A world leader in allergy immunotherapy

Transcription

1 A world leader in allergy immunotherapy AktieUgebrevet Copenhagen, 25 November 2015 Per Plotnikof, VP Corporate Communications & IR

2 Q3 Highlights Approvals of ACARIZAX in EU-11 and MITICURE in Japan Planning for submission of BLA in North America; filings in Turkey and Switzerland in Q3-15 Q3 results boosted by milestone payment and other partner income Overall revenue grew by 24% to DKK 667m (522) EBITDA result of DKK 171m (57) before special items Outlook: Revenue of ~DKK 2.5bn, ~DKK 400m EBITDA b.s.i.* 2 Growth rates in local currencies * before special items

3 A strong foundation for growth ALK s financials at a glance DKKm E - Base business 1 2,145 2,219 2,3bn - Partnerships ~200m Revenue 2,244 2,433 2,5bn - (Revenue in USDm) Gross margin 69% 70% - R&D ~400m (% of revenue) 21% 16% - S, M & A EBITDA ~400 - (In USDm) EPS M M ,618 1, ,821 1, % 66% % 15% CAPEX Free cash flow (85) 101 ~0 Equity ratio 69% 69% - Cash ) 3% growth in local currencies excl. Chinese one-off 2) Revenue from SLIT-tablet partnerships in North America and International markets. In years , this mainly consists of milestones and service fees 3) Before special items 3

4 Towards a global ALK Partnerships to leverage growth ALK North America Own sales and distribution in the USA and Canada Merck partnership (est. 2007) Development and commercialisation of SLITtablets in North America North America 21% of revenue* ALK Europe Own sales and distribution in 18 European countries Product Supply organisation with global capacity Europe 76% of revenue* Torii partnership (est. 2011) Development and commercialisation of SLIT-tablets in Japan Eddingpharm collaboration (est. 2014) Sales and distribution of SCIT products in China Abbott partnership (est. 2014) Sales and distribution of SLIT-tablets in Russia Seqirus (prev. biocsl) partnership (est. 2015) Sales and distribution of SLIT-tablets and AAIs in Australia and New Zealand International markets 3% of revenue* 4 * of 2014 revenue

5 Pipeline is key for ALK s global expansion Product GRAZAX Grass ARC GRAZAX Asthma prevention Pre-clinical Phase I Phase II Phase III Filing (exp.) Marketed ACARIZAX HDM rhinitis/asthma Tree SLIT-tablet Tree ARC GRASTEK * Grass ARC RAGWITEK TM * Ragweed ARC HDM SLIT-tablet* HDM rhinitis TBC*** TBC*** MITICURE ** HDM rhinitis Japanese cedar SLIT-tablet Cedar pollen ARC TBC*** ARC: allergic rhinoconjunctivitis America HDM: house dust mites *) Licensed to Merck for North **) Licensed to Torii for Japan ***) To be communicated 5

6 HDM SLIT-tablet approved in Europe and Japan Best documented AIT product ever Photo: Shutterstock/Sebastian Kaulitzki

7 Globalising ACARIZAX * Approvals granted: EU-11 (AA/AR) and Japan (AR) Next-wave EU registration (AA/AR) Filings: Australia, Switzerland and Turkey (AA/AR) Preparations for filing: USA/Canada (AR), Russia (AA/AR) Countries of interest AA = Allergic Asthma; AR = Allergic Rhinitis 77 *) ACARIZAX is trade name for ALK s HDM SLIT-tablet in Europe

8 Europe: Approved for both allergic rhinitis and allergic asthma Approved in 11 countries ACARIZAX is indicated in adult patients (18-65 years) diagnosed by 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 not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis and where patients' asthma status has been carefully evaluated 1, 3 and 6 SQ-HDM Next steps Price and reimbursement negotiations First launches expected in early 2016 Initiate paediatric development programme 8

9 Japan: Approved for allergic rhinitis MITICURE is indicated as allergy immunotherapy for the treatment of allergic rhinitis caused by house dust mites in adults and adolescents (12-64 years) Next steps: Price negotiations Launch expected in beginning of 2016 Paediatric development initiated 1, 3 and 6 SQ-HDM 9

10 Improving quality of life for allergic rhinitis patients HDM the most common cause of allergy in the world HDM allergy appears early in life and is present year-round 1 in 10 HDM allergy sufferers has a condition that is not well-controlled HDM SLIT-tablet works by adressing the cause of the HDM respiratory disease Reduces days impacted by severe AR symptoms by 50% Photo: Shutterstock/Sebastian Kaulitzki 10

11 Treating asthma in HDM allergic patients Link between HDM and asthma demonstrated Approximately half of adult asthma patients are sensitised to HDM More than half of HDM-allergic patients have both AR and AA ACARIZAX offers better asthma control Reduces the risk of moderate to severe asthma exacerbations by 34% Reduces risk of nocturnal awakenings by 36% Photo: Shutterstock/Sebastian Kaulitzki 11

12 Europe: the unmet medical need ACARIZAX for patients not well-controlled with symptom relieving medication HDM respiratory allergy sufferers ~ 35m adults ~ 9m children and adolescents Potential HDM AIT-eligible patients* ~ 3m adults ~ 1m children Approx. 50% have access to AIT ~ 1.5m adults ~ 0.5m children Patients currently treated with AIT ,000 patients DKK bn 12 * Moderate-severe, not well-controlled patients 12

13 FEATURED R&D PROGRAMME GAP trial: GRAZAX Asthma Prevention Preventing the progression of allergic disease Asthma prevention trial Assesses effect of GRAZAX on risk of developing asthma compared to placebo Potential new offering in the use of allergy immunotherapy Trial design Randomisation End of treatment End of trial GRAZAX Placebo Pan-European paediatric trial Multi-national, multi-centre trial: 101 sites in 11 European countries Patients: 812 children aged 5-12 with grass allergy but no asthma at inclusion Screening Treatment period Follow-up

14 Major pipeline events Short-term news-flow ( ) Events Europe First launches of ACARIZAX in Europe Registration of ACARIZAX in additional countries Top-line results from GAP (GRAZAX Asthma Prevention trial) Exp. timing Q Q US/CAN Submission of BLA for HDM SLIT-tablet (ACARIZAX ) Clinical trial with RAGWITEK in paediatric patients Not disclosed Q Japan Launch of MITICURE Regulatory filing of Japanese cedar SLIT-tablet Phase III trial with MITICURE in paediatric patients Q /2016 Q ROW Russia: Regulatory review of GRAZAX Russia: Filing of ACARIZAX Australia: Regulatory review of ACARIZAX Turkey: Regulatory review of ACARIZAX

15 Mid-cycle strategy review Foto: Ugebladet Hørsholm Global company with evidence-based products treating allergic rhinitis and asthma ACARIZAX and asthma opportunity engine for global reach and growth Value creation in the base business Growth in partner income to accelerate from 2017 Base business revenue growth of 0-5% in 2016 in line with strategic outlook Financial guidance in February 15

16 Thank you for your attention Read more: Investor Relations: Per Plotnikof VP, Head of Investor Relations Phone: