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Anteris Technologies Global Corp. — Investor Presentation 2016
May 2, 2016
33869_rns_2016-05-02_167c28fe-8329-4b5d-b838-ed1f078f3537.pdf
Investor Presentation
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Investor Presentation May 2016
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Investor Presentation / May 2016 / www.admedus.com
Disclaimer
This presentation is the property of Admedus Ltd (“Admedus”). This presentation is not and does not constitute an offer, invitation or recommendation to subscribe for, or purchase any security and neither this presentation nor anything contained in it shall form the basis of any contract or commitment.
This presentation does not constitute an offer, solicitation or invitation in any, state or jurisdiction anywhere, or to any person to whom, such an offer or sale would be unlawful. This presentation is not intended as an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in the United States or to any person to whom it is unlawful to make such an offer, invitation or solicitation. Reliance should not be placed on the information or opinions contained in this presentation. This presentation does not take into consideration the investment objectives, financial situation or particular needs of any particular investor. Any decision to purchase or subscribe for securities in Admedus must be made solely on the basis of the information contained in the public domain and if necessary after seeking appropriate financial and legal advice. No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, Admedus and its affiliates and related bodies corporate, and their respective officers, directors, employees and agents disclaim any liability (including, without limitation, any liabilities arising from fault or negligence) for any loss arising from any use of this presentation (or its content) or otherwise arising in connection with it. Admedus’ forward-looking statements, intentions, forecasts, prospects, returns, expectations, statements in relation to future matters or other forward looking statement contained in this presentation may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. There are usually differences between forecast and actual results because events and actual circumstances frequently do not occur as forecast and these differences may be material. They are based on a number of estimates, assumptions that are subject to business, scientific, economic and competitive uncertainties and contingencies, with respect to future business decisions, which are subject to change and, in many cases, are outside the control of Admedus and its directors. Neither Admedus nor its directors give any assurance that the forecast performance in the forecasts or any forward-looking statement contained in this presentation will be achieved.
This presentation is not an offer of securities for sale in the United States. The securities may not be offered or sold in the United States unless they are registered or exempt from registration. Any public offering of securities to be made in the United States will be made by means of a prospectus that will contain detailed information about the company and management, as well as financial statements.
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Investor Presentation / May 2016 / www.admedus.com
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Presentation Overview
Company overview
4C summary Strategic Outlook
CardioCel and ADAPT
Immunotherapies
Milestones
Investor Presentation / May 2016 / www.admedus.com Investor Presentation / May 2016 / www.admedus.com
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Sales & Distribution
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Established sales infrastructure
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Infusion, surgery and cardiac hospital markets
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Growing revenue
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Immunotherapies
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Next generation immunotherapies in HPV and herpes
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Progressing through clinical trials
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Commercialising Ian Frazer’s DNA vaccine technology
BUSINESS MODEL
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Regenerative Tissue
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Regenerative tissue product pipeline
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Product approved for sale and generating revenue
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Proprietary ADAPT tissue engineering technology
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Biomanufacturing
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R&D infrastructure and hub for future products
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Scale up of manufacturing
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State of the art facility
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Investor Presentation / May 2016 / www.admedus.com
4C Results
Executive Summary
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YTD Sales up 49% to $9.7M
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Quarterly sales of $3.3M – a 73% increase from the corresponding period last year
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CardioCel sales of $1.4M – up 83% from the corresponding period
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Infusion sales of $1.9M – up 12% from the corresponding period
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10th straight quarter of sales growth
Operating efficiencies – cost management
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Cost centre containment programs in place with further programs to be rolled out with further manufacturing efficiencies
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16% sequential decrease in staff expenses over Q2 FY16
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7% sequential decrease in working capital over Q2 FY16
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Management expects further efficiencies and cost reductions over the coming quarter and into next financial year
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Investor Presentation / May 2016 / www.admedus.com
4C Results
Executive Summary
Quarterly R&D expenditure of $1.1M
o Building out portfolio of ADAPT related products for large markets
o Aortic Heart Valve reconstruction study – recruiting 80 patient at 4 US & EU leading heart valve centres
o Important to show benefits of CardioCel in valve reconstructions instead of replacement valves on the market today.
o Clinical reviews and updates every 6, 12 and 24 months post surgery.
