Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 1 of 159 PageID #: 1047
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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 2 of 159 PageID #: 1048
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`Experience patients telling their stories.
`Scan the marked images with the
`Xtend app to watch the videos.
`
`Annual Report 2019
`
`

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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 3 of 159 PageID #: 1049
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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 4 of 159 PageID #: 1050
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`Experience Adeline telling her story.
`
`Scan the image with the Xtend app to
`watch the video.
`
`Every day
`
`Developing cures for patients—as a science-
`driven organisation we strive towards converting
`today’s knowledge into tomorrow’s therapies.
`We are pushing boundaries.
`
`Millions of people, like Adeline, have hepatitis B and we are developing medicines to help them.
`
`

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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 5 of 159 PageID #: 1051
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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 6 of 159 PageID #: 1052
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`Everywhere
`
`Bringing our products to patients—we are
`committed to bringing our medicines and tests
`rapidly and sustainably to those who need them.
`We are open to new ideas.
`
`Working in collaboration with healthcare systems and our partners is key to resolving critical access barriers to therapies.
`
`

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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 7 of 159 PageID #: 1053
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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 8 of 159 PageID #: 1054
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`Everyone
`
`Benefiting people in need—motivated and
`skilled employees collaborate across cultures
`and locations to develop life-saving products.
`We share one purpose.
`
`An abiding dedication to high quality ensures that doctors have the backing of pioneering science to treat their patients.
`
`

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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 9 of 159 PageID #: 1055
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`Doing
`now
`what
`patients
`need next
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 10 of 159 PageID #: 1056
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`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.
`
`

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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 11 of 159 PageID #: 1057
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`Filed 12/10/20 Page 11 of 159 PageID #: 1057
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`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 12 of 159 PageID #: 1058
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`“I feel that I have been able to strengthen
`the patient’s position as a stakeholder.”
`Ike de Rooij-van Haaren, Consultant, Oman
`
`I moved to Basel five years ago with my husband and
`three sons. Just a few months later I was diagnosed
`with HER2-positive breast cancer. Fortunately, I
`received timely treatment with two of Roche’s breast
`cancer medicines in my native Holland. For that, I
`had to leave my young boys and husband behind
`here in what was a new place for them.
`
`I made up my mind while still undergoing treatment
`that I wanted to give something back to Roche. The
`company had kindly allowed me to participate in
`a study of one of its medicines and this inspired me
`greatly. I mentioned it to a friend who worked at
`Roche and he came back to me with some details
`about a project aimed at putting a patient in one of
`the brand teams to see what effect that would have
`and if it would change the decision-making within
`the team.
`
`I was nervous at first, but decided to take the plunge.
`I realised that I just had to be myself and share my
`experiences. It took a couple of meetings with the
`brand team to get used to each other. The team I got
`to work with was working on the same breast cancer
`medicine that I had been treated with. They were
`curious to hear my experience and therefore I felt
`confident to share my opinions. From the beginning
`I could see the impact of having the actual patient’s
`voice in the room. I was never interested in the
`
`numbers and always asked what it meant for
`individual patients such as myself.
`
`The project itself was meant to last three months.
`But the team realised they could benefit more from
`my journey and real-life experiences as a patient.
`Therefore, I signed a patient consultant contract and
`continued to work with Roche. It has been more
`than three years now.
`
`I now live in the Middle East and this sometimes
`poses a logistical challenge. Technology helps, but I
`try to attend meetings in person when possible. I work
`with the broader HER2 franchise team these days
`and over the years have been involved in prelaunch,
`launch and postlaunch activities. My role is to give
`the patient perspective at any stage of the medicine’s
`life cycle. I am also a member of a committee set up
`by Roche, where, along with other patients, we review
`topics that teams request advice on, such as patient
`information materials and clinical trials.
`
`I feel that I have been able to strengthen the patient’s
`position as a stakeholder. It has been difficult to
`engage with patients at times and this makes it hard
`to understand their real needs. Now, with efforts such
`as the one I am involved in, business teams are really
`looking at ways to give this important stakeholder a
`stronger voice in the work they do.
