Acrux Limited · ASX:ACR
Acrux — Investor Presentation (February 2013)
20 slides from Acrux's investor presentation, Feb 18, 2013
Slide 1: Acrux (ASX: ACR) 18 February 2013
For personal use only Acrux (ASX: ACR) 18 February 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 For personal use only • Market cap ~$650m; joined S&P/ASX 200 in September 2011 • Profitable for the last 3 years – Paid special dividend (60 cents per share, total $100m) in 2011 – Paid first regular dividend (8 cents per share, total $13m) in 2012 • Pooled Developmen
Slide 4: ACR Share Price Performance Since IPO
4 ACR SHARE PRICE PERFORMANCE SINCE IPO For personal use only $100m ASX 200 Underarm dividend patent in US Axiron FDA approval Axiron Lilly deal Evamist $23m placement Phase 3 Phase 3 to fund Axiron success success $30m IPO
Slide 5: Axiron
For personal use only Axiron
Slide 6: US Testosterone Market
6 US TESTOSTERONE MARKET Male Testosterone Therapy Market, United States 2005 to 2012 (US$ million) For personal use only 35% 24% 29% 29% 21% 20% 15% Source: internal • Transdermal therapies excluding Androderm® comprise ~89% of sales value • Transdermal prescriptions in 2012 ~28% higher than 2011
Slide 7: US Market Share Since Axiron Launch
7 US MARKET SHARE SINCE AXIRON LAUNCH For personal use only Share of Total Prescriptions (TRx) for transdermal products1 in United States April 2011 30 Nov 2012 1 Feb 2013 Change in 2 months Androgel® 1% 77% 26.5% 23.9% -2.6% Androgel® 1.62% - 41.1% 40.9% -0.2% Total Androgel® 77% 67.6% 64.8% -2.8%
Slide 8: Net Sales
8 NET SALES For personal use only • Royalties and milestone payments depend on worldwide net sales • Net sales = invoiced sales less rebates, discounts, returns • Rebates in launch period were high – this is expected to reduce through 2013 • Rebates assisted patients prior to securing access to heal
Slide 9: Managed Care Formularies
9 MANAGED CARE FORMULARIES For personal use only • Improvements in access to both National and Regional Managed Care formularies from 1 January 2013: – CVS Caremark • Axiron upgraded from not reimbursed to preferred formulary status (~22m lives) – Capital Blue Cross – Sanford Health – BCBS Louisiana
Slide 10: Axiron Outlook for 2013
10 AXIRON OUTLOOK FOR 2013 For personal use only • Continuing US market growth – Transdermal prescriptions in January 2013 were ~18% higher than January 2012 • US market share growth – Axiron weekly share of Total Prescriptions (TRx) increased from 13.3% on 30 November 2012 to 14.6% on 1 February 20
Slide 11: Patent Protection in United States
11 PATENT PROTECTION IN UNITED STATES For personal use only Underarm administration Formulation and delivery system 1 allowed patent, expiry 2027 4 granted patents, expiry 2017 1 pending patent Applicator 1 granted patent, expiry 2030 1 pending patent
Slide 12: Competitive Landscape in United States
12 COMPETITIVE LANDSCAPE IN UNITED STATES For personal use only • Transdermal gels – Patent expiries - Androgel 2020, Testim 2023/25, Fortesta 2018 – Androgel and Testim patents challenged by substitutable (ANDA) and non-substitutable (NDA) products – multiple litigations in progress – US Supreme Co
Slide 13: Lilly's Investments in Axiron
13 LILLY’S INVESTMENTS IN AXIRON For personal use only • Payments to Acrux (to date ~ $150m) • Supply chain improvements • Manufacturing capacity expansion • Ex-US marketing applications and product launch preparations • Substantial and ongoing – Direct-to-consumer advertising – Promotion to special
Slide 14: Potential Beyond the Current US Market
14 POTENTIAL BEYOND THE CURRENT US MARKET For personal use only • Ex-US markets for testosterone therapy underdeveloped – 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 will be t
Slide 15: Other Products and Outlook
For personal use only Other products and outlook
Slide 16: Other Products
16 OTHER PRODUCTS • Animal health products For personal use only – Licensed to Elanco (Eli Lilly) – First royalties in 2013 from Recuvyra® in US and Europe – Other products in clinical development • Estradiol spray – Actively seeking distributor for Europe – Marketing applications under review in So
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 % Outlook: • Axiron royalties: • Percentages of worldwide net sales • Tiered structure with average rate increasing as sales increase • Multiple factors combini
Slide 18: Financial Outlook - Expenditure
18 FINANCIAL OUTLOOK - EXPENDITURE For personal use only • 2011/12 expenditure reduced to $5.3m, excluding: • Monash royalty (3.5% of product revenues, expiring 2017) • Amortisation of capitalised R&D costs • Expenditure excluding these items reduced to ~$5m in 2012/13 • Minimising costs, but retain
Slide 19: Summary of 2013 Milestones
19 SUMMARY OF 2013 MILESTONES For personal use only • Axiron: – US net sales growth – royalties and first sales milestone payment – marketing application decisions in Europe – launch in Australia and Canada • Other products: – Recuvyra first royalties – Estradiol spray distributor in Europe – Resolu
Slide 20: For personal use only
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