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BOTANIX PHARMACEUTICALS LTD — Investor Presentation 2017
Mar 21, 2017
64551_rns_2017-03-21_84cd6390-a17c-4d69-a65a-ecd8aca7bcd9.pdf
Investor Presentation
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ASX/Media Release
22 March 2017
Company update
Botanix Pharmaceuticals Limited (“Botanix” or the “Company”) is pleased to release a new company update presentation, which is enclosed with this announcement. The presentation outlines Botanix’s compelling investment case and strategy.
INVESTMENT HIGHLIGHTS
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Experienced US based leadership team in place with a proven track record of achieving FDA approvals
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Addressing growing, multi-billion dollar dermatology markets with no new products approved in last 20 years (within the acne space)
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Key products based on pharmaceutical grade synthetic cannabidiol (versus variable naturally derived cannabidiol), greatly enhances the probability of clinical development success
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Exclusive global rights to use Permetrex[TM] delivery technology for all drugs that treat skin diseases with potential to deliver near term revenues
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Accelerated development pathway for dermatology pharmaceuticals compared to standard development pathways, driving lower costs and a faster timeline to approval
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Strong intellectual property portfolio which includes 12 patent applications across 6 patent families, and substantial volumes of proprietary knowledge, know-how, and trade secrets
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Multiple near term potential revenue streams to complement longer term development upside
Matthew Callahan, Executive Director, commented, “Recent enhancements to Botanix’s senior leadership, expansion of the Permetrex[TM] license and new patent applications ensures Botanix is well positioned to capitalise on early value creation opportunities. Our focus now is on the rapid commercialisation of our lead acne product and developing our wider portfolio of medical dermatology products.”
About Botanix Pharmaceuticals
Botanix Pharmaceuticals is dedicated to developing next generation therapeutics for the treatment of serious skin diseases. Our mission is to improve the lives of patients battling acne, psoriasis and atopic dermatitis, by providing new treatment options for conditions that currently are inadequately addressed or are treated with therapeutics that are burdened with side effects profiles. Botanix is harnessing the untapped potential of a synthetic active pharmaceutical ingredient known as cannabidiol, which has a well-established safety profile. Botanix is preparing for the first human trials with synthetic cannabidiol utilising a proprietary drug delivery system (Permetrex™) for direct
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skin delivery of the therapy in 1H 2017 and plans to progress the development of its pipeline of other Permetrex[TM] enabled products alone, or in collaboration with partners.
For more information on Botanix, please visit www.botanixpharma.com or follow us on Twitter @Botanixpharma.
For more information, please contact:
General enquiries
Matt Callahan Botanix Pharmaceuticals Ltd Executive Director P: +1 215 767 4184 E: [email protected]
Investor Relations
Ben Walsh WE Buchan P: (02) 9237 2801 E: [email protected]
Media enquiries Arthur Chan WE Buchan P: (02) 9237 2805 E: [email protected]
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Investor Presentation March 2017
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Investment highlights
Botanix is well positioned to capitalise on early value creation opportunities
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Experienced US based leadership team in place with a proven track record of achieving FDA approvals
-
Addressing growing, multi-billion dollar dermatology markets with no new products approved in last 20 years (within the acne space)
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Key products based on pharmaceutical grade synthetic cannabidiol (versus variable naturally derived cannabidiol), greatly enhances the probability of clinical development success
-
Exclusive global rights to use Permetrex[TM] delivery technology for all drugs that treat skin diseases with potential to deliver near term revenues
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Accelerated development pathway for dermatology pharmaceuticals compared to standard development pathways, driving lower costs and a faster timeline to approval
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Strong intellectual property portfolio which includes 12 patent applications across 6 patent families, and substantial volumes of proprietary knowledge, know-how, and trade secrets
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Multiple near term potential revenue streams to complement longer term development upside
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Corporate overview
