Roche : Nine-month 2020 Presentation with appendix

Roche

YTD September 2020 sales

Basel, 15 October 2020

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.

Group

Severin Schwan

Chief Executive Officer

YTD Sep 2020 performance

Outlook

5

Growth despite significant COVID-19 and biosimilar impact

Pharmaceuticals

• Gradual recovery since Q2 2020; end of Q3 2020 back to pre-COVID-19 levels, some uncertainty remains
• Launch of NMEs, readouts & pivotal trial starts on track
• Continued good growth momentum of new products in Q3 2020 (+32%), offsetting severe biosimilar erosion

Diagnostics

• Increase of COVID-19 testing substantially overcompensating negative impact on routine testing in Q3 2020
• New launches and ramp up of SARS-CoV-2 test manufacturing capacity will support growth dynamics in Q4 2020 and 2021

Group

• Major trends expected to continue (e.g. new products growth)
• Strong Diagnostics sales and Pharma new products growth expected to overcompensate for biosimilar erosion and COVID-19

All growth rates at Constant Exchange Rates (CER)

6

YTD Sep 2020: Sales growth driven by Diagnostics Division

	2020	2019	Change in %
	CHFbn	CHFbn	CHF	CER
Pharmaceuticals Division	34.3	36.6	-6	-1
Diagnostics Division	9.7	9.5	2	9
Roche Group	44.0	46.1	-5	1

CER=Constant Exchange Rates

7

Q3 2020: Business recovery - back to growth

16%
14%												13%
12%
10%			8%								9% 9%
8%			7%		7%				7%7%		7%
6%	6%6%	6%		6%	6%
6%	5%		6%	6% 6%	8%	6%
4%					5% 5%		4%	4%	5%
	4%	4%	4%	4%		1%
2%			3%
2%							3%
0%
-2%
-4%												-4%
-6%
	Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
	12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 15 16 16 16 16 17 17 17 17 18 18 18 18 19 19 19 19 20 20 20

All growth rates at Constant Exchange Rates (CER)	8

YTD Sep 2020: Group sales - recovery started in June

%

+60%

+50% +50%

+40%
+30%				+25%	+32%
+20%					+18%
+10%	+7%			+2%
	+5%
+0%
			-6%	-4%
-10%
	Q1/20 vs.	Q2/20 vs.	Q3/20 vs.
	Q1/19		Q2/19	Q3/19
Pharma	Diagnostics	Pharma New Products

Growth rates at CER (Constant Exchange Rates)

Pharmaceuticals

• Recovery in Q3 2020 expected to continue in Q4 2020
• Severe impact from biosimilars

Diagnostics

• Recovery started in June 2020 with easing of restrictions
• COVID-19testing substantially overcompensating negative impact on routine testing in Q3 2020

9

YTD Sep 2020: Group sales - slow recovery in China

CHFm 2,000

-7%

1,500+1%

-6%

1,000

500

0

Q1	Q2		Q3	Q4
			2019		2020

Pharmaceuticals

• Stable performance in 2020 despite COVID-19
• Healthcare system capacity still constrained

Diagnostics

• Solid improvement quarter over quarter in 2020

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

10

YTD Sep 2020: Good sales growth in International and Europe

products and Diagnostics with strong momentum

-2%
+14%	CER growth	CHFm
CHFbn

Diagnostics

Pharma

-4%

nalUS

YTD values reported in CHFm and variances in CERm; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng,	11
Evrysdi; 2 MabThera, Herceptin & Avastin in Europe (Avastin as of Jul 20) and Japan; 3 Herceptin, Avastin & Rituxan in US (Herceptin & Avastin in US as of Jul 19; Rituxan as of Nov 19)

Pharma: New products with strong momentum

Accelerated rejuvenation in Q3 2020

CHFm					% of Pharma Sales
15,000
										40%
12,000
							29%
9,000
						21%
6,000
			15%
3,000
0
	YTD Sep 2017	YTD Sep 2018 YTD Sep 2019 YTD Sep 2020

Pharma sales mix

YTD 2019

42% 29%

29%

YTD 2020

31% 40%

29%

		Erivedge		Perjeta		Kadcyla		Gazyva	New products launched since 2012
		Esbriet		Cotellic		Alecensa		Tecentriq	Other products Herceptin + Rituxan + Avastin
		Ocrevus		Hemlibra		Xofluza		Polivy
		Rozlytrek		Phesgo		Enspryng		Evrysdi	12
All absolute values are presented in CHFm reported

Pharma: Significantly advancing patient care

36	Breakthrough Therapy Designations
	(BTD) since 2013
Year	Molecule		Indication
	mosunetuzumab		3L+ FL
2020	Tecentriq		unresectable or metastatic ASPS
	Esbriet			uILD
	Gavreto		RET fusion-positive NSCLC
	Gavreto		RET mutation-positive MTC
	Cotellic		Histiocytic neoplasms
2019	Gazyva			Lupus nephritis
	rhPentraxin-2		IPF
	Venclexta + Gazyva	1L unfit CLL
	Kadcyla		Adjuvant HER2+ BC
	SPK-8011		Hemophilia A
	Enspryng		NMOSD
2018	Xolair			Food allergies
Tecentriq + Avastin	1L HCC
	Hemlibra		Hemophilia A non-inhibitors
	Rozlytrek		NTRK+ solid tumors
	Polivy + BR		R/R DLBCL
2017	Venclexta + LDAC	1L unfit AML
Zelboraf		BRAF-mutated ECD
	Rituxan		Pemphigus vulgaris

New pivotal study starts in 2020 YTD

			mNSCLC (Ph III: SKYSCRAPER-01),ES-SCLC (Ph III: SKYSCRAPER-02), stage III
tiragolumab	NSCLC (Ph III: SKYSCRAPER-03), cervical cancer (Ph II: SKYSCRAPER-04),
			stage III esophageal cancer (Ph III: SKYSCRAPER-07)
PI3Kαi (RG6114)	HR+ mBC (Ph III: INAVO120)
SERD (RG6171)	1L mBC (Ph III: BO41843)
crovalimab	PNH (Ph III: COMMODORE 1 & 2)
Gavreto	1L RET+ mNSCLC (Ph III: AcceleRET Lung)
Venclexta+Gazyva	1L fit CLL (Ph III: CristaLLo)
Venclexta	1L MDS (Ph III: VERONA)
Tecentriq	NSCLC CPI exp. (Ph III: CONTACT-01), RCC (Ph III: CONTACT-03)
Hemlibra	Mild to moderate HemA (Ph III: HAVEN 6)
Actemra	severe COVID-19 pneumonia (Ph III: COVACTA, REMDACTA, EMPACTA)
Gazyva	lupus nephritis (Ph III: REGENCY)
REGN-COV2	COVID-19 treatment/prophylaxis
PDS	Diabetic retinopathy without CI-DME (Ph III: PAVILION)
		Oncology/Hematology		Immunology			Infectious diseases		Ophthalmology

13

Diagnostics: Comprehensive portfolio launched in a short time1

Clinical Labs

Molecular	•	cobas® SARS-CoV-2	Capacity increased to 20 million tests		Launched
		per month; further ramp-up planned
•	cobas® SARS-CoV-2 & Influenza A/B		Launched
solutions			for 2021
•	TIB MOLBIOL LightMix® Modular SARS-CoV-2		Launched
	•	Elecsys® Anti-SARS-CoV-2	Scale up to 100 million tests per month		Launched
		Elecsys® Anti-SARS-CoV-2 S* 3
Immunology	•			Launched
solutions	•	Elecsys® Anti-SARS-CoV-2 antigen			In-development
	• Elecsys® IL-6 Test to diagnose cytokine release			Launched
		syndrome
		Near Patient

Molecular

solutions

• cobas® SARS-CoV-2 & Influenza A/B

Launched

	•	SARS-CoV-2 rapid antibody			Launched 2
Immunology
•	SARS-CoV-2 rapid antigen	Scale up from 40 million to 80 million		Launched 2,3
solutions			tests per month
•	SARS-CoV-2 rapid antigen (saliva)		In-development2
	• SARS-CoV-2 & Influenza A/B rapid antigen			In-development2

1 not all products are available in all countries; 2 external distribution partnership; 3 not yet approved in the U.S.; *S=spike protein	14

YTD Sep 2020 performance

Outlook

15

2020 outlook confirmed

Further growing top and bottom line

Group sales growth1		• Low- to mid-single digit

Core EPS growth1		• Broadly in line with sales growth

Dividend outlook		• Further increase dividend in Swiss francs

1	At Constant Exchange Rates (CER); based on the current assessment of the COVID-19 impact	16

Pharmaceuticals Division

Bill Anderson

CEO Roche Pharmaceuticals

YTD Sep 2020: Pharmaceuticals Division sales

Good growth in International and Europe

		2020	2019	Change in %
		CHFm	CHFm	CHF	CER
	Pharmaceuticals Division	34,317	36,559	-6	-1
	United States	18,389	20,036	-8	-4
	Europe	6,268	6,310	-1	4
	Japan	2,802	3,076	-9	-6
	International	6,858	7,137	-4	6

CER=Constant Exchange Rates

18

YTD Sep 2020: New medicines compensating for biosimilar erosion

Tecentriq
Ocrevus
Hemlibra
Actemra / RoActemra
Perjeta
Kadcyla
Alecensa
Polivy
Gazyva
Esbriet
Xolair
TNKase / Activase
Xofluza
Lucentis
Avastin
MabThera
Herceptin
CHFm	-2,000

												64%
												29%
												79%
												33%
												17%
										37%
										35%
										>500%
										27%
										9%
										2%
										3%
										286%
						-14%					US
		-22%										Europe
-27%										Japan
-31%											International
-1,600	-1,200	-800	-400	0	400	800	1,200

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

19

New products account for >43% of Pharma sales*

4 NME approvals in 2020: GAVRETO and EVRYSDI approved in Q3

* Venclexta sales are booked by partner AbbVie and therefore not included

20

YTD Sep 2020: Oncology down -8% due to biosimilars & COVID-19

HER2 franchise

• Kadcyla and Perjeta with strong global uptake in adjuvant BC

Avastin franchise

• Biosimilar erosion momentum in EU

Hematology franchise*

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

Tecentriq

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

Alecensa

• Strong growth in China following NRDL listing

CER=Constant Exchange Rates; YTD Sep 2020 Oncology sales: CHF 18.2bn; CER growth -8%; * Venclexta sales booked by AbbVie and therefore not included; Polivy in collaboration with Seagen; BC=breast cancer;	21
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; NDRL=national drug reimbursement list

HER2 franchise: Growth for Perjeta and Kadcyla

CHFm								YoY CER growth
4,000
3,500
3,000
												+9%
						+7%
		+5%
2,500																		-11%
2,000
1,500
1,000
500
0
		Q3 17	Q3 18	Q3 19		Q3 20
					Herceptin			Perjeta			Kadcyla			Phesgo

HER2 franchise Q3 update

• Strong recovery in Q3 following COVID-19 impact in Q2
• Perjeta (+17%): Global growth driven by eBC (APHINITY) and early uptake in China
• Kadcyla (+33%): Growth in adjuvant setting for patients with residual disease (KATHERINE); switching as planned
• Herceptin (-38%): Decline due to global biosimilar erosion and switching to Kadcyla
• First US sales for Phesgo following approval

Outlook 2020

• Global Perjeta and Kadcyla uptake in eBC
• Continued Herceptin biosimilar erosion

CER=Constant Exchange Rates; eBC=early breast cancer

22

Hematology franchise: Growth from Venclexta, Gazyva, and Polivy

CHFm	YoY CER growth

2,000

1,500	0%	-6%	+3%

1,000		-26%

500

0

Q3 17

Q3 18

Q3 19

Q3 20

MabThera/Rituxan (Onc) Gazyva/Gazyvaro Polivy

Hematology franchise Q3 update

CD20 franchise

• MabThera/Rituxan (-34%): Biosimilar erosion in US as expected and market contraction due to COVID-19
• Gazyva (+15%): Growth driven by 1L CLL (CLL14) and 1L FL

Venclexta*

• Strong growth driven by 1L unfit AML
• Ph III (Viale-A) results in 1L unfit AML filed in US (RTOR) and EU

Polivy

• US/EU: Uptake in R/R DLBCL

Outlook 2020

• Strong growth of new products and on-going Rituxan erosion
• ASH: Updates on Polivy combinations and the CD20 x CD3 program including first mosunetuzumab SC data

CER=Constant Exchange Rates; * Venclexta sales are booked by AbbVie; Gazyva in collaboration with Biogen; Polivy in collaboration with Seagen; CLL=chronic lymphocytic leukemia; FL=follicular	23
lymphoma; AML=acute myeloid leukemia; RTOR=real-time oncology review; R/R DLBCL=relapsed/refractory diffuse large B cell lymphoma; SC=subcutaneous

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

17% US patient share in 1L HCC after 4 months

Tecentriq Q3 update

Lung franchise (NSCLC, SCLC)

• US/EU/Japan: Growth driven by 1L SCLC and 1L NSCLC

Breast franchise (TNBC)

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

GI franchise (HCC)

• US: Strong first-in-class launch in 1L HCC

• EU/China: 1L HCC filed

Skin franchise

• US: First approval for triplet combination (CIT+targeted therapy) in BRAF+ mM

CER=Constant Exchange Rates; HCC=hepatocellular cancer; NSCLC=non small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple negative breast cancer; CIT=cancer immunotherapy;	24
mM=metastatic melanoma

