Botanix Pharmaceuticals Limited · ASX:BOT

Botanix Pharmaceuticals — Shareholder Meeting (November 2016)

28 slides from Botanix Pharmaceuticals's shareholder meeting presentation, Nov 30, 2016

  1. Slide 1: AGM Presentation – 30 November 2016

    + For personal use only restoring healthy skin AGM Presentation – 30 November 2016 ASX:BOT www.botanixpharma.com

  2. Slide 2: Notice

    + Notice For personal use only 2 This presenta,on prepared by Botanix Pharmaceu,cals Limited ("Company") does not cons,tute, or form part of, an offer to sell or the solicita,on of an offer to subscribe for or buy any securi,es, nor the solicita,on of any vote or approval in any jurisdic,on, nor shall

  3. Slide 3: Agenda

    + Agenda For personal use only 3 1. Recap on Botanix 2. Achievements since listing/program update 3. Acne market opportunities and developments 4. Permetrex™ and other opportunities 5. Upcoming news flow and milestones Confidential Property of Botanix Pharma

  4. Slide 4: Recap on Botanix

    + Recap on Botanix For personal use only 4 n Focused on new treatments for serious skin diseases – initial target is acne n First product (BTX1503) utilizes a synthetic Business focus: form of cannabidiol as the drug active - – medical dermatology pharmaceutical grade and commercially manufactured I

  5. Slide 5: Corporate

    +Corporate For personal use only 5 Corporate Team ASX BOT Chairman Graham Griffiths • Nearmap • Pointerra Offer Price $0.020 • NGIS Exec Director Matt Callahan • iCeutica Cash raised under the Offer $3,500,000 • Churchill Pharma • Orthocell Share Price (@ close $0.046 Exec Director Dr Bill Bosch • i

  6. Slide 6: Cannabidiol drug showing promising results…

    + Cannabidiol drug showing 6 promising results… For personal use only

  7. Slide 7: BTX1503 – novel mechanism of action in acne

    + BTX1503 – novel mechanism of action in acne For personal use only 7 Switches off excessive oil or ‘sebum’ production Reduces inflammation Blocks cell proliferation Reduces infection BTX1503 also targeting a benign side effect profile

  8. Slide 8: Source and purity of drug material is important

    + Source and purity of drug material is important For personal use only 8 Extracted and purified Synthetically manufactured 100+ chemicals 1 chemical Multiple impurities 100% pure Scaled up to ≈ 1kg Scaled up to 50kg Not registered with FDA Registered with FDA Must comply with FDA’s No additional co

  9. Slide 9: The difference is clear

    + The difference is clear For personal use only 9 Naturally extracted Cannabidiol Synthetic Cannabidiol

  10. Slide 10: BTX1503 - planned positioning versus existing acne products

    + BTX1503 - planned positioning versus existing acne products For personal use only 10 Reduces Sebum ✓ ✗ ✗ ✗ ✗ ✗ ✓ Anti-inflammatory ✓ ✗ ✓ ✓ ✗ ✗ ✓ Anti-microbial ✓ ✓ ✗ ✗ ✓ ✓ ✓ Topical ✓ ✗ ✓ ✓ ✗ ✗ ✗ Minimal side effects ✓ ✗ ✓ ✓ ✗ ✓ ✗ “…the ‘Holy Grail’ of acne treatments would be a topical that can i

  11. Slide 11: Agenda

    + Agenda For personal use only 11 1. Recap on Botanix 2. Achievements since listing/program update 3. Acne market opportunities and developments 4. Permetrex™ and other opportunities 5. Upcoming news flow and milestones Confidential Property of Botanix Pharma

  12. Slide 12: Objective – avoid the usual drug development process

    + Objective – avoid the usual 12 drug development process For personal use only 5 Years 7 Years 2 Years ✗ $430m* $0.55m** $25.3m** $34.9m** $54m** $5.25m* Non-capitalized cost in millions USD (2013) Partner/Exit Sources: * J. A DiMasi et al J Health Econ. 2016 ** http://www.fda.gov/ForIndustry/UserF

  13. Slide 13: Botanix is pursuing a more investable approach

    + Botanix is pursuing a more 13 investable approach For personal use only 6 months 5 Years 6 months ~28 months 7 Years 2 Years ✔ $430m* $0.55m** $25.3m** $34.9m** $54m** $5.25m* $1m $1.5m ~$5m ~$15m Partner/Exit Sources: * J. A DiMasi et al J Health Econ. 2016 ** http://www.fda.gov/ForIndustry/UserF

  14. Slide 14: Achievements since listing

    + Achievements since listing For personal use only 14 BTX-1503: n Source of commercial scale synthetic cannabidiol secured n DEA Schedule-1 manufacturer engaged n Phase 1 trial formulation manufactured using FDA quality components n Genotox, bioassay, animal tox and other testing advanced n Phase 1a

