building a global life science company in nz. unlocking regenerative healing

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Building a Global Life Science Company in NZ

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Page 1: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Building a Global Life Science

Company in NZ

Page 2: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Unlocking Regenerative Healing

Page 3: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

RegenerativeTissue Substitutes

Page 4: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

US Soft Tissue Repair

Millennium US Markets for Soft Tissue Repair, 2008

Page 5: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

PlatformDura

Cardiovascular

Abdominal Wall

GastrointestinalPelvic Floor

Extremities

JointNerve

Dental & Oral

Tendon/Ligament

Breast

CMF

Page 6: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 7: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

>Angiogenesis

Irvine et al (2011) In press.

Page 8: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Endoform™

Day 7

Day 14

Day 42

4 x High magnification

Remodeled

Page 9: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Stronger

Page 10: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

• partial and full thickness wounds

• pressure ulcers• venous ulcers• chronic vascular ulcers• diabetic ulcers• tunnelled undermined

wounds• traumatic wounds• surgical wounds

Endoform™ D T

Page 11: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 12: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Endoform™ R TSoft Tissue Reconstruction

Floden et al. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2011;96B(1):67-75.

Page 13: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Infection ControlEndoform™

2.0

Page 14: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Milestones2008 2009 2010 2011 2012 2013 2014

Process US provisional patent filing

Completed STOF development

Refinement & scale-up qualification & validation

Facility operationalISO13485 accredited

EDT US provisional patent filing

Angiogenesis pre-clinical and in- vivo studiesBiocompatibility

Simcock studyFDA clearance

Liden studyMNCpartnershipMMP pre-clinical study

LaunchCE MarkMMP studyVenous ulcer RCT

ERT US provisional patent filing

Developed laminationmethods

Animal studyClinical study

FDA clearance Launch

CE Mark

EIC US provisional patent filing

Selected activeDeveloped deliveryprototypes

Final productPatent filings

Animal studyClinical study

FDA clearance CE MarkLaunch

EotherPartnering/licensingPrototyping Animal study

IND/IDE

Page 15: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

rapid vascular in-growth, stimulates cell proliferation , completely

remodeled & safe†

Competitive Advantage 1.0

Page 16: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

rapid vascular in-growth, stimulates cell proliferation , completely

remodeled & safe†

Strong in thin formats, laminated

for load bearing & persistence

Competitive Advantage 1.0

Page 17: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 18: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 19: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Low COGs

Ease to Use

Robust

Biology

Competitive Advantage 1.5

Page 20: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 21: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 22: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 23: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 24: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 25: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

High Contact Team Effort

Page 26: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 27: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
Page 28: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 29: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

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

Page 30: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

NZFactors

Page 31: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

???

Ingenuity

Page 32: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Rare & valuable

resources

Page 33: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

$???

Page 34: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

RegenMed Factors

Page 35: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

RegenMedWill 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 conditions1

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.

Page 36: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing
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Page 38: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

RegenMed• Devices/Therapeutics/

Combinations• Mixed regulatory paths• Mixed business models • No dominant players• Interest from Big device &

pharma• High growth and pricing

potential

Page 39: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

Date Company Capital Market or Acquirer

Enterprise Value ($US) Payment Premium

1-week

LTM Revenue

(M)

LTM RevenueMultiple

LTMEBITDA

LTM EBITDA

Multiple

Feb12 Avita ASX $34 - - ~$4M 4.5 -2.7 -Feb12 Tissue Therapies ASX $66 - - - - -3.5 -

Mar12 MiMedx OTCBB: MDXG $85.4  $7.8MMar12 Tissue Regenix AIM $58.64 0.1MMar12 Kensey Nash NASDAQ $253 - - $80M 2.5 28.00 7.2xDec10 Cryolife NASDAQ $150 - - $116M 1.2 7.28 20.6xDec11 Synovis Baxter $325 - 51% $82M 3.9 12.36 26.3xMay11 Orthovita Stryker $304 Cash 41% $95M 3.2 -2.04M -May 11 Advanced Biohealing Shire $750 Cash na 146.7 5.1 $21M 35x

May11 Nerites Kensey Nash $20 Cash na - - - -Aug10 Osteotech Medtronic $123 Cash 65% $100M 1.2 - -Jul 09 Pegasus Synovis $12 Cash na $10M 1.2 - -Dec08 Mentor Ethicon (J&J) $1,113 Cash 105.0% $382 2.9 $83 13.4xApr08 Lifecell KCI $1,716 Cash 21.3% $203 8.5 $49 34.7xMar08 Tissue Science Covidien $70 Cash 96.2% $25 2.8 ($5) -Nov07 Tutogen RTI $262 Stock 13.4% $54 4.9 $6 44.3xJul 06 OsteoBiologics Smith & Nephew $72 Cash - $3 21.9 na Na

Median 2.9x 26x Average 3.2x 26x

Comps

Page 40: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing

• 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

Page 41: Building a Global Life Science Company in NZ. Unlocking Regenerative Healing