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Fourth Quarter and Full Year 2012 15 February 2013 Svein W. F. Lien CEO

Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

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Page 1: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Fourth Quarter and Full Year 2012 15 February 2013

Svein W. F. Lien – CEO

Page 2: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Agenda

Q4 Highlights

Q4 and FY 2012 Financials

Beta-Glucans

– advanced wound care

Enzymes

– molecular testing

Summary and Outlook

2

Page 3: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Secured financing through NOK 40 million share issue

3

Beta-Glucans

• Signed market evaluation agreement

with Smith & Nephew for Woulgan®

Biogel

• Registration process ongoing for

Woulgan® Biogel as medical device

• Closing audit conducted for ISO 13485

certification

• Stable sales of bulk beta-glucans for the

consumer health market

Q4 highlights

ArcticZymes - Enzymes

• Improving revenue development

• Strategic change in sales & marketing

efforts towards larger accounts

• Start-up of global supply contract with

New England Biolabs

• Pursuing interest for similar contract

arrangements from other industry majors

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4

Q4 Highlights

Q4 and FY 2012 Financials

Beta-Glucans

– advanced wound care

Enzymes

– molecular testing

Summary and Outlook

Agenda

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Financial Highlights

NOK Thousand Q4 2012 Q4 2011 2012 2011

Beta-Glucans 1 685 1 091 8 709 7 847

ArcticZymes 4 344 2 640 12 766 15 185

Revenues (sales) 6 029 3 731 21 475 23 032

Beta-Glucans -5 100 -5 496 -14 751 -17 038

ArcticZymes -1 259 -1 111 -7 803 -2 076

EBITDA -6 359 -6 607 -22 554 -19 114

Profit before tax -6 877 -6 614 -24 318 -20 103

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Cash Flow

6

NOK Thousand Q4 2012 Q4 2011 2012 2011

Operating activities -3 719 -2 504 -24 583 -10 395

Investing activities 615 -3 336 -2 079 -4 988

Financing activities 0 -30 -33 8 097

Net Cash Flow -3 104 -5 869 -26 695 -7 286

Cash at end of period 9,380 36 075 9 380 36 075

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NOK 40 million share issue in Jan-2013

• Raised gross proceeds of NOK 40 million through private placement of

NOK 9.5 million shares at NOK 4.25 per share on 11 January 2013

• Approved by Extraordinary General Meeting on 1 February 2013

• Provides sufficient funding for ordinary activities through 2014

– Net proceeds primarily to be used to fund launch and commercialisation of

Woulgan® Biogel

– A limited amount to fund ArcticZymes through to positive cash flow

• Repair issue of up to 2.5 million shares at NOK 4.25 per share, with

subscription period running 13-27 February 2013

– Pre-emptive rights for shareholders per 10 January 2013 who were not

allocated new shares in the private placement

– Oversubscription possible

7

Page 8: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Q4 Highlights

Q4 and FY 2012 Financials

Beta-Glucans

– advanced wound care

Enzymes

– molecular testing

Summary and Outlook

8

Biotec BetaGlucans

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NOK million Q4 2012 Q4 2011 2012 2011

Sales Revenue 1.7 1.1 8.7 7.8

Other income -0.6 -0.6 1.1 1.6

Operating expenses -6.2 -6.0 -24.6 -26.5

Operating profit (EBITDA) -5.1 -5.5 -14.8 -17.0

Depreciation -0.3 -0.3 -1.1 -1.3

Operating profit (EBIT) -5.4 -5.8 -15.9 -18.4

Biotec BetaGlucans Segment numbers

-20

-15

-10

-5

0

5

10

15

Sale

s r

evenues

Oth

er

incom

e

Op

era

ting e

xpenses

Depre

cia

tion

Op

era

ting p

rofit (E

BIT

)

NOKm 2012 Key financials

9

Page 10: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Woulgan® Biogel offers major upside

• Targeting a large market in need

of new and advanced wound

healing solutions

• Strong documentation enables

efficiency claims and attractive

price/value proposition

• Expect CE-mark for Woulgan® as

medical device mid-2013

• World-leading partner secured in

Smith & Nephew

10

Our goal is to make Woulgan® a cost effective, high

volume product for advanced wound care

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Woulgan® Biogel development history

11

Pharmaceutical development

(- 2009)

Discontinuation of phase III clinical trial

(2009)

Exploring reasons for instability root cause

(2010)

Reformulation and reclassification of wound healing product as Medical Device

(2010-2012)

Commercializing Woulgan® Biogel

(2012 -)

Page 12: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Woulgan® addresses a growth market in

search of new products

12

Europe $1,816M

50 % USA

$1,175M 33 %

ROW $604M 17 %

Source: Espicom

0

1 000

2 000

3 000

4 000

5 000

6 000

2007 2008 2009 2010 2011 2012 2013 2014 2015

USDm

Moist Biologics

Moist and biologics market by region Moist and biologics market growth projections

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The European opportunity

• Primary target is topical ulcers

and wounds

• Most documentation related to

Diabetic Foot Ulcer

• A general CE mark will normally

open to expand use to other

wound healing applications as

well

The European opportunity

Population 571 m

# of Diabetic Foot

Ulcers 2.0 m

# of Leg Ulcers 0.9 m

# of Pressure Ulcers 5.0 m

# of burns 1.0 m

Europe is about 30% - 50% of world

market, dependent on definitions

13

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14

Successful animal study for final reformulated product

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

Animal study in diabetic mice shows Woulgan®

performance well above typical moister gels used for

wound healing

44% healing after 8 weeks vs 17% with

placebo

56% healing after 12 weeks vs 37% with

placebo

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

Successful phase 2 study in diabetic ulcer

SBG is well documented and shows

strong clinical performance

Page 15: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

CE-mark for Woulgan® expected for

advanced wound healing mid-2013

15

• Filed Woulgan® Biogel for CE-mark

approval with the Notified Body ,

company Presafe

• The Medicines and Healthcare

products Regulatory Authority

(MHRA) in the UK will approve the

anchillary claims

• Approval expected mid-2013

• Seeking advanced classification

(Class III, rule 13)