Innovative medical dermatology company with a clear path to commercialisation, and a highly aligned Board and management team holding 39% of Botanix shares
Trading information
Share price performance
| Share price (21-Mar-17) | A$0.061 |
|---|---|
| 52 week low / high | A$0.026 / A$0.072 |
| Shares outstanding1,2 | 408.8m |
| Market capitalisation | A$24.9m |
| Cash (as at 31-Dec-16)2 | A$2.4m |
| Debt (as at 31-Dec-16) | Nil |
| Enterprise value | A$22.5m |
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Share price (A$) Volume (m)
0.08 100
0.06 75
0.04 50
0.02 25
- -
Jul-16 Sep-16 Nov-16 Jan-17 Mar-17
Volume (RHS) BOT S&P/ASX 300 Health Care Index
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Top shareholders (as at Mar 2017)
| Top shareholders (as at Mar 2017) | |
|---|---|
| Shareholder | % |
| Matthew Callahan –Executive Director | 17.3 |
| Caperi Pty Ltd –Co-founder | 17.3 |
| Board and management (excl. shareholders above) | 5.0 |
Source: IRESS
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- Includes 156.5m fully paid ordinary shares subject to escrow until 15 July 2018 2. Excludes 38.8m unlisted options with exercise price range of A$0.03 - A$0.133 and expiry date range of Dec 2016 to Jun 2019
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Recent corporate and product development
Recent corporate developments have provided a strong platform for Botanix to accelerate its clinical development program
Corporate milestones
Jul 2016
Jul 2016 to Feb 2017
Feb 2017
Mar 2016
Key staff hires across the business divisions of clinical and regulatory, manufacturing, toxicology and operations
Completed expansion of Permetrex™ license to cover the delivery of all drug actives used in treating skin diseases
Completed RTO and commencement of trading as Botanix Pharmaceuticals (ASX:BOT)
Pre-RTO: Bone Medical announce reverse take over (RTO) by Botanix Pharmaceuticals
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Development milestones
Jul 2016
Nov 2016
Dec 2016
Mar 2016
Manufactured BTX 1503 trial formulation using FDA quality components
Completed first human safety and irritation study with Permetrex[TM]
Submitted ethics application for first human study utilising BTX 1503
Secured access to commercial scale synthetic cannabidiol
Accelerating business development through advancement of BTX 1503, Permetrex[TM] pipeline and other licensing and partnerships
Ethics approval and commencement of clinical trials of BTX 1503 and other pipeline products utilising Permetrex[TM] delivery platform
Formulation
Confirm Permetrex[TM] Safety
Proof of Concept
Key milestones achieved
Near term focus
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Strategic and commercialisation focus
Botanix is currently executing on its primary strategy of commercialising BTX 1503, while also developing a pipeline of other medical dermatology products
Targeted clinical applications
Active pharmaceutical
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Botanix product BTX 1503
Clinical application Acne
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Cannabidiol
Permetrex [TM] BTX 1503 BTX 1204
Delivery technology
Psoriasis Dermatitis
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Near term focus
Near to medium term focus
Medium to long term focus
BTX 1503 development and commercialisation
Permetrex[TM] licensing
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Other pipeline products
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Focused on designing and executing an efficient clinical development program for first-in-class acne product BTX 1503
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Accelerating clinical development through undertaking low cost initial clinical studies in Australia, feeding into US based FDA approvals
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Disciplined approach to the licensing of the Permetrex[TM] delivery system to strategic parties, to generate potential near term revenue
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Utilizing Permetrex[TM] to develop proof of concept products for near term outlicensing
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Leverage data from BTX 1503 program to accelerate development of new products in psoriasis and dermatitis
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Potential to further develop noncannabidiol product (BTX 1701) for “over the counter” markets which does not require FDA approval
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Senior leadership: track record of success
Proven industry professionals with a demonstrated ability to lead the development, financing, regulatory approval and commercialisation of pharmaceuticals
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Expertise: clinical and corporate
Mr Matthew Callahan
Executive Director (Appointed Jul 2016)
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Founding CEO of iCeutica Inc, which has developed 3 products to date that have received FDA approval
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Co-inventor of SoluMatrix Technology delivery platform that iCeutica uses to develop new pharmaceuticals
