throbber
UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`
`Washington, D.C. 20549
`
`FORM6-K
`
`REPORT OF FOREIGN PRIVATE ISSUER
`Pursuant to Rule 13a-16 or 15d-16
`of the Securities Exchange Act of 1934
`
`FEBRUARY 9, 2009
`
`NOVO NORDISK A/S
`(Exact name of Registrant as specified in its charter)
`
`Novo Alle
`DK- 2880, Bagsvaerd
`Denmark
`(Address of principal executive offices)
`
`Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
`
`Form 20-F [X]
`
`Form 40-F [ ]
`
`Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the
`Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
`
`If"Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_________ _
`
`Yes []
`
`No[X]
`
`Sanofi Exhibit 2136.001
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`IPR2018-01675
`
`

`

`

`

`

`

`Back to Contents
`
`Performance
`highlights
`2008
`
`Financial performance
`
`Sales total
`
`Diabetes care
`
`Of which modern insulins
`
`Biopharmaceuticals
`
`Gross profit
`
`Gross margin
`
`Sales and distribution costs
`
`Research and development costs
`
`Research and development costs excl AERx® *)
`
`Administration expenses
`
`Operating profit
`
`2008
`
`2007
`
`Change
`
`DKK million
`
`45,553
`
`41,831
`
`DKK million
`
`33,356
`
`30,478
`
`9%
`
`9%
`
`DKK million
`
`17,317
`
`14,008
`
`24%
`
`DKK million
`
`12,197
`
`11,353
`
`7%
`
`DKK million
`
`35,444
`
`32,038
`
`11%
`
`%
`
`% of sales
`
`% of sales
`
`% of sales
`
`77.8
`
`28.2
`
`17.2
`
`16.5
`
`76.6
`
`29.6
`
`20.4
`
`17.2
`
`% of sales
`
`5.8
`
`6.0
`
`DKK million
`
`12,373
`
`8,942
`
`38%
`
`Operating profit excl AERx® *l
`
`DKK million
`
`12,698
`
`10,267
`
`24%
`
`Net profit
`
`Effective tax rate
`
`Capital expenditure
`
`Free cash flow
`
`Long-term financial targets
`
`Operating profit growth
`
`Operating profit growth excl AERx® *)
`
`DKK million
`
`9,645
`
`8,522
`
`13%
`
`%
`
`24.0
`
`22.3
`
`DKK million
`
`1,754
`
`2,268
`
`(23%)
`
`DKK million
`
`11,015
`
`9,012
`
`22%
`
`%
`
`%
`
`38.4
`
`23.7
`
`(1.9)
`
`12.6
`
`Sanofi Exhibit 2136.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Operating margin
`
`Operating margin excl AERx® *l
`
`Return on invested capital (ROIC)
`
`Cash to earnings (three-year average)
`
`Non-financial performance
`
`%
`
`%
`
`%
`
`%
`
`27.2
`
`27.9
`
`37.4
`
`97.6
`
`21.4
`
`24.5
`
`27.2
`
`87.0
`
`Employment impact worldwide
`
`Number of jobs
`
`88,500
`
`81,600
`
`8%
`
`Water consumption
`
`Recycling percentage (waste)
`
`CO2 emissions
`
`Employees
`
`Employee turnover rate
`
`Engaging culture (employee engagement)
`
`New patent families (first filing)
`
`Share performance
`
`Dividend per share (proposed)
`
`Closing share price (B shares)
`
`Market capitalisation (B shares) **l
`
`1,000m3
`
`2,684
`
`3,231
`
`(17%)
`
`%
`
`1,000 tons
`
`51
`
`215
`
`38
`
`236
`
`FTE
`
`26,575
`
`25,516
`
`%
`
`12.1
`
`11.6
`
`(9%)
`
`4%
`
`Scale 1-5
`
`Number
`
`4.2
`
`71
`
`4.1
`
`116
`
`(39%)
`
`DKK
`
`DKK
`
`DKK billion
`
`6.00
`
`4.50
`
`33%
`
`271
`
`135
`
`335
`
`(19%)
`
`172
`
`(22%)
`
`**l Excluding non-recurring costs related to discontinuation of all pulmonary diabetes projects.
`
`**l Novo Nordisk B shares (excluding treasury shares).
`See more financial and non-financial highlights on pp 16-17.
`
`Sanofi Exhibit 2136.005
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`IPR2018-01675
`
`

