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ACRUX LIMITED — Investor Presentation 2021
Sep 1, 2021
64293_rns_2021-09-01_bf84f627-3b76-466f-885b-a72505895aac.pdf
Investor Presentation
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ACRUX INVESTOR PRESENTATION (ASX: ACR)
September 2021
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IMPORTANT NOTICE AND DISCLAIMERS
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 forwardlooking 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.
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Acrux has a demonstrated track record of development and commercialisation of topical prescription pharmaceuticals Acrux has growing revenue from its product portfolio including revenue share, profit share and milestones Acrux has 3 products sold globally with a pipeline of 12 products in various stages of development and 6 commercial partnerships in place
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Business overview
Acrux has a demonstrated track record of development and commercialisation of topical prescription pharmaceuticals
Acrux product history
Past Acrux outcomes
Testosterone solution The product generated substantial Was sold in 6 countries with revenue share returns for Acrux shareholders through and milestones received by Acrux from payment of milestones and revenue FY10 – FY18. share to the Company Products commercialised by Acrux Acrux currently marketed products Recent Acrux outcomes Estradiol spray Currently sold as Evamist® in the United Acrux revenue from its Estradiol States. licensees grew 25% in FY21 over prior financial year Currently sold as Lenzetto® in over 30 countries with milestones and revenue Revenue share payable to Acrux share received by Acrux from FY17 onwards. exceeded $1 million in FY21
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Business overview
Acrux has growing revenue from its product portfolio including revenue share, profit share and milestones
Acrux has 3 products sold globally with a pipeline of more than 12 products in various stages of development and 6 commercial partnerships in place
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Acrux product pipeline
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As at end August 2021 Acrux has 15 products in its generic topical portfolio 3 products FDA approved in 2021
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Product including one commercialised in August pipeline 2021 12 products under various stages of development by Acrux including 2 products under FDA review
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Recent Acrux outcomes
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FDA approval received for 3 products in 2021 to date
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Acrux licensee launched generic Testosterone Topical Solution in August 2021
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6 commercial agreements for 11 products including 4 agreements executed since 2020 for 9 products
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Key Investment highlights
3 products on market in over 30 countries including Testosterone Topical solution launched in August 2021 in the United States Focus on specialised 15 topical generic products in portfolio including 12 in various stages of and lucrative topical development with an addressable market of ~US$1.2bn[1] generic market The topical generic market provides attractive returns with low-risk and low development costs for highly specialised drug developers The size of the topical generic market in the US is ~US$16bn[2]
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Proven commercialisation strategy to bring a portfolio of products to market
Led by an experienced management team, Acrux possesses unique development and
Highly skilled commercialisation know-how and capabilities
development team TGA approved, Good Manufacturing Practice (GMP) facility with 25 specialised
scientists creates a substantial competitive advantage in generic product selection,
development and commercialisation
Products sold through licensees in Europe, the United States and other countries
R&D investment in
FDA approvals received for Prilocaine/Lidocaine cream 2.5%/2.5% and Efinaconazole
product pipeline solution 10% in mid 2021
entering 6 commercial agreements with 6 different pharma companies for 11 products in
commercialisation place. Licensing agreements feature recurring revenue on commercialisation
Objective to be cash flow positive by end of 2022
6 1. IQVIA Q2, 2021 MAT, US market sales (US$) 2. US market sales by dosage form, IQVIA Q3, 2020 MAT, (US$)
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Acrux is focussed on an underserved market segment
| Total market | Oral drugs | Acrux focus: Prescription topical drugs |
|
|---|---|---|---|
| Definition of market (all drugs including NCEs and generics) |
Total US prescription pharma market |
Drugs that are ingested orally (eg tablets, capsules) |
Drugs that are applied topically to the skin, eyes, ears and nose (egcreams,ointments, gels,solutions) |
| Market size1 | >US$520bn | ~US$200bn | ~US$16bn2 |
| Generic market share | ~90%3 | ~91%3 | 47%4 |
| Typical generic development complexity |
Variable | Low | Greater complexity than oral generic drug development |
| Generic competition | Variable | High competition from many generic drug manufacturers |
Limited generic competition given niche market and development complexity |
Source:
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US market by dosage form, IQVIA Q3, 2020 MAT, US market sales (US$); 2. Market size for topically applied drugs IQVIA Q3, 2020 MAT, US market sales (US$)
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IQVIA Global Generic and Biosimilars Trends and Insights – 2018; 4. IQVIA, National Sales Perspectives, January 2019 – Unbranded generic share of dermatology, MAT
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Revenue generating business model supporting long-term growth
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1 2
Product
Generic drug development
identification and technology
transfer to CMO
4 3
Product launch
and profit share FDA submission,
revenue from review
commercial and approval
marketing partners
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On market products are generating growing revenues for Acrux from growth of existing products and new launches
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Through the Acrux GMP facility with 25 specialised scientists, Acrux possesses the capabilities to develop and commercialise generic topical and transdermal pharmaceutical products
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The core business model of generic drug development is supported by ongoing licensing opportunities for commercial marketing and distribution
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FY21 Profit and Loss
| Profit and loss for the year ended 30 June 2021 | Profit and loss for the year ended 30 June 2021 |
|---|---|
| 2021 2020 Movement Movement $’000 $’000 $’000 % |
|
| Revenue and Other Income Revenue from licensing agreements R&D Tax Incentive Rebate Other income Total Revenue and Other Income Less: Expenses External R&D Expenses Salaries and Directors' Fees Depreciation and amortisation Other Expenses Total Expenses Loss before income tax Income tax benefit/(expense) |
1,337 1,253 84 7% 3,421 2,327 1,094 47% 398 365 33 9% |
| 5,156 3,945 1,211 31% 8,928 5,012 3,916 78% 6,109 5,712 397 7% 664 707 (43) -6% 1,887 1,899 (12) -1% |
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| 17,588 13,330 4,258 32% (12,432) (9,385) (3,047) 32% (197) (86) (111) 129% |
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| Net loss for theyear | (12,629) (9,471) (3,158) 33% |
| Basic loss per share (cents) Cash reserves |
(5.75) (5.65) (0.10) -2% 15,270 9,206 6,064 66% |
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FY21 Cashflow
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BENEFITS OF A POOLED DEVELOPMENT FUND
1 Companies with PDF status are taxed at 15% on their income and capital gains received from their investments 2
Australian resident shareholders are exempt from capital gains tax after selling their shares
3
Unfranked dividends received by an Australian resident shareholder from the Company will be exempt from tax in the hands of the shareholder 4
Franked dividends will also be exempt from tax unless the shareholder elects to treat the franked dividend as taxable
Shareholders should seek professional advice from their tax advisor regarding Pooled Development Funds and the benefits specifically available to their situation
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Acrux Investment Opportunity
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Track record of developing and launching products Increasing revenue from marketed products Extensive product pipeline under development FDA approval of 3 products in 2021 Additional product launches planned in 2022 Strong management team
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Thank you
Michael Kotsanis
CEO & Managing Director Acrux Limited
P: + 61 3 8379 0100 E: [email protected]
Visit our website: http://www.acrux.com.au/ Follow us on LinkedIn:
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