Svein W. F. Lien - CEO

Transcription

1 Svein W. F. Lien - CEO January 2011

2 Disclaimer This presentation (the "Presentation") is not intended to form the basis of any investment decision or any decision to purchase Biotec Pharmacon ASA ("Biotec" or the "Company") shares. The recipients should at their initiative obtain relevant information and documentation as well as seek adequate investment advice. This Presentation does not constitute an offer or invitation for the sale or purchase of securities or assets in any jurisdiction, and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. The distribution of this Presentation may in certain jurisdictions be restricted by law. Recipients of this Presentation must inform themselves about, and observe any applicable or regulatory requirements in relation to, the distribution or possession of this Presentation and, by accepting receipt of this Presentation, each recipient of this Presentation represents that it is able to receive this Presentation without contravention of any legal restrictions in the jurisdiction in which it resides or conducts business. The information contained herein does not purport to contain all information of relevance for an investment decision. In all cases, interested parties should conduct their own investigation and analysis of Biotec, its business, prospects, results of operations and financial condition. No party has made any kind of independent verification of any of the information set forth herein, including any statements with respect to projections or prospects of the Company or the assumptions on which such statements are based, and does not undertake any obligation to do so. Neither the Company nor its advisors make any representation or warranty, express or implied, as to the accuracy or completeness of this Presentation or of the information contained herein, and shall have no liability for the information contained in, or any omissions from, this Presentation, nor for any of the written, electronic or oral communications transmitted to the recipient in the course of the recipient s own investigation and evaluation of the Company. Included in this Presentation are various "forward-looking statements", including statements regarding the intent, opinion, belief or current expectations of the Company or its management with respect to, among other things, (i) goals and strategies, (ii) plans for new product development, (iii) marketing plans, the Company s target market, (iv) evaluation of the Company s markets, and (v) trends which may be expressed or implied by financial or other information or statements contained herein. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance and outcomes to be materially different from any future results, performance or outcomes expressed or implied by such forward-looking statements. Neither the receipt of this Presentation by any person, nor any information contained herein constitutes, or shall be relied upon as constituting, any advice relating to the future performance of the Company. Each person should make their own independent assessment of the merits of the business and should consult their own professional advisors. No liability whatsoever is accepted, and no representation, warranty or undertaking, expressed or implied, is or will be made by Biotec or any of its subsidiaries, affiliates, representatives, officers, employees, advisors or agents, or by any other persons identified in this Presentation, including projections and opinions, contained herein or for any errors, omissions or misstatements herein. 2

3 Agenda Biotec in brief Beta-Glucans Marine Biochemicals Financials and Summary 3

4 Biotec Pharmacon Value proposition Tromsø Beta -1,3/1,6-glucan Well documented effect in wound care - diabetic ulcer Animal study verified cause of unsuccessful phase III Company refocused on medical device product for ulcers/wounds Partner interest to take medical device to market Pharma path retained through partner interest and dormant development programs Marine Biochemicals Profitable business based on unique cold adapted enzymes Strong healthy growth forecast (doubling of sales ) Strong IP position for marketed products Large unexploited market Strong pipeline secured through strategic alliances and acquisition 20 years of research in key areas strong IP based science 4

5 Agenda Biotec in brief Beta-Glucans Marine Biochemicals Financials and Summary 5

6 Biotec s history in Beta-Glucans >20 years experience in the Beta-Glucan science area Developed products and businesses in: Animal Health (sold 2008) Food supplement (sold 2010) Developed Soluble Beta- Glucans in late 1990 ies Started pharmaceutical development and made successful phase II trials Did not succeed in phase III due to lack of stability Indication Preclinical Phase I Phase II Phase III NDA Diabetic Ulcer Oral mucositis Immunotherapy of cancer (mab) Cancer vaccine IBD Unsuccessful due to instability 6

7 % wound area remaining Yes, it was stability! -The gel was too fragile SBG stored in polycarbonate containers perform better than the same batch stored in polyethylene ampoules. 2% SBG in treatment of acute wounds in diabetic mice IB vehicle control +ve control Days Post-wounding Negative control PolyEthylene PolyCarbonate Positive control Accelerated stability data (37/4C w/shaking) shows that a more concentrated and solid gel has much better stability than the product used in the study 2% 2.6% 7

8 Sub-analysis of clinical data Phase III with short storage showed clinical results in line with phase II data Clinical phase III SBG in Nottingham study 2 nd batch (N=42) Product stored for 3 months Clinical phase II SBG Product % healed Placebo % healed p-value Control 52.4% 33.3%

9 SBG - Proof of Concept is still valid Focus on development of an advanced wound care product, for use in e.g. diabetic ulcer Intend to launch first product as medical device Development of drug product remains an option, with different technology at a later stage Additional indications: Immunotherapy of cancer, Phase I with MSKCC Inflammatory bowel disease (IBD), Preclinical Asthma - feasibility 9

