Roche in Australia Pharmaceutical business overvie · Pharmaceutical business overview. Business Overview | 3 ... Our business model drives our ambition to make a significant difference

Roche in Australia Pharmaceutical business overview

Business Overview | 3

About Roche

Innovating to improve lives

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, its two core business areas. We are the world’s largest biopharmaceutical company, with truly differentiated medicines in cancer, immunology, infectious diseases, ophthalmology and neuroscience. Twenty-nine medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them antibiotics, anti-malarials and chemotherapy. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

“For nearly 120 years, Roche has been committed to improving lives. The long term thinking of our founders and their descendants has allowed us to stay true to this vision and shapes the way we make a difference in the lives of millions of patients around the world. Our success in a rapidly evolving, complex healthcare environment hinges on our ability to develop strategies that benefit both industry and society. This means delivering innovative medical solutions and ensuring broad access to them, providing a rewarding workplace, being a responsible and compliant partner and engaging in the communities where we operate.

Our mission is to deliver the best possible patient outcomes by ensuring optimal access and appropriate use of our innovative medicines.

Ultimately, lasting innovation is our greatest contribution to society. This is our legacy and a great responsibility for the future as the world’s largest biopharmaceutical company.”

Svend Petersen Managing Director, Roche (Pharmaceuticals) Australia

At Roche, we strive to create superior

value for all our stakeholders – for

patients, healthcare professionals,

employees, shareholders and society

at large.

4 | Business Overview Business Overview | 5

* Figures correct December 2015 unless otherwise stated

charities supported in research, education and awareness activities for the public, patients and healthcare professionals

years of commitment to the health and wellbeing of Australians

+ 60

in the Dow Jones Sustainability Index for the 7th year runningNo.1

Australian dollars invested in local research and development each year

36 million

patients currently enrolled in Roche clinical trials in Australia

3,900

Highlights

+ 350employees working in 5 states across Australia

1200

9 additional treatment options made available on the Pharmaceutical Benefits Scheme in 2014 and 2015

provided to children’s charities through employee fundraising activities

19,766 Australian dollars

reduction in energyconsumption48%

(electricity and gas) over the last 8 years

16including 68 people dedicated to clinical research in Australia

clinical research employees

hours volunteered by employees to support local charitable causes

420

provided with free or subsidised access to Roche medicines in 2015

39medicines registered for use by Australian patients

+ + +

Roche clinical trials

sites nationwide

100700

active across

110

patients

Highlights


Roche Globally and in Australia

For over 60 years, Roche has been dedicated to the health and wellbeing of Australians.

Our historyF. Hoffmann-La Roche & Co. was founded at a time when industrial revolution was changing the face of Europe. On October 1, 1896, at the age of 28, Fritz Hoffmann launched his company in Basel, Switzerland. He was among the first to recognise that the industrial manufacture of medicines would be a major advance in the fight against disease. Over the years, Roche’s portfolio has included cough syrups, analgesics, sedatives, vitamins, cosmetics, antibiotics, diagnostics and many other specialty medicines for serious illnesses.

In 1942, Roche sold its first products in Australia, distributing from premises in central Sydney. In 1964, headquarters were established in Dee Why, on the Northern Beaches, including facilities for offices, distribution, and manufacturing for prescription and over the counter pharmaceuticals, and consumer health products.

Roche today Today, Roche has grown into one of the world’s leading healthcare companies operating in 100 countries with over 91,700 employees. Roche is a market-leading, research-focused healthcare company, working diligently to develop innovative diagnostics and medicines to address unmet medical need. Our business model drives our ambition to make a significant difference to patients, reaching as many people in need as possible whilst continuously reinvesting in innovation.

Globally, Roche has grown to be the largest biopharmaceutical company in the world, investing around 10 billion US dollars each year in research and development worldwide. Last year over 25 million patients were treated with one of Roche’s top 25 products.

Roche’s pharmaceutical division in Australia is dedicated to the clinical development, registration, sales, marketing and distribution of innovative pharmaceutical medicines. Each year Roche invests approximately 36 million Australian Dollars in local pharmaceutical research and development. Australian patients have access to 39 Roche medicines, and the company is the leading provider of cancer medicines in Australia by sales.

Over the last two decades, Roche has become a leading specialist in biotechnology focused on developing medicines in oncology (cancer), immunology, ophthalmology, infectious diseases and neuroscience therapeutic areas.

