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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.
HY 2017: A strong start into the year
Guidance raised
6
Group sales growth CHF 0.5bn from recent launches* +5%
Core EPS growth Strong underlying business momentum,
divestments partially offsetting PSI +6%
Cash flow Strong operating free cash flow
generation +37%
IFRS net income Strong operating performance partially
offset by impairments +2%
* Tecentriq, Ocrevus, Alecensa
At constant exchange rates (CER); PSI=Past Service Income
HY 2017: Strong sales growth in both divisions
7 CER=Constant Exchange Rates
HY 2017 HY 2016
CHFbn CHFbn CHF CER
Pharmaceuticals Division 20.5 19.5 5 5
Diagnostics Division 5.8 5.6 5 5
Roche Group 26.3 25.0 5 5
Change in %
Q2 2017: Sales growth for the sixth consecutive
year
8
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
7%
6%
4% 4%
6%
3% 3%
4%
6%
0%
2%
4%
6%
8%
10%
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
Q1
16
Q2
16
Q3
16
Q4
16
Q1
17
Q2
17
All growth rates at Constant Exchange Rates (CER)
HY 2017: Strong sales growth in US and
International
9
0
2
4
6
8
10
12
Japan International Europe US
Diagnostics
Pharma
CHFbn
+8%
0% +5%
0%
+1% +12%
+2%
0%
+7%
+1%
0%
+7%
All growth rates at Constant Exchange Rates (CER)
HY 2017: Successful launch activities
Differentiation driving growth
10
• ALEX: Superiority in 1L vs Standard of Care
• 1 L recommendation on NCCN guidelines
• CHMP recommendation in bladder (1/2L) & lung (2L),
ongoing market share gains in lung cancer (US)
• Approved in PPMS & RMS (US)
• Positive early feedback from all stakeholders
HY 2017 additional sales
of recent launches
+0.5bn
Ocrevus
+0.2bn
Alecensa
+0.1bn
Tecentriq
+0.2bn
CHF
PPMS=primary progressive multiple sclerosis; RMS=relapsing forms of multiple sclerosis; NCCN=national comprehensive cancer network;
CHMP=committee for medicinal products for human use
Total:
HY 2017: Major read-outs securing future growth
11
• Perjeta – APHINITY: 19% risk reduction of recurrence/death
after 3 years, further improvement with longer follow up Perjeta
(Early breast cancer)
• Emicizumab - HAVEN1 (Adults) and HAVEN2 (Pediatric):
Details presented at ISTH, filed in US, EU and Japan emicizumab
(Hem. A inhibitors)
SC=subcutaneous; ODAC=oncologic drug advisory committee
• Alecensa - ALEX: Superiority in 1L vs Standard of Care
• Recommended as 1st choice in 1L (ALK+) in NCCN guidelines Alecensa
(ALK+ lung cancer)
• Approved in US after the unanimous recommendation by
ODAC
Rituxan Hycela
(SC)
12 CER=Constant Exchange Rates
HY 2017: Strong Core operating profit
9.2 9.9
10.1
HY 2015 HY 2016 HY 2017
CHFbn
% of sales 39.2% 39.4%
38.5%
+3% at CER
HY 2017: Core EPS growth above sales growth
13
7.22 7.74
8.23
HY 2015 HY 2016 HY 2017
CHF
All growth rates at Constant Exchange Rates (CER)
+6% at CER
Roche significantly advancing patient care
Recognition for innovation 2013-present
14
Rank Company #
1 Roche 16
2 Novartis 12
3 BMS 10
4 Merck 9
5 AbbVie 7
5 Pfizer 7
16 Breakthrough Therapy Designations
Year Molecule
2017 Zelboraf (BRAF-mutated ECD)
Rituxan (Pemphigus vulgaris)
2016
Actemra (Giant cell arteritis)
Alecensa (1L ALK+ NSCLC)
Ocrevus (PPMS)
Venclexta (AML)
Venclexta + Rituxan (R/R CLL)
2015
Actemra (Systemic sclerosis)
Tecentriq (NSCLC)
Venclexta (R/R CLL 17p del)
Emicizumab/ACE 910 (Hemophilia A)
2014
Esbriet (IPF)
Lucentis (Diabetic retinopathy)
Tecentriq (Bladder)
2013 Alecensa (2L ALK+ NSCLC)
Gazyva (1L CLL)
Source: http://www.focr.org/breakthrough-therapies as of June 30, 2017; PPMS=Primary Progressive Multiple Sclerosis; CLL=Chronic
Lymphocytic Leukemia; NSCLC=Non-Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Fibrosis; ECD=Erdheim-Chester disease
2017: Another important year for our pipeline
Key read-outs
Q1 Q2 Q3 Q4
IMpower150 (Tecentriq 1L Lung)
APHINITY (Perjeta early BC, Her2+)
SPECTRI & CHROMA (Lampalizumab GA)
HAVEN 3 (Emicizumab in non-inh.)
17
2017
Outcome studies are event-driven: timelines may change
Outlook full year 2017
Sales
(+) Strong underlying sales momentum with good launch of new products
() Entry of first biosimilars
Core EPS
(+) PSI base effect washing out in H2 2017
() Expected lower profit growth contribution from gains on product
divestments in H2 2017
() Expected lower profit growth contribution from bond redemption and
equity securities in H2 2017
18 PSI=past service income from changes to group pension plans in 2016
2017 outlook raised
19
Group sales growth1 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)
HY 2017: Pharma sales
Strong growth in US & International
22 CER=Constant Exchange Rates
HY 2017 HY 2016
CHFm CHFm CHF CER
Pharmaceuticals Division 20,521 19,460 5 5
United States 10,185 9,273 10 8
Europe 4,539 4,639 -2 0
Japan 1,771 1,756 1 0
International 4,026 3,792 6 5
Change in %
CHFm % sales
Sales 20,521 100.0
Royalties & other op. inc. 1,115 5.4
Cost of sales -4,180 -20.3
M & D -3,107 -15.1
R & D -4,383 -21.4
G & A -709 -3.5
Core operating profit 9,257 45.1
+3% in CHF
2017 vs. 2016
CER growth
HY 2017
5%
6%
2%
6%
3%
94%
19%
94%
HY 2017: Pharma Division
Core operating profit up 3%, divestments partially offsetting PSI
23 CER=Constant Exchange Rates, PSI=Past Service Income
Admin +3%
HY 2017: Launches driving strong sales growth
24 Absolute values and growth rates at Constant Exchange Rates (CER)
-250 -125 0 125 250
Tarceva
Tamiflu
Pegasys
Avastin
Lucentis
Esbriet
Activase/TNKase
Alecensa
Herceptin
Actemra/RoActemra
Xolair
MabThera/Rituxan
Perjeta
Ocrevus
Tecentriq
US
Europe
Japan
International-17%
>500%
+17%
+3%
+17%
+13%
+103%
+3%
-12%
-35%
+16%
CHFm
-1%
+2%
+13%
n/a
0 2 4 6
Cotellic +
Zelboraf
Alecensa
Tecentriq
Tarceva
CD20
Avastin
HER2
Perjeta
Herceptin
Kadcyla
+6%
-1%
-17%
>+500%
+4%
Gazyva/Gazyvaro
Cotellic
MabThera/Rituxan
(Oncology)
-12%
+103%
25
