throbber
Annual Report 2016
`2016 saw good sales momentum
`across Pharmaceuticals, Vaccines
`and Consumer Healthcare
`and further pipeline progress
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 1 of 288
`
`

`

`We are a global science-led
`healthcare company.
`Our three world-leading businesses
`research and deliver innovative
`medicines, vaccines and consumer
`healthcare products.
`
`Front cover case study
`
`Arthur works at our Upper Providence R&D lab
`
`At GSK, innovation underpins each of our three businesses
`We are using next generation technology
`return on R&D investment and accelerate
`to develop new approaches to disease
`the development of new products that can
`management and control. In addition to
`improve patients’ lives.
`our own research and development,
`We have an active pipeline of innovative
`we gain insights through our network of
`products across six core areas: respiratory,
`collaborations with biotechs, other
`HIV and infectious diseases, vaccines,
`companies and academic institutions.
`immuno-inflammation, oncology and
`This enables more efficient trial design
`rare diseases.
`and greater use of software, analytics and
`new technology, all of which is helping to
`increase our productivity, maximise our
`
`Cautionary statement regarding forward-looking statements
`The Group’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document and written information released, or oral statements
`made, to the public in the future by or on behalf of the Group, may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or
`forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’,
`‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’ and other words and terms of similar meaning in connection with any discussion of future operating or financial
`performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and
`anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory
`obligations (including under the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update
`any forward-looking statements, whether as a result of new information, future events or otherwise.
`The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever
`located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and shareholders and investors are cautioned
`not to place undue reliance on the forward-looking statements.
`Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to factors that are beyond the Group’s control or precise
`estimate. The Group cautions investors that a number of important factors, including those in this document, could cause actual results to differ materially from those expressed
`or implied in any forward-looking statement. Such factors include, but are not limited to, those discussed under ‘Principal risks and uncertainties’ on pages 253-262 of this
`Annual Report. Any forward-looking statements made by or on behalf of the Group speak only as of the date they are made and are based upon the knowledge of and
`information available to the Directors on the date of this Annual Report.
`All expectations and targets regarding future performance should also be read together with ‘Assumptions related to 2016-2020 outlook’ on the inside back cover of this
`document.
`A number of adjusted measures are used to report the performance of our business. These measures are defined on page 57 and a reconciliation of core results to total results
`is set out on page 66.
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 2 of 288
`
`