6 | Business Overview

Roche Globally and in Australia


Patients

Our commitment to patientsEvery year, millions of people worldwide are diagnosed with a severe illness like cancer, asthma or arthritis. Two-thirds of all known diseases are either still not treated adequately or not treated at all. This represents an enormous challenge, but one with the potential to make an important difference to the lives of millions of patients and their families. At Roche, we focus exclusively on developing innovative medicines to offer patients significant benefits in terms of efficacy, quality and safety, and to help them live longer and healthier lives.

Access to healthcareEnsuring patients have access to healthcare is a shared responsibility requiring many stakeholders to work together. The pharmaceutical industry has an important role to play in this. At Roche, we believe our primary contribution is to deliver innovation in healthcare by developing medicines and diagnostics that significantly improve people’s lives.

Our aim is for every person who needs our products to be able to access them and receive their full benefit. However, there are many barriers preventing people from accessing our products. These range from inadequate disease awareness and inability to access diagnostics, healthcare facilities and trained healthcare professionals, to complex regulatory processes, reimbursement and affordability challenges.

Breaking down barriers We work with many different partners to continuously and sustainably create pathways for people to be diagnosed and treated with our medicines. Following development and registration of new medicines with the Therapeutic Goods Administration, the most equitable and sustainable access to medicines in Australia is via

the Pharmaceutical Benefits Scheme (PBS). In 2014 and 2015, nine additional Roche treatment options were made available on the PBS for the treatment of breast cancer, chronic lymphocytic leukaemia, juvenile idiopathic arthritis, lung cancer, ovarian cancer, and non-Hodgkin’s lymphoma.

The PBS has delivered broad access to medicines for generations of Australians, and Roche recognises the importance of its role. Roche supports the continued reform of the PBS to ensure the value of each medicine is assessed on a broad range of factors, such as improved health and wellbeing, productivity gains, healthcare efficiency and addressing an unmet need. We believe that continued investment in the PBS needs to be sustainable, and grow in line with the economic resources of Australia and the needs of an ageing population.

From improving affordability, to providing patients with early access to innovative medicines through clinical trials, to strengthening healthcare systems and supporting patients, Roche offers a range of practical initiatives to help those patients who need our products to access them. In 2015, we provided over 1,200 patients in Australia with access to free or subsidised Roche medicines, outside of PBS funding.

Supporting patients and their familiesWe also believe it is important to offer appropriate information and support to people who take our medicines. We work closely with a range of patient support and advocacy organisations across many disease areas to deepen our understanding of patients’ needs and the impact our medicines can have. We provide support for activities including disease awareness, education and advocacy projects, and we develop materials such as booklets and electronic apps to provide information and reminders on how to take our medicines. Through our patient kits we provide instructions for self-injection, as well as transportation and storage advice to assist patients in all aspects of managing their treatment. Our dedicated medical information line is available 24 hours a day, delivering information directly to patients, doctors and pharmacists. Each year, this service provides support to around 4,000 callers.

At Roche, patients are central to everything we do.

We are focused on increasing access to our medicines and providing support to patients.


Patients


Our Medicines

A global leader in healthcareAs an innovator of products for the detection, prevention, diagnosis and treatment of diseases, Roche contributes on a broad range of fronts, working to improve health and quality of life around the globe. We specialise in treating some of the world’s most serious diseases.

A legacy of innovationRoche has developed or produced some of modern medicine’s foundational therapies, many of which remain the standard of care across the world today, decades after their discovery. Twenty-nine medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines (2015), among them antibiotics, anti-malarials and chemotherapy.

World leader in cancer careGlobally, the Roche Group is the world’s leading provider of cancer care products. At the forefront of cancer research and treatment for over 50 years, we developed or produced some of the world’s first targeted biologic therapies – a class of monoclonal antibodies, which transformed the way many cancers are treated. Roche continues to provide patients with innovative therapies to treat breast, skin, blood, gastro-intestinal, ovarian, colorectal, lung, and numerous other cancers.

Providing other essential medicinesRoche has a broad and established portfolio of medicines beyond cancer. This includes interferon, anti-viral and anti-infective therapies to treat patients with a range of infectious diseases; monoclonal antibodies which target inflammatory conditions such as rheumatoid arthritis and vasculitis; and a range of therapies which help patients with neurological disorders such as Parkinson’s disease, depression and anxiety.

Leading in personalised healthcare At Roche, personalised healthcare means fitting the treatment to the patients – providing the right therapy for the right group of people at the right time. Personalised healthcare has the potential to identify those patients who will benefit most from a specific treatment, thereby reducing the risk of ineffective treatment and/or adverse events.

