The leading allergy specialist with a history dating back to 1923
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2 The leading allergy specialist with a history dating back to % 4 year CAGR 11% 4 year CAGR 33% of global allergy immunotherapy market 2012 Revenue: DKK 2.35b (EUR 314m) 2012 EBITDA: DKK 306m (EUR 41m)* Leading R&D pipeline with proven technology Strategic partnerships 1,850 employees 2 *) before special items
3 Sustained effect after completion of treatment Cut the symptoms, treat the cause Allergy immunotherapy is the only treatment documented to modify the underlying cause of the allergic disease leading to sustained effect after completion of treatment Additionally, it is the only treatment that holds the potential for asthma prevention 3
4 Continued unmet medical need in allergy Allergic rhinoconjunctivitis (prevalence) 85m (23%) 17m 1.5m 60m (19%) 12m 3m Patients in poor control Treated with immunotherapy 10m 35m (27%) Europe House dust mite (HDM) Grass North America House dust mite (HDM) Grass Japan House dust mite (HDM) Japanese cedar Tree Ragweed 4 Sources: UN Forecast, Bachau 2004; Adelphi Research (EU 5), Canonica Patients in poor control in the USA and Japan are extrapolated on basis of EU characteristics. Datamonitor 2010
5 ALK s business Focused on allergy and its consequences 9% Diagnosis and adrenaline 9% AIT 35% SLIT 47% SCIT 1,500,000 patients in treatment with ALK s products Percentage of 2012 product sales 5
6 Global reach through partnerships Clinical development, registration, marketing & sales USD 100 million in upfront and milestones USD 190 million in sales milestones Sales royalties undisclosed EUR 60 million in upfront and milestones Sales milestones undisclosed Sales royalties undisclosed TORII PHARMACEUTICAL CO., LTD. 6
7 Important progress in R&D Several milestones achieved in North America and Japan Product GRAZAX Grass ARC 5 Geography Europe Pre-clinical Phase I Phase II Phase III Filing (exp.) Marketed Grass AIT 1 Grass ARC North America 2013 GRAZAX Asthma prevention Europe 2016 Ragweed AIT 1,3 Ragweed ARC HDM 4 AIT HDM asthma HDM AIT HDM rhinitis HDM AIT 1 HDM rhinitis HDM AIT 2 HDM asthma HDM AIT 2 HDM rhinitis Tree AIT Tree ARC North America Europe Europe North America Japan Japan Europe n.d. 6 n.d. n.d. n.d. Notes: 1) Merck holds the product rights for the North American markets. Brand name not yet disclosed 2) Torii holds the product rights for the Japanese market 3) Ragweed is currently only developed for North America 4) HDM: House Dust Mite 5) ARC: Allergic Rhinoconjunctivitis 6) Not disclosed 7
8 Grass AIT: expanding reach US filing submitted Launched with reimbursement in all major European markets Licensed to Merck in North America Jan. 13: BLA submitted to the FDA Oct. 12: Phase III clinical trial met primary endpoint (1,500 patients) Co-promotion with MSD in France GAP: On-going landmark trial to investigate asthma prevention 800 children 8
9 Grass AIT Clinical trial overview Trial ID (Phase) Adults included Area Trial ID (Phase) Children included Area GT-01 (Phase I) 47 GT-03 (Phase I) 84 GT-04 (Phase I) 43 GT-07 (Phase II) 114 GT-02 (Phase II/III) 855 GT-08 Y1 (Phase III) 634 GT-08 Y2 (Phase III) 351 GT-08 Y3 (Phase III) 308 GT-08 Y4 (Phase III) 283 GT-08 Y5 (Phase III) 258 GT-14 (Phase III) 329 P05238 (Phase III) 438 P08067 (Phase III) 1218 Total number of adults 3762 EU EU EU EU EU+CA EU EU EU EU EU US US+CA US+CA Additional trials Six post-eu approval market support trials (N=1666) 25 completed and ongoing post-marketing surveillance trials (N>9,500) GT-09 (Phase I) 30 GT-11 (Phase I) 30 GT-12 (Phase III) 253 P05239 (Phase III) 344 P08067 (Phase III) 283 Total number of children 940 Efficacy data for pivotal trials EU EU EU US+CA US+CA Trial Relative difference* p-value GT-08** -34.2% <0.001 GT % P % <0.005 GT % P % P08067 Data not available <0.001 * Percentage reduction in mean total combined scored vs placebo ** Results from year 1 of the GT-08 trial 9