`

`02
`04
`05
`06
`08
`12
`14
`16
`18
`20
`28
`34
`40
`52
`
`80
`82
`86
`88
`94
`97
`97
`107
`
`108
`
`01 GSK Annual Report 2016
`
`Strategic report
`
`Governance and remuneration
`
`Financial statements
`
`Investor information
`
`2016 performance summary
`
`£27.9bn
`
`Group turnover
`(up 17% AER; 6% CER;
`5% pro-forma CER)a
`
`£2.6bn
`
`Total operating profit
`(down 75% AER; 86% CER)a,c
`
`18.8p
`
`Total earnings per share
`(down 89% AER; 99% CER)a,c
`
`£6.5bn
`
`Net cash inflow from
`operating activities
`
`£3.9bn
`
`Dividends declared
`for 2016
`
`£4.5bn
`
`New Pharmaceutical
`and Vaccine salesb
`(up >100% AER; >100% CER)a
`
`£7.8bn
`
`Core operating profit
`(up 36% AER; 14% CER;
`17% pro-forma CER)a
`
`102.4p
`
`Core earnings per share
`(up 35% AER; 12% CER)a
`
`£3.1bn
`
`Free cash flowa
`
`20-30
`
`Assets with data expected
`by end of 2018
`
`Delivering sustainable performance
`
`
`
` 1st in the Access
`to Medicine Index
`since launch in 2008
`
`3rd in the
`pharmaceutical sector
`for Dow Jones Sustainability Index
`
`Footnotes
`a AER growth rates represent growth at actual exchange rates. We use a number of adjusted, non-IFRS,
`measures to report the performance of our business, as described on page 57, including core results,
`free cash flow and CER and pro-forma growth rates. These measures are used by management for
`planning and reporting purposes and may not be directly comparable with similarly described measures
`used by other companies. Core results exclude a number of items and are presented as management
`believes that core results allow the key trends and factors driving that performance to be more easily
`and clearly identified by shareholders. Non-IFRS measures may be considered in addition to, but not
`as a substitute for or superior to, information presented in accordance with IFRS. A reconciliation
`of total results to core results is set out on page 66.
`b New products defined as:
`Pharmaceuticals: Relvar/Breo Ellipta, Incruse Ellipta, Anoro Ellipta, Arnuity Ellipta, Eperzan/Tanzeum,
`Nucala, Tivicay, Triumeq.
`Vaccines: Menveo, Bexsero, Shingrix (not yet approved).
`c Primarily reflecting impact of £9.2 billion profit in 2015 from disposal of Oncology business.
`
`Strategic report
`About us
`Chairman’s statement
`CEO’s statement
`Our integrated approach
`The market in which we operate
`Our business model
`A clear strategy for growth
`How we measure success
`How we manage risks
`Pharmaceuticals
`Vaccines
`Consumer Healthcare
`Responsible business
`Group financial review
`Governance and remuneration
`Chairman's Governance statement
`Our Board
`Our Corporate Executive Team
`Leadership and effectiveness
`Nominations Committee report
`Accountability
`Audit & Risk Committee report
`Relations with shareholders
`Corporate Responsibility
`Committee report
`Remuneration report
`Chairman’s annual statement
`Annual report on remuneration
`Remuneration policy summary
`Remuneration policy report
`Financial statements
`Directors’ statement of responsibilities 148
`Independent Auditors' report
`149
`Financial statements
`158
`Notes to the financial statements
`162
`Financial statements of GlaxoSmithKline
`plc prepared under UK GAAP
`232
`Investor information
`Quarterly trend
`Five year record
`Product development pipeline
`Product, competition and
`intellectual property
`Principal risks and uncertainties
`Share capital and share price
`Dividends
`Financial calendar
`Annual General Meeting 2017
`Tax information for shareholders
`Shareholder services and contacts
`US law and regulation
`Group companies
`Glossary of terms
`
`112
`115
`137
`138
`
`240
`244
`247
`
`250
`253
`263
`265
`265
`266
`266
`268
`270
`272
`283
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 3 of 288
`
`

`

`02 GSK Annual Report 2016
`
`About us
`
`At GSK, our mission
`is to improve the
`quality of human life
`by enabling people
`to do more, feel better
`and live longer.
`
`Three world-leading businesses
`
`Our Pharmaceuticals, Vaccines and Consumer Healthcare
`businesses generated combined turnover of £27.9 billion in 2016.
`Each business benefits from our global commercial infrastructure,
`integrated supply networks and innovative R&D.
`
` 99,300
`
`Number of employees
`
` 150+
`
`Number of markets
`
` 87
`
`Manufacturing sites
`
`R&D innovation underpins each of our businesses
`
`In 2016, we invested £3.6 billion in R&D across our three
`businesses. External partnerships and collaborations
`enable us to develop and access knowledge, and increase
`our understanding in new areas of science.
`We focus our research across six core areas and are using
`next generation technology to develop new approaches
`to disease management and control.
`
`Respiratory diseases
`
`HIV/infectious diseases
`
`Vaccines
`
`Immuno-inflammation
`
`Oncology
`
`Rare diseases
`
`Efficient global operating model
`
`We are focused on optimising our operations through restructuring,
`investment and modernisation to improve profitability and efficiency.
`
`Footnote
`a We use a number of adjusted, non-IFRS, measures to
`report the performance of our business, as described on
`page 57, including core results, free cash flow and CER
`and pro-forma growth rates. Non-IFRS measures may be
`considered in addition to, but not as a substitute for or
`superior to, information presented in accordance with IFRS.
`
`£1.4bn
`
`Incremental annual
`savings delivered in 2016
`(including £0.2 billion
`currency benefit)
`
`9.3%
`
`27.9%
`
`Total operating profit
`margin in 2016
`
`Core operating profit
`margin in 2016a
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 4 of 288
`
`