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Previous investment director of 2 venture capital firms investing in life sciences
Expertise: technology and clinical
Dr Bill Bosch
Executive Director (Appointed Jul 2016)
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6 FDA approved products to date and co-inventor of the iCeutica SoluMatrix Technology
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Managed the commercial development of 4 nanotechnology products as the former Director of Pharmaceutical research at Elan Corporation
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Co-founder of NanoSystems and the co-inventor of the drug delivery technology NanoCrystal
Expertise: regulatory and clinical
Dr Michael Thurn
Chief Operating Officer (Appointed Feb 2017)
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Extensive start up life sciences experience across a range of technology platforms
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Over 20 years experience in drug regulation, drug discovery, pre-clinical and clinical
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Previous Managing Director of Spinifex Pharmaceutical, which was taken out by Novartis for A$700m
20+ FDA approved products credited to the broader Botanix leadership team
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Industry experts that have identified a compelling unmet market opportunity in dermatology, with acne treatment being the initial primary clinical focus
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Significant and growing market opportunity
Global acne prescription products market expected to grow to >US$4.5bn by 2018, driven by the significant US market, and is only a subset of the global dermatology opportunity
Global prescription acne product revenues (topical Annual topical prescription acne product revenues and oral treatments)
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Value of the global acne prescription market is expected to Top branded acne products containing only generic drugs have
reach US$4.5bn by 2018 [1] achieved revenues of up to >US$300m p.a. [2]
$331
US$4,530m 2011
$285
2012
$199 2013
$175 $168 $167
US$3,951m
US$3,845m
$95 $85
2012 2013 2018 Epiduo Aczone Tazorac Differin Acanya Ziana Benzaclin Atralin
(Galderma) (Allergen) (Allergen) (Galderma) (Valeant) (Valeant) (Valeant) (Valeant)
(Valeant)
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Large demand with limited recent product development
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50 million patients (in the US alone) used an acne product in 2015
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No new chemical entities have been approved by the FDA in the last 20 years for the treatment of acne
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Only “new” products launched in this period were combinations of old drugs in new formulations or new packaging
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Little development expected in future years, with very few products currently in the development pipeline
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Acne is just a subset of an even larger dermatology market opportunity (psoriasis, eczema, etc.) which is in the order of US$20bn p.a.
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BCC Research, May 2013. Skin Disease Treatment and Global Markets
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- Symphony Health Solutions, Pharmaceutical Audit Suite for 2012 as reported in Demira S1
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Botanix’s most advanced product – BTX 1503
BTX 1503 is topically applied for the treatment of moderate and severe acne, and utilises synthetic cannabidiol combined with a novel skin delivery technology
Overview
Cannabidiol mechanism of action in acne
| ▪ BTX 1503 is a formulation of pure, synthetic cannabidiol that is administered via the PermetrexTMdelivery system ▪ Cannabidiol is a chemical that can be naturally found as an extract of the cannabis plant ▪ Cannabidiol has an established safety profile with >100 human clinical trials completed or underway, studying cannabidiol in a range of different diseases ▪ BTX 1503 is designed to maximise the delivery of cannabidiol to the sebaceous glands with little systemic exposure ▪ It has multiple mechanisms of action that directly target the 4 pathogenic factors that lead to acne: Switches off excessive oil production Reduces inflammation Blocks cell proliferation Reduces infection |
Lipostatic | ✓Normalises excessive and abnormal fatty oil production known as “sebum” |
|---|---|---|
| Anti-inflammatory | ✓Induces a novel anti-inflammatory pathway |
|
| ▪ It has multiple mechanisms of action that directly target the 4 pathogenic factors that lead to acne: Switches off excessive oil production Reduces inflammation Blocks cell proliferation Reduces infection |
||
| Anti-proliferation | ✓Inhibits proliferation of sebum producing sebocytes (cells), without affecting their viability (an important safety aspect) |
|
| Anti- bacterial |
✓Demonstrated anti-bacterial targeting acne specific_Propionibacterium acnes_ (P. acnes) |
Source: Cannabidiol exerts sebostatic and anti inflammatory effects on human sebocytes (2014).The Journal of Clinical Investigation
