Announcement PDF ACRUX Acrux is a specialty pharmaceutical company focussed on development and commercialisation Topically applied prescription pharmaceutical products are our expertise August 2024 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 operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this presentation, are expected to take place. Actual results could differ materially depending on factors such as the availability of resources, the results of non-clinical and clinical studies, the timing and effects of regulatory actions, the strength of competition, the outcome of legal proceedings and the effectiveness of patent protection. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of our Company, the Directors and our management. We cannot and do not give any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this presentation will actually occur and investors are cautioned not to place undue reliance on these forward-looking statements. We have no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation, except where required by law and under our continuous disclosure obligations. These forward looking statements are subject to various risk factors that could cause our actual results to differ materially from the results expressed or anticipated in these statements. Acrux is a leader in the development of topically applied prescription pharma products An Australian based leader in the development of topically applied prescription pharmaceutical products 3 Founded in 1998 with a 25+ year track record with US NDA, US ANDA and EMA product approvals Skills and competence to meet complex US FDA Product Specific Guidance for ANDA development Network of Contract Development and Manufacturing Organisations (CDMO) to provide development, scale up and commercial manufacturing Network of commercial licensees which have commercialised Acrux products in the United States and over 40 countries 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 Acrux is focussed on an underserved market segment in the United States Total market Oral drugs Acrux focus: Topical drugs Definition of market Total US prescription pharma market Drugs that are ingested orally (capsules, tablets) Drugs that are applied topically (including directly to the skin, eyes, ears) Market size1 >US$460bn ~US$200bn ~US$16bn2 Generic market share ~90%3 ~91%3 47%4 Typical generic development complexity Variable Low Higher complexity than oral generic drug development High Competition from many drug manufacturers Limited generic competition given niche market and development complexity Generic competition 5 Source: 1. US market by dosage form, IQVIA Q3, 2020 MAT, US$ market sales 2. Market size for topically applied drugs IQVIA Q3, 2020 MAT, USS market sales 3. IQVIA Global Generic and Biosimilars Trends and Insights – 2018 4. IQVIA, National Sales Perspectives, January 2019 – Unbranded generic share of dermatology, MAT Acrux topical product portfolio Development phase 7 topical prescription products Under FDA review Nitroglycerin rectal Ointment Acyclovir Cream Approved* Efinaconazole Topical Solution Dapsone 7.5%, Gel Marketed Dapsone 5%, Gel Prilocaine/ Lidocaine Cream Evamist® (estradiol) Topical Spray in US Acrux’s objective is to develop a diversified, on-market portfolio of products generating a sustainable revenue stream 6 * Efinaconazole Topical Solution US launch date is based on Paragraph IV IP settlement * Excludes Testosterone Topical Solution which was formerly approved and has been divested Lenzetto® (estradiol) Topical Spray in Europe Waterfall – Net Profit after Tax 7 Long Term Growth Model ➢ With a TGA approved GMP facility and 25 specialised scientists, Acrux possesses the capabilities for the development, regulatory submission and approval of generic topical and transdermal drugs ➢ Expertise extends to negotiating and dealing with commercial partners for the licensing and commercial launch of products on a global scale ➢ The core business model of drug development drives product regulatory submissions and commercial product launches 8 1 2 Development and tech transfer Generic drug identification 4 Product launch via licensing deals 3 FDA review and approval Development Processes 9 Activities may include development and testing in Acrux’s GMP facility and laboratory • Acrux has a current TGA license for manufacture of transdermal/topical and transmucosal products for clinical trials • FDA Remote Regulatory Assessment in 2023 for in-vitro bioequivalence testing which found no objectionable conditions Mid to later stage development activities • Analytical method development • Container closure selection, extractables and leachables testing • Stability testing • Manufacturing scale-up and technical transfer to commercial-scale facilities • Bioequivalence testing to FDA standards 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), pharmacokinetic (PK) testing and other specific FDA requirements FDA approval of products based on in vitro and in-vivo testing 10 Acrux recent product launches and future planned launches Prilocaine 2.5% Lidocaine 2.5% Cream Dapsone 5% Gel Launched December 2022 US FDA approved indication as a topical anesthetic for local analgesia* Launched April 2024 US FDA approved indication for the topical treatment of acne vulgaris* Planned launches 1. Dapsone 7.5% Gel for acne * 2. Nitroglycerine 0.4% Ointment for pain from anal fissure ** 3. Acyclovir 5% Cream for cold sores ** • Additional 7 products under active development 11 * Not approved outside the United States. Consult full prescribing information before use. ** Submitted and currently under US FDA review. Not yet approved for use. 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 12 Data – 27 August 2024 Substantial Shareholder Holding % Phillip Asset Management Ltd (Bioscience Managers Translation Fund I) 31.8 million shares 10.95% Top 20 shareholders 100.6 million shares 34.60% Connecting with Acrux www.acrux.com.au ASX: ACR info@acrux.com.au +61 3 8379 0100 13 Follow Acrux on LinkedIn