2009 annual report
`
`Exhibit 1079
`IPR2017-00807
`ARGENTUM
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`Contents | 2009 annual report
`
`Contents
`
`2 Milestones
`3 2009 in figures
`4 CEO’s report
`7 Trends and specialty pharma
`12 Strategy and business development
`14 Agreements, partnerships, and key events
`17 Meda in brief
`23 Sales and marketing
`26 Product portfolio
`37 Drug development
`41 Manufacturing
`43 Meda’s responsibilities
`52 Management report
`59 Consolidated accounts
`63 Group notes
`91 Parent company accounts
`96 Parent company notes
`
`106 Proposed allocation of profits
`107 Audit report
`108 Financial review
`110 Corporate governance report
`114 Definitions
`116 Risk factors
`119 The Meda share
`122 Board of directors
`124 Senior executives
`126 Product overview
`128 Glossary
`129 Shareholder information
`
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`MEDA | Milestones
`
`Milestones
`
`•
`
`Integration of Valeant’s European pharmaceutical operations completed.
`
`•
`
`FDA approval and launch on the US market of Astepro once-daily, the first single-
`dose nasal antihistamine, and Onsolis, for treatment of break-through pain in
`cancer patients.
`
`•
`
`Progress for Retigabine (treatment of epilepsy). New drug applications submitted
`to FDA and EMEA and approved for further evaluation.
`
`•
`
`New strategic partnerships:
`
`– In-licensing of exclusive rights to Xerese (cold sores) in North America.
`
`– In-licensing of exclusive rights to Ceplene (maintenance treatment and relapse
`prevention in patients with acute myeloid leukemia) in Australia, China, Europe,
`and Japan.
`
`– Extended commercialization rights for:
`
`* Onsolis (breakthrough pain in cancer patients)
`
`* Combination product azelastine and fluticasone (allergic rhinitis)
`
`* Axorid (rheumatic disorders)
`
`– Expanded product portfolio in dermatology via new license agreements with
`Valeant for two acne treatment products.
`
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`2009 in figures | 2009 annual report
`
`2009 in figures
`
`•
`
`Group sales reached SEK 13,178 million (10,675).
`
`•
`
`Profit after tax rose to SEK 1,537 million (954).
`
`•
`
`EBITDA rose to SEK 4,387 million (3,425).
`
`•
`
`Earnings per share increased to SEK 5.09 (3.49).
`
`•
`
`Operating profit rose to SEK 2,902 million (2,302).
`
`•
`
`Proposed dividend per share: SEK 1.00 (0.75).
`
`NET SALES
`
`EBITDA MARGIN*
`
`2008
`
`2009
`
`%
`
`35
`
`30
`
`25
`
`20
`
`15
`
`10
`
`05
`
`SEK million
`14,000
`
`12,000
`
`10,000
`
`8,000
`
`6,000
`
`4,000
`
`2,000
`
`0
`
`2008
`
`2009
`
`OPERATING PROFIT*
`
`PROFIT AFTER TAX*
`
`SEK million
`3,000
`
`SEK million
`1,600
`
`2,500
`
`2,000
`
`1,500
`
`1,000
`
`500
`
`0
`
`2008
`
`2009
`
`1,400
`
`1,200
`
`1,000
`
`800
`
`600
`
`400
`
`200
`
`0
`
`2008
`
`2009
`
`*) Including restructuring costs of SEK 215 million in 2008 and SEK 131 million in 2009.
`
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`MEDA | CEO’s report
`
`CEO’s report
`
`2009 was yet another successful year for Meda.
`Sales rose 23% to SEK 13,178 million and EBITDA
`increased 28% to SEK 4,387 million. The substan-
`tial impact of positive currency translation differ-
`ences on 2009 earnings should also be mentioned.
`Efforts in 2009 were aimed at integrating companies
`and products acquired in 2008 and registration and
`launch of new drugs in Europe and the US.
`The efficient integration of Valeant’s European
`pharmaceutical operations and the Roche product
`portfolio exceeded expectations and rewarded us
`with significant synergies. During the year Meda also
`received approval and launched Astepro once-daily
`(nasal spray for the treatment of allergic rhinitis), On-
`solis (treatment of breakthrough pain in patients with
`cancer), Edluar (treatment of temporary insomnia),
`and Axorid (the first NSAID and proton pump inhibitor
`combination product).
