Presentation Nordnet
23rd January 2014
Svein W. F. Lien – CEO
Agenda
 Highlights
 Q3 and 9M financials
 Beta-glucans
– advanced wound care
 Enzymes
– molecular testing
 Summary and Outlook
2
Highlights by Q3
Beta-glucans
Enzymes
• MHRA confirms the classification of
Woulgan® Biogel as a class III
medical device under rule 13
• Gaining traction with the large OEM
accounts with Cod UNG, dsDNase,
and SAN enzymes
• Awaiting CE-marking; in
communication with Presafe/MHRA
about last outstanding issues
• Seeking to sign more enzyme supply
agreements with global leaders in
molecular biology
• Product launch and market
evaluation process with Smith &
Nephew to start upon CE-marking
• Strengthening the business
development function in the US
• Continuing development of userfriendly enzyme kits
3
Financials
 Highlights
 Q3 and 9M financials
 Beta-glucans
– advanced wound care
 Enzymes
– molecular testing
 Summary and Outlook
4
Financial Highlights
NOK million
Q3 2013
Q3 2012
Enzymes
4.7
1.9
11.9
8.4
12.8
Beta-glucans
1.7
2.1
4.9
7.0
8.7
Sales revenues
6.3
9M 2013
4.0
9M 2012
16.8
2012
15.4
21.5
Enzymes
-0.1
-3.2
-2.1
-6.5
-7.8
Beta-glucans
-4.3
-3.2
-13.1
-9.7
-14.8
EBITDA
-4.4
-6.4
-15.2
-16.2
-22.6
Profit before tax
-5.0
-7.0
-16.9
-17.8
-24.3
Cash Flow and Cash Position
(Amounts in NOK 1.000)
Operating activities
Q3
2013
2012
9M
2013
2012
-6,765
-6,683
-16,488
-20,864
-51
-508
-690
-2,694
0
-33
43,259
-33
Changes in cash and cash
equivalents
-6,816
-7,224
26,081
-23,591
Cash and cash equivalents at the
beginning of period
42,276
19,708
9,379
36,075
Cash and cash equivalents at end
of period
35,460
12,484
35,460
12,484
Investing activities
Financing activities
6
Beta-glucans – Biotec BetaGlucans
 Highlights
 Q3 and 9M financials
 Beta-glucans
– advanced wound care
 Enzymes
– molecular testing
 Summary and Outlook
7
MHRA confirms classification of
Woulgan® Biogel
•
The UK Medicines and Healthcare products Regulatory
Authority (MHRA) confirms classification of Woulgan® Biogel as
a class III Medical Device under rule 13
– Advanced classification – unique for a gel in the wound market
– Enables Biotec BetaGlucans to claim medical effects in labelling and
marketing
•
CE-marking will be issued by Presafe as the Notified Body; the
parties are in communication about the last outstanding issues
•
The importance of class III rule 13 is the claims…..
8
Woulgan® Biogel: Principal label claims
• Woulgan® Biogel has high water content and the formulation makes the gel
effective in assisting the debridement and desloughing process in dry necrotic
wounds. It is able to rehydrate necrotic tissue, enhancing the natural autolysis
processes in wound healing.
• Woulgan® Biogel formulation increases the moisture within the wound through
water donation, whilst maintaining a moist wound environment for optimal
wound healing and preventing desiccation.
• The high viscosity and thixotropic properties of the Woulgan® Biogel formulation
allows the gel to be easily applied and remains in place. It also reduces the risk
of leakage and maceration to the surrounding skin, while maintaining a barrier
function and a moist environment.
• Woulgan® Biogel is an aqueous gel which gives a cooling and soothing sense
for the patient.
• Woulgan® Biogel is biocompatible and safe to use.
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Woulgan® Biogel: Ancillary action label claims
• In experimental wound healing studies, using diabetic mice, Woulgan® Biogel has
demonstrated its ability to be significantly more efficacious in wound healing than a gel
without SBG or an occlusive secondary dressing alone.
• Woulgan® Biogel can support the natural wound healing process within the wound bed.
• Woulgan® Biogel also exercises its biological effects in terms of increased wound
contraction as one of the hallmarks combined with allowing increased influx of
phagocytic cells to the wound bed.
• In-vitro studies have shown that the SBG content in Woulgan® Biogel modulates the
immunological system by activating macrophages and other phagocytic cells having
specific cell receptors for SBG.
• Attracting and stimulating phagocytic cells in the wound has a potential for reducing the
risk for contamination and microbial infection in the wound bed through the body’s own
defense mechanisms.
