Strategy, Rejuvenation, and Transformation
Alan Hippe | CFO Roche
Exane BNPP European CEO Conference, June 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
2
Managing COVID-19 / SARS-CoV-2: Roche’s contribution
We are passionate about innovation
Focusing on 4 key areas
Summary
3
Roche COVID-19 pandemic response
Ramping up SARS-CoV2 testing
SARS-CoV2 PCR test SARS-CoV2 antibody test
cobas 8800 cobas 6800 e 411 e 601/602 e 801
4,128 results in 24h 1,440 results in 24h
• EUA for the cobas SARS-CoV2 PCR test, developed • Elecsys Anti-SARS-CoV2 serology test for detection
in a record time of 6 weeks of total antibodies (IgA, IgM, IgG) launched in May
• Continuously increasing production capacity • Ramp up to >100 million tests per month by June
• 850 high throughput systems installed globally • Global cobas e1 installed base of >40,000
EUA=emergency use authorization; 1 cobas e: cobas e 801, cobas e 602, cobas e 601, cobas e 411; 2 300 tests per hour is the throughput rate for cobas e 801 4
Roche COVID-19 response
Placebo controlled Actemra trial initiated
Actemra: Ph III (COVACTA) in hospitalized patients
Preparing for increased global Actemra supply
with severe COVID-19 pneumonia
• First-in-class IL-6 receptor antagonist
• Approved in >110 countries
• Initially approved in RA and GCA
• Approved for CAR T-cell-induced cytokine
release syndrome (CRS)
• Ph III placebo controlled trial with BARDA started beginning of April
• IV Dose: 8 mg/kg (max 800 mg) + standard of care; if clinical signs do not improve one additional dose can be given,
endpoints include clinical status, mortality, mechanical ventilation and intensive care unit variables
• Patients followed for 28 days; read-out expected in early summer
RA=rheumatoid arthritis; GCA=giant cell arteritis; BARDA=Biomedical Advanced Research and Development Authority 5
Managing COVID-19 / SARS-CoV-2: Roche’s contribution
We are passionate about innovation
Focusing on 4 key areas
Summary
6
Roche business update in light of COVID-19
2020 outlook confirmed
Pharmaceuticals:
• New product sales overcompensate for entry of biosimilars (Q1: +7%)
• Launch of NMEs, pivotal readouts and pivotal trial starts largely on track
• Ph III Actemra readout in severe COVID-19 pneumonia expected in June
Watch-outs:
• Chronic diseases: Patients delaying appointments (Ocrevus, Lucentis)
• Potential trial delays for new patients starts (especially outside oncology)
Diagnostics:
• Portfolio shifts from routine testing to COVID-19 testing (Q1: +5%)
• Ramping up SARS-CoV-2 test manufacturing capacity (PCR and antibody)
All growth rates at Constant Exchange Rates (CER) 7
New products with strong momentum
CHFm % of Pharma Sales CHFm
5,000 37%
4,500
4,000
27%
3,500
3,000
2,500 19%
2,000
1,500 12%
1,000
500
0
Q1 17 Q1 18 Q1 19 Q1 20
Erivedge Perjeta Kadcyla Gazyva
Esbriet Cotellic Alecensa Tecentriq
Ocrevus Hemlibra Xofluza Polivy
Rozlytrek
Q1 values in reported CHFm, variances in CERm; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy & Rozlytrek; 2 MabThera & 8
Herceptin in Europe and MabThera, Herceptin & Avastin in Japan; 3 Herceptin, Avastin & MabThera in US
Managing COVID-19 / SARS-CoV-2: Roche’s contribution
We are passionate about innovation
Focusing on 4 key areas
Summary
9
4 Priorities to maintain leadership position
Cultural New medicines & Growing installed base Leading personalized