`Cash flow was strong during the year. Net debt
`decreased gradually, which strengthened Meda’s fi-
`nancial muscle and, by extension, increased its com-
`mercial freedom. 2009 was also the year when Meda
`took the definitive step to becoming a leading player
`in the international specialty pharma market. Relative
`to its size, Meda has one of the widest internation-
`al footprints in the industry with its own sales force
`in 50 countries and sales in more than 120. As such,
`Meda has a market presence in key growth markets
`where there is future potential to increase operations
`by forming its own sales and marketing organiza-
`tions. Prime examples are China and major markets in
`southeast Asia and Latin America.
`There is good potential for further geographical ex-
`pansion, but this will require a continued influx of
`
`attractive products, which is a high priority within the
`Group. Portfolio expansion occurs on several levels.
`As mentioned above, extensive drug development is
`ongoing within Meda’s key therapy areas. In parallel,
`we continuously evaluate acquisitions of companies
`and products. As its international presence is strength-
`ened, Meda is becoming an increasingly attractive
`partner for research and development companies pre-
`paring for global commercialization of new drugs.
`The Meda model—streamlined administration, a
`highly efficient sales and marketing organization, and
`outsourcing of specialized services—keeps Meda ag-
`ile and cost-effective. These characteristics are highly
`valued by companies looking for a partner, especially
`when the goal is to quickly reach the major markets in
`North America and Europe, which together represent
`about 70% of the global pharmaceutical market. As
`the proportion of specialist products in Meda’s prod-
`uct portfolio has gradually increased, marketing activi-
`ties in 2009 were geared more toward specialists. As
`marketing that targets medical specialists is more cost
`effective than marketing that targets general practi-
`tioners Meda began a reorganization in 2009 that af-
`fected all operations in western Europe and the US.
`In parallel, this year we will be reinforcing our sales
`organizations in emerging markets like Russia, Poland,
`and Turkey.
`
`GOING FORWARD
`The pharmaceutical market in western Europe, Ja-
`pan, and the US is defined by stiff price competi-
`tion and low growth. However, strong growth can
`be expected in markets like China, Brazil, Korea, and
`eastern Europe. Competition in the pharmaceutical
`
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`industry is becoming fiercer every year, as reflected
`by the high rate of mergers and acquisitions, es-
`pecially in the big pharma sector. The same trend
`is occurring among niched generic companies,
`and signs are emerging that this may also hap-
`pen among specialty pharma companies. The driv-
`ing force is largely the same: economies of scale in
`sales and marketing.
`Meda’s strategy for remaining competitive in
`this dynamic pharmaceutical environment is to
`stay active, with a priority on continued, profit-
`able expansion. Fiscal 2010 will be shaped by new
`product launches and a stronger pipeline, accom-
`panied by the challenges of greater price compe-
`tition for certain major products. The latest addi-
`tions came early in 2010, when Meda acquired
`exclusive rights to Xerese from Medivir AB, a
`Swedish research company, and to Ceplene
`from the US-based research company EpiCept
`Corporation.
`Finally, I want to thank all of Meda’s employ-
`ees—you delivered such a fine performance in
`2009. New challenges await us this year as we
`move towards our long-term objective of becom-
`ing a leader in the international specialty pharma
`market.
`
`Anders Lönner
` President and Chief Executive Officer
`
`CEO’s report | 2009 annual report
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`Trends and specialty pharma | 2009 annual report
`
`Trends and specialty pharma
`
`PHARMAceutIcAl MARKet
`In 2009, the global pharmaceutical market totaled
`nearly USD 800 billion in sales. North America and
`Europe dominate the market with North America
`making up more than 40% of sales and Europe rep-
`resenting more than 30%. Recent years have seen
`between 4 and 5% growth in North America and Eu-
`rope, with North America in the lower range of the
`interval and Europe in the upper. In the rest of the
`world, total growth was somewhat higher.
