dnb markets annual health care conference oslo, 11 december …€¦ · overview beta-glucans ......
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DNB Markets
5th Annual Health Care Conference
Oslo, 11th December 2014
Svein W. F. Lien – CEO
Børge Sørvoll - CFO
Agenda
Overview
Beta-Glucans
Advanced wound care
Enzymes
Molecular testing
Outlook
2
• Proprietary Beta-Glucans. Immuno-
modulatory substance activating the
immune system
• Supply products for Animal Health
and Nutrition. Own factory in Tromsø
• Promising pharmaceutical results
• Current focus on WOULGAN®
BIOGEL, a medical device for
advanced wound healing
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This is Biotec Pharmacon:
Enzymes BetaGlucans
• Unique Marine Enzymes business
• Supply a portfolio of arctic, cold-
adapted enzymes for the life
science industry
• Developed and commercialized
Shrimp Alkaline Phosphatase (SAP)
a gold standard in DNA/RNA
sequencing
Two businesses based on a strong scientific foundation and patent protection
Financial Highlights
NOK million Q3 2014 Q3 2013 9M 2014 9M 2013
Enzymes 3.4 4.7 11.9 11.9
Beta-Glucans 6.2 1.7 11.1 4.9
Sales revenues 9.6 6.3 23.0 16.8
Enzymes -2.2 -0.1 -2.7 -2.1
Beta-Glucans -3.9 -4.3 -12.7 -13.1
EBITDA -6.0 -4.4 -15.4 -15.2
Profit before tax -6.2 -4.8 -16.2 -16.2
* The segment figures reflect that all costs are allocated to the two operating units
Cash Flow and Cash Position
NOK million Q3 2014 Q3 2013 9M 2014 9M 2013 2013
Operating activities -4.1 -6.8 -22.5 -16.5 -17.4
Investing activities 0.8 0 -1.4 -0,7 -1.6
Financing activities 1.0 0 76.9 43.3 43.2
Changes in cash and cash
equivalents -2.3 -6.8 53.0 26.1 24.3
Cash and cash equivalents at the
beginning of period 89.0 42.3 33.6 9.4 9.4
Cash and cash equivalents at
end of period 86.7 35.5 86.7 35.5 33.7
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Company is well funded throughout the Woulgan® commercialization
process
Overview
Beta-Glucans
– advanced wound care
Enzymes
– molecular testing
Outlook
6
Biotec BetaGlucans
Beta-glucans
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• Animal health - Feed additive to fish farming
industry
• Nutrition - Bulk substance for use in nutrition and
cosmetics
• Cancer - Neuroblastom project with Memorial
Sloan Kettering Cancer Center in
New York
• Wound Care - WOULGAN® BIOGEL, a medical
device for advanced wound
healing…..
Woulgan® Biogel includes Soluble Beta-
Glucan (SBG®)
• Woulgan® Biogel
contains: – Hydrogel components
– Biotec’s proprietary
Soluble Beta-Glucan
(SBG®)
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Heals wounds faster
Medical device with an ancillary medicinal
substance (SBG®) that specifically accelerates the
wound healing process
How to create a commercial success in
wound care – elements needed:
1. To be considered:
That they have a need for new improved products
Regulatory approval with strong marketing claims
Positive Publications
2. To be used:
That the end user like the product
3. To be a commercial success:
A large market
Strong distribution partner(s)
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So, what is the status for the Woulgan® Biogel product?
To get in through the door to the key
customers you need:
• That they have a need for new improved products:
– Hard to heal wounds is a massive problem:
• E.g. every 30 second a diabetes related amputation takes place somewhere in
the world. Only in Norway, abt. 450 and in Denmark abt. 800 amputations
annually
– The Health Care Professionals and Opinion leaders are actively seeking
new products to improve the treatment of hard to heal wounds
• Regulatory approval with strong marketing claims which enable
you to actually claim it: …….
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Through the CE-marking
Woulgan® Biogel offers unique product claims:
Woulgan® Biogel:
• Has the ability to be significantly more efficacious in wound healing
than a gel without SBG ®
• Supports the natural wound healing process
• Modulates the immunological system by activating macrophages
• Offers potential for reducing the risk for contamination and
microbial infection
Studies show clear beneficial effects of SBG®
The positive effect of SBG in
healing of diabetic foot ulcers
was published in Journal of
Diabetes Investigation, vol 5.
July 2014.
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10
20
30
40
50
60
0 1 2 3 4 5 6 7 8 9 10 11 12
Duration of therapy (weeks)
Patients with complete healing (%)
44% healing after 8 weeks vs 17%
with placebo
56% healing after 12 weeks vs 37%
with placebo
How to create a commercial success in
wound care – elements needed:
To be considered:
That they have a need for new improved products
Regulatory approval with strong marketing claims
Positive Publications
To be used:
That the end user like the product
To be a commercial success:
A large market
Strong distribution partner(s)
13
Results from 50 patient cases all reported by HCP personnel in Norway
Up to one week 8 %
Several weeks 26 %
Several months 29 %
over 1 year 37 %
How "old" is the wound?