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BTX 1503 key advantages
Synthetic cannabidiol manufacturing process and skin based application provides significant competitive advantages compared to other products in development
Challenge
Significant commercial and regulatory hurdles in extracting enough naturally derived cannabidiol at the required purity, lowers the chance of achieving clinical success
Challenge
Medicinal cannabidiol is generally administered orally, however, only 6% of cannabidiol consumed orally is available in the blood stream (even less makes it to the target organs in the skin)
Botanix solution
Botanix solution
Synthetically derived cannabidiol allows for consistent manufacturing, greater scalability and more straightforward regulatory approval prospects
Permetrex[TM ] delivers cannabidiol efficiently into the skin for the targeted treatment of various skin diseases. Safe and non-irritating formulation facilitates the efficient delivery of cannabidiol into the skin
Advantages of synthetic cannabidiol
Synthetic cannabidiol Naturally extracted cannabidiol 1 chemical 100+ chemicals 100% pure Multiple impurities Scaled up to ~50kg Scaled up to ~1kg Material registered with FDA Not registered with FDA No additional Must comply with FDA’s compliance required “Botanical Drug Development Guidance for Industry”
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Unmodified drug With Permetrex [TM]
Epidermis
Dermis
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Botanix holds the exclusive rights to utilise Permetrex[TM] for all drugs that treat skin diseases
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BTX 1503 market positioning
Once developed and approved BTX 1503 has the potential to be the market leading product for acne treatment with no undesirable side effects
Market landscape for acne treatments[1]
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BTX 1503 has multiple mechanisms of action that directly treat the key pathogenic factors causing acne, making it a potentially superior treatment to existing therapies
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While systematic therapies (i.e. oral isotretinoin) may inhibit sebum (skin-oil) production, its use is limited by very serious side-effects
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Significant unmet need for an effective therapy that targets the cause of acne (i.e. sebum production) and does not have the undesirable side effects associated with traditional acne treatments
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Significant market opportunity; major existing treatments fetched annual revenues in the range of US$700m-US$800m when they were patented products
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BTX 1503’s patent protection is a significant competitive advantage, as all other treatments below are now generic products
| Method of action | BTX 1503 | Clindamycin | Tretinoin | Adapalene | Minocycline | Erythromycin | Accutane |
|---|---|---|---|---|---|---|---|
| Reduces excessive sebum (skin oil) production | ✓ | ✓ | |||||
| Anti-inflammatory | ✓ | ✓ | ✓ | ✓ | |||
| Anti-bacterial | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Topical (applied to a specific area of the body) | ✓ | ✓ | ✓ | ||||
| Minimal side effects | ✓ | ✓ | ✓ | ✓ | |||
| Patent protected (not a generic product) | ✓ |
- Subject to relevant successful development and approvals
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BTX 1503 accelerated clinical development
Botanix is pursuing a rapid clinical development strategy in order to minimise the time until product commercialisation and first revenues
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In December 2016, Botanix completed its first human study of the Permetrex[TM] delivery technology and successfully showed that Permetrex[TM] did not cause any safety or irritation issues
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First enrolment of Phase 1a acne study estimated for 2Q CY2017
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Successful product development of Permetrex[TM] skin delivery technology for the topical application of cannabidiol
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Botanix is funded through the Phase I clinical trials of BTX 1503, with potential further funding from Permetrex[TM ] licensing revenues
BTX 1503 clinical timeline
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Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2017 2017 2017 2017 2018 2018 2018 2018
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Ethics approval for Phase I BTX 1503 trial Phase Ia safety, dosing and pharmacokinetic trial Phase Ib acne pilot study Ethics approval for Phase II trial Phase II study
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Clinical milestones where potential development partnerships and/or licensing agreements may be considered
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Accelerated development timeline
Botanix is executing on an efficient, more economical and less risky clinical development strategy compared to traditional pharmaceutical development pathways
Botanix’s accelerated clinical timeline