Lung franchise: Gavreto new SOC in RET+ mNSCLC

Strong and durable responses including CNS disease control

RET inhibitor	Ph I/II (ARROW) results in RET fusion+ mNSCLC
	Tumor responses	CNS responses

• Oral small molecule kinase inhibitor
• Highly selective for RET fusions and mutations, including predicted resistence mutations
• Brain penetrant and CNS active
• Well-toleratedacross tumor types with most AEs of grade 1-2
• ~1-2%of NSCLC patients with RET fusions, thereof ~40% with brain metastases

Gainor J. F. et al, ASCO 2020

• 70% ORR in naive including 11% CR and 57% ORR in post-platinum patients including 6% CR*
• CNS ORR at 56% (n=9) including 33% CR; rapid and durable responses; mDOR not reached
• Ph III (AcceleRET Lung) in 1L advanced or metastatic RET+ NSCLC on-going
• US accelerated approval in RET+ mNSCLC achieved in Q3 2020; filed in the EU
• US priority review and RTOR for advanced or metastatic RET+ thyroid cancer on-going

Gainor J. F. et al, ASCO 2020; *Data in the label; SOC=standard of care; mNSCLC=metastatic non small cell lung cancer; CNS=central nervous system; BTD=break through designation; AE=adverse events; ORR=overall response rate; CR=complete	25
response; mDOR=median duration of response; Gavreto (pralsetinib) in collaboration with Blueprint Medicines; Gavreto, Blueprint Medicines and associated logos are trademarks of Blueprint Medicines Corporation; Gavreto was discovered by Blueprint

Medicines

Hemophilia A franchise: Hemlibra with strong rebound in Q3

25% total US patient share; Strong launch momentum in EU-5

Hemophilia Q3 update

• US: Gaining market share in non-inhibitors; patients on treatment stay on treatment, COVID-19 impact in Q2, but recovery of new patient starts in Q3
• EU-5:Non-inhibitor patient share already >10% after reimbursement was achieved in all major markets in Q2
• Overall >8,000 patients treated globally
• Hemlibra continues to penetrate across all patient types

Outlook 2020

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

CER=Constant Exchange Rates

26

SMA franchise: Strong virtual US launch of Evrysdi

Patient starts across all segments including Type I and switchers

Broad uptake across segments in first 2 months

Patients treated with all SMA types

~25% of patients with Type I SMA

Naive (~1/3) and switch (~2/3) patients

Pts switching from both Spinraza & Zolgensma

Broad range of ages

3m old infants to 70+ year old adults ~50% of patients under the age of 18 years

Access supported by responsible pricing

25% discount to current SOC over 5-yrs

(at max Evrysdi price)

• No additional administration costs
• Commercial & Medicaid plans moving fast to establish coverage

On-going Ph III development

• Ph II (JEWELFISH) switching study fully recruited (n=174); Prior treatments were olesoxime (n=74), Spinraza (n=73), Zolgensma (n=14); RG7800 (n=13); exploratory efficacy to be reported in 2021
• Ph II (RAINBOWFISH) presymptomatic study enrollment on-going

* Based on the average infant weight in the FIREFISH trial; SMA=spinal muscular atrophy; HCP=health care professional; SOC=standard of care

27

Immunology franchise: Growth for Actemra, Esbriet and Xolair

CHFm

2,500

2,000

1,500

1,000

500

0

YoY CER growth

						+5%
				+7%
							+1%
		+8%

Q3 17	Q3 18	Q3 19	Q3 20
MabThera/Rituxan (RA)		Actemra IV
Actemra SC			Xolair
CellCept			Pulmozyme
Esbriet			Other

Immunology Q3 update

Esbriet (+5%)

• Growth in mild/moderate segments; remains EU market leader

Actemra (+27%)

• Sales positively impacted by COVID-19

Xolair (+3%)

• Remains leader in biologics asthma market; growth in CIU

Rituxan (-32%)

• Decline due to biosimilars

Outlook 2020

• Ph III (REGENCY) Gazyva in lupus nephritis first-patient-in in Q3
• Ph III (STARSCAPE) initation of rhPentraxin-2+SOC in IPF in Q4

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

28

MS franchise: Ocrevus with strong rebound in Q3

Market leadership momentum in US back to pre-COVID-19 levels

Ocrevus Q3 update

• COVID-19impact in April/May due to reduced new patient starts and delayed dosing for existing patients
• Strong rebound in Q3 driven by both returning patients and new patient starts
• Higher dose and 7 yr follow-up OLE data presented at
  ACTRIMS-ECTRIMS

Outlook 2020

• Continued recovery in Q4 as fundamentals remain strong
• Ongoing launches in EU and International
• US approval of shorter infusion
• Higher dose Ocrevus: Ph III (MUSETTE) in RMS and Ph III (GAVOTTE) in PPMS to start
• Fenebrutinib (BTKi): Ph III program in RMS (FENhance) and PPMS (FENtrepid) to start

CER=Constant Exchange Rates; MS=multiple sclerosis; OLE=open-label extension; RMS=relapsing MS; PPMS=primary progressive MS	29

Ophthalmology franchise

PDS filing in nAMD & faricimab results in DME expected in Q4

Port delivery system (PDS)

Faricimab (anti-VEGF/Ang-2 biMab)

• Ph III (ARCHWAY) results in nAMD show more than 98% of patients were able to go six months between treatments
• Generally well tolerated with favorable benefit-risk profile
• US launch in nAMD expected in 2021
• Ph III (PAGODA) in DME restarted after COVID-19 pause; results expected in H1 2022
• Ph III (PAVILION) in DR started in Q3 2020

• Robust Ph II data in DME and nAMD
• COVID-19impact to ongoing trials mitigated with a focus on patient, site, and team safety
• Ph III (YOSEMITE & RHINE) results in DME expected in Q4 2020
• Ph III (LUCERNE & TENAYA) results in nAMD expected in Q1 2021
• Ph III in RVO to start in 2021

nAMD=neovascular age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy; RVO=retinal vein occlusion

30

Infectious diseases: Neutralizing Ab cocktail against SARS-CoV-2

Promising for treatment and prophylaxis

REGN-COV2 (nAb cocktail)		nAb cocktails for treatment & prophylaxis

• Two potent, virus-neutralizing Abs binding non-competitively to the critical receptor-binding domain of the virus' spike protein
• The virus would need to have multiple simultaneous mutations at multiple genetic sites in order to escape the nAb cocktail, which is an unlikely scenario*

Currently enrolling trials:

• Ph II/III study in hospitalized COVID-19 patients
• Ph II/III study in non-hospitalizedCOVID-19 patients
• Ph I multidose study in adult volunteers (pre-exposure)
• Ph III prophylaxis of housemates of infected individuals**

* A. Baum et al., Science 10.1126/science.abd0831 (2020); In collaboration with Regeneron; ** In collaboration with NIAID; nAb=neutralizing antibody	31

Infectious diseases: Neutralizing Ab cocktail against SARS-CoV-2

Early data show reduced viral load & time to symptom alleviation*

Ph I/II/III (Study 2067) results in outpatients

Viral load over time (copies/ml)	Alleviation of symptoms

• The REGN-COV2 nAb cocktail reduced viral load and symptoms vs. placebo in non-hospitalized patients infected with SARS-CoV-2
• Greatest improvements were observed in patients who had not mounted their own effective humoral immune response prior to treatment; these patients were characterized as antibody seronegative and/or showed high viral loads at baseline
• Request for emergency use authorization (EUA) has been submitted

* Data presented at the Regeneron IR call on 29 September; nAb=neutralizing antibody	32

2020: Key late-stage news flow*

Additional 2020 news flow:

• REGN-CoV2: Positive Ph I/II/III results in outpatients; US EUA filed	• Gavreto: US approval in RET fusion positive mNSCLC
• Actemra: Positive Ph III (EMPACTA) in severe COVID-19 related pneumonia	• Gavreto: US priority review and RTOR for advanced or metastatic RET+ thyroid cancer
• Actemra: Ph III (COVACTA) did not meet primary endpoint; potentially clinically	•	Xolair: US filing of prefilled syringe for self-administration across all indications
meaningful benefits in time to hospital discharge and duration of ICU stay	•	Evrysdi: Positive Ph III (FIREFISH part 2) results in type 1 SMA
* Outcome studies are event-driven: timelines may change		33

Diagnostics Division

Thomas Schinecker CEO Roche Diagnostics

YTD Sep 2020: Diagnostics Division sales

Strong growth driven by Molecular Diagnostics

	2020	2019	Change in %
	CHFm	CHFm	CHF	CER
Diagnostics Division	9,662	9,507	2	9
Centralised and Point of Care Solutions	5,028	5,766	-13	-7
Molecular Diagnostics	2,578	1,547	67	77
Diabetes Care	1,261	1,395	-10	-2
Tissue Diagnostics	795	799	-1	5

CER=Constant Exchange Rates; underlying growth of Molecular Diagnostics excluding sequencing business: +88%

35

YTD Sep 2020: Diagnostics Division regional sales

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

		Japan
North America		+5%
+22%	EMEA1	~4% of divisionalsales
~28% of divisional sales	+9%
	~38% of divisional sales

		Asia Pacific
Latin America
	-4%
+12%
	~24% of divisional sales
~6% of divisional sales

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

36

YTD Sep 2020: Diagnostics Division highlights

Strong growth driven by Molecular Diagnostics

Centralised

and Point

of Care

Solutions

Molecular Diagnostics1

Diabetes

Care

Tissue Diagnostics

CHFbn 0.0

YoY CER growth

-7%

+77%

-2%

											EMEA2
	+5%
									North America
											RoW
1.0	2.0	3.0	4.0	5.0	6.0

• Immunodiagnostics (-8%)
• Clinical Chemistry (-12%)
• POC3 Immunodiagnostics (+120%)
• Virology (+156%)
• LightMix Systems (+188%)
• POC3 Molecular (+46%)
• Blood glucose monitoring (-1%)
• Insulin delivery systems (-15%)
• Advanced staining (+4%)
• Companion diagnostics (+23%)

1 Underlying growth of Molecular Diagnostics excluding sequencing business: +88%; 2 EMEA=Europe, Middle East and Africa; 3 POC=point of care; CER=Constant Exchange Rates

37

SARS-CoV-2 diagnostics portfolio1

Comprehensive portfolio of tests and digital solutions

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

Immunology

solutions

• Elecsys® Anti-SARS-CoV-2
• Elecsys® Anti-SARS-CoV-2 S2,4
• Elecsys® Anti-SARS-CoV-2 antigen
• Elecsys® IL-6 Test to diagnose cytokine release syndrome

Launched

Launched

In-development

Launched

• SARS-CoV-2rapid antibody
• SARS-CoV-2rapid antigen
• SARS-CoV-2rapid antigen (saliva)
• SARS-CoV-2& Influenza A/B rapid antigen

Launched3

Launched3,4

In-development3

In-development3

	Digital					•	NAVIFY Remote Monitor5	Launched
					•	v-TAC6 digital algorithm for blood-gas
				Launched
• Viewics LabOps COVID-19 for efficiency	Launched
	solutions	improvements			•	iThemba Life COVID-19
		Launched
	Q3 Launch	Q4 Launch
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	38

New COVID-19 tests in near-patient setting

Fast answers to support clinical decision making

SARS-CoV-2 Rapid Antigen Test	cobas® SARS-CoV-2 & Influenza A/B Test for use on
	the cobas® Liat® System

• Rapid chromatographic immunoassay detecting specific antigens in human nasopharynx
• Instrument-freeresults in 15 minutes
• Excellent clinical performance for symptomatic (n=70) and asymptomatic (n=339) patients2:
• • Specificity 99.68% (n=311 negative samples)
  • Sensitivity 96.52% (n=115 positive samples)
• Production capacity >40M1 tests/month; Launch in >100 countries

• Highly sensitive and specific multiplex test with the ability to differentiate SARS-CoV-2 and influenza A/B in 20 minutes
• Lab like clinical performance
• Result in 20 minutes
• cobas® Liat System global installed base >5,000

1 Including SARS-CoV-2 Rapid Ab test production from our partner SD Biosensor; 217 additional patients classified under "other"

39

cobas® 6800/8800 menu expansion driving growth in molecular

More than 1000 systems installed

Donor Screening		Infectious Disease		Sexual Health		Transplant
MPX		HIV-1		HPV		CMV
WNV		HBV		CT/NG
			EBV
DPX		HCV		TV/MG
			BKV
HEV		HIV-1/2 Qual		HPV Self-sampling
Not available in the US				CE-IVD in 2021
CHIKV/DENV
Not available in the US
Zika
Babesia
Malaria
Global launch in 2023 (pre-DG est)

Installed instrument base >1,000

RespiratoryAntimicrobial Stewardship

MTB	MTB-RIF/INH
Not available in the US	Not available in the US

MAI

Not available in the US

SARS-CoV-2

EUA & CE-mark

SARS-CoV-2 & Influenza A/B

EUA & CE-mark

MPLX Respiratory

(CE-IVD in 2022, US-IVD in 2023)

