You are on page 1of 103

Roche Annual Report 2006

Part 1 Business Report

We Innovate Healthcare
Roche Business Report Survey
The Annual Report informs you about Roche’s financial and operating results in 2006, as well as
the company’s strategic direction for the longer term.

Because we value your opinion as a reader of our reports, we want to find out what you and other
readers think about our Annual Report, in particular the Business Report (Part 1). Please click
on the link below and fill in the online questionnaire (in all, this should only take five minutes).
Your opinion will help us to improve our Business Report next year.

You’ll find the questionnaire at http://www.RocheBusinessReportSurvey.com

Thank you very much for your support.

Make a difference!

For every completed questionnaire received, Roche will donate 10 Swiss francs to Re&Act, an independent
foundation that pools Roche employees’ initiatives and skills to support selected charitable projects and
organisations. The company will designate these survey response donations to Re&Act for support of
Phelophepa, a mobile health train serving rural villages throughout South Africa. Phelophepa sees an av-
erage of over 40,000 patients each year – among them many who previously had no access to basic health care.

Your completed questionnaire will thus help to provide funding and expertise for this sustainable work in
South Africa.
Innovation spanning the entire
healthcare spectrum

As a pharmaceuticals and a diagnostics company, Roche brings pioneering products


and services to market for every stage of the healthcare process, from identifying
disease susceptibilities and testing for disease in at-risk populations to prevention,
diagnosis, therapy and treatment monitoring.

Our focus on products that deliver significant benefits to patients and health
professionals is a core element of our business strategy, and one of the key reasons
for our success. As a research-intensive company with a long-term strategic focus,
Roche strives to deliver sustainable value to all stakeholders.
Predisposition Page 8 Table of Contents

‘Information on predisposition
to disease offers huge potential – Business Report 2006
but we’ve got a long way to go.’
Key figures 2
The year 2006 in brief 3
Letter from the Chairman 5

Early detection Page 14 Roche Group 10


Group results 10
‘If I hadn’t been so determined Outlook 10
to find out about HER2, I might Group strategy 11
not be alive today to tell my story.’
Pharmaceuticals 16
Pharmaceuticals Division in brief 16
Results 17
Therapeutic areas 17
Research and development 25
Prevention Page 40 R & D Pipeline 27

‘Our little brother caught the flu, Diagnostics 32


but we still got to go on holidays.’ Diagnostics Division in brief 32
Results 33
Business areas 34
Research and development 37
Key product launches scheduled
for 2007 38
Diagnosis Page 58
Corporate Governance,
Remuneration Report 42
‘If my doctor hadn’t thought of it, Corporate Governance 42
I’d never have known I had hep C.’ Remuneration Report 50

Creating sustainable value –


our management approach 60

Our key management topics 64


Therapy Page 76

Our people 78
‘I’ve got my life back,
and my children have got
Our communities 84
their father back.’

Safety, health and


environmental protection 88

Assurance 94
Monitoring Page 86 GRI statement 95
Roche – a Global Market Presence 96
‘I monitor my blood glucose myself
every day and only go to the hospital
once a month.’

Business Report 2006 1


Key figures

Roche Group Index 2004 = 100

Sales mCHF Equity ratio %


2006 42,041 2006 62.9
2005 35,511 2005 58.0
20041) 29,522 2004 56.9

Research and development mCHF Total employee remuneration mCHF


2006 6,589 2006 10,116
2005 5,672 2005 8,726
20041) 5,154 2004 8,354

Operating profit before exceptional items mCHF Dividend mCHF


2006 11,730 20063) 2,933
2005 9,189 2005 2,156
20041) 6,766 2004 1,725

Income taxes mCHF Number of employees


2006 3,436 2006 74,372
2005 2,284 2005 69,795
2004 1,865 2004 66,843

Profit from continuing businesses mCHF Patients participating in clinical trials4)


2006 9,151 2006 166,070
2005 6,878 2005 151,272
2004 4,726 2004 93,592

Core Earnings per Share CHF Eco-Efficiency Rate5)


2006 9.86 2006 49.97
2005 7.84 2005 24.39
2004 5.72 2004 18.31
Index2) 80 100 120 140 160 180 200 Index2) 80 100 120 140 160 180 200

Price development of non-voting equity security (Genussschein) in CHF

250

200

150

100
2004 2005 2006
Roche non-voting equity security Swiss Market Index (rebased)

1) Continuing businesses. Figures for 2004 as in Annual Report 2005.


2) Key figures indexed to 2004 = 100. For a full index of Global Reporting Initiative (GRI) indicators
3) Proposed by the Board of Directors. used in the report see: www.roche.com/sus-gri
4) Development phases I to IV.
5) For calculation of the Eco-Efficiency Rate see:
www.roche.com/sus-she_performance

2 Business Report 2006


The year 2006 in brief

Group
• Group sales advance 17% to 42.0 billion Swiss francs – a record increase
of over 6.5 billion Swiss francs.
• Operating profit margin increases 2.0 percentage points to 27.9%.
• Net income up 34% to 9.2 billion Swiss francs, driven by a strong operating
performance and significantly higher net financial income.
• Board to propose 20th consecutive dividend increase: 36% to 3.40 Swiss
francs per share and non-voting equity security.

Pharmaceuticals
• Pharmaceutical sales grow 21%, more than three times as fast as the global
market.
• Division reinforces its leadership in oncology.
• Operating profit margin rises 4.1 percentage points to 31.7%.
• Marketing approvals received for Avastin in lung cancer, Herceptin in early-
stage breast cancer and MabThera/Rituxan in rheumatoid arthritis.
• First marketing applications filed for Mircera in renal anemia.
• Major development targets met: 13 new marketing applications filed and
14 approvals received.

Diagnostics
• Division posts 5% sales growth, consolidating its global market leadership.
• As anticipated, divisional operating profit declines as a result of investments
in new product launches, impairment charges on intangible assets and
lower royalty income from licences in the molecular diagnostics segment.
• New range of Accu-Chek blood glucose monitoring products now available
worldwide.

Outlook for 2007


• Double-digit sales growth for the Roche Group and the Pharmaceuticals
Division.
• Above-market sales growth in both divisions.
• Core Earnings per Share growth target in line with sales growth.

For additional information about Roche, visit http://www.roche.com

All growth rates are based on local currencies.


Operating profits and operating profit margins are stated before exceptional items.

Business Report 2006 3


4 Business Report 2006
Letter from the Chairman

2006 was another year of strong growth and exceptional items) increased by 27% in local cur-
outstanding financial performance at Roche. The rencies to 11.7 billion Swiss francs. The Group’s
Group’s sales rose 17% in local currencies to a record operating profit margin increased further, to 27.9%.
high of 42 billion Swiss francs. This 6.5 billion Swiss At the same time, we invested more in our divisions’
franc revenue increase over 2005 reflects organic rich research and development pipelines and also
growth. Top-line growth was driven primarily by increased spending on launch activities and the con-
the Pharmaceuticals Division, where sales advanced struction of new biotech manufacturing facilities.
at more than three times the market growth rate in
2006. Roche Diagnostics maintained its leadership Net financial income was also up significantly
position in an increasingly competitive market, compared with 2005. Total net income rose by one-
thanks to numerous new product launches and third to 9.2 billion Swiss francs – the highest profit
continued growth in all of the division’s business ever recorded by Roche. Core Earnings per Share
areas. (Core EPS) rose 26%.

The Group’s earnings performance improved sig- The Board of Directors will propose that the divi-
nificantly again last year. Operating profit (before dend for 2006 be increased by 36% to 3.40 Swiss

Business Report 2006 5


Letter from the Chairman

francs per share and non-voting equity security (up Roche’s strategy remains firmly focused on pre-
from 2.50 Swiss francs in 2005). Subject to your scription medicines and modern diagnostics. With
approval at the Annual General Meeting of Share- our increased financial strength, we have the
holders, this will be our 20th consecutive dividend resources for targeted business-building invest-
increase. ments in both of these core businesses. Developing
healthcare innovations – products and services rep-
As I indicated before, the Pharmaceuticals Division resenting real advances in the fight against serious
was the main driver behind the Group’s excellent diseases – is the most important thing Roche does,
results in 2006. Its sales exceeded 33 billion Swiss and our mission is not about to change. Our
francs, an increase of 21% in local currencies in research and development activities are aimed at
a market that averaged 6% growth last year. extending patients’ lives and improving their health
This robust increase was driven primarily by sus- and quality of life. Worldwide, we spend 18 million
tained strong demand for our cancer medicines, Swiss francs every day in pursuit of these objectives.
continued government stockpiling of the anti- Last year R & D expenditure in the Pharmaceuticals
influenza drug Tamiflu and sales of Bonviva/Boniva, Division amounted to 17.7% of sales. In absolute
for osteoporosis. Oncology, transplantation and figures, total R & D expenditure for the Group rose
virology are currently our three leading therapeutic to well over 6 billion Swiss francs in 2006, making
franchises. Very importantly, sales of our cancer Roche one of the most research-intensive compa-
medicines surged approximately 40% to 15 billion nies in the industry.
Swiss francs, and now account for half of the divi-
sion’s total revenues. For the first time, the Pharma- We plan to intensify cooperation between our
ceuticals Division’s operating profit (before excep- Pharmaceuticals and Diagnostics Divisions in
tional items) exceeded 10 billion Swiss francs, and its major therapeutic areas, in order to deliver more
operating profit margin rose significantly, to 31.7%. products tailored to the needs of specific patient
populations. The benefits of more precise diag-
The Diagnostics Division posted sales of 8.7 billion noses and better targeted treatments are already
Swiss francs, a 5% increase in local currencies over evident – particularly in oncology. Tighter cross-
the previous year. After a slow start, sales growth divisional linkages between our research, develop-
accelerated to slightly above the market growth rate ment and marketing organisations will strengthen
in the second half of the year, helped by the roll- our ability to actively shape the future of therapeu-
out of new products. Once again, the division’s tics and diagnostics.
Centralized Diagnostics business – particularly the
immunodiagnostics portfolio – was the main con- Roche has been reselected for inclusion in the Dow
tributor to growth. With the new portfolio of Jones Sustainability Indexes and the FTSE4Good
Accu-Chek blood glucose monitoring products Index Series. This is recognition of our efforts to
now on the market, we expect Roche Diabetes Care balance corporate responsibility with our business
to return to above-market growth as well. Divi- objectives and core mission to innovate healthcare.
sional operating profit (before exceptional items) We believe that making sustainability an integral
declined 21% in local currencies to approximately part of our business model and operations fosters
1.4 billion Swiss francs. The decrease was primarily innovation, minimises business risks and creates
due to higher costs for new product launches and value for all stakeholders.
ongoing pricing pressure in the division’s markets.
Operating profit was also impacted by impairment In the final analysis, of course, it is Roche’s people
charges on intangible assets relating to the Dise- who have made it the prosperous, innovative com-
tronic acquisition in 2003. pany it is today. Thanks to their untiring dedication

6 Business Report 2006


Letter from the Chairman

and professionalism, Roche is able to bring prod-


ucts and services to market that make a real differ-
ence in patients’ lives. Our strong businesses con-
tinued to create new jobs last year. In 2006 the total
number of Roche employees worldwide increased
by about 4,600 to over 74,000. I would like to take
this additional opportunity to thank all of the
Roche Group’s employees for the tremendous job
they have been doing, and continue to do, in a
tough and challenging marketplace. The awards we
received last year for being an outstanding com-
pany to work for are a special source of pride to all
of us at Roche.

Without innovation, medical progress and access


to quality healthcare are unsustainable. For that
reason, it is vital to raise awareness of the role that
pricing and patent protection play in the industry’s
ability to innovate. Roche will continue to actively
engage with policymakers and the public on these
issues.

Tomorrow’s healthcare market will offer enormous


opportunities and pose some enormous challenges.
At Roche we can pursue those opportunities and
tackle those challenges with confidence and from a
position of strength. With our strategy of focused
innovation and our portfolio of new products, we
are well equipped for sustained growth. In 2007 we
once again expect the Group’s and the Pharmaceu-
ticals Division’s sales to grow at double-digit rates
in local currencies, and we expect to see continued
above-market sales growth in both divisions. We
are aiming for Core EPS to increase in line with
Group sales.

Franz B. Humer

Business Report 2006 7


‘Information on predisposition to disease offers huge
potential – but we’ve got a long way to go.’

8 Business Report 2006


Predisposition testing holds the promise
of predictive and preventative medicine

Identifying individuals at risk for complex diseases


is still a challenge. While technologies for genetic
testing – such as PCR or microarrays – are available,
identifying the right prognostic markers is not a
straightforward task. Henry Erlich, VP of Research
and Director of Human Genetics at Roche Molecular
Diagnostics (at left, in main picture), is in a good
position to know. As an internationally recognised
expert on genetic factors associated with disease he
has many contacts in the global research community.
Estimating risk for some diseases is already
standard clinical practice, such as measuring blood
pressure and cholesterol as risk factors for stroke
and heart attack. ‘Genetic predisposition testing
can become part of clinical practice,’ says Erlich,
‘but a number of challenges will have to be met
first, and we need a global, interdisciplinary effort.’
Researchers around the world have already begun
addressing these challenges. According to Erlich,
predisposition testing could aid in designing clinical
trials and understanding the natural course of
disease. In many cases, the same genetic markers
might one day also help clinicians to select the
best therapy. They might even point the way to new
discoveries that would allow doctors to prevent
a disease from occurring in a predisposed individual.

Predisposition
Not only must predisposition markers be predictive of disease,
effective preventive measures must also be available. For exam-
ple, statins and blood pressure medications are routinely pre-
scribed to reduce the risk of cardiovascular disease in individuals
at elevated risk. Similarly, osteoporosis medicines could be pre-
scribed to predisposed individuals before they have lost signifi-
cant bone mass. Preventive measures could reduce the public
health burden of disease and expand the market for effective
medicines.

Business Report 2006 9


Roche Group

Group results in 2005. The division’s operating profit margin


declined 5.2 percentage points to 16.3%. The mar-
Operationally and financially, 2006 was another gin decrease was primarily due to investments in
outstanding year for the Roche Group. Total sales the rollout of new products, impairment charges on
increased significantly, rising 17% in local curren- intangible assets and lower royalty income from
cies (18% in Swiss francs) to 42.0 billion Swiss licences.
francs. This 6.5 billion Swiss franc increase over
2005 revenues was all organic growth. Sales contin- The Group’s strong profitability is also reflected
ued to grow especially strongly in the Pharmaceuti- by other key indicators. EBITDA1) rose 2.9 billion
cals Division. Its sales increased 21% for the year in Swiss francs to 14.4 billion Swiss francs.
local currencies (22% in Swiss francs), or more than
three times the global market growth rate, led by Net financial income totalled 855 million Swiss
strong demand for the cancer medicines Herceptin, francs, up significantly from the 328 million Swiss
Avastin and MabThera/Rituxan, the anti-influenza francs recorded in 2005. The effective tax rate was
medicine Tamiflu, and Bonviva/Boniva, for osteo- 27.3%, compared with 24.9% in 2005.
porosis. As a result, Roche extended its market lead-
ership in oncology, transplantation and virology. In Group net income rose 34%, or 2.3 billion Swiss
the Diagnostics Division sales increased 5% in local francs, to 9.2 billion Swiss francs, and the Group’s
currencies (6% in Swiss francs) to 8.7 billion Swiss return on sales margin increased 2.5 percentage
francs, with the Centralized Diagnostics unit mak- points to 21.8%. Net income attributable to Roche
ing the largest contribution to growth. Diagnostics shareholders was 33% higher than the year before.
sales accelerated during 2006 and grew slightly Core Earnings per Share (Core EPS) rose 26%. The
ahead of the market for the year as a whole. Group’s balance sheet has thus been strengthened
further. The ratio of equity to total assets is now
The further robust increase in Group sales last year 63%, and 83% of assets are financed long-term.
had a very positive impact on earnings perform-
ance. The Group’s operating profit before excep-
tional items increased 27% in local currencies to Outlook
11.7 billion Swiss francs. The corresponding oper-
ating profit margin rose 2.0 percentage points to Barring unforeseen events, Roche anticipates fur-
27.9%. Once again, sales growth more than offset ther positive growth in 2007. We expect the Group’s
increased investments in Roche’s strong develop- and the Pharmaceuticals Division’s sales to con-
ment pipeline and in new product launches. tinue to grow at double-digit rates in local curren-
cies. In both the Pharmaceuticals Division and the
The Group’s improved earnings performance was Diagnostics Division, Roche anticipates continued
primarily due to the significantly higher profit con- above-market sales growth in local currencies.
tributed by the Pharmaceuticals Division. The divi- Roche’s target is for Core EPS to grow in line with
sion’s operating profit before exceptional items Group sales, despite significant investments in
increased 40% in local currencies to 10.5 billion research, development, production and marketing.
Swiss francs, resulting in a further margin improve-
ment of 4.1 percentage points to 31.7%.

The Diagnostics Division posted an operating 1) Earnings before exceptional items and before financial
profit of 1.4 billion Swiss francs, down 21% in local income, financing costs, tax, depreciation and amortisa-
currencies from the high divisional profit recorded tion, including impairment.

10 Business Report 2006


Roche Group

Group strategy Another trend fuelling demand for high-quality


healthcare is patient empowerment. Many people
Trends in our market today are better informed about health issues and
medical advances than they used to be. Under-
With the world’s population growing not only standably, they are therefore demanding a greater
larger but older, ever greater numbers of people say in decisions affecting their care, and they
are affected by diseases of ageing. Many cancers, want access to the latest medical procedures and
Alzheimer’s disease, diabetes and rheumatoid medicines.
arthritis, for example, are already becoming more
prevalent, making it all the more urgent to find But with health systems everywhere financially
effective ways of treating them. In a growing and stretched, how can these demands be satisfied and
ageing population, people are going to need more healthcare still be kept affordable?
and better healthcare, not just more of the same.

A pioneer in personalised
medicine
In healthcare, as in most things, one size does
not fit all. Our genes and countless environmen-
tal factors influence the outcomes of the treat-
ments we receive, including our response to
medicines. Moreover, many diseases occur
in genetically distinct subtypes that vary in
their clinical course and prognosis. Thus, two
patients who seemingly have the same disease
and are treated with the same medicine may
respond in radically different ways. One may
benefit from treatment, while the other experi-
ences unwanted side effects without having any
clinical benefit at all. In the fight against HIV/AIDS and hepatitis C, doctors
now routinely perform viral load tests to guide treat-
Roche is committed to providing healthcare pro- ment selection, track patients’ responses to treatment,
fessionals with more powerful diagnostic tools and and make dosing or other adjustments if necessary.
targeted treatments based on science’s increasing
understanding of how diseases arise at the molecular These tests also play a key role in the development of
level. This is the one approach that promises steady new antiviral drugs. ‘Similar successes can be achieved
improvements in the therapeutic options available to in oncology and rheumatology’, says Dr Tim M. Jaeger
patients. Using innovative diagnostic technologies, (pictured), who heads the ‘Drive Personalised Health-
physicians will increasingly be able to identify patient care’ initiative at Roche. ‘Our Diagnostics and Pharma-
populations most likely to benefit from particular ceuticals Divisions are working together, for example,
treatments. on better ways of detecting and differentiating certain
cancers and on exploiting new mechanisms of drug
In recent years Roche has provided some examples of action to provide specific groups of patients with more
how linking diagnostic and pharmaceutical knowledge effective, targeted treatments.’ Projects like these make
can lead to more personalised healthcare. Roche a pioneer in improving patient care – and they
can ultimately do a great deal to ease the pressure on
stretched healthcare budgets.

Business Report 2006 11


Roche Group

Group Innovation Network

Majority shareholdings Alliances and licensing agreements Spin-offs

Medical progress is essential for providing sustain- prioritise areas of significant unmet need where
able access to high-quality care – on this point we have the expertise to make a difference – areas
governments and other payers agree. To stay like oncology, virology, diabetes, inflammatory
competitive in today’s increasingly cost-sensitive and metabolic disorders and diseases of the central
market, research-based healthcare companies like nervous system. And we aim to be a leader in
Roche need to develop products with health eco- each of our areas of interest. Today Roche is the
nomic as well as clinical benefits. Medicines that market leader in high-growth therapeutic areas
extend patients’ lives, improve quality of life or such as oncology, transplantation and hepatitis,
have fewer side effects can offer both. And so can and a world leader in molecular and centralized
diagnostic tests that reduce treatment costs by diagnostics and diabetes management.
helping physicians choose the most appropriate
therapies for their patients the first time around. World-class R&D is the backbone of our strategy.
Diagnostics account for only 1–2% of healthcare That is why we spent well over 6 billion Swiss francs
spending, yet timely, accurate diagnostic informa- on it in 2006, and why in the coming years we will
tion is required for roughly 70% of all clinical continue to increase our R & D budget in selected
decisions. areas of opportunity. Our innovation model relies
on our own cutting-edge drug and diagnostics
Clinically differentiated products create value research and a global collaborative R & D network.
for all stakeholders Roche is the majority shareholder in Genentech
in the United States and Chugai in Japan. Both
At Roche our prime strategic focus is on innova- companies operate largely independently, because
tion. We strive to develop clinically differentiated we believe this encourages a greater diversity of
solutions for medical needs that have not yet been approaches, increasing the chances of success. In
adequately addressed. This creates value for all addition, the Group’s own research capabilities are
stakeholders, from patients, to providers, to health- augmented by a host of scientific and commercial
care systems as a whole. We devote all our resources collaborations with external biotech companies,
to two research-intensive businesses: pharmaceuti- universities and research organisations around the
cals and diagnostics. Within these businesses we world.

12 Business Report 2006


Roche Group

We recognise that innovation requires perseverence


and a long-term perspective. We invest early in new
technologies that we judge as being critical to the
long-term viability and strength of our develop-
ment pipeline. Roche was one of the first pharma-
ceutical companies to enter the biotech arena,
establishing a relationship with Genentech in the
early 1980s and then becoming majority share-
holder in 1990, at a time when molecular research
was still in its infancy. Around the same time we
acquired the worldwide rights to the polymerase
chain reaction (PCR), a technological advance in
molecular biology which we have developed into
diagnostic products that continue to set new stan-
dards for speed and accuracy. Today, biopharma-
ceuticals account for over half of Group sales, and
Roche is the global market leader in molecular
diagnostics.

Biotechnology has opened up completely new


approaches to diagnosing and treating disease, par-
ticularly cancer. Our development portfolio cur-
rently includes 15 therapeutic proteins, which are
being developed for a total of 54 indications, and
we are investing heavily in new manufacturing
facilities to meet the growing demand for our bio-
therapeutics and biodiagnostics.

The emerging field of personalised medicine has


tremendous potential to make healthcare better,
safer and more cost-effective. With our combined
strengths in diagnostics and therapeutics, we are
equipped to take the lead in realising this potential
(see A pioneer in personalised medicine, p. 11).

Our pharmaceuticals research network, our


strengths in biotechnology and our leadership in
diagnostics R & D are all competitive advantages
in a changing marketplace.

We believe that we can deliver greater value with


our innovation strategy than by selling ‘me-too’
products, generics or over-the-counter remedies.
Because they have economic as well as clinical
benefits, targeted therapies and diagnostic tests that
support better medical decision-making are more
likely to be approved by regulators, accepted by
patients and covered and reimbursed by payers. Our
goal is to deliver innovations that benefit all health-
care stakeholders, and that’s not about to change.

Business Report 2006 13


‘If I hadn’t been so determined to find out about HER2,
I might not be alive today to tell my story.’

14 Business Report 2006


Finding out more about cancer types helps
patients get the right treatment

When Donna Rullo, from north-west Victoria,


Australia, was first treated for early breast cancer
in 2001, something her doctor said stood out:
‘Your cancer is HER2-positive.’ Donna immediately
started gathering information about ‘HER2’,
determined to find out what it meant for her outlook
and treatment options.
Donna learned that HER2-positive tumours are
particularly aggressive, grow fast and are very
likely to relapse. Her search for more information
led her to Richard Bell, head of cancer care at
Geelong Hospital. He enrolled Donna in a clinical
trial investigating the effectiveness of Herceptin
(trastuzumab) in early HER2-positive breast
cancer. Herceptin is specifically designed to treat
HER2-positive tumours.
‘Breast cancer isn’t a single disease. Its stage and
type and other factors influence treatment decisions
and expected outcomes,’ explains Prof. Bell.
‘If the cancer is detected early and treatment tailored
to the specific tumour and patient characteristics,
better outcomes are achieved. I can’t stress enough
how important it is to determine all aspects of the
type of breast cancer as early as possible to optimise
treatment planning.’
In Donna’s case early identification of her breast
cancer as HER2-positive and targeted treatment
with Herceptin have paid off: she has stayed in
remission.

Early detection
Just as important as early diagnosis of breast cancer is fast iden-
tification of the tumour type, which can help doctors estimate
how quickly the cancer will grow and how it will respond to spe-
cific treatments. For example, knowing a breast cancer patient’s
HER2 status at diagnosis now enables doctors to select the most
effective treatment programme, increasing the patient’s chances
of survival.

Business Report 2006 15


Pharmaceuticals Division in brief

Sales in millions of CHF


2006 33,294
2005 27,268
2004 21,695

Operating profit before exceptional items1) in millions of CHF


2006 10,545
2005 7,539
2004 5,432
1) 2004 as published in Annual Report 2005

Number of employees
2006 53,241
2005 49,027
2004 46,871

Key figures
% change % change in
In millions of CHF in CHF local currencies % of sales
Sales 33,294 22 21 100
– Roche Pharmaceuticals 20,666 22 20 62
– Genentech 9,125 38 37 27
– Chugai 3,503 –5 –1 11
EBITDA 12,168 34 34 36.5
Operating profit1) 10,545 40 40 31.7
Research and development 5,889 18 19 17.7
1) Before exceptional items

Pharma Executive Committee 1 January 2007


William M. Burns CEO Division Roche Pharmaceuticals
George B. Abercrombie North America
Jennifer M. Allerton Informatics
Jean-Jacques Garaud Development
Eduard Holdener Chief Medical Officer
Peter Hug Partnering
Jonathan K. C. Knowles Research
Dominic P. Moorhead Finance and Controlling
Paul A. Newton-Syms Human Resources
Claude Schreiner Western Europe
Pascal Soriot Commercial Operations
Jan van Koeveringe Technical Operations

16 Business Report 2006


Pharmaceuticals

The Division Sales by region

The Roche Group’s Pharmaceuticals Division is


made up of Roche Pharmaceuticals, represented in
Latin America 6% (+21%)
over 150 countries, and majority shareholdings in
Japan 11% (–1%)
Genentech in the United States and Chugai in
Others 9% (+26%)
Japan. Roche cooperates closely with Genentech
and Chugai and also maintains licensing or other
collaborative agreements with some 80 companies
Europe 32% (+22%)
around the world, giving the Roche Group wide
North America 42% (+27%)
access to promising experimental medicines and
cutting-edge technologies.
Italics = growth rates

Results strong sales growth combined with further pro-


ductivity improvements, particularly in manu-
The Pharmaceuticals Division set new records in facturing. These factors more than outweighed
2006. Sales for the full year rose 21% in local cur- significantly higher investments in marketing
rencies and 22% in Swiss francs (21% in US dollars) and distribution, and research and development.
to 33.3 billion Swiss francs – 6 billion francs more EBITDA totalled 12.2 billion francs or 36.5% of
than 2005 and over three times the global market sales, compared with 33.3% in 2005.
growth rate. Roche has now outperformed the
global pharmaceuticals market every quarter for
the last four years. Regional sales growth sig- Therapeutic areas
nificantly outpaced the market average in North
America (27% vs 8%) and Europe (22% vs 5%). In Oncology
Japan sales declined 1%, in line with the market
average, due to government-mandated price cuts The Roche Group is the world’s leading provider
and healthcare reimbursement changes. of cancer medicines. With MabThera/Rituxan,
Herceptin, Avastin, Xeloda and Tarceva, the Group
Overall, growth was driven primarily by strong currently markets five innovative cancer treatments
demand for the division’s key oncology products, that have been shown to significantly extend patient
the influenza medicine Tamiflu, Genentech’s survival. We are continuing to investigate new uses
ophthalmology drug Lucentis, and the osteoporosis and more effective combinations for the Group’s
medicine Bonviva/Boniva. anticancer products in an extensive development
programme (see Major development activities, p. 27).
The division’s operating profit before exceptional
items advanced 40%1) to 10.5 billion Swiss francs,
and the operating margin 4.1 percentage points 1) Unless otherwise stated, all growth rates are in local cur-
to 31.7%. The margin increase was the result of the rencies.

