Investor Presentation Oslo Axess 30. januar 2008

Transcription

1 A Norwegian nutraceutical company Improving bone and cardiovascular health Investor Presentation Oslo Axess 30. januar 2008

2 Exclusive strategic partnership agreement with Sumitomo Corp. to develop, market and sell the natural Vitamin K2 Exclusive Research & Science contract with VitaK (Maastricht University), the world leading research-company in vitamin K. R&D is focused on developing K2 products in addition to build IPR to secure long-term market access Vitamin K2 is needed for optimal body utilization of Calcium and has documented beneficial effects on both Osteoporosis and Cardiovascular diseases

3 - a nutraceutical company NattoPharma focuses on Sales & Product Development, through own Product IPR- based on clinical studies (GCP), leaving the production to Sumitomo. Product development may also be carried out in collaboration with End-clients, depending upon customer and market requirements. Sumitomo Corp. End-client Production & Process IPR Clinical Studies IPR Product- Development Based on research Product-design End-product S&M NattoPharma

4 Calcification in health and disease: NattoPharma focus Eyes Brian Eyes Brian Teeth Lungs Bones Skin Heart Teeth Lungs Bones Skin Heart Kidneys Ligaments Kidneys Ligaments Arteries & Veins Tendons Arteries & Veins Tendons Joints Connective tissues Joints Connective tissues Normal condition: 99% of all Ca in bones & teeth; 1% in circulation Bone and cardiovascular health Prevention & Treatment Scientific evidence: Loss of calcification in bones; Increased calcification heart, arteries and in joints: Osteoporosis Cardiovascular disease Osteoarthrosis

5 NattoPharma s Vitamin K2 product MenaQ7 from natto food Content of various forms of vitamin K in natto Zero means not det ecable. Ref : St udies on t he role of vit amin K1 and K2 in bone metabolism and cardiovasular disease. L.J.Schurgers, ISBN x Vitamin K MenaQ ,1 34,7 0 7,5 13,8 0 K1 MK-4 MK-5 MK-6 MK-7 MK-8 MK-9 Vitamin K f orm Vitamin K2

6 Why MenaQ7? Functions as a co-factor for an enzyme which modifies important calcium binding proteins Y g S H E S M E S Y 1 E L N P F I 10 N R R R Q P I F T N A N R V K A W Q S Q g R I R g R S K P V H g L N R g A C D D Y E C Y R N Y A A N Y G Y V M A Y R L R F R K R R G A K Osteocalcin Protein made by bone cells When modified binds Calcium to hydroxyapatite and forms stronger bones Matrix Gla protein (MGP) Made by cells lining arteries and in cells in joints. When modified: Bonds calcium and INHIBITS Calcium from depositing The Calcium paradox! MenaQ7 strongly influences that calcium binds in bones and gets out of arteries

7 Bone health - Osteoporosis Calcium tablets NOT enough for optimal bone health Vitamin D + Ca better effect, but not optimal Vitamin K2 added Significantly better bone health Relationship Vitamin D - Vitamin K and Calcium Vitamin D is needed to regulate transcription of gene coding for osteocalcin + D 3 Synthesis of osteocalcin Vitamin K cofactor In carboxylation reaction Carboxylated osteocalcin Actively binding calcium Ca ++

8 Calcification of arteries Rosenhek, et al. New England Journal of Medicine 2000 Age < 40 years; calcification > 1000 units: Biological age 70 years! Scores > 400 added up to 30 years to younger subjects Calcium score < 10: Reduction in observed age by 10 years in subjects older than 70 years Ref: Shaw et al. Atherosclerosis vol 188, p. 112 ; asymptomatic individuals ( & ) referred by GP to coronary artery calcium screening in the US. 5 years follow-up for all-cause mortality

9 Calcification and arterial stiffening & arteriosclerosis ArterioscIerosis: Inflammation Macrophage invasion Foam cell formation Intima thickening Accretion of cholesterol Formation of plaque Arteriosclerotic plaque: Reducing lumen of vessel Reducing function of vessel Stiffening of arteries: Reduced elasticity Reduced functionality of vessel

10 The Rotterdam study: 10 years follow-up study of >4800 persons Risk for event (Hazard ratio) < >32 Dietary vitamin K2 intake (µg/day) Aorta calcification Cardiovascular mortality All cause mortality Conclusions: When consuming daily 45 µg dietary K2 you have: 50% reduction of arterial calcification 50% reduction of cardiovascular death 25 % reduction of all cause mortality as compared to low intake of dietary K2!

