Presentation of ALK London, 24 May 2011 UBS GLOBAL SPECIALTY PHARMACEUTICALS CONFERENCE : LONDON : 24 MAY 2011
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1 Presentation of ALK London, 24 May
2 ALK pharma specialist - treatment, prevention and diagnosis of allergies World leader in allergy immunotherapy ~ 33% global market share Expanding Base Business Sales 2010 : 2.1 billion DKK (CAGR 5-yr : 11%) EBITDA margin: 13% (CAGR 5-yr : 35%) Strong balance sheet (equity ratio: 71%) Leading R&D pipeline to redefine allergy treatment Strategic partnerships to secure global expansion Merck in North America Torii in Japan Leading R&D Pipeline 1,700 employees (600 in DK) 500+ new employees in last five years Publicly listed on NASDAQ OMX Copenhagen (Bloomberg: ALKB.DC) Balanced business model to sustain growth 2
3 Own expansion and acquisitions provide ALK with a global presence USA (1984) Germany (1984) the Netherlands (1987) Spain/Italy (1992, Abelló) Sweden (1993) Austria (1995) UK (1995) Norway (1997) Finland (1999) China (2000) France (2005) Switzerland (2006) Poland (2007) Canada (2008) Germany (2009) the Netherlands (2010) USA (2010) 3
4 Disease-modifying allergy treatments - treat the cause, cut the symptoms Allergy immunotherapy / vaccination Treatment with controlled doses of purified and standardised allergens (proteins), extracted from natural allergen sources: Pollens (grass, trees, weeds etc.) House dust mites Animals Insect venom Immune system is desensitised Symptom score Disease modification and effective symptom control End of treatment Year 1 Year 2 Year 3 Year 4 Year 5 Control group GRAZAX 4
5 ALK s base business Subcutaneous immunotherapy (SCIT) ~ 46% of sales (2010) Sublingual immunotherapy (SLIT) ~ 31% of sales Allergy diagnosis & emergency treatment for allergic shock (adrenaline pen) ~ 15% of sales Revenue distribution Tablet immunotherapy (AIT) ~ 8% of sales Northern Europe 23% Other Markets 11% Central Europe 38% Southern Europe 28% 5
6 Unmet medical need: uncontrolled allergy is a significant burden for the patient and society North America Japan Europe Population/prevalence Allergic rhinoconjunctivitis (prevalence) 60m (19%) 35m (27%) 85m (23%) Patients in poor control 12m* 10m 17m Treated with immunotherapy 3m Only few 1.5m Most common allergies Grass House dust mite Grass Ragweed Japanese cedar House dust mite House dust mite Tree Est. direct cost of disease 11b USD NA UK only: 1b GBP Recent survey (Sweden): 2.7b EUR in indirect costs related to allergic rhinitis (population of 9m) *) extrapolation from European data 6
7 R&D pipeline - redefining allergy treatment 7
8 R&D pipeline (AIT only) Product name Indication Geography Preclinical Phase I Phase II Phase III Marketed GRAZAX Grass Europe GRAZAX Asthma prevention Europe GRAZAX 1 Grass North America Not disclosed 1,3 Ragweed North America MITIZAX HDM 4 Europe MITIZAX 1 HDM North America MITIZAX 2 HDM Japan Not disclosed Tree (birch) Europe Notes: 1) Merck holds the product rights for the North American markets 2) Torii holds the product rights for the Japanese market 3) Ragweed is only developed in North America 4) HDM: House Dust Mite 8
9 GRAZAX the world s best documented allergy immunotherapy 15 randomised double-blind, placebo-controlled studies and 10 observation studies conducted >25 key peer-reviewed publications Launched in Europe in 13 countries License agreement with Merck in North America Latest news Denmark: GRAZAX granted general reimbursement from 2 May 2011 France: GRAZAX launched in January 2011 and positively received by allergy specialists Recruitment for GRAZAX Asthma Prevention five-year study successfully completed Long-term study with GRAZAX successfully complete US Phase III trials with adults and children meet primary endpoints 9
10 Tablet vaccine against ragweed allergy Phase I study completed Two clinical trials currently being finalised by Merck Phase III, multicenter, double-blind, randomised, placebo-controlled Primary endpoint: combined symptom and medication score averaged over the entire ragweed pollen season >1,400 adult patients with ragweed-induced rhinoconjunctivitis May form basis for a registration application with the FDA ALK awaits Merck s analyses and report on clinical findings Main results expected in
11 MITIZAX : House Dust Mite allergy Phase II/III clinical trial (MT-02) successfully completed Primary endpoint: reduction in use of inhaled corticosteroids (ICS) compared to placebo ICS reduction of 50% (p=0.004) New analysis enhances future clinical development ALK to initiate European, pivotal Phase III study in 2011 Study will investigate effect on asthma in 800 patients Merck has licensed the products rights for North America Torii has licensed the product rights for Japan 11
