Moving closer to people with allergy

Transcription

1 Moving closer to people with allergy Investor Relations Presentation January I Investor Relations Presentation January 2017

2 ALK: Towards redefining treatment of severe allergies The commercial leader and foremost innovator in Allergy Immunotherapy (AIT) ALK fundamentals AIT: A unique disease-modifying treatment for people with severe allergies Global reach Exclusivity via high-quality biological manufacturing processes including sourcing and standardisation of allergens 2,300 employees (+200 in 2016) Patient solutions in all areas of AIT SLIT-tablets Diagnostics, adrenaline 2016 outlook Revenue > DKK 2.9b SCIT (injections) SLIT-drops Today ~80% Europe 99% allergy-related Niche ~1.5m patients Strategic drivers Globalisation of AIT Standardised, evidence-based products Prescriber expansion Asthma treatment and prevention Future Truly global Allergy & asthma Mainstream for people with severe allergies 2 I Investor Relations Presentation January 2017

3 Re-educating the immune system Allergy Immunotherapy (AIT) AIT Treatment with standardised doses of allergens (proteins) Disease modification: Treats the cause of allergy in addition to reducing symptoms and use of other medications Typically recommended for three years Common causes of allergic rhinitis with/without conjunctivitis Other allergy sources House dust mite Grass Tree pollen Ragweed Japanese cedar Insects Food Prevalence: 10-30% globally, most common chronic disease 30-60% of patients with allergic rhinitis develop allergic asthma 3 I Investor Relations Presentation January 2017

4 Strategic direction Market access GMP compliance Mix of trusted and newer products Transform Expand Asthma New prescribers Asthma New markets Strategic intent From a European company focused on allergic rhinitis to a global company with standardised, evidence-based products which also treat and potentially prevent asthma. 4 I Investor Relations Presentation January 2017

5 Global footprint Partnership to leverage growth SLIT-tablets SLIT-tablets and SCIT EUR ~10 billion Global allergic rhinitis market EUR ~1 billion Global AIT market International; 10% North America; 15% Europe; 75% International; 8% ALK sales 2015 North America; 17% Europe; 75% ACARIZAX SLIT-tablets AIT treatment is mainly distributed as finished products in Europe and recently also in the USA and International markets - in North America, also as bulk extracts to allergy specialists 5 I Investor Relations Presentation January 2017

6 Financial overview DKK million E 9M M15 1) Base business 2,145 2,219 2,384 ~25% 2, % SLIT-tablet partnerships 2) N.A. 68 Revenue 2,244 2,433 2,569 ~3,000 2, % (Revenue in USDm) Gross margin 69% 70% 67% < 67% 68% R&D ~400m 282 (% of revenue) 21% 16% 16% - 13% S, M & A , EBITDA before special items and excl. milestones /royalties % EBITDA before special items > (in USDm) CAPEX ~ Free cash flow (85) N.A. 198 Equity ratio 69% 69% 63% - 62% Cash and marketable securities ) Growth in local currencies 2) Revenue from SLIT-tablet partnerships in North America and International markets. In years , this mainly consists of milestones and service fees. 6 I Investor Relations Presentation January 2017

7 The markets: Europe Growth rates are stated as organic growth in local currencies Q3: 20% growth DKK 500m revenue (428) Benefits from market disruptions in Q1-Q2 Market share gains in several markets Base business growth +20% 60% 40% High double-digit growth in tablet and SLIT-drops sales; declining SCIT sales Germany main market affected by production upgrades Q3-15 Q4-15 Q1-16 Q2-16 Q3-16 Revenue Growth rate 20% 0% ALK s strategy Grow base business profitability and optimise product portfolio Lead transition to evidence-based products Use ACARIZAX as catalyst for improving patient access Develop and launch tree SLIT-tablet +51% +63% 7 I Investor Relations Presentation January 2017

8 The markets: North America Growth rates are stated as organic growth in local currencies Q3: Total revenue up 6% to DKK 119m (113) 11% growth in base business Allergen extracts (SCIT), diagnostics, etc. Adverse impact of SCIT production update MSD partnership ended Two acquisitions completed in December 2016 Effective from 3 January 2017 DKKm Base business growth +11% Q3-15 Q4-15 Q1-16 Q2-16 Q3-16 Revenue Growth rate 20% 10% 0% USD 15m in additional revenue ALK s strategy 11% growth in base business Sales of allergen extracts to allergists Allergen extracts (SCIT), diagnostics, etc. Repatriate SLIT-tablets and complete registrations Transfer knowledge and insights, ~50 new employees Develop long-term business model 8 I Investor Relations Presentation January 2017

