becoming a global specialty pharma company - jefferies · tbc* tbc* product grazax® grass arc...

Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO

Becoming a global specialty pharma company

Jefferies Healthcare Conference2 June 2015


ALK at a glance

• ~33% market share

• 1.5m patients using ALK products

• 1,800 employees, ~300 in R&D

• SLIT-tablets to simplify allergy treatment

• ~15,000 patients in clinical development

programmes in past 10 years

• Next R&D frontier: asthma treatment &

prevention

2

Commercial leader and foremost innovator within allergy immunotherapy (AIT)

• Market cap. ~EUR 1bn

• Main shareholder: Lundbeck Foundation

AIT: Treats the root cause of allergy Products in all areas of AIT

Subcutaneous (SCIT) or allergy shots

Sublingual drops (SLIT-drops)

Other, including

diagnostics,

adrenaline auto-

injectors (AAIs)

and anti-venom

Sublingual tablets (SLIT-tablets)

Shareholder info (ALKB.DC)


A strong foundation for growth

3

ALK’s financials at a glance

DKKm - 2011 2012 2013 2014 2015E

- Base business 2,103 2,118 2,145 2,219 2,25-2,35

- Partnerships1 245 227 99 214 No

guidanceRevenue 2,348 2,345 2,244 2,433

- (Revenue in USDm) 435 434 416 432 -

Gross margin 74% 72% 69% 70% -

R&D 455 511 463 394 ~400

(% of revenue) 19% 22% 21% 16% -

S, M & A 985 1,004 954 994 -

EBITDA2 406 306 258 453 ~225-300

- (In USDm) 75 57 48 80 -

EPS 20.2 21.4 6.3 19 -

CAPEX 153 243 253 202 ~200

Free cash flow 271 (152) (85) 101 -100 to -200

Equity ratio 64% 68% 69% 69% -

Cash 754 477 312 289 -

1) Revenue from SLIT-tablet partnerships in North America and International markets. In years 2009-14, this mainly consists of

milestones and service fees

2) Before special items

0-5% growth in

local currencies

Influenced by

milestones and

build-up for HDM

SLIT-tablet

launch

Before milestone

payments &

sales royalties

from partners


• Allergy: an overreaction to substances that

are usually harmless

• Respiratory allergies involve allergic rhinitis

(AR) with/without conjunctivitis and allergic

asthma (AA)

4

• 30-60% of AR patients develop allergic

asthma

Allergy: A chronic global disease400-500 million patients affected worldwide, 10-20% severely

12m

North America Europe Japan

10-15m 10-20m 5-10mSevere AR cases*

Key allergensHDM, Grass,

Ragweed,

Tree

HDM,

Grass,

Tree

HDM,

Japanese

cedar

China

-40m

HDM

* Internal ALK estimates


Completion of SLIT-tablet portfolio

5

ARC: allergic rhinoconjunctivitis *) Licensed to Merck for North

America HDM: house dust mites **) Licensed to Torii for Japan

****) To be communicated

Pre-clinical Phase I Phase II Phase III MarketedFiling (exp.)

2016

TBC***

TBC***

Product

GRAZAX®

Grass ARC

GRAZAX®

Asthma prevention

HDM SLIT-tabletHDM rhinitis/asthma

Tree SLIT-tabletTree ARC

GRASTEK®*Grass ARC

RAGWITEKTM*Ragweed ARC

HDM SLIT-tablet*HDM rhinitis

HDM SLIT-tablet**HDM rhinitis

Japanese cedar SLIT-tabletCedar pollen ARC

2007

2014

2014

TBC***


Towards a global ALK

6

Partnerships to leverage growth

ALK North America

Own sales and distribution in

the USA and Canada

ALK Europe

Own sales and distribution in

18 European countries

Product Supply organisation

with global capacity

Merck partnership (est. 2007)

Development and

commercialisation of SLIT-

tablets in North America

North America

21% of revenue*

Europe

76% of revenue*

International markets

3% of revenue*

* of 2014 revenue

Eddingpharm collaboration (est. 2014)

