Acrux Limited · ASX:ACR
Acrux — Investor Presentation (November 2014)
22 slides from Acrux's investor presentation, Nov 12, 2014
Slide 1: Acrux (ASX: ACR)
For personal use only Acrux (ASX: ACR) 12 November 2014
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: Acrux (ASX: ACR) at a Glance
ACRUX (ASX: ACR) AT A GLANCE • Market cap ~$180 million1 For personal use only • Unique, patented technology for delivering drugs through the skin • Products developed by Acrux, approved and launched in major markets: 1. Axiron®, marketed by Lilly for hypogonadism in the US and other territories 2.
Slide 4: Facilities, Process and Capabilities
FACILITIES, PROCESS AND CAPABILITIES • R&D focus utilising existing assets For personal use only • Onsite laboratories and GMP manufacturing facility • Early development process established • Mid to later stage development capabilities: – Analytical method development and validation – Container clos
Slide 5: Key Financials
KEY FINANCIALS For personal use only A$m FY14 FY13 % Change FY14 – FY13 Product Royalties 25.4 15.5 64% Product Milestones and other revenue 28.5 1.2 2275% Total Revenue 53.9 16.7 223% Expenditure 10.0 6.6 52% NPAT 28.0 6.9 306% Net cash on hand 25.8 22.8 13% Earnings per share 17 cents 4 cents
Slide 6: Marketed Products
Marketed Products For personal use only Axiron® Evamist® Recuvyra®
Slide 7: Key Update – Axiron
KEY UPDATE – AXIRON® • Milestone payment received of US$25 million in March 2014 as net sales in the 2013 For personal use only calendar year exceeded milestone threshold • Maintained stable share of transdermal gel testosterone therapy prescriptions in United States (13.8% on IMS data2) • Regulator
Slide 8: Axiron Global Net Sales Since Launch
AXIRON GLOBAL NET SALES5 SINCE LAUNCH For personal use only Net sales since launch • Net sales for FY2014 increased to US$181 million (US$124 million in FY2013) • US testosterone replacement therapy market is valued at over $2 billion 5 Net sales = invoiced sales less rebates, discounts, returns
Slide 9: US Testosterone Market
US TESTOSTERONE MARKET • Axiron continued to hold steady share of For personal use only Share of Total Prescriptions (TRx) for market; transdermal products in US • Currently number two product in US 30 Jun 13 30 Jun 14 17 Oct 14 transdermal testosterone replacement Non-Genericised therapy sector • A
Slide 10: Axiron Commercial Managed Care
AXIRON COMMERCIAL MANAGED CARE 6 For personal use only • Axiron’s positioning with leading formularies improved in January 2014: – Axiron being the only transdermal testosterone replacement therapy registered as a preferred product on both ESI and CVS Caremark National Formularies (two of the leadin
Slide 11: Axiron Pricing
AXIRON PRICING • After initiating at a recommended starting dose (RSD), patients may undergo dose For personal use only titration to achieve an appropriate maintenance dose • The daily maintenance doses and costs of different topical testosterone treatments were compared from US payer perspective Ab
Slide 12: Expanding Knowledge of Axiron
EXPANDING KNOWLEDGE OF AXIRON Lilly is conducting clinical studies to evaluate potential benefits of Axiron treatment For personal use only • TSAT - Sex drive/energy levels – Phase III, 618 men – Study will measure the effects of testosterone solution on testosterone levels, sex drive and energy – T
Slide 13: Axiron IP Landscape in United States
AXIRON IP LANDSCAPE IN UNITED STATES • Existing transdermal products For personal use only – Patent expiries - Androgel 2020(1%)/2026(1.62%), Testim 2023/25, Fortesta 2018 – Androgel, Testim and Fortesta patents challenged by substitutable (ANDA) and non-substitutable (NDA) products – multiple litig
Slide 14: Axiron Potential Beyond the US Market
AXIRON POTENTIAL BEYOND THE US MARKET For personal use only • In last 12 months, Axiron launched in Ex-US Quarterly Sales of Axiron Germany, Brazil and South Korea 2.0 – Previously launched in Canada and Australia 1.5 – Collectively comprise more than half the US $m 1.0 current ex-US market by value
Slide 15: Other Marketed Products
For personal use only Other Marketed Products
Slide 16: Evamist
EVAMIST® Estradiol spray for menopausal symptoms in women For personal use only • US – Approved by FDA in July 2007 – US launch by KV Pharmaceutical (Now Lumara Health) in April 2008 – In September 2014 Lumara announced they had entered into a definitive agreement for the sale of its Women’s Healthc
Slide 17: Recuvyra
RECUVYRA® Fentanyl solution for pain relief in dogs For personal use only – Marketed by Elanco, Lilly’s Animal Health Division – Approved by FDA in June 2012 – Approved in Europe in November 2011 – Product rolled-out in US and EU markets though 2012 and 2013 – Other animal companion health products
Slide 18: Looking Ahead
LOOKING AHEAD • On-market products For personal use only • Expected reduction in volume of testosterone market in US partially offset by pricing increases, likely USD:AUD Fx rates and ex-US volume growth • Revenue and milestones from additional launches of estradiol spray • Expenditure • Royalty pay
Slide 19: Product Portfolio and Pipeline
PRODUCT PORTFOLIO AND PIPELINE Commercial Formulation Non-Clinical Pre-Clinical Indication(s) Phase 1 Phase 2 Phase 3 Registration Commercial For personal use only Partners Design Development Design MARKETED Hypogonadism Eli Lilly Hormone Lumara Health Deficiency Post-operative Elanco RECUVYRA® (fen
Slide 20: Appendix
For personal use only Appendix
Slide 21: Key Financials
KEY FINANCIALS 30-Jun-14 30-Jun-13 30-Jun-12 $m $m $m For personal use only Product Royalty 25.4 15.5 9.0 Product Milestones 28.0 - - • Earnings per share grew 17 cents on pcp Interest, grant and other income 0.5 1.2 1.7 Total revenue 53.9 16.7 10.7 • Two dividends totalling 20 cents were paid durin
Slide 22: For personal use only
For personal use only