`

`03 GSK Annual Report 2016
`
`Strategic report
`
`Governance and remuneration
`
`Financial statements
`
`Investor information
`
`Pharmaceuticals
`
`Vaccines
`
`Our Pharmaceuticals business
`discovers, develops and
`commercialises medicines to
`treat a range of acute and chronic
`diseases. We have a broad portfolio
`of innovative and established
`medicines in respiratory and HIV,
`in which we are global leaders.
`We focus our research across
`respiratory, HIV and infectious
`diseases, immuno-inflammation,
`oncology and rare diseases.
`
`Read more on pages 20 to 27
`
`Our Vaccines business has the
`broadest portfolio of any company,
`with vaccines for people of all
`ages – from babies and adolescents
`to adults and older people. We
`deliver over two million vaccine
`doses per day to people living
`in over 160 countries.
`
`Read more on pages 28 to 33
`
`Top three categories by sales
`Respiratory
`HIV
`Established products
`
`£m
`6,510
`3,556
`2,541
`
`Top three categories by sales
`Infanrix/Pediarix
`Hepatitis
`Meningitis
`
`£m
`769
`602
`592
`
`£16.1bn
`
`Turnover
`
`£4.6bn
`
`Turnover
`
`Consumer
`Healthcare
`
`Our Consumer Healthcare business
`develops and markets products
`in Wellness, Oral health, Nutrition
`and Skin health categories. Our
`seven global power brands – Otrivin,
`Panadol, parodontax, Poligrip,
`Sensodyne, Theraflu and Voltaren,
`include some of the most trusted
`and best-selling brands in the world.
`
`Read more on pages 34 to 39
`
`£m
`3,726
`2,223
`674
`570
`
`Sales by category
`Wellness
`Oral health
`Nutrition
`Skin health
`
`£7.2bn
`
`Turnover
`
`% of Group turnover
`
`% of Group turnover
`
`% of Group turnover
`
`58%
`
`16%
`
`2bn
`
`packs of medicines
`produced in 2016
`
`833m
`
`vaccines delivered
`in 2016
`
`26%
`
`5bn
`
`Consumer Healthcare products
`produced in 2016
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 5 of 288
`
`

