market announcements office for personal use only · via its partner themis medicare •...
TRANSCRIPT
Phosphagenics Limited ACN 056 482 403 ABN 32 056 482 403
11 Duerdin Street, Clayton VIC 3168 PO Box 1415, Clayton South MDC VIC 3169 Australia
Tel: +61 (0)3 9565 1119 Fax: +61 (0)3 9565 1151 www.phosphagenics.com Email: [email protected]
ASX Limited Market Announcements Office
Phosphagenics Investor Presentations
12 October 2016, Melbourne: Australian drug delivery company, Phosphagenics Limited (ASX: POH; OTCQX: PPGNY), please find attached the latest versions of the Phosphagenics non-confidential investor presentations. Enquiries Ross Murdoch Phosphagenics Limited +61 3 9565 1119 Kyahn Williamson WE Buchan +61 3 9866 4722/ +61 40 101 8828 Email: [email protected]
www.phosphagenics.com
For
per
sona
l use
onl
y
Page 2 of 2
About Phosphagenics
Phosphagenics Limited is focused on developing and commercialising innovative Human Health, Animal Health and Personal Care products using its proprietary drug delivery system called TPM® (Targeted Penetration Matrix). TPM® is derived from Vitamin E using a unique, proprietary and patented process and has been proven to enhance the solubility and oral, dermal and transdermal absorption of drugs and nutrients. Amongst its major projects, Phosphagenics’ is developing TPM® enhanced patches, gels and injectable products for the human health market and is also developing TPM® to enhance the feed efficiency and health of livestock. Phosphagenics' shares are listed on the Australian Securities Exchange (POH) and its ADR – Level 1 program in the US is with The Bank of New York Mellon (PPGNY). Inherent Risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Forward-looking Statements
Certain statements in this announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services. www.phosphagenics.com
For
per
sona
l use
onl
y
Investor Fact Sheet
TPM® Drug Delivery Technology| Pharmaceuticals | Consumer Products | Animal Health
Delivering More
At a Glance (12 Oct 2016)
Code: ASX:POH (listed 2004) Headquarters: Melbourne, Australia Sector: Healthcare Employees: 19 Shares on Issue: ~1.3 billion Market Cap: ~40 million (A$0.031/share) Revenue: A$2.3m (in 2015)
Cash & Rev: ~A$12 million (at 30 Jun ’16)
Share Price (6 months)
Company Profile • Phosphagenics (POH) is a research-based
biotechnology company focussed on enhancing the delivery, effectiveness, and tolerability of proven pharmaceutical, consumer and animal health products
• TPM® (Tocopheryl Phosphate Mixture) is
Phosphagenics’ proprietary drug delivery system based on patented, proven chemical modification of Vitamin E
• Phosphagenics has developed multiple TPM® based
novel products to address sizable, unmet industry needs across: ° Human Health, ° Animal Health and Nutrition, ° Personal Care
Market Opportunity Phosphagenics is addressing the growing need for more efficient delivery of active molecules, vitamins and nutrients with improved efficacy, efficiency and lower risk of complications and adverse events.