• Ensures product uniqueness and

enables efficacy claims

• Distances Woulgan® Biogel from

commodity hydrogels

Facsimile: Teknisk Ukeblad, 28 Sep 2012

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Woulgan® claims and market

Regulatory classification frames:

Medical Device - Class III rule 13

opens for claims related to “Medicinal

Product”

Product characteristics approved by

Notified Body and Medical Agency -

CE Mark

Approved Product and Claims give

Description and Arguments to be

used in marketing

16

Market Segments: Paid by:

Hospitals and Wound

Clinics

Budget

Primary Care

Reimbursement

OTC/Individuals Reimbursement

and individuals

16

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Advanced classification and attractive

health economics = premium position

• Advanced classification enables the company to make efficiency

claims

• Faster healing means attractive health economics and improved

patient convenience

• Supports competitive market positioning and opens for better

reimbursement opportunities

• Woulgan® holds large revenue potential at reasonable user costs

– ~USD 500 per patient, based on 1 dose every 3 days for 10 weeks

– Pricing strategy to be decided together with partner

17

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Product Unit cost

(approx.)

Treatment

cost (5 sqcm

wound)

Approx.

number of

treatments

Total cost

per wound Sales

20 $ 20 $ 24 480 $ ?

1500 $ 1500 $ 8 12000 $ Reported H1’12:

$101m

1700 $ 1700 $ 4 6800 $ Annual sales:

>$100m

700 $ 65 $ 56 3640 $

Peak sales:

>$100m

Black Box

warned

Advanced wound healing products

18

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Partnership agreement signed with

• 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/sublicenseable

technology rights until end of trials

• Preparatory collaboration already commenced

– Exploring manufacturing cost opportunities

– Evaluating alternative delivery systems, including sprays and combination

packages

19

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- the world leader in the wound care market

• Wound care revenue of USD 1bn in 2011

• Clear global number 1, more than twice the size of number 2

• Strengthened position through acquisition of Healthpoint for

USD 163 million in November 2012

• Leadership positions also in orthopaedic reconstruction, sports

medicine and trauma, in addition to advance wound

management

• Global presence, with almost 11,000 employees in more than

90 countries

• Annual sales of close the USD 4.3bn in 2011

20

Page 21: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Next generation products It is a technology platform

• Market need for increased convenience

• Possibility to combine SBG into a dressing

• Suitable for spray solutions, although not stable in the format used

21

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Next generation product tested in pilot

• Produced several

technical and validation

batches in 2012

• Last study included

testing of experimental

dry dressing

• Results show positive

effect of SBG to wound

healing efficacy also in

dry dressings

• Final validation batches

to be produced in H1-13

22

Wo

un

d a

rea r

em

ain

ing

(%

)

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ISO 13485 certification ongoing

-Closing audit conducted in January

• Closing audit carried out by Presafe (DNV Nemko) in January

• All internal issues cleared

• The few remaining issues related to contract manufacturer

Sanochemia AG are expected to be closed during Q1-13

23

Page 24: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Q4 Highlights

Q4 and FY 2012 Financials

Beta-Glucans

– advanced wound care

Enzymes

– molecular testing

Summary and Outlook

24

Page 25: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

NOK million Q4 2012 Q4 2011 2012 2011

Sales Revenue 4.3 2.6 12.8 15.2

Other income 1.0 1.6 4.4 1.2

Operating expenses -6.6 -5.3 -24.9 -18.5

Operating profit (EBITDA) -1.3 -1.1 -7.8 -2.1

Depreciation -0.3 -0.1 -1.1 -0.8

Operating profit (EBIT) -1.5 -1.2 -8.9 -2.8

ArcticZymes Segment numbers

-15

-10

-5

0

5

10

15

20

Sale

s r

evenues

Oth

er

incom

e

Op

era

ting e

xpenses

Depre

cia

tion

Op

era

ting p

rofit (E

BIT

)

NOKm 2012 Key financials

Page 26: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Strengthening focus on larger accounts

• Increased focus on larger accounts starting to have effect in Q4-12

• First deliveries under recent supply contract with New England Biolabs

• Full year revenue reflect low sales volumes of SAP and reduced prices

for Con-UNG in the first nine months

• Focusing 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; 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

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Page 27: Fourth Quarter and Full Year 2012208hdg36kg2o371mblzvwxiw.wpengine.netdna-cdn.com/... · Revenues (sales) 6 029 3 731 21 475 23 032 Beta-Glucans -5 100 -5 496 -14 751 -17 038 ArcticZymes

Q4 Highlights

Q4 and FY 2012 Financials

Beta-Glucans

– advanced wound care

Enzymes

– molecular testing

Summary and Outlook

27

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Summary & Outlook

Enzymes:

• Expect to establish new high-volume accounts

• Continuing development of ready-for-use product kits

• Expect revenue growth and improved results in 2013

• Beta-Glucans:

• On track for issuance of CE-mark for Woulgan® Biogel by end of H1-13

• Product launch and market evaluation process with Smith & Nephew to follow

Financial

• Completed equity issue provides funding for ordinary activities through 2013

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Questions?

Svein W. F. Lien

Mob: +4792289323

Email: [email protected]

www.biotec.no