Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Non-Deal Roadshow (April 2018)
31 slides from Botanix Pharmaceuticals's roadshow presentation, Apr 9, 2018
Slide 1: ASX/Media Release: Investor Presentation
ASX/Media Release 9 April 2018 For personal use only Investor Presentation Philadelphia PA and Sydney Australia, 9 April 2018: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or the “Company”) is pleased to release an updated investor presentation to be used in meetin
Slide 2: Investor update April 2018
For personal use only Investor update April 2018 1
Slide 3: Investment highlights
Investment highlights Botanix is an emerging global dermatology company with advanced clinical programs For personal use only Dermatology Targeting multi-billion dollar prescription markets for acne (with no new products approved Focused in the last 20 years) and atopic dermatitis Successful clinica
Slide 4: Corporate overview
Corporate overview Medical dermatology company with a clear path to commercialisation and a highly aligned Board and management team For personal use only Trading information Share price performance Share price (as at 6-Apr-2018) A$0.125 Share price (A$) Volume (m) 52 week low / high A$0.04 / A$0.16
Slide 5: Clinical programs with near term milestones
Clinical programs with near term milestones Rapidly advancing acne and atopic dermatitis programs, with deeper pipeline in development and Permetrex™ collaborations to augment revenue and news flow For personal use only Product candidate Indication Pre-Clin Ph 1 Ph 1b Ph 2 Next milestones Moderate t
Slide 6: Botanix's product portfolio value considerations
Botanix’s product portfolio value considerations Licensing and partnering transactions are potential monetisation options before FDA approval For personal use only Recent dermatology transactions (licensing, asset and corporate) US$5,200m Licensing deals Total upfront and milestone US$790m payments
Slide 7: BTX 1503 moderate to severe acne
BTX 1503 For personal use only moderate to severe acne 6 Investor Update
Slide 8: How does BTX 1503 work to treat acne?
How does BTX 1503 work to treat acne? BTX 1503 potentially address all 3 key pathologies of acne with a very safe side effect profile For personal use only Attacks P. Acnes Reduces Inflammation bacteria Retards formation of sebum “plugs” Switches off excess production of sebum Source: Cannabidiol ex
Slide 9: Why are we focused first on acne?
Why are we focused first on acne? In 2016, the global acne prescription market was worth ~US$4.9bn, with the potential to grow to ~US$7.3bn by 2025 For personal use only Global acne market size (US$m) Topical acne products revenue in 2016 (US$m) 494 The top two leading topical branded acne 7,350 456
Slide 10: Leading US branded topical acne products
Leading US branded topical acne products Leading topical branded acne products generated ~3m prescriptions in 2016 For personal use only Topical acne products prescriptions in 2016 (‘000s) 2016 list price and cost of topical acne products Drug List price (US$) Annual cost (US$)1 1,179 Epiduo® / $398
Slide 11: BTX 1503 outperformed leading acne products
BTX 1503 outperformed leading acne products Study data resulted in a reduction in inflammatory lesions greater than any other FDA approved topical acne product at 4 weeks For personal use only Lesion count reduction (%) Comparison of other FDA approved products Inflammatory lesions Non-inflammatory
Slide 12: Phase 1b acne patient study data
Phase 1b acne patient study data Patient satisfaction high due to the rapid onset of improvement and significant effect on inflammatory lesions For personal use only Photographs of acne study patient before and after treatment1 Patient result 57% reduction in inflammatory lesions 15% reduction in no
Slide 13: BTX 1503 Phase 2 study design
BTX 1503 Phase 2 study design 12-week randomised, treatment-blinded, vehicle controlled study to evaluate the safety and efficacy of BTX 1503 in patients with moderate to severe acne For personal use only Design Endpoints • 5 dose groups: ~360 subjects • Primary endpoints: – High Dose twice a day: ~
Slide 14: BTX 1503 development timeline overview
BTX 1503 development timeline overview Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues For personal use only • IND in final stages of preparation for filing with FDA to enable commencement of Phase 2 clinical trial in the
Slide 15: BTX 1204 mild to moderate atopic dermatitis
BTX 1204 For personal use only mild to moderate atopic dermatitis 14 Investor Update
Slide 16: BTX 1204 for atopic dermatitis
BTX 1204 for atopic dermatitis Atopic dermatitis shares many of the same pathologies as acne, but has an immune response element and itch side effect that cannabidiol can address For personal use only Treatment Topical ATP crisaborole Treatment cAMP Topical calcineurin inhibitors PDE4 ✖ INSIDE CELL