HY 2017: Oncology with +4% growth
CHFbn
YoY CER growth
HY 2017 Oncology sales: CHF 13.0bn; CER growth +4%; CER=Constant Exchange Rates; CIT=cancer immunotherapy; FL=follicular lymphoma;
NCCN=national comprehensive cancer network; CHMP=committee for medicinal products for human use
• Increased competition
• Breast cancer reimbursement in France, CIT competition
• Perjeta: Strong growth in all regions
• Kadcyla: Strong growth in US, EU and International
• US: Cotellic+Zelboraf stable 1/2L market share
• EU: Cotellic+Zelboraf increasing; Zelboraf mono declining
• US: 2L market share exceeding 50%
• US: NCCN category 1 listing in 1L as preferred option
• US: bladder: 1L cis- ineligible growing market share
• US: 2/3L lung (all-comers label) growing market share
• EU: Positive CHMP opinion in lung (2/3L) and bladder
• Gazyva in R/R FL (GADOLIN) off to a good start
• Gazyva in 1L FL (GALLIUM) on NCCN guidelines
• EU: Positive CHMP opinion in 1L FL
HER2 franchise: Good growth across all brands
26
0
500
1,000
1,500
2,000
2,500
3,000
Q2 14 Q2 15 Q2 16 Q2 17
Herceptin Perjeta Kadcyla
+23%
YoY CER growth
+11%
+19%
CER=Constant Exchange Rates; BC=breast cancer; SC=subcutaneous
CHFm
+7%
HER2 franchise Q2 2017
• Perjeta (+16%): Strong demand driven
by all regions
• Herceptin (+4%): Volume growth in EU
and US due to longer treatment
• Kadcyla (+7%): Growth in US, EU and
International
Outlook 2017
• US/EU filing of APHINITY (adj. BC)
• Herceptin: Further SC conversion
• Perjeta: Further increasing penetration in
1L and neoadjuvant
Avastin: International growth partly offsets
decline in developed markets
27 CER=Constant Exchange Rates
0
400
800
1,200
1,600
2,000
Q2 14 Q2 15 Q2 16 Q2 17
US Europe International Japan
YoY CER growth
0% +4% +13% +4%
CHFm Avastin Q2 2017
• US (-3%): Competition in lung from
cancer immunotherapies
• EU (-7%): Delisting of breast cancer
indication in France
• International (+15%): Growth mainly
driven by China
Outlook 2017
• Continued uptake in ovarian cancer
• Ph III (IMpower150) results in 1L
lung for Tecentriq+Avastin+chemo
expected in Q3/4
Immunology: Differentiation and new indications
contributing to good growth
28
0
400
800
1,200
1,600
2,000
Q2 14 Q2 15 Q2 16 Q2 17
MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other
CHFm
CER=Constant Exchange Rates; CHMP=committee for medicinal products for human use; CRS=cytokine release syndrom
YoY CER growth
+11%
+26%
+12%
+8%
Immunology Q2 2017
Xolair (+13%)
• Allergic asthma & chronic idiopathic
urticaria driving growth
• Asthma: US pediatrics launch ongoing;
only biologic approved for children
Actemra (+12%)
• US approval in giant cell arteritis
achieved; Positive CHMP opinion
• US: Filed for severe/life threatening CRS
• Increasing 1L monotherapy leadership
MabThera/Rituxan (+6%)
• Continues to grow in rheumatoid arthritis
and vasculitis (GPA and MPA)
Esbriet: Continuing to target mild to moderate
patient populations
29
CHFm
0
50
100
150
200
250
Q2 14 Q2 15 Q2 16 Q2 17
US Europe International
YoY CER growth
+19%
+24%
+336%
CER=Constant Exchange Rates
+150%
Esbriet Q2 2017
• US (+20%) / EU (+13%): Growth driven
by penetration into moderate and mild
patient segments
• Market leadership in US and EU5
• Penetration into mild patient segment
increasing, but slower than expected
Outlook 2017
• Increased investments in patient
education about urgency to treat
• More convenient tablet formulation
launched
Ocrevus launch off to a good start
Gaining ground in RMS and PPMS
30
• Strong launch in RMS and PPMS partly driven by patient bolus
• Initial market research indicates inroads in all treatment lines in RMS
• EU launch preparations on track
MS market shares1 MS competitive landscape
1 Source: Evaluate Pharma Multiples Sclerosis report, July 2017, data from full year 2016. Note: Market shares based on value (sales); 2 ABCR’s refers to
Avonex®, Betaferon® / Betaseron®, Copaxone®, Rebir®, Extavia®, Plegridy®; RMS=relapsing forms of multiple sclerosis; PPMS=primary progressive
multiple sclerosis
Tecfidera®19.0%
Aubagio® 6.9%
Gilenya® 14.9%
Tysabri® 9.4%
Lemtrada®2.3%
Zinbryta® 0.1%
ABCRs² 48%
Source: Adapted from Hauser SL, et al. Ann. Neurol. 2013;74(3):317-327
32
APHINITY: Perjeta+Herceptin in HER2+ eBC
Advancing care in a curative setting
von Minckwitz et al, ASCO 2017; eBC=early breast cancer (adjuvant setting); HR=hormone receptor; * Target population for
Herceptin in adjuvant breast cancer (US & EU5); current Herceptin penetration ~95%; Source: Datamonitor and internal estimates
0.8
0.6
0.4
0.2
0.0
1.0
0.8
0.6
0.4
0.2
0.0
1.0
• Risk of recurrence or death reduced by 19% in all patients, 23% in node+ and 24% in HR- patients
• Global filings ongoing
• SC co-formulation of Herceptin + Perjeta in development
Node+ subgroup
(n=3005)
HR- subgroup
(n=1722)
Perjeta+
Herceptin
(n = 1503)
Herceptin
(n = 1502)
Events, n (%) 139 (9.2) 181 (12.1)
Unstratified
HR (95% CI) 0.77 (0.62, 0.96)
p value 0.0188
0 6 12 18 24 30 36 42 48
Time (months)
90.2%
92.0%
86.7%
89.9%
Pro
po
rtio
n e
ve
nt-
fre
e
93.7%
94.9%
98.2%
98.1%
91.2%
92.8%
88.7%
91.0%
Perjeta+
Herceptin
(n = 864)
Herceptin
(n = 858)
Events, n (%) 71 (8.2) 91 (10.6)
Unstratified
HR (95% CI) 0.76 (0.56, 1.04)
p value 0.0847
93.7%
96.2%
97.9%
98.1%
Pro
po
rtio
n e
ve
nt-
fre
e
Time (months)
0 6 12 18 24 30 36 42 48
~75% of HER2+
eBC patients are
high risk*
33
ALEX: Alecensa in 1L ALK+ NSCLC
Recommended as 1L choice in NCCN guidelines
• Compared to crizotinib, Alecensa significantly prolonged PFS, delayed time to CNS progression,
improved intracranial ORR and DOR and had a more favorable safety profile
• NCCN guidelines recommend 1L use (as category 1 preferred option)
• 1L filing completed in the EU and submitted in US
Cumulative incidence
of CNS progression PFS* (ITT)