Combining our strength in pharmaceuticals with the Roche Group’s diagnostics division, we have positioned personalised healthcare at the centre of our business strategy. With growing insight into genetic differences, we are able to develop tests and treatments that help tailor medicines to the people who are most likely to respond well. This approach will continue to shape the future of medicine. In fact, two-thirds of our new medicines are being developed with companion diagnostics.

In 2015, Roche (globally) entered into a broad strategic collaboration with Foundation Medicine to leverage the organisation’s expertise in the field of genomics and molecular information. Combined with Roche’s expertise in oncology, this partnership provides the opportunity to characterise tumours and match them with approved targeted therapy options or novel treatments under development, to advance the progress of personalised treatments for patients with cancer.

Roche plays a pioneering role in healthcare.

In Australia, Roche is the

leading provider of cancer

medicines by sales.31%

Roche

22%Other

17%Novartis

8%Celgene

6%AstraZeneca

7%BMS


Our Medicines

Roche is the no. 1 provider of cancer medicines in Australia with 31% market share (IMS data, October 2015) 9%

Janssen


Innovation guided by long-term orientation The entrepreneurial spirit and inventiveness of the founding era still defines our culture – a culture that encourages innovation and a willingness to take risks. Roche regards lasting innovation as the company’s most important contribution to society. Backed by stable majority owners for over 100 years, Roche strives for long-term value creation rather than short-term gain, because real innovation in our industry requires perseverance and long-term thinking.

Our development pipelineRoche has an industry-leading pipeline. We focus on identifying potential first-in-class or best-in-class medicines which have the potential to offer significant benefits for patients in the future. Breakthrough innovation in science and technology increasingly allows us to understand what is malfunctioning in the body and develop medicines to counter the problem.

A greater understanding of the genetic drivers of disease and the ability to leverage technology means we may be able to get new medicines to patients faster and more efficiently.

Roche is consistently ranked among the top investors in research and development worldwide, across all sectors, reflecting our commitment to innovation and science.

For more information on the Roche development pipeline, visit: www.roche-australia.com/home/research.html

At Roche, we strive to address unmet medical needs through excellence in science.

We are passionate about fostering ideas and studies that help save lives. We focus our research activities on areas where there are currently no satisfactory therapeutic solutions.

InnovationInnovation

Roche has an industry-leading pipeline with 70 compounds in clinical development.


Innovation

Focus on significant unmet medical needWe’re developing medicines in the areas where we see the greatest need:

• In oncology (cancer), we are working to provide effective treatments through the discovery and development of novel therapeutics that target the specific molecular pathways associated with cancer

• In immunology, we are growing our expertise so that we can continue to discover and develop innovative medicines for patients living with diseases, such as rheumatoid arthritis or asthma

• In neuroscience, we are developing medicines for a range of serious neurological diseases including schizophrenia, Alzheimer’s disease, multiple sclerosis, depression, Parkinson’s disease, Down syndrome and autism

• In infectious diseases, we are committed to finding effective treatments for life-threatening viral and bacterial infections which are among the leading causes of disability and death

The benefit we bring to patients is the ultimate measure of our success. Roche will remain successful by continuing to develop medicines that add value for patients and their physicians in areas of high unmet medical need.

Collaboration is the keyWe do this by maintaining a model that values external innovation as highly as our own internal discoveries and we view established collaborations as a cornerstone of our research and development strategy. As a result, in 2015 we had over 200 external partnerships and alliances worldwide with companies and institutes.

Clinical researchClinical trials are critical for determining the safety and efficacy of new medicines. Globally, over 320,000 patients participated in a Roche clinical trial in 2015. In Australia, we have over 100 active clinical trials involving nearly 4,000 patients. Roche invests around 36 million Australian dollars each year in local research and development, and employs over 100 clinical research staff. Further information on Roche clinical trials is available at http://rochetrials.com.

Patient safety is our highest priority. Roche follows stringent principles, regulations and guidelines to ensure that we maintain the highest ethical standards in our research and that volunteers and patients are exposed to the lowest risk possible.