11 The MenaQ7 documentation program per Jan 2008 NattoPharma R & D program October Phase Technical documentation studies MenaQ7 Bioavailability studies MenaQ7 and matrix effects Vitamin K uptake in cell culture studies Safety study with MenaQ7 during anticoagulant therapy in human volunteers Dose finding study in human volunteers MenaQ7 supplementation in healthy children Long term MK/ treatment in post menopusal women Effects of MenaQ7 in humans on omega-3 and/or krill oil treatment Diagnostic study MGP in CVD patients RH, Oslo Animal studies arteial calcification Human studies arteial regression of calcification using MenaQ7 Diagnostic study MGP in kidey patients Human studies regarding calcification in kideys and effcts of MenaQ7 I I I I I/II II II II I I II I II Ongoing studies Planned studies Potential studies World leading experts in Vitamin K

12 Strong patent portfolio Patent Protection for K1 Protection for K2 (MKn`s) Market segment Major Claims: Indications Dose range K Food (Not Indian patent revealed here) NO YES (also MK-4) Food market Food supplements In combinations with Calcium, vitamin D, Mg Maintaining, optimizing, strengthening or promoting cardiovascular health ug/100 g food In combination with Ca; Mg; Vitamin D Age-related stiffening (C-I-P) YES YES Nutraceutical market (foods + supplements) Pharmaceutical market Reduce or reverse calcification of the blood vessels. Humans suffering from arteriosclerosis caused by calcification (aorta; carotid arteries) ug/day. Can be in combination with other ingredients Isoprenyl Derivatives of K molecule Pharmaceutical market Postmenopausal loss of bone in women. Juvenile or senile osteoporosis in men and women. Cardiovascular & ectopic (pancreas) calcification, renopathy, malignancies, primary & secondary bone tumors or metastasis Not indicated in the claims. Combined with one or more pharmacologically active substances from group of bisphosphonates, estrogens, calcitonins and low dose Vit K and/or Vit D K +Omega-3 and krill NO YES Incl. MK-7 to MK-10 Nutraceutical market (foods + supplements) Pharmaceutical market Profylaxis or treatment of atherosclerosis. Arteriosclerosis, osteoporosis, osteoarthritis or inflammatory or degenerative disease of cartilage ug/day Combined with EPA- DHA fatty acids

13 Nutraceutical regulatory affairs USA NattoPharma has obtained a Food & Drug Administration (FDA) Self affirmed GRAS (Generally Recognized as Safe) approval for the use of MenaQ7 in the USA. MenaQ7 is also approved as a dietary supplement in USA

14 Nutraceutical regulatory affairs EU Step I: Get MenaQ7 on the positive list of vitamins in EU Dossier submitted June 2005 Evaluated by EFSA July 2007 Feedback to NattoPharma August 2007 NattoPharma answers to EFSA 27. August 2007 Potential positive EFSA opinion 1Q08 Sales of MenaQ7 in food supplements allowed in Ireland UK Netherlands Sweden Finland Poland Latvia Estonia Slovenia Malta Food supplements Functional (fortified) food Step II: Marketing claims new legislation Dec Health claims for article 13.1 submitted October 2007

15 Market opportunities NattoPharma market strategy NattoPharma is working to include vitamin K2 in already existing global leading brands in the Dietary supplement (ex. Multivitamins, Calsium & Omega3) Functional Food marked (Dairy-products). Thus, the revenue from the clients has the potential to go from zero to 3-diget million figure, only during the first year after signing with a large client. Dietary supplement Stand-alone / combination (Multivitamins, Calcium, Omega-3 and Vitamin D) Fortified food Fortified food with vitamins and minerals (Dairy segment, drinks) Pharmacy Strategy is to co-operate with a strategic partner

16 Market strategy Sell MenaQ7 as an ingredients into all ready existing global leading brands in the following market segments: Pharmacy Volum vitamin K2 Fortified Food Dietary supplement

17 USA Market Distribution agreement with PL Thomas Inc. The largest US End-clients: NBTY Jarrows Formulas Enzymatic Therapy Swanson Partnership agreement with Ocean Nutrition Ltd. regarding launching of MEG-3 (omega-3) combined with MenaQ7 in the food and nutrition market

18 Clients & Distributors in EU Distributor Contract Manufacturer Own Brand Country Company name Category Belgium Frutarom x Finland Oy Vitala's Finland Ab x France Laboratry Monine x France Gilles Trolet (Valcanes ) x Italy Alesco SRL x x North Europe Leading Dairy x Norway TGM x Norway Nordic Health x Norway Pharmatech x x Poland EuropePharma Alliance x Sweden New Nordic Health x Switserland Dr. Dünner x x Switserland SwissCaps x The Netherlands Springfield x United Kingdom GeeLawson x x

19 Figures 3. quarter 2007 Figures 3. quarter 2007 Revenues NOK 7,9m (NOK 2,9m) EBIT NOK 0,4m (NOK 0,1m) Gross margin 69,6% (65,5%) Figures per 3. quarter 2007 Revenues NOK 20,3m (NOK 4,4m) EBIT NOK 0,2m (NOK -2,5m) Gross margin 60,8% (62,2%)

20 Outlook Expect EFSA approval in 1Q 2008 Increase the investment in R&D going forward Expect that the strong revenue growth will continue, and total revenues of between NOK mill in 2008.