`
`Experience Ike telling her story.
`
`Scan the images with the Xtend
`app to watch the video.
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 13 of 159 PageID #: 1059
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`Innovation—it’s in our DNA
`We have always worked across disciplines and geographies to
`drive scientific discovery and redefine what is possible to improve
`patients’ lives.
`
`We are working on understanding how diseases differ
`down to molecular level. So we can develop new
`tests and medicines that prevent, diagnose and treat
`diseases, and bring them to the patients who need
`them. With our combined strengths in diagnostics
`and pharmaceuticals, our personalised healthcare
`strategy aims to fit the right treatment to the right
`patient.
`
`As the world’s largest biotech company, we develop
`breakthrough medicines, improving the standard
`of care across oncology, immunology, infectious
`diseases, ophthalmology and neuroscience. We are
`
`also the world leader in the in vitro diagnostics
`business. This track record allows us to build lasting
`and meaningful partnerships across the world with
`research academia and public healthcare institutions.
`
`The founding families continue to hold the majority
`voting stake in the company. This stability allows for
`a tradition of sustainable thinking, so we can learn
`from setbacks and focus on lasting value for patients
`and society. We remain dedicated to the highest
`standards of quality, safety and integrity. Our legacy
`is based on respect for the individual as well as the
`communities and the world we live in.
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 14 of 159 PageID #: 1060
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`Experience more about Roche.
`
`Scan the world map with the Xtend
`app to watch the video.
`
`Key figures
`
`Highlights
`
`CHF 61,466 million
`
` Group sales
`
` +9%*
`
`CHF 22,479 million
`
` Core operating profit
`
` +11%
`
`CHF 9.00
`
` Dividend
`
`CHF 11,696 million
`
` R & D core investments
`
` +6%
`
`63 million patients
`
` treated with Roche medicines
`
`32 Roche medicines
`
` on the WHO Model List of Essential Medicines
`
`Driving growth
`With CHF 5.4 billion incremental sales,
`medicines launched since 2012 drive growth
`and rejuvenation of our product portfolio
`
` Read more on page 24
`
`Treating rare cancer
`Rozlytrek approved to treat rare form of lung
`cancer that occurs in 1–2% of patients only
`
` Read more on page 35
`
`Launching cobas pro
`Next-generation integrated Serum Work
`Area solutions improve efficiency and
`shorten results delivery
`
` Read more on page 26
`
`Contributing to sustainability
`Roche ranked amongst most sustainable
`healthcare companies in the Dow Jones
`Sustainability Indices
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 15 of 159 PageID #: 1061
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`97,735
`
`employees** worldwide
`
`North America
`26,176 employees
` Genentech, South San Francisco, US ( )
` Roche Diagnostics, Indianapolis, US ( )
`
`Europe
`42,112 employees
` Basel, Kaiseraugst and Rotkreuz, Switzerland ( )
` Mannheim and Penzberg, Germany ( )
`
`Latin America
`4,682 employees
`
`Africa
`1,258 employees
`
`Asia
`22,802 employees
` Chugai, Tokyo, Japan ( )
` Shanghai and Suzhou, China ( )
`
`Australia/New Zealand
`705 employees
`
`29
`
`research and development sites in
`Pharmaceuticals and Diagnostics worldwide
`
`23
`
`manufacturing sites in Pharmaceuticals
`and Diagnostics worldwide
`
` Roche Group headquarters
` Largest sites based on number of employees
` Research and development sites in Pharmaceuticals and Diagnostics
`
` Manufacturing sites in Pharmaceuticals and Diagnostics
` Sales sites in Pharmaceuticals and Diagnostics
`
`* All growth rates in this report are at constant exchange rates (CER; average 2018).