`

`Back to Contents
`
`About
`Novo Nordisk's
`annual reporting
`
`Novo Nordisk is the world leader in diabetes care and has
`leading positions within haemostasis management, growth
`hormone therapy and hormone replacement therapy. The
`company also has an ambition to build a strong platform within
`inflammation.
`
`With over 27,000 employees in 81 countries, Novo Nordisk
`manufactures and markets pharmaceutical products and
`services that make a significant difference to patients, the
`medical profession and society.
`
`This is the fifth consecutive year of reporting on the company's
`financial and non-financial performance in one inclusive
`document, the Annual Repott, covering the fiscal year 2008. The
`report discusses key challenges and strategic initiatives to
`develop the business in order to meet targets and sustain long(cid:173)
`term value creation. It also explains Novo Nordisk's way of doing
`business as a values-based company guided by a vision.
`
`The feature articles present company-driven activities in pursuit
`of the Novo Nordisk Vision and respond to concerns identified
`through interactions with shareholders, financial analysts and
`other stakeholders during the year.
`
`External opinion leaders have been invited to contribute their
`perspectives on some of the key issues: the current economic
`climate, challenges in the healthcare industry and marketplace,
`new treatment paradigms for diabetes care and the
`interrelationship of the global climate change and a healthy
`future.
`
`Designed to meet the information needs of shareholders,
`financial analysts and other corporate stakeholders, the report
`seeks to support business performance and enhance
`shareholder value by exploring the interactions between financial
`and non-financial objectives.
`
`internal controls for financial reporting. Novo Nordisk embarked
`in 2008 on a process of structuring the control environment for
`non-financial data with the aspiration to have full alignment
`with the control environment for financial data.
`
`• The accountability standard, the AA1000 Framework.
`
`• Global Reporting Initiative (GRI) G3 Sustainability Reporting
`Guidelines.
`
`• UN Global Compact, Communication on Progress.
`
`In the absence of global standards for inclusive reporting, the
`Annual Repott is prepared in respect of current best practice for
`financial and non-financial reporting, respectively. This includes
`applying the principles of materiality, completeness and
`responsiveness.
`
`Novo Nordisk has chosen to apply the term 'non-financial
`reporting' to performance on sustainability-driven issues. Hence,
`the Annual Repott includes both financial statements and non(cid:173)
`financial statements, while the narrative parts of the report
`present the company's performance from an inclusive
`perspective.
`
`The accuracy, completeness and reliability of the company's
`reporting is verified through internal controls, assurance and
`independent audits.
`
`The Annual Repott 2008 includes the financial statements of the
`parent company, Novo Nordisk A/S (see pp 105-112), and is
`issued in February 2009 for approval by shareholders at the
`Annual General Meeting on 18 March 2009. It is subsequently
`filed with the Danish Commerce and Companies Agency. In
`addition, a Form 20-F Report for 2008 is filed with the United
`States Securities and Exchange Commission in February 2009.
`
`Novo Nordisk is in compliance with applicable corporate
`governance codes and follows current international standards for
`mandatory and voluntary reporting:
`
`These two public filings contain references and links to
`information posted on the Company's website; such information
`is not incorporated by reference into the public filings.
`
`• International Financial Reporting Standards (IFRS).
`
`• AA 1000 Assurance Standard (2003).
`
`• US Sarbanes-Oxley Act requirements for documenting and
`reporting on the effectiveness of
`
`Additional reporting online provides more background, context
`and data. Many sections of this report reference additional on line
`information and an index on p 116 provides links to online
`content at annualreport2008.novonordisk.com.
`
`Sanofi Exhibit 2136.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`

