Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Calzada Ltd
ASX:CZD
Investor Overview
June 2013
1
Disclaimer Disclaimer
This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No party other than Calzada has
authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or undertakings in this
presentation.
This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment
objectives, financial situation or needs of any particular investor. Calzada Limited makes no warranty or representation (express or implied) as to
the accuracy, reliability or completeness of the information contained in this presentation. Specifically, several matters referred to in the
presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation. Further,
any opinions (including any forward looking statements) expressed in this presentation are subject to change without notice. Calzada and its
directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent
misstatement) for any statements, opinions, information or matters (express or implied) arising out of, or contained in or derived from, or for any
omissions from this presentation, except liability under statute that cannot be excluded.
This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect of
shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other jurisdiction
in which, or to any person to whom, such an offer would be illegal.
Forward-looking statements
This presentation may include forward-looking statements. Forward-looking statements are only predictions and are subject to known and
unknown risks, uncertainties and assumptions, many of which are outside the control of Calzada. Actual values, results or events may be
materially different to those expressed or implied in this presentation depending on a range of factors. Given these uncertainties, recipients are
cautioned not to place reliance on forward-looking statements. No representation or warranty (express or implied) is made by Calzada or any of
its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this presentation
will be achieved.
2
Calzada Limited
• ASX:CZD
• Share price: 8 cents
• Market Capitalisation: $28m
• Current Cash: $2.9m (+ approx $750k R&D refund from ATO expected Q3 2013)
• Cash Burn: approximately $2.5m per annum (net of R & D refund)
• Major Shareholders: Merchant Funds Management: 19.6%
Senior Management: 9%
Monash University & Prof Ng: 4%
• Two 100% owned subsidiaries: PolyNovo Biomaterials Pty Ltd:
Owns NovoSorb™, a suite of biodegradable polymers used in medical devices and as tissue repair scaffolds
Metabolic Pharmaceuticals Pty Ltd: Owns AOD9604, a peptide proven safe in human trials with activity in fat reduction, bone health, cartilage and muscle applications
3
4
PolyNovo Mission
“PolyNovo will develop a portfolio of medical devices,
based on its NovoSorb™ technology, focussed on
delivering superior clinical outcomes for patients and
economic benefits to healthcare providers.”
5
PolyNovo
1. Products and technology
2. Development
3. Commercialisation strategy
6
NovoSorb™
• NovoSorb™ can be used as a wound scaffold for multiple tissue
repair applications and dissolves when the repair is complete
• First applications in burns and wound management, developed by
NovoSkin (80% owned PolyNovo) in partnership with Dr John
Greenwood, AM (Director, Adult Burns Unit, Royal Adelaide Hospital)
7
NovoSorb™
• The NovoSorb™ family of polymers is the result of
over ten years of development including :
Four years of fundamental research conducted by world leading
biomaterial expert Dr Thilak Gunatillake at the Commonwealth
Scientific and Industrial Research Organisation (CSIRO)
Seven years of applied research and development conducted by
NovoSkin to develop the wound management products
$18 million invested to date in developing NovoSorb™
8
NovoSorb™
• Key advantages:
Excellent biocompatibility (material and degradation products)
Cost effective
Easy to process
Excellent scalability
Sterilisation by Gamma irradiation
Long shelf life at room temperature
9
NovoSorb™ Safety • Completed ISO 10993 testing to GLP standard
Sensitisation, Pyrogen, Irritation, Sub-cutaneous Implantation, Sub-chronic
Systemic Toxicity (90 days), Systemic Toxicity (180 days), Genotoxicity
(Ames, Mouse Lymphoma), Cytotoxicity
• Completed multiple large animal studies (30 pigs)
• Successfully completed 1 human clinical trial Topical Negative Pressure (TNP)
wound dressings
20 patients (controlled, randomised)
• Full thickness wound clinical trial underway
10 patients, Free Flap (full thickness wounds) donor site reconstruction
8 patients already recruited and treated
10
PolyNovo developments
11
Revenues
NovoSorb™
Topical Negative Pressure (TNP) Dressing
Diabetic,Pressure & Other Ulcers, Abdominal Surgical Wounds
Surgical wounds(BTM)
Surgical Wounds, Ulcers, Deep Dermal Burns,Other Wounds
Full thickness Burns (BTM)
Third Degree Burns
Urogynecology (Based on BTM)
Pelvic floor repair
Hernia Mesh (Based on BTM)
Smith and Nephew Partnership
Milestone achieved Target date Started Target date Not yet started
R&D Pre-clinical CE mark PartneringPMAClinical 510(k)
Undisclosed
Q4 2013 Q4 2013 Q4 2014
Q3 2013 Q4 2013 TBD TBD
Q2 2014 Q4 2015 Q1 2016
Q4 2014 Q2 2015
TBD
Q2 2014
Q4 2015
Biodegradable Temporising Matrix (BTM)
• BTM is a NovoSorb™ foam coated with a non-biodegradable membrane
used as a scaffold for dermal repair in full thickness wounds
12
BTM
13
• BTM advantages over current products:
Reduced risk of infection/ loss of device
Improved tissue growth and revascularisation
Mechanically robust
Cost effective manufacturing
Long term room temperature storage
Gamma sterilised.
