Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — American Academy of Dermatology Annual Meeting 2018
34 slides from Botanix Pharmaceuticals's conference presentation, Feb 15, 2018
Slide 1: Botanix to present at the American Academy of Dermatology annual meeting
ASX/Media Release 15 February 2018 For personal use only Botanix to present at the American Academy of Dermatology annual meeting • Botanix will be presenting at the 76th AAD annual meeting in San Diego, California • Botanix to showcase recent results of the BTX 1503 study and progression of other c
Slide 2: About Botanix and contact details
first acne patient studies with BTX 1503 and is currently conducting another patient study in atopic dermatitis subjects for its second clinical program, BTX 1204. The Company has an exclusive license to use a proprietary drug delivery system (PermetrexTM) for direct skin delivery of active For pers
Slide 3: American Academy of Dermatology February 2018
For personal use only American Academy of Dermatology February 2018
Slide 4: Investment highlights
+Investment highlights For personal use only Botanix is an emerging global dermatology company with advanced clinical programs in acne and atopic dermatitis, with a promising development pipeline § Targeting multi-billion dollar prescription markets for acne (with no new Dermatology products approve
Slide 5: Corporate overview
+Corporate overview For personal use only Medical dermatology company with a clear path to commercialisation and a highly aligned Board and management team Trading information Share price performance Share price (14-Feb-18) A$0.110 Share price (A$) Volume (m) 0.20 100 52 week low / high A$0.040 / A$
Slide 6: Senior leadership: proven track record of success
+Senior leadership: proven track record of success For personal use only Proven industry professionals with experience in rapid development of pharmaceuticals Mr Matthew Callahan Corporate + IP 20+ FDA approved Executive Director products § Developed 3 products to date that have received FDA approva
Slide 7: Clinical programs with near term milestones
+Clinical programs with near term milestones For personal use only Rapidly advancing acne and atopic dermatitis programs, with deeper pipeline in development as well as PermetrexTM collaborations to augment revenue and news flow Product candidate Indication Pre-Clin Ph 1 Ph 1b Ph 2 Next milestones M
Slide 8: BTX 1503 moderate to severe acne
For personal use only + BTX 1503 moderate to severe acne
Slide 9: How does BTX 1503 work to treat acne?
+ How does BTX 1503 work to treat acne? For personal use only BTX 1503 utilises synthetic form of a natural product known as cannabidiol, combined with the novel PermetrexTM skin delivery technology Attacks P. Acnes Reduces bacteria Inflammation Switches off excess Retards formation production of of
Slide 10: BTX 1503 Phase 1b acne patient study
+BTX 1503 Phase 1b acne patient study For personal use only 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 Baseline Safety § 21 subjects enrolled § 18 subjects completed the study ‒ Fema
Slide 11: BTX 1503 outperformed leading acne products
+BTX 1503 outperformed leading acne products For personal use only Phase 1b acne patient study data resulted in a reduction in inflammatory lesions greater than any other FDA approved topical acne product at 4 weeks Lesion count reduction (%) Comparison of other FDA approved products Inflammatory le
Slide 12: Phase 1b acne patient study data
+Phase 1b acne patient study data For personal use only Patient satisfaction high due to the rapid onset of improvement and significant effect on inflammatory lesions Photographs of acne study patient before and after treatment1 Patient result 57% reduction in inflammatory lesions 15% reduction in n
Slide 13: Why are we focused first on acne?
