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Roche in Brief 2016
Who we are
3
Asia 21,235 employees**
Chugai, Tokyo, Japan ( )
Shanghai, China ( )
North America 25,494 employees**
Genentech, San Francisco, US ( )
Basel and Kaiseraugst, Switzerland ( ) Mannheim and Penzberg, Germany ( )
Latin America 4,587 employees**
Africa 1,166 employees**
Australia/New Zealand 701 employees**
22 Research and development sites in Pharmaceuticals and Diagnostics worldwide
26 Manufacturing sites in Pharmaceuticals and Diagnostics worldwide
Roche Group headquarters
Largest sites based on number of employees
Research and development sites in Pharmaceuticals and Diagnostics
Manufacturing sites in Pharmaceuticals and Diagnostics
Sales sites in Pharmaceuticals and Diagnostics
Roche’s global presenceKey figures 2016
CHF 50.6 billion Group sales
CHF 11.5 billion Diagnostics sales
CHF 9.7 billion IFRS net income
CHF 39.1 billion Pharmaceuticals sales
CHF 18.4 billion Core operating profit
CHF 14.53 Core earnings per share
27 million patients treated with one of our top 25 selling medicines
29 Roche medicines on the WHO List of Essential Medicines
CHF 9.9 billion invested in research & development (R&D)
311,726 patients participating in clinical trials
74 NMEs in clinical development
2016
2015
2016
2015
2016
2015
2016
2015
2016
2015
2016
2015
9.7 bn +7%
9.1 bn
14.53 +5%
13.49
50.6 bn +4%*
48.1 bn
11.5 bn +7%
10.8 bn
39.1 bn +3%
37.3 bn
18.4 bn +4%
17.5 bn
94,052 employees**worldwide
Europe 40,869 employees**
* All growth rates in this report are at constant exchange rates (CER; average 2015).
** Number of employees expressed in full-time equivalents
54
Who we are
Our strategy
How we do it
Our focusFitting treatments to patients
Our peopleMaking their mark
Our distinctiveness Excellence in
science
Our structureBuilt for innovation
Our deliveryValue for all stakeholders
Our decision-makingAccountable and transparent
What we do
Who we are
Innovation: It’s in our DNA. We have always worked across disciplines and geographies to drive scientific discovery and redefine what is possible to improve patients’ lives.
We are working on understanding how diseases differ down to the molecular level. So we can develop new tests and medicines that prevent, diagnose and treat diseases, and bring them to the patients who need them. With our combined strengths in diagnostics and pharmaceuticals, our personalised healthcare strategy aims to fit the right treatment to the right patient.
As the world’s largest biotech company, we develop breakthrough medicines, improving the standard of care across oncology, immunology, infectious diseases, ophthalmology and neuroscience. We are also the world leader in the in vitro diagnostics business. This track record allows us to build lasting and meaningful partnerships across the world with research academia and public healthcare institutions.
The founding families continue to hold the majority voting stake in the company. This stability allows for a tradition of sustainable thinking, so we can learn from setbacks and focus on lasting value for patients and society. We remain dedicated to the highest standards of quality, safety and integrity. Our legacy is based on respect for the individual as well as the communities and the world we live in.
We focus on finding new medicines and diagnostics that help patients live longer, better lives and evolve the practice of medicine.
Our strategy:
roche.com/our-strategy
6 7
Who we are
From left to right
Prof. Dr Richard P. Lifton (1953) C, E
Julie Brown (1962) B*, E
Prof. Sir John Irving Bell (1952) B, E
Bernard Poussot (1952) C, E
Dr Christoph Franz (1960) Chairman, C, D*, E
André Hoffmann (1958) Vice-Chairman, Representative of the shareholder group with pooled voting rights, A, C*, D, E
Dr Andreas Oeri (1949) Representative of the shareholder group with pooled voting rights, A*, E
Dr Claudia Süssmuth Dyckerhoff (1967) A, B, E
Paul Bulcke (1954) B, E
Peter R. Voser (1958) C, E
Dr Severin Schwan (1967) F
Prof. Dr Pius Baschera (1950) A, E
A Corporate Governance and Sustainability Committee
B Audit Committee
C Remuneration Committee
D Presidium/Nomination Committee
E Non-executive director
F Executive director
* Committee chairperson
Roche Board of Directors on 31 December 2016
Board of Directors
8 9
Who we are
From left to right
Daniel O’Day (1964) CEO Roche Pharmaceuticals
Roland Diggelmann (1967) CEO Roche Diagnostics
Cristina A. Wilbur (1967) Head Group Human Resources
Dr Stephan Feldhaus* (1962) Head Group Communications
Dr Gottlieb A. Keller (1954)General Counsel
Dr Severin Schwan (1967) CEO Roche Group
Dr Sophie Kornowski-Bonnet* (1963)Head Roche Partnering
Dr Alan Hippe (1967) Chief Financial and IT Officer
Prof John C. Reed* (1958) Head Roche Pharma Research & Early Development (pRED)
Osamu Nagayama* (1947) Chairman and CEO Chugai
Dr Michael D. Varney* (1958) Head Genentech Research & Early Development (gRED) * Member of the Enlarged Corporate Executive Committee
Roche Corporate Executive Committee on 31 December 2016
Corporate Executive Committee
1110
2016 Performance
2016 Performance
We recently launched four new medicines and strengthened our leading position in the laboratory business. At the same time, we invested in the product pipeline and are among the top 10 investors in R&D across industries.
