science, patient benefits, and productivity8a9839cc-9997-4df0-a785...replace and extend the...
TRANSCRIPT
Science, patient benefits, and productivity
Severin Schwan, CEO Roche Group
UBS Global Healthcare Conference NY, 2019
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 protected2
Performance update
Growing new assets
Productivity
Outlook
3
New products with strong momentum
4All absolute values are presented in CHFm reported; 1 Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, and Xofluza; 2 MabThera & Herceptin in Europe & JP
13,583
14,826
+1,204+442
-12-391
Pharma biosimilarsexposed2
Pharma new
products1Q1 2018 Q1 2019Diagnostics
division
Pharmaother
products
CHFmCHFm % of Pharma sales
5
36.4% 35.7% 36.1%
Core operating profit
% of sales
14.1
17.8
18.7
2016 2017 2018
27.9%
33.4% 33.0%
Operating free cash flowCore EPS
14.5315.34
18.14
2016 2017 2018
18.4 19.0
20.5
2016 2017 2018
CHFbn +9% at CER +5% at CER+19%1 at CERCHF CHFbn
CER=Constant Exchange Rates; 1+8% at CER excl. US tax reform
2018: Strong Core results, significant operating free cash flow
Performance update
Growing new assets
Productivity
Outlook
6
Roche significantly advancing patient care
BTD’s and BDD’s reflecting the quality of our research
7* Real-Time Oncology Reviews (RTOR) pilot and BTD
Replace and extend the business: Excellent progress
Through continuously improving standard of care
Replace/extend existing businesses Entering new
franchises
8
MabThera/Rituxan
Gazyva,
Venclexta,
polatuzumab vedotin,
mosunetuzumab,
CD20 x CD3
Herceptin
Perjeta,
Kadcyla,
Herceptin + Perjeta SC
Avastin
Tecentriq,
Alecensa,
entrectinib
Lucentisfaricimab
Port delivery system (PDS)
Tamiflu Xofluza
Achievements 2018
MS:
Ocrevus
Hemophilia A:
Hemlibra
CNS:
SMA, Autism,
Huntington’s,
Alzheimer’s, NMOSD
SMA=spinal muscular atrophy; NMOSD=neuromyelitis optica spectrum disorder; RMS=relapsing MS; PPMS=primary progressive MS; R/R CLL=relapsed/refractory chronic lymphocytic leukemia;
AML=acute myeloid leukemia; BC=breast cancer; NSCLC=non-small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple-negative BC; nAMD=neovascular age-related macular degeneration;
DME=diabetic macular edema, PDS= Port Delivery System
Strong launches:
Ocrevus, Perjeta, Hemlibra, Tecentriq, Alecensa
Pivotal readouts:
Gazyva+Ven 1L CLL
Kadcyla: HER2+ eBC
Tecentriq: 1L non-sq NSCLC, 1L SCLC & TNBC,
Entrectinib : ROS1+ NSCLC & NTRK+ tumors
Xofluza: US approval in Influenza A and B
satralizumab: NMOSD
Venclexta: R/R CLL & 1L AML
Proof of Concept:
faricimab: Ophtalmology- nAMD and DME
PDS: Ophtalmology - nAMD
risdiplam: SMA- Type 1/2/3
balovaptan: Autism in adults
What we have achievedFurther growth momentum /
new market entries
Tecentriq
Strong US launch in 1L SCLC; 2L NSCLC share gains in EU
9
YoY CER growthCHFm
CER=Constant Exchange Rates; NSCLC=non-small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple negative breast cancer; HCC=hepatocellular carcinoma
(+) 1L HCC: Ph III readout in 2019
(+) Adj bladder cancer: Ph III readout in 2019 /20
(+) 1L Melanoma: Ph III readout in 2019
Main drivers: (+) 1L NSCLC (US/EU)
(+) 1L SCLC & 1L TNBC (US)
Replace and extend the business: Excellent progress
Through continuously improving standard of care
Replace/extend existing businesses Entering new
franchises
10
MabThera/Rituxan
Gazyva,
Venclexta,
polatuzumab vedotin,
mosunetuzumab,
CD20 x CD3
Herceptin
Perjeta,
Kadcyla,
Herceptin + Perjeta SC
Avastin
Tecentriq,
Alecensa,
entrectinib
Lucentisfaricimab
Port delivery system (PDS)
Tamiflu Xofluza
Achievements 2018
MS:
Ocrevus
Hemophilia A:
Hemlibra
CNS:
SMA, Autism,
Huntington’s,
Alzheimer’s, NMOSD
SMA=spinal muscular atrophy; NMOSD=neuromyelitis optica spectrum disorder; RMS=relapsing MS; PPMS=primary progressive MS; R/R CLL=relapsed/refractory chronic lymphocytic leukemia;
AML=acute myeloid leukemia; BC=breast cancer; NSCLC=non-small cell lung cancer; SCLC=small cell lung cancer; TNBC=triple-negative BC; nAMD=neovascular age-related macular degeneration;
DME=diabetic macular edema, PDS= Port Delivery System
Strong launches:
Ocrevus, Perjeta, Hemlibra, Tecentriq, Alecensa
Pivotal readouts:
Gazyva+Ven 1L CLL
Kadcyla: HER2+ eBC
Tecentriq: 1L non-sq NSCLC, 1L SCLC & TNBC,
Entrectinib : ROS1+ NSCLC & NTRK+ tumors
