Acrux Limited · ASX:ACR
Acrux — Investor Presentation (February 2025)
19 slides from Acrux's investor presentation, Feb 25, 2025
Slide 1: Investor Presentation
Investor Presentation February 2025 Acrux is a specialty pharmaceutical company focused on the development and commercialization of topically applied pharmaceutical products
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 Founded in 1998 with a 25+ year Skills and competence to meet Network of Contract Development and Commercial licensees have track record with US NDA, US complex US FDA Product Manufacturing Organisations (CDMO) co
Slide 4: Acrux growth platform
Acrux growth platform Through investment in our pipeline, Acrux has proven its capability to develop, receive approval for and monetise topical dru gs Targeting topical drugs 8 generic 40 Identified topical drugs, each A$20m* in 4 revenue generating 1 product >US$100m in sales products in total reve
Slide 5: Long term growth model and Facilities and Capabilities
Long term growth model 1 2 3 4 Facilities and Capabilities Generic Development Product FDA review drug and tech launch identification and approval via licensing R&D focus - onsite laboratories and GMP transfer deals licensed facility FDA remote regulatory assessment and inspected by TGA Early develo
Slide 6: Acrux topical product portfolio – United States
Acrux topical product portfolio – United States Acrux’s objective is to develop a diversified, on-market portfolio of products generating a sustainable revenue stream Revenue Under FDA Development generating Approved* review phase Evamist® Nitroglycerin Efinaconazole 8 topical Prilocaine/ (estradiol
Slide 7: Acrux revenue is generated through long term commercial relationships
Acrux revenue is generated through long term commercial relationships Commercial Padagis – is a generic pharmaceutical leader in topicals in the United States Partners in the TruPharma - is a US focused partner for the sale, marketing, and distribution of United States: prescription pharmaceutical p
Slide 8: Market for topically applied pharmaceuticals
Market for topically applied pharmaceuticals Topical pharmaceuticals represents a US$21 billion market in the United States. The market size for topically applied pharmaceutical products is US$21 billion* Different competitive dynamics to other market segments as fewer developers and manufacturers h
Slide 9: Acrux can target a significant number of topically applied pharmaceuticals
Acrux can target a significant number of topically applied pharmaceuticals US$21 billion* market has a broad range of development targets for topically applied pharmaceuticals Acrux is focussed on the specialty Application site >US$100m US$50m-100m US$10m-50m TOPICAL DERMATOLOGICALS 13 11 81 sector
Slide 10: Acrux portfolio – addressable market is over $1.2 billion
Acrux portfolio – addressable market is over $1.2 billion* Acrux products are targeting topical markets with limited competition US$64 million US$268 million 0 marketed generics (ANDAs) 1 marketed generics (ANDAs) 2 marketed generics (ANDAs) US$702 million 3 marketed generics (ANDAs) 5 marketed gene
Slide 11: Product launch – Nitroglycerin 0.4%, Ointment
Product launch – Nitroglycerin 0.4%, Ointment For the treatment of moderate to severe pain Indication associated with chronic anal fissure Key Milestones Addressable market US$23.2 million In house formulation Approved and marketed generics (ANDAs) 1 Completed and analytical phase Compare Acrux prod
Slide 12: Marketed Product – Prilocaine 2.5%, Lidocaine 2.5%, Cream
Marketed Product – Prilocaine 2.5%, Lidocaine 2.5%, Cream Topical anesthetic for use on normal intact skin for local analgesia, or, genital mucous Key Milestones Indication membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. In house formulation Completed and ana
Slide 13: Marketed Product – Dapsone 5%, Gel
Marketed Product – Dapsone 5%, Gel Indication The topical treatment of acne vulgaris Key Milestones Addressable market US$15.8 million In house formulation Completed and analytical phase Approved and marketed generics (ANDAs) 5 Technical transfer to Completed Compare Acrux product to reference drug
Slide 14: Product pending launch – Dapsone 7.5%, Gel
Product pending launch – Dapsone 7.5%, Gel For the topical treatment of acne vulgaris in Indication patients 9 years of age and older Key Milestones Addressable market US$37.4 million In house formulation Approved and marketed generics (ANDAs) 5 Completed and analytical phase Compare Acrux product t
Slide 15: Marketed Product – Evamist Estradiol Spray
Marketed Product – Evamist® Estradiol Spray Treatment of Moderate to Severe Vasomotor Indication Symptoms due to Menopause Key Milestones Addressable market (transdermal products) US$437 million In house formulation Completed Approved and marketed generics (ANDAs) 0 and analytical phase Technical tr
Slide 16: Pipeline Investment
Pipeline Investment Building upon a current US market size in excess of A$150M across the 5 commercialised products and soon to be launched products in FY25* Pipeline products Currently drive revenue investing in 8 growth in FY25 pipeline products and beyond Add new projects as pipeline products are
Slide 17: Acrux leadership
Acrux leadership Ross Dobinson Michael Kotsanis Joanna Johnson Chairman Chief Executive Officer CFO / Company Secretary • 30+ years of experience in investment • 30+ years of experience in the global • Chartered Accountant with 25+ years of banking and stockbroking pharma markets experience in senio
Slide 18: Acrux track record of developing and commercialising products
Acrux track record of developing and commercialising products 3 recent launches in the United States, 1 near term launch planned Total revenue generated A$20M* 1 product currently under evaluation by the FDA and 1 recently approved FDA approval of 6 products since 2021 Strong pipeline of products un
Slide 19: Connecting with Acrux
Connecting with Acrux www.acrux.com.au ASX: ACR info@acrux.com.au Follow Acrux +61 3 8379 0100 on LinkedIn