• A gel containing 2% SBG has been employed in several clinical trials, and has
demonstrated its ability to aid in inducing improved and more rapid wound healing of
ulcers in diabetes patients as well being safe and well tolerated.
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Obtained ISO 13485 certification and
validated production processes
• Certified for development,
production and sales of
soluble beta-glucans
• Manufactured three real-scale
validation batches, to be used
in a planned trial and
evaluation period
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collaboration
• Market evaluation trials commencing upon receipt of the CE-mark
– Evaluation in limited number of centres across Europe
– Seeking to establish end-user efficacy in routine clinical setting
– Smith & Nephew holds exclusive, non-transferable/sublicenseable
technology rights until end of trials
• Trial preparations and other collaboration activities are developing
as planned
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Targeting a mass market in wounds
• Partner Smith & Nephew
shares the vision of making
Woulgan® Biogel a mass
product
• Large market in need of new
and cost-effective wound
healing solutions
• First indications; Diabetic
ulcers, leg ulcers, pressure
ulcer and burns
Our goal is to make Woulgan® Biogel a cost effective
and high volume advanced wound care product
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Promising feedback from early users
• The overall composition of Woulgan®
Biogel, the choice and concentration
of hydrogel components and the
concentration of the beta-glucan
component SBG is based on years of
research and a number of studies
• Many have tested the product and we
have received strong positive
feedback from initial users making us
convinced about the positive effect of
the product
The phase II study and subsequent animal models
showed quite rapid response which will support the
market penetration
14
Journal of Diabetes Investigation
publishing Study of SBG, the medicinal
ingredient in Woulgan® Biogel
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The European market opportunity
Market estimate of annual number of wounds
Population
571 million
# of Diabetic Foot Ulcer
2.0 million
# of Leg Ulcers
0.9 million
# of Pressure Ulcers
5.0 million
# of burns
1.0 million
Europe is about 30% - 50% of world market,
dependent on definitions
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 Highlights
 Q3 and 9M financials
 Beta-glucans
– advanced wound care
 Enzymes
– molecular testing
 Summary and Outlook
17
Revenue development
• Gaining traction with new
OEM partners
Revenue
NOKm
5
– New England Biolabs
– GE Healthcare
• Particular interest for Cod
UNG, dsDnase and SAN
enzymes
• Generally increasing
awareness among both
diagnostic and research
companies
4
3
2
1
0
Q3-12
Q4-12
Q1-13
Q2-13
Q3-13
18
Strengthening business development
• Strengthening the US business development organization
– Hired Andrew Ward as US Business Development Manager in Boston
– Ensuring execution of the commercial strategy in North America
• Continued focused on the top-end of three distinct customer
segments:
1. Tier 1 Key Accounts; Large multi-national companies with scope and scale
to integrate ArcticZymes products and key components in branded kits
2. Tier 2 Accounts; Direct sales towards clients with geographical strength
and/or channel ownership
3. End-user segment execution; primarily a low-cost pull strategy serving to
develop brand online web-shop
19
Status sales and customer relations:
• We are now in communication with almost all of the larger
companies in this industry
• Our products are quite unique and generate enthusiasm
• The lead times for these processes can be quite long so we need
a mix between these larger more strategic accounts and smaller
accounts
• We have therefore also started to appoint distributors for own
labelled products and continue the development of kits and kit
components
• All to ensure a healthy mix of short- and long term growth
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R&D focus on user-friendly enzyme kits
• Continuing to develop ready-to-use
enzyme kits
• Launched PCR decontamination kit in
March 2013
• Launched Heat&Run® gDNA removal kit
in August 2012
• Grants from the Norwegian Research
Council support development of further
kits to meet demands and requests
from both OEM customers and
researchers
• A number of new enzymes and kit
components in the pipeline to expand
existing market position
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 Highlights
 Q3 and 9M financials
 Beta-glucans
– advanced wound care
 Enzymes
– molecular testing
 Summary and Outlook
22
Summary and Outlook
• Awaiting final decision of CE-marking of Woulgan® Biogel
following very positive confirmation of the classification as a class
III, rule 13 medical device:
– Presafe have confirmed they have finalized their part
– MHRA has very few outstanding issues left
• Product launch and market evaluation process with Smith &
Nephew to start upon CE-marking – pre-work started
• Seeking to expand the enzyme business by signing more supply
agreements in both the diagnostic and research markets
• Continuing development of novel user-friendly enzyme kits
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Questions?
Svein W. F. Lien
Mob: +4792289323
Email: [email protected]
www.biotec.no
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