Shaw A. et al, ASCO 2017; *Investigator assessment; Alecensa (alectinib) in collaboration with Chugai; ITT=intent to treat; CNS=central
nervous system; HR=hazard ratio; PFS=progression free survival; ORR=overall response rate; DOR=duration of response;
NCCN=National Comprehensive Cancer Network; BTD=breakthrough therapy designation
0
20
40
60 Alecensa
100
1 3 6 9 12 15 18 21 24 27 30
crizotinib
Months
151 132 104 84 65 46 35 16 5
152 135 113 109 97 81 67 35 15 3
C
A
At Risk
80
PFS
(%
)
HR (95% CI)
0.47 (0.34-0.65)
p<0.0001
NE
(17.7m-NE)
11.1m
(9.1m-13.1m)
34
CEA-TCB+Tecentriq in mCRC
Next-generation CIT to further expand benefit
Tabernero J, et al. ASCO 2017, abstract #3002; * Source: Datamonitor and internal estimates, US & EU5, equals target population;
TCB=T cell bispecific; CRC=colorectal cancer; CIT=cancer immuno therapy
• Encouraging anti-tumor activity and manageable safety in heavily pretreated patients with MSS mCRC
• CEA-TCB is the first T-cell engaging therapy to show activity in solid tumors
• Pivotal development program to be initiated
CEA-TCB + Tecentriq in 3L mCRC
Pancreas
1L: 57k*
Gastric
1L: 59k*
NSCLC
adeno
1L: 76k*
= CEAhigh patients
Colorectal
1L: 149k*
91% 74% 64% 64% 29%
Breast
1L: 130k*
35
IMvigor211: Tecentriq in prior platinum mUBC
Confirmed as important treatment option
Ph2 comparison OS OS (all patients; n=931)
• Primary endpoint OS in the IC2/3 population (n=234) not met; delayed curve separation in mOS does not
fully reflect the total benefit
• Meaningful improvement in median duration of response (21.7m vs 7.4m), long remissions
• OS results highly consistent with Phase II results (IMvigor210) confirming durability of response
Powles T, et al. EACR-AACR-SIC 2017; mUBC=metastatic urothelial bladder cancer; OS=overall survival; HR=hazard ratio;
CHMP=committee for medicinal products for human use; NSCLC=non-small cell lung cancer
36
IMvigor211: Tecentriq in prior platinum mUBC
Confirmed as important treatment option
• Improved OS with Tecentriq vs taxanes (HR=0.73), but not versus vinflunine (HR=0.97)
• No new safety signals and more favorable safety profile for Tecentriq than for chemotherapy
• Positive CHMP opinion (1L cisplatin ineligible mUBC; prior platinum mUBC; 2/3L NSCLC) obtained
Powles T, et al. EACR-AACR-SIC 2017; mUBC=metastatic urothelial bladder cancer; OS=overall survival; HR=hazard ratio;
CHMP=committee for medicinal products for human use; NSCLC=non-small cell lung cancer
All patients with taxane Treatment related adverse events
No. at Risk
Atezolizumab 215 186 153 125 106 89 81 66 45 34 19 7 0
Taxane 214 179 147 122 94 74 58 35 20 16 4 3 1
80
60
0
10 12 14 16 18 20 2 4 6 8 0 24 22
20
40
Ove
rall S
urv
iva
l
100
Months
HR (95% CI)
0.73 (0.58, 0.92)
8.3m
6.6, 9.8)
7.5m
(6.7, 8.6)
Tecentriq
taxane
No. at Risk
Atezolizumab 252 219 174 155 139 112 96 72 45 25 15 6 1
Vinflunine 250 218 183 146 125 101 82 64 20 26 13 4 0
80
60
0
10 12 14 16 18 20 2 4 6 8 0 24 22
20
40
Ove
rall S
urv
iva
l
100
Months
HR (95% CI)
0.97 (0.78, 1.19)
9.2m
(7.9, 10.4)
8.3m
(6.9, 9.6)
Tecentriq
vinflunine
Chemotherapy Tecentriq
HAVEN 1 intra-individual comparison (adults) Emicizumab vs prior BPA prophylaxis
37
• Event rate reduced by 79% with emicizumab prophylaxis vs prior BPA prophylaxis
• 70.8% of patients with zero events on emicizumab prophylaxis
• Filing in the US, EU and Japan completed
Reduction of treated bleeds
(n=24)
Number of treated bleeds
Oldenburg J, et al. ISTH 2017; ABR=annualized bleeding rate (calculated with negative binomial regression model); BPA=bypassing
agent; NIS=non-interventional study; BTD=breakthrough therapy designation
HAVEN 2 intra-individual comparison (pediatrics) Emicizumab vs prior BPA prophylaxis
38 Young G, et al. ISTH 2017; ABR=annualized bleeding rate (calculated with negative binomial regression model); BPA=bypassing
agent; NIS=non-interventional study; P=participant; BTD=breakthrough therapy designation
• Zero events for all 8 participants (P 1-8) receiving emicizumab (efficacy period 85–99 days)
• Substantial reductions in event rate with emicizumab prophylaxis vs prior BPA treatment
2017: Key late-stage news flow
Compound Indication Milestone
Regulatory
Alecensa 2L ALK+ NSCLC EU approval
Ocrevus RMS / PPMS US/EU launch
Tecentriq 1L cisplatin ineligible mUBC US approval
Tecentriq 2/3L NSCLC and 2L prior platinum mUBC EU approval
Gazyva 1L FL (iNHL) US/EU filing
Actemra Giant cell arteritis US/EU approval
emicizumab Hemophilia A inhibitors US/EU filing
Phase III
readouts*
Perjeta + Herceptin Adjuvant HER2+ BC Ph III APHINITY
Alecensa 1L ALK+ NSCLC Ph III ALEX
Venclexta + Rituxan R/R CLL Ph III MURANO
Tecentriq + chemo/
Tecentriq + chemo + Avastin 1L NSCLC Ph III IMpower150
lampalizumab Geographic atrophy Ph III SPECTRI and CHROMA
emicizumab Hemophilia A non-inhibitors Ph III HAVEN3
40 * Outcome studies are event-driven: Timelines may change; mCNV=choroidal neovascularisation secondary to myopia
Additional H1 2017 news flow:
• Lucentis: Approval in mCNV and diabetic retinopathy
• Rituxan Hycela for blood cancers approved and launched in the US
• Emicizumab: Interim results in pediatric inhibitors (HAVEN2)
• Positive CHMP opinion for Tecentriq in 1L cisplatin ineligible mUBC
HY 2017: Diagnostics Division sales
Good growth driven by Centralised and Point of Care Solutions and Tissue Diagnostics
42 CER=Constant Exchange Rates
Underlying growth of Molecular Diagnostics excluding sequencing business: +2%
HY 2017 HY 2016
CHFm CHFm CHF CER
Diagnostics Division 5,823 5,562 5 5
Centralised and Point of Care Solutions 3,456 3,233 7 8
Diabetes Care 962 998 -4 -4
Molecular Diagnostics 920 903 2 1
Tissue Diagnostics 485 428 13 13
Change in %
North America
+1%
26% of divisional sales
Latin America
+8%
7% of divisional sales
Japan
+2%
4% of divisional sales EMEA1
+3%
40% of divisional sales
