for personal use only - asx2012/05/23  · day 1 post‐recell week 3 post‐recell month 10 14 for...

37
Australian (ASX: AVH) U.S. (OTCQX: AVMXY) May 2012 For personal use only

Upload: others

Post on 06-Jul-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Australian (ASX: AVH)  

U.S. (OTCQX: AVMXY)

May 2012

For

per

sona

l use

onl

y

Page 2: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

This presentation may include forward‐looking statements. You can identify these

statements by the fact that they use words such as “anticipate”, “estimate”, “expect”,

“project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions.

These forward looking statements speak only as at the date of this presentation and

are based on management’s expectations and beliefs concerning future events.

Forward‐looking statements are necessarily subject to risks, uncertainties and other

factors, many of which are outside the control of Avita Medical that could cause actual

results to differ materially from such statements. Avita Medical makes no undertaking

to subsequently update or revise the forward‐looking statements made in this release

to reflect events or circumstances after the date of this release. This presentation is

intended to provide background information only and does not constitute or form part

of an offer of securities or a solicitation or invitation to buy or apply for securities, nor

may it or any part of it form the basis of, or be relied on in any connection with any

contract or commitment whatsoever.

2

For

per

sona

l use

onl

y

Page 3: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Avita Medical develops and distributesregenerative, tissue‐engineered products fortreating wounds, burns, scars and skin defects.

Avita's treatment utilizes the patients' own skin toregenerate and expedite wound healing.

• Lead product, ReCell® is on the market & generating revenues.• Regulatory clearance in Europe (CE Marked), Australia (TGA), China (SFDA).

• US FDA trials underway (U.S. Dept. of Defense funded; $3.65M to date); FDA submission expected in 2013

• Australian Exchange (ASX:AVH);  U.S. Exchange (OTCQX: AVMHY).• Consolidated Market Valuation $59.5 M (5/15/2012)

• Avg daily volume (3m):  624,658

3

For

per

sona

l use

onl

y

Page 4: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Frontier of medical 

technology

Unique product offering

Potential of the technology is 

recognized by US DoD

Established track record

4

Novel, patented, platform regenerative medicine technology, with vast market potential for  treating unmet therapeutic needs, including burns, reconstructive/ plastic applications, chronic wounds, vitiligo and aesthetics

ReCell® Spray‐on‐Skin® is rapid, low cost, accelerates healing, minimizes scarring, has a low risk of infection, minimizes the donor site, has no lab requirements and can be used in combination with other techniques

No similar harvesting, processing and delivery technology for autologous tissue commercially available 

Grants, contract and clinical trial support for the ReCell® technology provided by the US Department of Defense serve to validate ReCell’s potential

Avita’s burns study is the only study conducted by a non‐US company to receive such support from the US Armed Forces (as part of the AFIRM trial)

Over 4,500 patients have been successfully treated with ReCell Spray‐on‐Skin to date

Already commercialized and generating revenues in Europe, Australia and Asia; in late development in the US. (with FDA submission expected in 2013)

ReCell has been embraced by key influential surgeons and Centers of Excellence in the UK, France and Germany

Experienced management team with success in launching new clinical applications

For

per

sona

l use

onl

y

Page 5: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

REVENUES5.00

2.50

0.00

$ Millions

2008 2009 2010 2011

LOSS FROM OPERATIONS15.00

7.50

0.00

$ Millions

2008 2009 2010 2011

GROSS PROFIT4.00

2.00

0.00

$ Millions

2008 2009 2010 2011

Revenues of $4.54 million (year ending 30 June 2011)

Gross Profit of $3.5 Million 

Overall Gross Margins of 73%

Losses due to Continuing Operations $1.95 Million

Cash on Balance Sheet $9.7 Million (31 March 2012) 

No debt

Current U.S. FDA trials funded by US Department of Defense : $3.65 million in total

5

For

per

sona

l use

onl

y

Page 6: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Goal: Regrow, replace, restore function of tissues, organs or limbs damaged, lost or non‐functional (e.g. trauma, disease, senescence)

All tissues and organs – in theory – have capability to regenerate

Fundamental change to practice of medicine

Key Product: ReCell® Spray‐On Skin®

6

For

per

sona

l use

onl

y

Page 7: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Initial product ReCell® Spray‐On Skin®point‐of‐care stem‐cell treatment forwide range of wounds and dermaldefects:

• ChronicWounds• Burns• Plastic and Reconstructive Surgery• Aesthetic/Cosmetic Procedure