10 Ragweed AIT: a new treatment option US filing expected in 2013 First-in-class documentation Clinical trial overview Trial ID Total subjects 2011: Two Phase III trials successfully completed 1,400 patients Well-tolerated treatment 2012: Tolerability trial ends clinical development 900 patients Clinical trials conducted by Merck RT-01 (Phase I) 53 P06081 (Phase II) 203 P05751 (Phase III) 913 P05233 (Phase II/III) 565 P05234 (Phase II/III) 783 Total 2517 Key efficacy results of ragweed AIT Phase III trials Trial Relative difference* p-value P % P % * Percentage reduction in total daily rhinoconjunctivitis symptommedication score (amb 12 dosis), p 0.05 vs placebo 10
11 HDM: most common cause of allergy 200 million house dust mite allergy sufferers in Europe, USA, Japan and China Perennial allergy Strong link to asthma Early onset and occurrence in life ~9% ~11% ~8% ~12% UK birth cohort trial* 13% sensitised to HDM at age 4 years 50% subsequently developed asthma 8x higher risk of developing asthma if sensitised to HDM 11
12 HDM AIT: a tablet with global potential Largest development programme in history of allergy immunotherapy: 7,000 patients anticipated Phase Region N Main aim Completed trialsleted trials MT-01 I Europe 71 Tolerability and safety MT-02 II/III Europe 604 Dose-finding and efficacy on asthma MT-03 I Europe 72 Tolerability and safety TO-203 Phase I I Japan 48 Tolerability and safety Ongoing trials MT-04 III Europe 834 Efficacy on asthma MT-06 III Europe 900 Efficacy on rhinitis TO II/III Japan 900* Efficacy on asthma TO II/III Japan 900 Efficacy on rhinitis MK I North America 195* Tolerability and safety MK IIb Europe 120* Dose-finding (exposure chamber trial) MK III North America 1500* Efficacy on rhinitis/rhinoconjunctivitis 12
13 Tree AIT: Completing the tabelt portfolio Tree Disease-modifying treatment for tree ARC Covering birch, hazel, alder, elm (& oak) Phase II dose-finding trial initiated in Europe (TT-02, 600 patients results available Q4 2013) Not yet licensed to global partners Cedar AIT for cedar allergy in Japan in preclinical development About 14%* of the Japanese population is sensitised to cedar pollen 13 *MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis, 2011
14 Strategy Strategic initiatives INNOVATE Competitive AIT portfolio Expand AIT indications Next generation vaccines Targets Global Extend lead in Europe AIT portfolio developed AIT in EU/USA/JP New markets SIMPLIFY Optimise portfolio Consolidate production Streamline business GROW Win market share Promote adoption AIT in EU/USA/JP New markets Streamlining Products, production and structure Financial progress 2015: DKK 3bn revenue and 25% EBITDA margin 2016: Yearly cost savings of DKK 100m 14
15 Driving long-term value creation Potential upsides Partners' sales and product prices New partnerships or extensions of existing Expansion to new markets or in existing markets through acquisitions No risk-adjustment Risks Partners' sales and product prices Unforeseen regulatory demands New, mandatory price reductions/healthcare reforms or expansions of existing Partner revenues* Revenue DKK 3,000 million (EUR 400m) Reduced R&D/revenue ratio EBITDA 7% Cost reductions from Simplify initiatives Jext sales >DKK 200m in 2015 EBITDA 25% Moderate growth in vaccine sales *) Includes sales royalties, milestone payments, product supply and R&D costs reimbursements
16 2013 Outlook Revenue on par with 2012 Limited growth in vaccines sales: ALK to outgrow European markets and capture growth overseas Solid growth in Jext sales Minor growth in diagnostics and other products Lower income from partners (milestones, etc.) 2013 Outlook (DKK) Revenue >2.3bn Operating profit (EBITDA)* m CAPEX m *) before special items Unchanged capacity costs R&D costs > DKK 500m Robust operating profit Timing of partner milestones 16
17 Recent important progress Summary R&D pipeline Base business 17
18 2013 Milestones Filings and new clinical trials Grass AIT filing, USA FDA Ragweed AIT filing, USA FDA HDM AIT Phase III, USA Presentation of results from clinical development Presentation of results from Phase III grass AIT studies, USA/Canada HDM AIT MERIT Phase III, Europe HDM AIT MITRA Phase III, Europe HDM AIT Phase IIb, USA Tree AIT Phase II, Europe AVANZ Grass Phase III, Europe SLITone ULTRA HDM Phase II, Europe 18