HY 2017: Diagnostics regional sales
Growth driven by all regions
Asia Pacific
+13%
23% of divisional sales
43
+16% growth in E7 countries2
1 Europe, Middle East and Africa; 2 Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at Constant Exchange Rates
HY 2017: Diagnostics Division highlights
44
• Driven by immunodiagnostics (+13%);
clinical chemistry (+3%); PoC* (+3%)
• Continued US pricing and reimbursement
pressures
• Virology (-1%); Blood screening (+3%)
• Advanced staining portfolio (+9%); primary
staining (+15%) and companion diagnostics
(+40%)
0.0 1.0 2.0 3.0 4.0
Tissue
Diagnostics
Molecular
Diagnostics
Diabetes
Care
Centralised
and Point of
Care
Solutions
EMEA
North America
RoW
+13%
-4%
+8%
+1%
CHFbn
**
* PoC =Point of Care; ** Underlying growth of Molecular Diagnostics excluding sequencing business: +2%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
YoY CER growth
HY 2017: Diagnostics Division
Core operating profit growth partially offset by PSI
45
CHFm % sales
Sales 5,823 100.0
Royalties & other op. inc. 89 1.5
Cost of sales -2,649 -45.4
M & D -1,337 -23.0
R & D -642 -11.0
G & A -225 -3.9
Core operating profit 1,059 18.2
+5% in CHF
HY 2017 2017 vs. 2016
CER growth
5%
4%
5%
-1%
5%
70%
48%
70%Admin +2%
CER=Constant Exchange Rates; PSI=Past Service Income
Immunoassays contribute 1/3 of Diagnostics sales
Growing double digit > 19 years
46 CER=Constant Exchange Rates; “Other” include Needed Common Products, Allergy, Rheumatoid Arthritis, Immunosuppressants
HY 2017 Sales
12% 10%
Tumormarker
15%
Cardiac
10% 22%
Women’s
Health
Other Hormones
7%
Infectious
Diseases
Endo -
Thyroid
9%
Critical
Care
Anemia
36%
8%
Integrated workflow of cobas 8000 combined with
cobas 6800/8800
Broadest menu and superior integrated workflow
YoY CER growth
US launch of cobas e 801 and HIV assay*
Opens opportunities to gain market share
47
• 100% sensitivity to HIV-1 and recognition of all
known HIV groups and subtypes
• High specificity in samples from routine clinical,
pregnancy testing and dialysis patients
• Broadest infectious disease menu in the US
cobas e 801
*Currently the HIV combi PT is available on the cobas e 602
• Double throughput on same footprint
cobas® MRSA/SA* assay launched in CE markets
cobas® Liat® System menu expansion to meet European markets needs
* MRSA=methicillin resistant Staphylococcus Aureus; RSV=Respiratory Syncytial Virus ** In development; *** e.g. hospital emergency room, STAT lab, doctor’s office; pharmacy clinic
cobas® Liat®
assay tube
48
• Easy to use with minimal hands on time
• Lab quality performance in 30 minutes or less
• Suitable for testing in a variety of settings***
Menu of assays available and in development
cobas® Liat®
Analyzer
CE US CE US
cobas® Influenza A/B cobas® Cdiff
cobas® Strep A cobas® MRSA/SA
cobas® Influenza A/B & RSV*
cobas® Pertussis**
Market leader in Tissue Diagnostics
Superior multiplex IHC* clinical lab workflow driving double digit growth
Automated
multiplex IHC
staining
Automatic whole
slide image analysis
Result interpretation
“cold” vs. “hot tumor”
with TILs**
Whole slide scanning
(BF**, FL**)
Diagnostic
and/or treatment
decision
Spatial characterisation
of tumor
micro-environment
Patient specimen
arrives for analysis
49 * IHC = Immunohistochemistry; ** BF = brightfield; FL = fluorescent; TILs = tumor-infiltrating lymphocytes
Launch of three liquid biopsy oncology gene
panels
50 Validated on an on-market Illumina platform (Next Seq 500 and Next Seq 550). Next Seq 500/550 instruments and associated sequencing reagents are manufactured and sold by Illumina and are not supplied by Roche. * SNV – Single Nucleotide Variant; CNV – Copy number Variant; Indel – Insertion or Deletion.
• Includes all reagents & informatics for a "sample in, result out” solution
• Research Use Only
• All four mutation classes in one panel (SNV, CNV, fusions and indels)*
Three Kit Options
AVENIO ctDNA Targeted Kit
AVENIO ctDNA Expanded Kit
AVENIO ctDNA Surveillance Kit
Features
• Pan-cancer assay for tumor profiling
• 17 genes (81 kb)
• Pan-cancer assay for expanded tumor
profiling
• 77 genes (192 kb)
• Longitudinal tumor burden monitoring,
focus on lung and colorectal cancer
• 197 genes (198 kb)
Area Product Market
Instruments/
Devices
Central
Laboratory
cobas 8000 <e 801> – High throughput immunochemistry analyser
CCM High Speed – cobas connection module (CCM) for up to 6000 samples/hour
US
WW
Coagulation
Testing cobas t 511 / t 711 – Medium and high volume coagulation systems EU
Point of Care CoaguChek Vantus – Hand-held coagulation monitoring system for Patient Self-
Testing US
Diabetes Care Accu-Chek Instant bG System – Effortless, accurate and affordable bG system
for price sensitive markets EU
Tests/
Assays
HPV cobas HPV – Next generation HPV DNA test leveraging 68/8800 Automation to detect
14 hrHPV with simultaneous detection of genotypes 16 and 18
CINtec Histology – Diagnostic component of the Roche Cervical Cancer portfolio
EU
US
Virology cobas HIV 1&2 Qual – For use on the cobas 6800/8800 Systems; for diagnosis of acute
HIV 1 or 2 infection and for confirmation of HIV 1 or 2 infection EU
Sequencing AVENIO ctDNA panels - Liquid biopsy for circulating tumor DNA, 3 panels: targeted
panel (17 genes for cancer therapy selection), expanded panel (77 genes for cancer therapy selection), surveillance panel (197 genes)
EU/US
cobas Liat
cobas Liat C.diff – Qualitative IVD test, that utilizes real-time PCR, for the direct
detection of the tcdB gene of toxigenic C. difficile in unformed stool specimens
cobas Liat MRSA/SA – Qualitative IVD test, that utilizes real-time PCR, for the direct
detection of MRSA and Staphylococcus aureus DNA from nasal swabs
EU
EU
Women’s Health AMH – Immunoassay for the in vitro quantitative determination of anti-Mullerian hormone