Launched in 2020

In development

MPX=multiplex detection of HIV-1,HIV-2, HCV and HBV; WNV=West Nile virus; DPX=duplex detection of parvovirus B19 and HAV; HEV=Hepatitis E virus; CHIKV=chikungunya virus; DENV=Dengue virus; CMV=Cytomegalovirus; MTB=Mycobacterium	40
tuberculosis; MAI=Mycobacterium avium-intracellulare infection; RIF=rifampicin; INH=isoniazid (detection of RIF/INH resistance in MTB positive samples); TV=trichomonas vaginalis; MG=mycoplasma genitalium; Babesia=detection of babesiosis caused

by tick-born parasites; EBV=Epstein-Barr virus post-transplant monitoring; BKV=BK virus post-transplant monitoring; ADV=Adenovirus post-transplant monitoring; HSV-1/2/VZV=multiplex detection of Herpes simplex virus 1 and 2 and Varicella-zoster virus; MPLX=detect and discriminate multiple (up to 14) pathogens associated with a clinical syndrome, including SARS-CoV-2;Malaria=mosquito-borne infectious disease; SARS-CoV-2=2019 novel coronavirus

Improving care for transplant patients

FDA authorized cobas® EBV & cleared cobas® BKV; the first quantitative PCR tests

			Pre-transplantation		Post-transplantation
	EBV* serology to determine the infection stage of donor		Viral load tests (NAT) are used to monitor high risk
			and recipients		transplant patients
Elecsys	®	EBV EBNA IgG	In-Development		cobas® EBV**		FDA BDD
	Launched
Elecsys® EBV VCA IgG	In-Development		cobas® BKV**		FDA BDD
	Launched
Elecsys® EBV IgM
In-Development
	Organ characterization donor & recipient screening		Virus Load Monitoring

* EBV infections account for more than 150,000 cases of cancer each year and for 1.8% of all cancer-related deaths worldwide1-2; Sources: 1. de Martel C et al. Lancet Oncol. 2012;13(6):607-15.	41
2. Khan G et al. Infect Agent Cancer. 2014;9(1):38; **CE IVD and FDA; EBV=Epstein-Barr Virus; BKV= BK polyomavirus; NAT= Nucleic acid test; PCR=Polymerase chain reaction

Improving diagnostics for HIV/AIDS

FDA approval for cobas® HIV-1/2 Qual & Elecsys® HIV Duo

	Blood / Plasma	Diagnosis	Early Infant	Confirmatory	Baseline and
	Donor Screening	Diagnosis	Monitoring
Molecular	cobas® MPX1 on cobas®			cobas® HIV-12 Qual on cobas® 6800/8800 Systems
solutions	6800/8800 Systems

cobas® HIV-1/2 Qual on cobas® 6800/8800 Systems

Immunology		Elecsys® HIV Combi PT3,5
solutions
		Elecsys® HIV Duo4,5

US Launch 2020

1 MPX=multiplex detection of HIV-1,HIV-2, HCV and HBV; 2 there is not a confirmatory claim for cobas HIV-1 in the US, only CE; 3 for cobas e 411 analyzer and cobas e 601/602 modules and not available for Blood/Plasma Donor Screening in the	42
US; 4 for cobas e 801 and not available for Blood/Plasma Donor Screening in the US; 5 Covers individuals two years and older; HIV=human immunodeficiency virus; AIDS=acquired immunodeficiency syndrome

Key launches 2020

	Area	Product	Description	Market1
Instruments/	Workflow	cobas	®	prime	Next generation pre-analytical platform to support cobas® 6800/8800 Systems	CE
Devices	Diabetes	Accu-Chek Solo Diabetes	Integration of the Accu-Chek Guide test strip technology into the Accu-Chek	CE
Care	Manager	Solo Diabetes Manager (remote control)
		Elecsys® EBV EBNA IgG	EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA
		Elecsys® EBV VCA IgG	CE
					IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
	Infectious	Elecsys® EBV IgM
	Diseases	cobas® HIV-1/2 Qual	Qualitative detection, differentiation, and confirmation of HIV-1 & HIV-2	US
Tests/		cobas® EBV	Monitoring tests for transplant patients to aid in the management of EBV and	US
	cobas® BKV	BKV infections
Assays
	Cervical	cobas	®	HPV (6800/8800)	The world's leading cobas® HPV assay for use on the fully automated cobas®	US
		6800/8800 Systems
	Cancer	CINtec PLUS Cytology	Next generation "Pap" test which leverages p16/Ki-67dual-stain biomarker	US
					technology on cervical cytology samples
		VENTANA HER2 Dual ISH	Fully automated, brightfield ISH assay to determine eligibility for HER2 targeted	US
	Tissue Dx	therapy
	Algorithm - HER2 (4B5)	Whole slide image analysis algorithm for HER2 (4B5)	CE
	Sequencing	NAVIFY Mutation Profiler	Software as a medical device for annotating, variant classification, clinical	US
	interpretation and reporting from comprehensive genomic profile testing
		RocheDiabetes InsulinStart	A messaging service designed for people with type 2 diabetes to ease the	CE
Software		transition from oral antidiabetics to a complimentary insulin therapy
Diabetes
mySugr app	Enabling control of the Accu-Chek Insight insulin pump from the mySugr app	WW
	Care
	RocheDiabetes Care Platform	New releases with improved features focusing on device connectivity, integration	WW
		of 3rd parties, and healthcare professionals' workflow optimisation
1 CE: European Conformity, US: FDA approval, WW: Worldwide; EBV=Epstein-Barr virus; BKV=BK virus	43

Finance

Alan Hippe

Chief Financial Officer

YTD Sep 2020: Highlights

Sales

• Group sales growth (+1%); driven by Diagnostics Division (+9%), Pharma International (+6%) and Pharma Europe (+4%)
• Gradual recovery since Q2 2020

Currency impact on sales

• Negative currency impact due to all currencies, particularly USD

All growth rates at Constant Exchange Rates (CER)

45

Group sales YTD Sep 2020

CER sales increase of +1% driven by Diagnostics Division, Pharma International & Europe; Fx impact of -6%p

-4%	+4%	+6%	-6%		+1%		-5%
	Pharma Division		Dia Division
	-1%			+9%
				+815	+535
-788		+436	-185
	+257					-2,622	-2,087
	PY: -63
United States	Europe	Intl.	Chugai	Dia Division	Group	Fx 1	Group
			(Japan)				CHF

Absolute values in CHFm at Constant Exchange Rates (avg full year 2019); 1 avg full year 2019 to avg YTD Sep 2020 fx

46

High currency impact expected in 2020

CHF / USD
Average	-3%			-3%			-4%			-5%
YTD 2019				1.00			1.00			0.99	Assuming the 30 September 2020 exchange rates
		1.00
		0.97						0.95			0.94		remain stable until end of 2020,
				0.97								2020 impact 1 is expected to be (%p):
		Assumed average YTD 2020
0.97	0.97	0.96	0.97	0.97	0.95	0.94	0.91	0.91	0.92	0.92	0.92		Q1	HY	Sep	FY
			YTD
			Monthly avg fx rates 2020				FX rates at 30 September
							2020
											Sales	-5	-5	-6	-6
CHF / EUR
		-6%			-6%			-5%			-4%	Core operating	-7		-9
												profit
		1.13			1.13			1.12			1.11
												Core EPS	-8		-9
		1.07			1.06			1.07			1.07
1.08	1.07	1.06	1.06	1.06	1.07	1.07	1.08	1.08	1.08	1.08	1.08
1 On group growth rates														47

2020 outlook confirmed

Further growing top and bottom line

Group sales growth1		• Low- to mid-single digit

Core EPS growth1		• Broadly in line with sales growth

Dividend outlook		• Further increase dividend in Swiss francs

1	At Constant Exchange Rates (CER); based on the current assessment of the COVID-19 impact	48

Changes to the development pipeline

Q3 2020 update

New to phase I	New to phase II		New to phase III		New to registration
7 NMEs:	2 NMEs:	4 NMEs:		1 NME:
RG6091 UBE3A LNA - Angelman syndrome	RG7992 FGFR1 x KLB - NASH	RG6107 crovalimab - PNH		RG6396 Gavreto (pralsetinib) - RET fusion-
RG6286 NME - colorectal cancer	CHU Oncolytic Type 5 adenovirus - esophageal	RG6413+RG6412 REGN-COV2 - SARS-CoV-2		positive NSCLC
RG6315 NME - systemic sclerosis	cancer	prophylaxis
RG6330 KRAS G12C - KRAS-mutant solid tumors		RG6171 SERD(3) ER+/HER2 - metastatic breast		2 AIs:
RG6418 NLRP3 inhibitor - inflammation	5 AIs:	cancer		RG3648 Xolair - asthma home use
4D-MT 4D-R125 - X-linked retinitis pigmentosa	RG6171 SERD(3) - neoadjuvant HR+ breast	7 AIs:		RG6396 Gavreto (pralsetinitb) - RET-mutant
CHU CD137 agonist switch antibody - solid tumors	cancer	RG6058 tiragolumab+Tecentriq - stage III		medullary thyroid cancer (MTC)
		RG6413+RG6412 REGN-COV2 - COVID-19+	unresectable 1L NSCLC
2 AIs:	adult - ambulatory	RG6058 tiragolumab+Tecentriq - locally adv
RG7440 ipatasertib+Tecentriq - prostate cancer	RG6413+RG6412 REGN-COV2 - COVID-19+	esophageal cancer
previously treated with androgen receptor-targeted	adult - hospitalized	RG6321 PDS with ranibizumab - diabetic
therapy		retinopathy
RG7446 Tecentriq+Venclexta - maintenance 1L		RG7159 Gazyva - lupus nephritis
ES-SCLC		RG7601 Venclexta - 1L MDS
			RG7446 Tecentriq+cabozantinib - adv RCC
			RG7446 Tecentriq+cabozantinib - 2L NSCLC
Removed from phase I	Removed from phase II		Removed from phase III		Approvals

2 NMEs:	2 AIs:	3 AIs:
RG6000 DLK inhibitor - ALS	RG7421 Cotellic+Tecentriq+/- taxane - TNBC	RG7413 etrolizumab - ulceritis colitis
RG7861 anti-S.aureus - infectious diseases	RG7596 Polivy - r/r FL*	RG7446 Tecentriq+paclitaxel - 1L TNBC
		RG7446 Tecentriq+ chemo + Avastin - ovarian
		cancer

Status as of October 15, 2020 * FL cohort removed, DLBCL continues

3 NMEs approved in US RG7916 Evrysdi - SMA RG6168 Enspryng - NMOSD

RG6396 Gavreto - RET fusion positive NSCLC

1 NME approved in EU

RG6268 Rozlytrek - ROS1+ NSCLC

1 AI approved in US

RG7421 Cotellic+Zelboraf+Tecentriq - 1L+ BRAFm melanoma

1 AI approved in EU

RG6268 Rozlytrek - NTRK+ tumor-agnostic

49

Roche Group development pipeline

Phase I (45 NMEs + 17 AIs)

Phase II (21 NMEs + 14 AIs)

RG6026	glofitamab 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	FcRH5 x CD3			r/r MM
RG6171	SERD (3)			ER+/HER2- mBC 1L
RG6180	iNeST*± T			solid tumors
RG6185	belvarafenib (pan-RAF inh)+Cotellic	solid tumors
RG6194	HER2 x CD3			BC
RG6279	PD1-IL2v			solid tumors
RG6286	NME			colorectal cancer
RG6290	MAGE-A4 ImmTAC			solid tumors
RG6292	CD25 MAb			solid tumors
RG6296	BCMA x CD16a			r/r MM
RG6323	IL15/IL15Ra-Fc			solid tumors
RG6330	KRAS G12C			solid tumors
	ipatasertib + Taxane + T			TNBC
RG7440	ipatasertib + rucaparib			mCRPC, solid tumors
	ipatasertib	.prostate cancer, pretreated
	Morpheus platform			solid tumors
	T + Avastin + Cotellic			2/3L CRC
	T ± Avastin ± chemo			HCC, GC, PaC
RG7446	T + anti-CD20 combos			heme tumors
T + K/HP			HER2+ BC
	T + rucaparib			ovarian cancer
	T + CD47 MAb			r/r AML
	T + Venclexta		maintenance 1L ES-SCLC
RG7461	simlukafusp alfa combos			solid tumors
	Venclexta + AMG176			AML
RG7601	Venclexta ± azacitidine			r/r MDS
	Venclexta + gilteritinib			r/r AML

*Individualized Neoantigen Specific Immunotherapy; T=Tecentriq Status as of October 15, 2020

RG7769	PD1 x TIM3				solid tumors
RG7802	cibisatamab ± T				solid tumors
RG7827	FAP-4-1BBL + T				solid tumors
RG7828	mosunetuzumab 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	NME				systemic sclerosis
RG7835	IgG-IL2				autoimmune diseases
RG6084	-				HBV
RG6346	HBV siRNA				HBV
RG6091	UBE3A LNA				Angelman syndrome
RG6102	brain shuttle gantenerumab		Alzheimer's
RG6237	-			neuromuscular disorders
RG7637	-	.	neurodevelopmental disorders
RG7816	GABA Aa5 PAM				autism
RG6179	-				DME
RG6247	4D-R110				choroideremia
RG7921	-				nAMD
4D-MT	4D-R125		X-linked retinitis pigmentosa
CHU	PTH1 recep. ago				hypoparathyroidism
CHU	-				hyperphosphatemia
	New Molecular Entity (NME)				CardioMetabolism
	Additional Indication (AI)				Neuroscience
	Oncology / Hematology				Ophthalmology
	Immunology				Other
	Infectious Diseases