Proven ability to execute: Achieved since listing
| Proven ability to execute:Achieved since listing | Proven ability to execute:Achieved since listing | Proven ability to execute:Achieved since listing | Proven ability to execute:Achieved since listing | Proven ability to execute:Achieved since listing |
|---|---|---|---|---|
| Phases | Botanix approach Costs (est.) Timing (est.) ~$1m ~6 months |
|||
| Traditional process | ||||
| Costs (est.) | Timing (est.) |
Costs (est.) | ||
| Discovery and pre-clinical | ~$430m | ~5 years | ~$1m | |
| Investigational New Drug filing |
~$1m | |||
| Phase I clinical | ~$25m | ~7 years | ||
| ~$2m | ~6 months ~28 months ~12 months ~4 years |
|||
| Phase II clinical | ~$35m | ~$5m | ||
| Phase III clinical | ~$54m | ~$20m | ||
| New Drug Application | ~$5m | ~2 years | ~$2m | |
| Total | ~$460m | ~14 years | ~$30m |
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Accelerated development timeline, due to:
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Minimal pre-clinical development due to known safety profile of cannabidiol
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Dermatology studies tend to be shorter in duration and require smaller study populations
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Objective measurements of efficacy (end points are typically visual assessments)
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Opportunity to generate near term revenue from potential licensing agreements for Permetrex[TM]
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In house expertise ensures clinical trials are appropriately designed and efficiently implemented
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Known safety profile increases probability of successful clinical development
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Commercialisation strategy
Botanix’s focused and accelerated timeline to product commercialisation results in significant potential value uplift
Efficient commercialisation path with multiple options
Value uplift
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Continued clinical development success is reflected in significant value uplift after each successive phase
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Typically monetised via licensing, partnering and/or sale/merger opportunities
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Additional indications can be partnered while pursuing acne focus
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Potential future revenue streams:
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Product licensing agreements
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Partnership with strategic parties
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Product sales revenue
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Significant value uplift potential at the
completion of each phase of development
(as evidenced by recent dermatology
Phase 3
transactions)
(~ 24 months)
Phase 2
(~ 12 months)
Phase 1
Investment decision
(< 12 months)
License, partner and/or
sale opportunities
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Time
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Recent dermatology transactions
Licensing and partnering transactions are potential monetisation options before product sales, with value increasing significantly as a product progress through the FDA process Dermatology transactions
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US$5,200m
Licensing deals
US$790m Total upfront and US$770m
milestone payments US$639m
could exceed these
US$445m figures in aggregate
US$150m
US$90m
Deal date Sep 15 Dec 2016 Jan 2016 Dec 2016 Oct 2016 Apr 2016 May 2016
Deal type License License Corporate Corporate Corporate Asset/business Corporate
Licensee/Acquirer Allergan
Licensor/Target
(global dermatology
(rights) business)
In pre-clinical
In pre-clinical
Phase In Phase III Completed Phase I development / In Phase II On market Completing Phase III
development
Phase IIb
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Source: Bloomberg, Company disclosure
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Development pipeline
Development pipeline includes “over the counter” products with near term potential, that can be developed and marketed without FDA approval
Near term development potential
-
BTX 1701: cleanser/wash
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Target market: 50 million patients in the US alone purchased an acne treatment product in 2015
-
Market size: ~US$1bn+ p.a. for cleansers and washes
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Comments: acne treatment products (e.g. cleansers) will utilise the novel Permetrex[TM] delivery system
This product can be developed and marketed without FDA approval
Top 10 facial cleaners based on sales
| Change in | Unit sales | Change in | ||
|---|---|---|---|---|
| Sales (US$m) | sales (%) | (m) | unit sales (%) | |
| Private label | 137.5 | 6.0 | 33.5 | 5.2 |
| Bioré | 68.3 | 47.5 | 9.4 | 53.1 |
| Simple | 54.3 | 5.8 | 9.5 | 2.3 |
| Cetaphil | 51.1 | 22.2 | 5.8 | 12.0 |
| Olay | 46.6 | -9.6 | 7.6 | -10.1 |
| Burt’s Bees | 46.0 | 21.3 | 7.1 | 23.1 |
| Johnson’s Clean & Clear Morning Burst | 40.0 | -4.1 | 11.0 | 3.4 |
