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

Building a Global Life Science

Company in NZ

Unlocking Regenerative Healing

RegenerativeTissue Substitutes

US Soft Tissue Repair

Millennium US Markets for Soft Tissue Repair, 2008

PlatformDura

Cardiovascular

Abdominal Wall

GastrointestinalPelvic Floor

Extremities

JointNerve

Dental & Oral

Tendon/Ligament

Breast

CMF

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

>Angiogenesis

Irvine et al (2011) In press.

Endoform™

Day 7

Day 14

Day 42

4 x High magnification

Remodeled

Stronger

• partial and full thickness wounds

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

wounds• traumatic wounds• surgical wounds

Endoform™ D T

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

Endoform™ R TSoft Tissue Reconstruction

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

Infection ControlEndoform™

2.0

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

rapid vascular in-growth, stimulates cell proliferation , completely

remodeled & safe†

Competitive Advantage 1.0

rapid vascular in-growth, stimulates cell proliferation , completely

remodeled & safe†

Strong in thin formats, laminated

for load bearing & persistence

Competitive Advantage 1.0

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

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

Low COGs

Ease to Use

Robust

Biology

Competitive Advantage 1.5

High Contact Team Effort

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

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

NZFactors

???

Ingenuity

Rare & valuable

resources

$???

RegenMed Factors

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.

RegenMed• Devices/Therapeutics/

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

pharma• High growth and pricing

potential

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

• 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