  15. Slide 15: Achievements since listing (cont'd)

    + Achievements since listing 15 (cont’d) For personal use only General: n Experienced staff engaged including: n Mark Davis – clinical and regulatory – 35 years experience n Steve Newhard – manufacturing and packaging – 30 years experience n Doug Bakan - manufacturing and packaging – 28 years experi

  16. Slide 16: BTX 1503 – updated timeline

    + BTX 1503 – updated timeline For personal use only 16 2016 2017 Formulation manufacturing and testing Pre-clinical testing and animal studies Permetrex™ FDA standard manufacturing Permetrex™ human safety/irritation trial BTX-1503 FDA standard manufacturing BTX-1503 FDA material testing Ethics appli

  17. Slide 17: Agenda

    + Agenda For personal use only 17 1. Recap on Botanix 2. Achievements since listing/program update 3. Acne market opportunities and developments 4. Permetrex™ and other opportunities 5. Upcoming news flow and milestones Confidential Property of Botanix Pharma

  18. Slide 18: Market for prescription acne products is very large

    + Market for prescription acne 18 products is very large For personal use only Value of the Global Acne Prescription Market is expected to reach $4.5 billion by 2018 (1) The top branded topical prescription acne products have achieved peak revenues in the range of $85 - $331 million (2) 1) BCC Resea

  19. Slide 19: Market for OTC and generic acne products is also very large

    + Market for OTC and generic acne 19 products is also very large For personal use only Revenue from OTC acne treatments expected to increase to $2.7 billion by 2018 (1) Market is dominated by “me too” reformulations of old drugs and generics that carry significant side effect and patient usage issue

  20. Slide 20: Nothing new for the last years and little expected

    + Nothing new for the last 10 years 20 and little expected For personal use only • No products have approved by FDA in the last 10 years containing a new active ingredient • All “new products” launched in this period contain combinations of old drugs in new formulations or packaging • 50 million pat

  21. Slide 21: Agenda

    + Agenda For personal use only 21 1. Recap on Botanix 2. Achievements since listing/program update 3. Acne market opportunities and developments 4. Permetrex™ and other opportunities 5. Upcoming news flow and milestones Confidential Property of Botanix Pharma

  22. Slide 22: Permetrex™ - superior skin delivery

    + Permetrex™ - superior skin 22 delivery For personal use only Oral delivery of cannabidiol is only 6% bioavailable Unmodified Drug With Permetrex™ Epidermis Dermis Confidential Property of Botanix Pharma

  23. Slide 23: Pipeline – cannabidiol products

    + Pipeline – cannabidiol products For personal use only 23 • 7.5 million Americans have psoriasis (most have plaque psoriasis) • Cost of injectable biologic treatments in 2014 BTX 1308 was $20 billion (psoriasis) • Biologic drugs have serious side effect issues (including lymphoma) • US patient inci

  24. Slide 24: Market for skin care products (particularly facial) is significant

    + Market for skin care products (particularly facial) is significant For personal use only 24 The global skin care market is estimated to be worth $154 billion by 2021 Global Skin Care Market – Projected Revenue through $180 2021 $154 $160 $147 $140 Annual Revenue ($ billions) $140 $127 $133 $115 $1

  25. Slide 25: Many existing acne products can be improved

    + Many existing acne products can 25 be improved For personal use only % Reduction in Lesions and IGA Success 60% EPIDUO Clinical Trial Acanya Clinical Trial 50% 48% 42% 40% 37% 35% 31% 32% 29% 30% 26% 26% 20% 20% 16% 10% 8% 0% BPO 2.5% EPIDUO Vehicle Vehicle BPOAcanya 2.5% Vehicle Vehicle Inflammat

  26. Slide 26: Agenda

    + Agenda For personal use only 26 1. Recap on Botanix 2. Achievements since listing/program update 3. Acne market opportunities and developments 4. Permetrex™ and other opportunities 5. Upcoming news flow and milestones Confidential Property of Botanix Pharma

  27. Slide 27: Upcoming news flow and milestones in next months

    + Upcoming news flow and 27 milestones in next 9 months For personal use only n Permetrex™ safety and irritation clinical study results n Ethics application for Phase 1 studies n Import licenses for BTX-1503 clinical trial material n Collaborative research arrangements n New product addition to pipe

  28. Slide 28: Botanix …a compelling investment case

    + 28 Botanix …a compelling investment case For personal use only ü Significant unmet patient needs in serious skin diseases ü Novel treatment for acne with a growing evidence base ü Proprietary drug delivery system ü Fast and efficient development pathway, relative to usual pharmaceutical developmen

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