Business Report 2006 17


Pharmaceuticals

Sales by therapeutic area (known as HER2-positive) that accounts for


20–30% of all breast cancers. Worldwide sales of
the product nearly doubled in 2006. In addition to
strong uptake by the medical community, growth
Respiratory diseases 3% (+20%)
was driven mainly by reimbursement approvals in
Metabolic diseases,
bone diseases 7% (+23%)
the EU, the US and other key markets for wider use
Central nervous system 4% (–4%) of the product after surgery in early-stage breast
Infectious diseases 2% (–48%) cancer. These approvals are based on clinical trial
Cardiovascular results showing that in this setting Herceptin can
diseases 4% (–6%) reduce the risk of cancer recurrence by up to 50%
Inflammatory and and the risk of death by about a third. In October
autoimmune diseases,
transplantation 8% (+14%)
Roche filed an application with the EU authorities
Virology 16% (+24%)
for approval of Herceptin combined with hormonal
therapy to treat advanced (metastatic) breast cancer
Ophthalmology 1% (n.a.)
that is both hormone receptor-positive and HER2-
Others 4% (+6%)
positive. In November Chugai filed an application
Renal anemia 5% (–3%)
with the Japanese Ministry of Health, Labour and
Oncology 46% (+37%)
Welfare (MHLW), seeking expansion of the pro-
Italics = growth rates duct’s marketing licence to include operable early-
stage HER2-positive breast cancer.
Sales of the Roche Group’s oncology portfolio2)
grew by 37% in 2006 and now account for 46% of For information on Roche clinical trials, visit the Roche
pharmaceutical sales. clinical trial registry: www.roche-trials.com. See also
Roche’s clinical trial protocol registry and trial results
Sales of MabThera/Rituxan (rituximab), for the database on p. 73 of this report.
treatment of indolent and aggressive forms of
non-Hodgkin’s lymphoma (NHL), continued to Avastin (bevacizumab) is the first targeted anti-
advance strongly throughout 2006. Growth was angiogenic therapy with demonstrated patient
supported by increased use of the product as survival benefits in four major tumour types:
first-line treatment for both forms of the disease, metastatic colorectal, breast and lung cancer,
particularly in Europe and emerging markets such and now also advanced kidney cancer. Avastin
as Russia and Latin America. High treatment rates inhibits the growth of blood vessels into tumours,
with Rituxan in the US were maintained through- thus cutting off the blood supply tumours need
out the year. In July Roche received EU regulatory to grow and spread. It has now been launched in
approval to market MabThera for maintenance most markets worldwide as a first-line treatment
therapy of relapsed or refractory follicular NHL, for advanced (metastatic) colorectal cancer (CRC).
the most common form of indolent NHL. In the Sales grew strongly in 2006 and are expected to
US Genentech received marketing approvals for increase further, driven by continuing market
three additional indications for Rituxan, including uptake. Roche is preparing to ask the EU authorities
treatment of previously untreated follicular lym- to widen the product’s current marketing approval
phoma. in metastatic CRC to include combinations with
chemotherapy regimens based on Xeloda or oxali-
Herceptin (trastuzumab) is designed specifically to platin. The filing, planned for the first half of
treat a particularly aggressive form of tumour 2007, will be based on data from the largest-ever
clinical trial in first-line metastatic CRC, showing
that adding Avastin to chemotherapy (FOLFOX-4
2) Oncology portfolio: MabThera/Rituxan, Herceptin, Avastin, or XELOX) significantly improves progression-free
Xeloda, Tarceva, Bondronat, Kytril, Furtulon, Neupogen, survival compared with chemotherapy alone. In
NeoRecormon (37%), Roferon-A, Neutrogin, Picibanil, April Chugai filed the first marketing application
Vesanoid. for Avastin in Japan, for the treatment of advanced

18 Business Report 2006


Pharmaceuticals

Cancer – more than one disease

As the world’s leading provider of cancer With an estimated 1.2 million new cases annually, lung
medicines, the Roche Group is working hard to cancer is the most common form of cancer worldwide. It
help meet the enormous need for new treatment is the leading cause of cancer deaths in the world and in
options and targeted therapies. Europe. Non-small cell lung cancer is the most common
form of lung cancer, accounting for approximately 80%
Cancer is an abnormal growth of cells that proliferate of all cases. (→ Tarceva, Avastin)
through uncontrolled cell division. These malignant
cells may invade other tissues and spread (metasta- Each year, some 200,000 people worldwide are diag-
sise) to more distant parts of the body. Cancer is not nosed with kidney cancer, and 100,000 die of the
one disease but a group of more than 100 distinct disease, rates that are expected to increase. Kidney
disorders. It is one of the main causes of death in cancer is more common in men, and its incidence
industrialised countries. increases with age. Renal cell carcinoma accounts for
90% of all kidney cancers. (→ Avastin, Roferon-A)
Non-Hodgkin’s lymphoma, a group of over 30 cancers
that affect the lymphatic system, has grown in inci- Pancreatic cancer is a particularly aggressive disease
dence by 80% since the early 1970s. This class of that is extremely difficult to treat. It is often resistant to
cancer currently affects over 1.5 million people world- chemotherapy and radiotherapy and tends to spread
wide. (→ MabThera/Rituxan) quickly to other parts of the body. It kills a higher pro-
portion of patients in the first year after diagnosis than
Colorectal cancer – cancer of the large intestine or any other cancer. The fifth leading cause of cancer
rectum – accounts for over 1 million new cases (around deaths in the developed world, pancreatic cancer
10% of all newly diagnosed cancers) worldwide each claims the lives of 78,000 people every year. (→ Tarceva,
year. It is the second most common cause of cancer Xeloda)
deaths in Europe. The main treatment is surgery,
which may also be combined with radiotherapy and Stomach cancer accounts for close to 1 million new
chemotherapy. (→ Avastin, Xeloda) cases and at least 700,000 deaths each year, making
it the second most common type of cancer and the
Breast cancer is the most common cancer among second-largest cause of cancer deaths worldwide. It is
women worldwide, with over 1 million women newly the main type of cancer seen in China, Korea and
diagnosed and over 500,000 dying from the disease Japan, where over 80% of all cases occur. (→ Xeloda)
each year. There are different types of breast cancer,
and knowledge of tumour characteristics is important For more information, visit:
for treatment decisions. (→ Herceptin, Xeloda, Avastin) http://www.roche.com/diseases.htm

or recurrent colorectal cancer. The application was a filing for the same indication was submitted to
filed early under an MHLW initiative aimed at the EU’s European Medicines Agency (EMEA) in
expediting patient access to innovative medicines August. In addition, Roche filed an application
that are already approved in the US or EU, and it has in July for EU marketing authorisation of Avastin
also been given priority review status. for the treatment of advanced breast cancer. In
September the FDA asked Genentech to provide
In October, following priority review, the US Food additional data analysis to support its US applica-
and Drug Administration (FDA) approved Avastin tion for approval of Avastin to treat metastatic
for the treatment of non-small cell lung cancer breast cancer. Genentech has agreed to supply the
(NSCLC), the most common form of the disease; additional data by mid-2007.

Business Report 2006 19


Pharmaceuticals

Top-selling pharmaceutical products – Roche Group

Sales % change in
Product Generic name Indication in millions of CHF local currencies
MabThera/Rituxan rituximab non-Hodgkin’s lymphoma, 4,839 15
rheumatoid arthritis
Herceptin trastuzumab metastatic breast cancer, 3,927 81
adjuvant breast cancer
Avastin bevacizumab metastatic colorectal cancer, 2,962 76
advanced non-small cell lung cancer
Tamiflu oseltamivir treatment and prevention of influenza A and B 2,627 68
NeoRecormon, Epogin epoetin beta anemia 2,227 –1
CellCept mycophenolate mofetil transplantation 1,842 7
Pegasys peginterferon alfa-2a hepatitis B and C 1,467 3
Xeloda capecitabine colorectal cancer, breast cancer 971 20
Tarceva erlotinib non-small cell lung cancer, 813 108
advanced pancreatic cancer
Xenical orlistat weight loss, weight control 693 7
Xolair1) omalizumab asthma 537 31
Kytril granisetron nausea and vomiting induced by chemotherapy 498 0
or radiation therapy or following surgery
Nutropin somatropin growth hormone deficiency 494 3
Bonviva/Boniva ibandronic acid osteoporosis 488 462
Valcyte, Cymevene valganciclovir, ganciclovir cytomegalovirus infection 488 22
Lucentis1) ranibizumab wet age-related macular degeneration 478 –
Pulmozyme dornase alfa/DNase cystic fibrosis 436 10
Rocephin ceftriaxone bacterial infections 416 –56
Neutrogin lenograstim neutropenia associated with chemotherapy 379 9
Activase, TNKase alteplase, tenecteplase acute myocardial infarction (heart attack) 362 15

1) Jointly marketed by Genentech and Novartis.

Interim analysis of a major phase III trial metastatic breast and colorectal cancer. Marketing
(AVOREN) released in December has shown that applications are planned worldwide, except Japan,
Avastin is also effective in a fourth type of cancer: in the first half of 2007 for approval of a com-
it significantly improves progression-free survival bination of Xeloda, oxaliplatin and Avastin for
when given as a first-line treatment for advanced metastatic colorectal cancer. The filings will be
renal cell carcinoma. These results will form the based on the results of two phase III studies com-
basis for a supplemental EU marketing application, pleted in 2006.
planned for 2007.
In July Roche filed an EU marketing application
Xeloda (capecitabine) is an effective oral anticancer for approval of Xeloda in combination with
therapy that greatly simplifies treatment and also cisplatin for the treatment of stomach cancer.
saves costs by reducing the need for hospital visits. The filing is based on the results of a phase III
Strong sales growth in 2006 was fuelled mainly by comparative study of the efficacy and safety of
increased use of the product in the adjuvant treat- combined Xeloda and cisplatin versus the current
ment of colon cancer in the US and Europe. Xeloda standard therapy.
is currently also approved for the treatment of

20 Business Report 2006


Pharmaceuticals

Major product approvals in 20061)


Product Generic name Indication (dosage form) Country
Avastin bevacizumab second-line metastatic colorectal cancer, USA
combination with 5-FU-based chemotherapy
first-line non-small cell lung cancer USA
Bonviva/Boniva Injection ibandronic acid osteoporosis (intravenous formulation) USA, EU,
Switzerland
Copegus ribavirin chronic hepatitis C in combination with Pegasys Japan
Epogin epoetin beta anemia in premature infants Japan
Femara2) letrozole breast cancer in postmenopausal women Japan
Herceptin trastuzumab adjuvant (early-stage) HER2-positive breast cancer USA, EU
Switzerland
Invirase saquinavir HIV disease (500 mg tablet) Japan
3)
Lucentis ranibizumab wet age-related macular degeneration USA
MabThera/Rituxan rituximab rheumatoid arthritis, anti-TNF failures USA, EU,
Switzerland
first-line treatment of diffuse large B-cell CD20-positive USA
non-Hodgkin’s lymphoma (NHL)
first-line treatment of patients with follicular NHL USA
in combination with CVP chemotherapy
maintenance therapy for patients with relapsed EU,
or refractory follicular NHL Switzerland
treatment of low-grade NHL following first-line USA
treatment with CVP chemotherapy
NeoRecormon epoetin beta once-weekly treatment of anemia in patients with solid EU
tumours receiving chemotherapy (30,000 IU prefilled syringe)
Tamiflu oseltamivir pediatric influenza prophylaxis EU,
Switzerland
Tarceva erlotinib metastatic pancreatic cancer in combination with gemcitabine EU

1) Includes supplemental indications; updated to 29 January 2007.


2) Jointly marketed by Chugai and Novartis.
3) Jointly marketed by Genentech and Novartis.

Two years since its launch in 2004, sales and usage Anemia
of Tarceva (erlotinib), a targeted drug with proven
survival benefit in advanced non-small cell lung Anemia occurs when the number of red blood cells
cancer and advanced pancreatic cancer, continue to falls below normal, starving organs and tissues of
increase strongly. Tarceva has now been approved oxygen. It is seen in more than 80% of patients with
for the second- and third-line treatment of NSCLC chronic kidney (renal) disease, a condition that
in over 75 countries worldwide. In April Chugai affects more than 500 million people worldwide.
filed an application in Japan for approval of Tarceva Anemia is also seen in 75% of cancer patients
in advanced or recurrent NSCLC; the filing has undergoing chemotherapy. The potential long-
been given priority review status by the authorities. term effects of anemia include cardiovascular dis-
Market uptake of Tarceva for the treatment of pan- ease in renal patients, while in patients with cancer
creatic cancer is also strong, and the product is now it is associated with reduced survival and dimin-
the market leader in the US for this indication. In ished quality of life. Roche supports basic research
January 2007, after re-examining the data support- into anemia through its funding of the independent
ing Roche’s supplementary marketing application, Roche Foundation for Anemia Research (see Pro-
the EU authorities approved Tarceva for the treat- moting advances in science, p. 84).
ment of metastatic pancreatic cancer.

Business Report 2006 21


Pharmaceuticals

Despite sustained pricing pressure, sales of Neo- Sales of CellCept (mycophenolate mofetil) con-
Recormon (epoetin beta) rose 6% to 1.5 billion Swiss tinued to show solid growth in 2006, driven by
francs, with the product retaining a strong position particularly strong demand in the US. Thanks
in cancer-related anemia and its market leadership to its proven long-term survival benefits and low
in renal anemia in the regions where it is sold. As in toxicity, CellCept remains the leading product in
2005, market share gains in the oncology setting the mycophenolic acid market and the cornerstone
were driven by continued adoption of the conve- of immunosuppressant therapies.
nient once-weekly prefilled syringe formulation. In
January 2007 the EU authorities approved the use of Virology
the once-weekly dosage form to treat anemia in
patients with solid tumours. In Japan sales of Epogin Combined sales of Valcyte (valganciclovir) and
(epoetin beta) declined due to government-man- Cymevene (ganciclovir) continued to grow strongly
dated price cuts and the introduction of flat-rate in 2006, driven by increasing recognition among
reimbursement for epoetin products used in dialysis doctors of the need to prevent and treat cyto-
patients, which has reduced the overall size of the megalovirus infection in transplant patients, which
anemia market. Combined sales of NeoRecormon can be fatal. Sales are also being helped by increased
and Epogin declined slightly overall for the year. use of the products to treat cytomegalovirus infec-
tion in HIV/AIDS patients.
Mircera, the first continuous erythropoietin recep-
tor activator, is a new anti-anemia agent that differs Influenza, or flu, is a highly contagious viral illness
from existing medicines both functionally and that occurs mainly in the autumn and winter
structurally. In April Roche filed its first marketing months in temperate climates and year-round in
applications for approval of Mircera to treat anemia tropical areas. It is particularly dangerous for
resulting from chronic kidney disease. The EU and young children, the elderly and people with chronic
US filings seek approval for the use of the product health problems. Every year, 100 million people
both in patients who are on dialysis and in those not fall ill with the flu in Europe, Japan and the US
on dialysis (see Major development activities, p. 28). alone. Influenza outbreaks occur every year, though
In December the FDA accepted additional data their extent and severity vary widely. Pandemics,
submitted by Roche to facilitate the agency’s review or global epidemics, occur every 10 to 40 years and
of the US marketing application and extended can affect up to half the world’s population.
the review period by three months. The trial in
the patent lawsuit brought by Amgen in the US Worldwide sales of Tamiflu (oseltamivir) contin-
is expected to begin in September 2007. Roche ued to rise strongly, driven mainly by pandemic
remains confident that Mircera does not infringe stockpiling, as governments increased their popula-
any of Amgen’s erythropoietin patents. tion coverage. Since 2004 over 75 countries have
placed orders for pandemic stocks of Tamiflu, with
Transplantation some purchasing enough to cover 25–50% of their
populations. Through a collaborative network of its
The number of organ transplants performed own facilities and those of other companies, Roche
worldwide remains steady at approximately 70,000 now has access to manufacturing capacity for
annually. As medical science extends the life Tamiflu that exceeds all government orders received
expectancy of patients with transplanted organs, to date. Research into the most effective utilisation
demand continues to increase for safe, effective of Tamiflu against the H5N1 virus is continuing,
immunosuppressants to control transplant rejec- both at Roche and through collaborations with
tion and for medicines to combat infections associ- independent experts, the World Health Organiza-
ated with transplantation. Roche supports basic tion and other institutions. Following EU approval
transplantation research through its funding of of Tamiflu for influenza prophylaxis in children
the independent Roche Organ Transplantation aged 1–12 years, the medicine can now be pre-
Research Foundation (see Promoting advances in scribed for treatment or prophylaxis in all patients
science, p. 84). aged one year or older.

22 Business Report 2006


Pharmaceuticals

Balancing business and


responsibility – planning for
pandemic influenza

Roche’s antiviral drug Tamiflu may play a key role


in managing the next influenza pandemic. Our
Tamiflu Life Cycle Team is working closely with the
World Health Organization (WHO) and govern-
ments around the world to plan for such an event,
using lessons learned from our role in developing
a strategy to combat HIV/AIDS in Africa.

The H5N1 strain of influenza currently circulating in


birds could lead to a human pandemic, if it mutates
into a form that can be transmitted easily from person where it is needed. This includes a lowered uniform
to person. When governments began establishing price for governments stockpiling the drug for pan-
national pandemic plans and stockpiling medicines demic use and deeper price reductions for developing
and other supplies, Tamiflu (oseltamivir) was identified countries. To increase access in the world’s two most
as a critical antiviral, and demand soared. populated countries, we have granted sublicences
to major manufacturers in India and China and pro-
‘Roche had to boost production capacity to meet this vided technical know-how to a South African manu-
surge in demand without restricting availability of the facturer to expedite production of a generic version of
drug to treat and prevent seasonal flu, which still oseltamivir for Africa.
causes thousands of deaths each year,’ says Pandemic
Taskforce Leader David Reddy (second from right, with In addition, Roche has donated 3 million treatment
other team-members). ‘In October 2005 we took on courses for the WHO to send immediately to the epi-
additional suppliers and expanded our global manu- centre of a pandemic outbreak, should one occur, and
facturing network to include multiple Roche sites and a further 2 million as regional stockpiles for use in
more than 15 contractors in ten countries. As a result, poorer countries with limited stocks of the drug.
annual production capacity increased to 400 million
treatment courses by the end of 2006 — around Our contributions to pandemic preparedness are
15 times our capacity in 2004.’ further examples of our long-standing commitment to
working with governments, international agencies and
Roche has implemented a balanced pricing and patent other stakeholders to address major public health
policy to help ensure that Tamiflu is available when and needs.

The hepatitis B and C viruses (HBV, HCV) cause 4 million new cases occur each year. Hepatitis C is
acute and chronic liver disease, potentially leading the main reason for liver transplantation.
to liver failure, cirrhosis and liver cancer. World-
wide, 350 million people are thought to be chron- Despite an overall decline in market volume in the
ically infected with HBV, a highly infectious US and competition from a combination treatment
pathogen that is responsible for an estimated 1 mil- in Japan, sales of Pegasys (peginterferon alfa-2a),
lion deaths annually. More than 170 million people for the treatment of hepatitis B and C, continued to
around the world are infected with HCV, and 3 to grow in 2006. The product remains the leading

Business Report 2006 23


Pharmaceuticals

pegylated interferon treatment for chronic hepati- indication were issued by the FDA and the EMEA,
tis C. Sales of Copegus (ribavirin) continued to for use in patients with active RA who have an
decline overall due to generic competition in the inadequate response to or are unable to tolerate
US. In January 2007 Chugai received approval to anti-TNF therapy. Launches in the US, EU and else-
market Copegus in Japan for the treatment of where have commenced.
chronic hepatitis C in combination with Pegasys.
Actemra (tocilizumab) is a first-in-class humanised
With its proven medicines and diagnostic tests, monoclonal antibody designed to block inter-
Roche contributes to the global effort to combat leukin-6, an important protein involved in the
HIV infection and AIDS. We also continue to help inflammation associated with RA. In April 2006
improve the standard of HIV care worldwide by Chugai filed a marketing application in Japan
initiating and supporting projects that can make a for use of Actemra in the treatment of adult RA
difference at the local level. For information on and systemic onset juvenile idiopathic arthritis.
initiatives by Roche to help expand access to Supporting data include phase III results showing
HIV/AIDS treatment in the developing world, see that Actemra monotherapy significantly improves
Playing an active role (p. 67 of this report) and visit the symptoms of RA and slows the progression of
http://www.roche.com/home/sustainability.htm. joint damage. Roche plans to file marketing appli-
cations for Actemra in RA in the US and the EU in
Roche’s HIV medicines achieved steady growth 2007. The product is currently approved in Japan
throughout 2006. Sales of Fuzeon (enfuvirtide), for the treatment of Castleman’s disease, a rare
which works by blocking the entry of HIV into cells lymphatic condition. (See also Major development
of the immune system, rose 19% compared with activities, p. 28.)
2005. Combined sales of Invirase and Fortovase
(saquinavir) increased 28% to 182 million Swiss Other major products and franchises
francs. Growth is being fuelled by increasing uptake
of the recently introduced Invirase 500 mg tablet, Osteoporosis causes a gradual loss of bone density,
which offers patients greater convenience. making bones brittle and prone to break. It affects
millions of people worldwide, especially women
Rheumatoid arthritis after the menopause.

Rheumatoid arthritis (RA) is an autoimmune dis- Bonviva/Boniva (ibandronic acid) is the first and
order characterised by joint inflammation, but the only once-monthly oral bisphosphonate approved
disease can also affect the lungs, eyes and bone mar- for the treatment of postmenopausal osteoporosis.
row. Even when treated, it can result in progressive As the worldwide rollout gathered pace, full-year
joint destruction and loss of mobility. The exact sales of the product continued to rise strongly. In the
cause of RA is unknown, and as yet there is no cure. US Boniva now accounts for some 16% of new bis-
Within two years of developing RA, up to 70% of phosphonate prescriptions. New data published in
patients have X-ray evidence of joint damage, and September show that patients on monthly Boniva
within ten years 80% are unable to work or perform tend to continue treatment significantly longer than
everyday tasks. RA is one of the most common those taking weekly bisphosphonates, thus increas-
autoimmune disorders and is now thought to affect ing their chances of sustained treatment results.
over 21 million people worldwide. Current treat- Bonviva/Boniva Injection was approved in the US
ments include disease-modifying antirheumatic and Europe in January and March, respectively, and
drugs (DMARDs) and biologic medications that is currently being launched in those markets. Given
inhibit tumour necrosis factor (TNF), an inflam- once every three months, this new formulation
matory cytokine. offers effective treatment to women unable to take
or tolerate oral bisphosphonates.
MabThera/Rituxan is the first therapy developed
for RA that selectively targets B cells, which play Global sales of Xenical (orlistat 120 mg), for weight
a key role in the disease. First approvals in this loss, grew steadily in 2006, despite the launch of a

24 Business Report 2006


Pharmaceuticals

Advancing the treatment of


rheumatoid arthritis
During the 1990s, traditional thinking on the
mechanisms causing the inflammation and tis-
sue damage observed in the joints of people
with rheumatoid arthritis (RA) was challenged
by Jonathan Edwards, professor of medicine at
University College London.

Until then, immune cells called T lymphocytes were


considered to be the key factor driving RA. However,
research carried out by Edwards and his colleague
Geraldine Cambridge suggested that another type of
immune cell – called B lymphocytes – was far more
important in RA than had generally been appreciated. sented a major new opportunity in RA. Together with
This led the researchers to focus on the potential role Roche, the scientists began designing a full-scale
of B cells, and Edwards became convinced that target- clinical trial.
ing B cells could offer a way of preventing the inflam-
mation and deformity of RA. Now, with eight years’ clinical experience with ritux-
imab in RA, it is clear that the product is an effective,
He began looking for a medicine that might be capable well-tolerated treatment option for patients with active
of achieving this. In 1996 MabThera/Rituxan (ritux- disease. It is also very encouraging that none of the
imab), a selective B-cell depleting monoclonal antibody, patients treated by Prof. Edwards and his team in this
had been shown to be an effective treatment for a time has shown any sign of becoming resistant to ther-
type of cancer called non-Hodgkin’s lymphoma. In 1998, apy: MabThera continues to successfully control their
Edwards and Cambridge decided to put the medicine disease. ‘To a number of patients, rituximab really is a
to the test in five patients with long-standing severe godsend,’ says Edwards. ‘I have had several patients
RA who had not responded to any other treatment. All whose RA was so severe they were unable to get out of
five rapidly showed major improvement and the num- bed before lunchtime. Now they can not only get up,
ber of patients treated soon increased to 22. By halfway they also take a walk each day or have even gone back
through the trial, it was evident that MabThera repre- to work.’

new competitor in a number of markets. Growth Research and development


has been helped by increasing awareness of the risks
associated with overweight and obesity. Following In recent years the Roche Group has brought to
receipt of an ‘approvable’ letter from the FDA in market effective new treatments for many different
April, our partner GlaxoSmithKline is in discus- types of cancer, as well as medicines that represent
sions with the agency regarding its application to important advances in the treatment of hepatitis,
sell orlistat 60 mg as a non-prescription weight-loss HIV and osteoporosis. Roche aims to expand these
aid in the US. Subject to final FDA approval, GSK successes into other major areas, such as auto-
expects to launch the product under the brand- immune and metabolic diseases, and disorders of
name alli in the first half of 2007. the central nervous system.

Business Report 2006 25


Pharmaceuticals

In 2006, nine of the Group’s phase III clinical trials met their primary endpoints, and five major trials reported
positive follow-up data
Product Indication (trial) Result
Actemra Rheumatoid arthritis (SATORI) Significantly improved disease scores (ACR 20
and ACR 70) compared with methotrexate
Avastin + Xeloda Metastatic colorectal cancer, first-line treatment Avastin: Significantly longer progression-free
(NO16966) survival compared with chemotherapy alone
Xeloda: At least as effective as 5-fluorouracil
(5-FU) in terms of progression-free survival
when combined with oxaliplatin
Avastin Renal cell carcinoma (AVOREN) Significantly longer progression-free survival
compared with interferon alone
Bonviva/Boniva Osteoporosis (MOBILE, follow-up) Sustained efficacy at hip and spine,
good tolerability over 3 years
Herceptin Metastatic breast cancer, combination with Significantly longer progression-free survival
anastrozole hormonal treatment (TAnDEM) and time to progression compared with
hormonal treatment alone
Herceptin Adjuvant breast cancer Significantly longer overall survival
(HERA, 23-month follow-up) (34% reduced risk of death) compared
with chemotherapy alone
Herceptin Adjuvant breast cancer Significantly longer overall survival
(BCIRG 006, 36-month follow-up) (up to 41% reduced risk of death) compared
with no treatment following completion of
adjuvant chemotherapy
MabThera/Rituxan Indolent non-Hodgkin’s lymphoma, Significantly longer overall survival
first-line treatment (RCVP, follow-up) (40% reduced risk of death) compared with
CVP alone
MabThera/Rituxan Rheumatoid arthritis Significantly better inhibition of structural
(REFLEX, 12-month follow-up) damage to joints compared with methotrexate
alone
Mircera Renal anemia – correction of hemoglobin levels At least as effective as epoetin and
in dialysis patients (AMICUS) darbepoetin in terms of response rate
Mircera Renal anemia – correction of hemoglobin levels At least as effective as epoetin and
in predialysis patients (ARCTOS) darbepoetin in terms of response rate
Xeloda Gastric (stomach) cancer (ML17032) At least as effective as 5-FU in terms
of progression-free survival, with better
response rates
Xeloda Esophagogastric cancer (REAL 2) At least as effective as 5-FU in terms of
overall survival, with a significant overall
survival advantage when combined with
oxaliplatin
Xeloda Metastatic colorectal cancer, second-line treatment At least as effective as 5-FU in terms of
(NO16967) progression-free survival when combined
with oxaliplatin

26 Business Report 2006


Pharmaceuticals

Fold-out: R & D pipeline 

110 research projects in major therapeutic areas Roche Pharmaceuticals currently has 110 projects
(January 2007) in preclinical research across six therapeutic areas
and 90 development projects in eight therapeutic
areas, including 20 in phase 0 (transition from pre-
Oncology 29 clinical to clinical development).
Central nervous system 26
In 2006 fifteen projects were either terminated or
Viral diseases 9
reverted to our R&D partners. Of these, eight were
Respiratory diseases 5 in phase I, six in phase II and one in phase III.

Inflammatory, autoimmune
and bone diseases 14
Engaging partnerships
Cardiovascular and
metabolic diseases 27 In 2006 Roche Pharmaceuticals continued to
strengthen its R & D portfolio by entering into flex-
ible licensing and other collaborative agreements to
complement the Group’s in-house activities. Dur-
ing the year 40 new agreements were signed, includ-
The Roche Group’s many promising research ing nine product transactions and 23 research and
projects and late-stage development compounds technology collaborations. In addition to three new
are testimony to the expertise of its more than co-development projects with Chugai, announced
12,000 research and development specialists and to in July, Roche signed agreements in the second half
their commitment to one goal: creating and bring- of the year with Plexxikon (targeted cancer com-
ing to market innovative, clinically differentiated pound), InterMune (protease inhibitors for hepati-
medicines. In 2006, for the fifth consecutive year, tis C) and Actelion (S1P1 immunomodulator for
Roche Pharmaceuticals was named to Science’s list autoimmune disorders).
of the top 20 employers in the biotech and pharma-
ceutical industries, moving up to third place in a Major development activities
field of over 300 companies. Genentech, a member
of the Roche Group, was again ranked number one. Oncology
Roche and its partners continue to explore the
Roche continues to refine its R & D selection crite- benefits of Avastin, Tarceva, Xeloda, Herceptin
ria to maximise the success of projects that reach and MabThera/Rituxan in additional important
phase III clinical testing, the most costly and time- cancer indications and also in combination with
consuming part of the drug development process. each other and other treatments in comprehensive
In 2006 nine of the Group’s phase III clinical trials clinical development programmes. Our oncology
successfully reached their primary clinical end portfolio is being expanded further, as promising
points. compounds progress through clinical develop-
ment.
R & D pipeline
Because of its mode of action, Avastin is demon-
In 2006 the Pharmaceuticals Division filed 13 new strating effectiveness against a wide range of solid
marketing applications and gained 14 regulatory tumours. Roche and Genentech are currently test-
approvals. At the beginning of 2007 the Division’s ing Avastin in eight distinct types of cancer, with
R & D pipeline comprised 101 clinical projects, plans for development in another eight. Avastin
including 48 new molecular entities (NMEs) and is being studied in phase III trials as an adjuvant
53 additional indications. Twenty-five NMEs are treatment for colon cancer, and in advanced
currently in phase I, 18 in phase II and five in phase (metastatic) pancreatic, prostate and ovarian can-
III or filed for regulatory review. In 2006 the total cer. It is also being tested in combination with
number of late-stage projects (NMEs and addi- Tarceva in NSCLC and in combination with Her-
tional indications) increased from 41 to 47. ceptin and other drugs in metastatic breast cancer.

