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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