Currently on the market & generatingrevenue

• Regulatory clearance in Europe (CEMarked), Australia (TGA), China (SFDA)

• US FDA trials underway (US DoD funded$3.65M )

Regain your normal, healthy and beautiful skin

7

For

per

sona

l use

onl

y

Page 8: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Broad intellectual property portfolio 

• 9 patents granted (U.S., PCT, Australia, Japan and EU)

• 7 applications pending

Key technology and associated IP relates to:

• Dissociation of epithelial tissue

• Preparation of stem‐cell‐rich suspension

• Immediate reapplication to patient

Registered trademark ‘Spray‐On Skin’ reinforces the company’s 

global branding as ReCell increases its 

presence in worldwide markets.

8

For

per

sona

l use

onl

y

Page 9: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Harnesses body’s intrinsic ability to heal itself and packages it into an easy‐to‐use bedside kit for the clinician

Addresses needs of all stakeholders:

• Patients: Provides improved outcomes

• Surgeon/Clinician: Easy, fast and effective with reduced morbidity; revenue generator

• Healthcare System: Reduced patient care costs

Avita’s regenerative technology

9

For

per

sona

l use

onl

y

Page 10: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Thin, split thickness skin sample (20x20x0.2mm) of  similar skin

Tissue sample incubated in proprietary enzyme ‘cocktail’ approx. 20 min 

Tissue sample removed from incubator, mechanically agitated to separate cells

Cells rinsed in ‘buffer cocktail’

Suspension filtered

Suspension sprayed on wound, covered with dressing. Remove dressing 5‐7 days post‐op; wound fully re‐epithelialized

10

For

per

sona

l use

onl

y

Page 11: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

11

ReCell® suspension sprayed onto wound surface

Disaggregated cells migrate 

over wound area

Activated  progenitor cells undergo period of high mitotic activity 

with rapid proliferation and differentiation

Cell signalling encourages and 

directs proliferation, 

vascularisation and innervation

Result: ‘normal’, healthy, new skin with full complement of constituent cells types, including melanocytes, keratinocytes, fibroblasts and basal cells in proper 

proportionFor

per

sona

l use

onl

y

Page 12: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

NORMAL HEALING

Cells gradually detach from the ECM and slowly migrate inward from the 

wound edge, limiting cell proliferation and differentiation in order to achieve 

initial closure of the wound.

Healing by secondary intentionReCell HEALING

Wound bed ‘seeded’ with activated cells leading to rapid proliferation, 

differentiation  and radial dissemination outward from islets of regenerative 

clusters. 

Accelerated regeneration

ReCell counters, cancels and redirects “normal” healing, leading to accelerated regeneration

“Stop” to “Grow”

12

Vs.

For

per

sona

l use

onl

y

Page 13: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

13

Applications

Chronic wounds such as diabetic, venous, arterial or pressure ulcers

Burns, scalds and donor sites associated with grafts

Scar revisions to improve colour, texture & function 

Pigmentation disorders such as Vitiligo

Epidermal defects such as naevi, acne, discolouration

Prophylactic aesthetic rejuvenation procedures

For

per

sona

l use

onl

y

Page 14: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Prep and debridement

Day 1 

post‐ReCell

Week 3 

post‐ReCell

Month 10

14

For

per

sona

l use

onl

y

Page 15: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

12 months post‐ReCell®Neck pre‐treatment

15

For

per

sona

l use

onl

y

Page 16: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

10 month post‐ReCellNeck pre‐treatment

16

For

per

sona

l use

onl

y

Page 17: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

2 months post treatmentBefore treatment

17

For

per

sona

l use

onl

y

Page 18: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

12 month post‐ReCellPre‐ReCell

18

For

per

sona

l use

onl

y

Page 19: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Lower limb ulcers (venous, pressure and diabetic) are significant health problem and major healthcare burden in OECD countries

Afflicts approximately 1.5% of general population; >3% of population over 70 y.o.