Business Report 2006 27


2a JB 2006 ENG Pipeline 2.2.2007 13:47 Uhr Seite 1

R + D pipeline strengthened further


Therapeutic area Project ID Project/product (generic name) Pharmacological class Indication Phase Partner
Cardiovascular and R1439 dual PPAR agonist type 2 diabetes II
metabolic diseases R1440 glucokinase activator type 2 diabetes II
R1511 type 2 diabetes I
R1579 type 2 diabetes I
R1583 GLP-1 GLP-1 analogue type 2 diabetes II Ipsen (BIM51077)
R1658 CETP inhibitor dyslipidemia II Japan Tobacco (JTT-705)
R1663 anticoagulant I
Hematology R744 Mircera continous erythropoietin receptor activator renal anemia filed
and nephrology US/EU
R744 C.E.R.A. continous erythropoietin receptor activator cancer-related anemia II
Inflammatory, autoimmune R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody rheumatoid arthritis, DMARD inadequate responders III Genentech and Biogen Idec
and bone diseases R127 Valcyte (valganciclovir) inhibitor of CMV replication ulcerative colitis I
R1295 multiple sclerosis I
R1503 p53 kinase inhibitor rheumatoid arthritis II
R1569 Actemra (tocilizumab) humanised anti-IL-6 receptor monoclonal antibody rheumatoid arthritis III Chugai
filed Jpn
R1569 Actemra (tocilizumab) humanised anti-IL-6 receptor monoclonal antibody systemic onset juvenile idiopathic arthritis III Chugai
filed Jpn
R1594 (ocrelizumab) humanised anti-CD20 monoclonal antibody rheumatoid arthritis III Genentech
R1594 (ocrelizumab) humanised anti-CD20 monoclonal antibody relapsed remitting multiple sclerosis II Genentech
R3421 PNP inhibitor autoimmune diseases, transplantation I BioCryst
R3477 S1P1 receptor agonist autoimmune diseases, transplantation I Actelion
R99 CellCept (mycophenolate mofetil) IMPDH inhibitor lupus nephritis III Aspreva
R99 CellCept (mycophenolate mofetil) IMPDH inhibitor pemphigus vulgaris III Aspreva
Central R1450 anti-amyloid β-peptide antibody Alzheimer’s disease I Morphosys
nervous system R1646 overactive bladder I
R1647 depression I
R1678 schizophrenia I
R7090 anxiety I
R7118 schizophrenia I
Oncology R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody chronic lymphocytic leukemia, relapsed III Genentech and Biogen Idec
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody chronic lymphocytic leukemia (1st line) III
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody indolent non-Hodgkin’s lymphoma – maintenance (1st line) III Genentech and Biogen Idec
R1273 Omnitarg (pertuzumab) HER2 dimerisation inhibitor ovarian cancer II Genentech
R1273 Omnitarg (pertuzumab) HER2 dimerisation inhibitor metastatic breast cancer II Genentech
R1415 Tarceva (erlotinib) EGFR inhibitor pancreatic cancer approved Genentech and OSI Pharmaceuticals
US,
filed EU
R1415 Tarceva (erlotinib) EGFR inhibitor NSCLC (1st line) – maintenance III Genentech and OSI Pharmaceuticals
R1415 Tarceva (erlotinib) EGFR inhibitor adjuvant NSCLC III Genentech and OSI Pharmaceuticals
R1415 + Tarceva+Avastin EGFR inhibitor + anti-VEGF monoclonal antibody NSCLC (1st line) – maintenance III Genentech and OSI Pharmaceuticals
R435 (erlotinib + bevacizumab)
R1415 + Tarceva+Avastin EGFR inhibitor + anti-VEGF monoclonal antibody NSCLC (2nd line) III Genentech and OSI Pharmaceuticals
R435 (erlotinib + bevacizumab)
R1492 epothilone D solid tumours II Kosan Biosciences (KOS862)
R1507 solid tumours I Genmab
R1530 solid tumours I
R1645 epothilone D solid tumours I Kosan Biosciences (KOS1584)
R340 Xeloda (capecitabine) fluoropyrimidine gastric cancer filed EU
R340 Xeloda (capecitabine) fluoropyrimidine adjuvant breast cancer III
R340 Xeloda (capecitabine) fluoropyrimidine adjuvant colon cancer – combo oxaliplatin III
R340 Xeloda (capecitabine) fluoropyrimidine metastatic colorectal cancer (1st line) – combo III
R340 Xeloda (capecitabine) fluoropyrimidine metastatic colorectal cancer (2nd line) – combo III
R340 Xeloda (capecitabine) fluoropyrimidine adjuvant colon cancer – combo Avastin III
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody NSCLC (1st line) approved Genentech
US,
filed EU
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic breast cancer (1st line) – combo paclitaxel filed Genentech
US/EU

R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody NSCLC, squamous II Genentech


R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody adjuvant colon cancer III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic colorectal cancer (1st line) – combo extension III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic breast cancer (1st line) – combo Herceptin III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody pancreatic cancer III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody ovarian cancer (1st line) III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody prostate cancer III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody NSCLC with previously treated CNS metastases II Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic breast cancer (1st line) – combo docetaxel III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic breast cancer (1st line) – combo non-taxanes III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody renal cell carcinoma III Genentech
R547 solid tumours I
R597 Herceptin (trastuzumab) anti-HER2 monoclonal antibody metastatic breast cancer – filed EU Genentech
combination with hormonal therapy
R597 Herceptin (trastuzumab) anti-HER2 monoclonal antibody gastric cancer III
R7204 B-raf kinase inhibitor malignant melanoma I Plexxikon
Respiratory diseases R667 nuclear receptor agonist emphysema II
Viral and R127 Valcyte (valganciclovir) inhibitor of CMV replication cytomegalovirus, extension of treatment III
other infectious diseases R1558 antibiotic bacterial infections II Sankyo (CS023)
R1626 polymerase inhibitor hepatitis C II
R7025 hepatitis C I Maxygen
R7128 polymerase inhibitor hepatitis C I Pharmasset
R7227 protease inhibitor hepatitis C I InterMune
Opt-in opportunities ALTU-238 growth hormone deficiency II Genentech
Anti-CD40 anti-CD40 monoclonal antibody non-Hodgkin's lymphoma II Genentech
Anti-CD40 anti-CD40 monoclonal antibody chronic lymphocytic leukemia, multiple myeloma I Genentech
APO2L/TRAIL cancer I Genentech
PARP inhibitor malignant melanoma I Genentech
R1524 calcineurin inhibitor renal transplant II Isotechnika (ISA247)
R1589 Alzheimer’s disease I Memory Pharmaceuticals
R1668 E2F modulator solid tumours II ArQule (ARQ501)
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody glioblastoma multiforme II Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody adjuvant breast cancer (HER2-negative) II Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody ovarian cancer (2nd line) II Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody gastrointestinal stromal tumour III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody adjuvant rectal cancer III Genentech
R435 Avastin (bevacizumab) anti-VEGF monoclonal antibody metastatic breast cancer (2nd line) III Genentech
VEGF topical VEGF diabetic foot ulcer II Genentech
TP300 colorectal cancer I Chugai
Trastuzumab-DM1 metastatic breast cancer I Genentech
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody primary progressive multiple sclerosis III Genentech
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody lupus nephritis III Genentech
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody ANCA-associated vasculitis III Genentech
R105 MabThera/Rituxan (rituximab) anti-CD20 monoclonal antibody systemic lupus erythematosus III Genentech
Participation AVS Antevas (nicaraven) hydroxyl radical scavenger subarachnoid hemorrhage filed Jpn
through Chugai ED-71 activated vitamin D derivative osteoporosis III
EPOCH Epogin (epoetin beta) chemotherapy-induced anemia filed Jpn
GM-611 (mitemcinal fumarate) motilin agonist gastroparesis, irritable bowel syndrome II
SG-75 Sigmart (nicorandil) acute heart failure filed Jpn
VAL (valine) post-hepatectomy II
Participation Lucentis (ranibizumab) antibody fragment to VEGF diabetic macular edema II
through Genentech Xolair (omalizumab) anti-IgE antibody pediatric asthma III Novartis and Tanox
HAE1 asthma II

At the beginning of 2007 the Pharmaceuticals Division’s R&D pipeline comprised 101 projects, including Phase I: Initial studies in healthy volunteers and possibly in patients
48 new molecular entities (NMEs) and 53 additional indications. Twenty-five NMEs are currently in phase I, Phase II: Efficacy, tolerability and dose-finding studies in patients
eighteen in phase II and five in phase III or filed for regulatory review. Phase III: Large-scale studies in patients for statistical confirmation of safety and efficacy

Blue type signifies first indication, black type additional indications. Therapeutic protein
Current as of January 2007. Small molecule
Pharmaceuticals

Results from the phase III ‘Avastin in Lung’ trial Hematology and nephrology (anemia)
(BO17704), which is exploring the combination of The results of six major phase III trials of Mircera
Avastin with chemotherapy in the first-line treat- in renal anemia, involving over 2,400 patients
ment of advanced NSCLC, are expected in the first with chronic kidney disease, were presented at
half of 2007. major medical conferences in 2006. The data
show that dialysis patients can be switched directly
A phase II study investigating combined Herceptin and successfully to maintenance therapy with
and Avastin (without chemotherapy) in the first- once-monthly Mircera from other medicines
line treatment of HER2-positive metastatic breast requiring administration up to three times a week
cancer showed that 54% of the patients had a – the first time such a switch has been achieved.
complete or partial response (tumour shrinkage). In addition, two studies of anemia correction
Recruitment has started for a phase III trial in previously untreated patients with chronic
(AVEREL) to investigate adding Avastin to Her- kidney disease demonstrated that Mircera can be
ceptin plus docetaxel in the first-line treatment of given to these patients just twice monthly from
metastatic breast cancer. Roche and Genentech also the outset – another first. Clinical development
plan to investigate combined Avastin and Herceptin of Mircera for chemotherapy-induced anemia
in the adjuvant HER2-positive breast cancer set- in cancer patients, currently in phase II, is pro-
ting. ceeding as planned.

Roche and its partners are currently evaluating Rheumatology and autoimmune diseases
MabThera/Rituxan in a phase III trial as mainte- New clinical results published in 2006 on the use of
nance therapy following first-line treatment with MabThera/Rituxan in patients with rheumatoid
the product for indolent non-Hodgkin’s lym- arthritis (RA) who have not responded to therapy
phoma. MabThera/Rituxan is also being evaluated with one or more TNF inhibitors included the
in two phase III programmes as a first-line treat- first radiographic evidence that MabThera/Rituxan
ment and as therapy for relapses in chronic lym- significantly inhibits joint destruction and data
phocytic leukemia. showing the continued benefit of additional treat-
ment courses with the drug. Development of the
HERA, a major phase III trial in which Herceptin is product in a broader group of RA patients with
given to women with early-stage breast cancer for mild to moderate disease who have not responded
12 or 24 months, continues; further data will be adequately to treatment with disease-modifying
announced as the study matures. Herceptin is also antirheumatic drugs (DMARDs) is on track, with
being evaluated in phase III trials for the treatment four phase III trials in progress.
of HER2-positive stomach cancer.
Actemra is being developed as a treatment for RA in
Xeloda is currently being developed in the adjuvant one of the most extensive phase III programmes
breast cancer setting, and recruitment of patients Roche has ever undertaken. Five clinical trials
for a large phase III study of the product combined with over 4,000 patients are currently ongoing in
with docetaxel was completed in January 2007. 41 countries. Patient enrolment was completed in
December.
Omnitarg (pertuzumab), a HER2 dimerisation
inhibitor, is being developed for the treatment of Ocrelizumab is an anti-CD20 humanised mono-
ovarian and breast cancer. The results of a recent clonal antibody being developed by Roche and
phase II study of Omnitarg plus gemcitabine versus Genentech for moderate to severe rheumatoid
gemcitabine alone in advanced (platinum-resis- arthritis. Like MabThera/Rituxan, ocrelizumab also
tant) ovarian cancer are encouraging. Results from targets B cells. As a fully humanised antibody, it has
a phase II study of the drug in platinum-sensitive the potential to be even better tolerated. Promising
ovarian cancer are expected in 2007. The results of phase I/II data were presented at the American
both studies will form the basis for a decision on College of Rheumatology conference in November
progression to phase III development. showing that ocrelizumab was well tolerated and

28 Business Report 2006


Pharmaceuticals

Actemra – partnering
in action
Actemra (tocilizumab) is a humanised mono-
clonal antibody designed to block an inflamma-
tion-causing protein called interleukin-6 (IL-6).
It is the first drug of its class for rheumatoid
arthritis (RA), the first antibody-based drug to
originate in Japan and Roche and Chugai’s first
co-development project.

Actemra selectively targets the IL-6 receptor, blocking


the activity of IL-6, a protein that plays a major role in
the inflammation that characterises RA. Clinical trial
data indicate that Actemra can dramatically reduce the
painful, disabling symptoms and joint damage of RA.
years of R & D experience with the drug while con-
Since 2003 a life-cycle team of scientific, medical and tributing global development and marketing expertise.
business specialists from Roche and Chugai has been
managing the Actemra project, which now includes Collaboration between Chugai and Roche is excellent.
five phase III clinical trials at centres in 41 countries. Chugai successfully markets major Roche medicines in
The team is headed by Roche Life Cycle Leader Don Japan and is currently seeking Japanese regulatory
Maclean and Hiroyuki Ohta, Senior Vice President and approval for others, including Avastin. In research the
Head of the MRA Unit at Chugai (pictured above, at companies have complementary expertise and inter-
right and second from right, with other team members). ests in small molecules and therapeutic antibodies and
share insights and technologies.
The Actemra story is a story of partnering and diversity.
The members of the life-cycle team bring a broad range The next co-development projects are already lined up:
of strengths and perspectives to the common goal of in July the companies signed agreements covering
developing and commercialising Actemra worldwide. three new Chugai compounds – two for cancer and one
The Roche people are able to learn from Chugai’s ten for diabetes.

clinically active at all tested doses. An extensive Metabolic disorders


phase III clinical development programme is Type 2 (adult onset) diabetes has been recognised
planned to start early in 2007. as a global epidemic. By some estimates, 300 mil-
lion people worldwide will have this disease by
In addition, Roche is developing R1503, an oral p38 2020. Roche is currently investigating over 200 dif-
MAP kinase inhibitor, for moderate to severe RA. ferent biological targets and screening drug candi-
Inhibition of the enzyme p38 MAP kinase reduces dates against them.
the production of key mediators of inflammation.
Currently in phase II clinical testing, R1503 has Blood glucose control depends largely on the secre-
the potential to offer increased safety and efficacy tion of insulin by beta cells in the pancreas in
and easier administration compared with currently response to fluctuations in glucose levels. However,
available DMARDs. it is also related to glucose production, which is

Business Report 2006 29


Pharmaceuticals

Building for the future

Already a world leader in biotech manufacturing


capacity, the Roche Group continues to invest
in the future. To meet rising demand for its ther-
apeutic antibody products, Roche is building
state-of-the-art biotech facilities to produce
Avastin and Herceptin in Basel, Switzerland, and
Penzberg, Germany. Together, the two projects
represent an investment of 800 million Swiss
francs.

Both facilities are being built to very tight schedules to


ensure they will be fully operational and manufacturing
for the Group’s markets by 2009. Not only do the
project teams at both sites share a strong sense of
urgency, they are also employing the same ‘fast-track’ Both projects are within budget and ahead of schedule.
approach. This means that design and engineering Construction of the buildings was completed in only
phases take place concurrently, resulting in significant two years, and all equipment has been installed. Over
time savings. Commenting on the advantages, Daniel the next two years, final commissioning and qualifi-
Riekert (pictured here, standing), project manager in cation will take place, as well as final regulatory inspec-
Basel, says, ‘The fast-track approach makes it possible tions. ‘The speed with which these two facilities will
to complete complex building projects faster than ever become operational – four years in total – is remark-
before. We’ve accumulated a lot of experience in this able,’ says Penzberg project manager Claus Herrmann
area, which we share with our engineering colleagues (seated, at right). ‘It shows how committed the com-
in Genentech and Chugai. This know-how benefits the pany is to ensuring that its biotech medicines are avail-
entire Roche Group.’ able to patients.’

tightly controlled in the liver. Glucokinase is an closely mimics the action of the natural human
enzyme that plays a key role in both organs. By hormone GLP-1 and offers potential for weekly or
targeting both pathways, R1440, Roche’s first- longer administration intervals. Unlike other GLP-
in-class oral glucokinase activator, is designed to 1 analogues, R1583 has so far not provoked anti-
provide better control of type 2 diabetes than the body responses in any of the people given the drug.
current standard therapy. R1440 is currently in A phase IIb study is currently being prepared, with
phase II clinical trials. Roche is also developing first administration planned for early 2007.
other compounds that act on glucokinase and other
components of glucose metabolism as potential Dyslipidemia
treatments for type 2 diabetes. Lack of high-density lipoprotein cholesterol (HDL-
C), or ‘good’ cholesterol, is associated with an
In July Roche announced that it was exercising its increased risk of cardiovascular disease. R1658,
option to license, develop and market R1583 (BIM licensed from Japan Tobacco, is a cholesteryl ester
51077), a long-acting glucagon-like peptide-1 transfer protein (CETP) inhibitor with a unique
(GLP-1) analogue developed by Ipsen for type 2 mechanism of action that is designed to raise levels
diabetes. R1583 has a similar structure to and of HDL-C. Phase II studies are nearing completion;

30 Business Report 2006


Pharmaceuticals

the data indicate that the compound has a good Roche Pharmaceuticals is currently investing
safety profile and the desired effects on HDL-C and around 2 billion Swiss francs in manufacturing
other blood lipids (fats). The results of these stud- infrastructure projects, including major biotech
ies will form the basis for a decision in 2007 on facilities to produce the active ingredients of
entry into phase III testing. Unlike a development Avastin and Herceptin in Basel (Switzerland) and
compound from the same class that was recently Penzberg (Germany), new formulation, filling,
discontinued by another company, R1658 has not packaging and logistics facilities for injectable and
been associated with any adverse cardiovascular infusable medicines in Kaiseraugst (Switzerland)
changes or any increase in blood pressure when and Mannheim (Germany), and a facility in Toluca
given to patients as monotherapy or in combina- (Mexico) for the formulation of highly potent
tion with statins; nor did R1658 affect cardiovascu- medicines such as Xeloda.
lar parameters in animal models.

Virology
Chronic infection with HCV genotype 1 is one of
the most difficult types of hepatitis C to treat. This
viral subtype is found in the largest subgroup of
patients with hepatitis C. Only 50–55% of patients
with HCV genotype 1 respond to current treat-
ments, and many experience severe side effects. To
meet the need for new treatment options, Roche
has several novel anti-HCV agents in clinical devel-
opment. R1626, currently in phase II, is a potent
inhibitor of HCV polymerase, an enzyme that is
essential for replication of the virus. In addition,
two compounds from partnerships with Pharm-
asset and Maxygen entered phase I clinical testing
in 2006.

Central nervous system diseases


Diseases of the central nervous system represent
some of the greatest unmet medical needs world-
wide and one of the largest segments of the global
pharmaceuticals market. Roche currently has eight
projects in early clinical development in this
area, including promising phase I compounds for
Alzheimer’s disease, schizophrenia and depression.

Manufacturing infrastructure

Over the last few years, Roche has been systemati-


cally developing its manufacturing infrastructure
in line with ongoing changes in the Group’s prod-
uct mix and to meet current and expected demand
for its new biologic medicines. In addition, to
ensure our manufacturing operations remain effi-
cient, cost-effective and environmentally compati-
ble, we are continually incorporating improved
technology and updating processes in line with best
practices.

Business Report 2006 31


Diagnostics Division in brief

Sales in millions of CHF


2006 8,747
2005 8,243
2004 7 ,827

Operating profit before exceptional items1) in millions of CHF


2006 1,422
2005 1,771
2004 1,670
1) 2004 as published in Annual Report 2005.

Number of employees
2006 20,712
2005 20,352
2004 19,565

Key figures
% change % change in
In millions of CHF in CHF local currencies % of sales
Sales 8,747 6 5 100
– Diabetes Care 3,019 5 3 35
– Centralized Diagnostics 3,100 7 5 35
– Molecular Diagnostics 1,211 3 3 14
– Near Patient Testing 785 8 7 9
– Applied Science 632 12 12 7
EBITDA 2,500 –4 –5 28.6
Operating profit1) 1,422 –20 –21 16.3
Research and development 700 0 –1 8.0
1) Before exceptional items.

Diagnostics Executive Committee 1 January 2007


Severin Schwan CEO Division Roche Diagnostics
Per-Olof Attinger Platforms and Support
Silvia Ayyoubi Human Resources
Manfred Baier Applied Science
Christian Hebich Finance and Services
Daniel O’Day Molecular Diagnostics
Tiffany Olson North America
Volker Pfahlert Professional Diagnostics
Burkhard G. Piper Diabetes Care
Jürgen Schwiezer EMEA (Europe, Middle East, Africa) and Latin America
Robert Yates Business Development

32 Business Report 2006


Diagnostics

The Division Sales by region

Roche Diagnostics is the world leader in in-vitro


diagnostics: products used to test human body Europe/Middle East/
fluids and tissues to obtain information for the Africa 48% (+5%)
diagnosis, prevention and treatment of disease. Japan 5% (+3%)
And it is also a supplier of innovative solutions for Asia–Pacific 7% (+8%)
medical and biotechnology research. The division’s Others 1% (–4%)
large and growing product portfolio ranges from Iberia/
home blood glucose monitoring products for Latin America 11% (+9%)
North America 28% (+2%)
people with diabetes and point-of-care testing
devices for use in doctors’ offices to high-through-
put laboratory systems for hospitals and state-of- Italics = growth rate
the-art instruments for genetic research.
In October the Food and Drug Administration
The division has R & D and manufacturing facilities (FDA) lifted an import alert barring the US sale of
in Austria, Germany, Switzerland and the United Accu-Chek insulin pumps from Disetronic Medical
States, augmented by an extensive network of Systems. With its new Accu-Chek Spirit pump now
alliances and partnerships giving the division broad available in the world’s largest infusion systems
access to important new technologies. It is using market, Roche expects to further strengthen its
these capabilities to help make today’s healthcare market leadership in diabetes care.
better, safer and more cost-effective and to provide
scientists with the tools needed to discover tomor- Divisional operating profit (before exceptional
row’s medical advances. items) declined 21%1) to 1.4 billion Swiss francs,
resulting in a margin decline of 5.2 percentage
points. This was primarily due to increased invest-
Results ments in launch activities, impairment charges on
intangible assets and lower royalty income from
Roche Diagnostics remained the global leader in licences. The impairment charges mainly relate to
2006 in an increasingly competitive market, with intangible assets recorded following the Disetronic
a market share of 19%. Divisional sales increased acquisition in 2003. The decline in royalty income
5% for the year in local currencies (6% in Swiss followed the worldwide expiry of the foundational
francs; 5% in US dollars), fuelled by new product patents on polymerase chain reaction (PCR) tech-
launches. This was slightly above the market nology in many countries outside the US. EBITDA2)
growth rate. The Centralized Diagnostics, Near
Patient Testing and Applied Science units were
1) Unless otherwise stated, all growth rates are in local cur-
the main contributors to growth. Roche Diabetes rencies.
Care’s sales grew 3%. 2) Earnings before exceptional items and before financial
income, financing costs, tax, depreciation and amortisation,
including impairment.

Business Report 2006 33


Diagnostics

totalled 2.5 billion francs, or 28.6% of sales, com- In the United States customers have had access to
pared with 31.7% in 2005; this was well above the the complete Roche portfolio of insulin delivery
industry average. products since the FDA lifted its import alert
on Accu-Chek insulin pumps in October. The
customer response there to the Accu-Chek Spirit
Business areas pump, which is now available in more than 30 coun-
tries, was very positive during its first three months
Diabetes Care on the US market. Roche Diabetes Care’s insulin
delivery business posted double-digit growth.
Roche Diabetes Care supplies a broad range of
blood glucose meters and insulin delivery systems Centralized Diagnostics
for better diabetes management. Monitoring systems
with integrated lancets, test strips and software for Laboratory workloads are increasing with the
storing and analysing data are an increasingly growing demand for tests to detect diseases early
important part of Roche’s diabetes care portfolio and for more targeted therapies. At the same time,
because they improve glucose control for many hospital-based and commercial laboratories are
users, in addition to offering greater convenience. under pressure to contain or cut costs. Roche
Activities aimed at integrating glucose monitoring Centralized Diagnostics supplies instruments,
and data management with insulin delivery are tests, data management software and services that
ongoing and may one day result in systems that enable laboratories to cope with these challenges by
closely mimic the way the healthy pancreas regu- simplifying workflows and enhancing productivity
lates blood glucose levels. and efficiency.

Roche Diabetes Care remained the global market In 2006 Roche Centralized Diagnostics posted
leader in 2006. Following 1% growth in the first above-market sales growth of 5% and remained the
half-year, sales rose 5% in the third quarter and industry leader with a market share of about 13%.
6% in the fourth. Full-year sales were up 3% from The rollout of the medium-throughput cobas 6000
the previous year. analyser series and the European launch of the
cobas c 111 analyser for customers with small testing
The new Accu-Chek product portfolio makes it volumes marked important steps in a business
even easier for people with diabetes to manage their strategy centred on making clinical chemistry and
condition. Besides the Accu-Chek Spirit insulin immunochemistry testing simpler and more effi-
pump, it includes the Accu-Chek Aviva and Accu- cient. An application for US marketing approval for
Chek Go blood glucose monitoring systems and the cobas c 111 analyser was submitted to the FDA
Accu-Chek Compact Plus, an all-in-one system in late 2006. The cobas 6000 analyser series is a fully
integrating a glucose meter with an automatic test automated, integrated system capable of handling
strip dispenser and a lancing device. Also new is the more than 95% of the routine tests performed
Accu-Chek Multiclix lancing device, which features daily by a medium-volume laboratory. Thanks to its
a unique preloaded lancet drum for safer, more flexible, modular design, it can be configured exactly
convenient and comfortable blood sampling. to customers’ individual needs, and new modules
Market uptake of these products has been strong, can be added at any time as those needs grow.
spurring additional sales growth and helping to off-
set declining sales of the Accu-Chek Advantage sys- Immunoassay sales continued to grow significantly
tem, one of Roche Diabetes Care’s most successful faster than the market, advancing 13% in 2006
products for nearly a decade. The rollout of new thanks to products like the Elecsys proBNP and
monitoring systems was completed in mid-2006 Elecsys Troponin T assays for cardiac disorders.
with the launch of the Accu-Chek Compact Plus in Sales of the NT-proBNP marker grew 28%, helped
North America and Accu-Chek Aviva in Japan. The by additional US approval of the Elecsys proBNP
entire new family of Accu-Chek products is now assay for use in assessing the risk of cardiac events
available worldwide. in patients with stable coronary artery disease.

34 Business Report 2006


Diagnostics

Consolidation and flexibility


with the cobas 6000
Tergooi Hospitals in the neighbouring towns of
Hilversum and Blaricum, in the Netherlands,
recently merged and together have 500 beds.
Eric Vermeer (pictured) and Frits Fernhout, two
visionary young doctors at the hospitals, are in
charge of Europe’s first reference laboratory
equipped with instruments from Roche’s cobas
6000 analyser series, and their ambition over
the next several years is to make it one of the
Netherlands’ ten best reference labs. In June
2006 their laboratory became one of the first to
install these new analysers.
handling grows over the next few years — and we hope
‘One important reason for choosing the cobas 6000 it will — adapting and expanding the system to cope
analyser series was consolidation — it allows us to per- with the higher workload won’t be a problem. All we
form clinical chemistry and immunochemistry testing have to do is add another cobas e 601 or cobas c 501
on a single platform’, says Dr Vermeer. ‘The space module. It’s as simple as that.’
savings are significant. We used to have two relatively
large clinical chemistry analysers here, plus a third Improved workflow, more efficient use of the 75 staff
system for immunoassays. Today we have two new who work in the lab, shorter turnaround times and
cobas instruments instead, each capable of serving as lower costs are all advantages that Dr Vermeer and
a backup for the other. We intend to use the extra space Dr Fernhout have experienced first-hand since the
to expand the range of tests the laboratory offers.’ switch to the cobas 6000 analyser series. As for the
staff, they like the standardised, user-friendly interface
‘Another selling point for us was the system’s flexibility’, software. Before the switch, they had to master two
adds Dr Fernhout. ‘As the volume of test orders we’re different operator interfaces; those days are over.

