Biotec Pharmacon company presentation June 13 th , 2013 Rolf E Engstad – CSO Svein W. F. Lien - CEO
Biotec Pharmacon company presentation June 13th, 2013
Rolf E Engstad – CSO
Svein W. F. Lien - CEO
Disclaimer
2
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Agenda
Overview
Beta-Glucans – Rolf Engstad
– advanced wound care
Enzymes – Svein Lien
– molecular testing
Summary and Outlook
3
Biotec BetaGlucans
• 20 years of history in proprietary
BETA-GLUCANS
• Immuno-modulatory substance
activating the immune system
• Promising pharmaceutical
results
• Current focus on WOULGAN®
BIOGEL, a medical device for
advanced wound healing
ArcticZymes
• Unique MARINE ENZYMES
business supplying the life
science industry
• Developed and commercialized
Shrimp Alkaline Phosphatase
(SAP) – a leading enzyme in
DNA/RNA sequencing
• Broadening portfolio of arctic,
cold-adapted enzymes,
including Cod-UNG and DNases
4
Two businesses built on strong IP
Agenda
Overview
Beta-Glucans – Rolf Engstad
– advanced wound care
Enzymes – Svein Lien
– molecular testing
Summary and Outlook
5
6
Beta-glucan as a therapeutic agent:
action on specialised white blood cells
Directed action of
SBG on macrophages
holds potential in
treatment of a number
of immune related
diseases
SBG would act as a
PAMP on specific
receptors on white
blood cells -
macrophages
Inflammation – white blood cells
Proliferation – new cells
Remodelling - healing
Normal wound
Cytokines trigger
initial wound healing
Growth factors
give new cells Connective tissue
formation
Healing
Adding Soluble Beta-Glucan
SBG
White blood cells
activated by SBG
Fibroblasts and white blood cells
triggered by SBG
SBG induced
healed (closed)
ulcer
Diabetic ulcer
Dysregulated Inflammation
Imbalanced white blood cells
Chronic inflammation
Healing halted
Promoting healing through action on white
blood cells
7
Woulgan® Biogel – A unique medical device
for advanced wound healing
• Primary target: topical ulcers and wounds,
to be expanded to other wound healing
applications
• Strong documentation = efficiency claims
and attractive value proposition
• High demand for innovative and cost-
efficient advanced wound healing solutions
• World-leading partner in Smith & Nephew
• Finalised ISO-13485 process
• Validated production process
• CE-mark for Woulgan® Biogel as medical
device expected mid-2013
8
9
Animal study for Woulgan Biogel 2% SBG
0
20
40
60
80
100
120
0 4 8 12 16 20
Days Post-wounding
% w
ou
nd
are
a r
em
ain
ing
-ve control Water
Intrasite moister gel
Woulgan®
+ve control (not for humans)
1% CMC moister gel
The animal study in diabetic mice shows that the performance of
Woulgan® Biogel with SBG as compared to hydrogel without SBG
Placebo controlled double blinded study of 60 patients
Statistical significant after 8 weeks
0
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 (%)
SBG
Control
Phase 2 study in diabetic ulcer with 2% SBG
Well documented effect
44% healing after 8 weeks vs 17% with control
56% healing after 12 weeks vs 37% with control
0
20
40
60
80
100
120
0 4 8 12 16 20 24
% W
ou
nd
Are
a R
em
ain
ing
Days Post-wounding
Water
Woulgan Biogel
"Woulgan Biogel "without SBG
Woulgan Biogel:
Why a class III, rule 13 device?
Cell proliferation (left) and angiogenesis (right) in wound bed
10
0
5
10
15
20
25
30
35
Marginal Intermediate Centre
Pro
life
rati
ng
cell c
ou
nt
(fo
v)
0
20
40
60
80
100
120
140
160
Marginal Intermediate Centre
An
gio
gen
sis
Co
un
t (f
ov)
Water Woulgan Biogel «Woulgan Biogel» without SBG
SBG in Woulgan Biogel has a pharmacological effect on wound
healing that is ancillary to the pure gel effect of the formulation.
SBG is accordingly considered to be a medicinal substance giving
additional wound healing functionality in the formulation
Woulgan® claims and market
Regulatory classification frames:
Class III rule 13 opens for claims
related to “Medicinal Product” – i.e.
the effect of SBG in the formulation
Product Claims give description and
arguments to be used in marketing.