NovoSorb Current Products (Integra)
Vascularisation At 5 days Between 14 and 21 days
Tissue growth By day 10 By day 21
Skin grafting Start at day 14 Start at day 21
Seal removal >28 days possible Max 28 days
BTM Clinical Trial
Free flap full thickness wound donor site untreated
BTM implanted in donor site
Skin graft >10 weeks
14
Patient 1
Topical Negative Pressure Dressings
15
Rationale • Issues with existing TNP dressings listed in the FDA Preliminary Public Health Notification: Serious
Complications Associated with Negative Pressure Wound Therapy Systems
Infection
Fragmentation
Dressing embedded in wound
Bleeding
The NovoSorb™ Solution: Now:
Improved biocompatibility: less risk of infection from dressing fragments
Improved design: less fragmentation,
Biodegradable: will degrade safely if fragments are left behind
Less tissue ingrowth in dressing: Reduced bleeding
Potentially:
Reduce dressing change frequency
Increase patient pool
Reduce overall cost of treatment
Topical Negative Pressure Dressings
16
•Key market data:
Cost*: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care
ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each
pressure ulcer added $43,180 in costs to a hospital stay.
Deaths*: About 60,000 patients die as a direct result of a pressure ulcer each year.
*Source: Agency for Healthcare Research and Quality (US, AHRQ)
NovoSorb™ Commercialisation Strategy • Leverage our NovoSorb™ technology platform
• Establish commercial/strategic alliances to commercialise NovoSorb™ based medical
devices
• Focus on developing medical devices to improve on existing devices and/or to resolve
unmet clinical needs
Topical Negative Pressure (TNP) dressing
Biodegradable Temporising Matrix (BTM)
Leverage BTM/TNP development and clinical data for new applications • Hernia Repair
• Pelvic Floor Prolapse repair
• Facial reconstruction (chin augmentation (genioplasty), cheek augmentation (malarplasty),nose augmentation (rhinoplasty))
• Manufacture medical devices and/or device components
• Commercialisation pathways
Establish distribution partnership with market leaders for high volume applications
Establish collaborative partnership leveraging marketing/technical capabilities
Investigate potential for direct hospital supply in small volume/niche markets
17
NovoSorb™ next steps
• 510K regulatory submission for TNP application Submission Q3 2013
• Seeking a partner to distribute TNP dressing Market size >$400 m
In discussions with multiple potential partners
• Investigate
BTM for surgical wounds
BTM for third degree burn Market size > $200 m
• Awaiting BARDA contract response to determine commercialisation path
Hernia repair Market size >$1 b
• In discussions with potential partner
Pelvic Floor Prolapse repair Market size >$1 b
• In discussions with potential partner
Facial reconstruction
• In discussions with potential JV partner
18
19
20
2nd hormone - IGF1 (made in the liver)
Fat
AOD9604
Growth hormone fragment (only 8% of the GH molecule)
Bone
Muscle
and Organ
growth
Bone
length
Protein
synthesis
AOD9604 Activity Pathways
Burns fat,
Inhibits storage
IGF-1 and pro-diabetic
effects removed
Cartilage
& Muscle
Promotes repair
Growth Hormone activates both the IGF-1 (crossed out) and direct cellular pathways. AOD9604 does not act on the IGF-1 pathway which causes significant insulin resistance and other negative side-effects
IGF-1 pathway Direct cellular pathway
AOD9604 Background & Strategy
Background
• Positive in-vitro and in-vivo data in fat, bone, cartilage & muscle cells
• Past clinical development proved AOD9604 is very safe with some evidence of weight loss in population
sub-sets observed - 700 humans and >1,000 animals treated
• Has been used in Phosphagenics’ (ASX:POH) BodyShaper ant-cellulite cream
• Existing “Black market” use may indicate that it is being used to reduce body fat and muscle repair
Commercialisation Strategy
• Low cost strategy adopted to generate shareholder value. (Running costs approximately 10% of total CZD
costs)
• Exploring licensing opportunities
Potential human applications for the treatment of bone, muscle & cartilage disorders
Determine the legal viability of licensing to compounding pharmacies
Veterinary applications – osteoarthritis, obesity and others
• Over The Counter applications – AOD9604 could be added to foods, drinks & dietary supplements in USA.
Commercial options to be investigated. Has received conditional Generally Recognised As Safe (GRAS)
status subject only to publication of existing safety data in peer scientific journal
21