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Third Quarter 2010 Svein W. F. Lien - CEO Jan Buch Andersen - Managing Director - Marine Biochemicals AS 12 November 2010

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Page 1: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Third Quarter 2010

Svein W. F. Lien - CEO

Jan Buch Andersen - Managing Director - Marine Biochemicals AS

12 November 2010

Page 2: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Tromsø

15 years of research in key areas – strong IP based science

GMP approved manufacturing

Marine Biochemicals

• Cold-adapted enzymes from the

Arctic Ocean

• A number of patented enzymes

on the market

• Used in DNA/RNA analyses

(research and diagnostics)

• Close relationship with University

of Tromsø

• Strong pipeline

2

Beta -1,3/1,6-glucan

• Well documented effect in wound

care – in particular diabetic ulcer

• Failed in phase III studies - cause

found in lack of stability

• Developing first product as

medical device

• In discussion with potential

partners

Biotec PharmaconIn brief

Page 3: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Q3 highlights

Beta-glucans

• Final outcome from animal model verified that phase III failure was related

to the material in the product container

• Testing new gel compositions to create a more robust product and new IP

• Received feedback that a SBG wound care product could be launched as

medical device in EU

Marine Biochemicals

• Entry into the MARZymes project substantially increases pipeline and

potential

• Low sales volume in Q3 was compensated in October – healthy growth

outlook for the full year 2010

3

Page 4: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Agenda

Highlights and overview

Beta-Glucans

Marine Biochemicals

Q3 Financials

Summary

4

Page 5: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

SBG - Proof of Concept is still valid

• Focus on development of an

advanced wound care product,

for use in e.g. diabetic ulcer

• First version to be launched as

medical device

• Development of drug product

remains an option, with different

technology at a later stage

• Additional applications:

– Immunotherapy of cancer, Phase I with

MSKCC

– Inflammatory bowel disease (IBD), Pre-

clinical

– Asthma - feasilibility

5

Page 6: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Sub-analysis of clinical data2nd phase III batch showed results in line with phase II

6

SBG in Nottingham study2nd batch (N=21)

Product stored for 3 months

Product% healed

Placebo% healed

p-value

52.4% 33.3% 0.22

SBG

Control

Clinical phase III Clinical phase II

Page 7: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Retesting SBG in PE- and PC-containersSBG in treatment of wounds in diabetic mice

7

Bandage only

Vehicle control

PolyEthylene

PolyCarbonate

SBG stored in polycarbonate (PC) containers performs better than SBG (same batch)

stored in the polyethylene (PE) ampoules used in the Phase III trial

0

20

40

60

80

100

120

0 4 8 12 16

Days Post-wounding

PE SBG IB274

PC SBG 252-7

Vehicle control

Bandage only

control

% w

ou

nd

are

a r

em

ain

ing

Page 8: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Stability and product development

• Stability studies of the 2% SBG composition used in

the clinical trials show that the product needs to be

transformed into a more robust gel

• Test show that combining 2% SBG with different

standard gel substances gives a solid and robust gel

that seems to have the same biological effect

• Different prototypes will now be tested in vitro and in

the animal model

Page 9: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Advanced wound care product

The development should focus on

three building blocks:

• A moist substrate providing coverage and

protection while remaining 'breathable‘

– i.e. a hydrogel, hydrocolloid, alginate or foam

• The addition of antimicrobials to prevent

infection and thus accelerate healing

– i.e. silver

• The addition of natural epithelial growth

factors to trigger tissue layer re-growth

9

"The dressings that

help the body's

outer armour repair

itself are deploying

evermore exotic

materials to meet the

needs of a growing

$7.2bn global

market.“

Ron Sills of Nerac

Medicaldevice-network.com

Page 10: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Regulatory status and potential launch

• Received general confirmation that a SBG topical wound

product can be classified as a Medical Device in class IIb

• This means that a product may be developed and launched

over the next 15-18 months

• There are pros and cons with the various classifications as to

e.g. product claims but this leaves us with a certain freedom

Irish Medicines Board

Page 11: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Partner process

• We are in dialogue with potential partners that are well

positioned in the topical wound care market

• The initial goal is to obtain a two-step partnership:

• A joint development project to ensure best possible product

design and product(s) competitiveness

• A joint launch and market penetration program to ensure

maximum growth and value creation

• The partner process will also clarify which product

classification that will be their preference

Page 12: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Activity plan wound healing with time line(if class 2B device)

12mid 2010 end 2010 mid 2011 end 2011

Prototype development of

a medical device Ongoing

Initial EU classification

Done - class IIb device

Partner discussions Ongoing

New IP for new compositions Likely!