RG6171	SERD (3)			neoadjuvant HR+ BC
RG6180	iNeST* + pembrolizumab	malignant melanoma
RG6357	SPK-8011			hemophilia A
RG6358	SPK-8016	hemophilia A with inhibitors to factor VIII
RG6058	tiragolumab + T			NSCLC
tiragolumab + T			cervical cancer
RG7446	Tecentriq			SC NSCLC
RG7601	Venclexta + fulvestrant		2L HR+BC
Venclexta + carfilzomib		r/r MM t(11:14)
CHU	Oncolytic Type 5 adenovirus	esophageal cancer
RG6149	ST2 MAb			asthma
RG6173	anti-tryptase			asthma
RG6354	rhPTX-2(PRM-151)		myelofibrosis
rhPTX-2(PRM-151)	.	idiopathic pulmonary fibrosis
RG7845	fenebrutinib			RA
RG7880	IL22-Fc			inflammatory diseases
RG6149/RG7880	ST2 MAb or IL22-Fc		COVID-19 pneumonia
NOV	TLR4 MAb			autoimmune diseases
RG7854+RG7907	TLR7 ago(3) + CpAM (2)	HBV
RG6413+	REGN-COV2 nAbs	.	. COVID-19+adult-ambulatory
RG6412	REGN-COV2 nAbs		COVID-19+adult-hospitalised
RG7992	FGFR1 x KLB MAb		NASH
IONIS	ASO factor B			IgA nephropathy
RG6100	semorinemab			Alzheimer's
RG6356	microdystrophin (SRP-9001)	DMD
RG7412	crenezumab			familial Alzheimer's healthy pts
RG7906	ralmitaront			schizophrenia
RG7935	prasinezumab			Parkinson's
RG6147	-			geographic atrophy
RG6367	SPK-7001			choroideremia
RG7774	-			retinal disease
IONIS	ASO factor B			geographic atrophy

RG-No - Roche/Genentech	SQZ - SQZ Biotechnology managed	50
CHU - Chugai managed	NOV - Novimmune managed
IONIS - IONIS managed	4D-MT - 4D-MT managed

Roche Group development pipeline

Phase III (12 NMEs + 34 AIs)

Registration (5 NMEs + 11 AIs)

RG6013	Hemlibra	mild to moderate hemophilia A
	tiragolumab + T + chemo		1L SCLC
RG6058	tiragolumab + T		1L PD-L1+ NSCLC
tiragolumab + T	locally advanced esophageal cancer
	tiragolumab + T	.stage III unresectable 1L NSCLC
RG6107	crovalimab			PNH
RG6114	mPI3K alpha inh			1L HR+ mBC
RG6171	SERD (3)			ER+/HER2- mBC
	ipatasertib + abiraterone		1L CRPC
RG7440	ipatasertib + chemo			1L TNBC/HR+ BC
ipatasertib + fulvestrant + palbociclib	1L HR+ mBC
	ipatasertib + Tecentriq + taxane		1L TNBC
RG7596	Polivy			1L DLBCL
	Tecentriq			NSCLC adj
	Tecentriq			NMIBC, high risk
	Tecentriq			RCC adj
	Tecentriq + cabozantinib		advanced RCC
	Tecentriq + cabozantinib		2L NSCLC
RG7446	T ± chemo			SCCHN adj
Tecentriq			HER2+ BC neoadj
	T + capecitabine or carbo/gem		1L TNBC
	T + paclitaxel			TNBC adj
	T + nab-paclitaxel			TNBC neoadj
	T + Avastin			HCC adj
	T ± chemo			1L mUC

T=Tecentriq

RG7446/	Tecentriq bTMB-high			1L NSCLC
RG6268	or entrectinib ROS1+
RG7601	Venclexta			r/r MM t(11:14)
Venclexta + azacitidine			1L MDS
RG7853	Alecensa		ALK+ NSCLC adj
RG1569	Actemra	COVID-19 pneumonia
RG1569	Actemra + remdesivir	COVID-19 pneumonia
RG3648	Xolair			food allergy
RG7159	Gazyva			lupus nephritis
RG7413	etrolizumab			Crohn's
	Xofluza	influenza, hospitalized pts
RG6152	Xofluza	influenza, pediatric (0-1 year)
	Xofluza	influenza direct transmission
RG6413+	REGN-COV2 nABs	SARS-CoV2 prophylaxis
RG6412
RG1450	gantenerumab			Alzheimer's
RG6042	tominersen			Huntington's
	port delivery system with ranibizumab	.	wAMD
RG6321	port delivery system with ranibizumab	.	DME
	port delivery system with ranibizumab		DR
RG7716	faricimab			DME
faricimab			wAMD

RG6264	Phesgo 1 Perjeta + Herceptin FDC SC	HER2+ BC
RG6396	Gavreto (pralsetinib) 1			RET+ NSCLC
Gavreto (pralsetinib) 2			RET+ MTC
RG7446	Tecentriq Dx+ 1		1L sq + non-sq NSCLC
Tecentriq+ Avastin 1			1L HCC
RG7601	Venclexta + azacitidine			1L AML
RG7853	Alecensa				1LNSCLC Dx+
RG3648	Xolair 3				nasal polyps
Xolair 2				asthma home use
		Xofluza 1				influenza
RG6152	Xofluza 1				influenza, high risk
Xofluza	influenza post exposure prophylaxis
		Xofluza 2		influenza, pediatric (1-12 yrs)
RG1594	Ocrevus 3		short infusion RMS & PPMS
RG6168	Enspryng (satralizumab) 1			NMOSD
RG7916	Evrysdi (risdiplam) 1				SMA
1 Approved in US, filed in EU
2 Filed in US
3 Filed in US, approved in EU
	New Molecular Entity (NME)			CardioMetabolism
	Additional Indication (AI)			Neuroscience
	Oncology / Hematology			Ophthalmology
	Immunology			Other
	Infectious Diseases

51

Status as of October 15, 2020

NME submissions and their additional indications

Projects in phase II and III

	Port Delivery System		tiragolumab +	RG7907+	TLR7 ago (3)
RG6321	with ranibizumab	RG6058	Tecentriq (T)	+ CpAM (2)
RG7854
	wAMD		1L PD-L1+ cervical ca	HBV

	Xofluza ✓	RG6413+	REGN-COV2		Crovalimab		tiragolumab + T		FGFR1 x KLB MAb		rhPTX-2
RG6152	influenza, pediatric	RG6107	RG6058	RG7992	RG6354	(PRM-151)
RG6412	SARS-CoV2 prophylaxis	PNH	1L PD-L1+ NSCLC	NASH
	(1-12 yrs)					IPF
	Xofluza ✓	RG6413+	REGN-COV2		tominersen		tiragolumab + T		ralmitaront		rhPTX-2
RG6152	influenza post-exposure	COVID-19+	RG6042	RG6058	locally adv esophageal	RG7906	RG6354	(PRM-151)
RG6412	Huntington's	schizophrenia
	prophylaxis	adult-ambulatory			cancer			myelofibrosis
	Evrysdi (risdiplam)	RG6413+	REGN-COV2		gantenerumab		tiragolumab + T		microdystrophin		ST2 MAb
RG7916	COVID-19+	RG1450	RG6058 Stage III unresectable 1L	RG6356	SRP-9001	RG6149
SMA (EU)	RG6412	Alzheimer's	asthma
	adult-hospitalized			NSCLC		DMD
	Gavreto		Xofluza		etrolizumab		mPI3K alpha inh		semorinemab		Anti-tryptase
RG6396	(pralsetinib) ✓	RG6152	influenza, pediatric	RG7413	RG6114	RG6100	(Tau MAb )	RG6173
Crohn's	1L HR+ BC	asthma
	RET+ NSCLC		(0-1 year)				Alzheimer's
	Gavreto		Xofluza		Xofluza		iNeST**		prasinezumab		fenebrutinib
RG6396	(pralsetinib) ✓*	RG6152	RG6152	RG6180	RG7935	RG7845
influenza, hospitalized	direct transmission	oncology	Parkinson's	autoimmune diseases
	RET+ MTC
	ipatasertib +		faricimab		Port Delivery System		ipatasertib + fulv +		SERD(3)	RG7880	IL22-Fc
RG7440	abiraterone	RG7716	RG6321	with ranibizumab	RG7440	palbociclib	RG6171
DME	ER+/HER2- mBC		inflammatory diseases
	1L CRPC			DME		1L HR+ mBC
	ipatasertib + chemo		faricimab		tiragolumab +		ipatasertib +		SERD(3)		Port Delivery System
RG7440	RG7716	RG6058	Tecentriq	RG7440	Tecentriq + taxane	RG6171	RG6321	with ranibizumab
1L TNBC / HR+ BC	wAMD	neoadjuvant HR+ BC
			1L SCLC		1L TNBC			DR
	2020		2021		2022			2023 and beyond

• Indicates submission to health authorities has occurred

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

Status as of October 15, 2020

New Molecular Entity (NME)		CardioMetabolism
Additional Indication (AI)		Neuroscience
Oncology / Hematology		Ophthalmology
Immunology		Other
Infectious Diseases			52
	**Individualized Neoantigen Specific Immunotherapy

AI submissions for existing products

Projects in phase II and III

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

RG3648	Xolair ✓
Asthma home use
RG1569	Actemra
COVID-19 pneumonia
	Cotellic + Tecentriq +
RG7421	Zelboraf ✓
	1L+ BRAFm melanoma
RG7446	Tecentriq + nab-paclitaxel	RG1569		Actemra + remdesivir
TNBC neoadj		COVID-19 pneumonia
RG7446	Tecentriq ± chemo	RG6013		Hemlibra
	Mild to moderate
1L mUC
			hemophilia A (EU)
RG7446	Tecentriq + Avastin ✓	RG6268		Rozlytrek (BFAST)	RG3648		Xolair
1L HCC		1L NSCLC ROS1+		Food allergy
RG7601	Venclexta +azacitidine ✓	RG7446		Tecentriq (BFAST)	RG7446		Tecentriq
1L AML		1L NSCLC bTMB-high		NSCLC adj
RG7853	Alecensa (BFAST) ✓	RG7596		Polivy	RG7446		Tecentriq
1L NSCLC ALK+		1L DLBCL		RCC adj

RG7446	Tecentriq + Avastin
HCC adj
RG7446	Tecentriq SC
NSCLC
RG7446	Tecentriq
HER2+ BC neoadj
RG7446	Tecentriq + paclitaxel
TNBC adj
RG7446	Tecentriq
High risk NMIBC
RG7446	Tecentriq + chemo
SCCHN adj
	Tecentriq + capecitabine
RG7446	or carbo/gem
	TNBC
RG7446	Tecentriq + cabozantinib
adv RCC
RG7446	Tecentriq + cabozantinib
2L NSCLC

RG7159	Gazyva
lupus nephritis
	Venclexta
RG7601
r/r MM t(11:14)
RG7601	Venclexta + carfilzomib
r/r MM t(11:14)
RG7601	Venclexta + azacitidine
1L MDS
RG7601	Venclexta + fulvestrant
2L HR+BC
RG7853	Alecensa
ALK+ NSCLC adj

2020	2021	2022	2023 and beyond
Status as of October 15, 2020	✓ Indicates submission to health authorities has occurred		53

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

Major pending approvals 2020

US

EU

China

Japan-Chugai

	Xolair		Enspryng (satralizumab)		CellCept
RG3648	nasal polyps	RG6168	NMOSD	RG99	lupus nephritis
	Filed Sept 2019		Filed Aug 2019		Filed Aug 2018
	Alecensa (BFAST)		Tecentriq		Avastin
RG7853	1L NSCLC ALK+	RG7446	1L non-sq + sq NSCLC Dx+	RG405	1L/2L glioblastoma
	Filed Jan 2020		Filed Nov 2019		Filed Jan 2019
	Ocrevus		Xofluza		MabThera
RG1594	Short infusion RMS & PPMS	RG6152	influenza	RG105	CLL and FL
	Filed Feb 2020		Filed Nov 2019		Filed Apr 2019
	Xofluza		Xofluza		Tecentriq +Avastin
RG6152	post exposure prophylaxis	RG6152	influenza, high risk	RG7446	1L HCC
	Filed March 2020		Filed Nov 2019		Filed Jan 2020
	Xofluza	RG6152	Xofluza		Evrysdi (risdiplam)
RG6152	influenza, pediatric (1-12 yrs)	post exposure prophylaxis	RG7916	SMA
	Filed March 2020		Filed Nov 2019		Filed March 2020
	Venclexta+ azacitidine		Tecentriq +Avastin		Enspryng (satralizumab)
RG7601	1L AML	RG7446	1L HCC	RG6168	NMOSD
	Filed May 2020		Filed Jan 2020		Filed April 2020
	Gavreto (pralsetinib)		Phesgo FDC SC		Xofluza
RG6396	RET+ MTC	RG6264	Her2+BC	RG6152	influenza
	Filed July 2020		Filed Jan 2020		Filed May 2020
			Venclexta+ azacitidine		Xofluza
		RG7601	1L AML	RG6152	influenza, high risk
			Filed May 2020		Filed May 2020
			Gavreto (pralsetinib)		Hemlibra
		RG6396	RET+ NSCLC	RG6013	Hemophilia A
			Filed May 2020		Filed June 2020
					Gazyva
				RG7159	1L FL and r/r FL
					Sept 2020
					Tecentriq
				RG7446	1L non-sq + sq NSCLC Dx+
					Filed Sept 2020
					Tecentriq + pemetrexed
				RG7446	1L non-sq NSCLC
Status as of October 15, 2020				Filed Sept 2020