(AMH) in human serum and plasma for the assessment of the ovarian reserve in women presenting to fertility clinics
US
Companion
Diagnostics
PD-L1 (SP142) for Bladder Cancer* – complementary diagnostic for Tecentriq
PD-L1 (SP142) for NSCLC* – complementary diagnostic for Tecentriq
EU
EU
Key launch list 2017
51 * = Achieve commercial readiness, dependent on Pharma label and approval
• Strong sales growth of +5%1 and Core operating profit up +3%1
• Core EPS growth +6%1
HY 2017: Highlights
53
Business
Net financial results
• Core net financial result improved by +44%1 driven by lack of debt redemption and higher
income from equity securities, in addition to 18%1 lower interest expenses2
1 At Constant Exchange Rates (CER) 2 incl. amortisation of debt discount and net gains on interest rate derivatives
• Significant cash generation (Operating Free Cash Flow of CHF 7.6bn, +37%1)
• Net debt lower by CHF 4bn vs. June 30, 2016; higher by CHF 1bn vs. YE 2016 due to
dividend payments
Cash flow
IFRS
• Net income +2%1
HY 2017 HY 2016
CHFm CHFm CHF CER
Sales 26,344 25,022 5 5
Core operating profit 10,135 9,854 3 3
as % of sales 38.5 39.4
Core net income 7,187 6,761 6 7
as % of sales 27.3 27.0
Core EPS (CHF) 8.23 7.74 6 6
IFRS net income 5,577 5,467 2 2
Operating free cash flow 7,589 5,487 38 37
as % of sales 28.8 21.9
Free cash flow 5,605 2,849 97 95
as % of sales 21.3 11.4
Change in %
HY 2017: Group performance
Core EPS growth ahead of sales
54 CER=Constant Exchange Rates
HY 2017: Group operating performance
Core operating profit growth +3%
55 CER=Constant Exchange Rates
CHFm % sales
Sales 26,344 100.0
Royalties & other op. inc. 1,204 4.6
Cost of sales -6,829 -25.9
M & D -4,444 -16.9
R & D -5,025 -19.1
G & A -1,115 -4.2
Core operating profit 10,135 38.5
+3% in CHF
HY 2017 2017 vs. 2016
CER growth
5%
5%
3%
5%
3%
75%
21%
75%
CHFm % sales
Sales 26,344 100.0
Royalties & other op. inc. 1,204 4.6
Cost of sales -6,829 -25.9
M & D -4,444 -16.9
R & D -5,025 -19.1
G & A -1,115 -4.2
Core operating profit 10,135 38.5
+3% in CHF
HY 2017 2017 vs. 2016
CER growth
5%
5%
3%
5%
3%
75%
21%
75%
2017 vs. 2016
CER growth
Admin +3%
9,2368,392
1,021
9,8548,984
1,007
10,1359,257
1,059
Roche Group Pharma Division Diagnostics Division
2015 2016 2017
39.2% 39.4% 38.5%
45.7% 46.2% 45.1%
19.5% 18.1% 18.2%
HY 2017: Core operating profit and margin
Higher gains on product divestments partially offsetting PSI
56
CHFm
-0.8%p1
+0.1%p1
-0.9%p1
+5%1
+3%1 +3%1
% of sales
1 At CER=Constant Exchange Rates; PSI=past service income
-596
-496 -334
+100
+64
+53 +37 +8
Equity securities
Debt Redemption
HY 2016
HY 2017
FX G/L All other, net
Interest expenses1
CHFm
• Net financial result improved by +44% at CER
• Interest expenses1 down by +18% at CER
CER=Constant Exchange Rates 1 incl. amortisation of debt discount and net gains on interest rate derivatives
HY 2017: Core net financial result
Significant improvement +44%
57
Half Year 2017 2016 2017 CHFm CHF CER
Core operating profit 9,854 10,135 +281 +3% +3%
Global restructuring plans -391 -321 +70
Amortisation of intangible assets -896 -906 -10
Impairment of intangible assets1 -377 -1,475 -1,098
Alliances & Business Combinations -21 +197 +218
Legal & Environmental -27 +165 +192
Total non-core operating items -1,712 -2,340 -628
IFRS operating profit 8,142 7,795 -347 -4% -4%
Total financial result & taxes -2,675 -2,218 +457
IFRS net income 5,467 5,577 +110 +2% +2%
CER=Constant Exchange Rates; 1 incl. goodwill
HY 2017: Non-core items; IFRS result impacted
by impairments of intangible assets
59
6,525 6,645
146
5,4875,937
-183
7,589 7,560
260
Roche Group Pharma Division Diagnostics Division
2015 2016
2016
27.7%21.9%
28.8%
36.2%30.5%
36.8%
2.8%-3.3%
4.5%
2017
HY 2017: Strong operating free cash flow and
margin
60
CHFm
+6.7%p1
n.a.
+6.2%p1
n.a.
+26%1 +37%1
1 At CER=Constant Exchange Rates
% of sales
+5,487
+7,589
+844
+1,039
+121 +98
Investment in PP&E
OP net of cash adjustments
HY 2017: Operating Free Cash Flow
CHF +2bn / +37% higher than PY
61
HY 2016
HY 2017
Investment in IA
NWC movement
CHFm
OFCF improved by +37%/+2,046m at CER
CER=Constant Exchange Rates; OP=operating profit; NWC=net working capital; PP&E=property, plant & equipment;
IA=intangible assets
-13.2
+7.6
-6.6
-14.2 -2.0
Treasury -0.4
Taxes -1.6
CHFbn
HY 2017: Group net debt development
Higher net debt due to dividend payment, partially offset by FCF
62
0
Net debt
31 Dec 2016
Operating Free
Cash Flow
Dividends & others
Net debt
30 Jun 2017
Non-op. FCF
Free Cash Flow CHF 5.6bn
vs. 2.8bn in 2016
Dividends -7.1
Currency
Translation, +0.5
Others
CER=Constant Exchange Rates
[PY: -18.3] [PY: +5.5]
Balance sheet: Net debt to total assets
63
Net debt
(CHFbn)
Total assets
(CHFbn)
Net debt /
total assets
17.314.1
18.313.2 14.2
68.9
75.8 74.5 76.871.8
30 Jun 2015 31 Dec 2015 30 Jun 2016 31 Dec 2016 30 Jun 2017
25%
19%
25%
17%20%
20%
Net debt/
total assets:
Assets Equity & liabilities
48.1 45.2
26.4 25.3
19.6 19.7
27.8 25.9
9.1 6.922.6 20.6
31 Dec
2016
30 Jun
2017
31 Dec
2016
30 Jun
2017
71.8 71.8-3%
-23%
+4%
-3%
Current
liabilities
Non-current
liabilities
Equity
(Net assets)
12% 10%
25%
63%
27%
34% 35%
76.8 76.8
Current
liabilities
63%
30%
36%
29%
36%
-5%
% change in CER
vs 31 Dec 2016
-3%
-4%
-2%
Cash and
marketable
securities
Other
current
assets
Non-current
assets
CHFbn% change in CER
vs 31 Dec 2016
Balance sheet 30 June 2017
Net debt to total assets at 20%
CER=Constant Exchange Rates 64
CER
sales
growth
HY 2017
vs.
HY 2016
Exchange rate impact on sales growth
Slight positive impact from USD and Lat-Am currencies, partly offset by other Europe and EUR
65 CER=Constant Exchange Rates
+5.0% +5.3%
+0.6p +0.3p +0.2p +0.1p 0.0p -0.4p
-0.5p
CER USD Lat-Am Other JPY As-Pac EUR Other
Europe
CHF
CHF
sales
growth
HY 2017
vs.
HY 2016
1.01 1.00 1.00 1.00 0.99 0.97 0.96 0.96 0.96 0.96 0.96 0.96