`The five largest markets in Europe are France,
`Germany, Italy, Spain, and the UK, which together
`make up more than 60% of the European market.
`
`GROwTh FACTORS
`The most critical growth factors are (i) changes in
`available medicines and (ii) demographic evolution—
`our populations are growing older and requiring
`more medicines.
`Rising proportions of the elderly, primarily in devel-
`oped nations, has led to steady increases in pharma-
`ceutical use. Demand for medicines for age-related
`diseases is on the rise, as are costs. Average cost of
`medications for a 60-year-old is generally estimated
`to be double that for a 40-year-old. Today more pa-
`tients survive acute, serious conditions and as a result
`develop various chronic or secondary conditions that
`require drug treatment. Maintenance drug therapy
`to prevent various illnesses and hospital stays has
`received high priority from care providers and greater
`acceptance from patients. Growth in number of new
`
`patients, coupled with higher use of medications per
`patient, has led to an upswing in pharmaceutical
`market volumes concerning number of prescriptions
`and doses.
`As medications become more affordable for more
`people and populations continue to age, new drug
`R&D increasingly focuses on lifestyle diseases and ill-
`nesses that were never before subject to pharmaco-
`logical treatment. New drugs often command high
`prices. In many cases, such prices are being justified
`from a social or medical perspective because they re-
`duce expenses in other areas. This is often referred to
`as pharmacoeconomic benefit. In other cases, phar-
`maceutical companies’ marketing has successfully es-
`tablished changes in prescribing patterns.
`Most rising pharmaceutical costs in developed
`countries are due to doctors prescribing new, typi-
`cally more expensive drugs. Changes in the total
`pharmaceutical range can also have a cost-lowering
`effect, for example, increased prescription of generic
`drugs (chemical equivalent to a more expensive
`brand-name drug whose patent has expired).
`
`cHANGING PHARMAceutIcAl MARKet
`The pharmaceutical industry has become increas-
`ingly consolidated in recent years. The trend is for
`big international pharmaceutical companies—big
`pharma—to become ever larger through mergers
`or acquisitions. Driving these developments are
`opportunities to improve R&D productivity, loss
`of exclusivity for key products, and to exploit
`
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`MEDA | Trends and specialty pharma
`
`economies of scale in production and marketing.
`Typical of big pharma is also a distinct emphasis on
`finding new blockbusters—drugs with extremely high
`sales figures. Consequently, big pharma steers many
`of its resources toward developing drugs for condi-
`tions requiring lifelong treatment, such as obesity, dia-
`betes, cancer, and arteriosclerosis (hardening of the
`arteries).
`With this approach, many medically valuable prod-
`ucts are of less interest to big pharma. Future sales
`figures of these products are considered too low, or
`they are local products with sales on a limited num-
`ber of geographic markets. In some cases, these
`companies completely abandon certain therapy areas
`to concentrate on those in which they pursue long-
`term research.
`Limited resources force small, medium-sized, and
`new pharmaceutical companies to concentrate on
`well-defined specialty areas. This has helped new
`companies find market niches.
`Specialty pharmaceutical companies can offer part-
`ners access to core competencies such as R&D,
`manufacturing, or pharmaceutical sales and market-
`ing, which limits the need for partners to develop
`expensive proprietary organizations. In the past,
`companies needed to invest valuable resources in
`these periferal capabilities rather than dedicate all
`of their resources to value-centric activities.
`
`ChANGED MARKET CONDITIONS
`The cost of publicly financed medicine, especially in
`Europe, has gradually increased in recent years so
`that influence over choice of medications has grad-
`
`8
`
`ually shifted from the prescribing doctor to various
`coordinating committees and purchasing organiza-
`tions. Increasingly common are product compari-
`sons—of medical properties and price—which has
`greatly changed the playing field for the pharma-
`ceutical industry:
`•
`Demand for medicines is rising as the global popula-
`tion expands and life spans increase.
` Successful medical treatment means more patients
`not only survive acute conditions, but also develop
`various chronic or secondary conditions that require
`drug treatment.
` Lifestyle-disease prevention with blood pressure and
`blood lipid lowering drugs has increased.
