+5%

+48%

Diabetes Care


0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2.0

2.2

FY 2018 FY 2019 FY 2020

CHFbn

Blood Glucose Monitoring Other

2020 vs. 2019

CER growth

-4%

-15%

-5%

Tissue Diagnostics


0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

1.1

1.2

1.3

FY 2018 FY 2019 FY 2020

CHFbn

Advanced Staining Companion Dia Primary Staining

2020 vs. 2019

CER growth

+5%

+5%

+8%

2020 vs. 2019

CER growth

-8%

198

Pipeline summary





Spark


Diagnostics


CER = Constant Exchange Rates (avg full year 2019)

Exchange rate impact on sales growth

Negative impact due to all currencies and driven by the USD

199

CER

sales

growth

Full Year 2020

vs.

Full Year 2019

CHF

sales

growth

Full Year 2020

vs.

Full Year 2019

+1.0%

-5.1%

-2.6p

-1.0p

-0.8p

-0.6p

-0.5p-0.3p

-0.3p

CER USD LATAM APAC EUR Other

Europe

Other JPY CHF

CHF/USD

200

Q1

H1

Q3

FY

0.88

0.93

0.98

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

2019 2020

Monthly averages

-4% -4%-8%

0.88

0.93

0.98

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec2019 2020

Year-To-Date averages

-3% -3%-4%

-10%

-5%

CHF/USD

201

FY 2020 -5%

0.88

0.90

0.92

0.94

0.96

0.98

1.00

1.02


avg full year 2019 avg full year 2020 monthly avg 2019 monthly avg 2020

CHF/EUR

202

YTD Average

Q1

H1

Q3

FY

1.01

1.06

1.11

1.16


2019 2020

Monthly averages

-6% -4% -1%

1.01

1.06

1.11

1.16

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec2019 2020

Year-To-Date averages

-6% -6% -5%

-1%

-4%

CHF/EUR

203

FY 2020 -4%

1.01

1.03

1.05

1.07

1.09

1.11

1.13

1.15

1.17


avg full year 2019 avg full year 2020 monthly avg 2019 monthly avg 2020

Average CHF Exchange Rates

204

USD 0.94 0.99

EUR 1.07 1.11

JPY 0.88 0.91

-10% -5% 0% 5% 10%

-5%

-4%

-4%

FY 2020 FY 2019 FY 2020 vs. FY 2019


In 2020 negative impact due to all currencies

205CER = Constant Exchange Rates (avg full year 2019)

6.9%

1.3% 1.2% 1.0%2.1%

-3.9% -4.5% -5.1%

Q1 HY YTD 9 FY

CHF

growth

CER

growth

Sales

growth

2020

vs. 2019

Development of average exchange rates versus prior year period

CHF / USD -2.9% -3.4% -4.5% -5.5%

CHF / EUR -5.8% -5.8% -4.5% -3.8%

CHF / JPY -1.9% -1.8% -3.1% -3.5%

Difference

in CHF / CER -4.8%p -5.3%p -5.7%p -6.1%p

growth


In Q4 2020 negative impact of USD, EUR and JPY

206CER = Constant Exchange Rates (avg full year 2019)

6.9%

-3.9%

0.8% 0.5%2.1%

-9.6%

-5.8%-6.9%

Q1 Q2 Q3 Q4

Sales

growth

2020

vs. 2019

Development of average exchange rates versus prior year period

CHF / USD -2.9% -3.9% -6.7% -8.6%

CHF / EUR -5.8% -5.8% -1.9% -1.6%

CHF / JPY -1.9% -1.3% -5.8% -4.7%

Difference

in CHF / CER -4.8%p -5.7%p -6.6%p -7.4%p

growth

CHF

growth

CER

growth

Doing now what patients need next

Documents

This presentation contains certain forward-looking