Key highlights
Redefining treatment in oncologyCancer immunotherapy Tecentriq available against bladder and lung cancer
Transforming laboratory workcobas e 801 platform launched for faster and simpler laboratory testing
Managing rare blood disorder Potential new medicine emicizumab significantly reducing number of bleeds in a group of people with haemophilia A
Recognised for innovation Five breakthrough therapy designations granted by the US Food and Drug Administration
Partnering to improve careFormal agreements signed with several sub-Saharan countries to improve access to healthcare
Contributing to sustainabilityRoche ranked most sustainable healthcare company in the Dow Jones Sustainability Indices for the eighth year running
12 13
2016 Performance
CHF 39.1 billion Pharmaceuticals sales +3%* growth
Pharmaceuticals performance Top-selling pharma products in 2016 (CHF millions)
+3%US
+4%Asia-Pacific (APAC)
+7%Latin America (LATAM)
+4%Eastern Europe, Middle East, Africa (EEMEA)
+1%Japan
+4%Europe
7,300 +3%
MabThera / Rituxan
Oncology and immunology
6,782 +4%
Herceptin
Oncology
1,697 +16%
Actemra / RoActemra
Immunology
1,406 -10%
LucentisOphtalmology
1,024 -15%
TarcevaOncology
6,783 0%
Avastin
Oncology
1,846 +26%
Perjeta
Oncology
1,498 +15%
Xolair
Immunology
1,108 +16%
Activase / TNKase
Cardiovascular
831 +7%
Kadcyla
Oncology
EEMEA, LATAM, APAC and Canada form the ‘International’ region.
* All growth rates in this report are at constant exchange rates (CER; average 2015).
Pharmaceuticals:
roche.com/pharmaceuticals
14 15
2016 Performance
Diagnostics performance
3,394 +13%
Top-selling product portfolios in 2016 (CHF millions)
cobas, Immunodiagnostics
Modular analyser series for maximum
consolidation at a high throughput and
continuous operation
Ventana, Advanced staining
Automated system, improving workflow in the
histopathology lab and providing exceptional
staining quality
Accu-Chek, Diabetes Care
Products to make blood glucose monitoring
easier and to provide advanced accuracy for
diabetes management
cobas, Clinical chemistry
Automated systems offering highly efficient
workflow, yet requiring minimised operator
intervention
cobas, Virology
cobas 6800/8800: Setting new industry
standards for throughput, time to results,
automation and flexibility
685 +9%
2,016 -4%
1,675 +6%
632 +9%
CHF 11.5 billion Diagnostics sales +7%* growth
* All growth rates in this report are at constant exchange rates (CER; average 2015).