`
`|
`
`** Number of employees expressed in full-time equivalents, on 31.12.2019
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 16 of 159 PageID #: 1062
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` 12 Overview
`
` 76 Environment
`
` 22 Business performance
`
` 86 Community engagement
`
` 42 Science and innovation
`
` 92 Integrity in business
`
` 58 Access to healthcare
`
`102 Corporate Governance
`
` 68 Our people
`
`120 Remuneration Report
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 17 of 159 PageID #: 1063
`
`
`12
`
`Material topic covered in this chapter
`
`Cybersecurity
`
`Our reporting approach
`Roche is committed to transparent reporting and we endeavour
`to drive our economic, social and environmental performance
`with the same diligence as our financial performance.
`
`Reporting scope and boundaries
`Our financial and non- financial reporting consists
`of the Annual Report, the Finance Report and the
`online report. It contains the annual financial
`statements, consolidated financial statements and
`non- financial performance indicators. It covers
`all regions and divisions of the Roche Group from
`1 January to 31 December 2019. The financial
`reporting scope is defined and outlined in our
`Finance Report, and there have been no significant
`changes in scope in 2019 compared to 2018.
`
`GRI standards and materiality
`We have followed the GRI G4 guidelines (Global
`Reporting Initiative) since 2014, and have transitioned
`to the GRI Standards in 2017. By using the GRI
`guidelines, we disclose the most critical impacts of
`our activities on the environment, society and the
`economy. In this respect, we conducted a first
`materiality analysis at the corporate level in 2014. In
`2018/2019, we conducted a second global materiality
`assessment including expert interviews and feedback
`from more than 600 stakeholders. The results of this
`assessment are featured on pages 14 and 15 of this
`report and are also published on our website (see
`link on page 14).
`
`all material risks and opportunities, is discussed
`annually with the Corporate Executive Committee
`and reviewed by the Audit Committee of the Board
`of Directors and by the Board of Directors. The
`effectiveness of the Group Risk Management Process
`is regularly monitored by the Group Risk Advisory
`team, and the overall process is reviewed externally
`when appropriate. Risk management is embedded at
`all levels of the Group. Our Pharmaceuticals and
`Diagnostics Divisions and global functions conduct
`a formal risk assessment process at least once a year
`and must develop mitigation plans for their most
`material risks.
`
` Read more in ‘Corporate Governance’ on page 102
`
`We also identify long-term business sustainability
`trends with associated risks and opportunities on
`an annual basis and integrate these into our existing
`Group risk management process. Each year, emerging
`trends (including associated risks and opportunities)
`are identified from internal and external sources.
`Based on these findings the Corporate Sustainability
`Committee prioritises and selects the top business
`sustainability trends. Among those identified trends
`are technological transformation and rising cyber
`dependency.
`
`Risk management
`Our Risk Management Policy sets out Roche’s
`approach to identifying, analysing, managing and
`reporting internal and external risks and opportunities.
`A consolidated Group Risk Report, which covers
`
`UN Sustainable Development Goals
`We support the United Nations Sustainable
`Development Goals (SDGs) within the sphere of
`our corporate business strategy. We contribute to
`
`www
`
`Report 2019:
`ar19.roche.com
`roche.com/ar19e.pdf
`roche.com/fb19e.pdf
`
`Risk management:
`roche.com/risk-
`management
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 18 of 159 PageID #: 1064
`Our reporting approach | Roche
`13
`
`a number of the SDGs and are particularly
`pleased to see a dedicated goal on Health (SDG 3).
`This goal is closely connected with the achievement
`of universal health coverage, which goes hand in
`hand with better access to quality essential medicines
`and diagnostics. This fits in perfectly with our vision
`to improve and save lives. Since 2016, the SDGs
`have been an integral part of our annual reporting.
`Examples of our contribution to the UN goals
`are listed on our UN SDG webpage (see link on
`page 14).
`
`External assurance
`Our non-financial reporting has been verified by an
`independent third party. PricewaterhouseCoopers AG
`(PwC) focused on the materiality determination
`process, the design of the sustainability risks and
`opportunities determination process and on the
`figures in the areas of Safety, Security, Health and
`Environmental protection, people and contributions.