Only product with active component
directed to wound healing
Differentiation to other gel products
= Better market penetration
11
Market Segments: Paid by:
Hospitals and
Wound Clinics
Budget
Primary Care
Reimbursement
OTC/Individuals Reimbursement
and individuals
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
12
Woulgan® offers attractive economics
and performance
13
Strong clinical performance
• ~44% healing after 8 weeks, against
control of 17%
• ~56% healing after 12 weeks,
against control of 37%
• 20 days shorter healing time on
average
• Fewer amputations; 1 amputation
with product against 3 with placebo
in phase 2
Reasonable user cost
• ~USD 500 per treatment, based on one
dose every three days for 10 weeks
• Price ultimately dependent on partner
preferences
Attractive health economics
• Clinical cost savings; shorter healing
time = at least 5 less clinic visits
• Reduced number of amputations
• Increased healing ratio and improved
patient convenience
Our goal is to make Woulgan® Biogel a cost effective, high-volume
product for advanced wound care
Next generation products It is a technology platform
14
• Clear market need for increased convenience
• Possibility to combine SBG into a dressing
• SBG is also suitable for spray solutions, although maybe not stable in
the format used
Agreement with
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• Signed evaluation agreement for Woulgan® Biogel in late
December 2012
• Commencing market evaluation upon receipt of the CE-mark,
which is expected mid-2013
– Evaluation in limited number of centres across Europe
– Smith & Nephew holds exclusive, non-transferable/sublicensable
technology rights until end of trials
• Preparatory collaboration already commenced
– Exploring manufacturing cost opportunities
– Evaluating alternative delivery systems, including sprays and
combination packages
Key milestones and targets going forward
18
H1 2013 H2 2013 – H1 2014
Beta-
Glucans: Partner agreement(s)
Opinion leader/market
feedback
ISO 13485 accreditation Full launch
2. and 3. validation batch
Commercial sales revenues
MHRA clearance
CE mark approval
√
√
√
Other indications: SBG pipeline
– Finalised three clinical safety studies to treat
neuroblastoma, breast cancer and Non-Hodgkins
lymphoma with SBG combined with anti-cancer mAb
– Ongoing cancer vaccine trial (clinical phase I/II) at
Memorial Sloan Kettering Cancer Centre (MSKCC) in
children and young adults with neuroblastoma
– Secured broad patent portfolio in co-operation with
MSKCC
– Low activity for securing patent portfolio
– Clinical studies demonstrated need of more robust
product formulation
– Project on hold
– Preclinical data established – very promising effect of
SBG
– Project on hold
19
Cancer
SBG as adjuvant for anti-
cancer mAbs or vaccines
Oral mucositis
Inflammatory Bowel
Disease
Beta-glucan for consumer health
20
0
2 000
4 000
6 000
8 000
10 000
2010 2011 2012
kNOK Sales revenues
Revenues from sale of dietary supplement beta-glucan (NBG)
2013 sales expected to be in line with 2012
Agenda
Overview
Beta-Glucans – Rolf Engstad
– advanced wound care
Enzymes – Svein Lien
– molecular testing
Summary and Outlook
21
ArcticZymes – Marine Enzymes
22
Unique products with large potential
• Recombinant, patent protected
enzymes with large market opportunity
in the DNA analysis market
• Key components in sample
preparation and PCR contamination
control
• Easy deactivation through simple
heating after use
• Strong pipeline through strategic
alliances and acquisition
23
From industrial to molecular grade enzymes
1993: Production of native Shrimp
Alkaline Phosphatase, a waste
product from the shrimp
industry
~2000: Discontinued industrial enzymes
More molecular grade enzymes
2011: 6 patent protected unique enzymes
on the market
All enzymes produced recombinant
Strong pipeline of development
projects
24
Target markets for our enzymes An enzyme is an highly selective catalyst
Molecular Diagnostics
Patient
Extraction
Sample
Extracted
Nucleic
Acid
PCR process We have the results
from your test
Results
Multiple starting materials
Sample
Extraction
Cloning
RFLP
(Gel)
PCR process
Extracted
Nucleic
Acid
Research
Regulatory
Approval based
on clinical studies
Sequencing Microarray
Primary
enzyme
application
area
25
Application areas
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Market Application Area Enzyme Enzyme mkt Value
Available:
Sample Prep Removal of DNA from RNA HL-dsDNase
Heat&Run® $ 30m
DNA/RNA Amplification Removal of DNA from PCR
reactions
dsDNase
HL-dsDNase $ 40m
DNA/RNA Amplification Carry over prevention Cod UNG MDx $ 90m
RuO $ 40m
Under development:
Sample Prep
Under development
Removal of DNA/RNA in
Protein Preps
HL-SAN Nuclease
cocktails Unknown (kit)
Next Gen Sequencing
Under development
Normalization of cDNA
Libraries
dsDNase/HL-
dsDNase Unknown (kit)
Launcing new and user friendly products
• New ‘value added’ enzymes and kits in
strong demand from potential partners
• Kit-format products and ready-to-use
application solutions
• Shorter implementation phase – “ready to go”
• Easier sell-in for distributors and on webshop
• Launched ready-to-use PCR
decontamination kit in March
• Adding to Heat&Run® gDNA removal kit
launched in August 2012
• Further kits in development for new
applications
27
Main end users and suppliers:
Users Suppliers Characteristics %
Quality,
Safety and
Research
market
Thermo Fisher
(Life Tech, Applied, Invitrogen,
Ambion)
NEB, Qiagen
Roche, Bio-Rad, VWR, GE
Specialty labs, Unis, Pharma and other
industry.