` More comprehensive treatment of obesity, diabetes,
`cancer, and arteriosclerosis with expensive new
`drugs is occurring.
`
`•
`
`•
`
`•
`
`Prices are mainly controlled by legislation and regu-
`lation of subsidies for prescription drugs and by re-
`quiring prescribing doctors to always select the least
`expensive equivalent. Regulations vary from country
`to country, even within the EU. To further complicate
`matters, nations’ attempts to maximize competition
`by minimizing obstacles for new players must be bal-
`anced against the imperative to secure safe medi-
`cines for consumers.
`Exchange-rate fluctuations can also result in sig-
`nificant price variations for the same drug in various
`countries. Such price differences make parallel trade
`feasible, which in the long run counteracts excessive
`price differences.
`
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`Trends and specialty pharma | 2009 annual report
`
`GENERICS
`Generic drugs—less-expensive copies of medicines
`whose patents have expired—are increasingly used as
`alternatives to more expensive proprietary drugs.
`The US is the single biggest market for generics. In
`Europe, the market is split. In several eastern Europe-
`an countries, generic drugs represent a large propor-
`tion of total prescriptions— in some markets more
`than 70% of the volume is generic. At the same
`time, generics are not widely prescribed in many
`large markets, such as France, Spain, and Italy. Den-
`mark, Germany, Sweden, and the UK fall in the mid-
`range, however Germany and the UK have the great-
`est sales of generic drugs by value.
`A clear tendency is the efforts of the major ge-
`neric companies in the world—like big pharma—to
`improve their competitiveness through acquisitions
`and mergers. Their main motivation is to achieve
`economies of scale, chiefly in manufacturing and
`distribution.
`
`SPecIAltY PHARMA
`Besides big pharma and generic companies, a new
`type of drug company has emerged—specialty
`pharma. Here, the business concept often involves
`assertively taking advantage of opportunities for
`product acquisitions of everything from small niche
`products to potential blockbusters, while meeting
`market demands for cost-effective solutions.
`Specialty pharma companies acquire new products
`by working actively and systematically to identify prod-
`ucts for in-licensing or acquisition. Taking responsibility
`for developing new products in late clinical stages or in
`
`conjunction with registration allows these companies to
`avoid early, capital-intense, risky research.
`New products can also be procured by acquiring
`medically valuable drugs that the big pharma compa-
`nies are phasing out. Refinement can occur by prioritiz-
`ing sales and marketing so volumes can be kept at sat-
`isfactory levels.
`A specialty pharma product portfolio can contain
`everything from purely generic drugs to refined special-
`ist products called niche busters, which are aimed at
`smaller but more clearly defined target groups.
`Specialty pharma companies are often attractive part-
`ners for pharmaceutical, R&D, and biotech companies
`with no marketing organizations. They have the capac-
`ity and expertise to manage potential global blockbust-
`ers and smaller niche products, and they can adapt
`their marketing to local conditions.
`Consolidation within the specialty pharma sector will
`probably increase. Companies that research and de-
`velop new drug candidates with great potential want to
`reach global markets—and they want to do so quickly.
`This increases demand for specialty pharma companies
`to offer an efficient sales and marketing organization
`with a competitive presence in all large markets.
`Broadly speaking, the specialty pharma sector falls
`into three segments, based on focus:
`
`1. ACQuISITIONS AND IN-LICENSING
`Building a product portfolio in a limited number
`of therapy areas via acquisitions and in-licensing
`is the main strategy here. By limiting their activi-
`ties to a handful of therapy areas, while retaining
`the opportunity to focus on both blockbusters and
`
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`Trends and specialty pharma | 2009 annual report
`
`on the active ingredients of blockbuster products.
`In some cases, certain aspects of these products
`can be improved in order to set them apart.
`
`11
`
`niche products, these companies can compete with
`much larger ones with limited capital investment
`and minimal risk. This segment includes companies
`that combine marketing of specialist products and
`acquired original brands with proprietary product
`development such as new pharmaceutical formula-
`tions or new indications. Market-adapted product
`development is called product life-cycle manage-
`ment. Meda’s aim is to be a key global player in this
`category of specialty pharma companies.