+3%North America
+16%Asia-Pacific
+18%Latin America
+2%Japan
+2%Europe, Middle East and Africa (EMEA)
Diagnostics:
roche.com/diagnostics
16 17
2016 Performance
Value for investors
2016 2015 2014
Group sales (mCHF) 50,576 48,145 47,462
Core operating profit (mCHF) 18,420 17,542 17,636
IFRS Net Income (mCHF) 9,733 9,056 9,535
Core Earnings Per Share (CHF) 14.53 13.49 14.29
R&D investment (mCHF) 9,915 9,332 8,913
KPIs:
roche.com/performance
Value for partners
2016 2015 2014
Number of R&D partnerships around the world 222 190 -
Percentage of our pipeline coming from partnered
products 45.0% 33.0% -
Percentage of total pharmaceutical sales coming
from partnered or in-licensed products 36.5% 35.0% -
Number of new partnerships 106 - -
Number of suppliers ~60,000 - -
Value for communities and the environment
2016 2015 2014
Income taxes (mCHF) 4,735 4,289 3,987
Eco-balance (million impact points/employee) 6.35 6.99 7.25
Total energy consumption (TJ/year) 12,777 13,483 12,968
Water consumption (million cubic meters per year) 3.1 3.5 3.0
Share (%) of sustainable energy in total energy
consumption 16.2% 15.0% 12.9%
Value for patients
2016 2015 2014
Number of patients receiving treatment with top
25 Roche medicines 26,500,000 25,000,000 19,000,000
Number of patients receiving Roche medicines that
are off-patent 127,500,000 126,000,000 129,000,000
Number of major Pharmaceuticals product launches 4 5 11
Number of Diagnostics key product launches 9 15 14
Number of FDA breakthrough therapy designations 5 4 3
Value for employees
2016 2015 2014
Number of employees (full-time equivalents) 94,052 91,747 88,509
Employee engagement rate 88.0% 88.0% 88.0%
Percentage of women in management positions 41.5% 40.0% 40.0%
Percentage of international assignments to or from
developing regions 43.8% 39.9% -
Roche Accident Rate 0.064 0.066 0.052
We create value for all our stakeholders and track our performance against key financial and non-financial indicators.
Key performance indicators 2016
1918
Science and innovation
We belong to the top 10 investors in R&D across industries.
We invest more than CHF 9 billion in R&D per year to bring the next generation of targeted medicines and diagnostics to patients.
We have built strong R&D capabilities to address medical need in oncology, immunology and inflammation, infectious diseases, neuroscience and ophthalmology, and remain open to other areas including debilitating and deadly inherited genetic diseases where we can make a real difference for patients, many of whom are children.
Because we focus on diseases that are complex and continually raise the bar in R&D, not all projects are successful. Despite these challenges, we continue to invest heavily, take bold risks, and remain relentless in our pursuit of innovative therapies and state-of-the-art diagnostics that transform patients’ lives.
Science and innovation
We are embracing the best technology and partnerships that leverage the power of our unique pharmaceutical-diagnostic structure to advance science and develop new therapies.
20 21
Science and innovation
Strong progress in our product portfolioWe made significant progress in our product portfolio. We recently launched four new medicines, including our first cancer immunotherapy Tecentriq. In addition, the US FDA granted five breakthrough therapy designations for Roche medicines.
We are also seeking regulatory approval for ocrelizumab in both relapsing and primary progressive multiple sclerosis (RMS and PPMS) in the US and EU. For PPMS, this would be the first and only treatment for this type of the disease.
In Diagnostics, we added nine key instruments and tests to our comprehensive portfolio, further improving decision-making in healthcare, and supporting laboratories’ efforts to increase efficiency. Among the new instruments are the cobas e 801 immunoassay module, the CoaguChek INRange system to monitor vitamin K antagonist therapy, and the Accu-Chek Guide, a next-generation blood glucose monitoring system.
Key Pharmaceuticals clinical and regulatory newsflow
Milestone Compound Indication
Launches of new medicines Cotellic Advanced melanoma
Alecensa Lung cancer
Venclexta Chronic lymphocytic leukemia
Tecentriq Bladder and lung cancer
Key positive Phase III data
read-outs
Gazyva (Gallium) Follicular lymphoma
Tecentriq (Oak) Non-small cell lung cancer
Emicizumab (Haven 1) Haemophilia A
Actemra (Giacta) Giant cell arteritis
US FDA breakthrough
therapy designations
Venclexta+ MabThera/Rituxan Chronic lymphocytic leukemia
Venclexta Acute myeloid leukemia
Ocrelizumab Primary progressive multiple sclerosis
Alecensa Non-small cell lung cancer
Actemra/RoActemra Giant cell arteritis
Key Diagnostics product launches
Instruments/devices
Area Product name Description Market
Central
Laboratory
cobas 8000 e 801 High throughput immunochemistry analyser EU
cobas c 513 High throughput dedicated HbA1c analyser US
Point of Care CoaguChek INRange
(Zenith)
Modified analyser for intuitive self-testing with full
bluetooth connectivity EU
Diabetes Care Accu-Chek Guide Next-generation blood glucose monitoring system EU
Accu-Chek Insight CGM New high-performance continuous glucose
monitoring system EU
Tests /assays
Area Product name Description Market
HPV/
Microbiology
cobas 6800/8800
CT/NG
Fully automated solution for screening and diagnosis
of Chlamydia trachomatis and Neisseria gonorrhoeae
in symptomatic & asymptomatic patients EU
Point of Care cobas Liat Influenza
A/B plus RSV (CLIA)
Automated multiplex real time RT-PCR assay for qualitative
detection and discrimination of Influenza A virus, Influenza
B virus and respiratory syncytial virus (RSV) US
Companion
Diagnostics
PD-L1 (SP142) for
bladder cancer Complementary diagnostic for Tecentriq US
PD-L1 (SP142) for non-
small cell lung cancer Complementary diagnostic for Tecentriq US
22 23
Science and innovation
Gaining knowledge by data managementThe digital revolution has the potential to transform healthcare. Roche is well positioned to capitalise on technological progress. Having Diagnostics and Pharmaceuticals under one roof has enabled us to leverage our molecular biology expertise.
