world leader in tpm technology - phosphagenics · world leader in tpm ... tax losses ~$100m....
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October 2016
www.phosphagenics.com(ASX : POH)
World leader in TPM® technology
Non-Confidential Presentation
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Safe Harbour Statement
This presentation, and any representations made before, during or after the presentation, mayinclude forward-looking statements that are inherently subject to risks and uncertainties. Thesestatements relate to, but are not limited to: (1) the safety or efficacy of, or potential applications for,Phosphagenics’ TPM® platform technology; (2) the strength of Phosphagenics' intellectualproperty; (3) the timelines for Phosphagenics’ clinical trials and regulatory processes for its differentproducts; (4) the scalability and efficiency of manufacturing processes; (5) revenue projections,market share expectations, share price expectations and capital requirements.
Actual results may differ from the expectations expressed in these forward-looking statements, andthe differences may be material (whether positive or negative). The risks that may causePhosphagenics' actual results, performance or achievements to be materially different from thoseexpressed or implied by such forward-looking statements, include but are not limited to: (1) risksinherent in the development, approval and commercialisation of potential products; (2) uncertaintyof clinical trial results or regulatory approvals or clearances; (3) changes to market trends orgovernment laws or regulations; (4) the potential need for future capital; (5) dependence uponcollaborators; and (6) protection of intellectual property rights, among others. Accordingly, youshould not place undue reliance on these forward-looking statements.
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Key Highlights: Phosphagenics is a compelling investment opportunity
Approx. $10M cash (Jun’16) and receivables (~$2M R&D Tax Incentive expected 4Q’16) –funding through 2017
Revenues of 2M+ in 2015 from TPM® and Vital ET®
Improved efficiency, capacity and COG in place to capitalise on increased sales. Tax losses ~$100M.
Meaningful newsflow planned over last Qtr 2016/ 1H’17
TPM® technology already partnered for specific dermal and injectable useHigh interest in future business development opportunities
Attractive valuation: Share price/value disparity. Substantial upside potential
Management/Board with strong industry experience
ESOP in place to incentivise Management and Board (subject to shareholder vote at next AGM)
Focus is on shorter-term, value-adding endpoints: partnerships and revenue
“…we believe that Phosphagenics is substantially undervalued … the Company’s current total value should be A$80-100M, or 8.5c per share…(there is) substantial upside …” M.Wijma, Chief Research Analyst, Van Leeuwenhoeck Research, September 2015
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Our Structure Optimises Business Focus and Cross-Business Synergy
“…leverages TPM®’s unique properties and broad patent portfolio across multiple lucrative markets.”
“…sharing knowledge, data and expertise reduces development risk, time and cost.”
TPM®
Human Health & Nutrition
Production & Personal
Care
Animal Health & Nutrition
Primary Focus
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TPM® is already in over 100 marketed products*
Human Health & Wellbeing
* Either alone or as a component of Vital ET®
Note: this is only a selection of marketed products containing TPM®
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The Human Health pipeline has several innovative assets at various stages of development
Product Formulation Therapeutic Area Partner Research Development Marketed
Diclofenac Gel Pain (NSAID)
Novartis (India)Themis (17 countries)
Oxycodone Patch Pain (opioid) Terumo Corporation
Oxymorphone Patch Pain (opioid) Terumo Corporation
Daptomycin Injectable Antibiotic Mylan (Global)
Propofol Injectable Anesthetic Terumo Corporation
2 additional products* Other Pain Terumo Corporation
5 additional products* Injectable Assorted
Not PartneredPartnered Clinical POP achieved
Phosphagenics is poised to take advantage of the fast growing transdermal market with its unique opioid patches
Option pending
Option for Japan
Option for Japan
Global
Global
* undisclosed product
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Voveran® (TPM®/Diclofenac gel) was launched by Novartis in India in 2014
TPM®/Diclofenac gel is marketed by two companies: • Novartis • Themis Medicare
Demonstrated to: • outperformed the existing gold standard • delivered more diclofenac
Phosphagenics gains revenue through both: • Sales of TPM® for manufacture ($211,000 in 2015)• Royalties on sales (6-12%)
Now licensed across 17 countries with negotiations ongoing to further expand market.