`

`

`

`

`

`20 Doing business the Novo Nordisk
`Way
`21 Values drive performance
`22 Pursuing a focused strategy
`24 Managing risks
`26 Universal principles guide action
`27 Diversity supports global growth
`28 Strengthening environmental
`management
`
`42 Corporate governance
`44 Executive remuneration
`46 Board of Directors
`48 Executive Management
`49 Shares and capital structure
`
`information
`
`■ Page 116 and inside back cover
`
`116
`
`Index
`• Contacts
`• References
`• Novo Nordisk key products
`
`Novo Nordisk Annual Report 2008
`
`1
`
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`IPR2018-01675
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`

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`
`■ Welcome to Novo Nordisk Our focus is our strength
`
`Our focus
`■ 1s our
`strength
`
`The year 2008 is likely to be remembered by many as the year
`when, like a flash of lightning, a severe economic crisis brought
`an end to the belief in uninterrupted growth. The globalisation we
`have witnessed in recent years, which has had many positive
`effects, suddenly showed another face: no nation, no company
`and no individual is unaffected by the economic downturn.
`Businesses, large and small, are in crisis. Some that were
`considered icons in their industries no longer exist.
`
`Against such a backdrop it is with great humility, but also with
`pride and satisfaction, that we can report on a year that has
`been very positive for Novo Nordisk, demonstrating the results of
`our focused business approach. We increased sales by 12%
`(measured in local currencies) and our reported operating profit
`by 38%. Our investment in research and development resulted in
`a strengthened pipeline of new products. And we continued to
`optimise processes and globalise our sales and production
`activities, which makes our organisation even better prepared for
`challenges in coming years.
`
`One of the reasons why Novo Nordisk came through 2008 in
`better shape than many other companies is that we produce
`lifesaving medicines. Our customers, particularly people with
`chronic conditions, require treatment during recessions as well
`as periods of economic prosperity. But a great deal of our
`success is attributable to our more than 27,000 Novo Nordisk
`colleagues who have once again delivered excellent results. With
`doctors and patients, in the laboratories, in production, in
`administration and throughout our value chain, there has been a
`focus on achieving results for all stakeholders both in the short
`and long term.
`
`Innovation boosts competitiveness
`Innovation in our pipeline is the source of long-term
`competitiveness in our industry, and in this area 2008 was very
`eventful.
`
`Not everything has worked out as planned. In early 2008, we
`discontinued our attempts to develop inhalable insulin. Later in
`the year we had to reconcile ourselves to the fact that the effect
`of NovoSeven® for treatment of acute bleeds in trauma could not
`
`Liraglutide has the potential to improve the treatment of type 2
`dia betes. Even though requirements for approval of new
`medicines have become increasingly challenging, we are
`cautiously optimistic about the final outcome of regulatory