Polivy

RG7596r/r DLBCL

Filed June 2020

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

FDC = fixed-dose combination

54

Major granted approvals 2020

US		EU	China	Japan-Chugai

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

	Polivy		Kadcyla	RG6268	Rozlytrek (entrectinib)
RG7596	r/r DLBCL	RG3502	HER2+ eBC	ROS1+ NSCLC
	January 2020		Jan 2020		Feb 2020
	Venclexta+Gazyva		Tecentriq + chemo		Alecensa
RG7601	1L CLL	RG7446	1L extensive stage SCLC	RG7853	r/r ALK+ ALCL
	Mar 2020		Feb 2020		Feb 2020
	Ocrevus				Rituxan
RG1594	Short infusion RMS & PPMS			RG105	thrombocytopenic purpura
	May 2020				Feb 2020
				Enspryng (satralizumab)
	Rozlytrek (entrectinib)			RG6168
			NMOSD
RG6268	ROS1+ NSCLC
			June 2020
	Aug 2020
				Kadcyla
	Rozlytrek (entrectinib)			RG3502
			HER2+ eBC adj
RG6268	NTRK+ tumor-agnostic
			Aug 2020
	Aug 2020
				Tecentriq +Avastin
				RG7446	HCC
					Sept 2020

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

FDC = fixed-dose combination

Status as of October 15, 2020

55

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 YTD Sep 2020 sales

Diagnostics

Foreign exchange rate information

56

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

Indication	Hemophilia A patients	Hemophilia A pediatric patients
with inhibitors to factor VIII	with inhibitors to factor VIII
Phase/study	Phase III	Phase III
HAVEN 1	HAVEN 2
# of patients
N=118	N=88
	Patients on episodic treatment prior to study entry:	Patients on prophylactic or episodic treatment prior to study entry:
	 ARM A: Hemlibra prophylaxis	 Cohort A: Hemlibra prophylaxis qw
	 ARM B: Episodic treatment (no prophylaxis)	 Cohort B: Hemlibra prophylaxis q2w	Hemophilia
Design	Patients on prophylaxis prior to study entry:	 Cohort C: Hemlibra prophylaxis q4w
	 ARM C: Hemlibra prophylaxis
	Patients on episodic treatment previously on non-interventional study:
	 ARM D: Hemlibra prophylaxis
Primary endpoint	 Number of bleeds over 24 weeks	 Number of bleeds over 52 weeks
	 FPI Q4 2015, recruitment completed in arms A and B Q2 2016	 FPI Q3 2016, recruitment completed Q2 2017
	 Primary and all secondary endpoints met Q4 2016	 Positive interim data in Q2 2017
	 Data published in NEJM 2017; 377:809-818	 FPI cohorts B/C Q4 2017
Status		 Full primary data at ASH 2018
	
		Data published in Blood 2019;134(24):2127-2138
	 Data presented at ISTH 2017, updated data presented at ASH 2017
	 Filed in US and EU in Q2 2017; granted accelerated assessment (EMA) and priority review (FDA)
	 Approved in US Q4 2017 and EU Q1 2018
CT Identifier	NCT02622321	NCT02795767

In collaboration with Chugai

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

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

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

Phase/study

• of patients
  Design
  Primary endpoint
  Status

Phase III	Phase III
HAVEN 3	HAVEN 4
N=135	N=46
Patients on FVIII episodic treatment prior to study entry:	Multicenter, open-label,non-randomized study to assess the efficacy,
 ARM A: Hemlibra prophylaxis qw	safety, pharmacokinetics, and pharmacodynamics of Hemlibra
 ARM B: Hemlibra prophylaxis q2w	administered every 4 weeks.
 ARM C: Episodic FVIII treatment; switch to Hemlibra prophylaxis	 Part 1: Pharmacokinetic (PK) run-in part (N=6)
possible after 24 weeks	 Part 2: Expansion part (N=40)
Patients on FVIII prophylaxis prior to study entry:
 ARM D: Hemlibra prophylaxis qw
 Number of bleeds over 24 weeks	 Number of bleeds over 24 weeks
 FPI Q3 2016, recruitment completed Q2 2017	 FPI Q1 2017, recruitment completed Q2 2017
 Study met primary and key secondary endpoints Q4 2017	 PK run-in data at ASH 2017
 FDA granted Breakthrough Therapy Designation April 2018	 Positive interim analysis outcome reported Q4 2017
 Data presented at WFH 2018	 Data presented at WFH 2018
 Filed in US (priority review) and EU in Q2 2018	 Interim data filed in US and EU in Q2 2018
 Data published in NEJM 2018; 379: 811-822	 Data published in Lancet Haematology 2019 Jun;6(6):e295-e305

•Approved in US Q4 2018 and EU Q1 2019

Hemophilia

CT Identifier

NCT02847637

NCT03020160

In collaboration with Chugai

58

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

Hemlibra

Factor VIII mimetic for treatment of hemophilia A

Indication	Hemophilia A patients with and without inhibitors to Factor VIII	Hemophilia A mild to moderate patients without inhibitors to Factor
VIII
Phase/study	Phase III	Phase III
HAVEN 5	HAVEN 6
# of patients
N=85	N=70
	Patients with Hemophilia regardless of FVIII inhibitor status on	Multicenter, open-label study to evaluate the safety, efficacy,
	prophylactic or episodic treatment prior to study entry:	pharmacokinetics, and pharmacodynamics of Hemlibra in patients with	Hemophilia
Design	• Arm A: emicizumab prophylaxis qw	mild or moderate Hemophilia A without FVIII inhibitors
	• Arm B: emicizumab prophylaxis q4w
	• Arm C: No prophylaxis (control arm)
Primary endpoint	 Number of bleeds over 24 weeks	 Safety and efficacy
	 FPI Q2 2018	 FPI Q1 2020
	 Recruitment completed Q1 2019
Status	 Filed in China Q2 2020
CT Identifier	NCT03315455	NCT04158648

In collaboration with Chugai

59

Alecensa

New CNS-active inhibitor of anaplastic lymphoma kinase

Indication	Treatment-naïve	Adjuvant ALK+ NSCLC
ALK+ advanced NSCLC
Phase/study	Phase III	Phase III
ALEX	ALINA
# of patients
N=286	N=255
Design	 ARM A: Alecensa 600mg BID	 ARM A: Alecensa 600 mg BID	Oncology
 ARM B: Crizotinib 250mg BID	 ARM B: Platinum-based chemotherapy
Primary endpoint
 Progression-free survival	 Disease-free survival
	 Recruitment completed Q3 2015	 FPI Q3 2018
	 Primary endpoint met Q1 2017
	 Data presented at ASCO 2017, 2018, ESMO 2017, 2018
Status	 Data published in NEJM 2017; 377:829-838
	 CNS data presented at ESMO 2017
	 Final PFS and updated OS presented at ESMO 2019
	 Approved in US Q4 2017 (priority review) and in EU Q4 2017
CT Identifier	NCT02075840	NCT03456076

In collaboration with Chugai	60
NSCLC=non-small cell lung cancer; ASCO=American Society of Clinical Oncology; NEJM=New England Journal of Medicine; ESMO=European Society for Medical Oncology

Kadcyla

First ADC for HER2-positive breast cancer

Indication	HER2-positive early breast cancer
high-risk patients

Phase/study

• of patients
  Design
  Primary endpoint

Status

CT Identifier

Phase III

KATHERINE

N=1,484

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

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

NCT01772472

Oncology

In collaboration with ImmunoGen, Inc.	61
ADC=antibody drug conjugate; SABCS=San Antonio Breast Cancer Symposium; RTOR=Real time oncology review; ORR=Objective Response Rate

Perjeta

First-in-class HER2 dimerization inhibitor

Indication	Adjuvant HER2-positive breast cancer	Neoadjuvant HER2-positive breast cancer
Phase/study	Phase III	Phase III
APHINITY	IMpassion050
# of patients
N=4,803	N=453
	 ARM A: Perjeta (840mg loading, 420 q3w) + Herceptin for 52 weeks	 ARM A: ddAC Herceptin/Perjeta + paclitaxel followed by surgery and
	plus chemotherapy (6-8 cycles)	chemotherapy
	 ARM B: Placebo + Herceptin (52 weeks) plus chemotherapy (6-8	 ARM B: ddAC Herceptin/Perjeta + chemotherapy +Tecentriq followed	Oncology
Design	cycles)	by surgery and chemotherapy +Tecentriq
Primary endpoint	 Invasive disease-free survival (IDFS)	 Pathologic complete response (pCR)
	 Primary endpoint met Q1 2017	 FPI Q4 2018
	 Data presented at ASCO 2017 and published in NEJM 2017; 377:122-131	 Recruitment completed Q3 2020
Status	 Filed in US and EU Q3 2017
	 Approved in US Q4 2017 (priority review) and EU Q2 2018
	 Six year IDFS data presented at SABCS 2019
CT Identifier	NCT01358877	NCT03726879

62

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

Perjeta

First-in-class HER2 dimerization inhibitor

Indication	HER2-positive early breast cancer subcutaneous co-formulation
Phase/study	Phase III	Phase II
FeDeriCa	PHranceSCa
# of patients	N=500	N=160
	Fixed-dose combination (FDC) of Perjeta (P) and Herceptin (H) for	 ARM A: PH IV followed by FDC SC
	subcutaneous administration in combination with chemotherapy in the	 ARM B: PH FDC SC followed by IV
	neoadjuvant/adjuvant setting			Oncology
Design	 ARM A: P IV+H IV+chemotherapy
 ARM B: FDC of PH SC+chemotherapy
Primary endpoint	 Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7	 Percentage who preferred PH FDC SC
	 Recruitment completed Q4 2018	 FPI Q4 2018
	 Primary endpoint met Q3 2019	 Final analysis completed, 85% patients preferred FDC SC
Status	 Data presented at SABCS 2019	 Data presented at ESMO 2020
	 Filed in US Q4 2019 & in EU Jan 2020
	 Approved in US Q2 2020
CT Identifier	NCT03493854	NCT03674112	63

SABCS=San Antonio Breast Cancer Symposium

Perjeta/Kadcyla and Tecentriq

Her2 targeted agents in combination with anti-PD-L1

Indication	Metastatic and locally advanced early breast cancer (HER2-positive)
Phase/study	Phase I
# of patients
N=76
	 Cohort 1A (mBC): Tecentriq plus Perjeta plus Herceptin
	 Cohort 1B (mBC): Tecentriq plus Kadcyla1
	 Cohort 1F (mBC): Tecentriq plus Perjeta plus Herceptin plus docetaxel	Oncology
Design	 Cohort 2C (expansion on cohort 1B): Tecentriq plus Kadcyla1
 Cohort 2A (eBC): Tecentriq plus Perjeta plus Herceptin
	 Cohort 2B (eBC): Tecentriq plus Kadcyla1
Primary endpoint	 Safety
Status	 FPI Q4 2015
 Recruitment completed Q2 2018
CT Identifier	NCT02605915

1	In collaboration with ImmunoGen, Inc.	64

eBC=early breast cancer; mBC=metastatic breast cancer

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	1L non-squamous NSCLC	1L non-squamous and squamous NSCLC
PD-L1-selected patients
Phase/study	Phase III	Phase III	Phase III
IMpower150	IMpower132	IMpower110
# of patients
N=1,202	N=568	N=570
	 ARM A: Tecentriq plus paclitaxel plus	 ARM A: Tecentriq plus carboplatin or cisplatin	 ARM A: Tecentriq monotherapy
	carboplatin	plus pemetrexed	 ARM B: NSq: carboplatin or cisplatin plus
Design	 ARM B: Tecentriq plus Avastin plus paclitaxel	 ARM B: Carboplatin or cisplatin plus	pemetrexed
plus carboplatin	pemetrexed	Sq: carboplatin or cisplatin plus gemcitabine
	 ARM C: Avastin plus paclitaxel plus
	carboplatin
Primary endpoint	 Progression-free survival and overall survival	 Progression-free survival and overall survival	 Overall survival
	 Study met co-primary endpoint of PFS in Q4	 FPI Q2 2016	 IMpower111 consolidated into IMpower110 Q3
	2017 and OS in Q1 2018	 Recruitment completed Q2 2017	2016
	 PFS data presented at ESMO IO 2017 and OS	 Study met co-primary endpoint of PFS in Q2	 Recruitment completed Q1 2018
Status	at ASCO 2018	2018	 Study met primary endpoint in PD-L1 high
 Filed in US Q1 2018 (priority review) and EU	 Data presented at WCLC 2018	(IC3/TC3) Q3 2019
	(Q1 2018)		 Data presented at ESMO and ESMO-IO 2019
	 Data published in NEJM 2018; 378:2288-2301		 Filed in EU and US (priority review) Q4 2019
	 Approved in US Q4 2018 and EU Q1 2019		 Approved in US Q2 2020
CT Identifier	NCT02366143	NCT02657434	NCT02409342
NSCLC=non-small cell lung cancer; NSq=non-squamous; Sq=squamous; ESMO=European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; NEJM=New England Journal	65
of Medicine; WCLC=World Conference on Lung Cancer

