Acrux Limited · ASX:ACR
Acrux — Investor Presentation (April 2014)
23 slides from Acrux's investor presentation, Apr 28, 2014
Slide 1: Acrux (ASX: ACR) 28 April 2014
For personal use only Acrux (ASX: ACR) 28 April 2014
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 ~$283m; joined S&P/ASX 200 in September 2011 For personal use only • Profitable for the last 4 years – Dividends paid annually since 2011: total of 88 cents per share • Pooled Development Fund; capital gains and dividends exempt from tax • Unique, patented
Slide 4: Key Update
4 KEY UPDATE Axiron® For personal use only • Significant progress in international rollout of Axiron – Global net sales for the first 9 months of FY2014 increased by 74% over previous corresponding period – European launch in Germany • FDA Drug Safety Communication (DSC) prompted in part by two rece
Slide 5: Axiron
For personal use only Axiron
Slide 6: Global Net Sales Since Launch
6 GLOBAL NET SALES SINCE LAUNCH • Net sales = invoiced sales less rebates, Net sales since launch For personal use only discounts, returns • Unless overall market TRx volume (translating to $US) and/or Axiron Share of Market improve in CY2014, the US$50 million milestone payment may not be Q1 2014 r
Slide 7: US Testosterone Market
7 US TESTOSTERONE MARKET For personal use only Total transdermal US market demonstrates decline in total TRx, however total $ sales remains steady Effect of FDA Drug Safety Communication (DSC) and journal articles flowing through to TRx Based on IMS data
Slide 8: US Market Share Since Axiron Launch
8 US MARKET SHARE SINCE AXIRON LAUNCH Share of Total Prescriptions (TRx) for transdermal products1 in United States For personal use only 30 Jun 13 31 Jan 14 04 Apr 14 Change since 31 Jan Androgel® 1% 21.1% 18.7% 18.0% -0.7 Androgel® 1.62% 42.9% 47.6% 48.8% +1.2 Total Androgel® 64.0% 66.3% 66.8% +0.
Slide 9: FDA Drug Safety Communication
9 FDA DRUG SAFETY COMMUNICATION • US FDA issued a Drug Safety Communication (DSC) on 31 January 2014, prompted by For personal use only two recent observational studies1,2, which stated: – FDA is investigating the risk of stroke, heart attack and death in men taking FDA- approved testosterone produc
Slide 10: FDA Drug Safety Communication Cont.
10 FDA DRUG SAFETY COMMUNICATION Cont. • The observational studies were found to contain multiple inaccuracies and misreporting For personal use only of results • 3 professional medical societies and an international group of over 160 scientists and physicians have petitioned the Journal of the Amer
Slide 11: 2014 Axiron US Market Share Drivers
11 2014 AXIRON US MARKET SHARE DRIVERS • Direct to Consumer marketing; optimised marketing message initiated 01 January For personal use only 2014 • Men’s health sales force, operational since August 2013, making good progress with specialists and directing effort to Primary Care Physicians (PCPs) •
Slide 12: Commercial Managed Care
12 COMMERCIAL MANAGED CARE* For personal use only • Q1 2014: Axiron is the only transdermal TRT to register as a preferred product on both ESI and CVS Caremark National Formularies (2/3rds of market) Included • Step edits and prior authorisations ESI Axiron impact greater than anticipated • Physicia
Slide 13: Expanding Knowledge of Axiron
13 EXPANDING KNOWLEDGE OF AXIRON For personal use only Lilly is conducting clinical studies to evaluate other potential benefits of Axiron treatment • Sex drive/energy levels – Phase III, 618 men, currently recruiting with estimated completion June 2015 • Ejaculatory dysfunction – Phase II, 76 men,
Slide 14: Expanding Knowledge of Testosterone
14 EXPANDING KNOWLEDGE OF TESTOSTERONE Studies conducted by other medical institutes expand knowledge about men with For personal use only testosterone deficiency: • Growing incidence of Type II Diabetes and obesity with associated higher incidence of low testosterone – current studies indicate 50%
Slide 15: Competitor Awareness
15 COMPETITOR AWARENESS • Other testosterone delivery systems in development – nasal gel and oral capsules For personal use only • Aveed approved by FDA (after the DSC was issued) : an intramuscular injection in the buttock given once to begin therapy, once four weeks later, and every 10 weeks after
Slide 16: Competitive Landscape in United States
16 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 17: Potential Beyond the US Market
17 POTENTIAL BEYOND THE US MARKET For personal use only • Ex-US markets for testosterone therapy underdeveloped – Axiron recently launched in Canada, Australia, Germany and Brazil – Q3 FY14 net sales were US$1.21 million, an increase of 75% over Q2 FY14 sales – Canada, Australia, Germany and Brazil
Slide 18: Product Pipeline
For personal use only Product Pipeline
Slide 19: Human Antifungal Therapeutics
19 HUMAN ANTIFUNGAL THERAPEUTICS For personal use only • Human antifungal therapies market was valued at US$10.2 billion in 2008 (US$4 billion were topically applied products) • Fungal nail infections affect 20-25% of the population, and is increasing • Many antifungal treatments are fungistatic rat
Slide 20: Topical Antifungal Status
20 TOPICAL ANTIFUNGAL STATUS For personal use only In collaboration with Hexima Limited (Hexima’s lead molecules with Acrux’s new topical delivery technology) Lead compounds are active against the pathogens that cause fungal skin and nail infections In-vitro testing using human nails in progre
Slide 21: Non-Melanoma Skin Cancer (NMSC)
21 NON-MELANOMA SKIN CANCER (NMSC) Growing market in developed nations with over 2.15 million cases in the US in For personal use only • 2006. Expect a million cases in Australia in 2015 costing $700 million • Treatment of non-melanoma skin cancers increased by ~77% since early 1990’s • Skin cancer
Slide 22: Topical NMSC Status
22 TOPICAL NMSC STATUS • In collaboration with Hexima Limited (Hexima’s lead molecules with Acrux’s For personal use only new topical delivery technology) • Relationships established with leading Melbourne based medical and research institutions – In-vitro testing using human skin samples containing
Slide 23: For personal use only
,o ok ACR U X Ve © = Axiron’ topical solution G