`
`2. DRuG DELIVERY
`Specialty pharma companies that focus on drug
`delivery develop new methods of getting ac-
`tive drug ingredients into the body, be it a tablet,
`capsule, injection, spray, inhaler, or patch. Often,
`this involves inventing a new administration tech-
`nique for patent-free substances to create a new,
`improved, patented product. Risks and develop-
`ment costs for this type of product development
`are considerably lower than for new chemical enti-
`tities (NCE). This segment includes companies that
`focus solely on developing new drug delivery tech-
`nologies and companies that combine technology
`with marketing of the most important of their own
`products, whether on their own or in collaboration
`with other companies.
`
`3. GENERICS
`Successfully producing, marketing, and selling
`generics requires large economies of scale based
`on volume. Consequently, generic companies focus
`
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`MEDA | Strategy and business development
`
`Strategy and business development
`
`In the last decade, Meda has evolved into a leading international special-
`ty pharma company with full representation in Europe and North America
`through its own sales organizations in 50 countries. Meda has about 1,600
`employees in sales and marketing, and sales in 2009 topped SEK 13 billion.
`Meda’s strategy has been to expand via (i) the addition of proprietary prod-
`ucts and (ii) greater market orientation through company and product rights
`acquisitions; long-term partnerships; and enhanced skills in sales, marketing,
`and business development. Meda meets customer needs through a cost-effec-
`tive approach that focuses on medical quality.
`Efforts have been oriented mainly toward identifying potential acquisitions
`and in-licensing opportunities. The acquisition of the German pharmaceutical
`group Viatris in 2005 established Meda as one of the leading specialty phar-
`maceutical companies in Europe. Previously announced plans to build mar-
`keting companies in the major European markets were realized through the
`Viatris acquisition, whose established marketing organizations gave Meda sig-
`nificant sales synergies.
`By acquiring 3M’s European pharmaceutical division in early 2007, Meda
`solidified its position as a leading European specialty pharma company and
`became substantially stronger in the key therapy areas of cardiology and der-
`matology.
`Meda finalized the MedPointe acquisition (a US specialty pharma company)
`in August 2007. The acquisition established Meda as a multinational specialty
`pharma company with its own US sales organization. Expansion continued in
`2008: Meda acquired Valeant’s European pharmaceutical business and global
`rights to four well-established drugs from Roche, a Swiss company.
`Efforts in 2009 were aimed in part at integrating companies and products
`acquired in 2008 and in part at the registration and launch of new pharma-
`ceuticals in the US and Europe.
`Meda’s expansion strategy—through acquisition-driven and organic growth
`via market-adapted product development—remains highly relevant for the
`future. Acquired companies are immediately integrated into the Meda Group
`organization and mature and specialist product acquisitions are transferred di-
`rectly to the corporate product portfolio.
`Sales and marketing is the company’s top priority. Meda constantly strives
`to maintain the strength of a small company by leveraging its flat organiza-
`tion with short decision paths and efficient work processes. Combined with
`the resources of a large company, this creates clear competitive advantages
`and ensures continual realization of key business opportunities.
`Product acquisitions are preceded by meticulous analysis based on several
`criteria, such as the product’s phase in the life cycle, brand strength, market
`
`Meda’s business concept
` is to offer cost-effective, medically
`well-motivated products.
`
`Goal
`Enhance its position and
`become the world-leading
`specialty pharma company.
`
`Means
`Active acquisition strategy and
`organic growth through market-
`adapted product development.
`
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`

`conditions, patent protection, profitability, complexity of
`product formulations, and potential for continued product
`development.
`In-house drug development is aimed at reinforcing fu-
`ture organic growth in Meda’s key therapy areas.
`A strong pipeline has been established in recent years.
`As in the past, Meda refrains from capital-intensive, risky
`early research to instead concentrate on late clinical phase
`development.
`Meda made numerous important advances in drug de-
`velopment in 2009, among which were registration ap-
`provals and launches of several products during the fiscal
`year and for 2010.
`
`•
`
`•
`
`Most notably:
`•
`Astepro received FDA approval in October 2008; market
`launch began in Q1 2009.
`Astepro once-daily received FDA approval in September
`2009; market launch began the next month.