Does the substance work

Yes!

Clinical trials

Product

development

QA documentation and regulatory approval Ongoing

LAUNCH

H1 2012

Page 13: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Agenda

Highlights and overview

Beta-Glucans

Marine Biochemicals

Q3 Financials

Summary

13

Page 14: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Q3 2010 PresentationMarine Biochemicals AS

Jan Buch Andersen, Ph.D.Managing Director

E-mail: [email protected]

Telephone: +47 46 74 61 71

Website: www.marinebiochem.com

Page 15: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

November 12, 201015Q3 2010 Presentation Biotec PharmaconOslo

Healthy outlook for 2010

On track for doubling of revenue in 2009-12, with >95% of sales

in 2012 from existing products

Building international sales organisation to increase

customer contacts

Long sales-cycles from first contact to first sales

Essential to increase customer oriented trials

Long development and introduction periods

Increasing R&D activities to support new product development

Overview and outlook

Page 16: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

November 12, 201016Q3 2010 Presentation Biotec PharmaconOslo

Increased market activity

Exhibitions and trade shows increase customer

awareness and are the primary lead generators

9 exhibitions in 2010 vs. none in 2009

Sales processes are typically based on customer

trials with a high level of customer involvement

13 new trials in Q3 2010 vs. 1 trial in Q3 2009

72 new trials YTD vs. 8 new trials in H2 2009

Increasing recognition among Key Opinion Leaders

Gregg Shipley at XGen, San Diego, PCR Insider

and Labmanager.com webcast 23 July

Independent publications from French group

state the qualities of using our enzymes in

hypersensitive PCR applications (ancient DNA)

New Roche kit with our

dsDNase:

Key Opinion Leader testimonial

Their Transcriptor runs at 55˚C, which is

actually a pretty toasty reverse transcriptase

reaction; but they run the DNase reaction,

even though it's suboptimal, at 29˚C to do the

DNAse, and then they go on and make the

cDNA… boy, the data looks pretty nice so far

Gregg Shipley, Professor UTHSC-Houston,

PCR Insider 31 March 2010

Page 17: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

November 12, 201017Q3 2010 Presentation Biotec PharmaconOslo

Gearing for international expansion

Expansion of customer portfolio

OEM accounts

Large core-labs

End-users

Planning US sales representative for 2011

Satellite supply centers: Looking for

alternatives that are cheaper, with shorter

delivery time and larger capacity

Establishing web-shop in order to take

unsolicited high-margin end-user orders

Establishing e-marketing activities to

increase customer awareness

Obtaining strong customer statements

Customer testimonial

– Cod UNG at Siemens:

Siemens also uses Cod UNG in its Versant

kPCR assay for HCV, which is not yet on the

market.

Wagner said that Marine Biochem is "just

terrific to work with. They have amazing

customer service and … even though they

are so small, they manufacture really high-

quality products, which is really unusual in

this industry. It's easy to find little research-y

things that you can buy, but to be able to use

them in an IVD product is great.“

Cynthia Wagner, Senior Research Scientist,

Siemens Healthcare Diagnostics, Berkeley

PCR Insider 1 April 2010

Page 18: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

November 12, 201018Q3 2010 Presentation Biotec PharmaconOslo

Increased R&D activity

Entry into the MARZymes project significantly

increases the long-term growth potential

Acquisition of Marimol secured exclusive option to

the commercial outcome of the MARZymes project

Also exclusive enzyme partner in:

MabCent

UNIS project on eukaryotic microorganisms

KMB project on viral enzymes

Establishing an integrated product development

platform, to be further accelerated if Research

Council project is approved

Application development and support essential in

customers buying decision3D structure of Cod UNG

Page 19: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Smallstruct

FUGE

Marbank

Start-ups

at University

MabCent

Norstruct(Norwegian Structural

Biology Centre) Marbio

MARZymes

Specific projects

UNIS, Virus etc.