Molecular Diagnostics Roche Molecular Diagnostics maintained its lead-


ing market share at about 38% as sales advanced
Roche Molecular Diagnostics develops and com- 3% for the year. Virology – the largest segment by
mercialises innovative, highly sensitive systems sales – grew 5% in 2006, in line with the virology
and tests that reliably detect bacteria, viruses and market.
other pathogens in patient samples and in donated
blood, tissues and organs. These products use tech- Stepped-up sales efforts for the combined Cobas
nologies that directly detect the genetic material AmpliPrep/Cobas TaqMan platform and its menu
(DNA or RNA) of infecting pathogens such as HIV of viral load tests for HIV and hepatitis B and C
or hepatitis viruses, and therefore provide faster virus (HBV, HCV) drove product sales and
results than tests based on the body’s immune helped Roche Molecular Diagnostics to maintain
response to infection. The business area is also its market share in Europe. Offering fully auto-
working on additional gene-based tests to facilitate mated sample preparation and analysis, Cobas
differential diagnosis and treatment selection in a AmpliPrep/Cobas TaqMan enhances laboratory
number of other diseases. productivity and test result integrity. FDA review of

Business Report 2006 35


Diagnostics

the HIV viral load test for this platform is already monitoring and CoaguChek XS Plus for healthcare
well advanced, and Roche is preparing to submit professionals, commenced their European rollout in
its marketing application for the HCV test to the January and October, respectively. CoaguChek XS
FDA in early 2007. Monitoring viral load (the received FDA approval in the third quarter of 2006,
amount of virus in a patient’s blood) is an impor- and a full US launch is planned for the first quarter
tant way of assessing disease progression and treat- of 2007. These systems provide patients taking oral
ment response. anticoagulants and their health professionals accu-
rate, on-the-spot results from a single drop of blood.
In June Roche began rolling out the new fully Their successful launch has strengthened Roche’s
automated cobas s 201 modular blood screening global leadership in coagulation monitoring.
system and cobas TaqScreen MPX multiplex test
across Europe. The cobas TaqScreen MPX test, Roche Near Patient Testing is also the clear leader
which simultaneously detects HIV, HCV and HBV in hospital-based blood glucose monitoring. The
in donated blood, received CE Mark (Conformité Accu-Chek Inform meter and Accu-Chek Advan-
européenne) certification in March. These prod- tage and Accu-Chek Sensor test strips are the core
ucts are now available in all European countries. products driving Roche’s growing market share in
US filings for the multiplex test and a separate this segment.
West Nile Virus test on the cobas s 201 system are
planned for 2007. Applied Science

During the year additional large US laboratories The life sciences encompass disciplines ranging
signed on to offer the AmpliChip CYP450 Test, a from biology, genetics and proteomics to medical
microarray-based test that detects genetic varia- research into major disease areas such as cancer and
tions which can affect the way patients respond to virology. Roche Applied Science supplies a broad
treatment with many widely prescribed drugs. and growing array of instruments and highly spe-
cific test reagents and test kits for research applica-
Roche is preparing to submit filings to the FDA in tions in this diverse market.
the first half of 2007 for tests to detect and geno-
type low-, intermediate- and high-risk strains of Roche Applied Science’s sales grew 12% in 2006,
human papillomavirus (HPV). Persistent infection nearly twice the market growth rate. Growth
with certain HPV genotypes is a known risk factor was driven primarily by the LightCycler 480
for cervical cancer. instrument and Genome Sequencer 20 system.
LightCycler 480 is a highly versatile high-through-
Near Patient Testing put gene expression and mutation analysis plat-
form based on the polymerase chain reaction
Roche Near Patient Testing supplies products for (PCR) technology pioneered by Roche. The inno-
use outside the central laboratory, for example in vative Genome Sequencer 20 system, first launched
physicians’ offices and at patients’ bedsides. Portable in late 2005, marks Roche’s successful entry into
diagnostic and monitoring devices, rapid, simple- the attractive DNA sequencing research market.
to-perform tests and advanced software to support It can sequence long DNA fragments and entire
clinical decision-making at the point of care are its genomes 60 times faster than conventional com-
core product groups. mercially available instruments.

This business area reinforced its market leadership Roche Applied Science is also a supplier of indus-
in 2006. Overall sales rose 7% for the year, helped trial reagents and substrates, which account for a
by the continued trend towards decentralised major part of its sales revenues. These products
testing. were important contributors to growth in 2006.

Roche Near Patient Testing’s newest coagulation


monitoring systems, CoaguChek XS for patient self-

36 Business Report 2006


Diagnostics

Major product launches in 2006


Business area Product
Diabetes Care New Accu-Chek Go meter, offering improved feature set and design
Accu-Chek Smart Pix: Small, easy–to-use device reader; transfers data from any
Accu-Chek pump or blood glucose meter to the user’s PC

Centralized Diagnostics cobas 6000 analyser series: Integrated clinical chemistry (cobas c 501 module) and
immunoassay (cobas e 601 module) platform for mid-volume laboratories;
designed for easy on-site expandability
cobas c 111: Stand-alone clinical chemistry and electrolyte analyser for
extra-small-workload laboratories
cobas IT 5000 solution: Laboratory information system that supports all steps of laboratory
testing, from order entry to result reporting. Features connectivity, sample management,
quality control and validation capabilities

Molecular Diagnostics cobas TaqScreen MPX multiplex Test: Multiplex test for the detection of HIV-1
(groups M and O), HIV-2 and hepatitis B and C on the cobas s 201 system;
can be used to screen whole blood, plasma and organs and tissues from living donors
LightCycler SeptiFast Test (CE): Rapidly and reliably detects and identifies
the 25 pathogens responsible for 90% of all bloodstream infections

Near Patient Testing CoaguChek XS Plus: Hand-held coagulation monitoring system for professional use
CoaguChek XS: Hand-held coagulation monitoring system for self-testing

Applied Science LightCycler 480 instrument: New 96-well format and software modules extending
the system’s broad range of applications

Research and development regimens. The business area is exploring projects


ranging from safer, more convenient lancing
In 2006 Roche Diagnostics invested 700 million devices to insulin guidance software and decision
Swiss francs, or 8% of sales, in research and devel- support programs designed to help physicians and
opment. The molecular diagnostics, immuno- patients make better treatment decisions. A second-
chemistry and diabetes care businesses accounted generation continuous glucose monitoring system
for the largest shares of expenditure. is among the projects currently under develop-
ment.
Diabetes Care
Centralized Diagnostics
Roche Diabetes Care is pursuing continuous
improvements in integrated blood glucose moni- Following the 2006 rollout of the cobas 6000
toring. Integrated systems reduce the number of analyser series, Roche Centralized Diagnostics is
different devices and steps required to track blood preparing to launch its second cobas modular
glucose levels, making it easier for people with platform in 2007. The new platform, which will be
diabetes to adhere to their diabetes management marketed as the cobas 4000 analyser series, is geared

Business Report 2006 37


Diagnostics

Key product launches scheduled for 2007


Business area Product
Diabetes Care Accu-Chek Performa: Blood glucose monitoring system that gives test results
in five seconds, performs extensive quality checks and includes advanced data
management features
Accu-Chek 360°: Easy-to-use, customisable PC-based data management software
designed for a wide range of uses, from downloading data to performing detailed
analyses; for people with diabetes and healthcare professionals
New Accu-Chek Compact Plus blood glucose monitoring system, with improved
user-friendly design and an ergonomic user interface

Professional Diagnostics1) cobas e 411: Stand-alone immunochemistry analyser for small- and
medium-workload laboratories. Successor to Elecsys 2010
MPA connectivity for the cobas 6000 analyser series: Connectivity hardware and software
for cobas 6000 and Modular Pre-Analytics modules; offers laboratories total automation
from sample preparation to result
Additional configurations of the cobas 6000 analyser series, combining the cobas c 501
and cobas e 601 modules: cobas <5012I601>, cobas <5012>, cobas <501I6012>,
cobas <6012>. The new configurations are designed to suit an even wider range
of laboratory workloads
cobas c 311 system: Stand-alone clinical chemistry analyser for small- to
medium-workload laboratories
MyLabView: Portal for online benchmarking of results obtained with Serum Work
Area analysers
cobas IT 3000 solution: Central lab data management system (WAM/middleware)
for instrument interface consolidation, providing result-related reagent and test
information
cobas IT 1000 solution: Work area manager for hospital point of care; product updates
will be released periodically throughout 2007
cobas h 232: Portable system for bedside or fixed-location cardiac testing;
test menu of Roche cardiac assays
cobas h 152: Hand-held meter for measuring cholesterol, triglycerides and
lactate in blood; designed for professional and self-testing environments

Molecular Diagnostics Cobas TaqMan 48 HBV Test for automated real-time PCR amplification and
quantitation of hepatitis B virus (US)
Cobas TaqScreen WNV Test and cobas s 201 system for automated real-time
PCR detection of West Nile virus in donated blood and plasma (US)
Cobas AmpliPrep/Cobas TaqMan HIV, HBV and HCV Tests for automated
real-time PCR amplification and quantitation of HIV-1 and hepatitis B and C virus
(HIV in US; HIV, HBV, and HCV in Japan)

Applied Science Broad rollout of Genome Sequencer FLX, a next-generation DNA sequencing system
that is even faster and more cost-efficient than Roche´s ultrafast Genome Sequencer 20

1) Includes Roche Centralized Diagnostics and Roche Near Patient Testing.

38 Business Report 2006


Diagnostics

to the needs of low-workload laboratories. It com- of serious psychiatric diseases. Also in 2007, Roche
prises the cobas e 411 immunoassay system, will explore the use of its AmpliChip CYP450 Test
scheduled for launch in early 2007, and the cobas to identify variations in the CYP2D6 gene that
c 311 clinical chemistry system, due to follow in inhibit metabolism (conversion) of the breast
the second half of the year. The cobas e 411 system cancer drug tamoxifen in the body to its active
provides results for critical assays in as little as form. Women with CYP2D6 variants that make
nine minutes. them poor metabolisers of tamoxifen have been
shown to receive less therapeutic benefit from the
Proteomics research at Roche has identified several drug.
novel biomarker candidates for colorectal, lung and
breast cancer and rheumatoid arthritis. Near Patient Testing

Molecular Diagnostics Roche Near Patient Testing will continue to renew


its broad product portfolio in 2007 with launches of
One of Roche Molecular Diagnostics’ top priorities new instruments for testing cardiovascular param-
is to develop a second-generation multiplex blood eters in the hospital. Going forward, the overall
screening assay that will not only indicate whether focus will be on developing instruments that offer
a unit of blood is positive for viral contamination, greater ease of use and test consolidation. In partic-
but also identify which virus is present (HIV-1 ular, efforts will be aimed at addressing needs for
groups M and O, HIV-2, HBV or HCV). This will more automation in intensive care units and other
eliminate the need for separate ‘viral target resolu- settings where frequent testing is required.
tion’ testing, which is required with first-generation
multiplex assays, and make screening more effi- Applied Science
cient.
Development activities aimed at improving
In oncology, the first phase of a Roche-sponsored throughput and sample handling with the very
international research study has shown that successful LightCycler 480 instrument and Genome
microarray-based analysis of leukemias distin- Sequencer 20 system are ongoing. A next-genera-
guishes different subtypes as accurately as conven- tion sequencing system, Genome Sequencer FLX,
tional methods and is subject to less inter-labora- will become available in the first half of 2007. Roche
tory variation. Identifying which leukemia subtype Applied Science also plans to add new research
a patient has is critical for selecting the best avail- reagents and products for automated cell analysis
able treatment. Data from the study will be used to to its portfolio.
determine what gene sequences to include in the
AmpliChip leukemia microarray now in develop-
ment, which could potentially provide physicians
with a single standardised test for diagnosing
leukemia subtypes. In addition, Roche is develop-
ing the AmpliChip p53 Test to identify mutations of
the p53 gene that disable normal cell function and
allow cancer cells to proliferate. Mutations of p53
are found in virtually all tumour types. The test
may one day help in assessing the prognosis of
patients with cancer and in selecting the therapies
best suited to their individual needs.

In 2007 Roche will receive initial data from a large-


scale study correlating variations in two CYP450
genes (CYP2D6 and CYP2C19) with clinical out-
comes and treatment costs for inpatient treatment

Business Report 2006 39


‘Our little brother caught the flu,
but we still got to go on holidays.’

40 Business Report 2006


Tamiflu – stopping flu in its tracks

It was a Tuesday late in February, the weather


report said snow conditions were ideal, and a week’s
accommodation was already booked. Kristina
and Diana had only three more days of school before
the whole family was due to leave for its annual
skiing trip. Unfortunately, it was just then that their
brother Niklas suddenly became ill, rapidly devel-
oping fever and headache. And instead of being
his usual happy, active self, the six-year-old showed
no interest in doing anything much but rest.
Alerted by recent news stories about influenza
outbreaks in their part of Germany, the children’s
mother immediately took Niklas to the family’s
pediatrician. He promptly diagnosed flu and pre-
scribed treatment with Tamiflu (oseltamivir).
In addition, since the other family members had
by now probably also been exposed to the flu virus,
the doctor advised them to take Tamiflu for prophy-
laxis. The whole family started taking the medicine
that same day. After their mother showed them how,
the girls and Niklas measured out the correct doses
of Tamiflu suspension themselves, using the dispenser
provided.
To everyone’s relief, Niklas made a rapid recovery,
and the prophylaxis was also successful: no one else
in the family came down with the flu. The following
Saturday, the family was able to take off for the
mountains as planned.

Prevention
Not only can influenza disrupt holiday plans – it can be an illness
with devastating consequences. Each year, seasonal influenza
affects over 100 million people worldwide, with over 36,000 deaths
attributed to the disease in the US alone. Children and the
elderly are most at risk, along with people whose health is already
compromised by other conditions. Treating the initial case with
Tamiflu and giving Tamiflu prophylaxis to other family members is
proving effective in preventing transmission of influenza within
households.

Business Report 2006 41


Corporate Governance,
Remuneration Report

Corporate Governance

Roche meets all relevant corporate governance Mauro was elected as a new member of Roche’s
requirements. In particular, it complies with all highest governing body, also for a term of four
applicable laws and with Swiss Stock Exchange years. Rolf Hänggi, who had served as a Vice-Chair-
(SWX Swiss Exchange) directives (including the man of the Board of Directors since 1996, declined
commentaries thereto) and the Swiss Code of Best to stand for re-election at the AGM.
Practice for Corporate Governance promulgated
by the Swiss business federation economiesuisse. At its organising meeting immediately following
The company’s internal governance framework, par- the AGM, the Board of Directors adopted changes
ticularly its Articles of Incorporation and Bylaws, to its committee structure and committee member-
embodies all the principles needed to ensure that ships as shown in the table on page 43. In particu-
the company’s businesses are managed and super- lar, the Audit and Corporate Governance Commit-
vised in a manner consistent with good corporate tee was reconstituted as the Audit Committee, and
governance, including the necessary checks and responsibility for corporate governance, sustain-
balances.1) ability and reporting on legal compliance, safety,
health and environmental protection, which
Our printed Annual Report contains selected links was previously part of the Audit and Corporate
to the Roche website (www.roche.com). Readers are Governance Committee’s remit, was transferred to
thus provided not only with a ‘snapshot’ of our a newly established Corporate Governance and
company at the reporting date but are also directed Sustainability Committee, chaired by Andreas Oeri.
to sources which they can consult at any time for The Finance and Investment Committee was dis-
up-to-date information about corporate govern- solved and its remit transferred to the new Audit
ance at Roche. Whereas each Annual Report covers Committee, chaired by DeAnne Julius.
a single financial year ending 31 December, our
website contains information of a more permanent At the next Annual General Meeting of Roche
nature as well as the latest Roche news. Amend- shareholders on 5 March 2007, the Board of Direc-
ments to our company’s Articles of Incorporation tors will propose that Pius Baschera and Wolfgang
and Bylaws and changes in the curricula vitae of the Ruttenstorfer be elected as additional members of
members of the Board of Directors and the Corpo- the Board.
rate Executive Committee are published in timely
fashion on our website, where they can be accessed Pius Baschera, a Swiss citizen born in 1950, has
by anyone looking for this information. been chairman of the board of Hilti Corporation
since the start of 2007. After completing degrees in
mechanical engineering and management studies
Board of Directors at the Swiss Federal Institute of Technology, Zurich,
Pius Baschera joined Hilti in 1979. He held a num-
At the 88th Annual General Meeting (AGM) of ber of positions in the United States and Europe
Roche Holding Ltd, on 27 February 2006, DeAnne
Julius, Peter Brabeck-Letmathe and Horst Teltschik
were elected to additional four-year terms on the
Board of Directors. In addition, Beatrice Weder di 1) http://www.roche.com/home/company/com_gov.htm

42 Business Report 2006


Corporate Governance

Board of Directors as of 1 January 2007 (from left): John I. Bell, Beatrice Weder di Mauro, Peter Brabeck-Letmathe,
Bruno Gehrig, André Hoffmann, Franz B. Humer, Lodewijk J. R. de Vink, DeAnne Julius, Walter Frey, Andreas Oeri, Horst Teltschik

Name (year of birth) Term ends First elected


Board of Directors
Dr Franz B. Humer (1946) D*, F Chairman 2009 1995
Prof. Bruno Gehrig (1946) C*, D, E Vice-Chairman and Independent Lead Director 2008 2004
André Hoffmann (1958) C, D, E Vice-Chairman 2009 1996
Prof. John Irving Bell (1952) C, E 2009 2001
Peter Brabeck-Letmathe (1944) E 2010 2000
Lodewijk J.R. de Vink (1945) C, E 2008 2004
Walter Frey (1943) A, B, E 2008 2001
Dr DeAnne Julius (1949) B*, E 2010 2002
Dr Andreas Oeri (1949) A*, E 2008 1996
Prof. Horst Teltschik (1940) A, B, E 2010 2002
Prof. Beatrice Weder di Mauro (1965) A, B, E 2010 2006

Secretary to the Board of Directors


Dr Gottlieb A. Keller (1954)

Honorary Chairman of the Board of Directors


Dr Fritz Gerber (1929)

A Corporate Governance and Sustainability Committee. D Presidium/Nomination Committee.


B Audit Committee. E Non-executive director.
C Remuneration Committee. F Executive director.

* Committee chairperson.

1 January 2007.

Business Report 2006 43


Corporate Governance

before being appointed CFO in 1990. In 1994 he Information relating to Corporate


became chairman of the executive board, a position Governance
he stepped down from when he became chairman
of the board on 1 January 2007. Pius Baschera is an (1) Group structure and shareholders
honorary professor at the Swiss Federal Institute of • Roche’s operating businesses are organised into
Technology, Zurich. two divisions: Pharmaceuticals and Diagnostics.
The Pharmaceuticals Division comprises the
Wolfgang Ruttenstorfer, an Austrian citizen born in three business segments Roche Pharmaceuticals,
1950, is a graduate of Vienna University of Eco- Genentech and Chugai.
nomics and Business Administration. Since 2002 he The Diagnostics Division consists of the follow-
has been CEO and chairman of the executive board ing five business areas: Applied Science, Diabetes
of OMV Aktiengesellschaft, in addition to heading Care, Centralized Diagnostics, Molecular Diag-
the company’s natural gas and chemicals busi- nostics and Near Patient Testing. Business activi-
nesses. Wolfgang Ruttenstorfer joined OMV in ties are carried out through Group subsidiaries
1976 and was appointed to the executive board in and associated companies. Significant subsid-
1992. From 1997 to 1999 he was Austria’s deputy iaries and associated companies are listed in the
minister of finance, returning to OMV in 2000. Finance Report, Note 37 to the Roche Group
Wolfgang Ruttenstorfer is a recognised expert on Consolidated Financial Statements (‘Subsidiaries
the emerging markets of Eastern Europe and the and associated companies’, pages 93 to 96).
Middle East. • Major shareholders are listed in the Finance
Report, Notes 31 and 34 to the Roche Group
Consolidated Financial Statements (‘Equity
Corporate Executive Committee attributable to Roche shareholders’ and ‘Related
parties’, pages 84 and 89) and in the Notes to
Severin Schwan joined the Corporate Executive the Financial Statements of Roche Holding Ltd
Committee as the new CEO Division Roche Diag- (page 107).
nostics on 1 January 2006. Heino von Prondzynski, • André Hoffmann, Vice-Chairman of the Board
former CEO Division Roche Diagnostics, resigned of Directors, and Andreas Oeri, Chairman of
from Roche at the end of 2006. the Board’s Corporate Governance and Sustain-
ability Committee, serve in their respective
With effect from 1 January 2006, Burkhard G. capacities on the Board and its Committees as
Piper, Eduard Holdener, Peter Hug, Rolf Schläpfer representatives of the shareholder group with
and Osamu Nagayama were appointed members of pooled voting rights and receive the remunera-
Roche’s Enlarged Corporate Executive Committee. tion set forth in the Remuneration Report on
page 52. No other relationships exist with the
Effective 1 January 2007, Pascal Soriot, Head of shareholders with pooled voting rights.
Pharma Strategic Marketing, became Head of • There are no cross-shareholdings.
Commercial Operations of the Pharmaceuticals
Division and joined the Enlarged Corporate Exe- (2) Capital structure
cutive Committee. • Information on Roche’s capital structure is pro-
vided in the Finance Report, Notes to the Finan-
cial Statements of Roche Holding Ltd (page 106).
Additional details are contained in the Articles of
Incorporation of Roche Holding Ltd.2)
• Changes in equity are detailed in the Finance
Report, Notes to the Financial Statements of
Roche Holding Ltd (page 106).

2) http://www.roche.com/home/company/
com_gov/com_gov_arti.htm

44 Business Report 2006


Corporate Governance

Corporate Executive Committee as of 31 December 2006 (from left): Jonathan K. C. Knowles, Pierre Jaccoud,
Severin Schwan, Burkhard G. Piper, William M. Burns, Eduard Holdener, Franz B. Humer, Peter Hug, Erich Hunziker,
Rolf Schläpfer, Gottlieb A. Keller, Osamu Nagayama

Name (year of birth) Position


Corporate Executive Committee Dr Franz B. Humer (1946) Chairman and CEO of the Roche Group
Dr Erich Hunziker (1953) Chief Financial Officer and
Deputy Head of the Corporate Executive Committee
William M. Burns (1947) CEO Division Roche Pharmaceuticals
Dr Severin Schwan (1967) CEO Division Roche Diagnostics
Prof. Jonathan K. C. Knowles (1947) Head Global Research
Dr Gottlieb A. Keller (1954) Head Corporate Services and Human Resources

Enlarged Corporate Dr Eduard Holdener (1945) Head Global Pharma Development


Executive Committee Dr Peter Hug (1958) Head Pharma Partnering
Burkhard G. Piper (1961) Head Business Area Roche Diabetes Care
Pascal Soriot (1959) Head Commercial Operations Pharmaceuticals Division
Rolf Schläpfer (1956) Head Corporate Communications
Osamu Nagayama (1947) President and CEO Chugai

Secretary to Pierre Jaccoud (1955) Head Chairman’s Office


the Corporate Executive Committee

Statutory Auditors KPMG Klynveld Peat Marwick Goerdeler SA (since 2004)


of Roche Holding Ltd Principal auditor: John A. Morris (since 2004)
and Group Auditors

Compliance Officer Dr Andreas Greuter (1949)

Business Report 2006 45


Corporate Governance

• The company has a share capital of 160,000,000 (see §18 of the Articles of Incorporation of
Swiss francs, divided into 160,000,000 fully paid Roche Holding Ltd4) and the Minutes of the 88th
bearer shares with a nominal value of 1 Swiss Annual General Meeting of Roche Holding Ltd,
franc each. There are no restrictions on the exer- held 27 February 2006).5)
cise of the voting rights of these shares. Upon • Chairman of the Board of Directors Franz B.
deposit, shares can be voted without any restric- Humer continues to be the only director also
tions. serving in an executive capacity at Roche, and
• There is no authorised or conditional capital. the majority of seats on the Board of Directors
• In addition, 702,562,700 non-voting equity secur- are held by independent directors.
ities (NES) have been issued in bearer form. • None of the non-executive members of the
They do not form part of the share capital and Board of Directors has been a member of Roche’s
confer no voting rights. Each NES confers the Corporate Executive Committee or served in
same rights as one share to participate in avail- an executive capacity at any Group subsidiary
able earnings and in any liquidation proceeds during the three financial years preceding the
following repayment of the share capital. Roche’s current reporting period.
NES and the rights pertaining thereto (including • The internal organisation of the Board of Direc-
the provisions protecting the interests of NES tors and the division of authority and responsi-
holders) are described in §4 of the Articles of bilities between the Board and management, the
Incorporation of Roche Holding Ltd. remits of the Board committees and the informa-
• Information on debt instruments which have tion and control mechanisms available to the
been issued and on outstanding bonds is pro- Board in its dealings with corporate manage-
vided in the Finance Report, Note 30 to the ment are governed by the Bylaws.6)
Roche Group Consolidated Financial Statements • The Board of Directors of Roche Holding Ltd is
(‘Debt’, page 81). organised so as to ensure that the Group’s busi-
• Additional information on employee stock nesses are conducted responsibly and with a
options is provided in the Finance Report, Note focus on long-term value creation. To this end,
14 to the Roche Group Consolidated Financial the Roche Board has delegated certain responsi-
Statements (‘Employee stock options and other bilities to several committees.7) Their composi-
equity compensation benefits’, page 64). tion and chairpersons as of 1 January 2007 are
• Roche has issued no options apart from employee described on page 43.
stock options, Stock-settled Stock Appreciation • All the committees except the Presidium are
Rights (S-SARs) and options issued in connec- chaired by independent directors.
tion with debt instruments. • Under Articles 4.2.2 and 6.2/6.3 of the Bylaws of
• Neither the options awarded to employees nor the Board of Directors, the Independent Lead
the debt instruments which have been issued Director may, at his own discretion or at the
have any effect on Roche’s share capital. request of any member, convene a Board meeting
without the Chairman present. The Roche Board
(3) Board of Directors and Corporate Executive meets once a year to assess the Chairman’s per-
Committee formance. This meeting, which is not attended by
• Information on each member of the Board of the Chairman, is chaired by the Independent
Directors (including the years in which they were Lead Director.
elected and the years in which their terms end)
and each member of the Corporate Executive 3) http://www.roche.com/home/company/com_gov.htm
Committee is listed on pages 42 to 45 above. 4) http://www.roche.com/home/company/
com_gov/com_gov_arti.htm
Curricula vitae and other information (includ-
5) http://www.roche.com/home/company/
ing information on board memberships) are
com_gov/com_gov_gv.htm
available on the Internet.3) 6) http://www.roche.com/home/company/
• The Annual General Meeting elects the members com_gov/com_gov_bylaws.htm
of the Board of Directors in staggered elections 7) http://www.roche.com/home/company/
in which each nominee is voted on separately com_gov/com_gov_com.htm

46 Business Report 2006


Corporate Governance

• The Board of Directors regularly conducts a self- • The Chairman and the Secretary to the Board of
assessment of its performance. Directors are always present at Board meetings,
• The Board of Directors has established a system except when the Board is discussing their per-
of controls which is overseen by the Audit Com- formance or remuneration. The other members
mittee and by the Corporate Governance and of the Corporate Executive Committee are
Sustainability Committee and consists of the fol- invited to attend for, and report in person on,
lowing elements: those agenda items concerning them. When the
– Reports on financial and operating risks situation warrants, members of the Enlarged
– Internal audits Corporate Executive Committee may also be
– Compliance Officer invited to attend. The Board committees invite
– Safety, Health and Environmental Protection the Chairman of the Board and other Corporate
Department Executive Committee members to deliver reports
– Corporate Sustainability Committee at committee meetings and may elect to commis-
– Scientific and Ethics Advisory Group (SEAG), sion independent expert reports and call on the
for issues relating to genetics and genetic engi- services of consultants. The risk management
neering (established in 1999). system is subject to continuous review, with
• Each year several black-out periods are imposed review findings being presented to the Audit
during which senior employees are prohibited Committee or the full Board. Internal Audit regu-
from trading in company stock. The following larly briefs the Audit Committee with reference
black-out periods are in effect for 2007: to ongoing audit reports. Members of Internal
1 January to 7 February Audit attend Audit Committee meetings, as do
1 April to 17 April external auditors. For information on the exter-
1 July to 19 July nal auditors, see page 48.
1 October to 18 October • There are no management contracts which fall
Black-out periods can be changed by the Chair- within the meaning of Subsection 4.3 of the SWX
man of the Board of Directors if circumstances Directive on Information relating to Corporate
warrant. Governance.
• In 2006 the Board of Directors met for four
meetings, each from 3 to 6 hours in length*; once (4) Remuneration, shareholdings and loans
for a full-day meeting*; and once for a three-day All details regarding remuneration, sharehold-
official trip which included an additional Board ings and loans are set forth in the Remuneration
of Directors meeting*. The Board committees Report on pages 50 to 57.
met as follows in 2006:
– Presidium of the Board of Directors/ (5) Participatory rights of shareholders
Nomination Committee: five meetings • The participatory rights of shareholders are
(approx. 2 hours each*) defined in Roche’s Articles of Incorporation.8)
– Audit Committee: three meetings As Roche shares are issued to bearer, there are
(approx. 3 to 4 hours each*) no restrictions on admission to Annual General
– Corporate Governance and Sustainability Meetings, with the exception that shares must be
Committee: two meetings (approx. 3 hours deposited within a specified period before the
each*) date of a meeting and an admittance card must
– Remuneration Committee: two meetings be issued in the shareholder’s name, as provided
(approx. 2 to 3 hours each*) in §12 of the Articles of Incorporation. Any
– Audit and Corporate Governance Committee shareholder can elect to be represented by
(discontinued): one meeting (approx. 3 hours*) another shareholder at an Annual General Meet-
– Finance and Investment Committee (discon- ing. The Articles of Incorporation contain no
tinued): one meeting (approx. 2 hours*). restrictions on the exercise of voting rights, and
* These figures indicate the actual length of meetings and do
not include the directors’ extensive pre-meeting prepara- 8) http://www.roche.com/home/company/
tions and post-meeting follow-up activities. com_gov/com_gov_arti.htm

Business Report 2006 47


Corporate Governance

the only quorum requirements are those stipu- 2006 2005


lated in §16, in compliance with the Swiss Code (millions of CHF)
of Obligations. Auditing services 14.9 14.0
• Under §10.2 of the Articles of Incorporation, Audit-related services 1.9 1.9
shareholders representing shares with a nominal Tax consultancy services 0.7 0.6
value of at least 1 million Swiss francs can request Total 17.5 16.5
the placement of items on the agenda of an
Annual General Meeting. This must be done no The Group auditors and statutory auditors are
later than 60 days before the date of the meeting. elected each year by the Annual General Meeting.

