Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
Becoming a global specialty pharma company
Jefferies Healthcare Conference2 June 2015
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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)
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
• 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
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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***
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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)
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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%
* Revenue growth is measured in local currencies
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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%
* Revenue growth is measured in local currencies
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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
Jefferies 2015 Healthcare Conference: 2 June 2015 : Jens Bager, President and CEO
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]