`Roche strengthened its control framework, review
`procedures and reporting aspects in terms of
`contributions to healthcare and patient organisations
`in 2019. For example, a new Roche directive was
`developed and communicated to the respective
`internal stakeholders. As a result, the figures related
`to our grants, donations and sponsorships to
`healthcare and patient organisations are subject to
`reasonable assurance performed by PwC (limited
`assurance procedures in prior years).
`
` See ‘Independent assurance report’ on page 150
`
`Business sustainability trends
`
`Technological transformation
`Digital evolution in the external world helps drive the
`technological transformation of Roche and this allows us to
`develop more effective and tailored solutions in healthcare
`and to create new markets. Our Digital Growth Network
`has the mandate to safeguard compliance and, at the same
`time, to accelerate and enable digital innovation across
`the organisation. The Roche Digital Registry provides a
`live database of digital channels in our ecosystem that
`helps in ensuring compliance, transparency and efficiency.
`In addition, the risks associated with technological
`transformation are assessed and managed through the
`Group Risk Management Process.
`
`Rising cyber dependency
`In an era where cybersecurity threats are constantly on
`the rise, we are committed to security enhancements
`and personal privacy protection. Roche initiated the Bug
`Bounty programme where we partner with the global
`hacker community to identify the most relevant security
`issues before they are exploited by non-authorised external
`users. In addition, the data privacy aspect is included in
`our Roche Supplier Code of Conduct to ensure proper
`use of confidential information by third parties.
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 19 of 159 PageID #: 1065
`
`
`14
`
`Materiality assessment and stakeholder
`engagement
`Engaging with our stakeholders is essential to build trust and an
`understanding of their expectations. By embedding their feedback
`in our strategy and our daily business, we are able to jointly
`address our common issues and develop long-term solutions.
`
`In order to identify the topics that are particularly
`relevant to Roche, its stakeholders and society at
`large to deliver lasting shared value, we conducted
`an in-depth materiality assessment at corporate level
`among our key stakeholders in 2018/2019. This built
`on the first materiality analysis that was conducted
`in 2014 and added an external perspective, gaining
`critical insights into what is important to our
`stakeholders, and what they consider as emerging
`trends and topics.
`
`Our approach
`Our approach to materiality assessment is
`integrated—building on our Group Risk Management
`Process—and inclusive, being designed collaboratively
`with colleagues across multiple functions (Risk
`Advisory, Human Resources, Investor Relations,
`Compliance, Finance, Safety, Security, Health
`and Environmental Protection as well as
`Communications).
`
`We took the outcomes of our Group Risk
`Management Process as a starting point to identify
`those key emerging trends of relevance to the Roche
`Group. We then conducted qualitative interviews
`with more than 30 experts (across broad stakeholder
`categories, including patient organisations, global
`
`institutions, peers, suppliers, contract research
`organisations, universities and investors) and
`collected over 600 external and internal stakeholder
`views via an online survey to identify the most
`important and pressing issues that Roche should
`address in the next three to five years.
`
`In a final step, we analysed the various insights
`and identified 19 material topics that stood out as
`highly relevant to us and to our key stakeholders. To
`properly address these topics, we have then aligned
`them with our current goals and are measuring
`performance through our defined set of indicators.
`
`In addition, the materiality assessment has been
`shared internally with the functions in charge of
`managing respective topics. It has also informed
`discussion to define our new corporate goals,
`subsequent sustainability objectives and
`communications priorities that will be rolled out
`in 2020. Finally, the outcomes of the materiality
`assessment will be fed back into our 2020
`Group Risk Management Process.
`
`The process and the results of our materiality
`analysis have been endorsed by the Roche Corporate
`Sustainability Committee.
`
`www
`
`Materiality:
`roche.com/materiality
`
`Key performance
`indicators:
`roche.com/
`performance
`
`Our contribution
`to the UN SDGs:
`roche.com/un-sdgs
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 20 of 159 PageID #: 1066
`Materiality | Roche
`15
`
`Our 19 material topics
`
`We are committed to delivering sustainable value to all stakeholders by addressing the following material topics:
`
`Our commitment
`
`Our performance
`
`Our material topics
`
`Supporting UN SDGs
`
`Innovating for patients
`We are committed to developing medicines
`and diagnostics that significantly improve
`people’s lives, and to delivering rapid,
`broad, sustainable patient access to our
`products.