`Onsolis, a new pain product, received FDA approval in
`July 2009; market launch began in Q4 2009.
`Edluar, a new sublingual sleep-inducing drug, received
`FDA approval in March 2009; market launch began in
`the second half of 2009.
`Axorid (the first combination NSAID/proton pump
`inhibitor product) received approval for treatment of
`rheumatic diseases; market launch in the UK began in
`early 2010.
`
`•
`
`•
`
`See page 37 for more information about ongoing drug
`development at Meda.
`
`Strategy and business development | 2009 annual report
`
`SALES TREND
`
`SEK million
`14,000
`
`12,000
`
`10,000
`
`8,000
`
`6,000
`
`4,000
`
`2,000
`
`0
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`13
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`

`MEDA | Agreements, partnerships, and key events
`
`Agreements, partnerships, and key events
`
`INteGRAtION OF VAleANt’S euROPeAN
`PHARMAceutIcAlS BuSINeSS
`Integration of operations acquired from Valeant was
`completed in early 2009. A new organizational struc-
`ture for the European markets included certain reduc-
`tions in redundant employees and improvements in
`administrative efficiency. In parallel, several marketing
`organizations were expanded in priority growth mar-
`kets in eastern Europe.
`
`FDA APPROVAl AND lAuNcH OF AStePRO
`ONce-DAIlY
`In September 2009, the FDA approved Astepro
`(azelastine) nasal spray 0.15% for treatment of al-
`lergic rhinitis symptoms with a once-daily dosing for
`seasonal allergic rhinitis (SAR). Astepro 0.15% once-
`daily is the first and only nasal antihistamine ap-
`proved as once-daily for patients with seasonal aller-
`gies. Astepro 0.15% is also indicated for perennial
`allergic rhinitis (PAR).
`The FDA approval is based on results from seven
`double-blind placebo-controlled phase III studies
`and a 12-month safety study. A total of more than
`2,300 patients with allergic rhinitis caused by pollen
`and animal dander participated in the clinical trials.
`Astepro once-daily was launched in the US in Octo-
`ber 2009.
`
`ADVANceS FOR RetIGABINe
`In October 2009 Meda’s partner for Retigabine,
`Valeant Pharmaceuticals, submitted new drug appli-
`cations and marketing authorization applications for
`Retigabine to the FDA and the EMEA, respectively.
`The applications have been accepted for review.
`Retigabine has been documented for the treatment
`of epilepsy. It utilizes a unique method of action to
`
`affect potassium channels in the central nervous sys-
`tem. No other antiepileptic therapies have a similar
`mechanism.
`GlaxoSmithKline and Valeant Pharmaceuticals
`have a global partnership agreement for Retiga bine.
`Meda is entitled to royalties of 6–8% from sales in
`the US and Europe and a lower royalty in other mar-
`kets. Meda may also receive substantial milestone
`payments in connection with defined
`development stages for Retigabine.
`
`IN-lIceNSING OF eXcluSIVe RIGHtS tO XeReSe
`Meda in-licensed exclusive rights to Xerese, a drug
`developed by Medivir AB, a Swedish research com-
`pany. Xerese (formerly Lipsovir®, ME-609) is used for
`topical treatment of cold sores and contains a com-
`bination of acyclovir, an antiviral agent, and hydro-
`cortisone. Xerese is the first topical treatment indi-
`cated to both reduce the likelihood of cold sores and
`shorten healing. Meda’s exclusive rights cover the
`US, Canada, and Mexico as well as the development
`of new indications.
`The FDA approved Xerese in 2009 as a prescrip-
`tion drug. Launch will begin when sufficient com-
`mercial stock quantities have been produced.
`
`IN-lIceNSING OF eXcluSIVe RIGHtS tO
`cePleNe
`In early 2010, Meda in-licensed exclusive rights to
`Ceplene (histamine dihydrochloride) from EpiCept
`Corporation, a US-based biopharmaceutical research
`company. Meda’s rights cover Europe and most key
`Asian markets including Australia, China, and Japan.