`assessment. We currently anticipate regulatory approval in the
`US and some European countries in 2009, followed by Japan
`and a number of other countries in 2010.
`
`We know that even the best insulins available in the market
`today are not perfect. Phase 2 results for the company's new
`generation of insulins have demonstrated that long-acting
`insulins and insulins with a combined short- and long-acting
`effect can be further improved. If preliminary results are
`confirmed by additional trials, this new generation of insulins has
`the potential to offer better treatment for people with diabetes
`and to strengthen Novo Nordisk's competitive position.
`
`In 2008, we decided to focus our biopharmaceutical research
`efforts in haemostasis, growth disorders and inflammation.
`Research in inflammation will be conducted by our Danish
`research organisation and a newly established research centre
`for inflammation in Seattle, US. Collaboration with a number of
`biotech companies also plays a significant role in our ability to
`bring new products to market in this area.
`
`In 2008, Novo Nordisk made two significant
`breakthroughs that may have great impact on
`future diabetes treatment.
`
`International expansion supports growth
`In the diabetes market we have maintained our position as the
`world leader with a market share of more than 50% by volume.
`Demand for our products has increased and we see a continuing
`transition from traditional human insulin to modern insulins. Novo
`Nordisk won market share for modern insulins in 2008 and
`remains the only company with a full portfolio of short-acting,
`
`Sanofi Exhibit 2136.011
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`be proven in controlled clinical trials within the foreseeable future.
`We also decided to discontinue trials to investigate the benefits
`of growth hormone therapy for dialysis patients because of the
`difficulty in recruiting trial participants.
`
`mixed and long-acting insulins. To expand our competitive
`position and brand awareness, not least among general
`practitioners, we have expanded our sales organisation in several
`key markets.
`
`However, 2008 will mostly be remembered as the year in which
`Novo Nordisk made two significant breakthroughs that may have
`great impact on future diabetes treatment. The development of
`liraglutide for the treatment of type 2 diabetes was finalised and
`regulatory approval was sought in the US, Europe, Japan and
`many other countries. In addition, a new generation of insulins
`for both type 1 and type 2 diabetes showed promising results in
`phase 2 trials.
`
`In November, we laid the foundation stone for a major expansion
`of our production site in Tianjin, China, which will create 500 new
`jobs. The new insulin formulation and filling plant is one of the
`largest investments in the history of Novo Nordisk and our
`biggest single investment outside Denmark. The second-largest
`single investment, the production site in Montes Claros, Brazil,
`became fully operational in 2008 and today provides insulin to a
`number of markets.
`
`2 Novo Nordisk Annual Report 2008
`
`Sanofi Exhibit 2136.012
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`IPR2018-01675
`
`

