Investor Presentation 4. Quarter 2007

Transkript

1 Improving bone and cardiovascular health Investor Presentation 4. Quarter 2007

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 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 Teeth + - Lungs + Kidneys + 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 The calcium paradox Relationship osteoporosis - arterial calcification Function of both proteins needed for optimal health Osteocalcin OC synthesised in osteoblasts Glu residues carboxylated to Gla-residues which bind Ca ++ Binds Ca ++ to hydroxyapatite in bones Matrix Gla Protein MGP synthesised in chondrocytes in cartilage, and vascular smooth muscle cells in arteries Inhibits soft tissue calcification, including cartilage mineralization

6 NattoPharma clinical studies R&D Human studies: Bone Health: Effects of supplementing children with MenaQ7: Effects on activation of osteocalcin. Study finished Dose finding study for optimal activation of osteocalcin and for MGP. Results expected: Study finished Safety study: Optimal dose for activating osteocalcin without interfering with coagulation: Results expected 1Q 2008 Effects of low dose MenaQ7 combined with omega-3/krill on bone and arterial health: To be started 1Q Results expected 4Q 2008 Bone Health: Long term (3 years) MenaQ7 treatment in post menopausal women. Estimated start 2Q Effect of MenaQ7 in lung or heart transplanted patients. Rikshospitalet, Oslo Patient work finished. Analysis performed 4Q Q In vitro studies Cell culture studies using bone cells, liver cells and smooth muscle cells First results available

7 The MenaQ7 documentation program 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

8 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

9 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

10 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 end of 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

11 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

12 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

13 Headlines 4Q07 MARKET: Partnership agreement with Ocean Nutrition Ltd. regarding launching of MEG-3 (omega-3) combined with MenaQ7 in the food and nutrition market globally Distribution agreement with GeeLawson (UK) Distribution agreement with Cederroth (NO, SE, DK, FI & Island) SUMITOMO: New Partnership agreement with Sumitomo, global exclusivity for their natural Vitamin K2 for next 10 years (ex. part of Southeast Asia). Closer R&D co-operation

14 Figures 4. quarter 2007 Figures 4. quarter 2007 Revenues NOK 2,1m (NOK 3,4m) EBIT NOK -6,4m (NOK -2,2m) Gross margin 35,6% (39,9%) Figures per 4. quarter 2007 Revenues NOK 22,4m (NOK 7,5m) EBIT NOK -6,2m (NOK -4,9m) Gross margin 58,4% (49,9%)

15 Profit and Loss pr KONSOLIDERT RESULTATREGNSKAP (beløp i tusen NOK) DRIFTSINNTEKTER OG DRIFTSKOSTNADER Noter Omarbeidet Omarbeidet INNTEKTER Salgsinntekt Annen driftsinntekt 1 (355) SUM INNTEKTER DRIFTSKOSTNADER Varekostnad Lønnskostnader Avskrivninger Annen driftskostnad SUM DRIFTSKOSTNADER DRIFTSRESULTAT (6 393) (2 193) (6 174) (4 916) FINANSINNTEKTER OG KOSTNADER Renteinntekter Andre finansinntekter (29) Rentekostnader Andre finanskostnader (110) NETTO FINANSPOSTER (593) 15 (1 854) 9 ORDINÆRT RESULTAT FØR SKATT (6 986) (2 178) (8 028) (4 907) Skatteinntekt på ordinært resultat RESULTAT (5 106) (1 575) (5 856) (3 540)

16 Balance pr Noter (i tusen NOK) Omarbeidet EIENDELER Utsatt skattefordel Andre immaterielle eiendeler Driftsløsøre, inventar og.utstyr SUM ANLEGGSMIDLER OMLØPSMIDLER Varelager - - Kundefordringer Forskuddsbetalte kostnader Andre kortsiktige fordringer Kontanter og kontantekvivalenter SUM OMLØPSMIDLER SUM EIENDELER

17 Balance pr EGENKAPITAL OG GJELD EGENKAPITAL INNSKUTT EGENKAPITAL Aksjekapital Innbetalt - ikke registrert kapitalforhøyelse Overkursfond Annen innskutt egenkapital Akkumulert tap (11 548) (5 692) SUM EGENKAPITAL LANGSIKTIG GJELD Langsiktig gjeld Sum langsiktig gjeld KORTSIKTIG GJELD Leverandørgjeld Skyldig offentlige avgifter og feriepenger Annen kortsiktig gjeld Sum kortsiktig gjeld SUM GJELD SUM EGENKAPITAL OG GJELD

18 Cash flow statement 2007 KONSOLIDERT KONTANTSTRØMOPPSTILLING (beløp i tusen NOK) Netto kontantstrøm fra driftsaktiviteter (5 867) (4 815) Investeringsaktiviteter: Kjøp av driftsløsøre, inventar og.utstyr (299) (663) Kjøp av imaterielle eiendeler (3 235) (1 650) Kjøp av selskap - (156) Netto kontantstrøm fra investeringsaktiviteter (3 534) (2 469) Finansieringsaktiviteter: Innbetaling ved utstedelse av aksjer Innbetaling ved utstedelse av obligasjoner Innbetaling ved utstedelse av tegningsretter Innbetaling ved utøvelse av opsjoner Netto kontantstrøm fra finansieringsaktiviteter Netto endring i kontanter og kontantekvivalenter Kontanter og kontantekvivalenter Kontanter og kontantekvivaleneter

19 Outlook Expect EFSA approval by end 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 Positive EBIT in 2008