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Cognitive Dysfunction in Major Depression

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Cognitive Dysfunction in Major Depression 2 December 2013 Lundbeck Investor & Analyst Event Company disclaimer This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Lundbeck undertakes no duty to update forward-looking statements. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited. NOT FOR PROMOTIONAL USE 2 Agenda Time Min. Topic Speaker 1400-1430 - Coffee, registration - 1430-1450 20 Welcome and introduction + The Lundbeck journey Ulf Wiinberg 1450-1520 30 Lundbeck in psychiatry Andreas Eggert, Allan Wehnert 1520-1535 15 Break - 1535-1615 40 Brintellix – From idea to product, from product to brand Torsten Meldgaard Madsen, Andreas Eggert 1615-1630 15 Q&A Ulf Wiinberg moderator 1630-1645 15 Break - 1645-1705 20 Lu AE58054 – the next big product in Alzheimer’s? Allan Wehnert 1705-1730 25 Lundbeck in the U.S. Staffan Schuberg 1730-1755 25 Lundbeck in International Markets & Europe – focus on Brazil, Canada, China, and Japan Ole Chrintz, Herman Santoni Ramos 1755- - Final remarks and Q&A Ulf Wiinberg - Canapès and drinks NOT FOR PROMOTIONAL USE 3 Presenters Presenter Ulf Wiinberg President & CEO Ole Chrintz SVP, International Markets & Europe Andreas Eggert SVP, Global Product Strategy & Portfolio Development Torsten Meldgaard Divisional Director, Brintellix Science Team Madsen Herman Santoni Regional VP, Asia Ramos Staffan Schuberg President, Lundbeck Inc. (U.S.) Allan Wehnert VP, R&D Project Strategy & Portfolio Management NOT FOR PROMOTIONAL USE 4 The Lundbeck Journey By Ulf Wiinberg, President & CEO Our vision, mission and values OUR VISION OUR MISSION OUR VALUES …is to become a world …is to improve the quality of Imaginative – Dare to be different leader in psychiatry and life of people suffering from Passionate – Never give up neurology psychiatric and neurological Responsible – Do the right thing disorders NOT FOR PROMOTIONAL USE 6 Lundbeck – our strategy 1. R&D 2. LATE-STAGE STRATEGY PIPELINE Aggressive goal to rejuvenate our product portfolio 6. ORGANIZATIONAL EFFICIENCY AND 3. PRODUCT Stay focused on CNS HIGH PERFORMANCE DIVERSIFICATION CULTURE Be first or best in class High unmet need 5. PARTNERSHIPS 4. GEOGRAPHICAL AND BUSINESS EXPANSION DEVELOPMENT NOT FOR PROMOTIONAL USE 7 The journey started in 2009 2009 2010 2011 2012 2013 Efficiency programs Business Development Ovation Merck Xian- Cephalon Mochida Otsuka Janssen Product launches Xenazine Sabril Sycrest Lexapro - Onfi Treanda Abilify Selincro Japan Maintena (US) Phase III Brintellix Selincro Desmoteplase Onfi Zicronapine Abilify Maintena (EU) Brexpiprazole Health care reforms NOT FOR PROMOTIONAL USE 8 Lundbeck core growth 2008-2013 (excluding Lexapro U.S.) Revenue EBIT DKKm excl. Lexapro® excl. Lexapro® DKKm 16,000 2,000 15,000 * 1,800 14,000 1,600 * 1,400 13,000 1,200 12,000 1,000 11,000 800 600 10,000 400 200 0 0 2008 2009 2010 2011 2012 2013 -200 2008 2009 2010 2011 2012 2013 * Excl. restructuring costs of DKK 530m in 2012 and DKK 200m in 2013 NOT FOR PROMOTIONAL USE 9 Significant launch program ongoing Product diversification 3 launches from 2003 to 2008 8 launches from 2009 to 2013 NOT FOR PROMOTIONAL USE 10 Non-European core revenue close to tripled 2008 revenue (excl. Lexapro) Geographical expansion 28% ROW Europe DKK 2.4bn sales outside EU in 2008* 9m 2013 revenue DKK 4.9bn sales outside EU in 9m 2013* ROW 53% Europe *Excl. Lexapro in U.S. NOT FOR PROMOTIONAL USE 11 Lundbeck R&D achievements 2008-2013 5 FDA approvals in 5 years 2 EMA approvals and 1 positive CHMP opinion 1 PMDA approval Positive phase III outcome in 4 out of 4 drugs vs. <50% success rate in CNS NOT FOR PROMOTIONAL USE 12 Organizational structure in place for future growth Reduced European commercial setup from 30 to 10 business units Established a commercial Project Fit-for-the- infrastructure in the U.S. Future Expanded presence in Asia/Latin America Project RECO While… keeping costs in control Decisions Now NOT FOR PROMOTIONAL USE 