`
`Being a trustworthy partner
`We are committed to establishing mutually
`beneficial, long-term relationships with
`our partners.
`
`Providing a great workplace
`We are committed to providing a work
`environment where our employees are
`encouraged to build their careers and
`pursue their passions.
`
`Protecting the environment
`We are committed to minimising our
`environmental impact in our operations
`and in the use of our products.
`
`• 63 million patients treated with
`Roche medicines
`• 21 billion tests conducted with
`Roche Diagnostics products
`• 31 BTDs (breakthrough therapy
`designation) awarded by the FDA
`since 2013
`• 32 Roche medicines on the WHO
`Model List of Essential Medicines
`
`• Sustainable healthcare systems
`• Availability of healthcare
`• Affordability of healthcare
`• Personalised healthcare
`• Real-world data
`• Patient centricity
`• R&D efficiency
`• Preparedness for aging society
`• Product safety
`• Product quality
`
`• 128 new partnerships in
`Pharmaceuticals and Diagnostics
`• #1 partner of choice according to
`third-party surveys
`• 0 supplier with critical issue or
`discontinued based on audit results
`• 8 grievances about human rights
`impacts filed, addressed and resolved
`through formal grievance mechanism
`
`• Human rights
`• Ethics and transparency
`• Compliance
`• Product safety
`• Product quality
`• Cybersecurity
`• Data privacy
`• Real-world data
`
`• 32% of women in key leadership roles
`• 24% of key leaders with diverse work
`experience
`• 68% employee engagement
`
`• Talent attraction and retention
`• Organisational agility
`• Preparedness for aging society
`
`• 29% improvement in eco-balance
`since 2014
`• 12% decrease in energy consumption
`per employee since 2015
`• 11% decrease in general waste per
`employee since 2015
`
`• Energy efficiency
`• Long-term mindset
`
`Delivering continued growth
`We are committed to creating value
`continuously for our stakeholders and
`achieving sustainable, high profitability.
`
`• +9%* in Group sales
`• +11% in core operating profit
`• 19% of sales invested in R&D
`
`• Long-term mindset
`
`* All growth rates in this report are at constant exchange rates (CER; average 2018).
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 21 of 159 PageID #: 1067
`
`
`16
`
`What we do
`
`How we do it
`
`Our focus
`Fitting treatments to patients
`
`Our leadership
`Inspiring outcomes that matter
`
`Our distinctiveness
`Excellence in science
`
`Our delivery
`Value for all stakeholders
`
`Our ways of working
`Agile and networked
`
`Our set-up
`Built for innovation
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 22 of 159 PageID #: 1068
`Our strategy | Roche
`17
`
`Our strategy
`We focus on finding new medicines and diagnostics that help
`patients live longer, better lives and evolve the practice of medicine.
`
`We are guided by our purpose:
`Doing now what patients need next.
`Our company has a more than 120-year history of
`advancing the field of medicine and bringing novel
`treatments and diagnostics to patients. The patient is
`and will remain at the core of what we do, the reason
`we come to work every day.
`
`What we do
`
`Our focus is on fitting treatments to patients:
`providing the right therapy for the group of people
`that respond best at the right time for the right value.
`With our in-house combination of Pharmaceuticals
`and Diagnostics, we are uniquely positioned to
`deliver personalised healthcare. We are developing
`our internal capabilities and building strategic
`partnerships ready for the next stage in personalised
`healthcare: to combine insights from multiple data
`sources with sophisticated analytics to drive more
`effective and efficient research and allow for better
`therapeutic decisions for patients. Access to our
`products is also a critical part of our strategy. Our
`detailed access plans are embedded in the business
`at a local level.
`
`We will continue to concentrate our energies entirely
`on prescription medicines and in vitro diagnostics,
`rather than diversify into other sectors like generics,
`biosimilars or over-the-counter medicines.
