Announcement PDF Investor Presentation February 2025 Acrux is a specialty pharmaceutical company focused on the development and commercialization of topically applied pharmaceutical products 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. 2 Acrux is a leader in the development of topically applied prescription pharma products 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 Guidances for ANDA development of topically applied products Network of Contract Development and Manufacturing Organisations (CDMO) to provide development, scale up and commercial manufacturing Commercial licensees have commercialised Acrux products in the United States and over 40 countries Acrux has 4 marketed products in the US. Acrux is supported by 8 contracted manufacturers for its ANDA (generic) portfolio. Acrux has generated total revenue of A$20M over FY23 and FY24. An additional new product will be launched in the US shortly. Incorporated in 1998, Acrux draws on its highly skilled workforce, on-site laboratories, GMP manufacturing suite, technical and commercial experience to progress its pipeline and bring further affordable products to market. For further information on Acrux, visit www.acrux.com.au 3 Acrux growth platform Through investment in our pipeline, Acrux has proven its capability to develop, receive approval for and monetise topical dru gs A$20m* in total revenue Acrux receives royalties on a quarterly basis. Acrux typical licence agreement consists of a recurring profit share stream * Combined FY23 and FY24 4 revenue generating products 1 planned launch Dapsone 5%, Gel in April 2024 and . Nitroglycerin Ointment in December 2024 with Dapsone 7.5%, Gel expected to launch shortly. 6 ANDA products approved to date. 1 product under FDA review 1 product recently approved and 1 more product currently with the FDA for review 8 generic products in development R&D team with highly specific topical expertise drive development. Acrux has unique capabilities for topical drug development. Targeting topical drugs 40 Identified topical drugs, each >US$100m in sales 38 Identified topical drugs, each US$50-100m in sales 217 Identified topical drugs, each US$10-50m in sales Continue to review commercial market data, patent information and FDA Product Guidances to identif y high potential candidates 4 Long term growth model 1 Generic drug identification 2 3 Development and tech transfer FDA review and approval 4 Product launch via licensing deals 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 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 in the United States and other markets 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 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 5 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 generating Dapsone 5%, Gel Prilocaine/ Lidocaine Cream Evamist® (estradiol) Topical Spray in US Approved* Nitroglycerin rectal Ointment Dapsone 7.5%, Gel Efinaconazole Topical Solution Under FDA review Development phase Acyclovir Cream 8 topical prescription products * Efinaconazole Topical Solution US launch date is dependent on Paragraph IV IP settlement 6 Acrux revenue is generated through long term commercial relationships Commercial Partners in the United States: Commercial Partners exUnited States: Leveraging development expertise: Padagis – is a generic pharmaceutical leader in topicals in the United States TruPharma - is a US focused partner for the sale, marketing, and distribution of prescription pharmaceutical products Gedeon Richter - is a European multinational pharmaceutical and biotechnology company Active commercial discussions in multiple countries for commercial licensing of Acrux products Expertise to leverage US portfolio into new territories and expertise to bring other partner’s products to market Experienced team to manage development and regulatory process through to commercialisation Clear track record in achieving regulatory approvals in multiple jurisdictions Established licensee and CMO infrastructure and relationships 7 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 have the necessary competency Dosage forms include creams, gels, ointments, suspensions, solutions, patches Sterile and non-sterile dosage forms Total US pharmaceutical market estimated US$500 billion in sales* Total market includes oral, injectable, inhalation, topical and other dosage forms Development of topical generics is characterized by higher complexity than other dosage forms, especially oral drugs * Market size for topically applied drugs IQVIA June 2024 MAT, US$ sales. IQVIA data does not capture all distribution channels in the United States for topical products – market volume is likely underestimated * Total US pharma market size market based on IQVIA MAT sales data and Acrux estimates 8 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 sector of topically applied pharmaceuticals Application site >US$100m Opportunity to develop products for established but low competition generic products as well as newly genericised. US$10m-50m TOPICAL DERMATOLOGICALS 13 11 81 TOPICAL OPHTHALMIC 14 11 48 TRANSDERMAL PATCHES 4 8 32 3 8 1 11 TOPICAL EXTERNAL Why topicals? Generally smaller market size (volume and total market value) but generally fewer generic competitors and therefore lower price discounting. US$50m-100m TOPICAL NASAL 2 MOUTH/THROAT TOPICAL 9 TOPICAL RECTAL 8 TOPICAL VAGINAL 6 3 11 TOPICAL OTIC 1 1 5 TOPICAL UROLOGICAL 3 TOPICAL ALL OTHERS 1 Number of products - Total 40 38 217 * Market size for topically applied products. One product is a drug substance in one strength. IQVIA June 2024 MAT, US$ sales 9 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 generics (ANDAs) US$170 million US$23 million * IQVIA August 2024, MAT US$ sales. A marketed ANDA is a marketed generic. The graph excludes branded products Evamist ® and Lenzetto® (Estradiol Spray products) which have no generic competitors in Europe or the United States. 