Acrux Limited · ASX:ACR
Acrux — Investor Presentation (March 2010)
14 slides from Acrux's investor presentation, Mar 17, 2010
Slide 1: Acrux investor presentation, 16 March 2010
For personal use only Acrux investor presentation, 16 March 2010
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: A New Era for Acrux
A NEW ERA FOR ACRUX For personal use only • Global licensing deal for AXIRON with Eli Lilly • Acrux eligible for: – US$335m in milestones, including US$50m up-front and US$87m subject to issuance of a marketing authorisation by the FDA – Worldwide royalties, expected to provide a substantial part of
Slide 4: About the Partnership
ABOUT THE PARTNERSHIP For personal use only • Lilly receives exclusive worldwide rights to commercialize AXIRON • Acrux eligible for US$335 million in milestone payments: – US$50 million up-front payment – US$3 million on transfer of manufacturing assets – US$87 million subject to issuance of a mark
Slide 5: Eli Lilly – Scale and History
ELI LILLY – SCALE AND HISTORY For personal use only • Top 10 global pharmaceutical company • A heritage of more than 130 years • 2009 revenue US$21.8 billion • Market capitalisation approximately US$40 billion • Products distributed in 143 countries • Approximately 40,300 employees worldwide • Manuf
Slide 6: Lilly is the Ideal Commercial Partner
LILLY IS THE IDEAL COMMERCIAL PARTNER • Leadership in Men’s health through erectile dysfunction For personal use only therapy Cialis® – Sales grew to US$1.6 billion in 2009 – Rivals Pfizer’s Viagra® as largest seller, despite being 2nd/3rd to market • Established global commercial capability – Produ
Slide 7: Testosterone Therapy Market
TESTOSTERONE THERAPY MARKET For personal use only Symptoms of testosterone deficiency can include: reduced libido, erectile dysfunction, fatigue, depression, anger, decreased muscle strength, INJ/OTHER ANDRODERM TESTIM ANDROGEL decreased bone density $900,000 $800,000 $62,671 LATIN AMERICA, $32,468
Slide 8: Phase Results - Efficacy
PHASE 3 RESULTS - EFFICACY For personal use only 100 95 85% 84% 90 Response rate (%) 85 76% 80 75 75% primary endpoint target at Day 120 70 66.8% lower bound of 95% CI required to meet 65 primary endpoint 60 15 60 120 Time (days) Primary endpoint – proportion in normal range ±95% CI 8
Slide 9: Phase Results - Psychosexual
PHASE 3 RESULTS - PSYCHOSEXUAL For personal use only % Change from Baseline1 120% 104% 100% 79% 80% 60% 40% 35% 20% 13% 0% -20% -26% -40% Positive Mood Negative Mood Sexual Desire Sexual Activity Sexual Performance 1 p-value <0.0001 9
Slide 10: Next Steps for Acrux and AXIRON
NEXT STEPS FOR ACRUX AND AXIRON For personal use only • The regulatory review process, working closely with the FDA and with Lilly – Acrux expects outcome of FDA review in Q1 2011 • Ensuring the commercial manufacturing line at Orion Corporation is fully operational • Working with patent offices to
Slide 11: Existing Animal Health Partnership
EXISTING ANIMAL HEALTH PARTNERSHIP For personal use only • Exclusive global licence for animal health products utilising Acrux’s delivery technology • First marketing application submitted to FDA by Elanco Dec 2008 • Further products in clinical development • Acrux eligible for royalties plus up to
Slide 12: Financial Position Transformed
FINANCIAL POSITION TRANSFORMED For personal use only • AXIRON revenues transform Acrux financial position – US$50m in 2009/10 plus US$3m on transfer of manufacturing assets – US$87m in 2010/11 subject to FDA approval of AXIRON – Substantial royalties and milestone payments in future years • Maiden p
Slide 13: Investor Information
INVESTOR INFORMATION For personal use only • ACR joins S&P/ASX 300 after market close 19 March 2010 • Increased institutional investor interest expected • Pooled Development Fund concessions – capital gains and dividends exempt from tax 2.50 • 160m shares Acrux Ltd (ACR) 2.00 ASX All Ordinaries Acru
Slide 14: Strong News Flow in Next Months
STRONG NEWS FLOW IN NEXT 12 MONTHS For personal use only • Elanco animal health products – Outcome of FDA review of marketing application for first product – Progress of additional products • Progress update from Vivus regarding Arbitration Panel deadline of 1 April 2010 for the start of a Luramist™