Xofluza: US approval in Influenza A and B
satralizumab: NMOSD
Venclexta: R/R CLL & 1L AML
Proof of Concept:
faricimab: Ophtalmology- nAMD and DME
PDS: Ophtalmology - nAMD
risdiplam: SMA- Type 1/2/3
balovaptan: Autism in adults
Neuroscience franchise
Ocrevus growth driven by new/ switch patients
11CER=Constant Exchange Rates
What we have achieved
YoY CER growthCHFm
Main drivers: (+) Strong launch in US/ EU
Increasing US market share
7% 8% 8%
21% 18% 14%
26%21%
16%
2%
3%
5%
11%
11%
10%
2%
3%
3%
19%
18%
17%
11%
10%
9%
8%16%
0%
20%
40%
60%
80%
100%
Total patient share- R3M (Jan 2017 to Jan 2019)
AUBAGIO ABREPs COPAXONE
GENERIC COPAXONE GILENYA LEMTRADA
RITUXAN TECFIDERA TYSABRI
OCREVUS
Jan 17 Jan 18 Jan 19
12Data at AAN 2019. *Defined as ≥16 hours per day continuously for ≥2 weeks. †Supports weight. Cohort 1: Low dose cohort. Cohort 2: Dose adjusted per protocol. Data cut-off: 27 February 2019. BSID-III, Bayley Scales of Infant Development, Third Edition; CHOP-INTEND, Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders; HINE-2, Hammersmith Infant Neurological Examination, Section 2; SMA, spinal muscular atrophy.
A positive benefit-risk ratio for patients with Type 1 SMA
A compelling divergence from natural history
Risdiplam in SMA Typ 1 (FIREFISH-1) – strong 1 year results
Hemophilia A franchise
Transforming the market
13
Needs-based segmentation1
Total hemophila A market growing to USD 13bn by 20242
75-80%
target
population
5%
45%
15%
10%
20%
PWHA=People with Hemophilia A; Source: Treated patients MORSE 2017 (prevalence), UKHCDO Annual Report 2016 and internal assumptions (treatment rate); 1 Target population based on the US label; 2 Source: Evaluate Pharma
Inhibitors Non-inhibitor adults on treatment with bleeds
Non-inhibitor pediatric Non-inhibitor adults on treatment without bleeds
Non-inhibitor mild patients
Performance update
Growing new assets
Productivity
Outlook
14
Continuing to evolve our operating model
Build an effective organization for the future
• Simplify current set up for
Corporate, Pharma and Dia
• Centers in Kuala Lumpur,
Costa Rica, and Budapest
• Smaller, fit-for-purpose teams
with power to decide & act
• Resource shift to support key
launches
• Faster filing (strive for best in
class)
• Innovative trial designs
15
Corporate:
Shared Service Centers
Technical operations
• Reduction in COGS
• Cope with demand in China
• Lean management production
program
+11%
+3%
Volume Core COGS and
Period Costs
Sales organization
US
Europe
LATAM
APAC
EEMEA
US
International
Development
Performance update
Growing new assets
Productivity
Outlook
16
New products close to annualized sales of CHF 13bn*
Additional 4 NMEs approaching launch
17* Venclexta sales are booked by partner AbbVie and therefore not included.
CHFm % of Pharma sales
18
Q1 2019: Record number of NMEs at pivotal stage
entrectinib
polatuzumab vedotin
ipatasertib
Hemlibra (EU)
idasanutlin
Perjeta+Herceptin FDC SC
PDS with ranibizumab
faricimab
HTT-ASO
risdiplam
balovaptan
anti-myostatin adnectin
satralizumab
gantenerumab
Xofluza (EU)
etrolizumab
FY 2016 FY 2018
Hemlibra
idasanutlin
taselisib
Alecensa
Tecentriq
lampalizumab
crenezumab
satralizumab
gantenerumab
Ocrevus
etrolizumab
NM
Es
lin
e
exte
nsio
ns
5
1
33
3
1
37
3
Oncology
Neuroscience
Ophthalmology
Immunology
Infectious Disease
polatuzumab vedotin
ipatasertib
Hemlibra
idasanutlin
taselisib
faricimab
risdiplam
balovaptan
anti-myostatin adnectin
crenezumab
satralizumab
gantenerumab
Ocrevus
Xofluza
etrolizumab
FY 2017
4
1
31
NME=new molecular entities; FDC=Fixed dose combination; SC=Subcutaneous; PDS=Port delivery system; For details on the indications and line extensions please consult the pipeline appendix
entrectinib
polatuzumab vedotin
ipatasertib
idasanutlin
Perjeta+Herceptin FDC SC
PDS with ranibizumab
faricimab
HTT-ASO
risdiplam
balovaptan
anti-myostatin adnectin
satralizumab
gantenerumab
Xofluza (EU)
etrolizumab
Q1 2019
2
1
34
4
2019 outlook raised
Sales growth to “mid-single digit” from “low- to mid-single digit”
19
Group sales growth1 • Mid-single digit (from low- to mid-single digit)
Core EPS growth1 • Broadly in line with sales
Dividend outlook • Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER)
Doing now what patients need next