o Vascular clinical studies to treat carotid endarterectomies to reduce the incidence of strokes
o Expected rollout of enhanced vascular product in 2[nd] half of CY16
o Expansion of vascular product range including a curved conduits for treatment of aortic arch repairs
o Prototypes completed Q3, 2016
o ADAPT Vessels for “off-the-shelf” vessel repairs and reconstructions including for use in CABG – prototypes developed in 2[nd] half of CY16 for testing in large animals
o Dura Mater product development and animal studies being initiated on enhancements to treat head and brain injuries. Animal studies expected for US FDA filings in 2017
o Stem Cell delivery – in-vitro study with ADAPT tissue and stem cells being completed Q3, 2016
o Last CY > 70 publications and presentations on CardioCel and ADAPT tissue in process
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Investor Presentation / May 2016 / www.admedus.com
4C Results
Executive Summary
Quarterly R&D expenditure continued
o Immunotherapies: On-going HSV-2 Phase II Study and preparation for HPV Cervical Cancer Phase Ib
-
HSV-2 Phase II “unblinded” interim results anticipated in Q3, 2016
- Interim “blinded” data showed no safety issues and study participants had a marked decrease in viral lesions
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HPV Cervical Cancer program going through formal toxicology study in preparation for Phase Ib study next financial year
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Closing cash balance of $13M
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Additional R&D tax rebates expected over the coming quarter
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Capital strategies under review with the BOD
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Forecasting strongest 4[th] quarter sales and record sales this financial year
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Company pipeline ES
Admedus Pipeline
Admedus program Research Project Lead Preclinical Phase I Phase II Phase III On market CardioCel CHD and heart valve repairs and reconstructions Vascular repairs CEA, AAAs etc Dura mater Spinal and cranial repairs Whole vessels CABG and AV Fistula HSV-2 Herpes therapeutic HPV Cervical cancer HPV OncologyOncology Stem cell platform Multiple applications Hernia Hernia repair
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Investor Presentation / May 2016 / www.admedus.com
Strategic Outlook
Capital Management
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Capital requirements under review with the BOD
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Reviewing near, mid, long term capital requirements relative to revenue and R&D
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Fully aware of shareholder concerns regarding capital requirements and will
- resolve these
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Key cost containments underway
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Cost containment programs to reduce overall OPEX by a further ~ 15%
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Streamlining manufacturing and improvements in Company wide margins
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Growing revenue with additional products coming online
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Stronger revenue forecast across the Company
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Several strategic initiatives being pursued
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Market update pending review in next three months
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Strategic Outlook
The Future
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Profitable, sustainable global business
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Cost containment to manageable % of revenue
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Continued growth of our profitable, infusion portfolio
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Multiple products across multiple regions
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First product range CardioCel®
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Regional expansion with new approvals
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Increasing number of centers using CardioCel
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Increasing product use per center per region
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Expansion of ‘on market’ product range
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Internally and externally sourced
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E.g. Vascular product and Coroneo ring coming to market this CY
-
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Appointment of distributors to compliment sales and marketing teams
- Right balance of direct sales and partners
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Commercial partnerships and collaborations on our immunotherapy and ADAPT technologies
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Investor Presentation / May 2016 / www.admedus.com
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ADAPT [®] – Regenerative Tissue
Investor Presentation / January 2016 / www.admedus.com Investor Presentation / May 2016 / www.admedus.com
ADAPTADAPT[®][®]
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The ADAPT tissue benefits are:
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Safe
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Durable Remodels
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Promotes site specific tissue regrowth & regeneration
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Bio-compatible
oStrong with natural flexibility and -
oHaemocompatible elasticity -
Maximum haemostasis
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Prevents calcification
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oRetains tensile strength & elasticity -
No calcification
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Easy to use
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Off the shelf
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No specific preparation
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No special or technical training required for use
IP – core patents out to beyond 2030
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ADAPTADAPT[®][®]
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Regenerative Tissue Product Portfolio
| 2015 2016 2017 2018 2019 2020 |
CardioCel ® Congenital Heart Disease (CHD) Launched in North America, EU and Asia |
CardioCel ® Congenital Heart Disease (CHD) Launched in North America, EU and Asia |
|---|---|---|
| Cardiovascular Applications | Heart valve repairs & reconstructions* On market in North America, EU and Asia |
|
| Vascular tissue | Carotid Endarterectomy (CEA) Launch in 2016 |
|
| Dura mater repair | Spinal and cranial repair File 2017 |
|
| Whole vascular tissue | CABG, AV fistula File 2018 |
|
| Stem Cell or stem cell factor delivery | ADAPTTM tissue with stem cells File/partner 2019 |
|
| Abdominal surgery Hernia repairs File 2020 |
- Admedus is currently undertaking a supporting aortic valve reconstruction clinical study
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Investor Presentation / May 2016 / www.admedus.com
CARDIOCEL[®]
Regenerative bio-scaffold for cardiovascular repairs
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Launched in significant cardiovascular market
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6 sizes now on market
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Approved in major markets:
o EU – Nov 2013 (CE marking certification)
o US – February 2014 (510k)
o On market in Hong Kong, Malaysia & Singapore o Partnered with Genpharm for MENA
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Direct sales teams in North America & EU
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Initially targeting use in CHD centres
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o Moving into adult cardiovascular centers
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Significant potential in China
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Over 145+ centres globally using CardioCel
o Over 4000 patients implanted
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CARDIOCEL[®]
Cardiac market[1]
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CardioCel on market for these indications
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US CHD ~60,000+ case per annum
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EU ~ 58,000
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US heart valve market ~ 256,000 procedures per annum including:
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Mitral Valve repairs, replacements and reconstructions
o 67,000 procedures
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Aortic Replace - repair or reconstruction
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165,000+ procedures
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1LIfe Science Intelligence. SI-PV-US118SU: U.S. Surgical Procedure Volumes from 2007-2014. December 2011.