(6) Change of control and defensive measures Ernst & Young Ltd received the following remu-
• The Articles of Incorporation contain no provi- neration for their services as the auditors of
sions on the mandatory bid rule. Swiss law Genentech and Chugai:
applies.
• There are no change-of-control clauses. Those 2006 2005
components of remuneration based on Roche (millions of CHF)
NES would be terminated in the event of an Genentech and Chugai audits 4.8 4.4
acquisition, and vesting period restrictions on Other consulting services provided
pre-existing awards would be removed, so that all to Genentech and Chugai 0.7 0.5
such options could be immediately exercised. Total 5.5 4.9

(7) Relationship to Group auditors and (8) Information policy


statutory auditors • As provided by §33 of the Articles of Incorpora-
At the Annual General Meeting of Roche Hold- tion,10) corporate notices are published in the
ing Ltd on 27 February 2006, the shareholders Swiss Official Gazette of Commerce and in other
voted to appoint KPMG Klynveld Peat Marwick daily newspapers designated by the Board of
Goerdeler SA (KPMG) as Group auditors and Directors (Basler Zeitung, Finanz und Wirtschaft,
statutory auditors (information on how long the L’Agefi, Le Temps, Neue Zürcher Zeitung).
current Group auditors and principal auditor • Roche reports its half-year and full-year results
have been serving in these capacities is provided in business reports published in print and online
on page 45). The Group auditors and statutory formats and at media events. In addition,
auditors participate in Audit Committee meet- detailed first- and third-quarter sales figures are
ings. The auditors make written and oral reports published each year in April and October. The
on the results of their audits. The Audit Commit- most current list of publication dates is available
tee oversees and assesses the auditors and makes in English and German on the Internet.11)
recommendations to the Board (for information • All relevant information and documents, includ-
on the responsibilities of the Audit Committee, ing all media releases, investor updates12) and
see Article 8.1 of the Bylaws9)). The Group presentations to analyst and investor conferences
auditors and statutory auditors participated in are available on the Internet. Further publica-
four meetings of the Audit/Audit and Corporate tions can be ordered by e-mail, fax or telephone:
Governance Committee in 2006. basel.webmaster@roche.com;
The reports of the Group and statutory auditors tel. +41 (0)61 688 83 39; fax +41 (0)61 688 43 43.
can be found on page 97 and 109, respectively, of
this year’s Finance Report.
9) http://www.roche.com/home/company/
com_gov/com_gov_bylaws.htm
KPMG received the following remuneration for
10) http://www.roche.com/home/company/
their services as Group auditors and as statutory com_gov/com_gov_arti.htm
auditors of Roche Holding Ltd and other Roche 11) http://www.roche.com/home/media/med_events.htm
financial companies: 12) http://www.roche.com/home/investors/
inv_news_upd.htm

48 Business Report 2006


Corporate Governance

• The contact address for Investor Relations is:


F. Hoffmann-La Roche Ltd, Investor Relations,
Corporate Finance, 4070 Basel, Switzerland;
tel. +41(0)61 688 88 80, fax +41(0)61 691 00 14.
Additional information, including details on
specific contact persons, is available on the
Internet.13)

(9) Compliance Officer


The Compliance Officer is committed to ensur-
ing that Roche corporate principles are consis-
tently complied with throughout the Roche
Group and also serves as a contact person for
shareholders, employees, customers, suppliers
and the general public on issues relating to the
implementation of and compliance with these
principles. Employees and other parties who
become aware of violations of Roche corporate
principles can bring them to the attention of
their managers or supervisors or report them
to the Compliance Officer (Andreas Greuter,
direct phone number: +41(0) 61 688 75 37, e-mail:
andreas.greuter@roche.com). Such disclosures
will be treated as confidential. Employees who
make such disclosures will not be penalised by
the company for doing so, but are not immune
from prosecution for legal violations. The Com-
pliance Officer reports regularly to the Corporate
Governance and Sustainability Committee.

(10) Non-applicability/negative disclosure


It is expressly noted that any information not
contained or mentioned herein is non-applicable
or its omission is to be construed as a negative
declaration (according to the requirements of the
SWX Swiss Exchange Corporate Governance
Directive, including its Commentary).

13) http://www.roche.com/home/investors/
inv_contact.htm

Business Report 2006 49


Remuneration Report

Remuneration Report

Roche’s success depends on the abilities and dedica- Stock-settled Stock Appreciation Rights
tion of its people. Recognition of this is the founda-
tion of our remuneration policy and system. In this Stock-settled Stock Appreciation Rights (S-SARs)
remuneration report we inform our shareholders were introduced by Roche on 1 January 2005, thus
and interested members of the general public about establishing a uniform system of remuneration
the remuneration paid to our directors and senior throughout Roche. S-SARs entitle holders to bene-
executives. As an integral part of our Annual fit financially from any increase in the value of
Report, this remuneration report will be submitted Roche’s non-voting equity securities between the
for approval at the Annual General Meeting. grant date and the exercise date. Detailed informa-
tion is available on page 56 and 57.
Remuneration policy
Performance Share Plan
Roche revised its global remuneration policy in
2004. It is part of a framework of employee policies The members of the Corporate Executive Commit-
aimed at motivating and retaining current employ- tee and other members of senior management
ees, attracting talented new ones and helping all (some 50 individuals worldwide) participate in the
Roche employees to perform at consistently high Performance Share Plan (PSP), which was estab-
levels. Our remuneration policy is designed to fos- lished at the beginning of 2002 for periods of three
ter value creation and reinforce a culture of per- years each. The first performance cycle ended in
formance and innovation, and it applies to non- 2004, and the second cycle (PSP 2005–2007) is now
managerial employees as well as to managers. Key in its third year.
principles underpinning this policy are:
Starting in 2006, an adjusted plan design was intro-
• A focus on value creation duced. Under the new arrangements only one-third
• Pay for performance as many non-voting equity securities (NES) are
• Enabling employees to share in the company’s awarded, and a new three-year performance cycle
success starts each year, in contrast to the successive three-
• Fairness and transparency in remuneration year cycles under the old plan design. In 2006 there
decisions were thus two overlapping performance cycles, PSP
• Remuneration targeted at market median levels 2005–2007 and PSP 2006–2008, which however do
• A balanced mix of long- and short-term remu- not increase the total award. For details of the PSP,
neration components see page 53 and 54.
• Market-competitiveness.
Over the five years since the PSP was established in
Awards of Stock-settled Stock Appreciation Rights 2002, Roche securities (shares and NES), including
and a Performance Share Plan support these prin- dividend yields, have almost doubled in value,
ciples. These remuneration components are linked outperforming nine-fold the 11% value growth
to our company’s financial performance and com- delivered by a peer set of major pharmaceuticals
mercial success and thus align the interests of and diagnostics companies1).
Roche employees with those of the stockholders.

1) Peer set: Abbott Laboratories, Amgen, AstraZeneca, Bayer,


Beckton Dickinson, Biogen Idec, Bristol-Myers Squibb, Eli
Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis,
Pfizer, Sanofi-Aventis, Schering-Plough, Takeda, Wyeth.

50 Business Report 2006


Remuneration Report

TSR development 2002 to 31 December 2006

The value of CHF 100* invested 1st week of January 2002, for the period ending 31 December 2006

2002 2003 2004 2005 2006


220
200
180
160
140
120
100
80
60
Jan

Apr

July

Oct

Jan

Apr

July

Oct

Jan

Apr

July

Oct

Jan

Apr

July

Oct

Jan

Apr

July

Oct

Dec
Roche NES 204 Roche share 195 Peer Set 111 * Prices translated at constant CHF
Price = 218.50 Price = 247.50 Index* exchange rates.

Remuneration of the Corporate Executive Remuneration and additional compensation paid to


Committee non-executive members of the Board of Directors
totalled 3,283,333 Swiss francs in 2006 (previous
The Remuneration Committee, which is comprised year: 3,330,000 Swiss francs). With the exception of
entirely of independent external members of the the two vice-chairmen and the Independent Lead
Board of Directors, sets remuneration for the mem- Director, all members of the Board of Directors have
bers of the Corporate Executive Committee (cash received the same remuneration since 2001.
payments, bonuses, options, Stock-settled Stock
Appreciation Rights; policy decisions about pen- The non-executive members of the Board of Direc-
sion benefits). The terms of the Performance Share tors were not awarded any shares, non-voting
Plan are determined by the Board of Directors, equity securities, Stock-settled Stock Appreciation
acting upon recommendations from the Remu- Rights2) or stock options in 2006 and, as of
neration Committee. 31 December 2006, held no unvested options
awarded in previous years.
Following a detailed review, including market
comparisons, the Remuneration Committee has In addition, Rolf Hänggi received the pro rata
concluded that Roche’s current remuneration amount of 66,667 Swiss francs for serving on the
policy continues to be appropriate and suitable for Board of Directors from 1 January to 27 February
achieving the intended objectives. 2006. Mr Hänggi, who was a non-executive direc-
tor, resigned from the Board in 2006.
The following pages provide detailed information
on the remuneration paid to each member of the John Bell has been on a one-year sabbatical leave
Board of Directors and to each member of the from the University of Oxford since August 2006
Corporate Executive Committee for 2006, together and is spending the year at Roche. Roche will pay all
with figures for previous years. personal and family expenses that Prof. Bell incurs
in relation to his stay in Switzerland, including
(1) Remuneration insurance costs. In 2006 these expenses totalled
67,909 Swiss francs.
(1.1) Remuneration of members of the Board
of Directors
In 2006 the members of the Board of Directors 2) See ‘Stock options/Stock-settled Stock Appreciation Rights’,
received the remuneration shown in the table on page 56.
page 52 for serving on the Board.

Business Report 2006 51


Remuneration Report

Remuneration of members of the Board of Directors

Additional compensation 2006


Remuneration of members Remuneration 2006 for committee members3)
of the Board of Directors (in CHF) (in CHF)
F. B. Humer [300,000]4) –
B. Gehrig 450,0005) –
A. Hoffmann 383,3336) –
J. I. Bell 300,000 10,000
P. Brabeck-Letmathe 300,000 –
L. J. R. de Vink 300,000 10,000
W. Frey 300,000 20,000
D. A. Julius 300,000 10,000
A. Oeri 300,000 10,000
H. Teltschik 300,000 20,000
B. Weder di Mauro 250,0007) 20,000
Total 3,483,333 100,000

3) 10,000 Swiss francs per committee membership/year, except for members of the Presidium and vice-chairmen.
4) The remuneration paid to F.B. Humer (the only executive member of the Board of Directors) is deducted from his agreed
salary (see ‘Remuneration of members of the Corporate Executive Committee’).
5) Remuneration for serving as Independent Lead Director and Vice-Chairman of the Board.
6) Prorated remuneration for serving as a member of the Board of Directors in January and February 2006 and as Vice-Chair-
man of the Board for the period from March to December 2006.
7) Prorated remuneration for the period from March to December 2006.

Remuneration of members of the Corporate Executive Committee


A. Cash payments (in CHF)

Annual salary Annual salary Annual salary Bonus Bonus Bonus


2006 2005 2004 2006 2005 2004
F. B. Humer 6,030,000 6,030,000 6,030,000 1,500,000 1,000,000 1,000,000
W. M. Burns 1,875,000 1,425,000 1,200,000 1,000,000 900,000 800,000
E. Hunziker 1,900,000 1,567,500 1,470,000 1,000,000 900,000 800,000
G. A. Keller 850,000 662,500 530,007 400,000 350,000 300,000
J. K. C. Knowles 1,325,000 1,200,000 1,025,001 670,000 700,000 600,000
S. Schwan 762,500 – – 95,000 – –
Total 12,742,500 4,665,000

B. Stock options/Stock-settled Stock Appreciation Rights (S-SARs)

S-SARs8) S-SARs8) Stock options8)


2006 2005 2004
(value in CHF9)) (value in CHF9)) (value in CHF9))
F. B. Humer 1,779,824 1,779,389 1,780,338
W. M. Burns 889,963 711,806 712,135
E. Hunziker 889,963 711,806 667,606
G. A. Keller 533,978 266,911 222,642
J. K. C. Knowles 533,978 533,823 489,652
S. Schwan 533,978 – –
Total 5,161,684

8) See ‘Stock options/Stock-settled Stock Appreciation Rights’, page 56 and 57.


9) Black-Scholes value as described in ‘Stock options/Stock-settled Stock Appreciation Rights’, page 56 and 57.

52 Business Report 2006


Remuneration Report

Roche paid 122,719 Swiss francs into a retirement Members of the Corporate Executive Committee
policy for John Bell in 2006. additionally receive annual expense allowances of
30,000 Swiss francs; the Chief Executive Officer
Horst Teltschik received honoraria (including receives an annual expense allowance of 50,000
expenses) amounting to 25,132 euros (39,457 Swiss Swiss francs. In 2006 the members of the Executive
francs) for serving on the boards of several Roche Committee received expense allowances totalling
subsidiaries in Germany. 200,000 Swiss francs.

Otherwise, no additional remuneration was paid to Heino von Prondzynski stepped down from the
members of the Board of Directors. Corporate Executive Committee on 31 December
2005. During 2006 he assisted with the transition to
(1.2) Remuneration of members of the his successor. Heino von Prondzynski resigned from
Corporate Executive Committee Roche with effect from 31 December 2006. In 2006
The general provisions assigning authority for deci- he was paid a salary of 1,300,000 Swiss francs. He
sions on Corporate Executive Committee remuner- received a bonus of 700,000 Swiss francs in respect
ation to the Remuneration Committee and to the of 2005 and an expense allowance of 30,000 Swiss
Board of Directors are outlined on page 51 of this francs.
remuneration report.
C. Performance Share Plan
In 2006 the members of the Corporate Executive The members of the Corporate Executive Commit-
Committee received the salaries, bonuses, stock tee and other members of senior management
options/Stock-settled Stock Appreciation Rights and (some 50 individuals worldwide) participate in the
non-voting equity securities shown in the tables on Performance Share Plan (PSP).
page 52.

Performance Share Plan (PSP)

2006 2005
Total estimated Total estimated
value of PSP awards value of PSP awards
Target number of Target number of (2005–200710) (2005–2007)
NES for PSP NES for PSP and 2006–200811)) and 2006–200812))
2006–2008 2005–2007 (in CHF) (in CHF)
F. B. Humer 10,365 48,028 4,252,957 3,498,039
W. M. Burns 2,578 9,557 883,833 696,068
E. Hunziker 2,750 11,708 1,053,024 852,733
G. A. Keller 1,203 4,380 406,629 319,010
J. K. C. Knowles 2,148 8,363 765,551 609,105
S. Schwan 1,117 3,106 307,575 226,220
Total 20,161 85,142 7,669,569 6,201,175

10) Estimated value for 2006: calculated using the year-end price as of 31 December 2006 (CHF 218.50 per non-voting equity secur-
ity [NES]), based on the number of NES originally targeted (subject to changes in the number and value of NES awardable under
the plan on 31 December 2007), and spread over the relevant period of time, i. e. 1⁄3 for the year 2006. The Board of Directors will
vote on the actual allocation of NES originally targeted on 31 December 2007 according to the TSR growth achieved.
11) Estimated value for 2006: calculated using the year-end price as of 31 December 2006 (CHF 218.50 per non-voting equity secur-
ity [NES]), based on the number of NES originally targeted (subject to changes in the number and value of NES awardable under
the plan on 31 December 2008), and spread over the relevant period of time, i. e. 1⁄3 for the year 2006. The Board of Directors will
vote on the actual allocation of NES originally targeted on 31 December 2008 according to the TSR growth achieved.
12) Estimated value for 2005: calculated using the year-end price as of 31 December 2006 (CHF 218.50 per non-voting equity secur-
ity [NES]), based on the number of NES originally targeted (subject to changes in the number and value of NES awardable under
the plan on 31 December 2007), and spread over the relevant period of time, i. e. 1⁄3 for the year 2005. The Board of Directors will
vote on the actual allocation of NES originally targeted on 31 December 2007 according to the TSR growth achieved.

Business Report 2006 53


Remuneration Report

Roche’s performance 2005–2006

Roche TSR Average TSR of peer


group companies1)
1 Jan. 2005 31 Dec. 2006 1 Jan. 2005 31 Dec. 2006

Total Shareholder Return (TSR) 180

171
The value of CHF 1001) invested 140
on 1 January 2005 120

127
80

100

100
40
0

Roche market capitalisation in billions of CHF 113 192


Roche securities in CHF Non-voting equity security (NES) 130.90 218.50
Share 150.00 247.50

1) Prices translated at constant CHF exchange rates. TSR = stock price appreciation plus dividend.

In 2006 the PSP moved to overlapping three-year bers of the Corporate Executive Committee as
performance cycles, with a new cycle beginning shown in the table on page 53. The Board of Direc-
each year. In 2006 there were thus two cycles in tors will decide on the actual level of NES or cash
progress (PSP 2005–2007 and PSP 2006–2008). equivalent awards for the cycles 2005–2007 and
Under the provisions of this plan, a number of non- 2006–2008 after the close of the 2007 and 2008
voting equity securities (NES) have been reserved financial years, respectively.
for the participants in each cycle. The number of
securities actually awarded will depend on whether At the end of two years and one year, respectively,
and to what extent an investment in Roche securi- of the PSP 2005–2007 and PSP 2006–2008 per-
ties (shares and NES) outperforms the average formance cycles (both based on a three-month
return on an investment in securities issued by a moving average at constant exchange rates) Roche
peer set of comparator companies.13) Comparisons ranked 2 and 11 compared with its peer set14) of
are based on the securities’ market prices and divi- 17 companies operating in the same industry.
dend yields, i. e. on Total Shareholder Return (TSR).
To reduce the effect of any short-term market fluc- Roche’s market value rose from 113 billion to
tuations, security prices are averaged over the three 192 billion Swiss francs in the period from 1 January
months (October to December) prior to the start 2005 to 31 December 2006, an increase of 79 billion
of a performance cycle and over the three months Swiss francs or 69.9 %. Dividends totalling 3.881 bil-
(October to December) at the end of the cycle. If lion Swiss francs (2005: 1.725 billion Swiss francs,
Roche securities perform as well as or better than 2006: 2.156 billion Swiss francs) were distributed.
those of 75% of the peer set and, in addition,
Roche’s TSR increases at least 10% during a cycle, D. Indirect benefits
the Board of Directors can elect to increase the Employer contributions that were made in 2006
maximum NES award by as much as two-fold. In to social security schemes, pension plans and a
the event that an investment in Roche securities
underperforms the average return delivered by the
peer companies, fewer or no NES will be awarded. 13) See footnote 1, page 50.
In 2006 NES were reserved under the plan for mem- 14) See footnote 1, page 50.

54 Business Report 2006


Remuneration Report

Indirect benefits

Pension funds/MGB15) AHV/IV/ALV16) Roche Connect


(in CHF) (in CHF) (in CHF)
F. B. Humer 1,308,58517) 830,655 50,004
W. M. Burns 715,019 146,255 30,000
E. Hunziker 556,585 147,518 45,832
G. A. Keller 333,976 88,188 20,420
J. K. C. Knowles 886,153 101,815 22,500
S. Schwan 194,949 46,493 18,444
Total 3,995,267 1,360,924 187,200

15) MGB: Stiftung der F. Hoffmann-La Roche AG für Mitarbeiter-Gewinnbeteiligung (employee profit-sharing foundation
supplementing occupational pension benefits).
16) AHV/IV/ALV: Swiss social security programmes providing retirement, disability and unemployment benefits.
17) Owing to amendments to Switzerland’s Federal Occupational Old Age, Survivors’ and Disability Pension Act (BVG), contri-
butions on behalf of Franz B. Humer were limited to 1,308,585 Swiss francs. Existing contractual obligations result in an
additional provision of 1,549,862 Swiss francs by the company.

Group-wide employee stock purchase plan (Roche Pensions totalling 2,014,352 Swiss francs were paid
Connect) in respect of members of the Corporate to two former Corporate Executive Committee
Executive Committee are shown above in the table members.
‘Indirect benefits’.
Franz B. Humer, Erich Hunziker, William M. Burns
Roche Connect is a voluntary stock purchase plan and Jonathan K.C. Knowles received in total USD
offering employees the opportunity to buy Roche 193,104 (241,380 Swiss francs) for serving on the
non-voting equity securities (NES) up to an amount Chugai Board. Erich Hunziker, William M. Burns
equal to 10% of their annual salary at a 20% discount. and Jonathan K.C. Knowles are on the Genentech
NES purchased under this plan are subject to a hold- Board but have declined remuneration for serving
ing period, which in Switzerland is four years. in this capacity.

Roche paid 883,086 Swiss francs in occupational Otherwise, no additional remuneration was paid
pension contributions, 206,094 Swiss francs in to current or former members of the Corporate
employer AHV (social security) contributions and Executive Committee.
27,500 Swiss francs in Roche Connect contribu-
tions for Heino von Prondzynski. F. Highest total remuneration
Chairman and CEO Franz B. Humer was the mem-
E. Other remuneration, emoluments and loans ber of the Board and the member of the Corporate
to corporate officers Executive Committee with the highest total remu-
neration in 2006 (see ‘Remuneration of members
Gottlieb A. Keller repaid his mortgage loan from of the Corporate Executive Committee’, page 53).
the F. Hoffmann-La Roche Ltd Pension Fund at the Subject to changes in allocations and computations
end of 2006. relating to the three-year Performance Share Plan
(PSP) periods 2005–2007 and 2006–2008, Franz B.
Roche paid Severin Schwan 45,123 Swiss francs Humer’s salary was as follows:
for one-time relocation and housing costs.

Business Report 2006 55


Remuneration Report

Highest total remuneration (in CHF)


2006 2005 2004
Cash payments 7,530,000 7,030,000 7,030,000
Stock options/S-SARs
(Black-Scholes value18) at grant minus 11%) 1,779,824 1,779,389 1,780,338
Performance Share Plan 2005–2007 and 2006–200819) (4,252,957)20) (3,498,039)21) 4,440,65222)
Pension funds/MGB23) (2,858,447)24)/25) (2,723,261)25) (2,740,991)25)
Roche Connect 50,004 50,004 50,004
26)
Total (value) 16,694,669 15,080,693 16,041,985

18) Black-Scholes value as described in ‘Stock options/Stock-settled Stock Appreciation Rights’, see below.
19) See ‘Remuneration of members of the Corporate Executive Committee’, C. Performance Share Plan (PSP), page 53.
20) Estimated value for 2006 in the PSP 2005–2007 and PSP 2006-2008 cycles; not paid out in 2006.
21) Estimated value for 2005 in the PSP 2005–2007 cycle; not paid out in 2005.
22) Value for the year 2004 in the PSP 2002–2004 cycle.
23) MGB: Stiftung der F. Hoffmann-La Roche AG für Mitarbeiter-Gewinnbeteiligung (employee profit-sharing foundation
supplementing occupational pension benefits).
24) Including provision, see footnote 17, page 55.
25) Payments into pension schemes.
26) Including annual expense allowances and remuneration for serving on the Chugai Board [USD 138,750 (CHF 173,437)].

(1.3) Shareholdings the non-executive members of the Board of Direc-


Directors André Hoffmann and Andreas Oeri and tors and persons closely associated with them and
members of the founder’s families who are closely the members of the Executive Committee and per-
associated with them belong to a shareholder group sons closely associated with them held shares as
with pooled voting rights. At the end of 2006 this shown in the table below.
group held 80,020,000 shares (50.01% of issued
shares). André Hoffmann serves as spokesman for (1.4) Stock options/Stock-settled Stock
this shareholder group. Detailed information about Appreciation Rights
this group will be found in the Finance Report, At 31 December 2006 the members of the Corpo-
Note 34 to the Roche Group Consolidated Financial rate Executive Committee held options and Stock-
Statements (‘Related parties’, page 89) and in the settled Stock Appreciation Rights (S-SARs; first
Notes to the Financial Statements of Roche Holding introduced on 1 January 2005) as shown in the
Ltd (page 107). In addition, as of 31 December 2006 table on page 57.

Shareholdings (at 31 December 2006)

Members of the Corporate


Members of the Board of Directors Number of shares Executive Committee Number of shares
F. B. Humer 1 W.M. Burns 1
B. Gehrig 50 E. Hunziker 1
A. Hoffmann –* G. A. Keller 251
J. I. Bell 300 J. K. C. Knowles 1
P. Brabeck-Letmathe 800 S. Schwan 1
L. J. R. de Vink 1,000
W. Frey 72,500
D. A. Julius 350
A. Oeri 90,000*
H. Teltschik 385
B. Weder di Mauro 200
Total 165,586 Total 255

(* Figure does not include shares held in the shareholder group with pooled voting rights.)

56 Business Report 2006


Remuneration Report

Stock options and S-SARs

Number of stock options and S-SARs held by members of the Corporate Executive Committee
on 31 December 2006 (S-SARs first issued in 2005)
200627) 200527) 2004 2003 2002
Total number 151,725 196,641 115,743 101,958 8,784
Strike price in CHF 195 123 129.50 77.80 115.50
Expiry date 2. 2. 2013 3. 2. 2012 3. 2. 2011 25. 2. 2010 26. 2. 2009
Grant value per option and (starting in 2005) per S-SAR in CHF
(Black-Scholes value minus 11%) 34.02 20.89 31.92 16.27 30.10

27) S-SARs.

All of the options shown in the table were issued using the Black–Scholes formula and as if the
by Roche as employee stock options. Each option options were tradable, with an 11% deduction for
entitles the holder to purchase one Roche non- the average two-year vesting period.
voting equity security (NES).
The strike prices, expiry dates and grant values for
Under the terms of this multi-year option plan, the options and S-SARs are shown in the table above.
strike price of the options shown was the closing The numbers of options and S-SARs as calculated
price for Roche NES on the last day of trading prior at the time of issue have been entered as values in
to the Roche Annual Media Conference. All of the the table ‘Remuneration of members of the Corpo-
options shown are non-tradable. One-third of the rate Executive Committee, B. Stock options/Stock-
options are subject to a vesting period of one year, settled Stock Appreciation Rights’ on page 52.
one-third have a vesting period of two years, and
one-third a vesting period of three years. Unvested
options lapse without compensation if employ-
ment is terminated voluntarily (for reasons other
than retirement), while vested options must be
exercised within a limited period of time. The fair
value of the options is calculated at the date of issue
using the Black-Scholes formula and as if the
options were tradable, with an 11% deduction for
the average two-year vesting period.

The S-SARs shown in the table above were intro-


duced by Roche on 1 January 2005 in place of stock
options. S-SARs entitle holders to benefit finan-
cially from any increase in the value of Roche’s NES
between the grant date and the exercise date. The
strike price for S-SARs under the terms of this
multi-year plan was the closing price for Roche
NES on the first day of trading after the Roche
Annual Media Conference. All S-SARs vest within
three years of the grant date: i.e. one-third vest at
the end of one year, one-third at the end of two
years, and one-third at the end of three years. Vested
S-SARs must be exercised (converted into NES)
within seven years of the grant date, and unexer-
cised S-SARs lapse without compensation. The fair
value of the options is calculated at the date of issue

Business Report 2006 57


‘If my doctor hadn’t thought of it,
I’d never have known I had hep C.’

58 Business Report 2006


Identifying ‘early responders’ helps motivate
patients with difficult-to-cure hepatitis C

Alain Lacroix was 49 and a public relations manager


for the Paris public transport system when routine
screening by his company doctor in 1996 revealed
hepatitis C virus (HCV) infection. The source of
infection was traced to a gastric biopsy* he’d had
the year before. Alain recalls the shock. ‘I felt very
low,’ he says, ‘with all sorts of questions on my mind.’
Normally very outgoing, he found himself with-
drawing, worried about passing on the infection
to others.
Alain’s viral genotype was the difficult-to-cure 1b.
After starting treatment with standard interferon
and ribavirin in April 1997, he had nothing but side
effects to show for the 12-month course of three
painful injections a week: ‘I still had the virus.’
In October 2003 Alain’s hepatologist started
him on once-weekly Pegasys (pegylated interferon
alfa-2a), combined with Copegus (ribavirin).
She tracked the effect of treatment using the Amplicor
HCV Test. ‘After 4 weeks the virus was gone,’ says
Alain, recalling his elation on learning that such
a fast response gave him an 80% chance of a lasting
cure. ‘It’s stayed like that ever since. I’m extremely
grateful to the researchers who found answers to
this disease.’
*A source of infection now virtually eliminated by revised operative
procedures.