Oncology

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication		1L extensive-stage SCLC
Phase/study	Phase III	Phase Ib
IMpower133
# of patients
N=400	N=62
	 ARM A: Tecentriq plus carboplatin plus etoposide	 Carboplatin and etoposide +/- Tecentriq followed by maintenance
Design	 ARM B: Placebo plus carboplatin plus etoposide	Tecentriq plus Venclexta
		Oncology
Primary endpoint	 Progression-free survival and overall survival	 Safety and efficacy
	 FPI Q2 2016	 FPI Q3 2020
	 Orphan drug designation granted by FDA Q3 2016
	 Study met endpoints of OS and PFS in Q2 2018
Status	 Primary data presented at WCLC 2018
	 Data published in NEJM 2018; 379:2220-2229
	 Filed with the US and EU Q3 2018
	 Approved in US Q1 2019 and EU Q3 2019
CT Identifier	NCT02763579	NCT04422210

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

66

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	Adjuvant NSCLC	Neoadjuvant NSCLC
Phase/study	Phase III	Phase III
IMpower010	IMpower030
# of patients
N=1,280	N=450
	Following adjuvant cisplatin-based chemotherapy	 ARM A: Tecentriq + platinum-based chemotherapy
Design	 ARM A: Tecentriq	 ARM B: Platinum-based chemotherapy
 ARM B: Best supportive care		Oncology
Primary endpoint	 Disease-free survival	 Major pathological response and event free survival
	 FPI Q3 2015	 FPI Q2 2018
Status	 Trial amended from PD-L1+ selected patients to all-comers
 FPI for all-comer population Q4 2016
	 Recruitment completed Q3 2018
CT Identifier	NCT02486718	NCT03456063

NSCLC=non-small cell lung cancer

67

Tecentriq

Anti-PD-L1 cancer immunotherapy - lung cancer

Indication	1L NSCLC	Stage IV NSCLC	2L NSCLC previously treated with an immune
checkpoint inhibitor
Phase/stud	Phase II/III	Phase Ib/III	Phase III
y	B-FAST	IMscin001	CONTACT-01
# of
N=660	N=375	N=350
patients
	 Cohort A: ALK+ (Alecensa)	Part Ib	 ARM A: Tecentriq plus cabozantinib
	 Cohort B: RET+ (Alecensa)	 Dose finding, Tecentriq SC followed by	 ARM B: Docetaxel	Oncology
Design	 Cohort C: bTMB-high (Tecentriq)	Tecentriq IV
 Cohort D: ROS1+ (Rozlytrek)	Part III
	 Cohort E: BRAF+ (Zelboraf plus Cotellic plus	 2L NSCLC non inferiority of Tecentriq SC vs
	Tecentriq)	Tecentriq IV
Primary
 Cohort A/B: Objective response rate	 Observed concentration of Tecentriq in serum	 Overall survival
endpoint	 Cohort C: Progression-free survival	at cycle 1
	 FPI Q3 2017	 FPI Q4 2018	 FPI Q3 2020
	 Recruitment completed for cohort A Q3 2018 and
Status	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
CT	NCT03178552	NCT03735121	NCT04471428
Identifier

NSCLC=non-small cell lung cancer; ESMO=European Society for Medical Oncology	68

Tecentriq

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

Indication	Adjuvant squamous cell carcinoma of the		First-line BRAFv600 mutation-positive
Relapsed or refractory AML	metastatic or unresectable locally advanced
head and neck
		melanoma
Phase/study	Phase III	Phase I	Phase III
IMvoke010	IMspire150 TRILOGY1
# of patients
N=400	N=21	N=500
	 ARM A: Tecentriq 1200mg q3w	 Tecentriq plus anti-CD47	Double-blind, randomized, placebo-controlled
	 ARM B: Placebo		study
Design			 ARM A: Tecentriq plus Cotellic plus Zelboraf2	Oncology
			 ARM B: Placebo plus Cotellic plus Zelboraf2
Primary endpoint	 Event-free survival and overall survival	 Safety and efficacy	 Progression-free survival
	 FPI Q1 2018	 FPI Q4 2019	 FPI Q1 2017
	 Recruitment completed Q1 2020		 Recruitment completed Q2 2018
			 Primary endpoint met Q4 2019
Status			 Data presented at AACR 2020
		 Data published in Lancet;395(10240):1835-
			1844
			 Filed in US Q2 2020 under Project Orbis3
			 Approved in US Q3 2020
CT Identifier	NCT03452137	NCT03922477	NCT02908672

SCCHN=squamous cell carcinoma of the head and neck; AML=acute myeloid leukemia; 1In collaboration with Exelixis; 2Zelboraf in collaboration with Plexxikon, a member of Daiichi Sankyo Group; 3	69
Project Orbis=FDA framework for concurrent submission and review of oncology products among international partners; AACR=American Association for Cancer Research

Tecentriq

Anti-PD-L1 cancer immunotherapy - UC

Indication	1L metastatic urothelial carcinoma	High-risknon-muscle-invasive
bladder cancer
Phase/study	Phase III	Phase III
IMvigor130	ALBAN
# of patients	N=1,200	N=614
	 ARM A: Tecentriq plus gemcitabine and carboplatin or cisplatin	 ARM A: BCG induction and maintenance
Design	 ARM B: Tecentriq monotherapy	 ARM B: Tecentriq+ BCG induction and maintenance
 ARM C: Placebo plus gemcitabine and carboplatin or cisplatin		Oncology
Primary endpoint	 Progression-free survival, overall survival and safety	 Recurrence-free survival
	 FPI Q3 2016	 FPI Q4 2018
	 FPI for arm B (amended study) Q1 2017
Status	 Recruitment completed Q3 2018
	 Study met co-primary endpoint of PFS Q3 2019
	 Data presented at ESMO 2019
CT Identifier	NCT02807636	NCT03799835

UC=urothelial carcinoma; BCG=Bacille Calmette-Guérin

70

Tecentriq

Anti-PD-L1 cancer immunotherapy - renal cell cancer

Indication	Adjuvant renal cell carcinoma	Advanced renal cell carcinoma after immune checkpoint inhibitor
treatment
Phase/study	Phase III	Phase III
IMmotion010	Contact-031
# of patients	N=778	N=500
	 ARM A: Tecentriq monotherapy	 ARM A: Tecentriq plus cabozantinib
Design	 ARM B: Observation	 ARM B: cabozantinib
		Oncology
Primary endpoint	 Disease-free survival	 Progression-free survival and overall survival
	 FPI Q1 2017	 FPI Q3 2020
Status	 Recruitment completed Q1 2019
CT Identifier	NCT03024996	NCT04338269

1In collaboration with Exelixis

71

Tecentriq

Anti-PD-L1 cancer immunotherapy - CRC and HCC

Indication	2/3L metastatic colorectal cancer	1L hepatocellular carcinoma	Adjuvant hepatocellular carcinoma
Phase/study	Phase I	Phase III	Phase III
IMbrave150	IMbrave050
# of patients
N=84	N=501	N=662
	Open-label,single-arm,two-stage study	 ARM A: Tecentriq plus Avastin	 ARM A: Tecentriq plus Avastin
	with Cotellic plus Tecentriq plus Avastin	 ARM B: Sorafenib	 ARM B: Active surveillance
	• Stage 1: Safety run-in
Design	• Stage 2: Dose-expansion with two
	cohorts:
	- Expansion
	- Biopsy
Primary endpoint	 Safety	 Overall survival and progression free survival	 Recurrence-Free Survival (RFS)
	 FPI Q3 2016	 FPI Q1 2018; recruitment completed Q1 2019	 FPI Q4 2019
	 Recruitment completed Q3 2018	 Data presented at ESMO Asia 2019
	 Data presented at ESMO 2019	 US filing completed under RTOR Q1 2020; filed in
Status		EU Q1 2020
		 Data published in NEJM 2020;382:1894-1905
		 Approved in US Q2 2020
		 Positive CHMP opinion Q3 2020
CT Identifier
NCT02876224	NCT03434379	NCT04102098

Oncology

Cotellic in collaboration with Exelixis; ESMO=European Society for Medical Oncology; NEJM=New England Journal of Medicine; RTOR=Real time oncology review; CHMP=Committee for Medicinal Products for Human Use in the European Medicines Agency

72

Tecentriq

Anti-PD-L1 cancer immunotherapy - breast cancer

Indication		Previously untreated metastatic
	triple negative breast cancer
Phase/study	Phase III	Phase III	Phase III
IMpassion130	IMpassion131	IMpassion132
# of patients
N=900	N=540	N=572
	 ARM A: Tecentriq plus nab-paclitaxel	 ARM A: Tecentriq plus paclitaxel	 ARM A: Tecentriq plus capecitabine or
	 ARM B: Placebo plus nab-paclitaxel	 ARM B: Placebo plus paclitaxel	carbo/gem
Design			 ARM B: Placebo plus capecitabine or	Oncology
			carbo/gem
Primary endpoint	 Progression-free survival and overall survival	 Progression-free survival	 Overall survival
	(co-primary endpoint)
	 Recruitment completed Q2 2017	 FPI Q3 2017	 FPI Q1 2018
	 Study met co-primary endpoint of PFS in both	 Recruitment completed Q3 2019
	PDL1+ and ITT populations Jul 2018	 Study did not meet primary endpoint Q3 2020
Status	 Primary PFS and interim OS data presented at	 Data presented at ESMO 2020
ESMO 2018 and ASCO 2019
	 Data published in NEJM 2018; 379:2108-2121
	 US accelerated approval Q1 2019
	 Approved in EU Q3 2019
CT Identifier	NCT02425891	NCT03125902	NCT03371017

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

73

Tecentriq

Anti-PD-L1 cancer immunotherapy - breast cancer

Indication	Neoadjuvant triple negative breast cancer	Adjuvant triple negative breast cancer
Phase/study	Phase III	Phase III
IMpassion031	IMpassion030
# of patients
N=324	N=2,300
	 ARM A: Tecentriq plus nab-paclitaxel	 ARM A: Tecentriq + paclitaxel followed by AC followed by Tecentriq
	 ARM B: Placebo plus nab-paclitaxel	+ AC, followed by Tecentriq maintenance
Design		 ARM B: Placebo + paclitaxel followed by AC followed by placebo	Oncology
Primary endpoint	 Percentage of participants with pathologic complete response (pCR)	 Invasive Disease Free Survival
	 FPI Q3 2017	 FPI Q3 2018
	 Recruitment completed Q2 2018
	 Q1 2019 IDMC recommendation to expand study to recruit 120 additional
Status	patients (all comers and PDL1-positive). Recruitment completed for
	additional patients Q3 2019
	 Study met primary endpoint Q2 2020
	 Data presented at ESMO 2020
CT Identifier	NCT03197935	NCT03498716

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

74

Tecentriq

Anti-PD-L1 cancer immunotherapy - ovarian cancer

Indication	Front-line ovarian cancer	Advanced gynecological cancers
and triple negative breast cancer
Phase/study	Phase III	Phase Ib
IMaGYN050
# of patients
N=1,300	N=48
	 ARM A: Tecentriq plus carboplatin plus paclitaxel plus Avastin	 Part 1: Dose finding Tecentriq plus rucaparib (CO-338)1
	 ARM B: Carboplatin plus paclitaxel plus Avastin	 Part 2: Expansion Tecentriq plus rucaparib (CO-338)1	Oncology
Design
Primary endpoint	 Progression-free survival and overall survival (co-primary endpoint)	 Safety
	 FPI Q1 2017	 FPI Q2 2017
Status	 Recruitment completed Q1 2019
 Primary endpoint not met Q2 2020
	 Data presented at ESMO 2020
CT Identifier	NCT03038100	NCT03101280

1Rucaparib in collaboration with Clovis; ESMO=European Society for Medical Oncology

75

Venclexta

Novel small molecule Bcl-2 selective inhibitor - CLL

Indication	Untreated CLL patients with	Relapsed or refractory CLL	Untreated fit CLL patients
coexisting medical conditions
Phase/study	Phase III	Phase III	Phase III
CLL14	MURANO	CristaLLo
# of patients	N=432	N=391	N=165
	 ARM A: Venclexta plus Gazyva	 ARM A: Venclexta plus Rituxan	 ARM A: Venclexta plus Gazyva
Design	 ARM B: Chlorambucil plus Gazyva	 ARM B: Rituxan plus bendamustine	 ARM B: Fludarabine + cyclophosphamide
		+ Rituxan or bendamustine + Rituxan	Oncology
Primary endpoint	 Progression-free survival	 Progression-free survival	 MRD negativity rate in peripheral blood at
			15 months
	 Study met primary endpoint at pre-specified	 Study met primary endpoint at interim analysis	 FPI Q2 2020
	interim analysis Q4 2018	 Data presented at ASH 2017
	 BTD granted by FDA Q1 2019	 Filed in US Q4 2017 and EU Q1 2018
Status	 US filing completed under RTOR Q1 2019	 Data published in NEJM 2018; 378:1107-20
 Filed in EU Q2 2019	 Updated data presented at ASCO 2018 and ASH
	 Data presented at ASCO 2019 and ASH 2019	2019
	 Data published in NEJM 2019; 380:2225-2236	 Approved in US Q2 2018 (priority review)
	 Approved US Q2 2019 and EU Q1 2020	 EU approval Q4 2018
CT Identifier	NCT02242942	NCT02005471	NCT04285567

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute	76
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

