Acrux Limited · ASX:ACR
Acrux — Shareholder Meeting (October 2017)
26 slides from Acrux's shareholder meeting presentation, Oct 26, 2017
Slide 1: Annual General Meeting 26 October 2017
For personal use only Acrux (ASX: ACR) Annual General Meeting 26 October 2017
Slide 2: Introduction: Ross Dobinson, Non-Executive Chairman
For personal use only Introduction: Ross Dobinson Non-Executive Chairman
Slide 3: Operational review: Michael Kotsanis, CEO & Managing Director
For personal use only Operational review: Michael Kotsanis CEO & Managing Director
Slide 4: 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 5: Agenda
Agenda For personal use only Axiron patent litigation and status FY2017 outcomes and milestones Full year P&L and Cashflow Acrux pipeline selection and progress Near term milestones 5
Slide 6: Axiron timeline and status
Axiron® timeline and status For personal use only May / November 2013 Lilly and Acrux sue Perrigo for August 2016 patent infringement in May and May 2015 US District Court Actavis in November following December 2014 Lilly and decision that formulation October 2017 initial Axiron generic Lilly and Ac
Slide 7: Acrux outlook and priorities following Axiron license termination
Acrux outlook and priorities following Axiron license termination For personal use only Cash reserves At 30th June 2017: $34.0 million Future royalties • Axiron royalties cease in line with Axiron license termination • Acrux is pursuing a range of opportunities to realise the value of its intellectu
Slide 8: FY2017 outcomes
FY2017 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 At end June
Slide 9: FY2017 milestones
FY2017 milestones For personal use only • Scale up activities to manufacture exhibit batches for initial generic products ✓ • Gedeon Richter to continue country specific launches of Lenzetto in the ✓ European Union • Draft and submit patent application for ACR065 for onychomycosis ✓ • Contract manuf
Slide 10: Finance review: Tim Bateman, CFO & Company Secretary
For personal use only Finance review: Tim Bateman CFO & Company Secretary
Slide 11: Full year profit and loss
Full year profit and loss • Royalty revenue largely comprises Axiron revenue of $22.8m which is For personal use only Full Year Ending 2017 2016 10% down on prior year $'000 $'000 % Royalty revenue 23,321 25,469 (8.4%) • Prior financial year milestone income reflects multiple marketing Milestone rev
Slide 12: 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 $21.8m, down 22.6% on prior year due to: Cash flow from operating activities ‐ lower Axiron royalty receipts Receipts from product agreements 21,822 28,208 (22.6%) ‐ non rec
Slide 13: Operational Report continued: Michael Kotsanis
For personal use only Operational Report continued: Michael Kotsanis CEO & Managing Director
Slide 14: Generic pharmaceuticals
Generic pharmaceuticals… For personal use only According to the FDA: “Generic drugs…are just as safe and just as effective as their brand-name counterparts, and they are a cost effective way of achieving substantial savings.” “A generic drug is identical or bioequivalent to a brand-name drug in dosa
Slide 15: Generics dominate the United States market
…dominate the United States market For personal use only Ten years of quarterly prescription trends – United States Quarterly prescriptions (000s) 9 out of 10 scripts dispensed are generic Source: QuintilesIMS, Morgan Stanley Pharma Rx chart, Oct, 2017 15
Slide 16: The value of generic medicines to patients and the economy
The value of generic medicines to patients and the economy… For personal use only INCREASED PATIENT ACCESS PATIENT-RELATED VALUE OVERALL ECONOMIC VALUE • IMPROVED MEDICATION ADHERENCE • BETTER PATIENT HEALTH OUTCOMES HYPERTENSION BREAST CANCER DEPRESSION MORE PATIENTS TREATED SAME NUMBER OF PATIENTS
Slide 17: Generics will grow as more products face patent expiry
…will grow as more products face patent expiry Small molecule patent expiry exposure in the United States ($ Billion) For personal use only 35 >$50 billion 30 29.2 25.2 25 20.6 20 $ Billion 15.4 15 14 12.8 11 10 9.3 5 0 2013 2014 2015 2016 2017 2018 2019 2020 Over $50 billion of branded sales facing
Slide 18: The Acrux pipeline leverages core Acrux skills
The Acrux pipeline… …leverages core Acrux skills Technology For personal use only Attracts partners Regulatory NCE Ointments, creams, gels, solutions Generics (ANDA), 505(b)(2) ACRUX CORE CAPABILITY Discovery, Therapeutic Dermatology, Development and Generics or Drug area drugs on skin approval of r
Slide 19: 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 Oral 14 Generic Injectable 12 Liquids 10 $ Billion 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 20: Selecting a topical generic portfolio
Selecting a topical generic portfolio For personal use only 472 molecules • Acrux is targeting molecules with low applied to modest competition topically 165 generate sales molecules 80 molecules >$10 million >$50 million in sales • Drugs often have more than one in sales presentation (including cre
Slide 21: 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 Pipeline of generics - June 2017 drugs Acrux had 7 generic products in active d
Slide 22: Addressable market for Acrux generic pipeline
Addressable market for Acrux generic pipeline For personal use only Acrux generic pipeline Acrux generic pipeline by addressable market value number of generic competitors 1200 1200 1100 1000 1000 900 800 $ Million 800 $ Million 700 600 600 500 400 400 300 200 200 100 0 0 Pipeline of generics - June
Slide 23: Addressable market for Acrux generic pipeline
Addressable market for Acrux generic pipeline For personal use only Acrux generic pipeline by number of generic competitors hormones 1200 (testosterone, acne 1100 estradiol) 1000 900 800 $ Million 700 Example 600 therapeutic anti-rheumatic analgesic 500 areas 400 300 200 100 0 corticosteroids antifu
Slide 24: Advancing our generic pipeline to create value
Advancing our generic pipeline to create value MID-2018 For personal use only Formulation Process Bioequivalence Regulatory Approved/ Development Development / Clinical* Submission Launched MID-2017 3 Formulation Process Bioequivalence Regulatory Approved/ Products Development Development / Clinical
Slide 25: Future milestones
Future milestones For personal use only • Plans to submit first generic dossiers to FDA for review mid CY2018 • Axiron Appeal outcome • Initial revenue from generic pipeline expected CY2019 • Portfolio of 12 topical generic products in development by end FY2018 • Portfolio of 19 topical generic prod
Slide 26: Acrux Annual General Meeting October 2017
For personal use only Acrux (ASX: ACR) Annual General Meeting 26 October 2017