Diagnosis – Therapy – Monitoring


Sensitive tests are needed to diagnose hepatitis C – a potentially
fatal disease with few symptoms – and monitor treatment
response. Early responders to therapy with Pegasys and Copegus
enjoy a good chance of cure, so reliable measurement of viral
load is a must. Today, Roche offers even more sensitive real-time
PCR monitoring tests on the Cobas TaqMan platform, which
better enable doctors to confirm hepatitis C clearance.

Business Report 2006 59


Creating sustainable
value – our management
approach
Business is an integral part of society, providing Roche is in a good position to respond. Our busi-
essential products, jobs and other economic bene- ness strategy (see page 11) is based on creating
fits. The success of companies is largely determined value for patients, employees, shareholders and
by how well they contribute to society – how much society by focusing on innovative healthcare solu-
value they create by offering needed products and tions for unmet medical needs.
services.

Nowhere is this more relevant than in the healthcare Management model


sector, where our products are active at the very core for sustainability
of people’s lives, ensuring their health and well-
being. We perform an essential function in society, As a minimum, Roche runs its business in compli-
from which we obtain our ‘licence’ to operate. To ance with national and international laws, as well as
continue in business we must create sustainable some voluntary guidelines set by non-governmen-
value for all of our key stakeholders. tal organisations. Often our corporate standards go
beyond these requirements. At Roche, sustainabil-
But we are responsible for more than just our prod- ity is an integral part of our daily business. It is not
ucts and services. Increasingly, stakeholders demand managed by a stand-alone department, but through
that we manage our impacts on people and the envi- a network of people representing all aspects of the
ronment and actively contribute to wider society. company, allowing involvement and engagement
This means that in every step we take we have to on many levels. Our sustainability priorities and
consider a broad range of factors that influence our goals can be found in the table on page 65.
business. Over the past few decades this has become
even more important – and more complex.

Corporate Sustainability Management Model

60 Business Report 2006


Creating sustainable value – our management approach

Managing risk • Identify relevant sustainability issues arising


from our business model and the expectations
A variety of risks can expose Roche to pressures of our key stakeholders
that could prevent us from achieving our goals. • Analyse the link between those issues and our
The Roche Group manages risks by identifying economic success
them, evaluating their significance and then decid- • Develop relevant key performance indicators
ing what action to take. As part of this process, (KPIs)
we identify social, environmental or ethical risks • Embed KPIs into existing business processes
(SEE) and take action to mitigate risks if possible. throughout the Roche Group.
Established risks are monitored.
The findings present a strong business case for sus-
Our business units are individually accountable for tainability. We have identified sustainability issues
their performance and risks, and conduct regular relevant to our economic success and developed
risk assessments. These are fed into a consolidated a first draft of key performance indicators to meas-
annual Group Risk Report, which is discussed by ure the value the company creates for our main
the Corporate Executive Committee in the context stakeholders.
of the business plan, and reviewed by the Audit
Committee. Genentech and Chugai manage their The major value drivers of the issues identified are:
risks independently.
• Developing innovative drugs for unmet medical
needs
Sustainability, our business strategy • Retaining and attracting employees
and the business case • Protecting our reputation through good
business ethics
In 2005 we set up a project to define Roche’s ‘Busi- • Assuring future success through receiving
ness Case for Sustainability’. The aim is to ensure compensation to reward our innovation
that sustainability issues are fully integrated into • Maintaining our licence to operate through
our business to protect current company value and stakeholder acceptance
create future value. The project involves a large • Reducing business risk
network of people representing all aspects of the • Improving operational efficiency.
business, facilitated by the Corporate Sustainability
Committee. The project has four stages:

From Roche’s Business Model to the Business Case for Sustainability

Business Report 2006 61


Creating sustainable value – our management approach

Our Relationships with Key Stakeholders

Scientific community
Governments, NGOs,
Employees
Regulatory Authorities

Basic research

Income
s
on
uti
Pro sol e
d th rat
uc
tivi h eal op
e
ty a
Sa t ive nd
nd
pe lar ova tea
r fo y Inn ova
rm nn
an t oi
ce se
Li cen

Trust, reputation and income Return on investment


Doctors, patients and
Roche Investors
patient groups Health (benefits) Capital

fit s Ta
x
ne es
, jo Lic
tbe
Income and jobs
s bs e ns
-co an et
a lth dd oo
om
e He on
ati
pe
rat
Materials

Inc on
s
e

Healthcare payers Society


Suppliers and
business partners

We will continue to develop our business case for Engaging employees


sustainability. This includes finalising a set of KPIs
and integrating them into our internal reporting, At the end of 2005 we surveyed our internal stake-
planning, target-setting and further business pro- holders – our employees – on the effectiveness of
cesses within all affiliates. We also aim to use our internal communications and on their attitude
the project findings in our external sustainability towards the company. Further details can be found
reporting and stakeholder engagement. on pages 80 and 82.

Working with our customers


Engaging with our key stakeholders
Our customers are patients who benefit from our
Our stakeholders are the millions of people around medicines and diagnostics, health authorities who
the world with an influence on or interest in Roche. pay for them, healthcare professionals who pre-
These include patients and the medical community, scribe and administer them and laboratories that
our employees, governments and regulators, non- perform diagnostic testing. Our products are sold
governmental organisations (NGOs) and our share- in over 170 countries, improving patients’ health,
holders. quality and length of life.

Building and maintaining relationships with these We communicate with patients through health-
groups helps us to better understand their needs care professionals who pass on patients’ views
and develop our business strategy to generate max- to us, through product-related websites such as
imum benefits for both the company and our stake- www.accu-chek.com or www.bonepain.com, through
holders. The diagram ‘Our Relationships with Key our issue-management system and through patient
Stakeholders’ shows the main benefits of our rela- associations. In 2006 Roche worked with a number
tionships with different groups. of patient associations on a global, regional and

62 Business Report 2006


Creating sustainable value – our management approach

national level on issues important to patients such as time Innovest rated us top in their sustainability
healthcare policy, patient access to healthcare, dis- ranking of 44 global pharmaceutical companies.
ease awareness, education and patient information. These results clearly support the integration of sus-
We maintain close relationships with health author- tainability into our business.
ities and healthcare professionals to ensure new
products meet legal requirements and user needs. In partnership with our suppliers

In 2006 our Pharmaceuticals Division carried out Our aim is for suppliers and service providers to
an extensive stakeholder engagement project with meet our own internal standards for employment
key opinion leaders, patient groups, oncology soci- and environmental performance as well as legal
eties, clinical trial groups and the research commu- requirements. Roche’s internal guidelines explain
nity. The project aimed to gain a global perspective the conduct we expect from the companies we
of these groups and their perception of Roche and purchase from.
will be used as a basis for further developing our
relationships with them. We have around 80 key suppliers. We monitor
how well they comply with our guidelines, using
Dialogue with our customers can provide positive questionnaires and on-the-spot audits, keeping a
and negative feedback. Such reality checks are an particularly close eye on workplace safety, industrial
important source of information for improving our hygiene, pollution and waste management.
products and services, ensuring successful product
launches and meeting the needs of our customers. Two-thirds of these suppliers had been audited by
the end of 2006. Compliance was found to be accept-
Increasing value for our shareholders able or good at 85% of them. Roche is working with
and investors the remaining 15% to help them improve their
standards. Should a supplier refuse either an audit
We aim to achieve a fair valuation of our business, or request for improvement, Roche will cease to do
and our communication is based on the principle business with them.
of fair disclosure. We communicate with investors
and the wider financial community to help inform More on the web:
their investment decisions. An increasing number
of investors also seek information about environ- • Corporate Sustainability Committee Charter, goals
mental, social and governance issues. and activities: www.roche.com/sus-charter
• Access to medicines: www.roche.com/sus-access
In 2006 we engaged directly with investors through • Patient groups: www.roche.com/sus-patient_groups
the Annual General Meeting, customer visits to • Investor relations: www.roche.com/investors
Roche, Roche-organised events, our Annual and • Media: www.roche.com/media
Half-Year Reports and Investor Updates. We also • Suppliers: www.roche.com/sus-suppliers
participated in 26 broker conferences and held • Employees: www.roche.com/sus-employees
26 road shows in key markets. • Scientific community: www.roche.com/science
and www.roche.com/sus-foundations
Roche’s Investor Relations team was ranked by • Governments, NGOs, Regulatory Authorities, Health-
Institutional Investor amongst the best in Switzer- care Payers: www.roche.com/sus-external_affairs
land and the pharmaceutical sector in 2006 and
IR Magazine in Europe judged our investment com-
munity events to be the best in continental Europe Priority actions
across all sectors.
We have six key priorities (see table on page 65) to
Roche was listed as a healthcare leader in the Dow ensure we make the maximum contribution to sus-
Jones World, Dow Jones STOXX and FTSE4Good tainable development. These are part of a broad
Sustainability Indexes, for the third year. For the first work plan that covers our everyday activities.

Business Report 2006 63


Our key management
topics

There are many ethical and social issues that have Extending access to medicines is an integral part of
an impact on our business and must be well man- healthcare, along with prevention, diagnosis, treat-
aged. These include: ment and monitoring. Working with governments
and other organisations is the only way to increase
• Value, access to and affordability of our access to innovative and life-saving tests and
medicines and diagnostics medicines. This is why Roche has implemented dif-
• Retaining and attracting top talent ferent programmes and partnerships for improving
• Business ethics access in least developed and developed countries.
• Responsible marketing
• Conduct of clinical trials The value of innovative products
• Patient safety and product quality
• New technologies Cancer is the second biggest killer in Europe after
• Respecting human rights. heart disease. Some oncology specialists suggest
that the cost of innovative drugs such as Avastin,
This section explains each of these issues, their Roche’s treatment for colorectal cancer, prevents
importance to Roche and how we are responding to doctors from using it. With the increasing preva-
them. lence of cancer and stretched healthcare budgets
this debate will continue.

Value, access and affordability However, a focus on the price of the drug ignores
the medical value these products provide. Roche’s
Developing products and services that save and innovative drugs Avastin, Herceptin, MabThera,
improve lives is the greatest contribution Roche can Tarceva and Xeloda have revolutionised the way
make to society. But countless people in both the cancer is treated, providing significant benefits to
developed and developing world cannot access the millions of cancer patients and improving the effi-
tests and medicines they need. ciency of healthcare systems. These drugs can slow
the progression of cancer, dramatically improve
Many developing countries lack even the most basic quality of life and even save lives when used in the
healthcare facilities. As well as medicines, they early stage of the disease (see box).
need the infrastructure and health professionals
to ensure the right diagnosis is made and the right We increasingly find that governments and payers
medicines get to the right people. Education is also grant full reimbursement for our oncology drugs
essential for combating the spread of preventable once they have seen the demonstrable benefits
infections, including HIV/AIDS. to patients, society and healthcare systems. For
example, based on remarkable results in early
Even in industrialised nations, the availability breast cancer, payers in several countries have taken
of some medicines varies between neighbouring exceptional measures to reimburse early treatment
countries. Some patients with the same disease are with Herceptin before the drug received regulatory
able to live longer, healthier lives than others simply approval.
because of where they live, due to varying levels
of access to medicines. Even when medicines are Only 16% of total healthcare spend is on medicines,
available, some people cannot afford them, or the and just 1% on diagnostic tests. But use of diagnos-
insurance to pay for them. tics, combined with medicines, can dramatically
increase effectiveness in healthcare by enabling pre-
vention, early diagnosis, treatment and treatment

64 Business Report 2006


Our key management topics

Priority Actions
Priority Goals Progress
Embedding Ensure that contributing – Identified business-relevant sustainability issues and analysed links
sustainability to sustainable development between those issues and Roche’s economic success
is part of our daily work – Began developing key performance indicators to measure progress
and increases the success – Piloted sustainability risk identification process to flag SEE topics
of our business. – Reselected in DJSI and FTSE4Good Indexes
More on page 60 and at www.roche.com/sus-principles_objectives
Access to Continue to develop – 13 new marketing applications filed and 14 marketing approvals received
healthcare innovative medicines and – 166,070 patients participated in clinical trials
ways to increase access – 87% of people living with HIV/AIDS covered by reduced pricing
to our products globally – Established Technology Transfer Initiative for sub-Saharan Africa
(in developed, developing and the LDCs; 3 agreements signed in 2006
and least developed – Tamiflu manufacturing capacity increased over 500% in 2 years
countries). More on page 64 and at www.roche.com/sus-access
Ensuring Strengthen ethical – Code of Conduct e-learning programme available in ten languages
responsible compliance and awareness and launched in 86 countries
business in all Roche activities – Published revised position paper on clinical trials
practices – Published details of 375 clinical trials and 117 trial results
on independent website
– 17 phase I patient trials in seven different medical conditions published
for first time
– Developed guidelines on working with patient groups and published
list of key groups on website
– Over 80% of animal testing sites now AAALAC accredited.
More on page 69 and at www.roche.com/sus-governance,
www.roche.com/sus-research_dev and www.roche.com/sus-ethics
Patient safety Provide highly effective – Strengthened Safety Risk Management plan to emphasise safe use
medicines whose benefits of Roche products and maintain positive benefit/risk profile
exceed risks and with – Updated global website to improve transparency and disclosure on our
minimal adverse drug safety processes
reactions More on page 74 and at www.roche.com/sus-patient_safety
Retain and Establish programmes – Genentech ranked first and Roche Pharmaceuticals third in Science
attract top talent to retain and attract the magazine’s top employers in the biotech and pharmaceutical industries
best talent for the right job, – 90% of Roche employees surveyed say they are proud to work for Roche
and foster performance – 78% of key management positions filled internally
culture – 30% of eligible employees participated in employee non-voting equity
securities programme
– Introduced new secondment policy enabling employees to contribute
to projects in developing countries for 3 to 18 months
– Launched Roche Engage which focuses on how to engage employees
with our business strategy
More on page 78 and at www.roche.com/sus-employees
Safety, Implement action plans – Developed position papers covering key SHE issues
health and at all sites to achieve long- – Developed and allocated site-specific goals to contribute to Group goals
environmental term Group goals: – Organised global SHE conference focusing on risk management,
protection – Reduce accident and energy efficiency and on the development of action plans to reach goals
absence rates – Issued Group directive on energy conservation, based on international
– Reduce environmental energy workshops, including energy efficiency standards for equipment
impacts and installations
– Ensure energy efficiency – Met five-year targets for reducing emissions of greenhouse gases and
targets volatile organic compounds (VOCs) sooner than planned
– Reduce emissions of – 19 sites received the Roche Responsible Care Network award for
greenhouse gas and VOC outstanding low accident rates or positive trends
– Improve compliance with – Received no relevant fines relating to SHE
Roche’s SHE standards More on page 88 and at www.roche.com/sus-she

Business Report 2006 65


Our key management topics

The need for a common view

Nils Wilking of the Karolinska Institute in Stock-


holm, Sweden, discusses his research1) on the
roles of governments and industry in helping
cancer patients get the treatment they need.

What were the key findings of your research?


Huge differences between European countries in the
amount of investment in cancer treatments and the
time it takes to approve new drugs means access to
treatments can vary widely. Cancer accounts for over
16% of the total disease burden in Europe, yet spend-
ing on treatment amounts to just 6.4% of total health-
care costs.
What can pharmaceutical companies do to help?
How can governments help improve access to Wider research on the effectiveness of drugs once on
cancer treatments? the market would also help to underline their cost-
Pharmaceutical companies can develop innovative effectiveness. Companies like Roche can provide more
drugs but it is down to healthcare systems to integrate information for doctors on the value of new drugs to
these drugs into therapy programmes and to ensure help make sure they are offered to patients who need
patients have access to them. Authorities in individual them.
countries are currently making isolated decisions.
A universal evaluation procedure and homogeneous Where do we go from here?
reimbursement process would provide a common view Innovative drugs present an enormous opportunity to
on the effectiveness of a drug and help to speed up the treat diseases with unmet medical need. It is in the
approval process and availability onto the market. interests of healthcare providers, the pharmaceutical
industry and patients alike to recognise the value of
innovative new drugs and increase access to them.
1) A pan-European comparison regarding patient access to These groups must continue to work together to
cancer drugs, Karolinska Institute achieve this common aim.

monitoring. This brings great cost benefits and programmes. This often includes any additional
health benefits. We have an increasing respon- treatment and testing other than that normally
sibility to demonstrate not only the medical but the received. Where necessary we continue to provide
economic benefits our products bring. our drugs free of charge until the product is com-
mercially available.
Enabling global access
Over 7,000 hospitals and clinics worldwide are
We sell our products and services in more than compensated for each patient taking part in Roche
170 countries, and our customers have access to trials. This money is often used to fund additional
them through regular channels such as clinicians’ nursing staff, educational centres and research that
practices, pharmacies and hospitals. otherwise would not be possible. Phase IV, or post-
approval trials, allow clinicians to become familiar
We provide free medicines and testing to patients with a new drug and its safety profile prior to its
involved in our extensive phase I-IV clinical trial widespread availability.

66 Business Report 2006


Our key management topics

In the United States we support several Patient • Continue research and development into new
Assistance Programmes providing free medicines HIV/AIDS medicines
for people who need them but have inadequate • Promote education, training and knowledge-
or no health insurance. These include the Roche sharing
Patient Assistance Programme and the Partnership • Donate technical expertise to local service
for Prescription Assistance. providers and manufacturers.

The Genentech Access to Care Foundation and the Patents and pricing of HIV/AIDS medicines
Genentech Endowment for Cystic Fibrosis both
provide free medicines to eligible uninsured and With as many as 25 million people living with the
underinsured patients. In October 2006 Genentech disease in sub-Saharan Africa, improving access to
announced that it has doubled its contribution to HIV/AIDS treatment remains a priority.
independent charities that provide financial assis-
tance for the medical treatment of eligible patients. Roche’s policy is not to enforce existing patents
Genentech further unveiled plans to begin a first- or apply for new patents for any of our medicines
of-its-kind programme to cap the overall cost of in the least developed countries (LDCs1)). The
Avastin at USD 55,000 per year and per eligible same applies to HIV/AIDS medicines in other sub-
patient for any FDA-approved indication. The Saharan African countries. We supply our protease
programme will be available for eligible patients inhibitors Invirase (saquinavir) and Viracept (nelfi-
regardless of whether they are insured or not. navir) at no-profit prices to the LDCs and all of
The company anticipates the launch of the new sub-Saharan Africa. These are the lowest prices at
programme in the first quarter of 2007. which the medicines can viably be made available
in the long term. Roche also supplies the drugs at
Patients benefiting from access to free Roche Group reduced prices in countries defined by the World
products in 2006 Bank as low- or lower middle-income.
Number of patients actively participating
in phase I–IV trials worldwide 166,070 Our no-profit pricing applies to more than 26 mil-
Number of patients benefiting from lion people in 63 countries, covering 64% of all
Patient Assistance Programmes people living with HIV/AIDS. This increases to
(United States only) 75,500 87% if we include the reduced prices charged in
Total 241,570 low- and lower middle-income countries.

Programmes in least developed countries Patients covered by Roche’s pricing policy


% of HIV/AIDS patients living in LDCs and
The healthcare needs of people in different coun- sub-Saharan Africa 64%
tries and communities are hugely varied and can- % of HIV/AIDS patients living in low,
not be provided for with a single approach. It is lower and middle-income countries 23%
only by assessing each need and responding appro- Total 87%
priately that we can make a difference.
Playing an active role
While our primary role is to improve and discover
innovative medicines for unmet needs, we have also We are constantly striving for new, effective ways to
implemented programmes to help people living in increase access to our products and services. This
the poorest countries that are hardest hit by certain includes a number of programmes to expand access
diseases. Our strategy for improving access to to HIV/AIDS treatment in the developing world.
medicines in the developing world is to: Here are some examples:

• Have clear patent and pricing policies rather


than donating products 1) LDCs defined by the United Nations can be found at
• Build partnerships with governments, NGOs http://www.un.org/special-rep/ohrlls/ldc/list.htm
and other committed parties

Business Report 2006 67


Our key management topics

Sharing manufacturing know-


how with countries in need
Luc Schnitzler is technical expert for Roche’s
Technology Transfer Initiative (TTI).

What is Roche’s Technology Transfer Initiative?


The TTI was launched in January 2006 to help compa-
nies manufacture generic versions of our HIV medicine
Invirase (saquinavir) in the least developed countries
and all sub-Saharan Africa. Over 60% of all people with
HIV/AIDS live in these countries.

Is this different from what other companies do?


Rather than offering voluntary licences to selected
companies, Roche offers free, on-site technical assis- The evaluation criteria we use ensure that companies
tance to all appropriate local manufacturers in eligible we work with can produce saquinavir safely. For those
countries. Our patent policy means licensing is unnec- that do not currently comply, we recommend improve-
essary. We believe this offers more value, as local com- ments and will reassess them in the future.
panies often do not have the knowledge or infrastruc-
ture to start production on their own. What about quality?
The medicines must meet local standards. We will sup-
What does your job involve? port local manufacturers wherever possible but ulti-
My role is to assess the capabilities of interested com- mately the manufacturer is responsible for the quality
panies and provide technical know-how to those who of its generic medicines.
are eligible. Over 25 companies expressed interest in
manufacturing saquinavir and three agreements are Are you confident the programme will be a suc-
now in place in South Africa and Kenya. cess?
Yes. The strong interest shows how important this
What about companies that do not have suffi- manufacturing know-how is in areas hit hardest by
cient capability? HIV/AIDS. We are highly motivated to succeed.

Technology Transfer Initiative (see box). Three noses were made in sub-Saharan Africa on infants
agreements for technology-sharing were reached exposed to HIV. Some 440,000 patients in this
within nine months of the January 2006 launch, region had their HIV/AIDS treatment monitored.
and discussions continue with 22 companies from
14 countries. Cambodia Treatment Access Programme (CTAP).
This public-private partnership has increased the
AmpliCare. Viral load tests allow doctors to moni- availability of HIV/AIDS therapies and provides
tor precisely the progression of a patient’s HIV local training for healthcare professionals. Since
infection and modify treatment to keep drug resis- its launch in 2003, the programme has enrolled
tance under control. Through AmpliCare, local over 1,000 patients, provided HIV/AIDS training
authorities and hospitals have built and equipped for 400 Cambodian healthcare workers and, in
laboratories, trained lab workers and diagnosed and September 2006, opened a permanent treatment
monitored their patients. In 2006, 299,000 diag- centre in the capital, Phnom Penh.

68 Business Report 2006


Our key management topics

CARE. This partnership between Roche and the In 2006 we implemented an e-learning programme
PharmAccess Foundation has helped make – Behaviour in Business: Roche’s Principles and
HIV/AIDS treatment sustainable by strengthening Guidelines/Code of Conduct – to strengthen
local health systems and training African healthcare awareness. The programme is available in ten lan-
workers. In 2006, we hosted the fourth CARE man- guages, and rollout will be completed early in 2007
agement exchange workshop, a training meeting with a target participation rate of at least 90%
for 150 healthcare workers from 15 African coun- (excluding employees of Chugai, Genentech and
tries. The event provided valuable insight into the other US affiliates which have their own compli-
real needs of people involved in the fight against ance programmes).
HIV/AIDS in Africa. The findings will be submitted
for publication in 2007. This global initiative has increased compliance
awareness, leading to a higher number of alleged
WHO Division for Tropical Diseases. In 2006 we compliance failures referred to the compliance offi-
ran a series of workshops on auditing and quality cer. Out of 36 alleged compliance failures, 23 cases
assurance for researchers managing and moni- required corrective action, including termination
toring WHO trials on tropical diseases. We also of employment contracts. In 2007 we will continue
audited WHO trials of leishmaniasis and supported raising awareness of the Code of Conduct with an
training events in sub-Saharan Africa and Asia. emphasis on local training initiatives.

More on the web: Ethics in research and development

• Access programmes and partnerships: Ethical concerns often arise when developing new
www.roche.com/sus-access_programmes medicines and diagnostics. Groundbreaking sci-
• HIV/AIDS patent and pricing policies ence such as stem cell research brings great benefits,
www.roche-hiv.com but also presents risks and comes with responsibil-
• Roche Patient Assistant Foundation: ities.
www.rocheusa.com/programs/patientassist.asp

Roche has a clear position on all ethical issues


Retaining and attracting top talent affecting its research. We updated our global posi-
tion statement on clinical research in September
Our business strategy is based on innovation. 2006. This comprehensive document explains our
Employing and engaging the best people is key in policies and includes information on clinical trials
our knowledge-based business. People who work in in developing countries, protection of genetic data
the pharmaceutical industry want an employer that and publication of trials on our web database. All
offers a clear strategy, innovation and the chance policies and position statements can be found on
to make a difference. Details of how we retain and our website.
attract talented employees can be found in the sec-
tion on ‘Our people’ on page 78. Our employees inevitably come across ethical con-
cerns in their work on clinical trials. If these cannot
be resolved within the team, any employee can
Business ethics contact the Global Ethics Liaison Office. If a query
is not satisfactorily resolved through a process of
Code of conduct and compliance fact-finding and consultation with peers and appro-
priate subject-matter experts, it may be referred
Our Corporate Principles describe the company we to an internal committee of experts. If there is
want to be: one our employees are proud to work still uncertainty, an independent external advisory
for and our partners trust. The principles, com- group, the Clinical Research Ethics Advisory Group
bined with our directives, guidelines and policies in (CREAG), may then be consulted. During 2006 a
specific areas, form our Code of Conduct. total of 24 queries were brought to the Global

Business Report 2006 69


Our key management topics

Innovative use of technology


to refine and reduce
animal studies in research

Markus von Kienlin and Hansruedi Loetscher


from our preclinical imaging department in
Basel explain how magnetic resonance imaging
(MRI) is helping to strengthen our pipeline
while reducing the number of animals needed.

How can MRI reduce the need for animals?


MRI uses magnetic fields to create images from the
body and does not harm the animal in any way. This
means the same animal can be imaged many times,
and changes over time can be monitored. This reduces In which therapeutic areas is MRI being used?
the total number of animals needed. In addition, imag- Roche has a wide range of animal models for CNS dis-
ing data are often more reliable – measuring the same orders. We use MRI to identify patterns of brain activity
animals at the beginning and during the study usually associated with disease or the effects of treatment.
leads to an improved statistical outcome. We also use MRI to measure the efficacy of our com-
pounds in animal models of metabolic diseases, such
What are the advantages of using MRI? as diabetes.
MRI is non-invasive. It monitors physiological pro-
cesses in living, unperturbed organisms. MRI can How does the use of MRI give Roche a compet-
be applied to humans as well as animals, allowing itive advantage?
direct comparison of findings. This is particularly use- We feel we have an edge because we are combining
ful in disorders of the central nervous system (CNS) our advanced MRI technology and sophisticated ani-
where MRI is a unique tool to bridge preclinical mal research, particularly in CNS disorders, with our
research in animals and early clinical development in commitment to extend MRI to clinical studies in
humans. humans (‘translational medicine’).

Ethics Liaison Office and resolved. None of them mous samples to ensure patient confidentiality and
required further escalation. the redesign of patient consent forms to make them
clearer.
Key topics addressed at the 2006 CREAG meeting
included our policy on Transparency in Clinical Responsible animal testing
Trials, and a review of recent cases that have been
brought to the Global Ethics Liaison Office. Roche takes public concern about the use of ani-
mals for scientific research very seriously. We
A second independent panel, the Science and Ethics support all efforts to find alternatives, including
Advisory Group (SEAG), provides Roche with external organisations such as the Swiss 3Rs Foun-
guidance, advice and counsel on issues broadly dation (Replace, Reduce, Refine). In 2007 we plan
related to genetics, genomics and proteomics. Key to establish a Roche ‘3Rs award’ to stimulate further
topics discussed in 2006 included the use of anony- internal efforts in this area.

70 Business Report 2006


Our key management topics

We do not use animals if the same results can be As an active member of major industry associa-
obtained without them. But animal experiments are tions, Roche contributes to reviews of their codes of
sometimes the only suitable way to identify side practice. These include the EFPIA Code of Practice
effects and are often legally required. We then use the for the Promotion of Medicines, last reviewed in
test which causes the animal the least distress, such as November 2004, and the revised IFPMA Code of
non-invasive magnetic resonance imaging (see box). Pharmaceutical Marketing Practices which came
into force on January 1, 2007.
In 2006 we designed an animal welfare audit check-
list for our contractors. Our goal is to encourage The General Manager of each Roche affiliate is
discussion within our industry about independent responsible for ensuring compliance with their
auditing – possibly involving animal welfare organ- national code of practice, which is based on either
isations – of contractors such as specialised animal the IFPMA or EFPIA code, and all applicable laws
experimentation companies. on marketing of pharmaceuticals. Compliance is
monitored by our Internal Audit team and Com-
In 2006 over 95% of all animals used in our pliance Officer.
research were mice and rats. Just over 0.5% were
non-human primates. Animals used in research We strongly believe that patients should have an
carried out by contractors represent less than 10% active role in decisions regarding their health
of all animals used by the Roche Group. and well-being. To ensure this, we work alongside
patient groups who share our aim to provide new,
We expect all our testing sites will have received effective and safe treatments as quickly and system-
accreditation from the Association for the Assess- atically as possible.
ment and Accreditation of Laboratory Animal Care
(AAALAC) by the end of 2007. We introduced a set of guidelines for working with
patient groups in February 2006. These aim to cre-
More on the web: ate genuine and mutually beneficial partnerships
that reflect common values of integrity, indepen-
• Roche Corporate Principles and Code of Conduct: dence, respect and transparency. They specify that
www.roche.com/sus-principles_code_conduct work carried out must benefit the patients repre-
• The Clinical Research Ethics Advisory Group: sented by the group, and that groups should not be
www.roche.com/sus-creag asked to endorse a specific product (see box).
• The Science and Ethics Advisory Group:
www.roche.com/sus-seag Protecting our intellectual property
• Animal welfare:
www.roche.com/sus-animal_welfare Adequate protection of innovation is essential in
• Policy and position papers: our industry if we are to continue finding new diag-
www.roche.com/sus-policies_positions_guidelines nostics and drugs to fight diseases such as cancer,
Alzheimer’s, diabetes and HIV/AIDS.