1.00 0.99
0.98
0.98 0.99
0.98 0.98
0.99
J F M A M J J A S O N D
Low currency impact expected in 2017
66
Assuming the 30 June 2017 exchange rates
remain stable until end of 2017,
2017 impact is expected to be (%p):
CHF / USD
CHF / EUR
+1%
Average YTD 2016
1% 1% 0% -1%
-2% -2% -1% 0%
Assumed
average YTD
2017
Monthly avg fx rates 2017 Fx rates at 30 Jun 2017 Q1 HY Sep
YTD
FY
Sales 0 0
Core
operating
profit
0
Core EPS 0
1.07 1.07 1.07 1.07 1.09 1.09 1.09 1.09 1.09 1.09 1.09 1.09
1.07 1.08 1.08 1.08
1.10 1.10 1.09 1.09
J F M A M J J A S O N D
2017 outlook raised
67
Group sales growth1 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)
Pipeline summary
Marketed products additional indications
Global Development late-stage trials
pRED (Roche Pharma Research & Early Development)
gRED (Genentech Research & Early Development)
Roche Group HY 2017 results
Diagnostics
Foreign exchange rate information 68
New to phase I New to phase II New to phase III New to registration
Changes to the development pipeline
HY 2017 update
Removed from phase I Removed from phase II Removed from phase III Removed from registration
1 NME: RG7835 – autoimmune diseases
3 AIs: RG7421 Cotellic + Tecentriq – 2L
BRAF WT mM
RG7446 Tecentriq + rucaparib –
ovarian cancer
RG7446 Tecentriq-based Morpheus
platform – pancreatic cancer
4 NMEs: RG6061 HIF1 alpha LNA – solid
tumors
RG6078 IDO inh – solid tumors
RG7888 OX40 MAb – solid tumors
RG6016 LSD1 inh - SCLC
4 AIs: RG3616 Erivedge + Esbriet - IPF
RG6078 IDO inh + Tecentriq – solid
tumors
RG7159 obinutuzumab – renal
transplant
RG7888 OX40 MAb + Tecentriq –
solid tumors
1 NME in-licensed from BMS: RG6206 anti-myostatin adnectin – DMD
1 NME transitioned from Ph1: RG7935 α-synuclein MAb – Parkinson’s
1 NME following filing in EU/US: RG6013 emicizumab – hemophilia A
FVIII inh (pediatrics and adults)
1 AI following EU approval: RG435 Avastin – rel. ovarian ca. Pt-
sensitive
1 AI following US approval: RG105 Rituxan Hycela™ (SC) -
NHL/CLL
1 NME transitioned from Ph2: RG7440 ipatasertib – CRPC
1 AI: RG7446 Tecentriq + Abraxane – TNBC
neoadj
1 NME: CHU nemolizumab - atopic dermatitis
(out-licensed)
69
Status as of July 27, 2017
RG6026 CD20 TCB heme tumors
RG6047 SERD (2) ER+ (HER2-neg) mBC
RG6058 TIGIT ± Tecentriq solid tumors
RG6114 mPI3K alpha inh HR+ BC
RG6146 BET inh solid + heme tumors
RG6180 personalized cancer vaccine oncology
RG6185 pan-RAF inh + Cotellic solid tumors
RG7155 emactuzumab + Tecentriq solid tumors
emactuzumab + CD40 iMAb solid tumors
RG7159 anti-CD20 multiple combos heme tumors
RG7386 FAP-DR5 biMAb solid tumors
RG7421 Cotellic + Zelboraf + T melanoma
Cotellic + T 2L BRAF WT mM
RG7446
Tecentriq solid tumors
Tecentriq NMIBC
T-based Morpheus platform pancreatic ca
T + Avastin + Cotellic 2/3L CRC
T ± Avastin ± chemo HCC, GC, PaC
T ± Avastin ± chemo solid tumors
T + Cotellic solid tumors
T + ipi/IFN solid tumors
T + Tarceva/Alecensa NSCLC
T + anti-CD20 multiple combos lymphoma
T ± lenalidomide ± daratumumab MM
T + K/HP HER2+ BC
T + HMA MDS
T + radium 223 mCRPC
T + guadecitabine AML
T + rucaparib ovarian ca
RG7461 FAP IL2v FP + Tecentriq ± Avastin RCC
RG7601 Venclexta + Cotellic/idasanutlin AML
Venclexta ± azacitidine r/r MDS
RG7741 ChK1 inh solid tumors
RG7802 CEA TCB ± Tecentriq solid tumors
RG7813 CEA IL2v FP* + Tecentriq solid tumors
RG7828 CD20 TCB heme tumors
RG7876 CD40 iMAb + Tecentriq solid tumors
CD40 iMAb + vanucizumab solid tumors
RG7882 MUC16 ADC ovarian ca
RG7986 ADC r/r NHL
CHU Raf/MEK dual inh solid tumors
CHU glypican-3/CD3 biMAb solid tumors
RG3616 Erivedge + ruxolitinib myelofibrosis
RG6069 anti-fibrotic agent fibrosis
RG6107 C5 inh MAb PNH
RG7835 - autoimmune diseases
RG7880 IL-22Fc inflammatory diseases
RG7990 - asthma
RG6004 HBV LNA HBV
RG6080 nacubactam (DBO β-lactamase inh) bact.infections
RG7854 TLR7 agonist (3) HBV
RG7861 anti-S. aureus TAC infectious diseases
RG7907 HBV Capsid (2) HBV
RG7992 FGFR1/KLB MAb metabolic diseases
RG6000 - ALS
RG6029 Nav1.7 inh (2) pain
RG6100 Tau MAb Alzheimer’s
RG7203 PDE10A inh schizophrenia
RG7906 - psychiatric disorders
IONIS ASO Huntington’s
CHU PTH1 recep. ago hypoparathyroidism
CHU - Hyperphosphatemia
RG3502 Kadcyla + Tecentriq 2L HER2+ mBC
RG7221 vanucizumab mCRC
RG7421 Cotellic + Tecentriq ± taxane TNBC
RG7440 ipatasertib 1L TNBC
ipatasertib TNBC neoadj
RG7596 polatuzumab vedotin 1L DLBCL
RG7601
Venclexta + Rituxan DLBCL
Venclexta + Rituxan r/r FL
Venclexta + azacitidine 1L MDS
RG7604 taselisib + letrozole (HER2-neg) BC neoadj
RG7686 codrituzumab liver cancer
RG3637 lebrikizumab atopic dermatitis
lebrikizumab ± Esbriet IPF
RG6125 Cadherin-11 MAb RA
RG6149 ST2 MAb asthma
RG7159 obinutuzumab lupus
RG7625 Cat-S antag autoimmune diseases
RG7845 BTK inh RA, lupus, CSU
CHU nemolizumab** pruritus in dialysis patients
PRO VAP-1 inh inflammatory disease
NOV TLR4 MAb autoimmune diseases
RG6152 CAP endonuclease inh influenza
RG7745 Flu A MAb influenza A
CHU URAT1 inh gout
RG1662 basmisanil CIAS, post-stroke recovery
RG6083 olesoxime SMA
RG6206 anti-myostatin adnectin DMD
RG7314 V1a receptor antag autism
RG7916 SMN2 splicer(2) SMA
RG7935 α-synuclein MAb Parkinson's
RG3645 ranibizumab PDS wAMD
RG7716 VEGF-ANG2 biMAb wAMD, DME
70
New Molecular Entity (NME) RG-No Roche/Genentech
Additional Indication (AI) CHU Chugai managed
Oncology IONIS IONIS managed
Immunology PRO Proximagen managed
Infectious Diseases NOV Novimmune managed
CardioMetabolism *INN: cergutuzumab amunaleukin
Neuroscience **out-licensed to Galderma and Maruho
for atopic dermatitis Ophthalmology
Other T=Tecentriq; TCB=T cell bispecific
Phase I (38 NMEs + 24 AIs)
Status as of July 27, 2017
Phase II (21 NMEs + 11 AIs)
Roche Group development pipeline
RG1273 Perjeta + Herceptin HER2+ BC adj
Perjeta + Herceptin 1L HER2+ gastric ca
RG3502 Kadcyla HER2+ BC adj