`

`

`

`

`

`Back to Contents
`
`■ Welcome to Novo Nordisk Managing in the current economic climate
`
`Managing in the current
`economic climate
`Interview with Novo Nordisk's CFO, Jesper Brandgaard
`
`In your opinion, what impact will the
`current economic downturn have on
`the pharmaceutical industry?
`
`We have to recognise that this crisis is
`not only global, it is severe, and it is
`likely to be of significant duration. There
`are profound implications for wealth and
`growth throughout the world. Even in a
`sector less impacted by short-term
`economic swings, such as the
`pharmaceutical sector, there is a clear
`correlation between long-term economic
`growth at the societal level and growth
`opportunities for companies.
`
`We believe the pharmaceutical sector
`will first see an impact in economies
`that are largely dependent on exporting
`either goods or raw materials. Oil price
`volatility is, of course, important in this
`regard. Societies such as Russia,
`Algeria and Venezuela may experience
`an impact on their ability to procure
`advanced pharmaceutical products.
`
`In many countries, notably in Europe,
`pressure to reduce the growth of public
`spending for pharmaceutical products
`will increase, with more substitution of
`generic products. There will also be
`greater emphasis on health economics
`to make sure that products paid for by
`society are achieving the desired health
`outcomes.
`
`With the new administration in
`Washington, there is a high likelihood
`that 2009 will bring price reform in
`government-funded healthcare
`programmes such as Medicaid and
`Medicare. We have said that there has
`
`are likely to face higher co-payments.
`Everything else being equal, it will be
`increasingly difficult to obtain
`reimbursement for new, advanced
`treatments.
`
`of the Novo Group companies, including
`Novo Nordisk. Beyond the Foundation,
`we have experienced changes in the
`holdings of other large investors, notably
`US investors repatriating funds.
`
`How do you see the financial crisis
`impacting the structure of the
`industry?
`
`There is still a profound need for large
`pharmaceutical companies to acquire
`innovation. These companies are gene
`rating significant positive cash flows but
`are challenged by lack of innovation and
`regulatory hurdles. At the same time,
`small biopharm companies that do not
`yet have products on the market will
`have increasing difficulty accessing
`long-term venture capital. These firms
`are likely to either look for opportunities
`to partner with larger fi rms or put
`themselves up for sale. In this
`environment, we expect to see
`consolidation in the industry.
`
`We have not changed
`direction; we have stayed the
`course, and we believe this
`will now present us with new
`opportunities.
`
`How was Novo Nordisk impacted by
`market volatility in 2008?
`
`While Novo Nordisk has continued to
`
`We have also seen a number of Danish
`pension institutions reducing their
`holdings in Novo Nordisk in order to
`maintain portfolio diversification. The
`challenge in the Danish stock exchange
`environment is that the relative
`performance of Novo Nordisk compared
`with other companies listed on
`NASDAQ OMX Copenhagen increased
`Novo Nordisk's weighting on the
`exchange dramatically during 2008.
`
`So we have seen the shareholdings of
`some of the company's largest investors
`reduced. At the same time, we have
`seen solid support from new European
`and US investors, as well as from retail
`investors in Denmark.
`
`These changes have not impacted the
`way the company interacts with the
`equity market, but have highlighted the
`need to be very transparent.
`
`How does Novo Nordisk manage its
`balance sheet, and have there been
`recent changes in direction?
`
`Historically, Novo Nordisk, like most
`pharmaceutical and large-cap biopharm
`firms, has had a balance sheet with little
`debt. In fact, Novo Nordisk has operated
`with slightly positive net financial assets
`on its balance sheet. This is an
`advantage because having access to
`cash can now provide us with interesting
`
`Sanofi Exhibit 2136.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`been an advantage for the industry from
`the migration of patients from Medicaid
`to the Medicare Part D programme and
`we did not think this was sustainable.
`The details of a potential pricing reform
`remain to be seen, but we do anticipate
`changes in some of the schemes funded
`by the federal government, including
`Medicare Part D.
`
`In the private health insurance market in
`the US, we are also looking at a
`scenario where funds are getting tighter.
`Patients
`
`4 Novo Nordisk Annual Report 2008
`
`have strong sales and cash flow and has
`not experienced any liquidity issues,
`recent market turmoil has had a bigger
`impact on the composition of Novo
`Nordisk's shareholder base than we
`originally anticipated.
`
`Novo Nordisk's largest shareholder
`continues to be The Novo Nordisk
`Foundation through the Novo A/S
`holding company. The Foundation has
`bylaws stating that its primary objective
`is to be a stable owner
`
`investment possibilities. We have not
`changed direction; we have stayed the
`course, and we believe this will now
`present us with new opportunities.
`
`In terms of cash returned to
`shareholders, Novo Nordisk has adhered
`to its dividend policy of gradually
`increasing the payout ratio to a level
`around the pharma industry average,
`which is now approximately 40%.
`
`Sanofi Exhibit 2136.016
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`

