Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (January 2019)
34 slides from Botanix Pharmaceuticals's investor presentation, Jan 31, 2019
Slide 1: 2019 Outlook: Transformative Year
For personal use only 2019 Outlook Transformative Year January 2019
Slide 2: Botanix value proposition
Botanix value proposition Billion dollar markets, unmet patient needs and a novel mechanism of action for skin disease, supported by positive early data and a rapid and cost effective development timeline For personal use only Large markets Market need Novel products Combined value of the markets No
Slide 3: 2019 outlook
2019 outlook Transformative year ahead, with planned completion of two Phase 2 studies, a Phase 1b patient study, along with milestones for the broader pipeline and the Permetrex™ technology platform For personal use only Data read-outs in 2019 from fully funded clinical studies for Multiple value p
Slide 4: Clinical programs with near term milestones
Clinical programs with near term milestones Leading Phase 2 acne and atopic dermatitis programs supported by exciting development pipeline, with Permetrex™ collaborations to augment revenue and news flow For personal use only Product candidate Indication Pre-clin Ph 1 Ph 1b Ph 2 Status (upcoming mil
Slide 5: Botanix has significant upside...
Botanix has significant upside... Botanix’s focus on high value pharmaceuticals, with de-risked late stage studies underway, underpins its significant upside potential against cannabis-related ASX companies For personal use only Significant potential value upside (A$m)1 Botanix’s key differentiating
Slide 6: ...compared to other dermatology companies in Phase 2 studies…
...compared to other dermatology companies in Phase 2 studies… Botanix appears to be undervalued relative to comparable stage dermatology companies, with two Phase 2 trials underway targeting indications with significant addressable markets For personal use only Value of Botanix relative to other de
Slide 7: ...with significant re-rating potential if data continues to be positive
...with significant re-rating potential if data continues to be positive Botanix has one of the most advanced cannabidiol clinical programs globally, with potential for a significant value re-rating following multiple positive clinical study outcomes For personal use only Market cap (US$m)1 US$4.2bn
Slide 8: Small, but very experienced team
Small, but very experienced team Global team with proven experience in dermatology and a track record of securing drug approvals For personal use only Mr Matthew Callahan Dr Michael Thurn Dr Stephane Levy Founder + Board Executive Director Head Australian Operations Chief Medical Officer Corporate +
Slide 9: Broader dermatology market overview – many more opportunities
Broader dermatology market overview – many more opportunities Global dermatology market expected to continue grow to US$33.7bn by 20221 and pipeline of new products remains very thin For personal use only Global dermatology market (US$bn) $40 • More than 3,000 types of dermatological conditions exis
Slide 10: The next wave is pharmaceuticals…
The next wave is pharmaceuticals… Significant investment in the sector is now focused on products, particularly novel pharmaceutical products with attractive market opportunities For personal use only Botanix Overview – January 2019 www.botanixpharma.com 10
Slide 11: Clinical pipeline
For personal use only Clinical pipeline • BTX 1308: psoriasis • BTX 1503: acne • BTX 1204: atopic dermatitis Botanix Overview – January 2019 www.botanixpharma.com 11
Slide 12: Psoriasis – market opportunity
Psoriasis Psoriasis – market opportunity Despite the introduction of biologic injections for severe psoriasis, significant opportunity exists for mild to moderate patients and particularly those patients with pruritus (itch) For personal use only 7.5m Total psoriasis patient population1 80% 6.0m Mil
Slide 13: Near term study completion – BTX 1308 for psoriasis
Psoriasis Near term study completion – BTX 1308 for psoriasis Phase 1b patient study is testing BTX 1308 against placebo (vehicle) and a widely used psoriasis drug in parallel For personal use only Bioskin GmbH psoriasis plaque model1 Novel multi-drug comparison study format in the same Multiple d
Slide 14: Psoriasis study due for completion late 1Q CY2019
Psoriasis Psoriasis study due for completion late 1Q CY2019 Study mostly enrolled with data planned to be available early in 2Q CY2019 For personal use only • Fully funded study • Successful data provides opportunity for corporate partnering • Biological mechanism of action data from biopsies taken
Slide 15: Global acne market continues to grow
Acne Global acne market continues to grow More than US$5bn of acne products are sold each year with no new drugs approved to treat acne by FDA in more than 20 years For personal use only Global acne market size (US$bn) $8 Global acne market is projected to reach CAGR: 4.6% ~US$7.3bn in 2025 $6 • Key
Slide 16: Botanix's acne target market share exceeds US$1.5bn p.a.