9 Reshaping Product Supply for future growth SLIT-drops: Capacity expansion H1 2016: Capacity doubled H2 2016: Additional staff to meet demand Market leadership in France to be retained SCIT: Compliance/ production upgrades Response to high demand and increasing regulatory requirements Temporary reduction of capacity and prolonged delivery times for certain products and markets DKK m impact on sales in 2016 SLIT-tablets: Capacity expansion Expansion of Source Materials capacity Scale to global roll-out of ACARIZAX Scale to roll-out of tree SLIT-tablet Multiple auxiliary systems 9 I Investor Relations Presentation January 2017

10 Pipeline is key for ALK s global expansion Product GRAZAX Grass ARC GRAZAX Asthma prevention ACARIZAX HDM rhinitis/asthma Tree SLIT-tablet Tree ARC GRASTEK * Grass ARC RAGWITEK TM * Ragweed ARC HDM SLIT-tablet* HDM rhinitis Pre-clinical Phase I Phase II Phase III Filing Marketed 2016 TBC*** MITICURE ** HDM rhinitis 2015 Japanese cedar SLIT-tablet Cedar pollen ARC ACARIZAX **** HDM rhinitis/asthma GRAZAX **** Grass ARC Ragweed SLIT-tablet**** Ragweed ARC ARC: allergic rhinoconjunctivitis HDM: house dust mites *) Licensed to Merck for North America **) Licensed to Torii for Japan ***) To be communicated ****) Licensed to Abbott/Seqirus 10 I Investor Relations Presentation January 2017

11 Update on ACARIZAX globalisation No 1 in DE & DK FDA pre-approval inspection Uptake progressing Four new filings Official launch in Q3 Launched Approved Filed Preparations for filing 11 I Investor Relations Presentation January 2017 * ACARIZAX is the trade name for ALK s HDM SLIT-tablet in Europe

12 Major future pipeline events Pivotal news-flow concerning all five SLIT-tablets Region Event Exp. timing Europe Completion of Phase III trial with tree SLIT-tablet Additional launches of ACARIZAX Initiation of paediatric development of ACARIZAX ff 2017 USA Canada Review of BLA for ACARIZAX 2017 Review of NDA for ACARIZAX 2017 Japan Phase III trial with MITICURE in paediatric patients Approval of Japanese cedar SLIT-tablet Russia Approvals of GRAZAX and ragweed SLIT-tablet 2017 Regulatory filing of ACARIZAX 2016/17 Australia Approval of GRAZAX 2016/17 Rest of world ACARIZAX : Filings/approvals in South East Asia; Approval in Turkey 2016/17 12 I Investor Relations Presentation January 2017

13 Thank you for your attention Read more: Investor Relations: Per Plotnikof Head of Investor Relations Phone: I Investor Relations Presentation January 2017

14 APPENDIX 14 I Investor Relations Presentation January 2017

15 Europe: A market in transition Europe: Market profile Mature, diverse markets under regulatory transformation 40% 30% 30% 34% ~1.3m patients on AIT Mainly legacy and named-patient products Restricted market access 30% France Others Germany 36% ALK Others Stallergenes SLIT-tablets fully-documented and registered Main allergies: HDM, Grass and Tree ~EUR 675m total industry sales (2015) 15 I Investor Relations Presentation January 2017

16 North America: A significant opportunity USA: Market profile Self-mixing and compounding of SCIT by allergists common >6m severe patients eligible for AIT SCIT: low take-up and high drop-out rate 50% refuse treatment, 84% drop out 45% 30% 25% ALK Others Greer ~2.5m patients on AIT USD 2-3bn Billing to insurance USD 150m industry revenue (2015) Main allergies: HDM, Grass, Ragweed and Tree 16 I Investor Relations Presentation January 2017

17 Japan: A new opportunity Japan: Market profile Allergy prevalence higher than EU and USA AIT currently almost non-existent as a treatment option Japan: ALK s strategy Partnership with Torii MITICURE launched in December 2015 for treatment of HDM allergic rhinitis Positive Phase II/III results from cedar SLIT-tablet in August 2015, registration application submitted in December 2015 SCIT HDM licensed for market-building Main allergies: HDM and Japanese cedar 17 I Investor Relations Presentation January 2017

