Biotec Pharmacon ASA - Svein Lien

Agenda
 Business areas and Highlights
 Beta-Glucans – advanced wound care
 Enzymes – molecular testing
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Biotec Pharmacon
Tromsø
Business areas
Beta-Glucan
Enzymes – ArcticZymes
• Well documented effect in wound
care - diabetic ulcer but also
projects in cancer, oral mucositis,
and IBD
• Business based on unique cold
adapted enzymes
• Company focus on medical device
product for topical ulcers/wounds
• Partner interest to take such
product to market
• Pharma path retained through
partner interest and dormant
development programs
• Core role in PCR contamination
control
• Strong IP position for marketed
products
• Large unexploited market
• Strong pipeline secured through
strategic alliances and
acquisition
20 years of research in key areas – strong IP based science
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Financial Highlights
(MNOK)
Q3 2011
Q3 2010
9M 2011
9M 2010
Beta-Glucans
1.8
1.0
6.8
4.1
ArcticZymes
3.1
1.2
12.5
11.2
Revenues (sales)
4.9
2.2
19.3
15.3
Beta-Glucans
-4.0
-5.1
-11.5
-26.0
ArcticZymes
-1.2
-2.2
-1.0
1.0
EBITDA
-5.2
-7.3
-12.5
-25.0
Profit before tax
-5.7
-8.0
-14.2
-27.1
 Positive operating cash flow in Q3 2011 of NOK 1,0 million
 Cash at end of Q3 2011 was NOK 41.9 million
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Agenda
 Business areas and Highlights
 Beta-Glucans – advanced wound care
 Enzymes – molecular testing
5
Available market of USD 3.5bn for SBG
within professional wound care
Advanced Wound Care
Global Wound Care
(Total value USD 13bn, 2009)
-professional use
(Total value USD 5.1bn, 2009)
Other, $105M,
2%
Advanced
wound care
products
Professional
use;
$5,10bn;
40 %
Traditional
consumer
use; $4,7bn ;
36 %
Traditional
professional
market;
$3,15bn;
24 %
NPWT;
$1 540M;
30 %
Biologics;
$345M;
7%
Moist;
$3,145M;
61 %
Source: Espicom
Woulgan® will represent a high-end moist gel with biological effects
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Europe offers a large and growing market
opportunity
Moist and Biologics market
Growth projections
Moist and Biologics market
by regions
USDm
6 000
ROW
$604M
17 %
5 000
4 000
USA
$1,175M
33 %
Total
$3.5bn
3 000
Europe
$1,1816M
50 %
2 000
1 000
0
Source: Espicom
2007 2008 2009 2010 2011 2012 2013 2014 2015
Moist
Biologics
Woulgan® will address a growth segment in search of new products
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®
Initial Woulgan focus on diabetic ulcer
Strong documentation in DU
• More than 50 million people have
diabetes in Europe, US and
Japan – and the disease is
rapidly increasing
• 15% of diabetics will ultimately
develop diabetic foot ulcers;
– Representing about 8 million
ulcers in the Western World
– Annual incidence of at least 1.2
million new ulcers
– 71,000 amputations in people with
diabetes in the US alone
• US medical expenses of USD 27
billion for diabetes care
Improved diabetic ulcer treatment needed to
reduce amputation rates and cut costs
8
We have a good product
-with a lot of documentation on the SBG substance
Successful animal study for reformulated product
Successful phase 2 study in diabetic ulcer
120
-ve control Water
1% CMC moister gel
Intrasite moister gel
Woulgan®
+ve control not
for humans
% wound area remaining
100
80
SBG
60
40
Control
20
0
0
4
8
12
16
20
24
Days Post-wounding
The animal study in diabetic mice shows that the performance of
the reformulated SBG product (Woulgan®) with proven stability is
close to the positive control and well above typical moister gels
used for wound healing
Placebo controlled double blinded study of 60 patients
Statistical significant after 8 weeks
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Likely time line for launch of product as
Class IIB or III, rule 7 or 13 medical device
Official Journal of the European Union:
Council conclusions on innovation in the
medical device sector (2011/C 202/03)
Supportive clinical evidence for marketing (not required for launch) TBC
Notified body approval time class IIb
CE Mark Allocation and Device Approval
If class III
rule 7/13
Label claims and patient information
LAUNCH
Q4 2012-H1 2013
Clinical Evaluation Protocol and Reporting
(established SBG data and published material)
Technical dossier file for final product
Stability studies final formulation in final container
Stability studies final formulation
Technology transfer
Subcontractor filling, packaging
and labelling
ISO 13485 approval
...Q3 2011
Q4 2011
Q1 2012
Q2 2012…..
Q4 2012
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Agenda
 Business areas and Highlights
 Beta-Glucans
 Enzymes – molecular testing
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ArcticZymes – Marine Enzymes
Value proposal and focus
 Unique IP protected products for PCR sample preparation –
removal of contaminants
 Market attractive (~ USD 2 bn) and growing at >10%/Y.
Enzyme part of market 5-10%
 Unexploited market opportunities with current products
 Exclusive rights to commercialize new enzymes from
substantial bio prospecting programs
 International expansion of marketing and sales creates
increased growth opportunities
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Offering new opportunities in
hypersensitive PCR reactions
Article on analysis of ancient
DNA using hypersensitive
PCR
Cod UNG: Thus, codUNG is
roughly 100 fold more efficient
than the bacterial UNG
HL-dsDNase:
In conclusion, the hl-dsDNase
treatment is an efficient way to
decontaminate PCR reagents that
cannot be decontaminated by
irradiation, in particular Taq DNA
polymerase and dNTPs.
Decontamination of all reagents,
including primers, is particularly
important for forensic analyses
and studies of ancient human
remains where any reagent can be
contaminated with human DNA.
Champlos et al. (2010): PLoS ONE
5(9): e13042.
doi:10.1371/journal.pone.0013042
 Enzymes from ArcticZymes will reduce
background of qPCR tests by elimination of
contaminating DNA
 Simplified workflow by integration of
processes – suitable for automation
 No loss of precious sample
- Enzyme is heat-inactivated – no
extraction with loss involved
- Allows for multistep enzyme reactions by
heat-inactivation of previous enzyme
• Documented effect in the most critical
analyses (publication on ancient DNA)
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ArcticZymes expanding activities
 US office opening Q4
 Asian distributors being added
 Webshop introduced
 Full version with payment solution by the end
of 2011
 Established Gardermoen logistic
 Number of shipments and number
of active customers more than
doubled vs. 2010
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Questions?
Svein W. F. Lien
Mob: +4792289323
Email: [email protected]
www.biotec.no
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