`

`04 GSK Annual Report 2016
`
`Chairman’s statement
`
`GSK made further
`progress during 2016.
`Operating performance
`significantly improved
`and there was continued
`progress in the R&D
`pipeline.
`
`Read more
`
`See page 80
`
`See page 112
`
`Governance report
`Our Corporate Governance report sets out our
`corporate governance practices and includes the
`reports of our Board Committees.
`Remuneration
`Our Remuneration report sets out our
`remuneration arrangements for Executive and
`Non-Executive Directors and includes our new
`Remuneration policy for 2017.
`Diversity statement
`Our Board’s Diversity policy, including gender,
`sets out measurable objectives which our
`Nominations Committee monitors and reports
`progress towards their achievement.
`Viability statement
`Our Viability statement sets out our assessment of
`the prospects of the Group over the next
`three years.
`
`See page 96
`
`See page 56
`
`I am pleased to report that GSK made
`further good progress during 2016.
`Operating performance significantly
`improved in our three businesses and there
`was continued progress in the late and early
`stage R&D pipeline. In every important area,
`it has been a year of solid achievement.
`2016 performance
`Management continues to make strong
`progress in driving the sales and cost
`benefits from the integration of the Novartis
`businesses in Vaccines and Consumer
`Healthcare. These businesses have been
`transformed through the transaction and are
`now true global leaders in their respective
`markets, well positioned strategically and
`improving financially.
`In Pharmaceuticals, new product sales
`have shown very good momentum,
`particularly in HIV and Respiratory. New
`products now make up around a quarter of
`total pharmaceutical sales. This is important
`given the pricing pressure faced generally by
`pharmaceutical companies and the potential
`introduction of generic competition to Advair
`– for many years the Group’s biggest single
`source of profits – in the US during 2017.
`The Group’s improved operational
`performance also contributed to markedly
`increased cash generation. Operational
`cash flow also benefited strongly from
`the devaluation of Sterling following the
`Brexit vote in June, although the value
`of non-sterling liabilities for debt funding
`and contingent consideration, has also
`increased.
`Ordinary dividends of 80p per share have
`been declared for 2016, the same level as
`2015. The company expects to maintain the
`same payment in 2017, in accordance with
`the statements made in 2015. This level of
`distribution still exceeds the free cash flow
`generated by the business despite the
`material improvement in cash generated
`in 2016 referred to above. Given that 2017
`is the last year of the three year dividend
`commitment made in 2015, the Board will
`be considering the appropriate dividend
`policy for 2018 and beyond during the
`course of the year.
`CEO succession
`A key area of focus for the Board through
`2016 has been to manage the CEO
`succession as Sir Andrew steps down
`after 33 years with the company and into
`a tenth year as CEO. The Board conducted
`a thorough, global search for a successor,
`which included internal and external
`candidates.
`
`The Board was unanimous in its decision to
`appoint Emma Walmsley, previously Head
`of GSK’s Consumer Healthcare business,
`as the new CEO. Emma has very strong
`leadership skills and a clear track record of
`delivery on performance. The Board believe
`Emma will bring new thinking to how the
`Group operates in today’s healthcare
`environment, whilst at the same time
`harnessing the momentum evident in
`current performance.
`I want to thank Sir Andrew again for his
`dedicated service to GSK. Through his
`commitment and leadership GSK has built
`a balanced set of businesses with fine
`prospects and delivered very significant
`rewards to shareholders with substantial
`cash returns. He has also led efforts to
`address the most pressing concerns the
`industry faces, ranging from reforming our
`commercial model, increasing transparency
`of trial results, and ensuring medicines are
`priced more fairly and made more accessible
`to patients worldwide. He will be much
`missed within GSK and we wish him well in
`his future endeavours.
`Board changes during the year
`We continue to refresh the Board. In 2016
`we welcomed two new Non-Executive
`Directors: Dr Jesse Goodman and
`Dr Vivienne Cox. Jesse is Professor of
`Medicine at Georgetown University and a
`leader in public health, and Vivienne brings
`many years experience in complex global
`manufacturing organisations. Meanwhile,
`Stacey Cartwright stepped down from the
`Board at the end of December. My thanks go
`to Stacey for nearly six years of dedicated
`service to the Board.
`As we enter a critical period of pipeline
`activity, we have reflected this on the Board
`with the creation of a new Board Science
`Committee, chaired by Dr Goodman. In
`addition, Dr Patrick Vallance, President R&D,
`has joined the Board. Later this year, Moncef
`Slaoui will step down from the Board after
`28 years with the company. Moncef is a
`scientist of global repute and has been a
`remarkable presence at GSK, particularly
`in the Vaccines business. We wish him,
`too, well in the future.
`In closing, I would like to thank all GSK’s
`employees and partners for their hard
`work and dedication. The business has
`outstanding people and they have made
`2016 a very successful year.
`
`Philip Hampton
`Chairman
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 6 of 288
`
`

