Acrux Limited · ASX:ACR
Acrux — Investor Presentation (August 2013)
20 slides from Acrux's investor presentation, Aug 27, 2013
Slide 1: Acrux (ASX: ACR)
1 For personal use only Acrux (ASX: ACR) 27 August 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 ~$550m; 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 – Declared second r
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 July) • The injectable market has shown recent growth, however the topical market is still a substantially larger market in the
Slide 6: Expanding Knowledge of Testosterone
6 EXPANDING KNOWLEDGE OF TESTOSTERONE For personal use only • Growing incidence of Type II Diabetes and obesity with associated higher incidence of low testosterone – current studies indicate 50% of obese men (including obese diabetics) and ~30% of lean diabetics have low testosterone – World Health
Slide 7: Potential Beyond the Current US Market
7 POTENTIAL BEYOND THE CURRENT US MARKET • Current ex-US markets for testosterone therapy underdeveloped For personal use only – Current annual sales approximately US$300 million – Annual US sales were ~US$300 million ten years ago – Number of potential patients is greater than in the US – Axiron al
Slide 8: US Market Share Since Axiron Launch
8 US MARKET SHARE SINCE AXIRON LAUNCH For personal use only Share of Total Prescriptions (TRx) for transdermal products1 in United States April 2011 26 July 2013 Change Androgel® 1% 77% 20.6% -56.4% Androgel® 1.62% - 44.0% +44.0% Total Androgel® 77% 64.6% -12.4% Axiron® - 14.1% +14.1% Testim® 22% 13
Slide 9: Net Sales
9 NET SALES • Royalties and milestone payments US Net sales since launch For personal use only depend on worldwide net sales 50 45 • Net sales = invoiced sales less 40 rebates, discounts, returns 35 USD$ (MILLIONS) 30 • Rebates in launch period were 25 high, but reduced in 2013 – now 20 comparable w
Slide 10: Managed Care Formularies
10 MANAGED CARE FORMULARIES For personal use only • 88% of MHRT Volume flows through Commercial Managed Care plans – ~87% of all commercially insured lives have some form of access to Axiron • Tier 2 access to Express Scripts/Medco formularies from July 2012 (~23m lives) • Improvements in access to
Slide 11: Patent Protection in United States
11 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 12: Competitive Landscape in United States
12 COMPETITIVE LANDSCAPE IN UNITED STATES • Existing transdermal products For personal use only – Patent expiries - Androgel 2020, Testim 2023/25, Fortesta 2018 – Androgel, Testim and Fortesta patents challenged by substitutable (ANDA) and non- substitutable (NDA) products – multiple litigations – L
Slide 13: Lilly's Investments in Axiron
13 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 • Ex-US marketing applications and continuing product launch preparat
Slide 14: Other Products and Outlook
14 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: Reported Financials
16 REPORTED FINANCIALS FY 2010/11 FY 2011/12 FY 2012/13 For personal use only $m $m $m Revenue 931 11 16.7 Profit before tax 82 4.9 10.0 Tax (charge)/benefit (25) 2.5 (3.1) Profit after tax 57 7.4 6.9 Earnings per share 35 cents 4 cents 4 cents Dividend (tax-free) 60 cents 8 cents 8 cents Cash at 30
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 • Expenditure maintained at ~$5m in 2013/14 (2012/13: $4.8m) excluding: For personal use only • Monash royalty (3.5% of product revenues until February 2017) • Non-cash amortisation of capitalised R&D costs - $1.2m • One-off non-cash expense for issue of employee s
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 – Marketing application decisions in Europe – Product launches in Brazil and Europe (subject to approval) • Other products: – Gedeon Richter regulatory milestones for Eur
Slide 20: Axiron (testosterone) topical solution
Axiron’ WN (testosterone) topical solution @