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