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Investor Presentation / May 2016 / www.admedus.com
CARDIOCEL[®]
Cardiac market[1]
- Other heart valve repairs and reconstructions
o 19,000 procedures
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Similar numbers across Europe
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Also potential across MENA and Asian markets
o Admedus generating sales in both regions
o Partnered with Genpharma in MENA
- Growing number of cases for CardioCel across all indications
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- Backed by strong data
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Investor Presentation / May 2016 / www.admedus.com
CARDIOCEL[®]
Heart valve leaflet model – high pressure model – 200 days
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Leaflet reconstructed with Cardiocel – like natural tissue
Autologus natural leaflets
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1The Journal of Thoracic and Cardiovascular Surgery December ‘14
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CARDIOCEL[®]
Heart valve repair data summary
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Multiple positive animal pre-clinical studies completed
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Results showed:
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CardioCel very positive performance in high pressure environment
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After 7 months strong tissue regeneration around CardioCel[®]
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Endothelialisation (prerequisite for a normal physiological heart valve-blood interface)
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New valvular collagen on both sides of CardioCel[®]
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Typical of native valve tissue
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Progression to repaired heart valve tissue
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The trans-differentiation of some of the valvular
interstitial cells into functional phenotypes such as new smooth muscle cells
- No echocardiographic evidence of calcification in the CardioCel valve
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CARDIOCEL[®]
Aortic valve reconstruction clinical study
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Currently enrolling aortic valve reconstruction study
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Reconstructing the whole valve instead of replacement with a bio-prosthetic valve
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4 leading heart centres enrolling 80 adult patients
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Supporting CardioCel use in valve reconstructions instead of bio-prosthetic
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Particularly in the adult aortic valve market[1]
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~ 165,000 procedures per annum
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Treating aortic stenosis
- In 25% of the population over 65 yrs old
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1LIfe Science Intelligence. SI-PV-US118SU: U.S. Surgical Procedure Volumes from 2007-2014. December 2011.
