A world leader in allergy immunotherapy

A world leader in allergy immunotherapy Jefferies Global Healthcare Conference 10 June : Grand Hyatt, New York Per Plotnikof, VP Corporate Communicati...
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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

10 I

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

14 I

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

16 I

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