transformation technology platforms & expanding menu healthcare revolution
Improve structure, Improve on current Expansion with additional
Lead in digitalization &
processes, behaviour & standard of care & smart solutions and entering new
transform value chain
competitive fitness ways of development disciplines
10
4 Priorities to maintain leadership position
Cultural New medicines & Growing installed base Leading personalized
transformation technology platforms & expanding menu healthcare revolution
Improve structure, Improve on current Expansion with additional
Lead in digitalization &
processes, behaviour & standard of care & smart solutions and entering new
transform value chain
competitive fitness ways of development disciplines
11
Our cultural transformation: Simplify processes and empower our
people to enhance productivity in service of patients
Executive Committee focus on agile: start of major
changes to increase flexibility and dynamism
Tech Ops: PT Lean & agility programs start Some of our guiding principles:
Launch of US Transformation • From silos, functional and top down focus to small
empowered teams with accountability for results
Late Stage new ways of working
• From internal / org chart orientation to patient and
Corporate functions transform
external focus
Ex-US commercial model go live • From leadership as command & control to setting a
vision, architecting the system, coaching and
catalysing change
2016 2017 2018-19 2020+
12
4 Priorities to maintain leadership position
Cultural New medicines & Growing installed base Leading personalized
transformation technology platforms & expanding menu healthcare revolution
Improve structure, Improve on current Expansion with additional
Lead in digitalization &
processes, behaviour & standard of care & smart solutions and entering new
transform value chain
competitive fitness ways of development disciplines
13
New medicines: Replace and extend the business
Replace/extend existing businesses Entering new Sales mix (100%)
franchises (Conceptual)
Gazyva, Oncology: 2018
Venclexta, Tecentriq (mUC, HCC,
Polivy, melanoma) 21%
MabThera/Rituxan
mosunetuzumab, MS:
47%
CD20 x CD3, Ocrevus
idasanutlin 32%
Hemophilia A:
Perjeta, Hemlibra
Herceptin Kadcyla, 2023
Perjeta+Herceptin FDC-SC CNS:
satralizumab (NMOSD), 14%
Tecentriq, risdiplam (SMA),
Alecensa, Huntington’s,
Avastin 24%
Rozlytrek, Autism,
ipatasertib Alzheimer’s 62%
faricimab Immunology:
Lucentis
Port delivery system (PDS) etrolizumab (UC, CD), New products launched after 2012
Tamiflu Xofluza Gazyva (lupus nephritis) Other products Herceptin + Rituxan + Avastin
FDC=fixed dose combination; mUC=metastatic urothelial carcinoma; HCC=hepatocellular carcinoma; NMOSD=neuromyelitis optica spectrum disorder; SMA=spinal muscular atrophy;
UC=ulcerative colitis; CD=Crohn’s disease
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Establishing Tecentriq as Standard of Care in major tumour types
Tecentriq and aTIGIT in various
Wave 3 cancer types entering Ph III in Q1 20
Fourth 4
Personalized CIT,
wave
RNAseq, etc.
Combos/ NMEs: defined immune
profiles
Opportunity/ Cure Rate
Third
wave 3
Expand to novel CITs
Immune doublets: Tecentriq + Bi-specifics, aTIGIT,
etc. Ph II to be presented in H1 2020
Second 2 Wave 2 Tecentriq + Avastin in HCC
Combine with Existing Medications Medically meaningful improvement
wave Tecentriq + chemo/ targeted therapies in SCLC, TNBC, ovarian,
HCC, bladder, etc.