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Investor Presentation / May 2016 / www.admedus.com
CARDIOCEL[®]
Aortic valve reconstruction clinical study
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Will look at overall patient valve performance
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Looking to show benefits of full valve reconstruction instead of short-term options of bio-prosthetics
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To the overall benefit of the patient
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Better haemodynamics
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Complimented with autologous repair to form ‘native’ valve
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- Clinical reviews at 6, 12 and 24 months post-surgery
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CARDIOCEL[®]
Clinical data highlights
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CardioCel is a bio-scaffold on market for cardiovascular repairs
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Avoids calcification – a key differentiation
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No calcification at 48, 60, 72 and 84 month follow up in ongoing extension to clinical study
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Supported by several heart valve repair and reconstruction studies
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Currently in clinical trials for aortic valve reconstruction
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Strong regeneration of normal heart tissue around bio-scaffold
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Native tissue ‘feel’ appealing to surgeons
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CARDIOCEL[®]
Clinical data highlights
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Allows blood flow through and around facilitating tissue regeneration
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Initial use for congenital heart repairs and building in heart valve repairs
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Approved for both pediatric and adult use
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Also on market in US for vascular repairs
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Will expand use into other cardiovascular surgical uses
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Over 4000 patients implanted with CardioCel to date
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Investor Presentation / May 2016 / www.admedus.com
PARTNERSHIPS
Partnership with Coroneo
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Aortic annuloplasty ring
- Retains elasticity
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Licensed German, UK, Australia and NZ marketing rights
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Complementary to CardioCel
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Used in adults – provides adult market
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access
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To be sold through existing sales teams
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Will add revenue to the Company
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Currently being launched
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Initial sales in Germany
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ADAPT[®]
ADAPT[®] for vascular repairs LAUNCHING OF NEW PRODUCT RANGE
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Admedus looking to launch vascular focused product range
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Vascular tissue being used in pilot clinical programs
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Leverage off existing regulatory approval
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180,000 per annum in the US1
- Use in all vascular repairs
o Carotid Endarterectomy (CEA) Patch
o Coronary Revascularisation
o Endo AAA
o Open AAA
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Broader use across surgeries
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Approved in US
ADAPT tissue used on vascular repair
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Investor Presentation / May 2016 / www.admedus.com
ADAPT[®]
ADAPT[®] for dura mater
DEVELOPING A PRODUCT FOR DURA MATER REPAIRS
- US market around 200,000 procedures per annum[1]
Initial study shows:
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No post-op leakage
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No post-op infection
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Remodelling and endothelialisation within one month
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No adhesion to brain surface
ADAPT tissue
Entering a 2[nd] study
o Could be used for US market filing
1LIfe Science Intelligence. SI-PV-US118SU: U.S. Surgical Procedure Volumes from 2007-
- December 2011.
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ADAPT[®]
Summary
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ADAPT[®] technology the basis for a portfolio of products
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Already used in a larger number of surgical procedures
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Initially targeting cardiovascular disease
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Strong long term clinical data in Congenital Heart Disease and cardiovascular repairs
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Growing data in heart valve reconstructions
o With clear long-term patient advantage
o No calcification
- Post-implantation remodelling
o True alternative to whole bio-prosthetic valves
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Approved in EU, US and Asia (partnered with Genpharm for MENA region)
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145+ centres globally and over 4000 patients implanted with CardioCel
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Immunotherapies – Therapeutic Vaccines for Infectious Disease and Oncology
Investor Presentation / May 2016 / www.admedus.com Investor Presentation / May 2016 / www.admedus.com
IMMUNOTHERAPIES
Leveraging a patented DNA platform technology to deliver novel immunotherapies.
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Based on technology developed by Professor Ian Frazer
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Best known for his work in HPV leading to Gardasil[®] and Cervarix[®]
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Uses a combination of:
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Intra-dermal delivery
o Proprietary codon optimisation Coricode©
- Ubiquitin added in the codon to help stimulate the T-cell response Corimmune©
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Investor Presentation / May 2016 / www.admedus.com
IMMUNOTHERAPIES
Leveraging a patented DNA platform technology to deliver novel immunotherapies.
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Targeting therapeutic vaccines for infectious disease and oncology
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Two lead clinical programs – HSV-2 & HPV
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7 patent families – 6 US patents granted
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IMMUNOTHERAPIES ES
Admedus Immunotherapies Pipeline
Disease State Research Project Lead Preclinical Phase I Phase II Phase III HSV-2 Herpes therapeuticHerpes therapeutic Cervical cancer HPV Cervical cancer HPV OncologyOncology
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IMMUNOTHERAPIES
Herpes Simplex Virus-2 (HSV-2) TACKLING AN UNMET MEDICAL NEED
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HSV-2 commonly causes genital herpes
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1 in 6 people aged between 14 and 49 in the US estimated to be HSV positive[1]
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No cure currently available
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Addressable market estimated at $6bn+[2]
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Preclinical – total HSV-2 viral clearance
- Prevented establishment of latency reservoirs
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1 Centers for Disease Control and Prevention. “Genital Herpes – CDC Fact Sheet. November 17, 2015.
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2 Global Industry Analysts Inc., “Herpes Simple Virus Treatment:
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A Global Strategic Business Report.” April 2012.