Slide 17: BTX 1204 for atopic dermatitis
BTX 1204 for atopic dermatitis Atopic dermatitis (severe eczema) shares many of the same pathologies as acne, but has an immune response element and itch side effect that cannabidiol can address For personal use only Market overview BTX 1204: atopic dermatitis • Target market: US patient incidence e
Slide 18: Global atopic dermatitis market
Global atopic dermatitis market The global atopic dermatitis market is forecasted to grow at a CAGR of 12.8% from ~US$7bn in 2017 to ~US$24bn by 2027 For personal use only Projected AD market by revenue (US$bn) Leading topical branded AD products by revenue (US$m) $25 $400 PROTOPIC® (0.1% & 0.03%) E
Slide 19: Leading US branded atopic dermatitis products
Leading US branded atopic dermatitis products Leading topical branded atopic dermatitis products generated >550k prescriptions in 2017 For personal use only Leading topical AD products by prescription (‘000s) 2016 list price and cost of topical AD products PROTOPIC® (0.1% & 0.03%) ELIDEL® EUCRISA™ D
Slide 20: BTX 1204 Phase 1b atopic dermatitis study
BTX 1204 Phase 1b atopic dermatitis study 4-week randomised, double-blind, vehicle controlled patient study – NOW FULLY ENROLLED For personal use only Design Endpoints • ~36 subjects 18 years and older (24 active / 12 vehicle) • Primary endpoints: safety – AEs, labs, local tolerability and signs of
Slide 21: BTX 1204 for atopic dermatitis
BTX 1204 for atopic dermatitis Phase 1b patient study commenced in 4Q CY2017, with expected study completion and data planned for 2Q CY2018 For personal use only BTX 1204 indicative clinical timeline (CY) 1Q 2018 2Q 2018 3Q 2018 4Q 2018 Ethics approval • Expected study completion Phase 1b dermatitis
Slide 22: Development pipeline, Permetrex, key milestones and next steps
Development For personal use only pipeline, Permetrex™, key milestones and next steps 21 Investor Update
Slide 23: Development pipeline
Development pipeline Development pipeline also includes other synthetic cannabidiol and Permetrex™ enabled products targeting key dermatology markets For personal use only BTX 1308: psoriasis • Target market: ~7.5m Americans have psoriasis (note: most have plaque psoriasis) BTX 1308 leverages prior
Slide 24: Permetrex skin delivery technology
Permetrex™ skin delivery technology Permetrex™ delivers high doses of drug into the layers of the skin – oral administration only delivers ~6% to the blood stream and even less to the skin For personal use only Unmodified Drug With Permetrex™ Formulation technology drives drug into the skin Drug sit
Slide 25: Permetrex opportunities
Permetrex™ opportunities Range of opportunities to utilise Permetrex™ technology for internal product development and partnered programs For personal use only Early collaborations leading to license discussions • Botanix is working with multiple parties to test application of Permetrex™ to solve for
Slide 26: Upcoming milestones
Upcoming milestones Significant clinical and operational milestones expected over the next 12 months For personal use only Indicative activities and milestones 2Q CY2018 3Q CY2018 4Q CY2018 1Q CY2019 2Q CY2019 Phase Ib acne study data announcement IND (FDA) submission for Phase 2 trial BTX 1503 Acne
Slide 27: Appendix: additional information
Appendix: For personal use only additional information 26 Investor Update
Slide 28: Senior leadership: proven track record of success
Senior leadership: proven track record of success Proven industry professionals with experience in rapid development of pharmaceuticals For personal use only Mr Matthew Callahan Dr Michael Thurn Mr Mark Davis Dr Bill Bosch Executive Director Chief Operating Officer VP Clinical and Regulatory Executi
Slide 29: BTX 1503 Phase 1b acne patient study
BTX 1503 Phase 1b acne patient study The 4-week open-label acne study, which concluded in December 2017, indicated that BTX 1503 was safe and well tolerated in subjects with moderate to severe acne For personal use only Baseline Safety • 21 subjects enrolled • 18 subjects completed the study – Femal
Slide 30: BTX 1204 positioning and opportunity
BTX 1204 positioning and opportunity Botanix is targeting efficacy improvements with much better safety profile than monoclonal antibodies and high potency steroids For personal use only BTX 1204 has potential to meet a number of More Favorable “The potent medications have too many side effects” - G
Slide 31: Disclaimer
Disclaimer For personal use only 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,
Botanix Pharmaceuticals — Non-Deal Roadshow (April 2018) on 6ix