19 Forward-looking statements This presentation contains forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are naturally subject to risks and uncertainties as various factors, some of which are beyond the control of ALK, may cause actual results and performance to differ materially from the forecasts made in this presentation. Without being exhaustive, such factors include e.g. general economic and business-related conditions, including legal issues, uncertainty relating to demand, pricing, reimbursement rules, partners' plans and forecasts, fluctuations in exchange rates, reliance on suppliers and market structure. An additional factor is potential side effects from the use of ALK's existing and future products as allergy immunotherapy may be associated with allergic reactions of differing extent, duration and severity.. 19
20 Thank you for your attention Read more: Investor Relations: Per Plotnikof Director Head of Investor Relations Phone:
21 Appendix
22 Key revenue trends in 2012 Vaccine sales Mature European markets stagnating, except for France Growth in overseas and emerging markets, e.g. USA and China ALK vaccine sales of DKK 1,923m: +0.4% in lc & +1.3% in DKK (EUR 258m) AVANZ 46% growth Overall SCIT sales of DKK 987m (979) (EUR 132m) SLITone ULTRA launch Overall SLIT sales of DKK 734m (737) (EUR 98m) GRAZAX 10% growth Sales of DKK 202m (182) (EUR 27m) 22
23 Key revenue trends in 2012 Other revenue Sales of other products down 11% to DKK 186m (EUR 25m) Transition from in-licensed adrenaline pen to ALK s own Jext Other revenue (primarily partner income) higher than expected Strong growth in Jext Q3-Q4 sales following production ramp-up Growth in diagnostics etc. in North America driven by a.o. PRE-PEN Other income of DKK 236m (EUR 32m) mainly from partners in the USA and Japan 23
24 Q results Revenue growth driven by partner income, Jext sales and vaccine sales in France, North America and China Strict cost focus across all functions and implementation of Simplify initiatives Robust operating profit in line with expectations DKK million 2012 EURm 2011 Revenue EBITDA before special items Special items EBITDA
25 2012 Full-year results DKK million 2012 EURm 2011 Revenue 2, ,348 Gross profit 1, ,737 Capacity costs 1, ,440 EBITDA before special items EBITDA Net result Margins affected by AIT production ramp-up etc. Restructuring costs of DKK 64m in Q4 R&D costs of DKK 511m (+12%) DKK 155m gain on sale of Chr. Hansen in 2005 The Board proposes a dividend of DKK 5 per share (EUR 0.67) 23% yield in 2012 from dividends and higher share price 25
26 Financial performance (EUR 1 EUR = DKK 7.46) Revenue EBITDA Gross profit Balance sheet Research and development Sales, marketing and administration Equity Current liabilities Non-current assets Non-current liabilities Cash and cash equivalents Inventories and receivables Assets Liabilities Assets Liabilities
27 Two leaders in a highly fragmented industry ALK Stallergenes 28% 11% Allergopharma 28% Others (10+ companies) 33% Source: ALK analysis, ALK Annual Reports, Stallergenes Annual Reports, Thomson Reuters 27
28 Allergy immunotherapy in Europe Market overview Nordic 2011 Sales: EUR 15m Patients treated 2011: ~42,000 Key competitors: None Netherlands 2011 Sales: EUR 39m Patients treated 2011: ~40,000 Key competitors: HAL; Allergopharma; Allergy Therapeutics; Stallergenes UK 2011 Sales: EUR 2m Patients treated 2011: ~5,000 Key competitors: Allergy Therapeutics; Allergopharma Germany 2011 Sales: EUR 263m (after rebate) Patients treated 2011: ~560,000 Key competitors: Allergopharma; HAL; Leti; Bencard; Stallergenes; Roxall France 2011 Sales: EUR 178m Patients treated 2011: ~350,000 Key competitors: Stallergenes Austria 2011 Sales: EUR 20m Patients treated 2011: ~45,000 Key competitors: Allergopharma; Stallergenes; Bencard; HAL Spain 2011 Sales: EUR 72m Patients treated 2011: ~220,000 Key competitors: Leti; Stallergenes; DIATER; BIAL; Allergopharma Italy 2011 Sales: EUR 55m Patients treated 2011: ~145,000 Key competitors: Stallergenes; Lofarma; Anallergo; Allergopharma; BIAL Source: Internal Calculations based on countries market data and most recent competitors annual reports 28