November 12, 201019Q3 2010 Presentation Biotec Pharmacon

Oslo

Unparalleled bioprospecting environment

Page 20: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

November 12, 2010Q3 2010 Presentation Biotec Pharmacon

Oslo20

Marine BiochemicalsNORUT BioMabCent

Joint labNorStruct

Relocating around 1 February

Strong interface: academia - industry

Rational structure and resource utilization

New premises at the Barents BioCentreMoves us close to our research partners

Biotec Pharmacon

Page 21: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Remain committed to doubling of revenue in 2009-2012

Large unexplored potential in current product range

Increasing international sales footprint

Program for further development of marketing platform

and activities

Established strong R&D partnering structure

Essential to develop new product candidates and

secure long-term growth

November 12,

2010

Q3 2010 Presentation Biotec Pharmacon

Oslo21

Summary and Conclusions

Page 22: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Agenda

Highlights and overview

Beta-Glucans

Marine Biochemicals

Q3 Financials

Summary

22

Page 23: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Financial Highlights

Split into new segments as from Q4-09 and restated for the divestment of Consumer Health.

(MNOK) Q3-2010 Q3-2009 9M-2010 9M-2009 2009

Beta-Glucans 0.2 1.4 3.3 4.9 6.5

Marine Biochemicals 2.0 4.2 12.1 12.2 17.6

Revenues 2.2 5.6 15.3 17.0 24.1

Beta-Glucans -4.6 -20.3 -23.0 -51.2 -71.1

Marine Biochemicals -1.4 2.5 3.1 6.4 8.4

Corporate/ unallocated -1.2 -9.8 -5.1 -16.0 -19.4

EBITDA -7.3 -27.7 -25.0 -60.9 -82.1

Profit before tax -7.9 -27.8 -26.6 -59.6 -81.2

Net profit, continued

business-7.9 -27.8 -26.6 -59.6 -111.9

Page 24: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

(MNOK) Q3-2010 Q3-2009 9M-2010 9M-2009 2009

Sales revenue 2.0 4.2 12.1 12.2 17.6

Operating expenses, net -3.4 -1.8 -9.0 -5.8 -9.2

Operating profit (EBITDA) -1.4 2.4 3.1 6.4 8.4

Depreciation -0.1 0.0 -0.2 0.0 -0.1

Operating profit (EBIT) -1.5 2.4 2.9 6.4 8.3

Marine Biochemicals

-2

-1

0

1

2

3

4

5

Q3'09 Q3'10

NO

Km

Revenue EBITDA

0

2

4

6

8

10

12

14

9M'09 9M'10

NO

Km

Revenue EBITDA

Page 25: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

(MNOK) Q3-2010 Q3-2009 9M-2010 9M-2009 2009

Sales revenue 0.2 1.4 3.3 4.9 6.5

Operating expenses, net -4.8 -21.7 -26.3 -56.1 -77.6

Operating profit (EBITDA) -4.6 -20.3 -23.0 -51.2 -71.1

Depreciation -0.7 -0.7 -1.9 -2.0 -2.7

Operating profit (EBIT) -5.3 -21.0 -24.9 -53.2 -73.8

Beta Glucan developmentCompleted clinical Ph. III costs and staff reductions

-25

-20

-15

-10

-5

0

5

Q3'09 Q3'10

NO

Km

Revenue EBITDA

-60

-50

-40

-30

-20

-10

0

10

9M'09 9M'10

NO

Km

Revenue EBITDA

Page 26: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

Summary

Beta-glucans

New gel compositions = stable product and potentially new IP

Animal study will further clarify the effect of various product

compositions on wound healing

First wound healing product to be developed as medical device

Marine Biochemicals:

On track for doubling of revenue from 2009-12

The new MARZymes agreement significantly expands the

potential of the enzyme business in the longer term

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Page 27: Third Quarter 2010 · Customer testimonial –Cod UNG at Siemens: Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market. Wagner said that Marine

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Questions / Discussion