Acrux Limited · ASX:ACR
Acrux — FY2017 Earnings Presentation
15 slides from Acrux's earnings presentation, Aug 22, 2017
Slide 1: Acrux FY2017 Annual Result
For personal use only Acrux (ASX: ACR) FY2017 Annual Result 22 August 2017
Slide 2: Forward looking statements
Forward looking statements For personal use only This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Acrux to be mate
Slide 3: Agenda
Agenda For personal use only FY17 outcomes Full year P&L and Cashflow Topical generic pipeline progress Onychomycosis project progress 3
Slide 4: FY 2017 outcomes
FY 2017 outcomes For personal use only Cash reserves 2017: $34.0 million 2016: $29.4 million Net (Loss)/Profit 2017: $(0.2) million includes a non-cash impairment loss of $10.68 million After Tax 2016: $11.1 million Royalty revenue 2017: $23.3 million 2016: $25.4 million Pipeline progress 8 products
Slide 5: FY17 milestones
FY17 milestones For personal use only • Draft and submit patent application for ACR065 for onychomycosis ✓ • Gedeon Richter to continue country specific launches of Lenzetto in the ✓ European Union • Scale up activities to manufacture exhibit batches for initial generic products ✓ • Contract manufac
Slide 6: Axiron IP status
Axiron® IP status For personal use only • Acrux and Eli Lilly and Company appealed the United States District Court decision in August 2016 • Federal Circuit appeal expected to be scheduled in October / November 2017 • Perrigo announced the launch of a generic of Axiron on 5 July 2017 in the United
Slide 7: Axiron volume and market share
Axiron volume and market share For personal use only Axiron quarterly net sales Axiron generic share 60 100% 50 80% 40 60% USD $M 30 40% 20 10 20% - 0% Jun-11 Dec-11 Jun-12 Dec-12 Jun-13 Dec-13 Jun-14 Dec-14 Jun-15 Dec-15 Jun-16 Dec-16 Jun-17 Sep-11 Sep-12 Sep-13 Sep-14 Sep-15 Sep-16 Mar-11 Mar-12 M
Slide 8: Full year profit and loss
Full year profit and loss For personal use only Full Year Ending 2017 2016 $'000 $'000 % • Royalty revenue largely comprises Axiron revenue of $22.8m which is 10% down on prior year as global sales by our commercial partner were USD 143.0m down from Royalty revenue 23,321 25,469 (8.4%) USD 149.3m in
Slide 9: Full year cash flow
Full year cash flow Full Year Ending For personal use only 2017 2016 $'000 $'000 % • Cash received from product agreements was $21.8m down 22.6% on prior year due to: Cash flow from operating activities ‐ lower Axiron royalty receipts $21.5m Receipts from product agreements 21,822 28,208 (22.6%) ‐ n
Slide 10: United States market – sales by dosage form
United States market – sales by dosage form 18 Dosage proportion based on sales For personal use only 16 14 Generic Oral 12 Injectable 10 $ Billion Liquids Topical $200 billion 8 Aerosol $130 billion 6 Brands Powders 4 Other 2 0 Market size for topically applied drugs Topically applied drugs generat
Slide 11: The Acrux market opportunity
The Acrux market opportunity Acrux generic pipeline 18 addressable market value For personal use only 1200 16 14 Generic 1000 12 800 $ Million 10 $ Billion 600 8 6 Brands 400 4 200 2 0 0 Market size for topically applied Jun-17 drugs Acrux has 7 generic products in active development Acrux expects t
Slide 12: Acrux generic portfolio opportunities and challenges
Acrux generic portfolio opportunities and challenges For personal use only Opportunities Low project risk for generic pipeline compared to branded products Considered project selection including products with biowaiver potential or Paragraph IV opportunity Avoid commoditised market segments with sig
Slide 13: Acrux antifungal development
Acrux antifungal development Onychomycosis For personal use only Indication For treatment of fungal infection (onychomycosis) of toenails and fingernails Formulation and intellectual property • Solution for topical administration • Improved formulation of efinaconazole selected • New patent has been
Slide 14: Future milestones
Future milestones For personal use only • Submit first generic dossiers during FY18 • Initial revenue from generic pipeline expected 2019 • Portfolio of 12 topical generics in development by end FY18 • Initiate clinical program for onychomycosis following FDA Pre-IND meeting • Axiron Appeal outcome
Slide 15: For personal use only
For personal use only