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IMMUNOTHERAPIES
Herpes Simplex Virus-2 (HSV-2) TACKLING AN UNMET MEDICAL NEED
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Phase I – consistent with preclinical data
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Dose ranging study in sera-negative healthy people
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3 vaccinations with 3 weeks between
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Doses 10mcg, 30mcg, 100mcg, 300mcg and 1000mcg
Results showed:
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Phase I safe (primary endpoint) – no safety issues
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19 of 20 patients showed T-cell response
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Non-response in lower dose
-
Also strong local (DTH) response
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Investor Presentation / May 2016 / www.admedus.com
IMMUNOTHERAPIES
HSV-2 Vaccine
KEY VALUE INFLECTION POINT DURING 2015
Phase II
o Recruitment completed – waiting data
o Initial clinical trial participants received vaccine doses with no safety issues
- Anticipating unblinded interim results in Q3, 2016
HSV-2 positive patients
o Two arms – 1000 mcg vs placebo 3:1 ratio
o 20 patients per arm
o 45 day pre-vaccination ‘baseline’ period
o 3 injection regimen with 4 weeks between injections
o Followed by 6 month booster
o Looking at safety & viral load, viral shedding and viral flare frequency
Blinded, pooled data shows no safety issues
o Indicative data suggests positive study outcome
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IMMUNOTHERAPIES
Human papilloma virus (HPV) vaccine
DEVELOPING AN EFFECTIVE TREATMENT
HPV infection a direct cause of cervical cancer
-
Also related to other cancers
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Despite availability of first generation HPV vaccines
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(Gardasil[®] and Cervarix[®] )
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Low compliance; <35% vaccination completion rate in the US[1]
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Significant pool of people already HPV infected – vaccine ineffective
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14M new infections in the US per annum[1]
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Estimated >$1bn+ market potential for therapeutic vaccine[2]
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Targeting therapeutic use against HPV – E6 & E7
- 1Centers for Disease Control and Prevention. “Genital Herpes – CDC Fact Sheet. November 17, 2015.
2 Transparency Market Research. “Human Papillomavirus and Cytomegalovirus Therapeutics Market - Global Industry Analysis, Pipeline Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020.” June 2015.
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Investor Presentation / May 2016 / www.admedus.com
IMMUNOTHERAPIES
Human papilloma virus (HPV) vaccine
DEVELOPING AN EFFECTIVE TREATMENT
Strong preclinical data
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HPV viral clearance
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100% survival in TC-1 model (tumour transfer model)
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87.5% had no tumour 50 days post treatment
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Prevents disease progression in multiple HPV tumour models
Expected to enter Phase I/II next financial
year
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Company Milestones and News Flow
Investor Presentation / January 2016 / www.admedus.com Investor Presentation / May 2016 / www.admedus.com
NEWS FLOW
Expected 12 month news-flow
INFUSION & CARDIOCEL
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Growing sales from our infusion and CardioCel portfolio
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Growing number of Centers using CardioCel globally
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Additional Asian market approvals for CardioCel®
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Approvals & initial sales in the MENA region
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Additional distribution partnerships
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NEWS FLOW
Expected 12 month news-flow
ADAPT & CARDIOCEL
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Launch of ADAPT vascular tissue product range in 3[rd] qtr CY’16
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Tri-leaflet Aortic Heart Valve reconstruction study updates
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Initiation of dura mater tissue study for regulatory submission
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Progression of CardioCel[®] with cellular therapies program
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Initial CardioCel[®] studies for the Chinese market approval
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Investor Presentation / May 2016 / www.admedus.com
NEWS FLOW
Expected 12 month news-flow
IMMUNOTHERAPIES
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HSV-2 Phase II unblinded interim data expected Q3 ‘16
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Initiation of HPV Phase Ib expected in FY 16/17
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Exploring other HPV related cancer applications
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Full HSV-2 Phase II data expected in CY ’17
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Investor Presentation / May 2016 / www.admedus.com
SUMMARY
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Growing Integrated Specialist Healthcare Company
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Strong 3[rd] quarter and YTD sales
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Active cost management programs underway
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Expense reduction in 2[nd] & 3[rd] quarters and ongoing
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Focus on sales growth and expenditure containment on path to profitability
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Leveraging two proprietary and differentiated platform technologies
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ADAPT[®] – tissue engineering for regenerative medicine
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Lead ADAPT[®] product Cardiocel® on market globally
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Vascular product launch 2[nd] half of CY’16
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Whole heart valve reconstruction study initiated and ongoing clinical reviews
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Growing product pipeline
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Therapeutic vaccines and immunotherapies for infectious disease and oncology
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Two clinical programs – HSV-2 & HPV
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Exploring other technology applications in immuno-oncology
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Thank you!
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@Admedus facebook.com/Admedus www.admedus.com
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