Morbidity includes:• Pain & Infection• Impairment of mobility & function• Failure to resolve contributor to loss of limb

Standard of care ineffective• Costly, includes salves and ointments, frequent dressing changes, special compression bandages, medications (includes growth factors), skin grafts (auto or allo)

• Low success rate of treatment; approx. 70% of lower limb ulcers remain unresolved after 20 weeks of treatment

19

For

per

sona

l use

onl

y

Page 20: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Planar Arear:       830 mm2Real Area:             954 mm2Perimeter:             109 mmMissing Volume:    589 mm3

Pre‐op analysis using a Scanner 3D VideoCap® 

20

For

per

sona

l use

onl

y

Page 21: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

954 mm2 676 mm2 456 mm2 134 mm2

T1 T2 T3 T4 T5

21

For

per

sona

l use

onl

y

Page 22: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

T0 T1 @ 7 days

T2 @ 14 days

T3 @ 21 days

T4 @ 28 days

T5 @ 35 days

22

For

per

sona

l use

onl

y

Page 23: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Burns• ReCell® Alone• Combination with other treatments   (e.g., mesh grafts, dermal substitutes)

Acute wounds• Surgical• Abrasion• Lacerations

Chronic Wounds• Graft loss• Ulcers (diabetic or venous), alone or in combination with other treatments

Scar remodelling• Burn, graft scars• Surgical scars• Biopsy• Mohs surgery

Reconstructive procedures• Face, nose• In combination with prostheses 

Cosmetic relief• Acne scars• Hyper or hypo‐pigmentation

• Liver spots• Sun‐damaged skin• Rejuvenation procedures (wrinkle)

Disease treatment• Vitiligo• Leucoderma

WOUND CARE PLASTICS AESTHETICS

23

For

per

sona

l use

onl

y

Page 24: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Condition Annual number of procedures potentially appropriate for ReCell application

Chronic wounds (lower limb ulcers)

12,000,000Approximately 1.5% of general population (3.2%>70 yo) of OECD countries (1)

Burns650,000 Burns requiring medical intervention (2)

Plastic / Dermatology / Reconstructive

580,000 (US) Treatments sought from plastic surgeons for scar remodeling. (3)

Vitiligo>200,000 

Reported cases seeking treatment (prevalence: 2% of population ~ 12 million) (4)

Aesthetics600,000 (US)

Treatment sought from cosmetic surgeons for skin discoloration, acne, skin defects, stretch marks (3)

TOTAL 10 – 12 Million Potential annual procedures

1 Graham et al. Prevalence of lower‐limb ulceration. Adv Skin Wound Care 16(6):305‐16 2003.2 US Center for Disease Control (CDC); AM Burn Assoc National Burn Repository 20053 American Society for Aesthetic Plastic Surgery 20044 Forschner et al. Current state of vitiligo therapy. J Dtsch Dermatol Ges 5(6):467‐75 2007

24

For

per

sona

l use

onl

y

Page 25: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Direct

Distributor

Joint Venture

Regulatory Approval Pending

Avita Medical ItaliaMilan, Italy

Avita Medical EuropeCambridge, UK

Avita Medical  AmericasLos Angeles

Avita Medical MENAKuwait

Avita Medical Asia PacificAustralia

25

For

per

sona

l use

onl

y

Page 26: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Randomized, within‐patient, controlled study comparing clinical performance of ReCell® device with STMSG for treatment of deep partial‐thickness burns.

Patients must have injury patterns such that two, 100‐320 cm2 regions (not necessarily contiguous) of 2nd degree depth available for treatment with ReCell and STMSG (control)

Endpoints: 16 weeks post treatment• Superiority:  Donor site healing at 2 weeks• Non‐inferiority: Recipient site healing at 4 weeks

106 patients (includes 15% withdrawal rate)

Up to 18 US clinical sites; 8 Subjects per site

Approx. 60% completed with enrollment

26

Study Design

For

per

sona

l use

onl

y

Page 27: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

William F. Dolphin, Ph.D., CEO29 years international executive experience; significant M&A experience

Stella Sung, Ph.D., Business Development Officer18 years senior management, business development and venture capital

Andrew Quick, VP Research & Technology20 years medical device experience; expertise in design, development and clinical research

Lorraine Glover, General Manager, Asia Pacific20 years experience in the commercial biotechnology and medical devices industry

William Marshall, VP Operations31 years industry experience; expertise in lean manufacturing, quality and regulatory systems

27

For

per

sona

l use

onl

y

Page 28: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

28

Commencement of pilot study of ReCell in scar remodeling Q2 2012

China: Price Code listing; Commercial launch Q4 2012

Feasibility studies of ReCell in chronic wounds H2 2012

IDE for pivotal study of ReCell in scar remodeling Q1 2013

FDA submission for ReCell in burns Mid 2013

For

per

sona

l use

onl

y

Page 29: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Novel, patented, platform regenerative medicine technology—potential to change paradigm of wound healing and treatment of dermal defects