+Why are we focused first on acne? For personal use only In 2016, the global acne prescription market was worth ~US$4.9bn, with the potential to grow to ~US$7.3bn by 2025 Global acne market size (US$m) Topical acne products revenue in 2016 (US$m) Value of the global acne 494 456 The top two leading
Slide 14: Leading US branded topical acne products
+Leading US branded topical acne products For personal use only Leading topical branded acne products generated ~3m prescriptions in 2016 Topical acne products prescriptions in 2016 (‘000s) 2016 list price and cost of topical acne products Drug List price (US$) Annual cost (US$)1 1,179 Epiduo® / $39
Slide 15: BTX 1503 market positioning
+BTX 1503 market positioning For personal use only Current acne treatments do not treat all key acne pathogenic factors and have varying levels of side effects and disadvantages Market landscape for acne treatments1 Pathogenic factors Sebum Hyper P.Acnes Agents Inflammation Key considerations / disa
Slide 16: BTX 1503 development timeline overview
+BTX 1503 development timeline overview For personal use only Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first revenues § Proof of concept established in successful Phase 1b acne patient study § Pre-IND meeting with the FDA complet
Slide 17: BTX 1204 mild to moderate atopic dermatitis
For personal use only + BTX 1204 mild to moderate atopic dermatitis
Slide 18: BTX 1204 for atopic dermatitis
+BTX 1204 for atopic dermatitis For personal use only 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 Potential mechanism of actions ü Decrease differentiation, proliferation and activ
Slide 19: Global atopic dermatitis market
+Global atopic dermatitis market For personal use only The global atopic dermatitis market is forecasted to grow at a CAGR of 12.8% from ~US$7bn in 2017 to ~US$24bn by 2027 Projected AD market by revenue (US$bn) Leading topical branded AD products by revenue (US$m) $25 $400 $20 $300 $15 $200 $10 $10
Slide 20: Leading US branded atopic dermatitis products
+Leading US branded atopic dermatitis products For personal use only Leading topical branded atopic dermatitis products generated >550k prescriptions in 2017 Leading topical AD products by prescription (‘000s) 2016 list price and cost of topical AD products 800 Drug List price (US$) Annual cost (US$
Slide 21: BTX 1204 positioning and opportunity
+BTX 1204 positioning and opportunity For personal use only Botanix is targeting efficacy improvements with much better safety profile than monoclonal antibodies and high potency steroids BTX 1204 has potential to meet a number of “The potent medications have too many side effects” - GP unmet needs…
Slide 22: BTX 1204 Phase 1b atopic dermatitis study
+BTX 1204 Phase 1b atopic dermatitis study For personal use only 4-week randomised, double-blind, vehicle controlled patient study to determine the safety and tolerability of BTX 1204 in subjects with mild to moderate atopic dermatitis Design Endpoints § ~36 subjects 18 years and older (24 active /
Slide 23: BTX 1204 for atopic dermatitis
+BTX 1204 for atopic dermatitis For personal use only Phase 1b patient study commenced in late October 2017, with expected study completion and data planned for 2Q CY2018 BTX 1204 indicative clinical timeline (CY) 1Q 2018 2Q 2018 3Q 2018 4Q 2018 § Received HREC approval in late Ethics approval Octob
Slide 24: Development pipeline, Permetrex, key milestones and next steps
For personal use only + Development pipeline, Permetrex™, key milestones and next steps
Slide 25: Development pipeline
+Development pipeline For personal use only Development pipeline also includes other synthetic cannabidiol and PermetrexTM enabled products targeting key dermatology markets BTX 1308: psoriasis BTX 1308 leverages prior § Target market: ~7.5m Americans have psoriasis (note: most have plaque data from
Slide 26: Permetrex skin delivery technology
+Permetrex™ skin delivery technology For personal use only PermetrexTM 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 Unmodified Drug With Permetrex™ Formulation technology drives drug into the skin Drug s
Slide 27: Permetrex opportunities
+Permetrex™ opportunities For personal use only Range of opportunities to utilise Permetrex™ technology for internal product development and partnered programs Early collaborations leading to license discussions § Many companies have challenges formulating drugs for delivery into the skin § Botanix
Slide 28: Upcoming milestones
+Upcoming milestones For personal use only Significant operational milestones expected over the next 12 months, as Botanix advances key products, broadens product pipeline and undertakes further development 1Q 2Q 3Q 4Q 1Q Indicative activities and milestones CY2018 CY2018 CY2018 CY2018 CY2019 Phase
Slide 29: Appendix
For personal use only +Appendix
Slide 30: Botanix's product portfolio value considerations
+Botanix’s product portfolio value considerations For personal use only Licensing and partnering transactions are potential monetisation options before FDA approval, with value increasing significantly as a product progress through development Recent dermatology transactions (licensing, asset and co
Slide 31: Valuable intellectual property portfolio
+Valuable intellectual property portfolio For personal use only Botanix has protected its suit of development products through various patent applications across key global markets Expanded patent applications for BTX 1503 and other PermetrexTM § Botanix currently has 16 patent applications enabled
Slide 32: What do early clinical studies tell you?
+What do early clinical studies tell you? For personal use only Short term patient studies are valuable to provide indications of safety and efficacy which can be extrapolated (based on prior clinical data) for potential longer term effect Prior clinical data to extrapolate potential effect1 Mean re
Slide 33: Leading US branded products by revenue
+Leading US branded products by revenue For personal use only Leading topical and oral branded acne products generated sales of ~US$4.9bn in 2016 Topical branded acne product sales in 2016 (US$m) Oral branded acne product sales in 2016 (US$m) $494 $596 $456 $322 $225 $211 $161 $102 Epiduo®/ Aczone®
Slide 34: 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,
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