The future will see us integrating real-world data and creating insights from those data, both for research and development purposes and to support better treatment decisions and patient care.
This rationale drives our collaborations with Foundation Medicine and Flatiron Health, enabling us to better leverage data and advanced analytics to improve both the development of medicines and decisions in patient care.
At the forefront of finding cures for cancerFor more than 50 years, we have been at the forefront of developing medical solutions to fight cancer. Over the last 20 years, we have brought 14 new medicines to over 10 million cancer patients.
A major highlight in 2016 was the US launch of our first cancer immunotherapy medicine Tecentriq. It is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years. Cancer immunotherapy is revolutionising the way we treat cancer, and we are proud to be among the leaders in this field.
2. Cancer antigen presentation
3. Priming and activation
4. Migration of T cells to tumours
5. Infiltration of T cells into tumours
1. Release of cancer cell antigens
6. Recognition of cancer cells
7. Killing cancer cells
Cancer- immunity
cycle
The cancer-immunity cycle
Illustration of how the immune system recognises and kills a cancer cell. In any one patient, the cycle can
fail at any one of a number of points. Adapted from Chen & Mellman.1
1 Chen DS. and Mellman I., Oncology Meets Immunology: The Cancer-Immunity Cycle, Immunity, 2013.
24 25
Science and innovation
Oncology
Phase I Phase II Phase III Registr.
Inflammation/ Immunology
Neuroscience
Infectious Diseases
Ophthalmology
Others
Our pipeline of 74 new molecular entities (NMEs) covers a broad range of diseases and highly innovative
technologies are applied to create and produce the active molecules.
Numbers in brackets are referring to personalised healthcare projects included.
Pharmaceuticals clinical pipeline Key Diagnostics product launches planned in 2017
2 3 (1) 4 (2)
22 (11)
1 3 4 (1)
8 (3)
1 8 (3)
4 (2)
3 (1)
5 (4)
1 (1)
1
1
3 (1)
Pipeline:
roche.com/pipeline
Instruments/devices
Area Product name Description Market
Central Laboratory cobas 8000 <e 801> High throughput immunochemistry analyser US
CCM High Speed cobas connection module (CCM) for up to 6000 samples/hour
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
Blood glucose monitoring
EU
Tests /assays
Area Product name Description Market
HPV
cobas HPV Next generation HPV DNA test leveraging 6800/8800 automation to detect 14 hrHPV with simultaneous detection of genotypes 16 and 18
EU
CINtec Histology Diagnostic component of the Roche cervical cancer portfolio
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
EU
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
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 EU
PD-L1 (SP142) for non-small cell lung cancer
Complementary diagnostic for Tecentriq
EU
* ww=worldwide
26 27
Access to healthcare
26
Ground-breaking advances in medical science are only meaningful when they reach patients.
Today, about 400 million people across the globe lack access to essential healthcare services.¹ Access to healthcare is one of the biggest challenges society is facing and one that we have to work in partnership to address. We believe we have a responsibility to improve access for those who need it most and, by working together with our partners and resources all over the world, we have the ability to help facilitate change.
In 2016, we strengthened our commitment to widening access through an industry partnership, Access Accelerated, which brings together 22 biopharmaceutical companies to leverage innovation, expertise and resources to address the treatment of non-communicable diseases (NCDs). Access Accelerated is a multi-year programme facilitating cooperation with other healthcare stakeholders to achieve a tangible impact on improving access to treatment and care of NCDs.
Access to healthcare
We design access programmes at the country level to support healthcare systems, improve diagnosis, educate and build local skills, and address affordability issues.
