A world leader in allergy immunotherapy Jefferies Global Healthcare Conference 10 June : Grand Hyatt, New York Per Plotnikof, VP Corporate Communications and Investor Relations
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Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
A very strong start to the year Q1 highlights Close to doubling of SLIT-tablet sales in Europe (GRAZAX® and ACARIZAX®)~+15% EBITDA more than doubled to DKK 277 million (128) Free cash flow of DKK 155 million (-3) FY 2016 guidance increased: Revenue + DKK 150 million / EBITDA + DKK 125 million Launch of ACARIZAX® progresses well
•
• • • •
33%
Base business growth 30%
EBITDA margin
DKKm 900
DKKm 320
40
240
30
160
20
80
10
30%
675 20% 450 10%
225
0
0% Q1-15
Q2-15
Q3-15
Q4-15
Partner income Base business revenue Growth in base business
2 I
Q1-16
0
0 Q1-15
Q2-15 Q3-15 EBITDA
Q4-15 Q1-16 Margin
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
ALK at a glance Commercial leader and foremost innovator within respiratory allergies
• ~1.5m patients using ALK
Products in all areas of AIT 2015 revenue DKK 2.57 billion
products
SCIT 45%
• Direct presence and
partnerships in all major AIT markets worldwide
SLIT-tablets
17%
• Near-century long heritage
of pioneering allergy innovation; ~300 in R&D • ~2,000 employees
Other 11%
SLIT-drops
27%
Strategic drivers Shareholder info (ALKB.DC)
• Globalisation of AIT
• Main shareholder:
• Standardised, evidence-based products
Lundbeckfonden
• Base business growth and simplification • Asthma treatment and prevention
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Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
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
House dust mite
Grass
Tree pollen
Ragweed
Japanese cedar
Other allergy sources
Insects
• Prevalence: 10-30% globally, most common chronic disease • 30-60% of patients with allergic rhinitis develop allergic asthma 4 I
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Food
Towards a global ALK Partnership to leverage growth
SLIT-tablets
SLIT-tablets
SLIT-tablets and SCIT
SCIT products
International; 10%
EUR ~9 billion Global allergic rhinitis market
International; 8% North America; 17%
EUR ~1 billion Global AIT market
ACARIZAX®
North America; 15%
ALK sales Europe; 75%
2015
Europe; 75%
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
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
A strong foundation for growth 15% growth in base business expected in 2016 DKK million
2013
2014
2015
2016E
2,145
2,219
2,384
~2.75bn
807
626
99
214
185
N.A.
41
24
2,244
2,433
2,569
N.A.
848
650
335
363
383
-
69%
70%
67%
< 67%
71%
68%
R&D
463
394
407
~400m
100
91
(% of revenue)
21%
16%
16%
-
12%
14%
S, M & A
954
994
1,033
-
253
248
EBITDA b.s.i. and excluding milestones/royalties
221
273
331
~5752)
260
136
EBITDA
236
404
451
277
128
35
60
67
-
6
19
35
-
13
9
CAPEX
253
202
199
~200
5
34
Free cash flow
(85)
101
18
>’2015’
155
(3)
Equity ratio
69%
69%
63%
-
62%
69%
312
289
608
-
714
241
Base business SLIT-tablet partnerships 1) Revenue (Revenue in USDm)
Gross margin
(in USDm)
EPS
Cash and marketable securities 1) 2)
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Q1 2016 Q1 2015
Revenue from SLIT-tablet partnerships in North America and International markets. In years 2009-15, this mainly consists of milestones and service fees before additional milestones/royalties Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Europe: Very strong start to the year Sales positively affected by market disruption caused by competition
Q1: 31% organic revenue growth to DKK 681 million • 94% growth in SLIT-tablet sales Doubling of SLIT-drops production capacity by end Q2 • 130 new employees onboarded DKKm
Revenue in Europe*
2500 +4%
2000
ALK’s strategy • Optimisation of product portfolio • Standardised evidence-based products (eg GRAZAX®, ACARIZAX®) • Investments in market shaping activities (ALLERGY UNLOCKED®)
1500
1000
+31%
500 0 2013
2014
2015
Q1 2016
* Revenue growth is measured in local currencies 7 I
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
