Acrux Limited · ASX:ACR
Acrux — Investor Presentation (May 2010)
13 slides from Acrux's investor presentation, May 20, 2010
Slide 1: Acrux investor presentation
For personal use only Acrux investor presentation ASX Spotlight Series, 20 May 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: Acrux (ASX: ACR) at a Glance
ACRUX (ASX: ACR) AT A GLANCE For personal use only • Unique, patented platform technology for delivering drugs through the skin – commercialisation through partnerships • Range of products includes 1 marketed, 3 in registration • Global deal for AXIRON™ with Eli Lilly in March 2010 – largest Austral
Slide 4: Investor Information
INVESTOR INFORMATION • ACR joined S&P/ASX 300 on 19 March 2010 For personal use only • 160m shares; Orbis at 19% • Market cap ~$310m 2.50 Acrux Ltd (ACR) 2.00 ASX All Ordinaries • Cash $60m Acrux share price 1.50 • Pooled Development Fund 1.00 – capital gains and dividends 0.50 exempt from tax 0.00
Slide 5: Product Pipeline
PRODUCT PIPELINE For personal use only Therapeutic Area Formulation Phase 1 Phase 2 Phase 3 Registration Marketing Hypogonadism AXIRON™ Eli Lilly Companion animal health Undisclosed Eli Lilly Decreased libido in Testosterone MDTS®® women Menopausal symptoms Estradiol MDTS®® (Evamist™) KV Estradiol M
Slide 6: Testosterone Therapy Market
TESTOSTERONE THERAPY MARKET Symptoms of testosterone deficiency can include: For personal use only 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 7: AXIRON Partnership with Eli Lilly
AXIRON PARTNERSHIP WITH ELI LILLY • Lilly receives exclusive worldwide rights to commercialise For personal use only AXIRON • Acrux eligible for US$335 million in milestone payments: – US$50 million up-front payment (received March 2010) – US$3 million on transfer of manufacturing assets – US$87 mil
Slide 8: Lilly Is the Ideal Commercial Partner
LILLY IS THE IDEAL COMMERCIAL PARTNER 1. Top 10 global pharma company; 2009 revenue US$22 billion For personal use only 2. Leadership in Men’s health through erectile dysfunction therapy Cialis® – Sales grew to US$1.6 billion in 2009 – Rivals Pfizer’s Viagra® as largest seller, despite being 2nd/3rd
Slide 9: Phase Results - Efficacy
PHASE 3 RESULTS - EFFICACY 100 For personal use only 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 9
Slide 10: Phase Results - Psychosexual
PHASE 3 RESULTS - PSYCHOSEXUAL % Change from Baseline1 For personal use only 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 10
Slide 11: 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 – Marketing application accepted for review by FDA in April 2010 – Acrux expects outcome of FDA review in Q1 2011 • Ensuring the commercial manufacturing line at Orion C
Slide 12: Financial Position Transformed
FINANCIAL POSITION TRANSFORMED • AXIRON revenues transform Acrux financial position For personal use only – 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: Strong News Flow in Next Months
STRONG NEWS FLOW IN NEXT 12 MONTHS • Outcome of FDA review of the AXIRON marketing For personal use only application • Animal health partnership with Eli Lilly (Elanco) – Outcome of FDA review of marketing application for first product – Progress of additional products • Key regulatory milestones fo