`

`05 GSK Annual Report 2016
`
`CEO’s statement
`
`Strategic report
`
`Governance and remuneration
`
`Financial statements
`
`Investor information
`
`GSK performed strongly
`in 2016, with good sales
`growth across all three
`businesses, excellent new
`product momentum and
`further pipeline progress.
`
`The Group executed strongly in 2016,
`delivering sales growth across all three
`businesses, remaining disciplined on
`costs and progressing our pipeline of
`innovative products.
`Trading performance
`Group sales rose 17% at actual rates,
`6% CER (5% pro-forma) to £27.9 billion,
`despite the uncertainty and volatility
`experienced globally in 2016. Total earnings
`per share was 18.8p (down 89% at actual
`rates, 99% CER), primarily reflecting
`comparisons with the £9.2 billion profit
`in 2015 from the disposal of the marketed
`Oncology assets. Core earnings per share
`was 102.4pa – a 12% CER increase – and
`at the top end of our guidance for the year.
`We saw growth across all three of
`the Group’s businesses in 2016, with
`a particular contribution from new
`Pharmaceuticals and Vaccine products.
`Sales from this portfolio more than doubled
`to £4.5 billion and in Pharmaceuticals,
`new products accounted for 24% of sales.
`HIV products, Tivicay and Triumeq, continued
`to be the standout products with sales of
`£2.7 billion, while our new respiratory
`products – Relvar/Breo, Anoro, Incruse,
`Arnuity and Nucala – also grew strongly
`as did our meningitis vaccines, Bexsero and
`Menveo. We expect the momentum in this
`group of products to continue through 2017.
`Our Consumer Healthcare business
`performed strongly, with sales up 19%
`at actual rates, 9% CER (5% pro-forma)
`to £7.2 billion, driven by power brands
`such as Sensodyne, Voltaren and Panadol
`as well as growth from Flonase which
`we switched from prescription to
`over-the-counter.
`Strong R&D innovation pipeline
`We filed four assets with regulators in
`2016 which, if approved, have the potential
`to drive further growth in the business,
`including Shingrix, our candidate vaccine
`for shingles and our once-daily Closed
`Triple therapy for COPD. In addition, we
`also started a number of phase III trials for
`assets in HIV, respiratory and anaemia.
`
`Investment in our R&D organisation
`continues to deliver significant innovation.
`For example, 2016 saw the European
`approval of Strimvelis, our first of its kind
`gene therapy for children with the very rare
`condition ADA-SCID. This remarkable
`technology has the potential to be a platform
`for a number of other gene therapies.
`The next two years will be an exciting time
`for our R&D organisation, with key research
`data on 20-30 assets due by the end
`of 2018.
`Delivering performance responsibly
`GSK has a strong commitment to operating
`responsibly and playing our part in meeting
`some of society’s biggest healthcare
`challenges.
`In 2016, we took further industry-leading
`steps by stopping all payments to healthcare
`professionals to speak about our medicines
`to other prescribers, and offered essential
`vaccines at our lowest price to organisations
`supporting refugees in acute need. We
`also introduced a new approach to filing
`and enforcing patents and IP based on a
`country's economic maturity, and are working
`with partners to help the world better prepare
`for future epidemics such as Ebola and Zika.
`I was very pleased that our efforts to
`operate as a values-based company
`were recognised when we came first
`in the Access to Medicine Index for the
`fifth consecutive time.
`Outlook
`The progress in 2016 highlights the
`investments we have made in the Group
`over the last several years to build scale
`and sustainability as well as develop new
`products. I expect the Group to make
`continued progress in 2017 and, as we
`enter a new period of leadership for the
`company, I believe GSK is well positioned
`to deliver long-term performance for
`shareholders.
`Finally, as this is my last annual report
`before I retire, I would like to thank all our
`employees, partners and shareholders
`for their support during my time as CEO.
`GSK is a very special company that touches
`people’s lives across the world and which
`I have been enormously privileged to lead.
`
`Footnote
`a We use a number of adjusted, non-IFRS, measures to
`report the performance of our business, as described on
`page 57, including core results, free cash flow and CER
`and pro-forma growth rates. Non-IFRS measures may be
`considered in addition to, but not as a substitute for or
`superior to, information presented in accordance with IFRS.
`
`Sir Andrew Witty
`Chief Executive Officer
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 7 of 288
`
`

`

`
`
`06 GSK Annual Report 201606 GSK Annual Report 2016
`
`Our integrated approach
`
`By understanding our operating environment and having
`a clear strategy, against which we measure performance
`and manage risks, we deliver long-term value for
`shareholders and society.
`
`The market in which we operate
`
`Our business model
`
`We operate in a growing marketplace and our strategy
`is designed to respond to the challenges and opportunities
`in our sector.
`
`R&D underpins our three businesses and we prioritise our investments
`to where we see the most potential to develop innovative products for
`unmet medical needs.
`
`R&D
`
`Pharmaceuticals
`
`Vaccines
`
`Consumer Healthcare
`
`Manufacturing
`
`Commercialisation
`and distribution
`
`Demographic
`change
`
`Changing political
`landscape
`
`Increasing payer
`emphasis on cost,
`value and access
`
`Increased
`expectations
`of businesses
`
`Technological
`and scientific
`advances
`
`Read more on page 8
`
`Read more on page 12
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 8 of 288
`
`