12 Partnership with Merck in North America Development, registration and commercialisation of three AIT products GRAZAX (grass allergy) Registration application to the FDA under preparation US filing date under assessment Ragweed allergy Two large pivotal clinical studies to be completed in H MITIZAX (house dust mite allergy) Further clinical activities currently in the planning stage Merck responsible for clinical development, registration, marketing and sales ALK responsible for product supply Partnership based on milestones and royalties on net sales 240 USDm in additional development and sales milestones (50 USDm already received) 12
13 Partnership with Torii in Japan Development, registration and commercialisation of ALK s products House dust mite (MITIZAX and SCIT), Japanese cedar and diagnostics Torii responsible for clinical development, registration, marketing and sales ALK responsible for product supply Partnership based on milestones and royalties on net sales ALK has received 30 EURm in upfront payment Up to 30 EURm in development milestones Royalties and milestones on net sales in Japan Late-stage clinical development programme in the planning stage To be presented to the Japanese authorities later in
14 Recent financials 14
15 Q1: Satisfactory sales and earnings growth Revenue up 8% to 609 DKKm 6 pp impact from acquisitions Political austerity measures in Germany reduce growth by 6 pp (~30 DKKm) EBITDA up 78% to 242 DKKm (136) Effect of austerity measures: -30 DKKm Payment from Torii recognised with 134 DKKm % +14% % +16 % +11 % Positive currency effect % +14% +22% +13% 558-2% +8% 3M 10 SCIT SLIT AIT Other products 3M 11 EBITDA 3M 10 Sales COGS R&D SM&A Other Depr. EBITDA 3M 11 DKKm Limited currency impact on EBITDA Indicated growth rates are based on local currencies 15
16 Financial outlook for 2011 Growth in vaccine sales of 5% (in local currencies) Total net revenue expected around the level of last year Full year sales impact of political austerity measures in Germany of ~ -130 DKKm Lower sales of adrenaline products due to transition to Jext Slightly improved gross margin Improved product mix Increasing R&D expenses (AIT in EU/USA/JP and regulatory requirements in EU) Increasing sales, marketing and administration expenses (acquisitions, launch of Jext and GRAZAX in France) EBITDA expected to increase by 25% to 360 DKKm 16
17 Strategy - towards
18 Target: sustained growth in sales and earnings DKKm Historically Sales 5-yr CAGR 11% EBITDA 5-yr CAGR 35% % growth in vaccine sales EBITDA +25% Special items Transition to Jext Austerity measures Japan: license agreement By 2015 Revenue > 3 billion DKK EBITDA margin > 25% Growth drivers: Base business Jext Milestones from partnerships Initial AIT royalties Easing of austerity measures Acquisitions Beyond 2015 Growth acceleration Growth drivers AIT portfolio in EU AIT royalties (USA/Japan) Asthma prevention Jext outside EU 30% % % Graphic only for illustrative purposes Sales EBITDA margin 18
19 Balanced strategy Base business Aim: Continued progress in sales and earnings Initiatives Optimise product portfolio Complete development of AIT portfolio Launch Jext in Europe Lead industry consolidation Expand activities in the USA and China Explore supplementary business opportunities Growth outlook in base business: Moderate in medium term Partnerships Aim: Global development and commercialisation of ALK s products Initiatives Support to partnerships with Merck and Torii Local clinical development Regulatory requirements Secure adequate AIT supply AIT products and Jext on additional markets Milestone payments In , ALK may receive up to 500 DKKm in product development milestones from existing partnerships Royalties on sales in North America and Japan to contribute significantly to long-term growth 19
20 Anticipated news flow Ragweed: data from two pivotal clinical Phase III studies in the USA (Merck) GRAZAX : further clarification on registration process in the USA (Merck) MITIZAX : initiation of pivotal clinical Phase III trial in EU MITIZAX : initiation of clinical studies in Japan (Torii) Jext : launch in Europe New partnerships e.g. regarding Jext outside Europe and AIT 20
21 Thank you for your attention Read more: or contact Per Plotnikof Director Investor Relations Phone: Fax: UBS GLOBAL SPECIALTY PHARMACEUTICALS CONFERENCE : 24 MAY 2011
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