Slide 1: Acrux
ACRUX Acrux is a specialty pharmaceutical company focussed on development and commercialisation Topically applied prescription pharmaceutical products are our expertise August 2024
Slide 2: 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 3: 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 competence to meet Development and commercial development of 25+ year complex US FDA Manufacturing licensees which
Slide 4: Outlook based on a track record of developing and commercialising products
Outlook based on a track record of developing and commercialising products Revenue generation from commercialised products 2 products currently under evaluation by the FDA FDA approval of 5 products since 2021 2 recent launches in the United States Strong pipeline of products under development 4
Slide 5: Acrux is focussed on an underserved market segment in the United States
Acrux is focussed on an underserved market segment in the United States Total market Oral drugs Acrux focus: Topical drugs Drugs that are Total US prescription Drugs that are applied topically Definition of market ingested orally pharma market (including directly to the skin, eyes, ears) (capsules,
Slide 6: Acrux 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 7: Waterfall – Net Profit after Tax
Waterfall – Net Profit after Tax 7
Slide 8: 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 9: Development Processes
Development Processes Activities may include • Acrux has a current TGA license for development manufacture of transdermal/topical and transmucosal products for clinical trials and testing in • FDA Remote Regulatory Assessment in 2023 Acrux’s GMP for in-vitro bioequivalence testing which found facili
Slide 10: Facilities and Capabilities
Facilities and Capabilities R&D focus - onsite laboratories and GMP licensed facility Inspected by TGA and FDA Early development process conducted at Acrux laboratory in Melbourne, Australia Bioequivalence testing conducted to meet FDA Product Specific Guidances including in-vitro tests (IVRT, IVPT)
Slide 11: Acrux recent product launches and future planned launches
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 US FDA approved indication for the topical anesthetic for local analgesia* topical treatment of acne vulgaris* Plan
Slide 12: Corporate Overview
Corporate Overview Ticker ASX: ACR Market capitalisation $19 million Share price $0.07 Shares on issue 290,716,856 Average daily liquidity 567k shares (average over 6 months) Source: https://www.morningstar.com.au/investments/security/ASX/ACR/chart - 1 year chart Substantial Shareholder Holding % Ph
Slide 13: Connecting with Acrux
Connecting with Acrux www.acrux.com.au ASX: ACR info@acrux.com.au +61 3 8379 0100 Follow Acrux on LinkedIn 13