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ArcticZymes Technologies Earnings Release 2013

Feb 14, 2014

3538_rns_2014-02-14_a6075e69-f645-4734-822f-0ca8079f39a1.pdf

Earnings Release

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Fourth Quarter and Full-Year 2013 14 February 2014

Svein W. F. Lien – CEO

Agenda

  • Highlights
  • Q4 and FY financials
  • Beta-Glucans
  • – advanced wound care
  • Enzymes
  • – molecular testing
  • Summary and Outlook

Highlights

BetaGlucans

  • UK healthcare authorities (MHRA) is finalizing the procedural review of Woulgan® Biogel as an advanced Class III, rule 13 medical device
  • Market evaluation process with Smith & Nephew and a limited product launch starting upon CEmarking
  • Considers re-entering the animal health market

• Increased shipments of the rSAP enzyme to key OEM partner

Enzymes

  • Gaining traction with the Cod-UNG enzyme to diagnostic kit manufacturers
  • Continued focus on large OEM accounts and working to increase regional distribution

Financials

  • Highlights
  • Q4 and FY financials
  • Beta-Glucans
  • – advanced wound care
  • Enzymes
  • – molecular testing
  • Summary and Outlook

Financial Highlights

NOK million Q4 2013 Q4 2012 2013 2012
Enzymes 4.0 4.3 15.8 12.8
Beta-Glucans 1.4 1.7 6.3 8.7
Sales revenues 5.3 6.0 22.1 21.5
Enzymes -0.5 -1.3 -2.6 -7.8
Beta-Glucans -5.8 -5.1 -18.9 -14.8
EBITDA -6.3 -6.4 -21.5 -22.6
Profit before tax -6.7 -6.9 -22.9 -24.3

Cash Flow and Cash Position

Q4 12M
(Amounts
in NOK 1.000)
2013 2012 2013 2012
Operating activities -897 -3,719 -17,385 -24,583
Investing activities -871 615 -1,561 -2,079
Financing activities -36 0 43,223 -33
Changes in cash and cash
equivalents
-1,804 -3,104 24,277 -26,695
Cash and cash equivalents at the
beginning of period
35,460 12,484 9,379 36,075
Cash and cash equivalents at end
of period
33,656 9,380 33,656 9,380

Biotec BetaGlucans

  • Highlights
  • Q4 and FY financials
  • Beta-Glucans
  • – advanced wound care
  • Enzymes
  • – molecular testing
  • Summary and Outlook

Biotec BetaGlucans

Segment numbers

NOK million Q4 2013 Q4 2012 2013 2012
Sales Revenue 1.4 1.7 6.3 8.7
Other income 0.2 -0.6 1.2 1.1
Operating expenses -7.4 -6.2 -26.4 -24.6
EBITDA -5.8 -5.1 -18.9 -14.8
Depreciation -0.3 -0.3 -1.3 -1.1
EBIT -6.1 -5.4 -20.2 -15.9

CE-marking of Woulgan expected in Q1

    • Received informal notice from the UK Medicines and Healthcare products Regulatory Authority (MHRA):
  • All outstanding issues have been addressed satisfactory
  • Application has been submitted for internal sign-off at MHRA
  • ..but even though it is unlikely, it may still come questions or concerns
  • If formal sign-off is conducted, the Decision Notification Report is expected to be forwarded to the Notified Body within short
    • Notified Body has informed us they have no further questions regarding this application
  • = So giving the positive outcome of the formal procedure, an issuance of CE-mark could be expected soon

Advanced classification enables claiming of medical effects in labels and marketing

• Supported by article publication in 2014 Journal of Diabetes

"Macrophage stimulating agent soluble yeast b-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study"