18 ACARIZAX for allergic rhinitis and allergic asthma First product for both indications In Europe, ACARIZAX is indicated in adults (18-65 years) diagnosed by clinical history and positive test of HDM sensitisation, with at least one of the following conditions: Persistent moderate to severe HDM allergic rhinitis despite the use of symptom-relieving medication HDM allergic asthma which is not well controlled by inhaled corticosteroids and is associated with mild to severe HDM allergic rhinitis and where patients' asthma status has been carefully evaluated In Japan, ACARIZAX under the name MITICURE is indicated for the treatment of allergic rhinitis caused by HDM in adults and adolescents (12-64 years). 18 I Investor Relations Presentation January 2017

19 ACARIZAX for the most common allergy Allergic rhinitis (hay fever) is the most common childhood allergy; allergic asthma is the most common chronic lower respiratory disease in children The link between house dust mite (HDM) induced allergic rhinitis and asthma: Allergic asthma and allergic rhinitis frequently co-exist in the same person ~50% of HDM allergic rhinitis patients also suffer from allergic asthma ~50% of asthmatic patients are reported to be sensitised to HDM HDM-allergic patients risk of developing asthma is significantly higher than that of other allergy patients 19 I Investor Relations Presentation January 2017

20 Best documented AIT product ACARIZAX : Approved for allergic rhinitis and allergic asthma in Europe Asthma results (MT04) published in JAMA* in April 2016 ACARIZAX works by addressing the cause of the respiratory disease Reduces days impacted by severe allergic rhinitis symptoms by 50% ACARIZAX furthermore offers better asthma control Reduces the risk of moderate to severe asthma exacerbations by 34% Reduces risk of nocturnal awakenings by 36% * Journal of the American Medical Association 20 I Investor Relations Presentation January 2017

21 The unmet medical need in Europe ACARIZAX for patients not well-controlled with symptom relieving medication HDM respiratory allergy sufferers ~35m adults and ~9m children and adolescents Potential HDM AIT-eligible patients* ~3m adults and ~1m children Approximately 50% have access to AIT ~1.5m adults and ~0.5m children Patients currently treated with AIT ,000 patients, DKK bn industry sales * Moderate-severe, not well-controlled patients 21 I Investor Relations Presentation January 2017

22 GRAZAX Asthma Prevention (GAP) trial Initiated in 2009, completed in 2016 First large, multinational placebo-controlled trial with AIT (GRAZAX ) in asthma prevention 812 children with grass pollen allergy, but no signs of asthma Three years with daily intake of GRAZAX or placebo; Twoyear follow-up to monitor effects post-treatment Objective: To investigate the effect of GRAZAX on children s risk of developing asthma Top-line results Significant reduction in proportion of children experiencing asthma symptoms or using asthma medication; effect sustained two years after treatment Significant reduction of allergic rhinoconjunctivitis symptoms; effect sustained two years after treatment GRAZAX disease-modifying effect confirmed *: p<0.05 **: p<0.01 Placebo GRAZAX The trial showed no effect in terms of time to first diagnosis of reversible impairment of lung function. 22 I Investor Relations Presentation January 2017

23 Sponsored ADR Programme ALK has a sponsered Level l ADR programme in the USA. The ADRs trade on Over-The-Counter ( OTC ) market in the USA. Details are as follows: Ticker Symbol: AKABY CUSIP: Ratio: 5 ADR : 1 Ordinary Share ADR depositary: Deutsche Bank Share price information: Please contact the Deutsche Bank s dedicated ADR broker desks: Jay Berman (New York) Simon Davies (London) Tel: Tel: jay.x.berman@db.com simon.davies@db.com 23 I Investor Relations Presentation January 2017

24 ALK Equity and shareholder structure ALK (ALK B) listed on NASDAQ Copenhagen (Reuters: ALKB.CO / Bloomberg: ALKB.DC) Number of shares outstanding: 10.1m Two share classes (A / B) Market Cap: ~EUR 1.2bn Largest shareholder groups: Lundbeck Foundation (40%), since 1987 ATP, Danish Labour Market Pension Fund (>5%) Jupiter Asset Management, Ltd. (>5%) ~13,000 retail investors (~25%) 24 I Investor Relations Presentation January 2017

25 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 subject to risks and uncertainties as various factors, some of which are beyond ALK s control, may cause actual results and performance to differ materially from the forecasts made in this presentation. Without being exhaustive, such factors include 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, as well as changes to market structures. An additional factor would be the consequences of potential side effects from the use of ALK s products, as allergy immunotherapy may be associated with allergic reactions of differing extents, duration and severity. 25 I Investor Relations Presentation January 2017