Enquiries
Dr Ross Murdoch CEO and Managing Director Phosphagenics Limited +61 3 9565 1119
Oct ‘15
Key Milestones
4Q‘16
Oxymorphone patch option (Terumo) matures
Oxycodone patch option (Terumo) matures
ProPhase Arbitration ruling Sale of BioElixia® Cosmetics Brand
Poultry FCR Study headline results
Lead Injectable candidates enter development
1H’17 Additional TPM®/Diclofenac gel launches
2H’17 Mylan Arbitration – formal hearing
Management Dr Ross Murdoch – CEO and Managing Director Ms Anna Legg – CFO and Company Secretary Dr Paul Gavin – CSO and GM, Human Health Dr Roksan Libinaki – GM, Animal Health and Nutrition Mr Greg Moses – GM, Operations and Production Dr Alex Stojanovic – VP, BD and Commercial
Oct ‘16 May ‘16
- 0.03
- 0.01
- 0.02
---Price (AUD)
For
per
sona
l use
onl
y
Phosphagenics has Three Business Units
Human Health (primary focus) • There is great need for enhanced drug delivery of human
therapeutics • TPM® is an effective drug delivery platform already
marketed in multiple products for humans • TPM® is protected by over 100 patents and 13 patent
families • TPM® can enhance dermal, oral and intravenous routes of
administration - thereby potentially lowering the amount of active drug delivered and associated side effects
• TPM®/Diclofenac gel is already commercialised in India and is being prepared for registration in 16 other markets via its partner Themis Medicare
• Phosphagenics has a number of advanced R&D programs including world first TPM®/oxymorphone and TPM®/Oxycodone Patches, (currently under license option with Terumo for Japan), TPM®/Propofol injectable, TPM® gels and an enhanced injectable TPM®/Daptomycin (with Mylan)
• In addition, Phosphagenics also has a number of in-house R&D programs focussed primarily on injectables
Animal Health and Nutrition • TPM® is able to enhance the uptake of vitamins and nutrients in
humans and animals • As a feed additive TPM® has the potential to address two main
commercial opportunities in Animal Health: ° improve feed efficiency in multiple livestock species ° improve immunity, milk quality and fertility in dairy cows
• In 2016 Phosphagenics: ° completed two trials in pigs, demonstrating significantly
improved feed efficiency in weaners ° initiated a feed efficiency poultry study, results - late 2016 ° Initiated a large dairy cattle study, results - late 2017
Production and Personal Care • Phosphagenics has its own purpose built manufacturing plant
in Clayton, Australia, to manufacture TPM® and Vital ET® • The manufacturing process is proprietary and patent protected • In 2015 Phosphagenics manufactured and sold over 22
tonnes to partners in the Personal Care industry • “Production and Personal Care” is already a cash flow positive
business for Phosphagenics • TPM® and Vital ET® are already used in up to 100 cosmetic
and skin care products, including the prestige label Le Métier de Beauté
• Phosphagenics has a global distribution agreement with Ashland, supplying TPM® and Vital ET® as a raw ingredient to multiple other commercial partners
Product Status
Diclofenac Gel Marketed (& under registration) Novartis, Themis Medicare
Oxycodone Patch Development Terumo option (Japan)
Oxymorphone Patch Development Terumo option (Japan)
Daptomycin Injectable Development Mylan (Global)
Propofol Injectable Development Terumo (Global)
2 additional products* Research Terumo (Global)
*undisclosed products
Product Status
Horse Racing Nutrition Marketed IAH (Global)
Dairy Cattle Mastitis Marketed IAH, (AU, NZ, UK & IRE)
Pigs, Poultry Feed Efficiency Trials Active
Dairy Cattle Mastitis, Fertility Trials Active
Product Status
TPM® based BioElixia® TBD (for sale)
TPM® based Products Partnered Le Métier + multiple others
Vital-ET® based Products Marketed Ashland
This document may include forward-looking statements that are inherently subject to risks and uncertainties. These statements 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' intellectual property; (3) the timelines for Phosphagenics’ clinical trials and regulatory processes for its different products; (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, and the differences may be material (whether positive or negative). The risks that may cause Phosphagenics' actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, include but are not limited to: (1) risks inherent in the development, approval and commercialization of potential products; (2) uncertainty of clinical trial results or regulatory approvals or clearances; (3) changes to market trends or government laws or regulations; (4) the potential need for future capital; (5) dependence upon collaborators; and (6) protection of intellectual property rights, among others. Accordingly, you should not place undue reliance on these forward-looking statements.
For
per
sona
l use
onl
y
October 2016
www.phosphagenics.com(ASX : POH)
World leader in TPM® technology
Non-Confidential Presentation
For
per
sona
l use
onl
y
2
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.
For
per
sona
l use
onl
y
3
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
For
per
sona
l use
onl
y
4
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
For
per
sona
l use
onl
y
5
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®
For
per
sona
l use
onl
y
6
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
For
per
sona
l use
onl
y
7
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.F
or p
erso
nal u
se o
nly
8
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)
For
per
sona
l use
onl
y
9
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 companiesF
or p
erso
nal u
se o
nly
10
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
For
per
sona
l use
onl
y
11
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)
For
per
sona
l use
onl
y
Dr Ross Murdoch, CEO & Managing [email protected]
Dr Paul Gavin, [email protected]
Melbourne Office11 Duerdin StClayton VIC 3168Australia Tel: +61 3 95651119Email: [email protected]
Investor Relations QuestionsKyahn WilliamsonWE BuchanTel: +61 3 9866 4722/+61 401 018 828Email: [email protected]
www.phosphagenics.com
For
per
sona
l use
onl
y