10 Product launch – Nitroglycerin 0.4%, Ointment Indication For the treatment of moderate to severe pain associated with chronic anal fissure Addressable market US$23.2 million Approved and marketed generics (ANDAs) 1 Development pathway for United States market Compare Acrux product to reference drug with Q1 (same ingredients), Q2 (same concentration of ingredients), Q3 (same physical and chemical properties. Bioequivalence study with IVRT endpoint (in vitro drug testing). Regulatory status in United States Commercial status in United States Approved by FDA Launch activities underway US commercially licensee TruPharma Ex-US commercial rights Discussions underway * Not approved outside the United States. Consult full prescribing information before use. Key Milestones In house formulation and analytical phase Completed Technical transfer to manufacturing site Completed Bioequivalence testing Completed FDA regulatory evaluation Completed Launch Underway 11 Marketed Product – Prilocaine 2.5%, Lidocaine 2.5%, Cream Indication Addressable market Topical anesthetic for use on normal intact skin for local analgesia, or, genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. US$24.4 million Approved and marketed generics (ANDAs) 3 Development pathway for United States market Bioequivalence study to demonstrate equivalent drug levels in plasma compared to reference product. Comparability of local skin reactions for the Acrux product and reference product. Regulatory status in United States Approved by US FDA Commercial status in United States Launched on 12/22 US commercially licensee Padagis Ex-US commercial rights Discussions underway * Not approved outside the United States. Consult full prescribing information before use. Key Milestones In house formulation and analytical phase Completed Technical transfer to manufacturing site Completed Bioequivalence testing Completed FDA regulatory evaluation Completed Launched Completed 12 Marketed Product – Dapsone 5%, Gel Indication The topical treatment of acne vulgaris Addressable market US$15.8 million Approved and marketed generics (ANDAs) 5 Development pathway for United States market Compare Acrux product to reference drug with Q1 (same ingredients), Q2 (same concentration of ingredients), Q3 (same physical and chemical properties). Bioequivalence studies with IVRT, IVPT endpoints (in vitro drug testing). Regulatory status in United States Approved by US FDA Commercial status in United States Launched 04/24, range extension launch 12/24 US commercially licensee TruPharma Ex-US commercial rights Discussions underway * Not approved outside the United States. Consult full prescribing information before use. Key Milestones In house formulation and analytical phase Completed Technical transfer to manufacturing site Completed Bioequivalence testing Completed FDA regulatory evaluation Completed Launched Completed 13 Product pending launch – Dapsone 7.5%, Gel Indication For the topical treatment of acne vulgaris in patients 9 years of age and older Addressable market US$37.4 million Approved and marketed generics (ANDAs) 5 Development pathway for United States market Compare Acrux product to reference drug with Q1 (same ingredients), Q2 (same concentration of ingredients), Q3 (same physical and chemical properties). Bioequivalence studies with IVRT, IVPT endpoints (in vitro drug testing). Regulatory status in United States Commercial status in United States Approved by US FDA Launch planned FY25 US commercially licensee TruPharma Ex-US commercial rights Discussions underway * Not approved outside the United States. Consult full prescribing information before use. Key Milestones In house formulation and analytical phase Completed Technical transfer to manufacturing site Completed Bioequivalence testing Completed FDA regulatory evaluation Completed Launch To be completed 14 Marketed Product – Evamist® Estradiol Spray Indication Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Addressable market (transdermal products) US$437 million Approved and marketed generics (ANDAs) Development pathway for United States market Regulatory status in United States Key Milestones 0 In house formulation and analytical phase Completed New Drug Application (NDA) pathway Technical transfer to manufacturing site Completed Bioequivalence testing Completed FDA regulatory evaluation Completed Launched Completed Approved by FDA Commercial status in United States Launched in 2008 US Commercially licensee Padagis Ex-US commercial rights Not available for partnering * Not approved outside the United States. Consult full prescribing information before use. 15 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 drive revenue growth in FY25 and beyond Currently investing in 8 pipeline products Add new projects as pipeline products are approved and launched, aim to add 2/year 16 * IQVIA August 2024, MAT sales. Acrux leadership Ross Dobinson Chairman Michael Kotsanis Chief Executive Officer Joanna Johnson CFO / Company Secretary • 30+ years of experience in investment banking and stockbroking • Formerly a Director of Reliance (RWC), Starpharma (SPL) • 30+ years of experience in the global pharma markets • Formerly CCO, Synthon; President, Hospira EMEA • Chartered Accountant with 25+ years of experience in senior finance roles in Hospira, Lupin and IDT Geoff Brooke Non-executive Director Don Brumley Non-executive Director • 30+ years experience in the healthcare investment industry • Founder and MD of Medvest Inc and GBS Venture Partners Tim Oldham Non-executive Director • 20+ years of experience in life sciences. • Currently CEO AdAlta (1AD) and formerly President, Hospira APAC • 30+ years of experience as senior partner of Ernst and Young, Oceania • Formerly Chairman of Bi-Gene (BGT) Mark Hyman Project Director • 35 years of experience in pharmaceutical manufacturing, development and project management • Local and international roles with Sandoz, Novartis and Hospira Felicia Colagrande R&D Director • 25+ years of experience in pharma/biotech industry • Previous roles at Faulding Pharmaceuticals and Austin Hospital Highly skilled and experienced Board and Management Team with decades of industry specific experience 17 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 under development * FY23 and FY24 18 Connecting with Acrux www.acrux.com.au info@acrux.com.au +61 3 8379 0100 ASX: ACR Follow Acrux on LinkedIn