Diabetic ulcer 18 %
Pressure ulcer 22 %
Leg ulcer 28 %
Post-operative surgical wound
14 %
1st or 2nd degree burn
4 %
Abration or laceration
8 %
Don't know 6 %
Wound diagnosis
Dayly 14 %
every other day 8 %
3 times a week 46 %
Once a week 10 %
Other 22 %
How often was WBG applied? Hospital
8 % Clinic 8 %
GPs office 10 %
Nursing homes 10 %
Home nursing 41 %
Other 23 %
Where was the treatment conducted?
Very good; 2
Good; 6
Quite good; 1
Results from 50 patient cases
Fantastic 20 %
Very good 27 %
Good 25 %
Quite good 12 %
Poor 10 %
Don't know 6 %
How would you rate WBGs effect?
Yes 88 %
No 2 % Don't
know 10 %
Do you want to continue to use WBG?
Diabetic Ulcers: How would you rate WBGs effect?
Fantastic; 3
Very good; 2
Good; 5
Quite good; 3
Poor; 1
Leg Ulcers: How would you rate WBGs effect?
A picture tells more than a 1000 words:
1 ½ year old wound. Patient diagnosed with systemic sclerosis. The ulcer had previously been treated with antibiotics and silver. Wound healed after 1 month treatment with Woulgan® Biogel applied once a week. Reported from podiatrist specialized in wound treatment.
A picture tells more than a 1000 words:
6-7 months old leg ulcer. Debrided and treated with Woulgan® Biogel, healed in 8 days after one application with Woulgan® Biogel. Reported from podiatrist specialized in wound treatment.
Main Message from posters presented at
Wounds UK from the S&N Evaluation Study
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Venous Leg Ulcers (clinic in Hull): • All patients showed improvement or significant
improvement at week 4
• Significant wound improvement at week 12
• Patients experienced less pain and improved
comfort
• Exudate levels were lowered.
• Patient concordance with the treatment regime was
significantly high
• 93% of patients assessed the healing as “very
good”, 7% assessed it as “good”.
Diabetic Foot Ulcers (clinic in London): • No adverse side effects registered
• No problems with maceration
• No ulcer deterioration
• Some wounds improved
• One «limb saving» report
How to create a commercial success in
wound care – elements needed:
To be considered:
That they have a need for new improved products
That you have a good product
Regulatory approval with strong marketing claims
Positive Publications
To be used:
That the end user like the product! (looks good but not concluded)
To be a commercial success:
A large market
Strong distribution partner(s)!
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Broad indication area -large wound healing market opportunity
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Europe represents ~1/3 of the total available global wound market
• The European market counts
~9 million wounds in the initial
indication areas
Diabetic ulcers, leg ulcers,
pressure ulcers, burns
• Approved also for other major
wound areas
Post-surgery wounds, trauma
wounds, lacerations, and
abrasions
Diabetic foot
ulcers 23 %
Leg ulcers 10 %
Pressure ulcers 56 %
Burns 11 %
Europe; 9 million wounds annually
The partner process
• The market evaluation study carried out by Smith & Nephew is
delayed but still high interest
• The data published in the UK posters from the sites included in
the Smith & Nephew evaluation study support the strong data
from the Norwegian survey
• Biotec BetaGlucan continues its communication with Smith &
Nephew to clarify the basis for a long term agreement while the
study is being completed
• The delay means that the exclusivity agreed with Smith &
Nephew expires but has no other effect on the process
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How to create a commercial success in
wound care – elements needed:
To be considered:
That they have a need for new improved products
That you have a good product
Regulatory approval with strong marketing claims
Positive Publications
To be used:
That the end user like the product! (looks good but not concluded)
To be a commercial success:
A large market
Strong distribution partner(s)!
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On this basis it is likely we
will get strong distribution
partner(s)!
Overview
Beta-Glucans
– advanced wound care
Enzymes
– molecular testing
Outlook
23
Broadening the distribution
• Received the award as “Supplier of
the Year for Biologics” by the worlds
largest company in Life Science,
Thermo Fisher Scientific
• ArcticZymes continue to broadening
its interaction with the largest
companies in the molecular research
and diagnostic industry
• China will be an important market
going forward
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From left to right: Mark O’Donnell (VP Global
Operations), Svein W. F. Lien CEO ArcticZymes, Tom
Fenwick (Strategic Sourcing Manager), Peter Granick (VP
Global Sourcing Thermo Fisher Scientific), and Wayne
Woodward (VP Global Supply Chain)
Overview
Beta-Glucans
– advanced wound care
Enzymes
– molecular testing
Outlook
25
Outlook
For Woulgan® Biogel:
• Conclude the evaluation study!
• Ensure strong distribution and launch in the
major markets
Continue to expand also other opportunities in
beta-glucans and in the enzyme business
Woulgan® Biogel is a an approved product with
favorable documentation addressing a large
market in need of new products 26