13 We free up resources from efficiency programs to invest in growth markets 2008: Q3 2013: 5,758 employees* 5,474 employees* 2% 10% 23% 37% 26% 35% 38% 29% Headquarters Int. Markets EU excl. Headquarters US. NOT FOR PROMOTIONAL USE * Incl. contracted sales force 14 Business development activity strengthen product offerings Licensing partner of choice in CNS Strong history and experience with all forms of licensing Use of partnerships to ensure critical mass and innovation Business development remains a priority NOT FOR PROMOTIONAL USE 15 Mental disorders affect a wide range of patients in many ways NOT FOR PROMOTIONAL USE 16 Mental disorders affect a wide range of patients in many ways Risks & Harms Mortality & Morbidity i.e. crime, violence i.e. suicide, comorbidities Social Family & Withdrawal Caregiver Burden i.e. i.e. emotional, unemployment physical and and deprivation financial support NOT FOR PROMOTIONAL USE 17 Mental disorders cost EUR 113bn yearly – a quarter of the disease burden in EU Mood disorders Dementia Psychotic disorders Anxiety Addiction Stroke Headache Mental retardation Sleep disorders TBI Personality disorders Child/Adolescent disorders Somatoform disorders Multiple sclerosis Epilepsy Direct healthcare costs Direct non-medical costs Parkinson's Neuromuscular disorders Indirect costs Brain tumor Eating disorders 0 20.000 40.000 60.000 80.000 100.000 120.000 = Lundbeck disease areas NOT FOR PROMOTIONAL USE Gustavsson et al. 2011, EBC 2011, Eur Psychopharm 18 Huge disease burden provides need for new medicines • CNS is the largest • USD 825bn WW in cost of • Dementia projected to therapeutic area (ref IMS depression nearly double every 20 2012) • By 2030 depression will be years • Over 1/3 of people in most the leading cause of • In 2013, Alzheimer's will countries report problems disease burden globally cost the U.S. USD 200bn with mental health (ref WHO) • >70 millions DALYs WW1) • This number is expected • USD >2,100bn WW in cost to rise to USD 1.2 trillion of illness by 20301) by 20502) Mental Mood Alzheimer’s disorders disorders disease 1) Estimations calculated on World Eco Forum, 2011. 2) Alz.org (US Alzheimer’s Association) NOT FOR PROMOTIONAL USE 19 Factors influencing performance in the next few years + New product sales + Product launches + Underlying volume growth + Efficiency programs - Generic exposures - Continued price pressure NOT FOR PROMOTIONAL USE 20 Well placed for long-term growth In 2018, we will have replaced Cipralex with Brintellix In 2019, we will have more than doubled the importance of emerging markets Lundbeck to resume In 2020, we will have more than doubled our revenue base long-term growth We have the sales potential to create 2-3 Lundbecks as we know it today NOT FOR PROMOTIONAL USE 21 Agenda Time Topic Speaker 1430-1450 Welcome and introduction + The Lundbeck journey Ulf Wiinberg 1450-1520 Lundbeck in psychiatry Allan Wehnert Andreas Eggert 1520-1535 Break - 1535-1615 Brintellix – From idea to product, from product to brand Torsten Meldgaard Madsen, Andreas Eggert 1615-1630 Q&A Ulf Wiinberg moderator 1630-1645 Break - 1645-1705 Lu AE58054 – the next big product in Alzheimer’s? Allan Wehnert 1705-1730 Lundbeck in the U.S. Staffan Schuberg 1730-1755 Lundbeck in International Markets & Europe – focus on Brazil, Canada, China, and Japan Ole Chrintz, Herman Santoni Ramos 1755- Newsflow, final remarks and Q&A Ulf Wiinberg Canapès and drinks NOT FOR PROMOTIONAL USE 22 Lundbeck in psychiatry By Andreas Eggert & Allan Wehnert We are passionate about advancing the science and treatment of psychiatric brain diseases Progress in Mind Our heritage is psychiatry Our passion and focus across functions is unique → Fully integrated from research to commercialization We know and understand the science, the patients and their treating physicians NOT FOR PROMOTIONAL USE 24 Progress in Mind In 2013 we received approvals for 3 new psychiatric therapies Brexpiprazole 2012 2013 2014 2015+ NOT FOR PROMOTIONAL USE 25 Our passion is reflected in
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