`

`
`
`07 GSK Annual Report 201607 GSK Annual Report 2016
`
`
`
`Strategic reportStrategic report
`
`
`
`Governance and remunerationGovernance and remuneration
`
`
`
`Financial statementsFinancial statements
`
`
`
`Investor informationInvestor information
`
`A clear strategy for growth
`
`How we measure success
`
`How we manage risks
`
`Our strategic priorities provide a framework
`to create long-term value for shareholders
`and society.
`
`We assess our performance against
`a set of financial and non-financial
`measures, many of which form the
`basis of our executive remuneration.
`
`We manage a number of current and
`emerging risks. Below, our Principal Risks
`are mapped against the primary strategic
`priority they are most likely to impact.
`
`Grow
`
`Grow a balanced business and
`product portfolio, centred on our
`three global businesses.
`
`Deliver
`
`Deliver more products of value to
`offer improved treatment for patients,
`consumers and healthcare providers.
`
`Simplify
`
`Simplify the way we operate to reduce
`complexity, increase efficiency and free
`up resources to reinvest in the business
`or return to shareholders, wherever we
`see the most attractive returns.
`
`Responsible business
`
`Being a responsible business,
`as how we deliver success is as
`important as the results we achieve.
`
` – Turnover growth
` – Growth of earnings per share
`
`Intellectual property
`Commercialisation
`
` – New Pharmaceuticals and Vaccines
`product performance
`
`Product quality
`Research practices
`Supply continuity and crisis management
`
` – Operating profit and margin
` – Free cash flow
` – Dividends declared
` – Net debt
`
`Financial control and reporting
`Information protection
`
` – Access to Medicine Index
` – Dow Jones Sustainability Index
`
`Patient safety
`Anti-bribery and Corruption
`Environment, Health and Safety
`and Sustainability
`
`Read more on page 14
`
`Read more on page 16
`
`Read more on page 18
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 9 of 288
`
`

`

`08 GSK Annual Report 2016
`
`We operate in a growing marketplace and
`our strategy is designed to respond to the
`challenges and opportunities we face.
`
`The market in which we operate
`
`1.4bn
`
`By 2030, the world’s
`population of people
`aged 60+ will be 1.4 billiona
`
`60%
`
`of the world’s population will
`live in urban areas
`by 2030f
`
`75%
`
`of the global population has
`access to a mobile phone f
`
`90%
`
`of global youth resides in
`developing countries f
`
`Future State 2030: The global megatrends shaping government. KPMG
`
`66%
`
`of the global middle class
`will reside in Asia-Pacific
`by 2030 f
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 10 of 288
`
`

`

`09 GSK Annual Report 2016
`
`Strategic report
`
`Governance and remuneration
`
`Financial statements
`
`Investor information
`
`Our business model
`
`A clear strategy for growth
`
`How we measure success
`
`How we manage risks
`
`In 2016, the global
`healthcare market
`continued to grow
`against a backdrop
`of a challenging global
`economic environment.
`
`Global pharmaceutical sales were
`£648 billion on a 12 month rolling
`basis (September 2015-2016), up from
`£605 billion during the equivalent period
`(September 2014-2015). North America
`remained the largest pharmaceuticals
`market with a 50% share of global sales.
`Europe represented 21%, Asia Pacific
`(including Japan) was 21% and emerging
`markets was 8%.b
`Global vaccine sales totalled ~£18 billion
`in 2016 and are expected to grow 5%
`annually by 2022.c
`The consumer healthcare markets in which
`GSK operates account for approximately
`$70 billion, and are projected to grow
`3-4% annually over the next five years.d
`Societal trends supported market growth,
`but are also contributing to challenges in
`the healthcare sector, particularly on price
`and affordability.
`Demographic change
`The world population continues to grow
`and, according to the United Nations,
`is predicted to reach 8.5 billion by 2030.
`The proportion of elderly people is growing
`and the number of people over the age
`of 60 is expected to reach 1.4 billion by
`2030.e At the same time, developing
`countries are experiencing growth in their
`middle classes, and by 2030 it is expected
`that 60% of the world’s population will be
`middle class.f
`In emerging markets, long-term economic
`growth, increasing expectations of
`healthcare provision, and changing diets
`and lifestyles are increasing demand for
`healthcare products, especially to treat
`chronic conditions including respiratory
`and cardiovascular disease. This demand
`is expected to grow significantly faster in
`these markets over the coming years than
`in more mature economies.
`
`In developed economies, demand for
`healthcare provision continues to remain
`high, although the dynamics are becoming
`more complex. Trends such as higher life
`expectancy are contributing towards the
`increasing proportion of elderly people,
`and along with improvements in medical
`technology, are putting pressure on
`healthcare budgets.
`The changing global political landscape
`Shifting attitudes to globalisation and
`free trade, wage stagnation for many and
`concerns about inequality are causing
`significant volatility and uncertainty in
`western markets.
`2016 was characterised by political
`uncertainty and this was exemplified
`by the vote to leave the EU in the UK and
`the result of the US Presidential Election.
`Political uncertainty in Europe is expected
`to continue in 2017 with national elections
`in France and Germany.
`In the US there is also uncertainty as
`to how the new administration will shape
`healthcare, particularly with respect to
`repealing and replacing the Affordable
`Care Act, prescription drug pricing and
`regulation. This is coupled with questions
`over the impact of the new administration’s
`economic, tax and trade policies.
`In the UK, it remains unclear how Brexit
`will affect the country’s trading relationships,
`corporate taxation policy, the movement
`of people, and regulatory affairs.
`
`b
`c
`
`d
`
`Footnotes
`a
` World Population Ageing 2015 Highlights.
`United Nations.
`IMS data (latest available at time of publishing).
` Internal data and EvaluatePharma, World
`Preview 2016.
` Internal forecasts based on Nicholas Hall
`and Euromonitor.
` World Population Ageing 2015 Highlights.
`United Nations.
` Future State 2030: The global megatrends
`shaping government. KPMG.
`
`e
`
`f
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 11 of 288
`
`