Kadcyla + Perjeta HER2+ BC adj
RG6013 emicizumab hemophilia A w/o FVIII inh
emicizumab Q4W hemophilia A
RG7204 Zelboraf BRAFm melanoma adj
RG7388 idasanutlin AML
RG7440 ipatasertib CRPC
RG7421 Cotellic + Zelboraf +T BRAFm melanoma
RG7446
Tecentriq NSCLC adj
Tecentriq MIBC adj
Tecentriq Dx+ 1L sq + non-sq SCLC
Tecentriq RCC adj
T + Abraxane 1L non-sq NSCLC
T + chemo + Avastin 1L ovarian cancer
T + chemo + Avastin 1L non-sq NSCLC
T + chemo + pemetrexed 1L non-sq NSCLC
T + Abraxane 1L sq NSCLC
T + Abraxane 1L TNBC
T + Abraxane TNBC neoadj
T + Avastin RCC
T + Cotellic 3L CRC
T ± chemo 1L mUC
T + chemo 1L extensive stage SCLC
T + enzalutamide CRPC
RG7601
Venclexta + Rituxan r/r CLL
Venclexta + Gazyva 1L CLL
Venclexta + bortezomib MM
Venclexta + HMA 1L AML
RG7604 taselisib + fulvestrant ER+(HER2-neg) mBC
RG105 MabThera pemphigus vulgaris
RG1569 Actemra systemic sclerosis
RG7413 etrolizumab ulcerative colitis
etrolizumab Crohn’s
RG1450 gantenerumab Alzheimer’s
RG6168 IL-6R Mab (SA237) neuromyelitis optica
RG7412 crenezumab Alzheimer’s
RG7417 lampalizumab geographic atrophy
RG3645 Lucentis 0,3mg PFS1 DME/DR
RG435 Avastin1 GBM
RG6013 emicizumab hemophilia A FVIII inh
RG7159 Gazyva2 1L FL
RG7446 Tecentriq2,3 2L mUC
Tecentriq2,4 2L+ NSCLC
RG7853 Alecensa 1L ALK+ NSCLC
RG1569 Actemra2,4 giant cell arteritis
CHU Actemra large-vessel vasculitis
RG1594 OCREVUS®4 PPMS + RMS
Roche Group development pipeline
71
1 US only
2
3
Positive CHMP opinion
Filing based on IMvigor210; accelerated approval
in US for 1L & 2L; phase III completed
4 Approved in US
Phase III (8 NMEs + 32 AIs) Registration (3 NMEs + 6 AIs)
Status as of July 27, 2017
New Molecular Entity (NME) RG-No Roche/Genentech
Additional Indication (AI) CHU Chugai managed
Oncology RG1569 Branded as RoActemra (EU)
Immunology RG7159 Branded as Gazyvaro (EU)
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other T=Tecentriq; TCB=T cell bispecific
NME submissions and their additional indications
Projects currently in phase II and III
72
RG6013 Emicizumab ✓
hemophilia A FVIII inh
pediatrics and adults
RG7417 lampalizumab
geographic atrophy
RG6168 IL-6R MAb SA237 neuromyelitis optica
RG7604 taselisib+fulvestrant
PIK3CAmut ER+ (HER2-neg) mBC
RG6013
emicizumab hemophilia A FVIII non-inh
RG6013 emicizumab
hemophilia A, Q4W
RG7440 ipatasertib
CRPC
RG7440 ipatasertib
1L TNBC
RG7440 ipatasertib
TNBC neoadj
RG7596
polatuzumab vedotin
1L DLBCL
RG7604 taselisib + letrozole
ER+ (HER2-neg) BC neoadj
RG7716 VEGF/ANG2 biMAb
wAMD/DME
RG1450 gantenerumab
Alzheimer‘s
RG1662
basmisanil CIAS, post-stroke
recovery
RG6083 olesoxime
SMA
RG6206
anti-myostatin adnectin
DMD
RG7314 V1 receptor antag
autism
RG7412 crenezumab Alzheimer’s
RG7916 SMN2 splicer(2)
SMA
RG7935 α-synuclein MAb
Parkinson’s
RG6152
CAP endo- nuclease inh
influenza
RG7745 Flu A MAb influenza
RG3637 lebrikizumab
atopic dermatitis
RG3637
lebrikizumab ± Esbriet
IPF
RG6125 Cadherin-11 MAb
RA
RG6149 ST2 MAb Asthma
RG7413 etrolizumab
ulcerative colitis
RG7413 etrolizumab
Crohn’s
RG7625 Cat S antag
autoimmune diseases
RG7845 BTK inh
autoimmune diseases
2018 2017 2020 and beyond 2019
RG7388 idasanutlin
AML
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
✓ Indicates a submission which has occurred with regulatory action pending
Unless stated otherwise submissions are planned to occur in US and EU
Status as of July 27, 2017
AI submissions for existing products
Projects currently in phase II and III
73
✓ Indicates submission to health authorities has occurred
Unless stated otherwise submissions are planned to occur in US and EU
2018 2017 2020 and beyond 2019
RG3645
Lucentis 0.3mg PFS (US)
DME/DR
RG435 Avastin (US) ✓
GBM
RG1273
Perjeta + Herceptin 1L HER2+
gastric cancer
RG1273 Perjeta + Herceptin
HER2+ BC adj.
RG7159 Gazyva (US) ✓
1L FL
RG7204 Zelboraf
BRAFmut melanoma adj.
RG7601 Venclexta + Rituxan
r/r CLL
RG7853 Alecensa ✓
1L ALK+ NSCLC
RG105 MabThera
pemphigus vulgaris
RG1569 Actemra
systemic sclerosis
RG7446
Tecentriq + chemo + Avastin
1L non-sq NSCLC
RG7446 Tecentriq + Abraxane
1L sq NSCLC
RG7446 Tecentriq + Abraxane
1L non-sq NSCLC
RG7446 Tecentriq + chemo
1L extens. stage SCLC
RG7446 Tecentriq + Avastin
RCC
RG7446 Tecentriq + Abraxane
1L TNBC
RG3502 Kadcyla + Tecentriq
2L Her2+ mBC
RG3502 Kadcyla + Perjeta
HER2+ BC adj.
RG3502 Kadcyla
HER2+ BC adj.
RG7601 Venclexta + Rituxan
r/r FL
RG7601 Venclexta + Rituxan
DLBCL
RG7601 Venclexta + HMA
1L AML
RG7601 Venclexta + HMA
1L MDS
RG7421
Cotellic + Tecentriq ± taxane
TNBC
RG3645 ranibizumab PDS
wAMD
RG7159 obinutuzumab
lupus nephritis
RG7446
Tecentriq + Abraxane TNBC neoadj
RG7446 Tecentriq ± chemo
1L mUC
RG7446 Tecentriq NSCLC adj
RG7446 Tecentriq MIBC adj
RG7446
Tecentriq + enzalutamide
CRPC
RG7446 Tecentriq RCC adj
RG7446
Tecentriq + chemo + Avastin
1L ovarian cancer
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
RG7446 Tecentriq + Cotellic
3L CRC
RG7421
Cotellic + Tecentriq + Zelboraf
BRAFmut melanoma
RG7446
Tecentriq 1L non-sq + sq NSCLC (Dx+)
RG7446
Tecentriq + chemo + pemetrexed
1L non-sq NSCLC
RG7601 Venclexta + Gazyva
1L CLL
RG7601
Venclexta + bortezomib
MM
Status as of July 27, 2017
EU Japan-Chugai US
Major granted and pending approvals 2017
74
RG105
Rituxan Hycela™ (SC)
NHL/CLL
June 2017
RG7446
Tecentriq 1L bladder cancer, cis-ineligible
April 2017
RG1569
Actemra giant cell arteritis
May 2017
RG1594
OCREVUS®
PPMS & RMS
March 2017
RG3645
Lucentis mCNV
January 2017
RG3645
Lucentis diabetic retinopathy w/o DME
April 2017
RG435
Avastin GBM
Filed February 2017
RG6013
emicizumab hemophilia A FVIII inh (pediatrics and adults)
Filed June 2017
RG7853
Alecensa 1L ALK+ NSCLC Filed May 2017
RG7159
Gazyva
follicular lymphoma 1L
Filed June 2017
RG6013
emicizumab hemophilia A FVIII inh (pediatrics and adults)
Filed June 2017
RG7853
Alecensa
1L ALK+ NSCLC
Filed March 2017
RG7446
Tecentriq