1 who.int/mediacentre/news/releases/2015/uhc-report
28 29
Access to healthcare
Our approach to access to healthcare To really make a difference on the ground, we need a deep understanding of the challenges in each individual healthcare system. We take a systematic and comprehensive approach, identifying the key hurdles and the right stakeholders, in order to develop tailored, effective solutions that reach more patients. Partnerships with a broad spectrum of stakeholders are essential to improve access to healthcare for people in need.
To date, we have developed 60 access plans in total, each with a clear proposal for overcoming access barriers within a particular country. These plans are integrated into the local business, ensuring continued and sustained support, thus demonstrating an ongoing commitment to those markets as an integral part of our business model.
We believe four key factors need to be in place for successful treatment: awareness, diagnosis, healthcare capacity and funding. We have a wide array of initiatives to support all four areas and improve access to our medicines and tests. They include working with governments on disease awareness campaigns, training lab technicians in sophisticated diagnostics, training community healthcare workers, and providing flexible pricing solutions.
We strive for more flexible pricing models. Instead of the established practice of pricing medicines based on vials or milligrams, we want to link remuneration more closely to patient benefit. This can, for instance, vary for the same medicine, depending on which indication it is being used for and in which combination.
Working closely with payers and service providers, we have already introduced flexible pricing solutions in several European countries—including different prices for medicines used as combination therapies versus monotherapies in breast and skin cancer. In other countries we have initiated pilot projects.
Private insurance to complement public healthcare systems We work with private insurance companies to make a meaningful impact onpatient access to diagnostics and treatments through creating private fundingsolutions in countries where public coverage is inadequate. Working together with local insurance company partners focusing on cancer coverage, we have enabled the launch of several private insurance products in countries like China, India, Portugal, Vietnam and Thailand.
We are currently exploring options to expand the initiative beyond cancer funding.
Cancer insurance for
millions
Supported development of 21 new private insurance policies covering cancer therapy
22 countries involved
Collaboration with private insurance companies provides increased access to cancer care.
12 global and regional partners involved
Pipeline of 20 additional cancer insurance policies
As many more cancer insurance products are in development by multiple providers, the number of people
gaining access to cancer care is expected to grow strongly.
30 31
Access to healthcare
Partnerships for progress in AfricaWe aim to bring quality healthcare to all Africans, regardless of where they live or their ability to pay. We work towards this goal with a thoughtful and multidisciplinary approach to partnerships, collaboration and investment, and by empowering local healthcare providers.
In 2016, we continued to implement our Africa Strategy, which involves developing tailored solutions with local partners. We have signed formal agreements (memorandums of understanding) with several sub-Saharan countries, including Ghana and Kenya, following the first agreement with Côte d’Ivoire in 2014. The aim of these agreements is to improve access to timely and precise diagnostic services and treatments to make high-quality care more widely available.
To help diagnose and combat HIV infections in children and adults, we partner with UNAIDS, the Clinton Health Access Initiative, the President’s Emergency Plan for AIDS Relief and the Global Fund. Through our Global Access Programme we have initiated the largest infant testing programme in the world featuring a dried blood sampling diagnostic technique—to date, over seven million infants have been tested for HIV.
As a result of scaled-up HIV treatment services, overall life expectancy in sub-Saharan Africa has sharply increased.1 Receiving antiretroviral therapy leads to remarkable improvements in quality of life for people living with HIV and substantially improves their economic prospects.2, 3
World Zimbabwe Uganda Kenya
Swaziland South Africa Botswana Sub-Sahara
Dramatic impact of HIV response on life expectancy1, 1950-2015
1 United Nations Population Division. World Population Prospect, 2015. 2 Rosen, S., et al. Effect of antiretroviral therapy on patients’ economic wellbeing: five-year follow-up. AIDS, 2014. 3 Lifson, A. and Grund, B. Increased Quality of Life with Immediate ART Initiation: results from the START Trial (# 475), in Conference on Retroviruses and Opportunistic Infections, 2016.
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Cautionary statement regarding forward-looking statementsRoche in Brief 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 Roche in Brief, 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.
The statement 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 2017 or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
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Published byF. Hoffmann-La Roche LtdGroup Communications4070 Basel, SwitzerlandTel. +41 (0)61 688 11 11www.roche.com
To order/download publicationsInternet: roche.com/publications
E-mail: [email protected]
Fax +41 (0)61 688 41 96
We believe it’s urgent to deliver medical solutions right now—even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
We are Roche.
The pictures have been submitted by Roche employees.
F. Hoffmann-La Roche Ltd4070 Basel, Switzerland
© 2017
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