`

`10 GSK Annual Report 2016
`
`The market in which we operate continued
`
`Our strategy to create
`a balanced business
`and product portfolio
`positions us well for
`the changes in our
`marketplace.
`
`Increasing payer emphasis on cost,
`value and access
`Demographic changes are contributing
`to increased demand for healthcare and
`in turn putting pressure on government
`budgets and payers. This has led to
`continued focus on, and public debate
`about, the industry’s approach to drug
`pricing across all key markets.
`In the US the ultimately unsuccessful
`Proposition 61 vote, which called for
`medicine price controls in California,
`was the first of several drug pricing ballot
`initiatives expected in the US. There has
`also been increasing use of healthcare
`technology assessments to consider
`value for money as well as medical efficacy,
`by government-appointed bodies like the
`UK’s National Institute for Health and Care
`Excellence and Australia’s Pharmaceutical
`Benefits Advisory Committee.
`As demand for healthcare in emerging
`markets rises, governments are continuing
`to reform healthcare systems to support
`access. In China, the government continues
`to work to realise the goals set out in the
`Healthy China 2030 plan, with significant
`measures taken during the year to reduce
`pharmaceutical prices through the National
`Price Negotiations.
`During the year, the UN’s High-Level Panel
`on Access to Medicines report, reiterated
`the rights of countries to issue compulsory
`licences to access cheaper supplies of
`generic drugs.
`We expect the political and public scrutiny
`on pricing to continue.
`
`Technological and scientific advances
`Key advances in the understanding of
`human biology and genomics are leading
`to fundamental changes in how we research
`diseases, and the pharmaceutical industry’s
`ability to develop treatments specifically
`to tackle them with innovative treatment
`approaches has increased substantially
`in recent years. Alongside these scientific
`advances, digital technology and data
`analytics are enabling researchers to explore
`and interpret larger volumes of biological
`data from genomics and disease biology
`than ever before. This is providing
`opportunities to increase the speed and
`efficiency of drug discovery and the
`development of novel therapies that could
`transform how diseases are managed.
`Increasing expectations of companies
`Beyond our sector-specific context, where
`value, cost and affordability are so important,
`society has increasing and changing
`expectations of companies, particularly
`of large global companies. Stakeholders
`– from employees to consumers to policy
`makers and influencers – expect companies
`to behave with integrity and fairness; operate
`transparently; be connected to their local
`communities; and play their part in
`addressing global challenges from health
`epidemics to climate change. Responding
`to this requires strong partnership and
`connectivity between public and private
`sector organisations.
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1118, p. 12 of 288
`
`

`

`11 GSK Annual Report 2016
`
`Strategic report
`
`Governance and remuneration
`
`Financial statements
`
`Investor information
`
`Our business model
`
`A clear strategy for growth
`
`How we measure success
`
`How we manage risks
`
`Our strategic response
`
`Three world-leading
`businesses,
`underpinned
`by innovative R&D
`
`GSK is well positioned to take advantage of d

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket