Acrux Limited · ASX:ACR
Acrux — ASX Small and Mid Cap Conference 2024
19 slides from Acrux's conference presentation, Sep 24, 2024
Slide 1: ASX Release: ASX Small and Mid Cap Conference Acrux presentation
ASX Release ASX Small and Mid Cap Conference Acrux presentation Melbourne, Australia; 24 September 2024 Acrux Limited (ASX:ACR, “Acrux” or the “Company”), is pleased to publish the presentation that will be given by CEO and Managing Director, Michael Kotsanis on Wednesday 25 September at 11.27am at
Slide 2: Approved for release by the Acrux Board of Directors
Approved for release by the Acrux Board of Directors. For more information, please contact: Michael Kotsanis Acrux Limited CEO & Managing Director P: + 61 3 8379 0100 E: michael.kotsanis@acrux.com.au About Acrux Acrux is a specialty pharma company with a successful track record of developing and com
Slide 3: Acrux: specialty pharmaceutical company
ACRUX Acrux is a specialty pharmaceutical company focussed on development and commercialisation Topically applied prescription pharmaceutical products are our expertise ASX Small and Mid Cap Conference 25 September 2024
Slide 4: Disclaimer
Disclaimer This presentation contains forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements are based on an assessment of present economic and op
Slide 5: Acrux is a leader in the development of topically applied prescription pharma products
Acrux is a leader in the development of topically applied prescription pharma products An Australian based Founded in 1998 Skills and Network of Contract Network of leader in the with a 25+ year competence to meet Development and commercial development of track record with US complex US FDA Manufact
Slide 6: Acrux is well on the pathway to commercial sustainability
Acrux is well on the pathway to commercial sustainability Future 2024 2021 Increasing operating cash flows as products 3 product launches are approved and 2017 First FDA 5 FDA approved products launched ANDA 2 products pending approval approval Development of initial products in topical 2014 Single
Slide 7: Acrux growth platform
Acrux growth platform Through investment in our pipeline, Acrux has proven its capability to develop, receive approval and monetise topical drugs Acrux receives royalties on a quarterly basis. Acrux ON MARKET 3 Revenue generating products expects a typical licence agreement to consist of a recurring
Slide 8: 2 recent launches in the United States, 2 more launches planned
Acrux recent product launches and future planned launches Prilocaine 2.5% Lidocaine 2.5%, Cream Dapsone 5%, Gel Launched December 2022 Launched April 2024 US FDA approved indication as a topical anesthetic US FDA approved indication for the topical treatment for local analgesia* of acne vulgaris* 2
Slide 9: Acrux focusses on topically applied pharmaceutical products
Acrux focusses on topically applied pharmaceutical products The market size for topically applied pharmaceutical products is US$21 billion1 Dosage forms include creams gels, ointments, suspensions, solutions, patches Total market includes oral, injectable, inhalation and topical dosage forms Sterile
Slide 10: US$21 billion market has a broad range of development targets
There is a significant range of topically applied pharmaceuticals that Acrux can target US$21 billion* market has a broad range of development targets for topically applied pharmaceuticals Application site >US$100m US$50m-100m US$10m-50m TOPICAL DERMATOLOGICALS 13 11 81 TOPICAL OPHTHALMIC 14 11 48 T
Slide 11: Topical product portfolio
Acrux topical product portfolio Development Under FDA Approved* Marketed phase review Evamist® Lenzetto® 7 topical Nitroglycerin Efinaconazole Dapsone 7.5%, Prilocaine/ (estradiol) (estradiol) prescription Acyclovir Cream Dapsone 5%, Gel rectal Ointment Topical Solution Gel Lidocaine Cream Topical S
Slide 12: Acrux topical generic portfolio – addressable market is over US$1.1 billion
Acrux topical generic portfolio – addressable market is over $1.1 billion* US$64 million US$228 million 0 marketed generics 1 marketed generics 2 marketed generics US$591 million 3 marketed generics US$66 million 4 marketed generics 5 marketed generics US$167 million US$22 million Strong pipeline of
Slide 13: Long Term Growth Model
Long Term Growth Model With a TGA approved GMP facility and 25 specialised scientists, Acrux possesses the 1 2 capabilities for the development, regulatory Development submission and approval of generic topical and Generic drug and tech identification transdermal drugs transfer Expertise extends
Slide 14: Facilities and Capabilities
Facilities and Capabilities R&D focus - onsite laboratories and GMP licensed facility FDA remote regulatory assessment and inspected by TGA Early development process conducted at Acrux laboratory in Melbourne, Australia Bioequivalence testing conducted to meet FDA Product Specific Guidances includin
Slide 15: Growth outlook based on a track record of developing and commercialising products
Growth outlook based on a track record of developing and commercialising products 2 recent launches in the United States, 2 more launches planned Revenue generation from commercialised products 2 products currently under evaluation by the FDA FDA approval of 5 products since 2021 Strong pipeline of
Slide 16: Appendix
Appendix ACRUX
Slide 17: What is a generic drug?
What is a generic drug? Therapeutic Goods Administration (TGA) – Australia “A generic medicine is an additional brand of an existing medicine. It contains the same active ingredient (the chemical that makes the medicine work) as the existing medicine. Apart from containing the same active ingredient
Slide 18: Corporate Overview and share price
Corporate Overview and share price Key Data Acrux over 12 months Ticker ASX: ACR ASX: ACR - Last 12 Months $0.090 45.000 m Market capitalisation $15.7 million $0.080 40.000 m 52 week range $0.035 - $0.099 $0.070 35.000 m Share price $0.054 $0.060 30.000 m Share Price Shares on issue 290.7 million $0
Slide 19: Connecting with Acrux
Connecting with Acrux www.acrux.com.au ASX: ACR info@acrux.com.au +61 3 8379 0100 Follow Acrux on LinkedIn 17