Venclexta

Novel small molecule Bcl-2 selective inhibitor - MM

Indication		Relapsed or refractory multiple myeloma
Phase/study	Phase I	Phase Ib/II	Phase III
CANOVA
# of patients
N=166	N=120	N=244
	 Dose escalation cohort:	 Venclexta plus carfilzomib plus dexamethasone in	 Venclexta plus dexamethazone vs pomalidomide
	Venclexta dose escalation	t(11;14) positive r/r MM	plus dexamethasone in t(11;14) positive r/r MM
	 Safety expansion cohort (t11:14):			Oncology
Design	Venclexta expansion
	 Combination:
	Venclexta plus dexamethasone
Primary endpoint	 Safety and maximum tolerated dose	 Safety, objective response rate, PK, PD	 Progression-free survival
	 FPI Q4 2012	 FPI Q1 2017	 FPI Q4 2018
Status	 Data presented at ASCO 2015
 Updated data presented at ASCO 2016
	and ASH 2016
CT Identifier	NCT01794520	NCT02899052	NCT03539744

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;	77
MM=multiple myeloma; ASCO=American Society of Clinical Oncology; ASH=American Society of Hematology

Venclexta

Novel small molecule Bcl-2 selective inhibitor - AML

Indication	Treatment-naïve AML not eligible for standard induction therapy
Phase/study	Phase III	Phase III
Viale-A	Viale-C
# of patients
N=443	N=175
	• ARM A: Venclexta plus azacitidine	 ARM A: Venclexta plus low-dose cytarabine
	• ARM B: Azacitidine	• ARM B: Low-dose cytarabine
Design			Oncology
Primary endpoint	 Overall survival and percentage of participants with complete	 Overall survival
	remission
	 FPI Q1 2017	 FPI Q2 2017
	 Study met dual primary endpoints Q1 2020	 Study did not meet primary endpoint Q1 2020
	 Data presented at EHA 2020	 Primary and additional 6 month overall survival data presented at ASCO
Status	 Data published NEJM 2020 Aug 13;383(7):617-629	2020
	 Filed in US and EU Q2 2020
CT Identifier	NCT02993523	NCT03069352

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute	78
AML=acute myeloid leukemia; EHA=European Hematology Association

Venclexta

Novel small molecule Bcl-2 selective inhibitor - AML

Indication	Treatment-naïve AML not eligible for standard induction therapy
Phase/study	Phase Ib	Phase Ib/II
# of patients
N=212	N=92
	 Venclexta (dose escalation) plus decitabine	 Venclexta (dose escalation) plus low-dose cytarabine
	 Venclexta (dose escalation) plus azacitidine
Design	 Venclexta (dose escalation) plus decitabine plus posaconazole		Oncology
Primary endpoint	 Safety	 Safety, PK, PD and efficacy
	 FPI Q4 2014	 FPI Q1 2015
	 Initial data presented at ASH 2015, updated data presented at ASCO 2016	 Initial data presented at ASCO 2016, updated data presented at ASH
	and ASCO 2018	2016 and ASH 2017
Status	 Breakthrough Therapy Designation granted by FDA Q1 2016	 Breakthrough Therapy Designation granted by FDA Q3 2017
	 Data published in Blood. 2019 Jan 3;133(1):7-17
	 Filed in US Q3 2018
	 US accelerated approval Q4 2018
CT Identifier
NCT02203773	NCT02287233

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;	79
AML=acute myeloid leukemia; ASH=American Society of Hematology; ASCO=American Society of Clinical Oncology

Venclexta

Novel small molecule Bcl-2 selective inhibitor - AML

Indication	Relapsed or refractory AML	Relapsed or refractory hematological malignancies
Phase/study	Phase I	Phase I
# of patients
N=52	N=86
	 Venclexta in combination with gilteritinib	 Venclexta plus AMG176 dose escalation
		 Dose expansion phase to confirm safety and preliminary RPTD
Design			Oncology
Primary endpoint	 Dose and composite complete remission (CRc) Rate	 Maximum tolerated dose and safety
	 FPI Q4 2018	 FPI Q2 2019
Status	 Initial data presented at ASH 2019	 Study on clinical hold
CT Identifier	NCT03625505	NCT03797261

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute;	80
AML=acute myeloid leukemia; ASH=American Society of Hematology; RPTD =recommended phase II dose

Venclexta

Novel small molecule Bcl-2 selective inhibitor - MDS

Indication	Relapsed or refractory myelodysplastic	Treatment-naive myelodysplastic syndromes	Newly diagnosed higher-risk
syndromes	myelodysplatic syndrome
Phase/stud	Phase Ib	Phase II	Phase III
y	VERONA
# of
N=70	N=129	N=500
patients
	Cohort 1:	 ARM A: Venclexta 400 mg plus azacitidine	 ARM A: Venclexta plus azacitidine
	 ARM A: Venclexta 400 mg	 ARM B: Venclexta 800 mg plus azacitidine	 ARM B: Placebo plus azacitidine	Oncology
	 ARM B: Venclexta 800 mg	 ARM C: Azacitidine
Design	Cohort 2:
	 ARM A: Venclexta plus azacitidine
	Study expansion:
	 Venclexta or Venclexta plus azacitidine
Primary
 Safety, efficacy, PK and PD	 Overall response rate	 Complete remission rate and overall survival
endpoint
Status	 FPI Q1 2017	 FPI Q1 2017	 FPI Oct 2020
	 Data presented at ASH 2019
CT	NCT02966782	NCT02942290	NCT04401748
Identifier

Joint project with AbbVie, in collaboration with The Walter and Eliza Hall Institute	81
MDS=myelodysplastic syndromes; ASH=American Society of Hematology

Venclexta

Novel small molecule Bcl-2 selective inhibitor - breast cancer

Indication		≥2L HR+ breast cancer
Phase/study		Phase II
	VERONICA
# of patients
	N=103
	 ARM A: Venclexta plus fulvestrant
Design	 ARM B: Fulvestrant
		Oncology
Primary endpoint	 Clinical benefit lasting equal or more than 24 weeks
	 FPI Q3 2018
Status
CT Identifier		NCT03584009

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

82

Polivy (polatuzumab vedotin)

ADC targeting CD79b to treat B cell malignancies

Indication	Relapsed or refractory	1L DLBCL
FL and DLBCL
Phase/study	Phase Ib/II	Phase III
POLARIX
# of patients
N=329	N=875
	 PIb: Dose escalation	 ARM A: Polatuzumab vedotin plus R-CHP
Design	 PhII: Polatuzumab vedotin plus BR vs. BR	 ARM B: R-CHOP
 PhII expansion: Polatuzumab vedotin plus Gazyva (non-randomized)		Oncology
Primary endpoint	 Safety and response by PET/CT	 Progression-free survival
	 FPI Q4 2014	 FPI Q4 2017
	 PRIME Designation (Q2 2017) and Breakthrough Therapy Designation	 Recruitment completed Q2 2019
	(Q3 2017) granted for r/r DLBCL
Status	 Pivotal randomized Ph2 in r/r DLBCL presented at ASH 2017
	 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
CT Identifier	NCT02257567	NCT03274492

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	83
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

Indication		Relapsed or refractory FL or DLBCL
Phase/study	Phase I/II		Phase I/II
# of patients
N=134		N=128
	• Dose escalation cohort:		 Dose escalation cohort:
	Polatuzumab vedotin plus Gazyva plus Venclexta1		Polatuzumab vedotin plus Gazyva plus lenalidomide
Design	• Expansion cohort DLBCL:		 Expansion cohort DLBCL:	Oncology
Polatuzumab vedotin plus Rituxan plus Venclexta1		Polatuzumab vedotin plus Rituxan plus lenalidomide
	• Expansion cohort FL:		 Expansion cohort FL:
	Polatuzumab vedotin plus Gazyva plus Venclexta1		Polatuzumab vedotin plus Gazyva plus lenalidomide
Primary endpoint	 Percentage of participants with CR		 Percentage of participants with CR
	 FPI Q1 2016		 FPI Q1 2016
Status	 FL not developed further due to portfolio priorities		 Interim data in FL presented at ASCO, EHA and ICML 2019
			 Primary data presented at ASH 2019
CT Identifier	NCT02611323		NCT02600897

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	84
Hematology Association; ICML=International Conference on Malignant Lymphoma

Rozlytrek (entrectinib)

CNS-active and selective inhibitor of NTRK/ROS1

Indication	Locally Advanced or Metastatic tumors with	Locally Advanced or Metastatic tumors with	Pediatric tumors with NTRK 1/2/3, ROS-1
ROS1 gene rearrangement	NTRK1/2/3 gene rearrangement	or ALK rearrangement
Phase/study	Phase II	Phase II	Phase I/Ib
STARTRK2	STARTRK2	STARTRK - NG
# of patients
N~300 total	N~300 total	N~80
	Single arm with Baskets based on tumor type	Single arm with Baskets based on tumor type	Single arm with Baskets based on tumor type
Design	and genomic alteration status	and genomic alteration status	and genomic alteration status
			Oncology
Primary endpoint	 Objective response rate	 Objective response rate	 Maximum tolerated dose (MTD) and
		recommended phase II dose (RP2D)
	 FPI Q1 2016	 FPI Q1 2016	 FPI Q2 2016
	 Data presented at WCLC 2018	 Data presented at ESMO 2018	 Initial data presented at ASCO 2019
Status	 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
		 Approved in US Q3 2019 and EU Q3 2020
	 Published in Lancet Oncol. 2020 Feb;21(2):261-271 and 271-282
CT Identifier
NCT02568267	NCT02568267	NCT02650401

WCLC=World Conference on Lung Cancer; ESMO=European Society for Medical Oncology; ASCO=American Society of Clinical Oncology; NTRK=neurotrophic receptor tyrosine kinase;	85
PRIME= priority medicines

Gavreto (pralsetinib, RG6396)

Highly selective RET inhibitor

Indication	RET+ NSCLC, thyroid cancer and	1L RET fusion-positive, metastatic NSCLC
other advanced solid tumors
Phase/study	Phase I/II	Phase III
ARROW	AcceleRET Lung
# of patients
N=647	N=250
	 Part 1: Gavreto 30-600mgdose-escalation	 Arm A: Gavreto 400mg
Design	 Part 2: Gavreto 400mg dose expansion	 Arm B: Platinum-based chemotherapy +/- pembrolizumab
		Oncology
Primary endpoint	 Safety and efficacy	 Progression-free survival
	 Data presented at ASCO (NSCLC) and ESMO (medullary thyroid cancer)	 Study initiated in Q1 2020
	2020
Status	 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 September 2020 in RET fusion-positive NSCLC
CT Identifier	NCT03037385	NCT04222972

In collaboration with Blueprint Medicines
NSCLC=non-small cell lung cancer; ASCO=American Society of Clinical Oncology; ESMO=European Society for Medical Oncology	86

Ocrevus (ocrelizumab, RG1594)

Humanized mAb selectively targeting CD20+ B cells

Indication		Relapsing multiple sclerosis (RMS)		Primary-progressive
		multiple sclerosis (PPMS)
Phase/study	Phase III	Phase III		Phase III
OPERA I	OPERA II		ORATORIO
# of patients
N=821	N=835		N=732
	96-week treatment period:	96-week treatment period:	120-week treatment period:
	 ARM A: Ocrelizumab 2x300 mg iv	 ARM A: Ocrelizumab 2x300 mg iv	 ARM A: Ocrelizumab 2x300 mg iv every 24 weeks
Design	followed by 600 mg iv every 24 weeks	followed by 600 mg iv every 24 weeks	 ARM B: Placebo	Neuroscience
	versus Rebif	β-1a	versus Rebif		Disability Status Scale (EDSS)
	 ARM B: Interferon	 ARM B: Interferon β-1a
Primary endpoint	 Annualized relapse rate at 96 weeks	 Annualized relapse rate at 96 weeks	 Sustained disability progression versus placebo by Expanded
	 Primary endpoint met Q2 2015, OLE ongoing	 Primary endpoint met Q3 2015
		 Primary data presented at ECTRIMS 2015	 Primary data presented at ECTRIMS 2015, updated data
Status	 Updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018		presented at AAN and ECTRIMS 2017, AAN and EAN 2018
	Data published in NEJM 2017; 376:221-234		Data published in NEJM 2017; 376:209-220
			 Approved in US Q1 2017 and EU Q1 2018
CT Identifier	NCT01247324	NCT01412333		NCT01194570

OLE=Open label extension; ECTRIMS=European Committee for Treatment and Research in Multiple Sclerosis; AAN=Annual Meeting of the American Academy of Neurology; EAN=European	87
Academy of Neurology; NEJM=New England Journal of Medicine

Ocrevus (ocrelizumab, RG1594)

Humanized mAb selectively targeting CD20+ B cells

Indication	Relapsing and primary progressive multiple sclerosis (RMS &	Primary progressive multiple sclerosis (PPMS)
PPMS)
Phase/study	Phase IIIb	Phase IIIb
ENSEMBLE PLUS	ORATORIO-HAND
# of patients
N=1225	N ~ 1000
	• Substudy of ongoing phase IIIb, open-label,single-arm ENSEMBLE	120-week treatment period:
Design	study	 ARM A: Ocrelizumab 600mg IV every 24 weeks
• Shorter two-hour infusion time	 ARM B: Placebo	Neuroscience
	 Safety, measured by the proportion of patients with IRRs following the	 Time to upper limb disability progression confirmed for at least 12 weeks
Primary endpoint	first randomised 600 mg infusion (frequency/severity assessed during
and 24-hours post infusion)
	• Filed in US and EU Q1 2020	 FPI Q3 2019
Status	• Approved in EU Q2 2020
• Data published Neurol, Neuroimmunol and Neuroinflamm Sept 2020;
	7(5), e807
CT Identifier	NCT03085810	NCT04035005

