A world leader in allergy immunotherapy

Transcription

1 A world leader in allergy immunotherapy Investor Relations presentation June I Investor Relations presentation I June 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 Revenue DKK 3bn 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 I June 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 I June 2017

4 Global footprint Partnerships to leverage growth SLIT-tablets SLIT-tablets and SCIT Allergic rhinitis AIT industry sales 2016 ALK AIT sales 2016 EUR ~10 billion Global allergic rhinitis market North America; 18% International; 7% EUR ~0.9 billion Global AIT market Europe; 75% International; 2% North America; 13% EUR ~360 million Europe; 85% ACARIZAX SLIT-tablets ALK Partner markets 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 Investor Relations presentation I June 2017

5 Financial overview 2016 disruption profits to be reinvested in building growth and robustness DKK million E Base business 2,219 2,384 2,918 SLIT-tablet partnerships 2) Revenue 2,433 2,569 3, bn (Revenue in USDm) Gross margin 70% 67% 67% R&D (% of revenue) 16% 16% 13% - S, M & A 994 1,033 1,091 EBITDA before special items and excl. milestones /royalties EBITDA ~300 (in USDm) CAPEX Free cash flow > -500 Equity ratio 69% 63% 60% - Cash and marketable securities priorities US scale-up for repatriated SLITtablets ~+150 DKKm Market shaping in Europe and Int l markets ~+50 DKKm Capacity expansion and Product Supply robustness: +75 DKKm (COGS) ~ DKKm (CAPEX) 1) 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. 5 I Investor Relations presentation I June 2017

6 ALK s path to long-term growth 2017: Extra allocations of DKK ~275 million (OPEX) and DKK million (CAPEX) to fund growth initiatives Extend market leadership in Europe North American build-up Expand reach in International markets Across regions ACARIZAX launches Explore adjacencies: in-license or acquire Jext in new markets Customer-centric approach Basis Expand capacity and robustness in Product Supply 6 I Investor Relations presentation I June 2017

7 Pipeline is key for ALK s global expansion GRAZAX Europe Adults and children Allergic rhinitis GRASTEK North America Adults and children Allergic rhinitis GRAZAX International markets* Adults and children Allergic rhinitis RAGWITEK North America Adults Allergic rhinitis Ragweed SLIT-tablet International markets* Adults Allergic rhinitis Ragweed SLIT-tablet Europe Adults Allergic rhinitis RAGWITEK SLIT-tablet North America Children Allergic rhinitis MITICURE Japan** Adults Allergic rhinitis ACARIZAX Europe Adults Allergic rhinitis and allergic asthma ACARIZAX International markets* Adults - Allergic rhinitis and allergic asthma HDM SLIT-tablet North America Adults Allergic rhinitis MITICURE Japan** Children Allergic rhinitis Japanese cedar SLIT-tablet Japan** Adults Allergic rhinitis Tree SLIT-tablet Europe Adults Allergic rhinitis Phase I Phase II Phase III Filing Marketed *) Licensed Abbott for Russia and South-East Asia and Seqirus for Australia/New Zealand **) Licensed to Torii for Japan *** Already marketed in selected markets 7 I Investor Relations presentation I June 2017 *** ***

8 ACARIZAX globalisation Commercial highlights Available in nine markets ~40,000 patients world-wide European sales tripled in Q1 Clinical highlights GINA asthma recommendation Approval by the FDA and Health Canada Adolescent use approved in EU Paediatric application in Japan Launched Approved Filed Preparations for filing * ACARIZAX is the trade name for ALK s HDM SLIT-tablet in Europe 8 I Investor Relations presentation I June 2017

9 Europe: Market disruptions affecting performance DKK 616 million revenue (681) 9% decrease vs. Q disrupted markets 20% increase vs. Q normal markets DKK million global impact from temporary reductions of SCIT production capacity DKKm Revenue and growth Q1-16 Q2-16 Q3-16 Q4-16 Q1-17 Revenue Reported growth 50% 30% 10% -10% Tablets: -13% SCIT/SLIT -9% Other: +2% 9 I Investor Relations presentation I June 2017

10 North America & Int l markets: A year of transition North America: DKK 152m revenue (151) 1% growth on a like-for-like basis Bulk extracts sales affected by SCIT upgrades Higher sales of diagnostics and other products Tablet revenue of DKK 17 million (39) DKKm Revenue and growth Q1-16 Q2-16 Q3-16 Q4-16 Q1-16 Revenue Partner income Reported growth 50% 40% 30% 20% 10% 0% DKK 34m milestone payment in Q Transfer of Biologics Licenses delayed Intl. markets: DKK 21m revenue (+35%) New distribution set-up in China Progress in Turkey and South-East Asia 10 I Investor Relations presentation I June 2017

11 Q results DKK million Q Q Revenue Gross profit Capacity costs EBITDA Financials, net (8) (13) Tax Net profit % DKK underlying 260m margin (70%) 98% effective tax rate (45%) DKK 260m DKK 11% 260m organic increase Free cash flow (206) I Investor Relations presentation I June 2017

12 2017 outlook unchanged DKK 2016A 2017E Comments Revenue 3.0bn bn Lower revenue in EU; growth in North America and International markets Gross margin 67% Changes in product mix, increased fixed costs Capacity costs 1,476m Significant growth investments EBITDA 642m ~300m Earnings on 2015-level, excl. milestones CAPEX 204m Accelerated investments in capacity and robustness Free cash flow 201m Down to (500m) Growth investments, acquisitions, continued inventory build-up, relatively high tax payments 12 I Investor Relations presentation I June 2017

13 APPENDIX 13 I Investor Relations presentation I June 2017

14 Future pipeline events I Pivotal newsflow concerning all five SLIT-tablets GRAZAX Russia Australia Ragweed pollen Europe Russia Event Launch after regulatory approval Launch after regulatory approval Completion of regulatory review/approval Completion of regulatory review/approval Exp. timing Tree pollen Europe Completion of Phase III trial and top-line results H Japanese cedar Japan Approval of Japanese cedar SLIT-tablet I Investor Relations presentation I June 2017

15 Future pipeline events II Pivotal newsflow concerning all five SLIT-tablets ACARIZAX Event Exp. timing North America Canada USA Launch Launch ~2018 ~2018 Europe International markets South-East Asia, New Zealand, Turkey Russia China Japan Launches in seven remaining markets Initiation of paediatric development into asthma Approvals and launches Submission of regulatory filing Initiation of Phase I clinical trial Extension of label to include children I Investor Relations presentation I June 2017

16 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. 16 I Investor Relations presentation I June 2017

17 Thank you for your attention Read more: Investor Relations: Per Plotnikof Head of Investor Relations Phone: I Investor Relations presentation I June 2017