`
`In our pursuit of excellence in science, our
`distinctiveness rests on four key elements: an
`exceptionally broad and deep understanding of
`disease biology, the seamless integration of our
`
`pharmaceuticals and diagnostics capabilities, a
`diversity of approaches to maximise innovation,
`and a long-term orientation.
`
`Our delivery is to create value for all our
`stakeholders: being a partner of choice; bringing
`significant medical benefit for patients, doctors and
`payers; offering a great place to work for employees;
`delivering a sustainable positive contribution to
`society; and earning competitive returns for
`our investors.
`
`How we do it
`
`Ultimately, it takes people with integrity, courage
`and passion to make a difference for patients. It
`is our people who are proud to say: We are Roche.
`Our leadership inspires outcomes that matter
`by embracing diversity and inclusion. Different
`backgrounds, perspectives and experiences, across
`the entire organisation, foster innovative solutions
`for the benefit of patients.
`
`Our ways of working enable agile and networked
`responses to the ever-increasing pace of change by
`balancing the needs for stability, speed and flexibility.
`
`Our set-up is built for innovation. Our autonomous
`research and development centres and alliances with
`more than 200 external partners foster a diversity
`of scientific approaches and agility. Our global
`geographical scale and reach enables us to attract
`talent in the leading global science clusters and to
`bring our diagnostics and medicines quickly to
`people who need them.
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 23 of 159 PageID #: 1069
`
`18
`
`Dear Shareholders,
`In 2019, we continued to make significant progress in our efforts
`to use outstanding scientific achievements to give people a better
`quality of life and help them lead healthy lives.
`
`The demand for our recently launched medicines
`for multiple sclerosis (Ocrevus) and haemophilia
`(Hemlibra) was particularly high, and the same
`goes for our cancer immunotherapy Tecentriq. These
`three products were major contributors to the Roche
`Group’s impressive sales growth of 9%** in 2019 to
`CHF 61.5 billion.
`
`The approval of the targeted cancer treatment
`(Rozlytrek) with a genomic test enabled us to open
`up a new chapter in the development of personalised
`healthcare. Because this new medicine is effective
`against tumours that exhibit two relatively rare
`genetic changes, accurate pre-treatment diagnosis is
`essential, which is where one of Roche’s biggest core
`competencies really comes into its own. Our ability
`to combine diagnostic procedures, data from clinical
`practice and medicines brings us closer to our goal of
`finding personalised treatment options for as many
`patients as possible and eventually offering even more
`effective treatment options. By doing so we alleviate
`people’s symptoms and, in the best case, help them
`make a full recovery from their disease.
`
`We intend to use our partnership-based approach
`to help resolve the challenges facing the healthcare
`system. Not only does this mean partnering research
`laboratories, patient organisations and biotech
`companies, but also the authorities. For example,
`I signed a framework agreement with the Croatian
`government in 2019 with a view to providing
`personalised cancer treatment for the approximately
`25,000 people in the country diagnosed with the
`disease annually. Globally, Roche is working with
`many other partners to deliver better care to patients.
`
`Progress was made not only in oncology, but also in
`other therapeutic areas. We were thus able to submit
`dossiers for two new medicines in the second half of
`the year: risdiplam in the hereditary disorder spinal
`muscular atrophy, and satralizumab for a specific
`disease of the central nervous system. Both of these
`new active ingredients bring hope to people with
`rare, severely debilitating diseases. For risdiplam, the
`US Food and Drug Administration (FDA) granted
`priority review and for satralizumab breakthrough
`therapy designation.
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 24 of 159 PageID #: 1070
`Chairman’s shareholder letter | Roche
`19
`
`Gene therapies are particularly promising for a
`number of rare diseases because they directly address
`the genetic cause of such conditions. We therefore
`intend to bolster our presence substantially in this
`area, expanding our portfolio of therapeutic active
`ingredients through our acquisition of the US gene
`therapy company Spark Therapeutics.
`
`However, innovation and life-improving medicines
`come at a price. In his interview on pages 20 and 21,
`Severin Schwan, CEO Roche Group, discusses both
`the added value that these new treatments offer
`patients and their potential for generating economic
`benefits for the healthcare system overall.