88

Ocrevus (ocrelizumab, RG1594)

Humanized mAb selectively targeting CD20+ B cells

Indication	Primary progressive multiple sclerosis (PPMS)	Relapsing multiple sclerosis (RMS)
Phase/study	Phase IIIb	Phase IIIb
GAVOTTE	MUSETTE
# of patients
N ~ 699	N ~ 786
	120-week treatment period:	120-week treatment period:
Design	 ARM A: Ocrelizumab 600mg IV every 24 weeks	 ARM A: Ocrelizumab 600mg IV every 24 weeks
 ARM B: Ocrelizumab 1200mg if body weight <75kg or 1800mg if body	 ARM B: Ocrelizumab 1200mg if body weight <75kg or 1800mg if body	Neuroscience
	weight > or equal to 75kg every 24 weeks	weight > or equal to 75kg every 24 weeks
Primary endpoint	 Superiority of Ocrelizumab higher dose versus approved dose on	 Superiority of Ocrelizumab higher dose versus approved dose on
	composite confirmed disability progression (cCDP)	composite confirmed disability progression (cCDP)
	 FPI expected Q4 2020	 FPI expected Q4 2020
Status
CT Identifier	NCT04548999	NCT04544436

89

Evrysdi (risdiplam, RG7916)

Oral SMN2 splicing modifier

Indication	Spinal muscular atrophy

Phase/study

• of patients
  Design
  Primary endpoint

Status

Phase II/III	Phase II/III	Phase II
FIREFISH	SUNFISH	JEWELFISH
N=21 (Part 1), 41 (Part 2)	N=51 (Part 1), 180 (Part 2)	N=174
Open-label study in infants with type 1 spinal	Randomized, double-blind,placebo-controlled	 Open-label single arm study in adult and
muscular atrophy:	study in adult and pediatric patients with type 2	pediatric patients with previously treated SMA
 Part 1 (dose-finding):At least 4 weeks	or type 3 spinal muscular atrophy:	type 1, 2 and 3
 Part 2 (confirmatory): 24 months	 Part 1 (dose-finding):At least 12 weeks
	 Part 2 (confirmatory): 24 months
 Safety, tolerability, PK, PD and efficacy	 Safety, tolerability, PK, PD and efficacy	 Safety, tolerability and PK/PD
 Recruitment completed for part 2 Q4 2018	 Recruitment completed for part 2 Q3 2018	 FPI Q1 2017
 12 month data from Part 1 presented at AAN,	 12 month data from Part 1 presented at AAN,	 Data presented at WMS 2017, AAN 2018, WMS
CureSMA and EAN 2019; 16 month data	CureSMA and EAN 2019; 16 month data	2018, CureSMA 2019, WMS 2019 and
presented at WMS 2019	presented at WMS 2019	CureSMA2020
 Study met primary endpoint in part 2 Jan 2020	 Study met primary endpoint in part 2 Q4 2019	 Recruitment completed Q1 2020
 Part 2 1-year data presented at AAN 2020 and	 Part 2 Data presented at SMA Europe 2020
part 1 2-year data at WMS 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

Neuroscience

CT Identifier

NCT02913482

NCT02908685

NCT03032172

In collaboration with PTC Therapeutics and SMA Foundation	90
SMN=survival motor neuron; AAN=American Academy of Neurology; WMS=World Muscle Society; EAN=European Academy of Neurology; PRIME=priority medicines

Evrysdi (risdiplam, RG7916)

Oral SMN2 splicing modifier

Indication	Spinal muscular atrophy

Phase/study	Phase II
RAINBOWFISH
# of patients	N=25

Design

Primary endpoint

Status

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

• 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
• FPI Q3 2019

Neuroscience

CT Identifier	NCT03779334

In collaboration with PTC Therapeutics and SMA Foundation	91
SMN=survival motor neuron; CMAP=compound muscle action potential

Enspryng (satralizumab, RG6168, SA237)

Anti-IL-6 receptor humanized monoclonal antibody

Indication	Neuromyelitis optica spectrum disorder (NMOSD)
Phase/study	Phase III	Phase III
Sakura Star	Sakura Sky
# of patients	N=95	N=70 (adults); N=6 (adolescents)
	Satralizumab as monotherapy:	Add-on therapy of satralizumab:
	• Group A: Satralizumab 120mg SC monthly	• Group A: Satralizumab 120mg SC monthly
Design	• Group B: Placebo SC monthly	• Group B: Placebo SC	Neuroscience
		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
	 Primary endpoint met Q4 2018	 FPI Q3 2017
	 Data presented at ECTRIMS 2019	 Primary endpoint met Q3 2018
	 Published in Lancet Neurology 2020; 19(5): 402-412	 Data presented at ECTRIMS 2018 and AAN 2019
Status		 Published in NEJM 2019; 381:2114-2124
		 BTD granted Q4 2018
	 Filed in EU Q3 2019; US acceptance of filing Q4 2019,
		 Approved in US Q3 2020
CT Identifier
NCT02073279	NCT02028884

*Trials managed by Chugai (Roche opted-in)	92
ECTRIMS=European Committee for Treatment and Research in Multiple Sclerosis; AAN=American Academy of Neurology; NEJM=New England Journal of Medicine

Gazyva (obinutuzumab)

Immunology development program

Indication	Lupus nephritis
Phase/study	Phase II	Phase III
NOBILITY	REGENCY
# of patients
N=126	N=252
	 ARM A: Obinutuzumab 1000mg IV plus mycophenolate mofetil /	 ARM A: Obinutuzumab 1000 mg IV (six doses through Week 52) plus
	mycophenolic acid	mycophenolate mofetil
Design	 ARM B: Placebo IV plus mycophenolate mofetil / mycophenolic acid	 ARM B: Obinutuzumab 1000 mg IV (five doses through Week 52) plus	Immunology
	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)
	 Recruitment completed Q4 2017	 FPI Q3 2020
Status	 Primary endpoint met Q2 2019
 Breakthrough therapy designation granted by the FDA Q3 2019
	 Data presented at ASN and ACR 2019
CT Identifier	NCT02550652	NCT04221477

In collaboration with Biogen	93
ASN=American Society of Nephrology; ACR=American College of Rheumatology

Actemra/RoActemra (RG-1569)

Interleukin 6 receptor inhibitor

Indication	Adult hospitalised with severe COVID-19 pneumonia
Phase/study	Phase III	Phase III
COVACTA1	REMDACTA2
# of patients	N=450	N=500
	 Arm A: tocilizumab plus standard of care	 Arm A: remdesivir plus tocilizumab
	 Arm B: placebo plus standard of care	 Arm B: remdesivir plus placebo
Design
Primary endpoint	 Clinical status assessed using 7-Category Ordinal Scale (Day 28)	 Time to hospital discharge or ready for discharge
	 Primary endpoint not met Q3 2020
Status	 FPI Q1 2020	 FPI Q2 2020
 LPI Q2 2020
CT Identifier	NCT04320615	NCT04409262

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

Immunology

94

Actemra/RoActemra (RG-1569)

Interleukin 6 receptor inhibitor

Indication	Adult hospitalised with severe COVID-19 pneumonia
Phase/study	Phase II	Phase III
MARIPOSA	EMPACTA
# of patients
N=100	N=379
	 Arm A: 8 mg/kg tocilizumab plus standard of care	Conducted in sites known to provide critical care to underserved and
	 Arm B: 4mg/kg tocilizumab plus standard of care	minority populations that often do not have access to clinical trials
Design		 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	 FPI Q2 2020
 LPI Q2 2020	 Primary endpoint met Q3 2020
CT Identifier	NCT04363736	NCT04372186

Immunology

95

Xolair

Humanized mAb that selectively binds to IgE

Indication	Chronic rhinosinusitis with nasal polyps	Food allergy
Phase/study	Phase III	Phase III	Phase III
POLYP 1	POLYP 2	OUtMATCH1
# of patients	N=138	N=127	N=225
	Adult patients with chronic rhinosinusitis	Adult patients with chronic rhinosinusitis with	• Xolair by subcutaneous injection either every 2
	with nasal polyps (CRSwNP) who have had	nasal polyps (CRSwNP) who have had an	weeks or every 4 weeks for 16 to 20 weeks
Design	an inadequate response to SOC:	inadequate response to SOC:
• ARM A: Xolair every 2 wks or every 4 wks	• ARM A: Xolair every 2 wks or every 4 wks
	• ARM B: Placebo	• ARM B: Placebo
	 Change from baseline in average daily	 Change from baseline in average daily nasal	• Number of participants who successfully
Primary endpoint	nasal congestion score (NCS) at week 24	congestion score (NCS) at week 24	consume ≥600 mg of peanut protein without
 Change from baseline in nasal polyp score	 Change from baseline in nasal polyp score (NPS)	dose-limiting symptoms
	(NPS) to week 24	to week 24
	 FPI Q4 2017	 FPI Q4 2017	• FPI July 2019
	 Recruitment completed Q3 2018	 Recruitment completed Q3 2018
Status	 Co-primary endpoints met Q2 2019	 Co-primary endpoints met Q2 2019

• • Filed in US Q4 2019
• Approved in the EU Q3 2020

CT Identifier

NCT03280550

NCT03280537

NCT03881696

Immunology

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

96

Xofluza (baloxavir marboxil, RG6152, S-033188 )

Small molecule, novel CAP-dependent endonuclease inhibitor

Indication		Influenza
Phase/study	Phase III	Phase III
CAPSTONE-1	CAPSTONE-2
# of patients
N=1,436	N=2,184
	 Randomized, double-blind study of a single dose of Xofluza	 Randomized, double-blind study of a single dose of Xofluza compared with
	compared with placebo or Tamiflu 75 mg twice daily for 5 days in	placebo or Tamiflu 75 mg twice daily for 5 days in patients with influenza at
Design	otherwise healthy patients with influenza	high risk of influenza complications

Primary endpoint	 Time to alleviation of symptoms	 Time to improvement of influenza symptoms
	 FPI Q4 2016, recruitment completed Q1 2017	 FPI Q1 2017, recruitment completed Q1 2018
	 Primary endpoint met Q3 2017	 Primary endpoint met Q3 2018
	 Filed in US Q2 2018 (priority review), approval Q4 2018	 Data presented at IDweek 2018
Status	 Data published in NEJM 2018; 379:913-923	 Filed in US Q1 2019, approval Q4 2019
	 Filed in EU Q4 2019	 Filed in EU Q4 2019
		 Data published in Lancet Infectious Diseases 2020 Jun 8;S1473-
		3099(20)30004-9
CT Identifier	NCT02954354	NCT02949011
In collaboration with Shionogi & Co., Ltd.	97
NEJM=New England Journal of Medicine

Infectious Diseases

Xofluza (baloxavir marboxil, RG6152, S-033188 )

Small molecule, novel CAP-dependent endonuclease inhibitor

Indication			Influenza
Phase/study		Phase III	Phase III	Phase III
	FLAGSTONE (hospitalised patients)	miniSTONE 1 (0-1 year old)	miniSTONE 2 (1-12 years old )
# of patients
	N=366	N=30	N=176
	• Xofluza + neuraminidase inhibitor vs placebo	• Xofluza on Day 1 (based on body weight and age)	• Xofluza vs Tamiflu in healthy pediatric
	+ neuraminidase inhibitor in hospitalized	in healthy pediatric patients from birth to <1 year	patients 1 to <12 years of age with influenza-	Diseases
Design	patients with influenza	with influenza-like symptoms	like symptoms
					Infectious
		Time to clinical improvement	 Safety	 Safety
Primary endpoint	
		FPI Jan 2019	• FPI Q1 2019	• FPI Q4 2018
	 Recruitment completed Q1 2020		• Recruitment completed Q1 2019
				• Primary endpoint met Q2 2019
Status				• Data presented at OPTIONS X 2019
				• Filed in US Q1 2020
				• Data published in Pediatric Infectious
				Disease 2020 Aug;39(8):700-705
CT Identifier		NCT03684044	NCT03653364	NCT03629184

In collaboration with Shionogi & Co., Ltd.	98

Xofluza (baloxavir marboxil, RG6152, S-033188)

Small molecule, novel CAP-dependent endonuclease inhibitor

Indication		Influenza
Phase/study	Phase III		Phase IIIb
BLOCKSTONE		CENTERSTONE
# of patients	N= 752		N= 3,160
	 Post exposure prophylaxis to prevent disease onset in household		 Reduction of direct transmission of influenza from otherwise healthy
	contacts. Used after known exposure to infected person.		patients to household contacts
Design	 Household contacts treated with Xofluza vs placebo		 Patients treated with Xofluza vs placebo	Diseases
				Infectious
	 Study met primary endpoint Q2 2019
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		 FPI Q4 2019
 Filed in US Q1 2020
	 Data published in NEJM 2020 Jul 8. doi:10.1056/NEJMoa1915341
CT Identifier	JapicCTI-184180		NCT03969212

In collaboration with Shionogi & Co., Ltd.	99
PCR=Polymerase chain reaction; NEJM=New England Journal of Medicine

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 YTD Sep 2020 sales

Diagnostics

Foreign exchange rate information

100