`

`

`

`

`

`Performance: The number of people
`with diabetes in the US is now 24
`million, according to the national
`Centers for Disease Control (CDC), and
`this is projected to exceed 30 million
`within 1 O years. The rate of new cases
`of diabetes soared by about 90% in the
`past decade, according to the CDC,
`fuelled by growing obesity and
`sedentary lifestyles.
`
`Novo Nordisk sees significant
`opportunities to improve care and
`treatment for people with diabetes in the
`US. To deliver on these opportunities,
`market access is crucial. More than
`80% of the US population is currently
`covered by medical insurance. Novo
`Nordisk's products are eligible for
`reimbursement through 90% of managed
`care formularies, a key competitive
`advantage.
`
`Performance: Novo Nordisk's
`International Operations - covering
`South and Central America, the Middle
`East, Africa and Asia (excluding Japan
`& Oceania) - is a vast area representing
`85% of the world's population and 80%
`of all people with diabetes.
`
`Lack of access to adequate diabetes
`care is a continuing concern in these
`countries, although there are
`encouraging signs that diabetes is rising
`on the public health agenda. A growing
`middle class in emerging markets such
`as China and India are also better able
`to afford more advanced treatments. The
`dramatic rise in the number of people
`with diabetes in these markets is driven
`by several factors, including
`urbanisation, an ageing population,
`unhealthy eating habits and sedentary
`lifestyles.
`
`Capacity-building: 89,500 healthcare
`professionals have been trained or
`educated through Novo Nordisk's
`National Changing Diabetes®
`programmes.
`
`Capacity-building: 151,500 healthcare
`professionals have been trained or
`educated through Novo Nordisk's
`National Changing Diabetes®
`programmes.
`
`Performance: Modern insulins are
`driving growth in the company's
`European operations. Levemir®, the
`company's basal insulin, is reinforcing
`Novo Nordisk's market leadership in the
`region.
`
`Through its affiliates, Novo Nordisk is
`driving home the message that changing
`diabetes care begins with raising
`awareness and working with partners. In
`Italy, Novo Nordisk supported a meeting
`of about 200 diabetes experts, policy(cid:173)
`makers, patient representatives,
`industry and media to discuss how to
`stop the epidemic growth of diabetes.
`Marking its 5oth anniversary, Novo
`Nordisk's affiliate in Germany held its
`second Camp D for young people with
`diabetes in 2008. Nearly 700 young
`people attended the four-day event,
`which focuses on enhancing quality of
`life for people with type 1 diabetes.
`
`Capacity-building: 79,000 healthcare
`professionals have been trained or
`educated through Novo Nordisk's
`National Changing Diabetes®
`programmes.
`
`6 Novo Nordisk Annual Report 2008
`
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`IPR2018-01675
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`

`Back to Contents
`
`■ Business results Performance in 2008
`
`Performance
`in 2008
`
`Novo Nordisk continued on a
`sustainable growth path in all its major
`business areas and delivered solid
`results in 2008.
`
`Sales increased by 12% measured in
`local currencies and by 9% in Danish
`kroner. Modern insulins continued to be
`the main contributor to growth
`increasing by 28% in local currencies
`(24% in Danish kroner), and
`
`Earnings per share (diluted) increased
`by 16% to DKK 15.54.
`
`2008 performance on long-term
`financial targets
`Focusing on growth, profitability,
`financial return and generation of cash,
`the four long-term financial targets guide
`the
`
`company's financial development, aimed
`at ensuring a focus on shareholder value
`creation. These targets are operating
`profit growth, operating margin, return on
`invested capital and cash conversion.
`By 2008, Novo Nordisk reached the
`performance level stipulated in the four
`long-term financial targets which were
`outlined in 2006. The four ratios are still
`considered an appropriate way to ensure
`value creation, and several of the targets
`
`Sanofi Exhibit 2136.023
`Mylan v. Sanofi
`IPR2018-01675
`
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`