First 1 Checkpoint Inhibitors Monotherapy
wave Tecentriq in NSCLC: Impower110
NSCLC=non-small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple-negative breast cancer; HCC=hepatocellular carcinoma
15
Risdiplam in spinal muscular atrophy (SMA)
Compelling benefit/risk profile in infants, children, teenagers, and adults
Over 450 patients treated with risdiplam to date
• Durably increases SMN protein
throughout the CNS and in peripheral
tissues
• Positive efficacy in Type 1 infants
(n=62 total)
• Positive efficacy in large (n=180)
placebo-controlled study in a broad
spectrum of Type 2/3 patients
• Consistent safety profile across trials Primary analysis Primary analysis Enrollment
Enrolling
completed completed completed
• No treatment-related safety findings
have led to withdrawal in any study
Potential to be the treatment of choice for a majority of patients living with SMA
Risdiplam program is a collaboration with PTC Therapeutics and the SMA Foundation 16
4 Priorities to maintain leadership position
Cultural New medicines & Growing installed base Leading personalized
transformation technology platforms & expanding menu healthcare revolution
Improve structure, Improve on current Expansion with additional
Lead in digitalization &
processes, behaviour & standard of care & smart solutions and entering new
transform value chain
competitive fitness ways of development disciplines
17
Growing installed base worldwide driving reagents consumption
Integrated Core Lab
+11% cobas 6000/8000
+36% cobas 6800/8800
+17% Connectivity
+21%
+21% Preanalytics
Middleware
cobas 4000 +9%
2019
Growth
Growth rates being from the period of January 1, 2019 to December 31, 2019 18
4 Priorities to maintain leadership position
Cultural New medicines & Growing installed base Leading personalized
transformation technology platforms & expanding menu healthcare revolution
Improve structure, Improve on current Expansion with additional
Lead in digitalization &
processes, behaviour & standard of care & smart solutions and entering new
transform value chain
competitive fitness ways of development disciplines
19
Building the PHC ecosystem
Using data & insights to improve patient outcomes
Access to comprehensive
genomic profiling (CGP)
- early, personalized diagnosis
Capturing clinical outcomes data & Molecular tumor board (MTB) /
- Leveraging RWD for regulatory insights clinical decision support (CDS)
filings, publications, policy change, - personalized care plan
innovative access models
Access to molecularly guided
treatment options
- rapid therapy access and innovative
access models
More patients on optimal therapy & creation of ‘learning healthcare system’
PHC=personalized healthcare; RWD=real world data 20
Managing COVID-19 / SARS-CoV-2: Roche’s contribution
We are passionate about innovation
Focusing on 4 key areas
Summary
21
Strong short term news flow
Diversifying late stage pipeline & setting new standards of care
Product Timing Population Product Filing date Population
risdiplam in SMA Filed for type 1/2/3 ~18k (rare disease) ✔ Tecentriq in 1L HCC 2019 ~300k1 ✔
satralizumab in NMOSD Filed ~21k (rare disease) ✔ Tecentriq in neoadj TNBC 2020 ~19k
Ph II & III ongoing; Tecentriq in adj bladder cancer 2020 ~50k
HTT-ASO in Huntington’s ~83k (rare disease)
Trial fully recruited
Tecentriq in 1L melanoma 2020 ~11k (Dx+) ✔
Gazyva in lupus nephritis initiating Ph III ~190k
Tecentriq in FL ovarian cancer 2020 ~41k
UC ~700k
etrolizumab in UC and idasanutlin in R/R AML 2020 ~22k
filing in UC in 2020 CD ~640k
Crohn’s Disease
(moderate to severe)
Perjeta + Herceptin FDC-SC 2020 ~75k ✔
fully recruited;
PDS in nAMD ipatasertib 1/2L TNBC 2020 ~11k (Dx+)
filing in 2020 nAMD ~4,090k
recruitment ahead of DME ~4,400k ipatasertib 1L+ HR+ ~83k (Dx+)
faricimab in DME/nAMD 2020
plan; filing in 2021/22 (chemo treated only) ~15k (Dx+/chemo only)
ipatasertib in 1L mCRPC 2020 ~200k (AC) 100k (Dx+)
Neuroscience Ophthalmology
Polivy in 1L DLBCL 2020/21 ~52k
Immunology Oncology
✔ Filing completed or positive pivotal data Tecentriq in (neo)adj NSCLC 2021/22 ~75k
Source: Roche/Genentech, incidence/prevalence in the major markets (US, FR, DE, IT, ES, GB); 1 including China; SOC=standard of care; SMA=spinal muscular atrophy; NMOSD=neuromyelitis optica spectrum disorder; UC=ulcerative colitis;
CD=Crohn’s disease; nAMD=neovascular age-related macular degeneration; DME=diabetic macular edema; HCC=hepatocellular carcinoma; TNBC=triple-negative breast cancer; FL=front line; R/R AML=relapsed/refractory acute myeloid leukemia; 22
FDC=fixed dose combination; HR=hormone receptor; mCRPC=metastatic castration resistant prostate cancer; DLBCL=diffuse large B-cell lymphoma; NSCLC=non-small cell lung cancer; AC=all comers
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 23
Doing now what patients need next