Responsible marketing Pharmaceutical companies patent their new drugs


to make sure they can recoup their investment. By
Patients have a right to factual information about being the sole manufacturer of a drug for a limited
medicines. We follow external guidelines and codes period, usually eight to ten years, companies are
of practice for marketing pharmaceuticals. These motivated to ensure the process of innovation is
include the World Health Organization’s Ethical not interrupted and to continue bringing new and
Criteria for Medicinal Drug Promotion. We also improved medicines to market.
have internal guidelines on the design and use of
promotional materials and activities, and comply We do not file patents in the world’s least developed
with all regulations concerning advertising directly countries, to ensure patients are not prevented from
to the consumer. receiving Roche medicines due to patents.

Business Report 2006 71


Our key management topics

Working effectively with


patient groups
Jean Mossman – former CEO of leading UK
cancer support charity Cancerbackup – helped
Roche develop guidelines for working with
patient groups to ensure patients’ opinions are
taken into account.

How can companies and patient groups best


work together?
Patients want access to more effective treatment and
industry wants to commercialise its products. The com-
mon agenda is to get the right treatments to the right
patients, at the right time.
Patient groups and companies can best achieve this In effective partnerships, both sides are equal. Compa-
by understanding each other’s perspective. Long-term nies should not see their contribution as more valuable
partnerships provide the most mutual benefit. than that of the patient group. They must not try to
influence a group’s agenda, and should not try to put
What are the benefits for company, patients and their brand on patient groups’ products. Companies
society in general? should also ensure relationships don’t suffer when
Patients often don’t take medicines as directed, mak- there are changes to personnel.
ing treatment ineffective. Input from patients ensures
information about drugs is simple and clear. Com- How did you co-develop the guidelines ‘Working
panies can then better understand the experience of with Patient Groups’ with Roche?
living with a disease and what matters to patients. Roche recognised that various teams were working
They also see how drugs fit into the whole treatment with patient groups in different ways. A common
plan. approach was needed. By asking me to draft the guide-
lines, Roche ensured that though they are for use by
What should companies avoid when working its employees, they reflect the needs of patients and
with patient groups? patient organisations.

Counterfeiting poses health risks ment and customs officials. We are doing our
utmost to tackle the problem. Our statement on
Fake pharmaceutical and diagnostic products are counterfeiting is available on our website.
not only an infringement of intellectual property
rights, but more importantly endanger the lives and Biosimilars
well-being of patients. Fakes can cause serious
illness or death if they contain harmful ingredients Several innovative biological medicines will reach
or deprive patients of proper treatment. the end of their patent period in the next few years,
and the introduction of products claiming to be
Responsibility for preventing and controlling drug similar to the original is likely. These are known as
counterfeiting rests primarily with national gov- biosimilars, or follow-on biologics. As the manu-
ernments and international organisations. Roche facture of both the active substance and the finished
cooperates worldwide with regulators, law enforce- product requires a high level of quality control to

72 Business Report 2006


Our key management topics

ensure clinical safety, the approval of biosimilars There are concerns that clinical trials in developing
requires its own set of guidelines, and we are con- countries may not be carried out to the same stan-
tributing to their development. dard as in the developed world. Roche employs
ICH GCP as the minimum global standard for all
More on the web: Roche trials. In 2005, we introduced additional
policies for conducting clinical trials in low- and
• Marketing guidelines: middle-income countries to support our wider
www.roche.com/sus-marketing global position on clinical research.
• Guidelines for working with patient groups:
www.roche.com/sus-patient_groups We support training on good clinical practice in sub-
• Global patent function: www.roche.com/sus-patents Saharan Africa and on quality assessments in Asia
• Counterfeiting: www.roche.com/sus-patents through the Forum for Ethical Review Committees
• Biosimilars: www.roche.com/sus-biosimilars in Asia and the Western Pacific Region (FERCAP).

Roche’s clinical trial protocol registry


Conduct of clinical trials and trial results database

Before medicines are released, evidence of their We publish data from our clinical trials, so that
safety and effectiveness must be provided, using more people can benefit from the findings. Our
well-designed and controlled clinical studies. online clinical trial protocol registry and results
database (see address below) provides information
All clinical studies in Roche are conducted in com- about all new trials and key results from completed
pliance with international guidelines and must be phase II–IV trials. Both the registry and the database
approved by regulatory authorities. These include are hosted by an independent company.
the Food and Drug Administration (FDA), the
European Agency for the Evaluation of Medicinal Details of 375 clinical trials and 117 trial results
Products (EMEA) and Ethics Committees and local have been published on the website since its launch
Institutional Review Boards. in April 2005, with more than 100,000 people
accessing the database. This includes 39 studies on
These boards ensure proposed trials are acceptable, breast cancer, 47 on anemia and 66 on hepatitis.
that participants are fully informed about benefits In addition, from December 2006 all Roche trials
and risks related to their participation and that are now posted on the US National Institutes of
investigators take appropriate actions to protect Health’s global registry at www.clinicaltrials.gov.
patients from any harm.
Following requests from patient groups, recom-
Our Framework for Discussing and Resolving Eth- mendation by the WHO, and consultation with the
ical Issues in Clinical Research, together with the Clinical Research Ethics Advisory Group (CREAG),
Good Clinical Practice Toolkit we provide to those we now post information on phase I trials con-
involved, ensure all trials of our pharmaceutical ducted in patients (17 posted year to date, in seven
products meet International Conference on Har- different medical conditions). This enables patients
monisation (ICH), WHO and other internation- with serious diseases to seize this – albeit small –
ally-recognised standards on good clinical practice, opportunity to find a new treatment solution.
as well as local laws.
More on the web:
Our guidelines are available on our intranet and
employees working on trials are trained and • Global position statement on clinical research,
required to follow them. All trials, and the processes resolving ethical issues and clinical trials in
and systems used to conduct them, are audited by developing countries:
our Pharmaceuticals Division Quality Assurance all at www.roche.com/sus-clinical_research
team. • Clinical trial registry: www.roche-trials.com

Business Report 2006 73


Our key management topics

Ensuring patient safety and firms the safety and effectiveness of our products
product quality in the marketplace, giving us early indications of
potential product issues and helping us to take
Users of our medicines and diagnostics have the preventative action.
right to expect every effort is made to ensure their
safety. Roche has systematic processes for collect- In early 2007 we plan to update our website to
ing, reporting and analysing data to ensure patient include more detail about patient safety, product
safety throughout the product lifecycle, in full com- quality and related procedures.
pliance with local regulations.
More on the web:
We work hard to protect patients from potential
adverse reactions to our drugs. We examine all • Patient safety:
reported adverse events to identify what is related to www.roche.com/sus-patient_safety
the product and what might be incidental to use of • Risk management procedure:
the product. Adverse reactions are identified as early www.roche.com/sus-risk_management
as possible and classified in terms of their severity
and whether the risks outweigh the benefits.
Position on new technologies
Our drug safety department works with all Roche
affiliates to monitor drugs both before and after New technologies offer great opportunities for
they are launched. While reporting a suspected medical advances but their development and use
adverse reaction to Roche is mandatory during also create legitimate social concerns. For this
phase I–III trials, once the drug has been launched reason, we continuously monitor, evaluate and
we rely on patients, healthcare professionals and discuss the use of developing technologies.
authorities to do so. Employees must immediately
report any information on a suspected adverse Biotechnology uses living organisms to make or
event or quality issue to our Drug Safety Depart- modify products or processes for a specific use.
ment. Applications of biotechnology include genetic
engineering, gene and stem cell therapy. Roche does
Our risk management procedure ensures patients not currently carry out any stem cell research.
and the relevant authorities are informed promptly
once an adverse reaction has been confirmed. Many Biotechnology also has the potential to replace
health authorities require us to report serious certain chemicals during drug manufacture,
adverse reactions within 15 days. Our country and making processes safer and more environmentally
manufacturing sites are also subject to health sound. In 2006 we published a new position paper
authority inspections. on the safety, health and environmental aspects
of biotechnology. A paper on nanotechnology is
Our Pharma Manufacturing Standards lay out rules currently being drafted.
and tightly-controlled procedures to ensure high
quality standards and compliance with external More on the web:
regulations. They cover all aspects of our business
and include a comprehensive safety data review • Roche Position paper on biotechnology:
process. This ensures any new information we www.roche.com/sus-biotechnology
receive about a drug is assessed and product infor- • Roche charter on genetics:
mation is updated as necessary. www.roche.com/sus-genetics
• Science and Ethics Advisory Group:
Our Diagnostics Division ensures product design, www.roche.com/sus-seag
production, release and post-market surveillance • Embryonic stem cells and therapeutic cloning:
activities all meet regulatory and customer require- www.roche.com/sus-stem_cell
ments. Our global complaint handling system con- • Bioprospecting and biodiversity:
www.roche.com/sus-biodiversity

74 Business Report 2006


Our key management topics

Unlocking the breakthrough


potential of Avastin
Peter Wenner is Franchise Director for Avastin,
Roche’s revolutionary cancer treatment.

Why was the Avastin launch so successful?


Avastin is a significant advance in cancer treatment.
It is the first and only anti-angiogenic agent to con-
sistently improve chances of survival in metastatic
colorectal, lung, breast and renal cell cancer, with
limited side effects. Authorities recognise the consider-
able benefits Avastin brings to patients and have
granted reimbursement of the drug in record time
for use in colorectal cancer treatment. Since its first
launch in February 2004, it has been approved in gramme to further unlock the potential of this drug.
over 90 countries and used by more than 115,000 Over 9,000 patients have been recruited for trials in
people. 2006 and 40,000 are expected to take part in trials over
the lifecycle of the drug.
Avastin is being developed in different types
of cancer in parallel. Isn’t this unusual? Has Roche’s unique lifecycle management struc-
Normally a drug must be shown to work effectively in ture contributed to the success of the product?
one indication before it is developed in another. Roche Absolutely. Our lifecycle teams include individuals
and Genentech took a bold step in conducting trials from every key function in the organisation – research,
of Avastin in pancreatic, prostate and ovarian cancer development, manufacturing, regulatory, marketing –
at the same time as continuing trials in colorectal, lung, all dedicated to one product. Their goals are to unlock
breast and renal cell cancer. As a result, Avastin has the potential of a product for the benefit of patients and
been approved within a short timeframe in metastatic maximise the value of the brand.
colorectal cancer and is waiting for approval for use in
metastatic breast and lung cancer. Our lifecycle management structure and close cooper-
ation between Roche and Genentech have contributed
In addition to this, twelve phase III trials are currently to Avastin enjoying one of the fastest launches of any
underway as part of our extensive development pro- oncology product to date.

Respecting human rights More on the web:

Roche believes firmly in the universal human • Respecting human rights:


rights declared by the United Nations. Our Group www.roche.com/sus-human_rights
Employment Policy prohibits discrimination, • Group Employment Policy:
harassment and forced or child labour on any www.roche.com/sus-employment_policy
grounds and respects our employees’ right to join
any legally recognised employee association. Fur-
ther information on our commitment to human
rights is on our website.

Business Report 2006 75


‘I’ve got my life back,
and my children have got
their father back.’

76 Business Report 2006


A new, effective treatment option for people
with rheumatoid arthritis

Steve Robson, from Bedford (UK), was 35 when


he found out he had rheumatoid arthritis (RA).
On assignment for his company, a specialist piping
contractor, he suddenly developed severe pain in
his hands after working with a jackhammer for part
of the day.
The worsening pain and swelling in his hands,
feet and shoulders soon made everyday tasks like
tying shoelaces difficult or impossible. Even walking
became unbearable. No longer able to do hard
physical work, Steve was fortunate in having an
employer who offered him a transfer to an office job.
Two years after diagnosis, Steve needed a hip
replacement, because the disease had destroyed the
joint. For nine years he tried a variety of treatments,
but none worked for long. In 2003 his rheuma-
tologist enrolled him in a clinical trial of MabThera
(rituximab).
Since his first course of MabThera three years
ago and two subsequent courses, Steve has been pain
free and the joint swelling is reduced. He can now
walk comfortably, do household chores, work in
the garden, and even play football with his children.
It’s understandable why he describes discovering
MabThera as being like winning the lottery – and
why he says, ‘I wouldn’t swap it for winning the
lottery.’

Therapy
By selectively targeting the B cells that play a key role in RA,
MabThera interrupts a series of reactions in the process that
leads to the joint inflammation, cartilage loss and bone erosion
characteristic of the disease. More than 1,000 patients with RA
have been treated with MabThera in clinical trials to date.
MabThera is marketed in the US by Genentech and Biogen Idec
under the brand name Rituxan.

Business Report 2006 77


Our people

In brief Our Employment Policy sets out our commitment


to employees and our expectations of them. It out-
• 4,577 new jobs created lines our objectives and practices on all aspects of
• 10,116 million Swiss francs’ remuneration paid people management, including talent attraction,
• Genentech ranked first and Roche Pharmaceu- recruitment, performance management, develop-
ticals third in Science magazine’s top employers ment, compensation, diversity, discrimination,
in the biotech and pharmaceutical industries zero tolerance of child labour, freedom of asso-
• Won various other national ‘Employer of choice’ ciation, and health, safety and environmental
awards protection.
• 90% of employees surveyed are proud to work
for Roche Total employees (full-time equivalent – FTE)
• 2.1% regretted losses (down from 2.2% in 2005) 2006 2005 2004
• 13,800 employees participating in Roche Con- Number of employees 74,372 69,795 66,843
nect non-voting equity securities programme
• 34 hours of training per employee

We employ 74,372 people in 66 countries around Employees (FTE) by operating divisional group in 2006
the world. Roche created 4,577 new jobs in 2006,
increasing our total workforce by 6.6%.
Roche Pharmaceuticals 36,608
Chugai 6,161
The Roche business strategy is based on sustained
Genentech 10,472
innovation and growth. Our main source of innova-
tion comes from talented individuals within the
company. Therefore our ability to retain, attract and Other 419
recruit the most talented and motivated employees
is vital to our continued business success. To retain Diagnostics 20,712
these people, it is essential that they can successfully
develop their skills and careers at Roche. We must
also continue to attract and recruit the best talent on
the market to enable our business to grow. Employees (FTE) by region in 2006

We want to be the most attractive employer for our


Europe 32,818
staff and potential recruits at every stage – from
Latin America 4,632
attraction and recruitment to performance, devel-
North America 23,239
opment and retention (see Value chain).

In our Corporate Principles, we state our commit-


ment to creating a working environment that pro-
Other 1,564
motes mutual respect, trust and integrity, where
Asia 12,119
employees are always treated fairly.

Value chain

Attraction Recruiting Performance Development Retention

78 Business Report 2006


Our people

Roche Engage – strategy-


based executive development
‘Roche Engage supports our strategy. It provides great
insights into how we can build and maintain a culture
of innovation.’
Ursula Redeker – Global Head Safety and Technical
Sciences

‘Our strategy clearly sets the direction for the com-


pany. The entire Roche community must connect with it
and Roche Engage facilitates this.’
Roy Rothenberg – Finance Manager Korea

‘We must deliver sustained growth and value by motivat-


ing and inspiring our co-workers. Roche Engage is about
changing our leadership model, one leader at a time.’
Paul Nakagaki – Head of Research Strategy

Talent attraction Recruitment

We want to attract the best talent in our industry. Our ‘One door into Roche’ programme, launched
To achieve this objective we must remain an in 2005, enables prospective employees to search
employer of choice. We monitor perceptions of for jobs throughout the company on our website –
Roche as an employer through feedback on our by function, division or country. Job seekers receive
website and our ratings in external surveys. personalised e-mail alerts when appropriate posi-
tions become available. We have accumulated a
Our continual efforts to be an employer of choice global talent pool of more than 60,000 external can-
were again recognised by external studies around didates through this process, allowing us to build
the world in 2006. Science magazine voted Genen- relationships with potential recruits. Since 2005 we
tech first and Roche Pharmaceuticals third out of have filled 1,700 positions using this system.
330 companies in the top employers in the biotech
and pharmaceutical industries. The survey covered Roche is keen to reach as many people as pos-
questions such as corporate image, leadership and sible as a potential employer. In October 2006,
direction, work culture and environment, social we launched accessibility features on our career
responsibility, compensation and benefits, and website to improve usability and accessibility for
work–life balance. We have consistently improved people with disabilities.
our position over the last five years. Genentech held
on to the number one spot for the fifth year running. E-recruiting has halved the time it takes to recruit.
This improves efficiency and reduces the dropout
In 2006 Roche was also named an ‘employer of rate of desirable candidates by enabling us to act
choice’ by surveys in Canada, Chile, Italy, Germany, faster than competitors. It also helps to increase
Portugal, Spain and the US. Our Australian recruit- mobility and development opportunities for exist-
ing team was awarded ‘Best recruiting team’ and ing employees who have the chance to work else-
Roche Diagnostics Germany was named ‘Best where within the Roche Group, by opening up the
employer for women’. For a full list of awards internal job market for all to see.
received by local divisions, visit our dedicated
career website at http://careers.roche.com.

Business Report 2006 79


Our people

Developing talent through


international assignments
Monica Arosio, Head of International Assign-
ments at Roche, explains why Roche encourages
employees to work abroad for their own develop-
ment and the company’s.

Why does Roche offer international assign-


ments?
‘Roche has a long-standing tradition in promoting and
sustaining international assignments programmes.
Now, more than ever, our business needs individuals
who are trained to deal successfully with the complex-
ities of different markets, countries and cultures.’

How does an international assignment con- skills in an ever-changing environment like ours. It
tribute to individual and company performance? enables people to reach beyond their limits and strive
‘An international assignment offers a unique oppor- to achieve more. An international assignment is a
tunity to be exposed to unusual circumstances, be it powerful tool to develop talent, share best practices
personally, professionally, and culturally. It fosters a between countries and come up with innovative ways
greater creativity, flexibility and adaptability – crucial to support our strategy.’

Performance management ment. Scores on these areas remained above the


and development global employee research company ISR’s average
for the pharmaceutical sector but below its high-
The success of our business now and in the future performance companies norm in 2005. Roche
depends on motivated employees. Our work cul- Pharmaceuticals is rolling out a new global per-
ture emphasises individual responsibility. formance management process across the division,
focusing on training and feedback.
All employees receive regular feedback on their
performance and meet with their managers to Individual sites and divisions have their own
discuss their careers. Performance management training policies to meet local needs. For example,
programmes are in place in 95% of our affiliates. Pharma Global Informatics is rolling out a career
These covered 85% of the total workforce in 2006, development programme for all its employees
similar to the previous year. In 2006, training or (over 2,000 in total). Roche Venezuela celebrated the
development plans were agreed with 62% of our first graduation of students from its three-year train-
employees (down from 64% in 2005). ing course for senior sales representatives in 2006.

Our Pharmaceuticals Division conducted a global In addition to offering development opportunities


survey on performance management at the end for existing employees, we give young people the
of 2005. More than three-quarters of employees opportunity to train as apprentices with the
surveyed rated our development planning and prospect of a career with Roche. We are currently
training positively. Performance monitoring and training 982 apprentices.
feedback were identified as key areas for improve-

80 Business Report 2006


Our people

Developing successful
careers
‘I like the fact that Roche expects efficiency and results
from its employees, while providing a fair and caring
working environment.’
Udo Bäckert is Head of Technical Services in Basel and
has been with the company for 23 years

‘We are provided with all we need to do a good job.


Working in close contact with talented colleagues all
around the world is a fun and enriching experience.’
Eva-Maria Gutknecht was one of the first female
chemists hired in the industry and has been with Roche
for 26 years

‘The global opportunities which I have enjoyed in my In her three years at Roche, Louisa Shen has worked in
career at Roche have tremendously broadened my a range of Diagnostics roles in Switzerland, Canada and
perspective in both my work and personal life. The work China
is always very demanding and challenging, I can say
for certain that there is never a boring day.’

Twenty mid- and top-level managers from our Asia Roche Pharmaceuticals introduced a new policy in
Pacific Diagnostics Division took part in our first 2006, enabling employees to expand their horizons
annual APAC Discovery programme in September and contribute their skills and expertise to projects
2006. The two-week course at the internationally in developing countries by taking a secondment of
recognised Nanyang Business School in Singapore three to 18 months away from their regular jobs.
focuses on development of their leadership skills.
Participants are selected for their high leadership Roche Diagnostics has set up an exchange pro-
potential, consistent track record and commitment gramme enabling employees from IT departments
to the company. Graduates of the programme will in Germany, Switzerland and the US to work in
form a pool of emerging leaders to ensure Roche’s another country.
continuing success in the region. Rapid growth of
our Asia–Pacific companies underlines the need for We focus on developing leadership skills to build a
a highly-trained and ambitious workforce in this pool of talented leaders within Roche to ensure our
region. future success. In 2006 we launched Roche Engage
– a new senior executive development programme
A career at Roche can be very international. We are for the top 350 managers across the Group. The
keen to enable our employees to broaden their programme focuses on helping senior leaders to
experience by working in other countries (see box). apply their leadership skills, engaging employees
Almost 350 employees from 35 different countries in our strategies and enabling them to deliver our
are currently on international assignments in 52 business goals.
countries.

Business Report 2006 81


Our people

Our Leadership Charter sets out a consistent frame- Engaging employees


work of leadership competencies essential for man-
agers across the company: to focus on providing a We engage regularly with our employees to assess
model of integrity, driving business success, meeting satisfaction levels and gain feedback on our pro-
the needs of our customers, and motivating employ- grammes. In late 2005 we surveyed employees on
ees to help them further improve their performance. the effectiveness of our internal communications
and on their attitude towards the company. Around
Senior and middle managers throughout the Group 17,000 employees took part – a response rate of
are set specific goals with the overall objective of almost 30%.
raising the value of the company. Their perform-
ance is measured against their ability to meet these Around 90% of those surveyed said they are proud
goals and contribute to an increase in operating to work for Roche and are comfortable presenting
profit after tax and capital charges (OPAC). Roche in a positive light to the outside world. Fac-
tors cited that make Roche stand out from other
As part of our succession planning, we review companies include the Group’s strategy and princi-
potential candidates for senior management posi- ples, its success through innovation and products,
tions (approximately top 1,000) across the business a good working atmosphere, motivated managers
every year. We found an average of 2.9 succession and co-workers, appreciation of employees and
candidates for each position in 2006, compared social benefits.
with 2.5 the previous year. This is within our target
range of 2.5 to 3.0 candidates per position. Our global intranet, internal newsletters, letters
from the Corporate Executive Committee and
Training information meetings keep employees informed
2006 2005 2004 about the company’s objectives, strategy, results,
Total hours invested in current research and new products. In addition,
training and employee divisions and sites have their own communication
development (millions) 2.57 2.14 1.85 channels with employees.
Training time 4.3 days 3.3 days 2.9 days
per employee (34.5 hours) (26.7 hours) (23 hours)
Pay and benefits

Retention Roche is committed to providing fair compensation


and benefits, based on local competitive conditions
In addition to personal development opportu- and our employees’ contribution to the business.
nities, we consider employee satisfaction and work- Our total remuneration cost was 10,116 million
life balance vital to retaining our best employees. Swiss francs in 2006.

The total attrition rate of permanent staff was We offer several non-voting equity securities-owner-
6.6% in 2006. The proportion of regretted losses ship programmes that give employees the opportu-
(those not initiated by Roche) was only 2.1% (1,574 nity to have a financial stake in the company’s suc-
employees). We are pleased that our research func- cess. Roche Long-Term, launched in 2005, provides a
tion – the source of our innovation – continues consistent approach to performance-related equity-
to see a low number of departures of qualified based remuneration, enabling senior managers to
employees. share in the company’s long-term financial growth.

Staff turnover and regretted losses Roche Connect allows all employees (except those
2006 2005 2004 in the US, due to legal restrictions) to purchase non-
Fluctuation 6.6% 6.7% 6.1% voting equity in the company at a discounted rate.
Regretted losses 2.1% 2.2% 2.9% Around 13,800 employees (30% of those eligible)
are participating in this programme, up from
11,600 in 2005.

82 Business Report 2006


Our people

Promoting diversity Freedom of association

Diversity within our workforce is invaluable to our Roche respects the right of every employee to be
capacity for innovation, on which the success of our part of an employee organisation. Roche is working
business depends. Roche does not tolerate discrim- in an open dialogue with legal employee represen-
ination on any grounds. We promote people on tations in all countries where we operate. Roche
three criteria only: performance, potential and does not record individual memberships of unions
functional and geographic mobility. but we estimate that 8% of our employees are
members of a union. 86% of employees are repre-
We employ people from all over the world. 55% of sented by a works council or a similar organisation.
our employees at our corporate headquarters in the Roche has founded the Roche Euroforum to repre-
Basel region are foreigners and represent 65 nation- sent all employees in Europe (approximately 33,000
alities. Around 52% of our affiliate companies are people).
headed by nationals of where the company is based
(down from 60% last year) and their management More on the web:
teams include a consistently high proportion of
local staff. • ‘One door into Roche’ e-recruitment facility:
http://careers.roche.com
We want Roche to be an attractive employer for • Corporate Principles:
both men and women. Women account for around www.roche.com/sus-principles_code_conduct
45% of our total workforce, 31% of centrally • Group Employment Policy:
tracked managers and 4.3% of senior managers. www.roche.com/sus-employment_policy
We are working to attract and retain more women. • Human rights: www.roche.com/sus-human_rights
The proportion of women at Roche has been • Local employer of choice awards:
steadily increasing. www.roche.com/sus-emp_of_choice and
http://careers.roche.com
Gender diversity • Safety, health and environment:
2006 2005 2004 www.roche.com/sus-she
Women in total workforce 45% 43% 42%
Women in management 31% 32% 31%
Number of women in top
80 management positions 4 7 5
Women candidates for top
management positions 22% 16% 12%

We recognise that a healthy work–life balance is


vital to both the well-being and performance of our
employees. We offer a range of programmes to
enable employees to balance work and family com-
mitments. Employees can choose a working pattern
that suits them – be it full-time, part-time, flexi-
time or working from home. We offer the option of
part-time employment wherever the requirements
of the job permit. Around 6.3% of our employees
work part-time. Parental leave and sabbaticals can
also be arranged.

Work–life balance
2006 2005 2004
Part-time employees 6.3% 6% 5.8%

Business Report 2006 83


Our communities

Our community involvement – as described by our or through our support for projects to promote
new Group Policy on Donations and non-commer- advances in basic science and encourage young
cial Sponsorship – is targeted in four key areas: people to be enthusiastic about life sciences.

• Improve access to medicines and diagnostics In addition to local projects, we provide global sup-
• Promote advances in basic science through port for research in specific areas through a number
education of foundations, such as the Roche Organ Trans-
• Encourage innovation and excellence through plantation Research Foundation and the Roche
contemporary culture and arts Foundation for Anemia Research (RoFAR). To date
• Support communities in which our employees RoFAR has awarded over seven million Swiss francs
live and work. to 34 research projects around the world. The
Roche Research Foundation in Switzerland gave
While this is part of our civic responsibility, it also financial support to 70 research projects of young
provides an environment that inspires our employees scientists in 2006. Our MBA Fellowship pro-
to make Roche a successful, sustainable business. gramme provides grants to encourage talented
scientists to complement their medical or science
We usually get involved in projects where our qualifications with a degree in business.
knowledge and expertise can make a significant dif-
ference and prefer to work closely with local partners
and other parties with special expertise. We measure Encouraging innovation in the arts
our success by the impact of each project and not
by the total amount spent. This is why we do not We see close links between artistic creativity and
publish detailed figures on the amount we spend on innovation in our own activities – in science and
community support. We do not donate drugs except elsewhere in the business. Roche has been a patron
for disaster relief and pandemic situations. of contemporary arts and music for more than a
century. As part of this commitment, Roche Com-
Community support by area (% spend) missions sponsors new musical works by outstand-
Humanitarian and social projects 82.8% ing contemporary composers (see box).
Science and education 14.0%
Arts and culture 1.9% In November 2006 Roche launched a joint project
Community and environment 1.3% with the Salzburg Festival. The ‘Roche Continents –
Youth! Arts! Science!’ series encourages young
people to attend contemporary music events and
Access to healthcare explore the link between innovation in music and
art and innovation in science.
We use our expertise to improve access to health-
care and our medicines. We focus our efforts where Roche founded and maintains the Museum
they will benefit those in greatest need. For further Tinguely AG in Basel, showcasing innovative art-
details please see page 64. work. Roche’n’Jazz, launched in September 2005,
is a monthly evening of live contemporary jazz
music held at the Museum Tinguely and regularly
Promoting advances in science attended by up to 400 employees and members
of the public. We plan to roll out local
In many countries Roche is a driving force in the Roche’n’ Jazz events at other Roche sites around
scientific community through our own activities the world.