`

`

`

`

`Growth in operating profit
`Operating margin
`Return on invested capital (ROIC)
`Cash to earnings (three-year average)
`
`15%
`25%
`30%
`70%
`
`38.4%
`27.2%
`37.4%
`97.6%
`
`15%
`30%
`50%
`80%
`
`Novo Nordisk Annual Report 2008
`
`9
`
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`Back to Contents
`
`■ Business results Performance in 2008
`
`Diabetes care
`
`Novo Nordisk retained its position as
`global leader with 52% of the total insulin
`market and 44% of the modern insulin
`market, both measured by volume. The
`company is determined to sustain its
`leadership in diabetes care by leveraging
`the value of its full portfolio of modern
`insulins and delivery devices while
`developing new antidiabetic agents and a
`new generation of insulins to better
`address future needs for effective
`diabetes care. See pp 30-37.
`
`Sales performance
`Sales of diabetes care products
`increased by 13% measured in local
`currencies and by 9% in Danish kroner
`to DKK 33,356 million compared to last
`year.
`
`Modern insulins, human insulins and
`insulin-related products
`Sales of modern insulins, human
`insulins and insulin-related products
`increased by 12% measured in local
`currencies and by 9% in Danish kroner
`to DKK 30,965 million. All regions
`contributed to growth, with North
`America and International Operations
`having the highest growth rates.
`
`Sales of modern insulins increased by
`28% in local currencies in 2008 and by
`24% in Danish kroner to DKK 17,317
`million. Sales of Levemir® increased by
`
`55%, sales of NovoRapid® (Novolog® in
`the US) increased by 22% and sales of
`
`NovoMix® (Novolog® Mix 70/30 in the
`US) increased by 23%, all measured in
`local currencies. All regions realised
`solid growth rates, with North America
`
`in Danish kroner. The sales
`development reflects sales growth for
`the modern insulins NovoRapid®,
`
`NovoRapid Mix® 30 and Levemir®. Novo
`Nordisk holds 72% of the total insulin
`market in Japan and 64% of the modern
`insulin market, both measured by
`volume.
`
`Oral antidiabetic products
`(NovoNorm®/Prandin®)
`Sales of oral antidiabetic products
`increased by 16% in local currencies
`and by 11 % in Danish kroner to DKK
`2,391 million compared to 2007. This
`primarily reflects increased sales in
`International Operations and North
`America, mainly due to an increased
`market share in China and a higher
`average sales price in the US market.
`
`Sanofi Exhibit 2136.027
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`

`

`Back to Contents
`
`Business results Performance in 2008 ■
`
`growth measured in local currencies.
`Novo Nordisk is the second-largest
`company in this market with 23%
`market share measured by volume.
`
`Other products
`Sales of other products within bio(cid:173)
`pharmaceuticals, which predominantly
`consist of hormone replacement therapy
`(HRT)-related products, increased by
`1 % in local currencies and decreased
`by 2% in Danish kroner to DKK 1,936
`million. This development primarily
`reflects generic competition in the US
`
`for Activella®, a continuous-combined
`HRT product, but also continued sales
`progress for Vagifem®, Novo Nordisk's
`topical oestrogen product.
`
`Pipeline progress
`
`Novo Nordisk made significant progress
`in research and development in 2008.
`See pp 18-19 for a status on the current
`pipeline and progress during the year.
`
`Within biopharmaceuticals the key
`events for late-stage pipeline
`compounds in 2008 were:
`
`• Novo Nordisk received marketing
`approval for a temperature-stable
`
`version of NovoSeven® which is
`expected to deliver significant patient
`benefits including immediate access
`to treatment as well as fast and
`convenient administration when a
`bleeding episode occurs.
`
`• A phase 3 study with recombinant
`FXIII in congenital FXIII deficiency was
`initiated.
`
`• A phase 2 clinical study was initiated
`with a long-acting human growth
`hormone analogue designed for once(cid:173)
`weekly treatment.
`
`• Novo Nordisk decided to discontinue
`the phase 3 clinical study with Novo-
`Seven® for the treatment of bleeding in
`patients with severe trauma.
`
`In 2008, costs amounting to DKK 171
`million in connection with general
`employee share programmes were
`expensed. In 2008, Novo Nordisk
`expensed costs in relation to share(cid:173)
`based long-term incentive programmes
`for senior management and other senior
`employees (around 580 participants in
`total) amounting to DKK 160 million. The
`comparable expense for 2007 was DKK
`121 million (around 525 participants in
`total).
`
`Licence fees and other operating income
`were DKK 286 million in 2008 compared
`to DKK 321 million in 2007.
`
`Operating profit in 2008 increased by
`38% to DKK 12,373 million compared to
`2007.
`
`Net financials and tax
`Net financials showed a net income of
`DKK 322 million in 2008 compared to a
`net income of DKK 2,029 million in
`2007.
`
`Sanofi Exhibit 2136.029
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`

