Acrux Limited · ASX:ACR
Acrux — Investor Presentation (November 2013)
20 slides from Acrux's investor presentation, Nov 14, 2013
Slide 1: Acrux (ASX: ACR)
For personal use only Acrux (ASX: ACR) 14 November 2013
Slide 2: Forward-Looking Statements
2 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 ma
Slide 3: Acrux (ASX: ACR) at a Glance
3 ACRUX (ASX: ACR) AT A GLANCE • Market cap ~$450m; joined S&P/ASX 200 in September 2011 For personal use only • Profitable for the last 4 years – Paid special dividend (60 cents per share, total $100m) in 2011 – Paid first regular dividend (8 cents per share, total $13m) in 2012 – Paid second regul
Slide 4: Axiron
For personal use only Axiron 4
Slide 5: US Testosterone Market
5 US TESTOSTERONE MARKET • The topical market continues to grow but has slowed to a lower rate than the For personal use only last two years, currently at 6% (YTD over YTD August) • The injectable market has shown recent growth, however the topical market is still a substantially larger market in th
Slide 6: US Market Share Since Axiron Launch
6 US MARKET SHARE SINCE AXIRON LAUNCH For personal use only Share of Total Prescriptions (TRx) for transdermal products1 in United States April 2011 25 Oct 2013 Change Androgel® 1% 77% 19.4% -57.6% Androgel® 1.62% - 45.3% +45.3% Total Androgel® 77% 64.7% -12.3% Axiron® - 14.3% +14.3% Testim® 22% 13.
Slide 7: Global Net Sales Since Launch
7 GLOBAL NET SALES SINCE LAUNCH • Net sales = invoiced sales less rebates, US Net sales since launch For personal use only discounts, returns 50 45 • Formulary rebates typically accrued, as 40 35 invoiced 6mths+ in arrears* USD$ (MILLIONS) 30 25 • Q3 net sales typically adjusted to 20 account for ac
Slide 8: Managed Care Formularies
8 MANAGED CARE FORMULARIES For personal use only • 82% of MHRT Volume flows through Commercial Managed Care plans – at least 87% of all commercially insured lives now have some form of access to Axiron (including prior authorisations and step-edits) • Tier 2 access to Express Scripts/Medco formulari
Slide 9: Potential Beyond the Current US Market
9 POTENTIAL BEYOND THE CURRENT US MARKET For personal use only • Current ex-US markets for testosterone therapy underdeveloped – Current annual sales approximately US$300 million – Annual US sales were ~US$300 million ten years ago – Axiron already launched in Canada, Australia and approved in Brazi
Slide 10: Lilly's Investments in Axiron
10 LILLY’S INVESTMENTS IN AXIRON • Payments to Acrux (to date ~ AUD$166m) For personal use only • Men’s health sales force within Lilly fully operational • Supply chain improvements and significant manufacturing capacity expansion • Continuing product launch preparations • Substantial and ongoing –
Slide 11: Expanding Knowledge of Testosterone
11 EXPANDING KNOWLEDGE OF TESTOSTERONE Studies conducted by medical institutes demonstrate potential for For personal use only testosterone market growth: • Growing incidence of Type II Diabetes and obesity with associated higher incidence of low testosterone – current studies indicate 50% of obese
Slide 12: Patent Protection in United States
12 PATENT PROTECTION IN UNITED STATES Underarm administration For personal use only Formulation and delivery system 1 granted patent, expiry 2027 4 granted patents, expiry 2017 1 allowed patent, expiry 2026 1 patent application pending Applicator 2 granted patents, expiry 2026 and 2030 1 patent appl
Slide 13: Competitive Landscape in United States
13 COMPETITIVE 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
Slide 14: Other Products and Outlook
For personal use only Other products and outlook
Slide 15: Other Products
15 OTHER PRODUCTS • Estradiol spray For personal use only – Gedeon Richter contracted for ex-US distribution • US$1m upfront and up to US$2.6m in further regulatory milestones for the EU • Royalties on sales expected to commence in 2015 – Marketing applications under review in South Africa and South
Slide 16: Pipeline Products
16 PIPELINE PRODUCTS New products For personal use only • – Low cost proof of concept development initiated for two new topical products: – Non-melanoma skin cancer (NMSC) therapeutic – Anti-fungal therapeutic – Both products address unmet need in large (billion dollar+) markets – In collaboration w
Slide 17: Financial Outlook - Revenue
17 FINANCIAL OUTLOOK - REVENUE For personal use only Royalty = (US market size x US market share – Rebates + Ex-US sales) x average royalty % • Axiron royalties: • Percentages of worldwide net sales • Tiered structure with average rate increasing as sales increase • Multiple factors combining to dri
Slide 18: Financial Outlook - Expenditure
18 FINANCIAL OUTLOOK - EXPENDITURE For personal use only • Expenditure maintained at ~$5m in 2013/14 (2012/13: $4.8m) excluding: • Monash royalty (3.5% of product revenues until February 2017) • Non-cash amortisation of capitalised R&D costs - $1.2m per annum • One-off non-cash expense for issue of
Slide 19: Summary of 2013/14 Milestones
19 SUMMARY OF 2013/14 MILESTONES • Axiron: For personal use only – Net sales growth – royalties and first sales milestone payment – Product launches in Brazil and Europe • Other products: – Gedeon Richter regulatory milestones – Results of proof of concept for two new topical product opportunities
Slide 20: For personal use only
,o ok ACR U X Ve © = Axiron’ topical solution G