Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (June 2018)
32 slides from Botanix Pharmaceuticals's investor presentation, Jun 12, 2018
Slide 1: ASX/Media Release: Updated investor presentation
ASX/Media Release 12 June 2018 For personal use only Updated investor presentation Philadelphia PA and Sydney Australia, 12 June 2018: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or the “Company”) is pleased to release an updated investor presentation following th
Slide 2: For more information, please contact
For more information, please contact: General enquiries Investor enquiries For personal use only Matt Callahan Joel Seah Botanix Pharmaceuticals Vesparum Capital Executive Director P: +61 3 8582 4800 P: +1 215 767 4184 E: botanixpharma@vesparum.com E: mcallahan@botanixpharma.com Media enquiries Juli
Slide 3: Investor presentation June 2018
For personal use only Investor presentation June 2018 1
Slide 4: Agenda
Agenda For personal use only 1. Overview of Botanix Pharmaceuticals 2. BTX 1204 for mild to moderate atopic dermatitis 3. BTX 1503 for moderate to severe acne 4. Development pipeline, key milestones and next steps 2 Investor update
Slide 5: Overview of Botanix Pharmaceuticals
1. Overview of For personal use only Botanix Pharmaceuticals 3 Investor update
Slide 6: Investment highlights
Investment highlights Botanix is an emerging global dermatology company with 2 advanced clinical programs and a strong pipeline 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 derma
Slide 7: 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 8-June-2018) A$0.15 Share price (A$) Volume (m) 52 week low / high A$0.041 / A$0.1
Slide 8: 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™ For personal use only collaborations to augment revenue and news flow Product candidate Indication Pre-Clin Ph 1 Ph 1b Ph 2 Next milestones Moderate t
Slide 9: 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 10: BTX 1204: mild to moderate atopic dermatitis
2. BTX 1204: mild to For personal use only moderate atopic dermatitis 8 Investor update
Slide 11: Atopic dermatitis disease overview
Atopic dermatitis disease overview Atopic dermatitis (AD) is a chronically relapsing skin disorder with an immunologic basis, but for which environmental For personal use only factors (allergens, stress, food and skin flora) all play a part Disease pathology and common treatments • The exact cause o
Slide 12: Global atopic dermatitis market
Global atopic dermatitis market The global AD 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%) ELIDEL® EUCRISA™
Slide 13: Leading US branded atopic dermatitis products
Leading US branded atopic dermatitis products Leading topical branded AD products generated >550k prescriptions in 2017 For personal use only Leading topical AD products by prescription (‘000s)1 2016 list price and cost of topical AD products PROTOPIC® (0.1% & 0.03%) ELIDEL® EUCRISA™ Drug List price
Slide 14: BTX 1204 Phase 1b atopic dermatitis patient study
BTX 1204 Phase 1b atopic dermatitis patient study The successful 4-week, double-blind, vehicle controlled patient study commenced in November 2017 and concluded in For personal use only June 2018 Design Endpoints • 37 subjects 18 years and older: • Primary endpoints: – 25 on BTX 1204 / 12 vehicle –
Slide 15: BTX 1204 Phase 1b study results
BTX 1204 Phase 1b study results After only 4 weeks of treatment, study data indicated BTX 1204 was twice as effective over the vehicle (with efficacy still For personal use only increasing) and substantial improvement in the key signs of AD observed Treatment success (%)1 Key takeaways 40% Efficacy
Slide 16: BTX 1204 Phase 1b study results
BTX 1204 Phase 1b study results Substantial reduction in key signs of AD, provides confidence that unmet needs in AD (itch / inflammation) can be For personal use only addressed Treatment Success1 Substantial reduction in the key signs of AD2 Erythema Exudation Lichenification 0 (0.2) (0.4) (0.6) BT
Slide 17: BTX 1204 study data in context
BTX 1204 study data in context Substantial reduction in key signs of AD, provides confidence that unmet needs in AD (itch / inflammation) can be For personal use only addressed Treatment success1 across treatment period (%) Comparison with other FDA approved products 40% Based on increasing efficacy
Slide 18: BTX 1204 positioning and opportunity
BTX 1204 positioning and opportunity post Phase 1b study data Botanix is targeting efficacy improvements with much better safety profile than monoclonal antibodies (Dupixent®), TCI’s For personal use only (Protopic®) and high potency steroids, with new benefits in inflammation and itch reduction BTX
Slide 19: Proposed BTX 1204 Phase 2 study design
Proposed BTX 1204 Phase 2 study design 10-12 week randomised, double-blind, vehicle controlled study to evaluate the safety and efficacy of BTX 1204 in patients For personal use only with moderate AD1 Design Endpoints • 3 dose groups: ~270 subjects • Primary endpoints: – High Dose twice a day: ~90 s
Slide 20: BTX 1204 next steps
BTX 1204 next steps Botanix is pursuing a rapid clinical development strategy to accelerate product commercialisation and timing to first For personal use only revenues BTX 1204 indicative clinical timeline (CY) 2Q 2018 3Q 2018 4Q 2018 1Q 2018 2Q 2018 • Development program leverages existing data fr
Slide 21: BTX 1503: moderate to severe acne
3. BTX 1503: For personal use only moderate to severe acne 19 Investor update
Slide 22: 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 23: 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 For personal use only weeks Lesion count reduction (%) Comparison of other FDA approved products Inflammatory lesions Non-inflammatory
Slide 24: 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 For personal use only patients with moderate to severe acne Design Endpoints • 5 dose groups: ~360 subjects • Primary endpoints: – High Dose twice a day: ~
Slide 25: 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 For personal use only revenues • IND approved by FDA to enable commencement of Phase 2 clinical trial in the US and Australia • Phase 2 clinica
Slide 26: Development pipeline, key milestones and next steps
4. Development pipeline, key For personal use only milestones and next steps 24 Investor update
Slide 27: Development pipeline
Development pipeline Development pipeline also includes other synthetic cannabidiol and Permetrex™ enabled products targeting key For personal use only dermatology markets BTX 1308: psoriasis • Target market: ~7.5m Americans have psoriasis (note: most have plaque psoriasis) BTX 1308 leverages prior
Slide 28: 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 For personal use only stream and even less to the skin Unmodified Drug With Permetrex™ Formulation technology drives drug into the skin Drug sit
Slide 29: 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 30: Company upcoming milestones
Company upcoming milestones Significant clinical and operational milestones across multiple programs expected over the next 12 months For personal use only Indicative activities and milestones 2Q CY2018 3Q CY2018 4Q CY2018 1Q CY2019 2Q CY2019 First patient enrolled in Phase 2 trial BTX 1503 Acne Pha
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,
Slide 32: Contact us
For personal use only Contact us Matt Callahan Visit us Botanix Pharmaceuticals www.botanixpharma.com Executive Director Follow us on social media P: +1 215 767 4184 E: mcallahan@botanixpharma.com 30 Botanix Pharmaceuticals Limited (ASX:BOT)
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