| CeraVe | 39.8 | 24.1 | 3.7 | 33.4 |
| Neutrogena Deep Clean | 37.0 | -4.9 | 5.9 | -5.1 |
| Pond’s | 33.4 | 4.5 | 7.0 | 0.5 |
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Source: IRI for the 52 weeks ended May 15 across total U.S. multi-outlet (supermarkets, drug stores, mass market retailers, military commissaries and select club and dollar retail chians)
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Development pipeline
Development pipeline also includes other synthetic cannabidiol clinical development products targeting key dermatology markets
Mid-term clinical development products
BTX 1204: dermatitis
BTX 1308: psoriasis
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Target market: 7.5 million Americans have psoriasis (most have plaque psoriasis)
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Target market: US patient incidence estimated to be 31 million (10% to 18% of children)
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Market size: estimated annual cost of treating atopic dermatitis in the US is ~US$4bn
-
Market size: estimated annual costs of injectable biologic treatments in the US is ~US$20bn
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Current issues: biologic drugs are very expensive have serious side effect issues (including lymphoma)
-
Current issues: most treatments on the market (i.e. steroids) only address the symptoms
These products will leverage both the BTX 1503 synthetic cannabidiol clinical program as well as the Permetrex[TM] delivery system
Psoriasis
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Dermatitis
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Valuable intellectual property portfolio
Botanix has protected its suit of development products through various patent applications across key global markets
-
Botanix currently has 12 patent applications across 6 different patent families
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Patents applications cover lead acne product and other Permetrex[TM] enabled products
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Patent protection targeted at key geographic regions with large and viable dermatology markets (i.e. initially filed in US and Australia, but following into the EU, UK, Japan, India, China, South America and other jurisdictions in National phase)
-
Botanix positioned as the leading player in the sector – underpinned by substantial volumes of proprietary knowledge, manufacturing know-how and trade secrets
-
Additional IP opportunities will be pursued on each Permetrex[TM] product developed internally or with partners
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Expanded patent applications for
BTX 1503 and other Permetrex [TM]
enabled products
Initial patent applications protecting
BTX 1503
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Botanix vs. ASX-listed medical cannabis companies
Botanix is the most compelling early stage cannabis related opportunity on the ASX
Botanix’s competitive advantages :
-
Synthetic cannabidiol formulation - probability and speed of FDA approval
-
Unmet clinical need - No FDA approved acne treatments in last 20 years
-
Significant addressable market - $4.5 billion in annual prescription sales of acne products
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Faster development pathway – simple end points and skin based administration
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161
149
Potential for re-rating given competitive advantages 106
73
54
Market 40
capitalisation 25
(A$m) [1]
Botanix Creso Pharma Zelda Therapeutics MGC MMJ PhytoTech AusCann Group Medlab Clinical
Pharmaceutical (ASX:CPH) (ASX:ZLD) Pharmaceuticals (ASX:MMJ) (ASX:AC8) (ASX:MDC)
(ASX:BOT) (ASX:MXC)
Focus Dermatology Nutraceutical Oncology/ Dermatology/ Epilepsy Epilepsy/ Oncology
Dermatology Epilepsy Oncology
Drug Source Synthetic Natural Natural Natural Natural Natural Natural
Administration Topical Oral Variable Variable Variable Oral Mouth spray
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Source: IRESS, Company disclosure
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- Market capitalisation as at close 21 March 2017 and calculated via the following formula (ordinary shares on issue + ordinary shares subject to escrow)*share price
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ASX market landscape
An accelerated clinical development timeline and near term catalysts should support a sustained re-rating in market valuation
Botanix vs. early stage ASX-listed pharmaceutical and biotechnology companies
Botanix’s clinical development pathway is de-risked compared to peers :
-
Simple clinical trials with an accelerated development timeline - ↓ time and cost to achieve FDA approval
-
Targeting an unmet clinical need with large market opportunity and few competing products in development
-
Permetrex[TM] is a highly flexible technology with a broad opportunity base and near term revenue potential
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178
170
Potential for re-rating given clinical
development is de-risked compared to peers
Market 46
capitalisation 25 30
(A$m) [1]
Botanix Pharmaceuticals Orthocell (ASX:OCC) Paradigm Innate Bionomics (ASX:BNO)