WEB and distributors.
Product portfolio and support important
A tendency to more kit solutions
50%
MDx
(diagnostic
devices)
Roche
Myriad Genetics
Qiagen
Abbott
Siemens, Life Technology, GE
Products registered as devices restrict
parallel sales
Mostly proprietary instrument platforms
35%
Home brew
diagnostics
As for MDx but also component
suppliers
Sale directly to user
Labs need approval
Rapidly growing in Asia
5%
Forensic Applied Biosystems (Thermo F)
dominant
Specialized market 10%
28
ArcticZymes Resource Allocation
29
Segment Rationale Target Focus Marketing strategy
TIER 1
Volume
(Scale &
Scope)
Current Revenue
and Growth
(Horizontal and
Vertical Reach)
Global
Research &
Diagnostic
Companies
60% Direct; Account Mapping,
Vertical and Horizontal
Integration, Match with AZ.
Require individual follow-up
at the account.
TIER 2
Availability
Market
Identify the Next
Tier 1 Accounts
Positive Revenue
Mid-Size
Companies
25% Direct marketing,
opportunity/benefit based
evaluation of prospects, and
individual follow-up.
TIER 3
Strategic
Market
Ensure
implementation in
novel technology
End-user
R&D
15% Webshop, low-cost pull
strategy, outbound effort,
web design, application
focus, limited exhibition
presence
E.g. Tier 1 Account – Thermo Fisher
(Just acquired Life Technologies)
Thermo Fisher – Account Diversity and Map:
• Life Technologies
• Invitrogen (Multiple sites)
• Applied Biosystems (Multiple sites)
• Ambion
• Ion Torrent
• Thermo
• Fermentas
• Other business units
30
Apps Spec. Tech Support
Customer Service
E-Marketing and Webshop
Account Manager Account Manager Account Manager
ArcticZymes Goal:
• Coordinated account effort to leverages internal resources and facilitate growth
• Vertical integration
• Requires internal adoption of language, business practice and internal support, and the ability to transfer goodwill from one part of the customer organization to others
Global supply agreement with
• Ideal type of partner in the
commercialisation process
• World leader in the production and
supply of reagents for the life
science industry
• Offers the largest available
selection of recombinant and native
enzymes for genomic research
• Current agreement covers
ArcticZymes’ recombinant SAP
(rSAP), and opens for other
products at a later stage
31
Agenda
Overview
Beta-Glucans – Rolf Engstad
– advanced wound care
Enzymes – Svein Lien
– molecular testing
Summary and Outlook
32
Summary & Outlook
Enzymes:
• Expects to sign more supply agreements with global leaders
• Continuing development of ready-for-use product kits
• Beta-glucans:
• The process regarding the CE-mark for Woulgan® Biogel is getting close
to conclusion
• Product launch and market evaluation process with Smith & Nephew to
start upon CE-marking
Financial
• Completed equity issues provide funding of normal activities through
2014
33
34
Questions?
Svein W. F. Lien
Mob: +4792289323
Email: [email protected]
Rolf Engstad
Mob: +4795941542
Email: [email protected]
www.biotec.no