Strong Intellectual Property and first‐mover advantage

Enormous market potential due to applicability in multiple indications

Commercialized and generating revenues internationally

Relatively near term significant value inflection point—FDA submission in 2013

Public Australian company just beginning to gain exposure to US investors

29

For

per

sona

l use

onl

y

Page 30: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

COMPANYStella M. Sung, Ph.D., Business Development Officer

9221 Corbin Ave, Suite 220Northridge, CA 91324‐2494

Tel: +1‐818 356 9418Email: [email protected]

www.avitamedical.com 

Investor RelationsMark A. McPartland, Senior Vice President

MZ GroupMain: +1‐646‐593‐7140Mobile: +1‐910‐297‐[email protected]

30

For

per

sona

l use

onl

y

Page 31: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

31

For

per

sona

l use

onl

y

Page 32: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

32

For

per

sona

l use

onl

y

Page 33: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

With ReCell® the regenerative process is regulated and controlled by the presence of “Positively Stressed” keratinocytes (K) yielding enhanced release of key proteins (e.g.,HSP90), platelets (P), releasing PDGF, and Stem Cells (SC) (“intelligent bags of  growth factors“ (proliferators, e.g., VEGF), cytokines (immunomodulators) and chemokines (migrators)).

33

For

per

sona

l use

onl

y

Page 34: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

HSP90 blocks action of TGFb, disinhibiting response to VEGF (vascular endothelial growth factor) and PDGF (platelet‐derived growth factor) by endothelial cells and fibroblasts (Fb) resulting in proliferation and differentiation of key cell types accompanied by rapid development of blood vessels and nerves. 

Interplay of inhibition, disinhibition and activation generates a positive feedback cascade resulting in further release of growth factors, cytokines and chemokines.

34

For

per

sona

l use

onl

y

Page 35: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

‘Normal’ skin regenerates through maturation and remodeling with appropriate stratification and mix of all cells types (stem cells, keratinocytes, fibroblasts, melanocytes, Langerhans cells, nervous tissue, blood vessels, etc. ) producing texture, pliability, sensitivity , pigmentation and coloration matching the surrounding skin.

35

For

per

sona

l use

onl

y

Page 36: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Procedure Advantages Disadvantages

Skin graft • Standard of care• Specific graft procedure inexpensive• Rapid procedure

• Scarring, cosmetic issues, skin ”quality”• Large, painful donor site• Infection, rejection

• Extended hospitalization• Repeated operations

Cultured epithelia(auto or allo)

• Large coverage• Small donor site• Low infection

• Expensive• 2‐6 weeks to grow• Allograph  high rejection rate• Fragile• Cosmetic issues (skin matching, scarring)

• Extended hospitalization with interim wound coverage• Multiple procedures• Require specialised lab facilities• cost of immunosuppressive treatment

Artificial skin • Large coverage• No donor site• Low infection / reject

• Expensive• Fragile• Not skin matched: scarring

• Multiple procedures• “Not‐ready‐for‐prime‐time”

Dermal matrixes  • Requires combination of above• Provide rapid coverage• Useful in severe, deep wounds

• Expensive• Extended hospitalization with interim wound coverage

• Multiple procedures• Requires ‘skin’ of some sort

ReCell Spray‐On Skin

• Rapid• Low cost, decrease hospitalization• Minimize donor site• Minimal scar• Low infection / reject• No lab requirements• Can be used in combination with          other techniques

• Requires paradigm change

36

For

per

sona

l use

onl

y

Page 37: For personal use only - ASX2012/05/23  · Day 1 post‐ReCell Week 3 post‐ReCell Month 10 14 For personal use only Neck pre‐treatment 12 months post‐ReCell

Procedure  Companies

Skin graft/Wound care:

• 3M Health Care • Baxter• Carrington Laboratories, Inc. • ConvaTec, Ltd. • Covidien, Ltd.• Derma Sciences • GlaxoSmithKline Plc • Healthpoint, Ltd. 

• Hill‐Rom Company, Inc. • Johnson & Johnson • Kinetic Concepts, Inc. • Medline Industries • Molnlycke HealthCare • Mylan• Pfizer, Inc. • Smith & Nephew, Plc

Cultured epithelia(autologous, allogeneic or xenogeneic)

• Advanced BioHealing • Ethicon• Fidia Farmaceutici s.p.a.

• Genzyme• Organogenesis Inc.

Dermal matrixes  • Integra Inc.

Spray‐on (ReCell)  • Avita Medical

37

Range of companies involved with burns/wound care products 

For

per

sona

l use

onl

y