A world leader in allergy immunotherapy

Transcription

1 A world leader in allergy immunotherapy Company presentation Per Plotnikof, VP Corporate Communications and IR 1 I

2 ALK at a glance Commercial leader and foremost innovator within respiratory allergies ~1.5m patients using ALK products Direct presence and partnerships in all major AIT markets worldwide Near-century long heritage of pioneering allergy innovation; ~300 in R&D ~2,000 employees Products in all areas of AIT 2015 revenue DKK 2.57 billion SLIT-tablets 17% Other 11% Strategic drivers SCIT 45% SLIT-drops 27% Shareholder info (ALKB.DC) Main shareholder: Lundbeckfonden Globalisation of AIT Standardised, evidence-based products Base business growth and simplification Asthma treatment and prevention 2 I

3 A strong foundation for growth ALK s financials at a glance DKK million E Base business 2,118 2,145 2,219 2,384 ~2.6bn SLIT-tablet partnerships 1) N.A. Revenue 2,345 2,244 2,433 2,569 N.A. (Revenue in USDm) Gross margin 72% 69% 70% 67% <67% R&D ~400m (% of revenue) 22% 21% 16% 16% - S, M & A 1, ,033 - EBITDA b.s.i. and excluding milestones/royalties ~450 EBITDA (in USDm) EPS CAPEX ~200 Free cash flow (152) (85) ~ 2015 Equity ratio 68% 69% 69% 63% - Cash and marketable securities ~+10% Organic growth in base business (CAGR : 3%) 1) Revenue from SLIT-tablet partnerships in North America and International markets. In years , this mainly consists of milestones and service fees 3 I

4 Towards a global ALK Partnership to leverage growth SLIT-tablets SLIT-tablets SLIT-tablets and SCIT 8% 17% 10% 15% SCIT products ALK sales % Industry sales E % DKK ~7bn AIT world market ACARIZAX North America Europe International North America Europe International 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 4 I

5 The situation in France ALK s number one priority is to support doctors, patients and authorities Objective to double capacity in French SLIT-drops production by end Q2 Actions taken so far: SLIT-drops capacity being rapidly scaled up ~80 new employees already on-boarded Evidence-based products suggested as alternative for main allergies ALK in process with authorities on price and reimbursement for ACARIZAX Ramp-up of production of SLIT-tablets 5 I

6 Globalising ACARIZAX Approvals granted EU-11 and Japan Filings USA, Australia, Turkey and Switzerland Preparations for filing Canada, Russia and South-East Asia Next-wave Registrations * ACARIZAX is the trade name for ALK s HDM SLIT-tablet in Europe 6 I

7 ACARIZAX for allergic rhinitis and allergic asthma First product for both indications so far launched in Denmark, Germany and Japan Approved by 11 European countries, ACARIZAX is indicated in adults (18-65 years) diagnosed by a clinical history and a 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) 7 I

8 Best documented AIT product House dust mites (HDM) are the most common cause of allergy globally HDM allergy appears early in life and is present year-round 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% 8 I

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

10 GRAZAX Asthma Prevention (GAP) trial First large, multinational placebo-controlled trial with AIT (GRAZAX ) in asthma prevention 812 children with a clinical history of grass pollen allergy, but no signs of asthma 3 years with daily intake of GRAZAX or placebo; 2-year follow-up to monitor effects post-treatment Objective: To investigate GRAZAX effect on children s risk of developing asthma Encouraging top-line results Significant reduction in proportion of children experiencing asthma symptoms or using asthma medication; effect sustained 2 years after treatment Significant reduction of allergic rhinoconjunctivitis symptoms; effect sustained 2 years after treatment GRAZAX disease-modifying effect confirmed Screening Trial design Randomisation End of treatment End of trial GRAZAX Placebo Treatment period Follow-up The trial showed no effect in terms of time to first diagnosis of reversible impairment of lung function I

11 GAP: Symptoms and usage of medication Next step to discuss results with authorities 11 I

12 Major pipeline events in 2016/17 Pivotal news-flow concerning all five SLIT-tablets Events Europe USA Canada Japan Russia Launches of ACARIZAX in EU-11 Registration of ACARIZAX in additional countries Paediatric development of ACARIZAX Initiation of Phase III clinical trial with tree SLIT-tablet Exp. timing Submission of BLA for ACARIZAX Q Submission of NDA for ACARIZAX 2016 Phase III trial with MITICURE in paediatric patients Approval of SLIT-tablet for Japanese cedar pollen 2016/ /17 Approvals of GRAZAX and ragweed SLIT-tablet 2016/17 Regulatory filing of ACARIZAX 2016/17 Australia Approvals of ACARIZAX and GRAZAX 2016/17 Rest of world Turkey: Approval of ACARIZAX South-East Asia: Regulatory filings of ACARIZAX 2016/ /17 12 I

13 Strategic priorities in 2016 Base business ACARIZAX in Europe ACARIZAX Rest of world Secure organic growth Simplify business structure Acceptance and advocacy Product of choice Significant capture rate Market access and reimbursement Paediatric development Significant capture rate in Japan Regulatory reviews in the USA, Australia and Turkey Filings in Canada, Russia and South-East Asia 13 I

14 Thank you for your attention Read more: Upcoming events: 7 Apr: Kempen & Co Life Sciences Conference, Amsterdam Investor Relations: Per Plotnikof Head of Investor Relations Phone: ppidk@alk.net 14 I