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The Opioid Market is very large with unmet needs that could be addressed with patch technology
Extended Release (ER) opioids account for 70% of the market by revenue ($6B)
Oxycodone and oxymorphone account for 50% of all ER opioid revenues ($3B) (despite serious PK and abuse liabilities)
Transdermal opioids (buprenorphine and fentanyl) account for 25% of all ER opioid revenues ($1.5B)
US$8 billion Opioid Market (USA)
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Phosphagenics’ two opioid patches are “World First”
Development Status
EstimatedLaunch
Date (US/Japan)
PeakSales
Potential (Global)
Partner Status
TPM®/Oxymorphone
Patch
Being reformulated; further dev.
H2’16 / H1’17
2021 $350M+
• Exclusive option to license with Terumo Corporation (license anticipated in H2’16)
• Discussions underway with several companies in US
TPM®/Oxycodone
Patch
Ph2a complete; additional
dev. planning underway
2020 $500M+
• Exclusive option to license with Terumo Corporation (license anticipated in H2’16)
• Discussions underway with several companies
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We target considerable newsflow over the next 12 months
Human
1. Initial results for TPM®/Oxycodone Patch Phase 2a trial Announced 1Q’16
2. Options (2 patches) and R&D Alliance deal (4 other products) with Terumo Announced2Q’16
3. R&D Feasibility Agreement completed for new projects with Terumo. Complete 3Q’16
4. Reformulation candidates of TPM®/Oxymorphone Patch - progression 4Q’16
5. Dev. & License Agreement - “Opioid Patch” with Terumo 2H’16
6. Multiple additional Business Development outcomes 4Q’16
Legal1. ProPhase Arbitration Decision 4Q’16
2. Mylan Arbitration Formal Hearing 2H’17
Animal
1. Results for 1st Swine FCR trial (weaners to 20kg) Announced 1Q’16
2. Cattle program initiates Complete 3Q’16
3. First results for Poultry FCR program 4Q’16
Personal Care 1. Sale of BioElixia® brand (dependent on ProPhase Arbitration) 4Q’16
Business Milestones Timing
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PHOSPHAGENICSAn Innovative Biotechnology Company Headquartered in Australia
Key Statistics:ASX/OTCQX Code POH/PPGNY
Headquarters Melbourne, Australia
Employees 19
Cash (at Jun 2016) ~$10M+ ( + ~$2M R&D tax incentive)
Revenue (2015) ~$2.2M
Share on Issue ~1.26 Billion
Top Shareholders (by volume): Citicorp Nominees Pty Limited 10.4%
Merrill Lynch (Aust) Nominees Pty Limited 5.3%
National Nominees Limited 4.2%
Paroha Nominees Pty Ltd 4.1%
J P Morgan Nominees Aust. Limited 2.5%
Key Management Personnel: Since
Dr Ross Murdoch (CEO & Managing Director) 2015
Dr Paul Gavin (CSO) 2002
Ms Anna Legg (CFO & Co. Secretary) 2012
Dr Alex Stojanovic (VP, BD & Commercial) 2014
Dr Roksan Libinaki (GM, Animal Heath & Nutrition) 2001
Mr Greg Moses (GM, Operations & Production)
Dr Mahmoud El-Tamimy (VP, Innovation & Dev.)
2012
2007
Board of Directors:Mr Peter Lankau (Chairman & Independent Director)
Dr Ross Murdoch (CEO & Managing Director)D
Dr Geert Cauwenbergh (Independent Director)
Dr Greg Collier (Independent Director)
Mr David Segal (Non-Independent Director)
Dr Ross Murdoch, CEO & Managing Directorrmurdoch@phosphagenics.com
Dr Paul Gavin, CSOpgavin@phosphagenics.com
Melbourne Office11 Duerdin StClayton VIC 3168Australia Tel: +61 3 95651119Email: info@phosphagenics.com
Investor Relations QuestionsKyahn WilliamsonWE BuchanTel: +61 3 9866 4722/+61 401 018 828Email: kwilliamson@buchanwe.com.au
www.phosphagenics.com
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