  • Shows clear beneficial effect of SBG treatment in healing of diabetic foot ulcers
  • Claims offer a unique opportunity for a gel in the wound market
  • Significantly more efficacious wound healing than gels without SBG or occlusive secondary dressings alone
  • Modulates the immunological system by activating macrophages and other phagocytic cells having specific cell receptors for SBG, and supports the natural wound healing process within the wound bed
  • Exercises biological effects in terms of increased wound contraction, while allowing increased influx of phagocytic cells to the wound bed
  • Attracting and stimulating phagocytic cells in the wound has potential for reducing risk of contamination and microbial infection in the wound bed

Publication in «Sår 2013»

Targeting a mass market in wounds

  • Partner Smith & Nephew shares the vision of potentially 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

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
  • Obtaining planning tools and parameters for commercial strategy
  • Clarifying the basis for a long-term relationship with Smith & Nephew, who hold exclusive, non-transferable technology rights until end of trials
  • Biotec BetaGlucans are also actively contacting opinion leaders and the professional wound healing market in general
  • Promoting the product and obtaining information about the competitiveness and market potential
  • Web-shop ready to launch immediately upon CE-mark

Considers re-entry into animal health

  • Working to secure key customers for use of our unique beta-glucans in animal feed
  • Extensive experience from the animal health market before divestment of the business area in 2008
  • Utilizing supply capabilities

  • Highlights

  • Q4 and FY financials
  • Beta-Glucans
  • – advanced wound care
  • Enzymes
  • – molecular testing

Summary and Outlook

ArcticZymes Segment numbers

NOK million Q4 2013 Q4 2012 2013 2012
Sales Revenue 4.0 4.3 15.8 12.8
Other income 1.3 1.0 5.1 4.4
Operating expenses -5.7 -6.6 -23.5 -24.9
EBITDA -0.5 -1.3 -2.6 -7.8
Depreciation -0.3 -0.2 -1.1 -1.1
EBIT -0.8 -1.5 -3.7 -8.9

Revenue development

  • In general high activity level and much interest for the company's products
  • Higher sales of rSAP to key OEM customer
  • Beginning to see adoption of Cod-UNG in diagnostic kits
  • Strong dynamics in the relevant markets
  • Research market maturing
  • PCR based diagnostic market still low, but rapidly growing

Continued focus on multi-national companies and building more regional distribution

  • 1. Tier 1 Key Accounts; Large multinational companies with scope and scale to integrate ArcticZymes products and key components in branded kits
  • In dialogue with most of Tier 1 companies
  • Started shipment to several of these global players, also OEM discussions
  • 2. Tier 2 Accounts; Direct sales towards clients with geographical strength and/or channel ownership
  • Will appoint several new distributors of own labelled products
  • 3. End-user segment execution; primarily a low-cost pull strategy serving to develop brand
  • Online web-shop, user-focused web site, Google Ads, e-mail blasts

18 Tri-Con San Fransisco this week

R&D

  • Received NOK 4 million grants from the Norwegian Research Council for "NextZyme – enabling new concepts for marine enzymes in Next Gen- and Single-Cell Sequencing"
  • R&D efforts to continue to focus on readyto-use enzyme kits
  • PCR decontamination kit
  • Heat&Run® gDNA removal kit
  • Demand from both commercial customers and researchers ensure market oriented product development

  • Highlights

  • Q4 and FY financials
  • Beta-Glucans
  • – advanced wound care
  • Enzymes
  • – molecular testing
  • Summary and Outlook

Outlook

Biotec BetaGlucans:

  • If sign-off successfully concluded, expect CE-mark for Woulgan® Biogel soon
  • Market evaluation process with Smith & Nephew and a limited product launch to start upon CE-marking
  • Addressing large markets with high unmet medical needs within diabetic ulcers, leg ulcers, pressure ulcer and burns
  • Considering re-entry into the animal health market

ArcticZymes:

  • Establishing commercial relations with most of the larger players in the molecular diagnostics and research market. Appointing a limited number of regional distributors for sale of ArcticZymes label products
  • Continuing development of novel user-friendly enzyme kits

Questions?

Svein W. F. Lien Mob: +4792289323 Email: [email protected] www.biotec.no