Sales and distribution of SCIT products in China

Torii partnership (est. 2011)

Development and commercialisation of SLIT-tablets in

Japan

Abbott partnership (est. 2014)

Sales and distribution of SLIT-tablets in Russia

bioCSL (est. 2015)

Sales and distribution of SLIT-tablets and AAIs in Australia

and New Zealand


United States: Parallel growth strategy

• Merck

• GRASTEK® and RAGWITEK® approved

and launched

• HDM tablet in Phase III

• ALK North America

• Allergen extracts and other products

delivered to allergists

• FY 2014: 15% sales growth

7

Merck partnership co-exists with ALK’s allergen extracts business

USA: ALK’s strategy Revenue in North America*

Milestones and services cause revenue to fluctuate

DKKm

0

100

200

300

400

500

2011 2012 2013 2014 Q1 2015

+42%

-45%

* Revenue growth is measured in local currencies


Introduction of SLIT-tablets in North America

8

Seasonal dosing begins ~12 weeks ahead of pollen seasons

New treatment option for patients suffering from moderate to severe allergy, who

refuse SCIT

• List price (USA): USD 8.25 per tablet

• Focus in 2014: insurance coverage and

awareness building among AIT

practitioners and selected ENTs

Source: Symphony

Weekly SLIT-tablet prescription data (USA)


Globalising a proven portfolio

• Japan with Torii: Development and

commercialisation of SLIT-tablets

• First launch possible in 2016

• China with Eddingpharm: Sales and

distribution of HDM SCIT products

• Already marketed

9

Expanding beyond established AIT markets

• Russia with Abbott: Sales and distribution of

SLIT-tablets

• First launches possible in 2017

• Australia and New Zealand with bioCSL:

Sales and distribution of SLIT-tablets and AAIs

• First launches possible in 2017

Revenue in International markets*

International markets:

ALK presence New markets of interestMilestones and services cause revenue to fluctuate

DKKm

0

50

100

150

200

250

2011 2012 2013 2014 Q1 2015

+31%

-4%



Europe: A market in transition

• Optimisation of product portfolio

• Product introductions (e.g. HDM SLIT-tablet, Jext®)

• Cost savings and restructuring programmes

• Investments in market shaping activities

10

Mature, diverse markets under regulatory transformation

Europe: ALK’s strategy Revenue in Europe*

Allergy Unlocked®

• Raise awareness of disease burden

• Secure scientific support

• Improve market access

• Increase patient awareness

• Expand prescriber base

Visit www.allergyunlocked.com

DKKm

0

500

1000

1500

2000

2011 2012 2013 2014 Q1 2015

+2%

+4%



Setting the scene for 2015/16

11

Pivotal newsflow expected to support globalisation of ALK

Events Exp. timing

Europe Regulatory approval of HDM SLIT-tablet

Completion of GAP (GRAZAX Asthma Prevention trial)

Further development of the tree SLIT-tablet

Q4 2015

Q4 2015/Q1 2016

2015/16

North

America

Completion of HDM SLIT-tablet (rhinitis) Phase III trial

Submission of BLA for HDM SLIT-tablet

Initiation of paediatric development of RAGWITEK®

Q2/Q3 2015

2015/16

2015/16

Japan Regulatory filing of HDM SLIT-tablet

Data from Japanese cedar SLIT-tablet Phase II/III trial

Regulatory review of HDM SLIT-tablet

Q1 2015

2015/16

2015/16

Rest of

world

Regulatory filing of GRAZAX® in Russia

Filing of GRAZAX® and HDM SLIT-tablet in AUS & NZ

2016

2015/16


Thank you for your attention

Read more: www.alk.net

Investor Relations:

Per Plotnikof

VP Corporate Communications,

IR and Strategic Planning

Phone: +45 4574 7576

E-mail: [email protected]

becoming a global specialty pharma company - jefferies · tbc*** tbc*** product grazax® grass arc...

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