Acne Botanix’s acne target market share exceeds US$1.5bn p.a. Competitive products with less ideal safety profiles and potentially poorer efficacy generate more than US$1.5bn per annum between them in revenue For personal use only Top oral brands Top topical brands Revenue Revenue Rank Brands Script
Slide 17: Novel mechanism of action is proving out in studies
Acne Novel mechanism of action is proving out in studies BTX 1503 is a safe and well tolerated topical treatment that addresses all of the 3 causes of acne (current topical treatments only treat inflammation or bacterial infection) For personal use only BTX 1503 addresses acne pathologies in a CB1 a
Slide 18: Clinical data shows BTX 1503 outperforms leading acne products
Acne Clinical data shows BTX 1503 outperforms leading acne products 4 week Phase 1b study data shows a marked reduction in inflammatory lesions, greater than any other FDA approved topical acne product1 For personal use only Lesion count reduction (%) Comparison with other FDA approved products Lesi
Slide 19: Phase 2 patient study advancing on schedule
Acne Phase 2 patient study advancing on schedule All sites are active and recruiting patients, with some Australian sites already reaching maximum recruitment numbers in early 1Q CY2019 For personal use only • Fully funded study • No safety issues arising from treated patients to date • Positive fee
Slide 20: Atopic dermatitis – large unmet need for topical drugs
Atopic dermatitis Atopic dermatitis – large unmet need for topical drugs BTX 1204 addresses the need for a safe, non steroid topical option for chronic use with multiple mechanisms of action including anti-inflammatory, anti-microbial and immune modulating For personal use only Projected AD market b
Slide 21: BTX 1204: atopic dermatitis – mechanism of action
Atopic dermatitis BTX 1204: atopic dermatitis – mechanism of action Atopic dermatitis (and psoriasis) are both T-cell mediated inflammatory diseases of the skin For personal use only Acute phase Chronic phase 1. During the “acute phase”, dendritic cells cause excessive Th2 and Th17 cell activation 2
Slide 22: Phase 1b study results support efficacy and safety potential
Atopic dermatitis Phase 1b study results support efficacy and safety potential BTX 1204 was twice as effective as vehicle (with efficacy still increasing) and displayed a substantial improvement in the key signs of AD1 For personal use only Treatment success (%)2 40% Efficacy still increasing at 4 w
Slide 23: BTX 1204: atopic dermatitis – Phase 2 study design
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 study design 12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients with moderate AD For personal use only Design Endpoints • 2 dose groups: ~200 subjects • Primary endpoint - BTX
Slide 24: BTX 1204: atopic dermatitis – Phase 2 study underway
Atopic dermatitis BTX 1204: atopic dermatitis – Phase 2 study underway Phase 2 study commenced in late 4Q CY2018 and targeting top line data in 4Q CY2019 For personal use only • Program leverages existing data from BTX 1503 acne studies, lowering regulatory and safety hurdles • Common DEA licensed d
Slide 25: Development pipeline
For personal use only Development pipeline • BTX 1801: antimicrobial Botanix Overview – January 2019 www.botanixpharma.com 25
Slide 26: BTX 1801: novel antimicrobial for serious skin diseases
Antimicrobial BTX 1801: novel antimicrobial for serious skin diseases Natural potential of cannabinoids is enhanced by delivery with Permetrex™ technology For personal use only Minimum Inhibitory Concentration (MIC) effect of BTX 1801 against industry standard antibiotics 1 BTX 1801 may have the fol
Slide 27: BTX 1801 – market review complete for target indications
Antimicrobial BTX 1801 – market review complete for target indications Review addressed the potential for BTX 1801 in a range of skin infections based on performance of the product, bacteria that can be effectively killed and competitive position of target indications For personal use only Prioritis
Slide 28: Market for skin infections exceeds US$6.5bn per annum
Antimicrobial Market for skin infections exceeds US$6.5bn per annum The market for skin infection drugs continues to increase with the challenges of resistance driving the price of more effective products higher For personal use only Skin infection drugs market forecast 2014-2025 (US$m) 10,000 • Ski
Slide 29: First two targets - for impetigo and bacterial folliculitis
Antimicrobial First two targets - for impetigo and bacterial folliculitis Impetigo and bacterial folliculitis are two of the most common skin infections caused by Staph Aureus bacteria, where bacterial resistance to antibiotics is a growing problem For personal use only Impetigo Bacterial Folliculit
Slide 30: Permetrex™ skin delivery technology
Permetrex™ skin delivery technology Proprietary Permetrex™ technology delivers high doses of drug into the layers of the skin without use of permeation enhancers, preservatives, or irritating levels of alcohol / petrolatum additives For personal use only Unmodified drug With Permetrex™ Drug sits on
Slide 31: Permetrex™ technology enables superior delivery of cannabidiol (CBD)
Permetrex™ technology enables superior delivery of cannabidiol (CBD) Permetrex™ delivers more CBD into the target layers of the skin, even though the CBD concentration of the BTX 1503 formulation is only 25% to 50% the concentration of alternative formulations For personal use only Cannabidiol (CBD)
Slide 32: Outlook
For personal use only Outlook • CY2019 - Transformative year Botanix Overview – January 2019 www.botanixpharma.com 32
Slide 33: Key catalysts
Key catalysts Significant clinical and operational milestones across multiple programs expected over the next 12 months For personal use only Indicative activities and milestones 1Q CY2019 2Q CY2019 3Q CY2019 4Q CY2019 Upcoming milestones BTX 1308 Phase 1b study in psoriasis Top line data early 2Q P
Slide 34: Contact us
For personal use only Contact us Matt Callahan Botanix Pharmaceuticals Founder and Board Executive Director P: +1 215 767 4184 E: mcallahan@botanixpharma.com Visit us www.botanixpharma.com Follow us on social media Botanix Pharmaceuticals Limited (ASX:BOT) Botanix Overview – January 2019 www.botanix
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