`Ceplene is indicated for remission maintenance ther-
`apy and prevention of relapse in adult patients with
`acute myeloid leukemia (AML). AML is one of the
`
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`Agreements, partnerships, and key events | 2009 annual report
`
`future, a combination product may give patients
`more effective treatment of allergic rhinitis than cur-
`rently available therapies. Meda and Cipla expand-
`ed their partnership in 2009 to include other major
`markets such as Australia, Brazil, Europe, Japan,
`and South Korea.
`
`eXPANDeD RIGHtS FOR AXORID
`Meda expanded its partnership with Ethypharm,
`a French development company, for Axorid to in-
`clude new markets such as eastern Europe, Russia,
`and Turkey. Previously, Meda held commercialization
`rights for this patented combination product in cen-
`tral and western Europe.
`Axorid consists of the well-known and widely used
`drugs ketoprofen, a non-steroidal anti-inflammatory
`drug (NSAID) for treatment of rheumatic disorders,
`and omeprazole, an acid-reducing proton pump in-
`hibitor (PPI). Axorid can prevent gastrointestinal side
`effects due to NSAID use. Axorid’s once-daily admin-
`istration can also improve patient compliance.
`
`eNHANceD PRODuct PORtFOlIO IN
`DeRMAtOlOGY
`Meda made long-term licensing agreements with
`Valeant in 2009 regarding two products for treat-
`ment of acne. The agreements cover all of Europe
`and strengthen Meda’s position in dermatology, a
`key therapy area.
`
`four main types of leukemia. Approximately 16,000
`new cases of AML are reported in Europe every year.
`Most patients suffer from relapse after initial treat-
`ment. There is currently no alternative treatment,
`and the medical need is substantial.
`The European Commission has approved Ceplene
`as an orphan drug. Orphan drugs are granted ex-
`clusive commercial rights for 10 years in the EU, and
`comparable protection will probably be granted in
`other markets. Ceplene is also being investigated for
`other indications such as Myelodysplastic Syndrome
`(MDS) and chronic myelogenous leukemia (CML).
`
`AcQuISItION OF WORlDWIDe RIGHtS
`tO ONSOlIS
`Meda acquired worldwide rights to Onsolis (for treat-
`ment of breakthrough cancer pain) in January 2009
`from its partner, BioDelivery Sciences International.
`The agreement added growth markets, such as
`China and Japan. These markets are in addition to
`the North American and European rights Meda al-
`ready held. Onsolis has been launched in the United
`States and is in the registration phase in other markets.
`
`eXPANDeD PARtNeRSHIP AGReeMeNt FOR
`AZelAStINe–FlutIcASONe cOMBINAtION
`PRODuct
`Meda has expanded its long-term partnership agree-
`ment with Cipla Ltd, a leading pharmaceutical com-
`pany in India, for the azelastine and fluticasone com-
`bination product.
`Azelastine is an antihistamine and fluticasone is
`a corticosteroid; both substances are indicated for
`intranasal treatment of allergic rhinitis. As mono–
`therapies, both are leaders in the US antihistamine
`and corticosteroid markets, respectively. In the
`
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`MEDA | Meda in brief
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`Meda in brief | 2009 annual report
`
`Dublin
`
`Ireland
`
`Cambridge
`Nether-
`lands
`UK
`Amstelveen
`
`Brussels
`
`Belgium
`
`Paris
`
`France
`
`Mérignac
`Bordeaux
`
`Meda in brief
`
`CANADA
`
`USA
`
`Decatur
`
`Somerset
`
`Sweden
`
`Norway
`
`Sverige
`
`Finland
`
`Finland
`
`Madrid
`
`Portugal
`
`Spain
`
`Lisbon
`
`Norge
`
`Oslo
`
`Denmark
`
`Danmark
`
`Köpenhamn
`Germany
`Poland
`
`Tyskland
`
`Polen
`
`Åbo
`
`Stockholm
`
`Estonia
`
`Estland
`Latvia
`
`Russia
`
`Lithuania
`Letland
`
`Litauen
`Belarus
`
`MEXICO
`
`Dublin
`
`Ireland
`
`Irland
`
`UK
`
`Nether-
`lands
`Cambridge
`Neder-
`länderna
`Belgium
`Storbritannien
`Amsterdam
`
`Bryssel
`
`Belgien
`
`Cologne
`
`Warszawa
`
`Czech Rep.