2015 Rank

2014 Rank Company Geography Industry R&D Spend

(US $Bn)*

1 1 Volkswagen Germany Automotive 15.3

2 2 Samsung South Korea Computing and electronics 14.1

3 3 Intel United States Computing and electronics 11.5

4 4 Microsoft United States Software and internet 11.4

5 5 Roche Switzerland Healthcare 10.8

6 9 Google United States Software and internet 9.8

7 14 Amazon United States Software and internet 9.3

8 7 Toyota United States Automotive 9.2

9 6 Novartis Switzerland Healthcare 9.1

10 8 Johnson & Johnson United States Healthcare 8.5

11 13 Pfizer United States Healthcare 8.4

12 12 Daimler Germany Automotive 7.6

13 11 GM United States Automotive 7.4

14 10 Merck United States Healthcare 7.2

15 15 Ford United States Automotive 6.9

16 16 Sanofi-Aventis France Healthcare 6.4

17 20 Cisco United States Computing and electronics 6.3

18 32 Apple United States Computing and electronics 6.0

19 19 GlaxoSmithKline United Kingdom Healthcare 5.7

20 28 AstraZeneca United Kingdom Healthcare 5.6

Top 20 R D Spenders

*Global Innovation 1000 Study Report, PwC (2015)

2015

Roche aims to be the partner of choice for biotechnology companies and research institutions worldwide.

Innovation


People People

Globally, Roche is a force of around 91,700 people working together across more than 100 countries, with over 350 employees in Australia. We strive to attract and retain the very best talent in the industry. This commitment stems from our belief that our people are the key to bringing our medicines to patients in the most effective way.

We are dedicated to creating a dynamic, engaged, accountable and connected culture, with leaders who provide clear direction, balancing the needs of employees and the business.

We ask each of our employees for their opinion and measure their engagement through our regular employee survey. Acting on the results, we work to build an even better place to work for our people.

Embracing diversity and inclusion At Roche, we embrace the diversity of cultures and people. We are inclusive and encourage the richness of ideas and approaches that our diversity brings. 135 nationalities are represented at Roche worldwide.

All facets of diversity are important to us and we strive to create an environment where everyone, regardless of gender, race, ethnicity, sexual preference or religious background, can contribute and realise their potential. We believe diversity goes beyond visible differences to include different educational backgrounds, professional knowledge, personality types, thinking styles and life experiences. By embracing diversity, we can enrich every decision and discussion at Roche and bring our purpose to life.

Health and wellbeingWe care about what makes working at Roche a rewarding experience for our employees and we understand that many things matter: health and wellbeing, receiving support to develop your career, having the tools to do your job and being recognised when you do it well.

We have established a comprehensive wellbeing program for our employees, which includes regular health and skin checks, influenza vaccinations, an employee counselling service, access to gyms and other sports facilities. We also encourage and support our employees to participate in events outside of work to promote a healthy, active lifestyle.

In Australia, Roche is aiming to be one of the best employers in the pharmaceutical industry.

We believe that employees

who are engaged in

their work deliver the

highest quality outcomes

and the greatest levels

of innovation.

This is more than just

a job. It’s an international

family dedicated to

making a real impact on

the world around us.


More than just a jobOur people make our business. Our people research, develop and commercialise our products – products which treat some of the world’s most serious diseases – and they ensure that our medicines ultimately reach the patients who need them. For this reason, we’ve created a supportive work environment where people can be truly invested in their work.

Roche encourages big thinking and provides staff with the support, flexibility, training and development opportunities they need to make their mark.


Customer Focus

Meeting the highest safety and quality standards, ensuring the continual supply of medicines, and providing patients and their doctors with ongoing support to ensure that medicines are used in the most effective way are all fundamentally important.

Education for healthcare professionalsThe greater understanding that healthcare professionals have of our products and the best practice use of them in treating disease, the better the outcomes will be for patients. To facilitate this, we produce a broad range of educational and training materials. In addition, we host and support medical events throughout the year to provide ongoing knowledge development for healthcare practitioners in many fields.

For example, Roche’s Haematology and Oncology Targeted Therapies (HOTT) symposium has been providing ongoing training and education to oncology clinicians since 2003, by engaging many local and international thought leaders. Each year, between 150 and 400 oncology clinicians have attended the HOTT symposium.

Committed to ongoing safety monitoringWe are committed to bringing safe, effective medicines of the highest quality to our patients. To achieve this, we apply the same rigorous standards wherever a Roche medicine is manufactured or sourced.

Our quality management systems ensure adherence to laws, regulations, standards and practices. At the same time, our safety monitoring process applies for each marketed Roche medicine to assess its ongoing safety and effectiveness throughout its lifecycle. We closely monitor and alert regulatory authorities to any reports of adverse events (serious side effects). Our priority is to make sure that the therapeutic benefit of every medicine outweighs the risks.