(ASX:BOT) Biopharmaceuticals Immunotherapeutics
(ASX:PAR) (ASX:IIL)
Hay fever / Bone Oncology/ Central
Focus Dermatology Regenerative Multiple Sclerosis
Marrow Edema Nervous System disease
Accelerated Development ✓ ✓ ✓
Near term revenue ✓ ✓ ✓
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Source: IRESS, Company disclosure
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- Market capitalisation as at close 21 March 2017 and calculated via the following formula (ordinary shares on issue + ordinary shares subject to escrow)*share price
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International landscape
Botanix represents a significant value accretive opportunity when compared to key global peers with positive Phase I and Phase II data
Market capitalisation of key international peers[1]
Zynerba share price performance (US$)
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US$1,441m
US$335m
US$251m
US$104m
Novan Zynerba Cassiopea Dermira
Dermatology ✓ ✓ ✓
focused
Cannabidiol ✓
focused
No. of
Multiple Multiple Multiple Multiple
products
Glycopyrronium
SB206: II Winlevi©:III
Clinical ZYN002 CBD Gel: II Tosylate:III
SB208: II Breezula©:III
development SB414: I ZYN001 THC Pro- CB-06-01: II CIMZIA©:III
phase SB414: I Drug Patch: I CB-06-02: II Olumacostat
Glasaretil:III
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24
Announced positive
20 ZYN002 Phase I
results
16
12
8
Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17
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Dermira share price performance (US$)
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Announced positive
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DRM01 Phase II
results
20
16
12
Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15
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Source: Bloomberg, Company disclosure
Botanix Pharmaceuticals Ltd.
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- Market capitalisation figures as at close 21 March 2017
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Key catalysts over the next 12 months
Significant operational milestones expected over the next 12 months, as Botanix completes preparation for and launches first human studies
1H CY2017 2H CY2017
| 1H CY2017 | 2H CY2017 | ||
|---|---|---|---|
| ▪Ethics approval for BTX 1503 Phase Ia study | ▪Commencement (and completion) of BTX 1503 Phase Ib acne pilot study and results |
||
| BTX 1503 milestones |
▪DEA export licenses for cannabidiol to be used in clinical studies |
▪Collaboration on pipeline cannabidiol program with external partner |
|
| ▪Study commencement (and data) for BTX 1503 Phase Ia safety study |
▪Preparation for Phase II BTX 1503 clinical study |
||
| PermetrexTM | ▪Study data from PermetrexTM pipeline product | ▪Sign collaborative research arrangement/s | |
| and pipeline | ▪Sign licensing agreement for PermetrexTM | ▪New product additions to pipeline (utilising | |
| product | technology with external strategic partner | the Permetrex™ technology) | |
| milestones | ▪New patent filings on other pipeline products | ▪Sign agreement/s on pipeline product/s |
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Appendix Board of Directors and clinical team
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Botanix Board of Directors
Highly credentialed Board of Directors with a proven record of building and leading successful pharmaceuticals businesses
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Graham Griffiths Chairman Appointed July 2016
Matthew Callahan Executive Director Appointed July 2016
Dr Bill Bosch Executive Director Appointed July 2016
Rob Towner Director Appointed July 2016
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40 years executive experience in technology based companies, across sales, marketing and product development
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Former Managing Director of ipernica, responsible for acquisition and commercialisation of nearmap.com (ASX:NEA)
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Non-Executive Director of Pointerra (ASX:3DP), iperative and NGIS Australia
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Commercialisation
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Founding CEO of iCeutica and Churchill Pharmaceuticals
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Co-inventor of iCeutica’s SoluMatrix Technology
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Developed 3 FDA approved products
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Investment director at 2 venture capital firms
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20 years experience in legal, IP and investment management
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Director of Orthocell (ASX:OCC) and Glycan Bioscience LLC
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Clinical and corporate
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20 years corporate advisory experience
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20 years experience in the pharmaceutical industry
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Founder and sole director of Cornerstone Corporate
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Co-inventor of iCeutica’s SoluMatrix Technology