North America: Parallel growth strategy Q1: Continued high growth for legacy products • 22% growth in sales of allergen extracts, diagnostics, etc. DKK 39 million (17) in revenue from MSD • Milestone payment and sales royalties
DKKm
Revenue in North America*
500
-26%
400
ALK’s strategy
300
• Exclusive partnership with MSD for SLITtablets (GRASTEK®, RAGWITEK® and HDM SLIT-tablet) • ALK’s own presence: Sales of allergen extracts and other products to allergists 8 I
37%
200 100 0 2013
2014
2015
Milestones and services cause revenue to fluctuate * Revenue growth is measured in local currencies
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Q1 2016
International markets: Parallel growth strategy Q1: Organic growth and pipeline progress 32% growth in base business • Turkey and China Pipeline progress • ACARIZAX® (MITICURE™) launched in Japan • Early access for ACARIZAX® in Australia • Partnership with Abbott expanded
DKKm
Revenue in International markets*
250 +127%
200 150
ALK’s strategy
100
• Own expansion in selected markets • Partnerships with Torii, Abbott and Seqirus for SLIT-tablets
50
-4%
0 2013
2014
2015
Q1 2016
Milestones and services cause revenue to fluctuate * Revenue growth is measured in local currencies 9 I
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Pipeline is key for ALK’s global expansion Product
Pre-clinical
Phase I
Phase II
Phase III
Filing (exp.)
GRAZAX®
2007
Grass ARC
GRAZAX®
Marketed
2016
Asthma prevention
ACARIZAX® HDM rhinitis/asthma
Tree SLIT-tablet Tree ARC
TBC***
GRASTEK®* Grass ARC
RAGWITEKTM* Ragweed ARC
2014 2014
HDM SLIT-tablet* HDM rhinitis
MITICURE™** HDM rhinitis
Japanese cedar SLIT-tablet Cedar pollen ARC
ACARIZAX®**** HDM rhinitis/asthma
GRAZAX®**** Grass ARC
Ragweed SLIT-tablet**** Ragweed ARC
ARC: allergic rhinoconjunctivitis *) Licensed to Merck for North America HDM: house dust mites **) Licensed to Torii for Japan ***) To be communicated ****) Licensed to Abbott/Seqirus
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Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
2015
Latest product advances
11 I
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
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 coexist 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
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Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Best documented AIT product ACARIZAX®: Approved for allergic rhinitis and allergic asthma in Europe
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%
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Asthma results (MT04) published in JAMA* in April 2016
* Journal of the American Medical Association
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
Globalising ACARIZAX®
Approvals granted EU-12 and Japan
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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
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
ACARIZAX® European roll-out Market authorisation in 12 EU countries • Launched in Germany and Denmark
• Regulatory approval in Spain in April 2016 • Ongoing discussions on pricing and reimbursement in other countries • Preparation for additional registrations
• Efforts focused on gaining acceptance and support among key opinion leaders >5,000 patients so far
In Japan, ACARIZAX® under the name MITICURE™ is indicated for the treatment of allergic rhinitis 15 I
• Launched in Germany and Denmark in January - satisfactory sales • 2016 goal of achieving significant share of 2030,000 annual HDM initiations
Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
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
Approximately 50% have access to AIT ~1.5m adults and ~0.5m children
Patients currently treated with AIT 400-450,000 patients, DKK 1.5–2.0bn industry sales 16 * Moderate-severe, not well-controlled patients
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Jefferies Global Healthcare Conference : New York : 10 June 2016 : Per Plotnikof, VP Corporate Communications and IR
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; Two-year follow-up to monitor effects post-treatment
•
Objective: To investigate GRAZAX®’ effect 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
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Placebo *: p