`

`

`

`Equity
`Total equity was DKK 32,979 million at
`the end of 2008, equal to 65.2% of total
`assets, compared to 67.4% at the end
`of 2007.
`
`will amount to DKK 620,000,000 divided
`into an A share capital of DKK
`107,487,200 and a B share capital of
`DKK 512,512,800.
`
`12 Novo Nordisk Annual Report 2008
`
`Sanofi Exhibit 2136.032
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Back to Contents
`
`Legal issues
`Novo Nordisk is party to a number of
`legal cases. See key legal issues and
`information on contingencies for pending
`litigations on pp 86-87.
`
`Long-term incentive
`programmes
`
`Novo Nordisk's existing remuneration
`policy for executives aims to attract,
`retain and motivate members of the
`Board of Directors and Executive
`Management of Novo Nordisk.
`Remuneration levels are designed to be
`competitive and to align the interest of
`the executives with those of the
`shareholders.
`
`Long-term share-based incentive
`programme for senior management
`As from 2004, members of Novo
`Nordisk's Executive Management
`(currently five) and the other members of
`the Senior Management Board ( currently
`24) have participated in a performance(cid:173)
`based incentive programme where a
`proportion of the calculated shareholder
`value creation has been allocated to a
`joint pool for the participants. For
`members of Executive Management and
`the other members of the Senior
`Management Board the joint pool
`operates with a yearly maximum
`allocation per participant equal to eight
`months' fixed base salary plus pension
`contribution. Once the joint pool has
`been approved by the Board of Directors
`the total cash amount is converted into
`Novo Nordisk A/S B shares at market
`price. The shares in the joint pool are
`locked up for a three-year period before
`they potentially may be transferred to
`the participants.
`
`Business results Performance in 2008 ■
`
`will, according to the principles of the
`scheme, be transferred to 23 current
`and former members of senior
`management immediately after the
`announcement of the full-year 2008
`financial results on 29 January 2009.
`
`For 2008 and based on an assessment
`of the economic value generated in
`2008, as well as the performance of the
`R&D portfolio and key sustainability
`projects, the Board of Directors on 28
`January 2009 approved the
`establishment of a joint pool for the
`financial year 2008 by allocating a total
`of 171,492 Novo Nordisk B shares,
`corresponding to a cash value of DKK
`55 million. This allocation amounts to
`eight months of fixed base salary and
`pension on average per participant. This
`amount was expensed in 2008.
`
`As the long-term share-based incentive
`programme is evaluated by the Board of
`Directors to have worked successfully in
`2008, it is planned to continue in 2009
`with an unchanged structure.
`
`Long-term share-based incentive
`programme for corporate vice
`presidents and vice presidents
`As from 2007, a number of key
`employees below top-level management
`also participate in a share-based
`programme with similar performance
`criteria as the programme for the
`members of Executive Management and
`the other members of the Senior
`Management Board. The share-based
`incentive programme for key employees
`will, as is the case for the programme
`for Executive Management and the other
`members of the Senior Management
`Board, be based on an annual
`calculation of shareholder value creation
`
`performance of the R&D portfolio and
`key sustainability projects, the Board of
`Directors on 28 January 2009 approved
`the establishment of a pool for 2008 by
`allocating a total of 570,390 Novo
`Nordisk B shares, corresponding to a
`cash value of DKK 181 million. This
`allocation amounts to four months of
`fixed base salary on average per
`participant. The number of participants
`for 2008 is approximately 550. The cash
`value of the allocation will be amortised
`over four years.
`
`Compliance with Sarbanes(cid:173)
`Oxley requirements
`
`In 2008, Novo Nordisk was, as was the
`case in 2007, compliant with the US
`Sarbanes-Oxley Act section 404 that
`requires detailed documentation of how
`financial reporting processes, systems
`and controls are designed and
`operating. Management's conclusion
`and the external auditor's certification of
`the 2008 compliance are included in the
`Form 20-F, which Novo Nordisk as a
`listed company on the New York Stock
`Exchange is required to file with the US
`Securites and Exchange Commission
`(SEC). Form 2

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