29 Grass, HDM and tree: >80% of European SIT Market size by country and allergen 2011 in-market sales (EURm) Total Other 10% 6% 13% 23% 8% 10% 15% 14% 13% Tree 33% 39% 7% 30% 23% 24% 23% 22% Mite 19% 55% 9% 35% 21% 17% 7% 12% 30% 35% Grass 38% 27% 17% 35% 41% 54% 50% 50% 34% DE FR ES IT NL AT Nordic CH + UK Europe Source: TrendSIT (affiliate input) 29
30 Clinical practice varies across Europe Market size by country and administration form 2011 in-market sales (EURm) AIT 263 6% 178 1% 72 1% 55 2% 39 10% % 16% Total 5% SLIT 16% 28% 31% 11% 26% 44% 74% 59% 97% SCIT 78% 71% 69% 80% 58% 51% 24% 31% 2% DE FR ES IT NL AT Nordic CH + UK Europe 30 Source: TrendSIT (internal input)
31 Growth led by France, Germany flat Vaccine sales Europe EURm % % % Austria Nordic, CH, UK Netherlands Italy Spain France Germany After mandatory rebate 263 After mandatory rebate Source: TrendSIT (affiliate input) 31
32 AIT growing in double digits Vaccine sales Europe* After mandatory rebate in DE EURm ,7% +50,2% ,1% +25,8% +0,7% ,5% 33 AIT SLIT SCIT ,4% ,4% ,8% ,7% -2,9% 327-2,4% Source: TrendSIT (affiliate input) Note: *DE,FR,NL,Nordic,IT,ES,AT,CH,UK 32
33 Current medical practice in the USA No FDA approved allergy immunotherapy products in the USA 5,500 allergy immunotherapy practitioners: ~3,000 allergists Increasing interest from ENTs (~20,000) and others SCIT: self-mixing common practice among allergists Increased off-label SLIT usage in recent years Compounding pharmacies under scrutiny Extracts seen as commodity: Total sales ~ USD 100 million Six companies granted license Diagnosis service important to allergists Reimbursed by private insurance, MediCare and MedicAid 33
34 Patient dynamics in the USA AIT to supplement existing practice US population 306m Available for treatment with immunotherapy Treated with immunotherapy (~ 3M, 9%) 2 Mod/sev seasonal (~11.2M, 35%) 1 Mild seasonal (~3.5M, 11%) 1 Mod/sev perennial (~14.7M, 46%) 1 Allergic rhinitis (60M, 19%) 1 AR diagnosed (~32M, 55%) 1 Mild perennial (~2.6M, 8%) 1 Diagnosed AR patients are typically moderate-to-severe, as patients with mild symptoms may not seek medical consultation 34 Sources: 1) Immunotherapy in Allergic Rhinitis. Moving away from injections. Datamonitor. March 2006; 2) Internal estimate
35 The adrenaline auto-injector market RoEU 35% UK 44% Approx. 7 million units distributed (2011) Total sales ~ DKK 4 billion Projected market growth ~ 5% p.a. EpiPen dominates France 13% Germany 8% Allergy prevalence USA Europe EU 18% RoW 7% Units Food 6m 9m Venom 8m 11m USA 75% 35 Sources: ALK market research
36 Market exclusivity secured through know-how, patents and regulation Raw materials in Pollen House dust mite Animal dander Analysis Bulk (API) production Extraction Purification Freeze drying Analysis Proprietary rights Patents Licensed rights (e.g. Zydis) Clinical data Trademarks High barriers of entrance Finished production Unique formulation Filling Analysis 36
37 Product Supply with global capacity High quality pharmaceutical production standards 12m AITs in 2012 Long-term capacity to produce 500m AIT tablets/year State of the art raw materials facility in the USA Tablet API unit in Denmark In-licensed tablet casting unit in UK 37
38 Expanding the AIT indication Exploring asthma and asthma prevention 2013: Asthma results in adults from the HDM AIT clinical programme 2015/16: Asthma prevention results in children from the grass AIT clinical programme 38
39 Mite tablet treatment of asthma (MITRA trial) Treatment of house dust mite allergic patients with asthma Primary endpoint is reduction of asthma exacerbations 39
40 GRAZAX asthma prevention (GAP trial) Children with grass allergy but no asthma Prophylactic treatment with grass allergy immunotherapy tablets Treatment initiation at 5-12 years of age 40
41 ALK equity and shareholder structure ALK (ALK B) listed on NASDAQ OMX Copenhagen (Reuters: ALKB.CO / Bloomberg: ALKB.DC) Number of shares outstanding: 10.1 million Two share classes (A / B) Market Cap: ~570 EURm Largest shareholder groups Lundbeck Foundation (40%), since 1987 ATP, Danish Labour Market Pension Fund (>5%) Other insitutitional investors (~30%) ~13,000 retail investors (~25%) Foreign ownership: ~25% Domestic ownership: ~75% 41
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