Acrux Limited · ASX:ACR
Acrux — 18th Bioshares Biotech Summit 2024
14 slides from Acrux's conference presentation, Jul 15, 2024
Slide 1: Acrux presentation at the 18th Bioshares Biotech Summit
ASX Release Acrux presentation at the 18th Bioshares Biotech Summit Melbourne, Australia; 15 July 2024 Acrux Limited (ASX:ACR, “Acrux” or the “Company”), is pleased to publish the presentation given by CEO and Managing Director, Michael Kotsanis on Saturday 13 July at the 18th Bioshares Biotech Summ
Slide 2: Acrux
ACRUX Acrux is a specialty pharmaceutical company focussed on development and commercialisation Topically applied prescription pharmaceutical products are our expertise Bioshares, 18th Biotech Summit July 2024
Slide 3: 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 4: Acrux is a leader in 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 5: Acrux focus: Topical drugs
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 pharma market ingested orally (including directly to the skin, eyes, ears) (capsules,
Slide 6: 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 7: Acrux's objective is to develop a diversified product portfolio
Acrux topical product portfolio Development Under FDA Approved* Marketed phase review Evamist® Lenzetto® 7 topical Dapsone 7.5%, Nitroglycerin Efinaconazole Prilocaine/ (estradiol) (estradiol) prescription Acyclovir Cream Dapsone 5%, Gel Gel rectal Ointment Topical Solution Lidocaine Cream Topical S
Slide 8: 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 9: 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 10: 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 11: Acrux quarterly cashflow
Acrux quarterly cashflow ($000s) 10,000 8,000 6,000 4,000 2,000 $000s 0 -2,000 -4,000 Q3, 2022 Q4, 2022 Q1, 2023 Q2, 2023 Q3, 2023 Q4, 2023 Q1, 2024 QTR Net Cash from Operating Activities Cash and Cash Equivalents at end of period 10 Data – Appendix 4C from Q3, 2022 to Q1, 2024
Slide 12: 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 3 products currently under evaluation by the FDA FDA approval of 4 products since 2021 2 recent launches in the United States Strong pipeline of products under development 11
Slide 13: Corporate Overview
Corporate Overview Ticker ASX: ACR Market capitalisation $17.4 million Share price $0.06 Shares on issue 290,716,856 Average daily liquidity 553k shares (average over 6 months) Source: https://www.morningstar.com.au/investments/security/ASX/ACR/chart - 1 year chart Substantial Shareholder Holding %
Slide 14: 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