First class customer service Our professional customer service team is at the front line in ensuring the safe and timely delivery of our medicines. The highly skilled team works to maintain first-class standards of service and quality throughout the supply chain. It operates a proactive supply management process and is amongst the industry leaders in order processing accuracy and timely delivery to customers. Beyond standard office hours, the team is contactable 24 hours a day, 7 days a week to deal with emergencies, ensuring vital medicines reach patients when they need them most.

At Roche, our commitment to patients goes far beyond the development of new medicines.


Customer Focus


Sustainable Business

As a responsible corporate citizen, Roche is committed to creating value for all stakeholders.

Guided by valuesAt Roche, we believe that a good business is an ethical business. Our three company values – courage, integrity and passion – are central to how we want to behave as individuals, and collectively as an organisation. More than just words, they are adopted by everyone who works at Roche.

Upholding ethics and compliance As one of the world’s largest healthcare companies, Roche takes its obligation seriously to meet the highest standards of business ethics and integrity. Meeting those standards is the responsibility of all our employees, as set out in our Global Code of Conduct and in our local policies, procedures and guidelines.

As a member of the industry body, Medicines Australia, Roche is committed to abiding by the Medicines Australia Code of Conduct, which provides a robust framework and standards for the communication and promotion of innovative prescription medicines in Australia. This includes the transparent reporting of support for healthcare professionals and patient organisations in relation to educational and consultancy activities to maintain trust and confidence in Roche and the wider industry.

Embedding sustainability in our work environment Throughout our operations, we continually strive to increase efficiency and effectiveness in how we operate by refining processes, prioritising the safety of our employees and our local communities and promoting The Three R’s: reduce, reuse and recycle. We consult our employees through our internal Sustainability Group and have participated in the New South Wales Office of Environment and Heritage Energy Saver program to agree on our priority focus areas.

Through a range of initiatives over the last eight years, we have significantly reduced the emissions from our fleet and travel, as well as the energy usage on our site. These initiatives include: automation of air-conditioning systems, upgrading to energy efficient lighting, installing solar hot water systems and converting air conditioning to natural refrigerants. We are also aiming for all Roche fleet vehicles to have a fuel consumption rate of 6.6L/100km or less by 2017, in line with Roche global standards.

We have established a comprehensive recycling program across our business which encourages employees not only to recycle in the office but also at home. Employees have the option of identifying and bringing items that can be used or recycled by charitable organisations to work, for further distribution.

Recognising our societal responsibilityWe are passionate about supporting the communities in which we operate. Since 2003, Roche employees worldwide have been raising funds through the annual Roche Children’s Walk. Each year, the total amount raised by local employees is matched by Roche, with 50% donated to a local children’s charity and the other 50% directed to Roche’s charitable work with children in Malawi, one of the world’s poorest countries.

Our ‘Reach Out’ volunteer week also provides every Roche employee with the opportunity to spend a day volunteering in our local community in a variety of ways. Organised events include parks, bush and beach conservation, supporting those with learning difficulties and providing welfare to disadvantaged community groups.

Roche is also proud to provide a number of philanthropic donations each year to charitable (not-for-profit) organisations in support of a wide variety of projects in areas such as: science and education, arts and culture, community and the environment, as well as humanitarian and societal support.

Integrating sustainability into our businessAt Roche, we believe sustainability is about behaving responsibly towards society as a whole. We can only be successful if we work with our stakeholders to develop strategies where both industry and society benefit in a sustainable way. By creating innovative products and ensuring broad access to them, providing a rewarding workplace, and supporting community-based projects, we can use our business to build a better tomorrow.

Reducing our energy consumption 2008 - 2015

2008

120

100

80

60

40

20

02009 2010 2011 2012 2013 2014 2015

TJ/yr

Electricity Travel Natural gas


Sustainable Business

TJ/yr = Terajoules consumed per year.


We are Roche

We believe it’s urgent to deliver medical solutions right now – even

as we develop innovations for the future. We are passionate about

transforming patients’ lives. We are courageous in both decision and

action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to

scientific rigour, unassailable ethics, and access to medical innovations

for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are

many, working as one across functions, across companies, and across

the world.

We are Roche.

Doing now what patients need next

Published byRoche Products Pty LimitedPharmaceuticals Division4-10 Inman Road, Dee Why NSW 2099, Australia +61 2 9454 9000ABN 70 000 132 865

© 2016www.roche-australia.comMaterial Number: 37556526

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Roche in Australia Pharmaceutical business overvie · Pharmaceutical business overview. Business Overview | 3 ... Our business model drives our ambition to make a significant difference