84 Business Report 2006


Our communities

Connecting innovation
in music and science
The Cleveland Orchestra is a partner in Roche
Commissions, a pioneering international project
for the advancement of contemporary classical
music. Its conductor, Franz Welser-Möst, dis-
cusses what makes the partnership work.

Why is innovation important for the Cleveland


Orchestra?
The Cleveland Orchestra stands for both innovation
and tradition but, to us, tradition means handing things
down and carrying them forward. It involves movement,
and so doesn’t exclude innovation.

Are there links between innovation in music and Do you think Roche Commissions is successful?
in science? Absolutely – we both share a common goal. We aim
In both science and music, everything we discover for quality in our work, not quantity. Like Roche,
already exists in some form; we just have to find it. the Cleveland Orchestra is known for outstanding
Science takes a technical approach to research and technical ability and innovation. We give new pieces of
musicians take a more emotional approach. What’s music a chance to be heard for the first time in quality
fascinating is the point where these two meet. Whether performances at the highest level. Both organisations
we are developing new medicines or composing new also share a curiosity about the future and recognise
music, our work is to create a response, physical or the need to invest in it.
emotional, in human beings.

Supporting our communities We founded the independent charity ‘Roche


Employee Action and Charity Trust’ (Re & Act) in
Our support for communities is guided by our 2006 to help coordinate employee donations and
employees, focusing primarily on local projects community support. Its goal is to provide support
identified by them. We encourage employees to play for selected sustainable projects and charitable
a part in their communities through volunteering organisations that address long-term humanitarian
and fundraising. Roche will often match funds they needs and post-disaster rebuilding, especially in the
raise, doubling the total contribution made. least developed countries.

In 2006 Roche began working with UNICEF to More on the web:


support schools in Malawi attended by children
orphaned by HIV/AIDS. Funding for these pro- • Group policy on donations and criteria for
jects comes from our annual Global Roche sponsorship: www.roche.com/sus-giving
Employee AIDS Walk. Some 13,000 employees at • Roche Drug Donation Policy:
95 sites in 45 countries took part in December www.roche.com/sus-access
2006. Roche matched the funds they raised to • Roche foundations:
donate a total of one million Swiss francs to www.roche.com/sus-foundations
orphans in Malawi. • Roche’n’Jazz: www.roche-n-jazz.net

Business Report 2006 85


‘I monitor my blood glucose myself every day
and only go to the hospital once a month.’

86 Business Report 2006


Monitoring diabetes – avoiding complications

As CEO of Eschenbach Optik of Japan, Tomio Koga,


59, has a demanding job with a busy schedule. Even
so, he manages to combine this with a private role
as a high-school baseball umpire. In his private life
Tomio also has to shoulder another, quite different
responsibility. When his doctor diagnosed diabetes
during a routine check-up some years ago, he was
deeply shocked and conscientiously embarked on
his therapy, never missing an appointment at the
hospital. However, if managed well, diabetes causes
no discomfort and no symptoms: Tomio gradually
forgot about his illness and at one point stopped
seeing his doctor altogether.
The turning point came on a trip to Germany,
where a colleague told him, ‘When you have dia-
betes, you have to monitor your blood glucose levels
regularly, or you risk developing cardiovascular or
other complications.’ ‘When I explained how hard
it was to combine frequent check-ups with my
schedule, he told me I could check my blood glucose
myself,’ says Tomio. He now checks his blood glucose
levels regularly with an Accu-Chek Compact Plus
and manages the data with Accu-Chek Smart Pix.
This means that he can track his readings and
quickly identify deviations.
‘Apart from being even faster and needing even
less blood, my new meter is small and easy to use,
which is particularly important because of all my
business travel.’

Monitoring
People with type 2 diabetes do produce insulin, but their body
doesn’t produce enough or cannot make effective use of it. After
diagnosis they can control their blood glucose levels by adopting
a healthy lifestyle and diet but may also have to inject insulin
or take tablets. Products such as Accu-Chek meters and strips
enable people with diabetes to monitor their own blood glucose
accurately and conveniently.

Business Report 2006 87


Safety, health and
environmental protection

In brief improvements were made at all sites and imple-


mentation of the necessary actions is monitored
• Published new position papers on six key SHE and enforced. Strategically important suppliers –
issues based on risk-assessment and level of spend – are
• 16.5% reduction in Roche Accident Rate also audited to monitor their SHE management
• Energy use per employee reduced by 8.0% and performance. 19 suppliers were audited in 2006
• 11.2% reduction in greenhouse gas emissions and our recommendations for improvements have
• Inorganic emissions to air reduced by 54% since been implemented.

Safety, health and environmental protection (SHE) Roche is committed to upholding the high environ-
cannot be separated from our business success. mental and safety standards set by Responsible Care
SHE is fully integrated in everything we do. All – a global initiative established by the chemical
employees are expected to play their part in pro- industry to achieve continual improvement in its
tecting the environment and making Roche a safe SHE performance. Our Responsible Care Network
and healthy place to work. communicates our commitment to these standards
and provides a forum for sites to share advice and
Our commitment to SHE is enshrined in the Roche best practice.
Corporate Principles. We revised our Safety, Health
and Environmental Protection Policy in late 2005 to Our SHE management system covers all relevant
restate and strengthen our commitments. aspects of internationally-recognised standards
such as the International Organization for Stan-
In 2006 we invested 271 million Swiss francs in SHE dardization’s environmental management stan-
infrastructure in new manufacturing buildings dard, ISO 14001, and the European Eco-Manage-
and extension of existing installations. Operating ment and Audit Scheme (EMAS). It is not our goal
costs including SHE services and personnel costs to achieve ISO or EMAS certification for all our
amounted to 351 million Swiss francs. sites but nine Roche manufacturing sites have
chosen to implement this standard voluntarily and
are certified to ISO 14001. Three of these sites have
SHE management also attained EMAS certification.

Responsibility for implementing the SHE policy Awareness and continual reduction of risks is
and guidelines lies with the general managers of essential to prevent accidents and incidents that
affiliate companies and individual site managers. could affect people, the environment and our busi-
They are supported by a safety and environmental ness. All risks are registered and evaluated via a
officer at each site who coordinates with the cor- web-based tool. This information is assessed at
porate SHE team. Divisional champions – Eco- Group level to build a global risk profile.
delegates – are responsible for raising awareness
of SHE within their divisions, in addition to their
regular jobs. A total of 570 of our employees work Goals
full-time in SHE across the Group.
In 2005, we set a number of new long-term quanti-
Roche monitors implementation of the SHE policy, tative targets for global SHE performance, adding
guidelines and directives by auditing sites across to our existing goals to:
the Group – 23 were audited in 2006. Higher-risk • Reduce the Roche Accident Rate by 20% by 2010
sites are audited more often. Recommendations for from 2005 baseline (workdays lost/employee)

88 Business Report 2006


Safety, health and environmental protection

• Reduce general absence rate including illness Informative accidents are made anonymously and
and home accidents by 10% by 2015 from 2005 are published on our intranet so other sites are
baseline (days lost/employee) made aware of potential hazards and can take
• Reduce total energy consumption by 10% action to prevent similar incidents.
by 2010 from 2005 baseline (GJ/employee)
• Improve total ecobalance by 10% by 2015 from The annual Roche Responsible Care Network
2005 baseline (points/employee) Awards recognise sustained outstanding health and
• Reduce greenhouse gas emissions by 10% by 2008 safety performance of individual sites based on
from 2003 baseline (CO 2 equivalent/unit sales) their Roche Accident Rates over the previous three
• Reduce VOC emissions by 10% by 2008 from years. In 2006 19 sites received the award for out-
2003 baseline (tonnes VOC/unit sales) standing low accident rates or positive trends.
• Have no relevant SHE-related fines.
We recognise that employee well-being is not only
affected in work hours. We have started to collect
Occupational health and safety data on general absences and non work-related
accidents to assess the causes of such absences and
A safe and healthy workplace is essential for our seek possible improvements.
employees’ well-being and productivity. In our large
research and manufacturing operations, safety and Roche offers a range of programmes at our sites to
health committees have been established to help the promote employee health and well-being inside
safety, health and environment officer (SEO) raise and outside the workplace. These include free
awareness, organise training and implement tech- medical check-ups, workplace ergonomic evalua-
nical improvements to reduce risks in the work- tions, counselling, fitness centres, healthy meals at
place. In smaller sites this responsibility lies solely staff restaurants and other programmes to promote
with the SEO. In 2006 a total of 126,329 hours were healthy lifestyles. We also have several initiatives to
invested globally in SHE training at Roche. promote well-being by improving our employees’
work–life balance (see page 82).
We measure our safety and health performance
using the Roche Accident Rate – the number of
working days lost due to occupational accidents Environmental footprint
per employee per year. The rate decreased by 16.5%
to 0.083 in 2006. The development of the Roche Roche is committed to environmental protection
accident rate (RAR) is showing a positive trend, throughout the lifecycle of its products – from
i. e. a decreasing number of accidents. The severity research and production to packaging, transport
of the accidents, however, is going into the oppo- and distribution, use and disposal.
site direction, i. e. more lost days per accident are
reported than last year. Concerning occupational We measure our global environmental footprint
diseases, both numbers of recognised cases as well using our Eco-Efficiency Rate (EER) – the ratio of
as lost days per case are lower than in 2005. The sales to environmental impacts and expenditure.
majority of cases (77%) are still referring to the Eco-efficiency as described by the World Business
locomotor system. Council for Sustainable Development (WBCSD) is
the concept of creating more value with less nega-
Health and safety tive impact. The EER takes into account a wide
2006 2005 2004 range of factors such as energy use and emissions to
Roche Accident Rate 0.083 0.099 0.088 air and water – weighted according to their signifi-
Occupational accidents 473 563 493 cance – to produce a single value. The higher the
Occupational illnesses 302 333 208 EER, the greater the degree of eco-efficiency. A full
Work-related fatalities 0 0 0 explanation of how the EER is calculated can be
Work-related accidents found on our website.
per million working hours 3.67 4.66 4.78

Business Report 2006 89


Safety, health and environmental protection

In 2006 our EER was 49.97, an increase of more than nated soil; water; SHE aspects of biotechnology
100% from the previous year. The different sources and prevention of misuse of biological materials for
of this tremendous improvement are an almost 50% biowarfare. These are available on our website.
reduction in the environmental damage (in par-
ticular emissions to the air and the water, including
corrections of former overreportings) as well as the Energy and climate change
very pleasing development of the sales figures.
Global warming and climate change have been well
Eco-Efficiency Rate documented. Greenhouse gas emissions – such as
2006 2005 2004 carbon dioxide – resulting from human activities
Sales (in millions of CHF) 42,041 35,511 29,522 are considered responsible for accelerating these
Environmental expenditure global trends. Industry is one source of these emis-
(in millions of CHF) 255 242 192 sions and must take appropriate measures to reduce
Environmental damage its impact. International agreements, such as the
(in millions of environmental Kyoto Protocol, and national legislation define tar-
damage units) 3.30 6.02 8.40 gets and schedules for reducing emissions.
EER 49.97 24.39 18.31
Roche supports the targets set out in the Kyoto Pro-
We also calculate our eco-balance to define the tocol to reduce global greenhouse gas emissions.
ecological impact of Roche’s operations without We are working towards our own goal – set in 2003
considering economic parameters, according to the – to reduce our emissions by 10% over the five years
method set out by the Swiss Agency for the Envi- until 2008. Because of the close link between car-
ronment (BAFU). Eco-balance takes into account bon dioxide emissions and energy use, most meas-
outputs to the environment – emissions and waste – ures to reduce energy consumption also decrease
and use of resources such as raw materials and these emissions. Roche promotes measures such as
energy. Each parameter is weighted according to the moving to less emission-intensive energy sources,
significance of its impact. By setting a global target applying innovative building technology and con-
to improve our eco-balance – encompassing our tinually upgrading our infrastructure to improve
entire environmental footprint – individual sites energy efficiency. In 2006 Roche used 12,467 tera-
are able to identify and focus on areas where they joules of energy, almost the same amount as in 2005
can make most significant improvements. Our eco- despite business growth of 18.4%.
balance in 2006 was 5.42, already matching our
global target for 2015. We run an ECOmpetition Roche is introducing fuel-efficient low-emission
every three years to encourage employees to think hybrid vehicles to its fleet of corporate cars,
about the environment and submit ideas on its to reduce emissions from transport. More than
protection. These initiatives not only benefit the 240 hybrid vehicles have been introduced to Roche
environment but can also cut costs significantly, Pharmaceuticals’ fleet in the USA since a similar
for example by introducing measures to reduce programme was introduced there in 2004. Roche
energy use of air-conditioning systems at several Group member Chugai, in Japan, added more
sites. Entries are being submitted for the current hybrid cars to its fleet in 2006, bringing the total to
competition launched in October 2006. From 2007 48. Employees in Australia are now offered hybrid
the Roche Responsible Care Network Awards will vehicles as company cars. Roche Australia has
reward energy-saving initiatives to encourage sites begun to offset carbon emissions from transport by
to help us meet our global commitment to reduce planting trees on an area destroyed by fire.
energy use by 10% by 2010. In 2006, we published
new global position papers setting out our strategies Our affiliates in North and South America held
on six key environmental issues, meeting last year’s their first annual energy conservation summit in
goal to hold a public position on key topics of 2006 to discuss strategy, share best practice on
public interest. Topics covered are: greenhouse gases energy conservation and promote the message that
and climate change; energy; landfills and contami- every employee can help to conserve energy.

90 Business Report 2006


Safety, health and environmental protection

Roche is committed to phasing out all halogenated Energy use by type (%)
hydrocarbons – potent greenhouse gases and ozone
depleters – from our cooling systems by 2015. In
2006, we reduced our holdings of these gases by 5%
Natural gas 39.9
to 141.2 tonnes, compared to 2005. The gases are
Oil 3
held in sealed cooling systems and fire extinguish-
Coal 0
ers but some leakage does occur, resulting in emis-
Waste 1.4
sions of 7.7 tonnes in 2006, up from 7.2 tonnes the
Renewable energy 0.4
previous year.

We have developed plans to replace cooling equip- District heating 4.6


ment containing halogenated hydrocarbons across
Fuel used by
the business. Roche Diagnostics, for example, is company vehicles 9.3
investing around 64 million Swiss francs in an
Fuel due to business air travel 12.7
ammonia-based refrigeration plant at its US head-
Grid electricity 28.7
quarters in Indianapolis. The new plant – due for
completion in 2009 – will replace all current cool-
ing systems at the site that contain environmentally
hazardous refrigerants. Emissions to air

We measure our greenhouse gas emissions in Volatile organic compounds (VOCs) from manu-
accordance with the Greenhouse Gas Protocol, facturing processes and particulates from combus-
taking into account both direct emissions (from tion plants contribute to local air pollution and
waste incineration, transport, power generation smog. In 2006 Roche emitted 281 tonnes of VOCs
from fossil fuels) and indirect emissions (from grid and 27 tonnes of particulates, compared with 604
electricity). Emissions from halogenated hydro- tonnes and 50 tonnes in 2005, respectively.
carbons are included as CO2 equivalents. Roche
emitted 0.980 million tonnes of CO2 equivalents These significant reductions are to a large extent
in 2006, 9.1% down from 1.078 million tonnes in due to over-reporting by one main contributor in
2005. previous years that has now been corrected. We
have introduced closed systems or suitable exhaust
Roche calculates its impact on climate change by air treatment at a number of our sites to reduce
normalising our total emissions – expressed as CO2 these emissions.
equivalents – per million Swiss francs of sales. In
2006, the result was 23.31, a decrease of 23.2% from Nitrogen oxides (NOX) and sulphur dioxide (SO2)
the previous year. emissions can contribute to acid rain. Roche emit-
ted 219 tonnes of NOX and 15 tonnes of SO2 from
Total energy use (terajoules) burning fossil fuels in 2006. This represents – on a
2006 2005 2004 very low level – a reduction in overall inorganic
Total energy use 12,467 12,515 11,909 emissions of 54% from the previous year.
Total energy use per
million CHF of sales 0.296 0.352 0.403 We invested some 25 million Swiss francs to mod-
ernise and convert the power station that supplies
Greenhouse gas emissions (tonnes CO2 equivalents) our Mannheim site in Germany from coal to natu-
2006 2005 2004 ral gas in 2005. This has reduced emissions of nitro-
Total emissions 980,008 1,078,445 1,027,567 gen oxides by nearly 30% a year and emissions of
Total emissions per sulphur dioxide and dust to almost zero. The more
million CHF of sales 23.31 30.37 34.80 efficient modernised plant has cut carbon dioxide
emissions by more than 30,000 tonnes a year, a
reduction of more than 45%.

Business Report 2006 91


Safety, health and environmental protection

SHE training

Manuel Glauser, Head of the Corporate Safety


and Environment audit team and Andreas
Riesen, Health Protection Manager for our Basel
and Kaiseraugst sites in Switzerland, talk about
SHE training at Roche.

How does training at Group level help to embed


SHE knowledge throughout the Group?
We drive SHE awareness through the company by
‘teaching the teachers’. We hold a conference every
two years to train SEOs from around the world. They
share this knowledge with employees at their own sites.

Does this training raise awareness of Roche SHE representatives can use at their sites. We also offer a
goals? further education programme on SHE issues for those
The SHE goals were a key focus of this year’s confer- interested in knowing more.
ence in Germany. Participants created local action
plans for their own sites to support our global SHE Are new recruits introduced to SHE procedures
goals. as part of their induction?
Until now, new employees have been introduced to
Do you have local training? SHE as part of their general induction to their depart-
Our network of SEOs are the backbone of the SHE ments. Right now, we are completing a computer-
organisation at Roche. They lead the SHE organisation based training programme which will be mandatory for
at site and company level and provide professional all new employees. All new employees will be asked to
knowledge, tools and support. We have a range of complete a checklist with the help of their supervisor or
tailor-made SHE training courses – from classroom- colleagues to help them learn about SHE procedures
based lectures to hands-on training – that local SHE specific to their workplace.

Waste tinually working to improve yields. In addition, we


explore possibilities of recycling or valorisation –
Chemical waste – a result of pharmaceuticals pro- finding a customer who can use a waste product from
duction – can pose potential risks to the environ- our process as a raw material for something else.
ment if not disposed of responsibly. In 2006
51,155 tonnes of chemical wastes were generated, Our operations generated 20,719 tonnes of general
of which 91% were incinerated. A further 9% – waste in 2006, compared with 17,604 tonnes the
inert materials such as incineration ash and slag previous year. This increase is mainly a result of
– went to landfill. This increase in chemical waste construction waste. Around 23% was incinerated
from 2005 of around one third is primarily as a and the rest was sent to landfill. Landfills that have
result of increased production waste from Tamiflu historically been used for chemical waste besides
manufacturing. inert materials are subject to increased monitoring.
Where Roche assumes responsibility for such a
Chemical waste originates from our manufacturing landfill site, we conduct a risk assessment on poten-
processes. To reduce this type of waste, we are con- tial leakage and take preventative action. Remedia-

92 Business Report 2006


Safety, health and environmental protection

tion has already been completed at some sites and is potentially damage ecosystems. In 2006, 1,086 kilo-
ongoing at others. grams of heavy metals were emitted after treat-
ment, down 26% from the previous year.
An additional 25,200 tonnes of materials such as
paper, cardboard, glass, metals, wood and plastics Roche supports research into the source and impact
were recycled. of trace chemicals – including pharmaceuticals –
in watercourses. Environmental risk assessments
have shown that active pharmaceutical ingredients
Water found in watercourses are primarily caused by
both normal use and inappropriate disposal of
The availability of clean water is critical to Roche. our products by consumers, not by pollution from
We cannot manufacture pharmaceuticals and diag- manufacturing sites.
nostic products without it. The use of biotechnol-
ogy is replacing some chemical processes in our
research and production, reducing safety risks, but Compliance and incidents
these techniques also require greater water use.
In 2006 we used 4.3 million cubic metres of water. We are committed to fully complying with all rele-
We are committed to reducing our water consump- vant laws and regulations in all countries where we
tion through local programmes at site level as well operate. Our own SHE global standards and guide-
as through efforts to improve our eco-balance. lines take precedence where they exceed local regu-
lations. Roche received no significant SHE-related
A winning idea from the 2004 ECOmpetition was fines in 2006 and no incident or accident with a
realised in 2006. Roche Jacarepaguá in Brazil has significant impact on people or the environment
cut its total water use by 12% by reusing wastewater was reported anywhere in the Roche Group.
in a cooling system, saving approximately 130,000
Swiss francs a year. Roche recognises that some substances used in
the manufacture of pharmaceutical products could
Water consumption (million cubic metres) potentially be misused for narcotics, toxins or
2006 2005 2004 chemical weapons. Such regulated chemicals are
Water use 4.3 3.9 4.3 used by Roche only in small quantities, under rig-
Total water use (cubic metres orous control and in compliance with all applicable
per million CHF of sales) 101.5 109.8 145.65 legislation.

Contaminated wastewater from manufacturing is, More on the web:


where necessary, processed at on-site pre-treatment
plants before it is released to public treatment • SHE Policy, Guidelines and organisational structure:
plants or watercourses. Some volatile solvents can www.roche.com/sus-she
be removed before treatment. In 2006, 313 tonnes • Position papers:
of organic materials (total organic carbon – TOC) www.roche.com/sus-she_policies_positions
were discharged into watercourses after treatment, • Policy on regulated chemicals
a decrease of 83% from 2005. This significant www.roche.com/sus-chemicals
reduction is partly due to the detection of over- • Responsible Care:
reporting from a major contributor in previous www.roche.com/sus-responsible_care
years. In addition, our Clarecastle site in Ireland • Performance data long-term trends and definitions:
has made considerable improvements to its TOC www.roche.com/sus-she_performance
elimination processes.

Small amounts of heavy metals such as copper, zinc


and chromium are leached from piping by acidic
wastewater. These are not biodegradable and can

Business Report 2006 93


Assurance

Assurance

Independent Assurance Report on the Roche nal guidelines, definitions and procedures estab-
Group Sustainability Reporting lished to prepare and report on its sustainability
performance.
To the Roche Corporate Sustainability Committee:
Roche Group is responsible for both the subject
We have performed evidence-gathering procedures matter and the evaluation criteria.
to provide assurance on the Sustainability Report-
ing of Roche and its consolidated subsidiaries Our responsibility is to provide a conclusion on the
excluding Chugai and Genentech (the ‘Group’), all subject matter based on our evidence-gathering
for the year ended December 31, 2006. procedures in accordance with the International
Standard on Assurance Engagements (ISAE) 3000
We have performed evidence-gathering proce- ‘Assurance Engagements other than Audits or
dures on (hereafter jointly referred as the ‘subject Reviews of Historical Information’, approved
matter’): December 2003 by the International Auditing and
Assurance Standards Board (IAASB).
• The SHE key figures in the tables from pages 88
to 93; We planned and performed our evidence-gathering
• Some selected social dimension information procedures to obtain a basis for our conclusions in
(‘social data’); accordance with an ISAE 3000 limited and reason-
• The management and reporting processes for the able assurance engagement. We have not performed
preparation of the report and figures. an audit according to International Standards on
Auditing. Accordingly, we do not express such an
We have evaluated the subject matter against the audit opinion.
following criteria (‘evaluation criteria’) described
on pages 88 and 95: Our evidence-gathering procedures included the
following work:
• The Roche Group internal sustainability report-
ing guidelines with respect to the Responsible • At the site level, assessing how Roche staff apply
Care Health, Safety and Environmental reporting the Group internal sustainability reporting
guidelines published by the European Chemical guidelines as well as observing compliance with
Industry Council CEFIC and the ‘Sustainability the Group internal sustainability reporting
Reporting Guidelines 2002’ published by the guidelines, visiting a sample of five sites in
Global Reporting Initiative (GRI); Switzerland, Sweden, Poland, and the US, cover-
• The procedures by which the SHE data and the ing the Pharmaceuticals and Diagnostics divi-
social data are prepared, collated and aggregated sions;
internally; • Performing tests on a sample basis of the internal
• The control environment over the accuracy and sustainability reporting system used to collect
completeness of the SHE data and the social SHE data and the social data from Group sites;
data. • Performing specific procedures to check, on a
sample basis, the SHE data and the social data;
The accuracy and completeness of sustainability • Interviewing the responsible staff for data collec-
data is subject to inherent limitations given their tion and sustainability reporting on the sites we
nature and methods for determining, calculating or visited and on Group level;
estimating such data. Our Assurance Report should • Assessing the data consolidation process on
therefore be read in connection with Roche’s inter- Group level;

94 Business Report 2006


Assurance

• Reading and performing tests of the relevant dimension information, in all material respects,
documentation on a sample basis, including based on the evaluation criteria.
Group policies, management and reporting
structures, documentation and systems used to Based on our work described in this report, nothing
collect, analyse and aggregate reported SHE data has come to our attention that causes us to believe
and social data; that the SHE and social dimension information dis-
• Performing tests on a sample basis of evidence closed with the Sustainability Reporting does not
supporting selected SHE data and social data with give a fair picture of the SHE and social perform-
regard to the reported data aggregation from the ance, or that the procedures by which the SHE
selected sites to Group level. data and social dimension information were pre-
pared, collated and aggregated are not based on
However, we have not performed site visits at established and accepted measurement and analyt-
Chugai and Genentech. ical methods, in all material respects, based on the
evaluation criteria.
In our opinion
PricewaterhouseCoopers AG, Basel,
• the Roche Group internal sustainability reporting 19 January, 2007
guidelines are applied properly at the selected
sites;
• the internal SHE reporting system on the Group
level to collect the SHE data is functioning as
designed;
• the social dimension reporting provides an
appropriate basis for the disclosure of social Dr Thomas Scheiwiller Jürg Hutter

The Global Reporting Initiative ‘This report has been prepared in accordance with
sustainability reporting guidelines the 2002 GRI Guidelines. It represents a balanced
and reasonable presentation of our organisation’s
We report in accordance with the 2002 Global economic, environmental, and social performance.’
Reporting Initiative (GRI) Guidelines through our
Annual Report and website. The GRI has reviewed
this report and confirms it meets ‘In Accordance’
criterion.

Details of how we report against each indicator can


be found at www.roche.com/sus_gri Franz B. Humer

Business Report 2006 95


Sales Manufacturing

Overview Switzerland Croatia


Argentina Czech Republic
Australia Denmark
Austria Dominican Republic
Belgium Ecuador
Bermuda El Salvador
Brazil Estonia
Bulgaria Finland
Canada France
Chile Germany
China Greece
Colombia Guatemala
Costa Rica Honduras

96 Business Report 2006


Roche – a Global Market Presence

Roche – a Global Market Presence

Research and development Services, financing Toll manufacturing by third parties

Hungary New Zealand Slovakia


India Nicaragua Slovenia
Indonesia Norway South Africa
Ireland Pakistan South Korea
Italy Panama Spain
Japan Peru Sweden
Latvia Philippines Taiwan
Lithuania Poland Thailand
Luxembourg Portugal Turkey
Malaysia Romania United Kingdom
Mexico Russia United States
Morocco Serbia Uruguay
Netherlands Singapore Venezuela

Business Report 2006 97


Published by Cautionary statement regarding forward-
F. Hoffmann-La Roche Ltd looking statements
4070 Basel, Switzerland This Annual Report contains certain forward-look-
Tel. +41 (0)61 688 11 11 ing statements. These forward-looking statements
Fax +41 (0)61 691 93 91 may be identified by words such as ‘believes’,
‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’,
Media Office ‘seeks’, ‘estimates’, ‘future’ or similar expressions
Corporate Communications or by discussion of, among other things, strategy,
4070 Basel, Switzerland goals, plans or intentions. Various factors may
Tel. +41 (0)61 688 88 88 cause actual results to differ materially in the future
Fax +41 (0)61 688 27 75 from those reflected in forward-looking statements
contained in this Annual Report, among others:
Investor Relations (1) pricing and product initiatives of competitors;
4070 Basel, Switzerland (2) legislative and regulatory developments and
Tel. +41 (0)61 688 88 80 economic conditions; (3) delay or inability in
Fax +41 (0)61 691 00 14 obtaining regulatory approvals or bringing prod-
ucts to market; (4) fluctuations in currency
World Wide Web exchange rates and general financial market condi-
http://www.roche.com tions; (5) uncertainties in the discovery, develop-
ment or marketing of new products or new uses
Corporate Sustainability Committee of existing products, including without limitation
Pierre Jaccoud, Chair negative results of clinical trials or research projects,
Tel. +41 (0)61 688 85 95 unexpected side effects of pipeline or marketed
E-mail: pierre.jaccoud@roche.com products; (6) increased government pricing pres-
sures; (7) interruptions in production; (8) loss of
To order publications or inability to obtain adequate protection for intel-
Tel. +41 (0)61 688 83 39 lectual property rights; (9) litigation; (10) loss of
Fax +41 (0)61 688 43 43 key executives or other employees; and (11) adverse
E-mail: basel.webmaster@roche.com publicity and news coverage.

The statement regarding earnings per share growth


is not a profit forecast and should not be inter-
preted to mean that Roche’s earnings or earnings
per share for 2007 or any subsequent period will
necessarily match or exceed the historical published
earnings or earnings per share of Roche.

Next Annual General Meeting: 5 March 2007

All trademarks mentioned enjoy legal protection.

The Roche Annual Report is published in German and English.

Printed on non-chloride bleached paper.

The Roche Annual Report is issued by F. Hoffmann-La Roche


Ltd, Basel, Corporate Communications.

98 Business Report 2006


7-000-769

You might also like