mUC 2L
Filed April 2016
RG7446
Tecentriq
2L+ NSCLC
Filed April 2016
RG7159
Gazyva
1L follicular lymphoma
Filed October 2016
RG1594
OCREVUS®
PPMS & RMS
Filed April 2016
RG1569
Actemra
giant cell arteritis
Filed November 2016
Approved
Pending Approval
RG6013
emicizumab hemophilia A FVIII inh (pediatrics and adults)
Filed July 2017
RG7446
Tecentriq
2L+ NSCLC
Filed February 2017
CHU
Actemra
large-vessel vasculitis
Filed November 2016
RG7853
Alecensa
2L ALK+ NSCLC
February 2017
RG435
Avastin
chemo backbone extension
rel. OC Pt-sensitive
June 2017
New Molecular Entity (NME) CardioMetabolism
Additional Indication (AI) Neuroscience
Oncology Ophthalmology
Immunology Other
Infectious Diseases
Status as of July 27, 2017
Roche Group development pipeline
Combinations
RG6058 TIGIT ± Tecentriq solid tumors
RG7155 emactuzumab + Tecentriq solid tumors
emactuzumab + CD40 iMAb solid tumors
RG7159 anti-CD20 multiple combos heme tumors
RG7421 Cotellic + Zelboraf + T melanoma
Cotellic + T BRAF WT mM2L
RG7446
T-based Morpheus platform pancreatic ca
T + Cotellic ± Avastin 2/3L CRC
T ± Avastin ± chemo HCC, GC, PaC
T ± Avastin ± chemo solid tumors
T + Cotellic solid tumors
T + ipi/IFN solid tumors
T + Tarceva/Alecensa NSCLC
T + anti-CD20 multiple combos lymphoma
T ± lenalidomide ± daratumumab MM
T + K/HP HER2+ BC
T + HMA MDS
T + radium 223 mCRPC
T + guadecitabine AML
T + rucaparib ovarian ca
RG7461 FAP IL2v FP + Tecentriq ± Avastin RCC
RG7601
RG7601
Venclexta + Cotellic/idasanutlin AML
Venclexta ± azacitidine r/r MDS
RG7802 CEA TCB ± Tecentriq solid tumors
RG7813 CEA IL2v FP* + Tecentriq solid tumors
RG7876 CD40 iMAb + Tecentriq solid tumors
CD40 iMAb + vanucizumab solid tumors
RG3616 Erivedge + ruxolitinib myelofibrosis
Phase I (6 NMEs + 22 AIs)
RG3502 Kadcyla + Tecentriq 2L HER2+ mBC
RG7421 Cotellic + Tecentriq ± taxane TNBC
RG7601
Venclexta + Rituxan DLBCL
Venclexta + Rituxan r/r FL
Venclexta + azacitidine 1L MDS
RG7604 taselisib + letrozole (HER2-) BC neoadj
RG3637 lebrikizumab ± Esbriet IPF
Phase II (7 AIs)
RG1273 Perjeta + Herceptin HER2+ BC adj
Perjeta + Herceptin 1L HER2+ gastric ca
RG3502 Kadcyla + Perjeta HER2+ BC adj
RG7421 Cotellic + Zelboraf + T BRAFm melanoma
RG7446
T + Abraxane 1L non-sq NSCLC
T + chemo + Avastin 1L ovarian cancer
T + chemo + Avastin 1L non-sq NSCLC
T + chemo + pemetrexed 1L non-sq NSCLC
T + Abraxane 1L sq NSCLC
T + Abraxane 1L TNBC
T + Abraxane TNBC neoadj
T + Cotellic 3L CRC
T + Avastin RCC
T ± chemo 1L mUC
T + chemo 1L extens. stage SCLC
T + enzalutamide CRPC
RG7601
Venclexta + Rituxan r/r CLL
Venclexta + Gazyva 1L CLL
Venclexta + bortezomib MM
Venclexta + HMA 1L AML
RG7604 taselisib + fulvestrant ER+ (HER2-neg) mBC
Phase III (1 NME + 20 AIs)
New Molecular Entity (NME) RG-No Roche/Genentech
Additional Indication (AI) CHU Chugai managed
Oncology *INN: cergutuzumab amunaleukin
Immunology T=Tecentriq; TCB=T cell bispecific 75
Status as of July 27, 2017
Cancer immunotherapy pipeline overview
RG6026 CD20 TCB hematopoietic tumors
RG6058 TIGIT ± Tecentriq solid tumors
RG6180 personalized cancer vaccine oncology
RG7155 emactuzumab + Tecentriq solid tumors
emactuzumab + CD40 iMAb solid tumors
RG7421 Cotellic + Zelboraf + T melanoma
Cotellic + T BRAF WT mM2L
RG7446
Tecentriq solid tumors
Tecentriq NMIBC
T-based Morpheus platform pancreatic ca
T + Cotellic ± Avastin 2/3L CRC
T ± Avastin ± chemo HCC, GC, PaC
T ± Avastin ± chemo solid tumors
T + Cotellic solid tumors
T + ipi/IFN solid tumors
T + Tarceva/Alecensa NSCLC
T + anti-CD20 multiple combos lymphoma
T ± lenalidomide ± daratumumab MM
T + K/HP HER2+ BC
T + HMA MDS
T + radium 223 mCRPC
T + guadecitabine AML
T + rucaparib ovarian ca
RG7461 FAP IL2v FP + Tecentriq ± Avastin RCC
RG7802 CEA TCB ± Tecentriq solid tumors
RG7813 CEA IL2v FP* + Tecentriq solid tumors
RG7828 CD20 TCB heme tumors
RG7876 CD40 iMAb + Tecentriq solid tumors
CD40 iMAb + vanucizumab solid tumors
RG3502 Kadcyla + Tecentriq 2L HER2+ mBC
RG7421 Cotellic + Tecentriq ± taxane TNBC
IMDZ** Tecentriq + NY-ESO-1 soft tissue sarcoma
SNDX** Tecentriq + entinostat TNBC
RG7446 Tecentriq1 2L mUC
Tecentriq2 2L+ NSCLC
RG7421 Cotellic + Zelboraf + T BRAFm melanoma
RG7446
Tecentriq NSCLC adj
Tecentriq MIBC adj
Tecentriq Dx+ 1L sq + non-sq SCLC
Tecentriq RCC adj
T + Abraxane 1L non-sq NSCLC
T + chemo + Avastin 1L ovarian cancer
T + chemo + Avastin 1L non-sq NSCLC
T + chemo + pemetrexed 1L non-sq NSCLC
T + Abraxane 1L sq NSCLC
T + Abraxane 1L TNBC
T + Abraxane TNBC neoadj
T + Avastin RCC
T + Cotellic 3L CRC
T ± chemo 1L mUC
T + chemo 1L extensive stage SCLC
T + enzalutamide CRPC
1 Filing based on IMvigor210, accelerated approval in US
for 1L & 2L; positive CHMP opinion, phase III completed
2 Approved in US, positive CHMP opinion ** External collaborations: INCY- Incyte IDO inh; CLDX - Celldex CD27 MAb; CRVS – Corvus ADORA2A antag; KITE – Kite KTE-C19; AMGN – Amgen oncolytic virus; JNJ – Janssen CD38 MAb; CLVS – Clovis PARP inh; EPZM – Epizyme EZH2 inh; BLRX - BioLine Rx CXCR4 antag; IMDZ – Immune Design CMB305; SNDX – Syndax HDAC inh
New Molecular Entity (NME) RG-No Roche/Genentech
Additional Indication (AI) *INN: cergutuzumab amunaleukin
Oncology T=Tecentriq; TCB=T cell bispecific
76
RG7446
T + Cotellic pancreatic ca
T + PEGPH20 pancreatic ca
T + BL-8040 pancreatic ca
INCY** Tecentriq + epacadostat solid tumors
CLDX** Tecentriq + varlilumab solid tumors
CRVS** Tecentriq + CPI-444 solid tumors
KITE** Tecentriq + KTE-C19 r/r DLBCL
AMGN** Tecentriq + talimogene laherp TNBC, CRC
JNJ** Tecentriq ± daratumumab solid tumors
CLVS** Tecentriq + rucaparib ovarian ca
EPZM** Tecentriq + tazemetostat r/r DLBCL
BLRX** Tecentriq + BL-8040 AML, solid tumors
Phase I (9 NMEs + 29 AIs) Phase III (17 AIs)
Registration (1 NME + 1 AIs) Phase II (4 AIs)
MORPHEUS Platform - Phase Ib/II (1 AI)
Status as of July 27, 2017