`Radebeul
`Slovakia
`
`Prag
`Tjeckien
`Austria
`Slovakien
`Hungary
`Bratislava
`Wien
`Budapest
`Österike Ungern
`Serbia
`Milano
`
`Ukraine
`
`Moldova
`
`Switzerland
`Bad Hamburg
`Wangen
`Frankrike
`
`France
`Paris
`
`Schweiz
`
`Somerset
`
`Mérignac
`Bordeaux
`
`Portugal
`
`Portugal
`
`Lisabon
`
`Spain
`
`Madrid
`
`Spanien
`
`Italy
`
`Italien
`
`Greece
`
`Istanbul
`
`Grekland
`
`Athen
`
`Turkey
`
`Turkiet
`
`Libya
`
`Jordan
`
`Egypt
`
`Saudi Arabia
`
`OPeRAtIONS
`Meda is an international specialty pharma com -
`pany with proprietary sales organizations in 50 coun-
`tries, including full representation in Europe and the
`US. As of December 31, 2009, Meda had a total of
`2,601 employees (2,715), of which 1,600 are in the
`sales and marketing organization. In 2009 Meda’s
`net sales exceeded SEK 13 billion.
`In other markets worldwide, its products are mar-
`keted and sold via agents and partnerships with other
`pharmaceutical companies. In total, Meda’s pharma-
`ceutical products are sold in more than 120 countries.
`
`Meda AB is the Group’s parent company; its head of-
`fice is in Solna, outside of Stockholm, Sweden. Meda
`is listed under Large Cap on the NASDAQ OMX
`Stockholm exchange.
`In 2009, operations were influenced by the inte-
`gration of Valeant’s European drug operation and
`products acquired from Roche, as well as develop-
`ment and registration of new products, aiming to
`further strengthen competitiveness in the Group’s
`pipeline.
`
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`
`000019
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`

`%
`
`70
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`
`Gross margin
`
`eBItDA*
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`*) Including restructuring costs of SEK 215 million in
`2008 and SEK 131 million in 2009.
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`MEDA | Meda in brief
`
`SEK million
`14,000
`
`12,000
`
`10,000
`
`8,000
`
`6,000
`
`4,000
`
`2,000
`
`0
`
`Portugal
`Russia
`UK
` Belgium
`Sweden
`
`Spain
`
`Italy
`
`18
`
`SALES TREND
`
`MARGIN TREND
`
`EMPLOYEES BY COuNTRY
`
`SALES BY COuNTRY
`
`Other
`
`US
`
`Other
`
`US
`
`Austria
`Netherlands
`Belgium
`
`UK
`
`France
`
`France
`
`Germany
`
`Spain
`
`Sweden
`
`Italy
`
`Germany
`
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`

`Meda in brief | 2009 annual report
`
`PRODuctS AND KeY tHeRAPY AReAS
`
`SALES BY ThERAPY AREA
`
`Meda’s product portfolio consists primarily of prod-
`ucts in five key therapy areas: respiratory, cardiol-
`ogy, pain and inflammation, dermatology, and CNS.
`These groups make up about 80% of total sales. Lo-
`cal products constitute another major part of Meda’s
`product portfolio.
`Meda’s strategy is to focus increasingly on spe cialty
`drugs. Specialty drugs often have lower sales and
`marketing overhead, because efforts can be directed
`toward a limited, clearly defined target group. Special-
`ty markets are often less subject to competition and
`may be less price sensitive compared to blockbuster
`drugs, which require massive marketing efforts on a
`market that is often highly competitive.
`
`Local products
`
`Respiratory
`
`CNS
`
`Pain and
`inflammation
`
`Cardiology
`
`Dermatology
`
`SELECTED KEY PRODuCTS
`
`Product
`
`Astelin
`Astepro
`Tambocor
`Betadine
`Minitran
`Aldara
`Soma
`Zamadol
`Mestinon
`Novopulmon
`
`Therapy area
`
`Respiratory
`Respiratory
`Cardiology
`Dermatology
`C