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Developed 6 FDA approved ▪ Founding Executive Director of products bioMD
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Developed 4 commercial ▪ bioMD merged with Allied nanotechnology products at Elan Health Care in 2011 to form Corporation Admedus (ASX:AHZ, $200m market capitalisation)
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Co-founder of NanoSystems LLC and co-inventor of NanoCrystal Technology
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Executive Director of Triangle Energy (ASX:TEG)
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Technology and clinical
Financing and capital markets
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Botanix executive management
Highly credentialed clinical development team with extensive expertise in leading novel products through clinical and regulatory development
Dr Mark Davis VP Clinical and Regulatory
Dr Michael Thurn Chief Operating Officer
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30 years of clinical experience with 19 ▪ Extensive start up life sciences FDA approved products experience across a range of technology
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▪ Unique experience with cannabidiol platforms
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Unique experience with cannabidiol through Insys
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+20 years experience in drug regulation, drug discovery, pre-clinical and clinical
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Former clinical lead with Medicis and Connetics
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Previous Managing Director of Spinifex Pharmaceuticals
Clinical and regulatory
Regulatory and clinical
Dr Gene Cooper Consultant
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40 years pharmaceutical experience
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10 FDA approved products
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Expert in skin delivery
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Inventor of Permetrex™
Technology and innovation
Dr Joel Gelfand Medical Director of Clinical Studies
Professor James Leyden Scientific Adviser
Professor Diane Thiboutot Scientific Adviser
Steve Newhard Manufacturing/ Quality
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Professor of Dermatology at the University of Pennsylvania
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Expert in skin disease and clinical trial management
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Professor of Dermatology at the University of Pennsylvania
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World leading acne and skin specialist
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Professor of Dermatology at Pennsylvania State University
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Researcher in acne and rosacea
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▪ Pre-clinical and clinical trials services provider
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35 years manufacturing and development experience
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Former senior executive with Medicis
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Project leader for formulation
Clinical Studies
Key Opinion Leader
Key Opinion Leader
Formulation/manufacturing
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Disclaimer
This presentation prepared by Botanix Pharmaceuticals Limited (" Company ") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor.
This document is confidential and has been made available in confidence. It may not be reproduced, disclosed to third parties or made public in any way or used for any purpose other than in connection with the proposed investment opportunity without the express written permission of the Company.
This presentation should not be relied upon as a representation of any matter that an advisor or potential investor should consider in evaluating the Company. The Company and its related bodies corporate or any of its directors, agents, officers or employees do not make any representation or warranty, express or implied, as to the accuracy or completeness of any information, statements or representations contained in this presentation, and they do not accept any liability whatsoever (including in negligence) for any information, representation or statement made in or omitted from this presentation.
This document contains certain forward looking statements which involve known and unknown risks, delays and uncertainties not under the Company’s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward looking statements. The Company makes no representation or warranty, express or implied, as to or endorsement of the accuracy or completeness of any information, statements or representations contained in this presentation with respect to the Company.
It is acknowledged that the Company will not undertake any obligation to release publicly any revisions or updates to these forwardlooking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
Botanix Pharmaceuticals Ltd.
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