10 Highlights Beta-Glucans There is no good Diabetic Ulcer treatment on the market Diabetic Ulcer is a USD 1.5 billion/year market Soluble Beta-Glucan (SBG) showed good clinical performance against Diabetic Ulcer in phase II, and the part of phase III performed with an active product Soluble Beta-Glucan (SBG) is likely to be effective in other advanced wound healing applications, with a market potential >USD 5 billion/year No treatment for Diabetic Ulcer really works today Professor William Jeffcote Department of Diabetes and Endocrinology, Nottingham City Hospital 10

11 Some existing wound care products: Price, classification, composition Product name Producer Size Main component 1 (ex water) Main component 2 (ex water) Approx price (Euro) Normlgel Mölnlycke 5/10 g Xanthan gum NaCl 8 (5 g) Intrasite S&N 8/15/25 Croscarmellose (CMC) Propylene glycol 10 (8 g) Purilon Coloplast 15 g CMC Alginate 10 Tegaderm 3M 15 g Propylene glycol Guar gum 10 AquaSite Derma Sc 28 g Special formulation Glycerine 8 Curasol Healthpoint 28 g Glycerin glyceryl polyacrylate 10 Xelma Mölnlycke 0.5/1 ml Extracellular matrix Prop.glyc. alginate 90 (0.5 ml) Regranex Systagenix 15 g rhpdgf Carmellose (CMC) 600 Class 2B Device Class 3 Device Drug 11

12 We know we can make a medical device 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 months Irish Medicines Board Pros and cons with the various classifications, as to e.g. product claims - We have a high degree of freedom

13 Partner process Partner talks ongoing - well positioned in the topical wound care market First goal is 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 Partner process will determine product classification Partner preferences, and Biotec s choice of balance between risk, time, investments, and potential

14 Wound healing activity plan and timeline -in a class 2B device scenario Clinical trials Product development QA documentation and regulatory approval Ongoing LAUNCH H Initial EU classification Done - class IIb device Prototype development of a medical device Ongoing Partner discussions Ongoing New IP for new compositions Likely! Does the substance work Yes! mid 2010 end 2010 mid 2011 end

15 Agenda Highlights and overview Beta-Glucans Marine Biochemicals Financials and Summary 15

16 Overview and outlook Several patent protected cold adapted Arctic ocean enzymes with unique heat inactivity features Used in RNA/DNA processing, e.g. PCR sample preparation, for removal of contaminants Attractive market at ~USD 2bn, growing at >10%. Enzymes make up 5-10% of the market Strong need for new products Expanding from research market to routine kits 16 November 12, 2010

17 Gearing for international expansion Key Issue: Outstanding products few customers broad applications Focus I Exhibitions to generate sales and trial requests Successful for new trials vs 9 in 2009 Focus II Optimize supply chain local warehouses Focus III Increase fields sales activity for 2011 Key account managers USA and Europe 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 Focus IV Considering moving up the food chain Focus V Further recognition by key opinion leaders, i.e: Gregg Shipley at XGen, San Diego, PCR Insider and Labmanager.com webcast 23 July 17

18 New products out of Bioprospecting Long tradition for collaboration with academic institutions Have given access to: o Unique products o Strong product knowledge o Strong IP protection Acquisition of Marimol secured exclusive rights to commercialize outcome of MARZymes project o Received NOK 35 M in up front grants from NFR Participation as exclusive enzyme partner in MabCent is starting to generate new product candidates STRONG PIPELINE! 18

19 Agenda Highlights and overview Beta-Glucans Marine Biochemicals Financials and Summary 19

20 Key figures for business areas Annual run rate corporate cost at NOK [x]m Pharmaceutical Development Cost level reduced Marine Biochemicals 3Q sales postponed until 4Q (Oct at NOK 3.8m) Q 09 2Q 09 3Q 09 4Q 09 1Q 10 2Q 10 3Q Q 09 2Q 09 3Q 09 4Q 09 1Q 10 2Q 10 3Q 10 Sales EBITDA Sales EBITDA Sales of NOK 3.8m in October On track for full years sales target

21 Cash position to finance operation until mid Q 09 2Q 09 3Q 09 4Q 09 1Q 10 2Q 10 3Q 10 4Q 10 Private placement end December of NOK 22.5m + rights issue

22 Summary Beta-Glucans We are about to develop a wound healing product for Diabetic Ulcer and potentially other wound care applications It is a substantial need for an effective treatment in wound care The partner process is ongoing and will determine what product formulation that will be the preference Marine Biochemicals: Internationally recognized as a provider of unique enzymes for RNA/DNA analyses On track for doubling of revenue from The new MARZymes agreement significantly expands the potential of the enzyme business in the longer term 22

23 Questions / Discussion 23