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Building a Global Life Science Company in NZ
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Unlocking Regenerative Healing
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Regenerative Tissue Substitutes
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US Soft Tissue Repair Millennium US Markets for Soft Tissue Repair, 2008
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Platform Dura Cardiovascular Abdominal Wall Gastrointestinal Pelvic Floor Extremities Joint Nerve Dental & Oral Tendon/Ligament Breast CMF
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Endoform & Cell cross-talk Lun, S et al. (2010). Biomaterials 31(16): 4517-29. Schultz GS et al Wound Repair Regen 2011 Mar-Apr;19(2):134-148
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>Angiogenesis Irvine et al (2011) In press.
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Endoform ™ Day 7 Day 14 Day 42 4 xHigh magnification Remodeled
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Stronger
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partial and full thickness wounds pressure ulcers venous ulcers chronic vascular ulcers diabetic ulcers tunnelled undermined wounds traumatic wounds surgical wounds Endoform ™ D T
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Dr Jeremy Simcock (NZ) pilot study 12 patients DFU’s and VU’s Increased vascularity and granulation tissue formation Dr Brock Liden (USA) 19 participants with 24 wounds (DFU and VU) Mean decrease in wound area at 12 weeks was 73.4%. Mean time to complete closure was 6.8 weeks. 50% closed at 12 weeks Increased vascularity and granulation tissue formation Dr Jeremy Simcock (NZ) 5 patient tumor resection with single-stage split- thickness graft onto Endoform Clinical
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Endoform ™ R T Soft Tissue Reconstruction Floden et al. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2011;96B(1):67-75.
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Infection Control Endoform ™ 2.0
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Milestones 2008200920102011201220132014 Process US provisional patent filing Completed STOF development Refinement & scale-up qualification & validation Facility operational ISO13485 accredited EDT US provisional patent filing Angiogenesis pre-clinical and in- vivo studies Biocompatibilit y Simcock study FDA clearance Liden study MNC partnership MMP pre- clinical study Launch CE Mark MMP study Venous ulcer RCT ERT US provisional patent filing Developed lamination methods Animal study Clinical study FDA clearance Launch CE Mark EIC US provisional patent filing Selected active Developed delivery prototypes Final product Patent filings Animal study Clinical study FDA clearance CE Mark Launch E other Partnering/ licensing Prototyping Animal study IND/IDE
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rapid vascular in-growth, stimulates cell proliferation, completely remodeled & safe † Competitive Advantage 1.0
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rapid vascular in-growth, stimulates cell proliferation, completely remodeled & safe † Strong in thin formats, laminated for load bearing & persistence Competitive Advantage 1.0
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Simple and quick to use rapid vascular in-growth, stimulates cell proliferation, completely remodeled & safe † Strong in thin formats, laminated for load bearing & persistence Competitive Advantage 1.0
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Simple and quick to use Low COGs rapid vascular in-growth, stimulates cell proliferation, completely remodeled & safe † Strong in thin formats, laminated for load bearing & persistence Competitive Advantage 1.0
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Low COGs Ease to Use Robust Biology Competitive Advantage 1.5
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High Contact Team Effort
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Business Model Active Wound Care Soft Tissue Reconstruction Orthopaedic Cardiovascular Single + Layers + Bioactives + Stem/Progenitor cells $$$ development & clinical complexity $ $$$$$ Strong positive cashflows - Partnered Exceptional returns +/- Partners Product Format
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Business Model Start simple, validate the opportunity, learn & iterate Develop (r&D) and manufacture to produce strong positive cash flow Partner with proven companies for sales and marketing Pursue more complex applications for exceptional returns
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NZ Factors
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??? Ingenuity
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Rare & valuable resources
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$???
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RegenMed Factors
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RegenMed Will lead to therapies that will fundamentally change current therapies and complement the use of pharmaceuticals, biologicals & medical devices because offers the opportunity to restore function and cure chronic conditions 1 1. Mason C., Brindley, D.A., Culme-Seymour E.J. and Davie N.L. (2011).Cell therapy industry: billion dollar global business with unlimited potential. Regenerative Medicine, May 2011, Vol. 6(3), 265-272.
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RegenMed Devices/Therapeutics/Combinations Mixed regulatory paths Mixed business models No dominant players Interest from Big device & pharma High growth and pricing potential
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DateCompany Capital Market or Acquirer Enterprise Value ($US) Payment Premium 1-week LTM Revenue (M) LTM Revenue Multiple LTM EBITDA LTM EBITDA Multiple Feb12AvitaASX$34--~$4M4.5-2.7- Feb12Tissue TherapiesASX$66-----3.5- Mar12MiMedxOTCBB: MDXG$85.4 $7.8M Mar12Tissue RegenixAIM$58.640.1M Mar12Kensey NashNASDAQ$253--$80M2.528.007.2x Dec10CryolifeNASDAQ$150--$116M1.27.2820.6x Dec11SynovisBaxter$325-51%$82M3.912.3626.3x May11OrthovitaStryker$304Cash41%$95M3.2-2.04M- May 11 Advanced BiohealingShire$750Cashna146.75.1$21M35x May11NeritesKensey Nash$20Cashna---- Aug10OsteotechMedtronic$123Cash65%$100M1.2-- Jul 09PegasusSynovis$12Cashna$10M1.2-- Dec08MentorEthicon (J&J)$1,113Cash105.0%$3822.9$8313.4x Apr08LifecellKCI$1,716Cash21.3%$2038.5$4934.7x Mar08Tissue ScienceCovidien$70Cash96.2%$252.8($5)- Nov07TutogenRTI$262Stock13.4%$544.9$644.3x Jul 06OsteoBiologicsSmith & Nephew$72Cash-$321.9naNa Median2.9x 26x Average3.2x 26x Comps
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Strong platform, multiple products, unmet clinical need & large fast-growing markets Attained no. of value accretive milestones & external validation Revenue and cash-flow – WIP Many challenges ahead - no set formula or prescription… Summary
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