`
`Despite the progress in medicine, the global demand
`for state-of-the-art diagnostics and personalised
`treatments remains huge. We therefore invested
`CHF 11.7 billion in research and development last
`year and intend to maintain this record level of
`investment for the industry. It is gratifying to note
`that the FDA was sufficiently persuaded by the clinical
`benefits of four more Roche medicines to award them
`breakthrough therapy designations in 2019, bringing
`the total to 31 since 2013. This achievement is an
`expression not least of the value that our new products
`represent for patients and society.
`
`Roche’s innovativeness is also reflected in its net
`income (under IFRS), which rose by a substantial
`32% to CHF 14.1 billion. In view of this strong
`business performance, we will be proposing a
`dividend of CHF 9.00 per share and non-voting
`equity security at the Annual General Meeting
`on 17 March 2020. Subject to your approval, this
`will be the 33rd consecutive dividend increase.
`
`Thanks to successful new launches and a first-class
`development portfolio, we are confident that Roche
`will continue on its growth trajectory despite some
`of our important medicines going off patent.
`
`I would like to thank our partners for their trust and
`cooperation and the 97,735 Roche Group employees
`for their tireless commitment to patient wellbeing.
`And I offer you, our shareholders, my heartfelt thanks
`for the trust you have placed in us and your affinity
`with our company.
`
`
`
`Dr Christoph Franz
`Chairman of the Board of Directors
`
`| Dr Christoph Franz (1960) Chairman,
`| Prof. Sir John Bell (1952) E, G
` Paul Bulcke (1954) B, E, G
`Roche Board of Directors on 31 December 2019.
`C, D*, E, G
`| Anita Hauser (1969) A, E, G
`| Bernard Poussot (1952) C, E, G
`| Dr Andreas Oeri (1949) Representative of the shareholder group with
`pooled voting rights, A*, E, G
`| André Hoffmann (1958) Vice-Chairman, Representative of the shareholder group with pooled voting rights, A, C*, D, E, G
`Dr Severin Schwan (1967) F
`| Dr Claudia Suessmuth Dyckerhoff (1967) A, B, E, G
`| Julie Brown (1962) B*, E, G
`| Prof. Dr Richard P. Lifton (1953)
`C, E, G
`| Prof. Dr Hans Clevers (1957) B, E, G
`
`|
`
`
`
`
`|
`| D Chairman’s/Nomination Committee
`| C Remuneration Committee
`| B Audit Committee
`A Corporate Governance and Sustainability Committee
`E Non-executive director
`| F Executive director
`| G Independent member of the Board of Directors
`|
`* Committee chairperson
`|
`** All growth rates
`in this report are at constant exchange rates (CER; average 2018).
`
`

`

`Case 1:20-cv-01580-LPS Document 9-8 Filed 12/10/20 Page 25 of 159 PageID #: 1071
`
`20
`
`“The most important thing is that such
`medicines exist at all.”
`Severin Schwan, CEO Roche Group, talks about the blessings of
`new medicines, their prices and emotional moments in his work.
`
`Perhaps you have heard about baby Pia, a nine-
`month-old girl from Belgium with spinal muscular
`atrophy (SMA). Her mother financed her treatment
`with extremely expensive gene therapy via crowd
`funding. What would we say to the world if something
`like that happened with a Roche medicine?
`First, I think the commitment shown by Pia’s mother
`is wonderful. And the most important thing is that
`medicines that can help her daughter exist at all.
`I remember very well spending time with the Swiss
`patients’ organisation for SMA a few years ago. At that
`time, there were absolutely no options for SMA and
`many of the parents lost their children at a very young
`age. When you see how far we have come—two drugs
`to treat SMA are already on the market and ours is
`coming soon—then it is a huge blessing for families.
`
`A blessing if those affected have access to the
`medicines …
`Yes, the question of access is crucial. First and
`foremost, this requires a functioning insurance system
`to which we all make our regular contributions so
`that medical care can be guaranteed for the patients
`affected in such unfortunate cases