Acrux Limited · ASX:ACR
Acrux — Shareholder Meeting (November 2010)
28 slides from Acrux's shareholder meeting presentation, Nov 30, 2010
Slide 1: 2010 AGM Chairman's Address and CEO's Presentation
ACRUX LIMITED (ACR) - ASX ANNOUNCEMENT 30 NOVEMBER 2010 2010 AGM CHAIRMAN’S ADDRESS AND CEO’S PRESENTATION Chairman’s Address For personal use only Before addressing the formal matters before the AGM I would like to provide you with a brief summary of the history of Acrux. Recent successes may have
Slide 2: Chairman's Address (continued)
resources for most of its commercial life, and we have only been in a position to undertake the development internally following our success with the licensing and outsourcing of the development of Evamist to a US based licensee. Our success with the development of Axiron may help overcome the histo
Slide 3: Chairman's Address (continued)
Company's inaugural presentation to investors in the offices of Deutschebank in mid 1999. We believe the next phase of the Company's commercial maturation will be more rapid and more rewarding for investors, and I would like to extend the appreciation of the Board for the confidence, support and pat
Slide 4: Chairman's Address (continued)
decision to pursue the late stage development of Axiron in-house to enable the Company to structure a licensing deal with Lilly which provided the Company with a royalty stream that enabled meaningful dividends. The Board is confident that its expectations are not overly optimistic. The Board is kee
Slide 5: Forward Looking Statements and Achievements of the Last 12 Months
This broad level of interest in your company and in Axiron and our partnership with Lilly illustrates the remarkable achievement of Acrux in delivering on its major promise of winning FDA approval for our testosterone product. Forward Looking Statements For personal use only This presentation includ
Slide 6: Axiron
On completion of the license deal, US$50m was received from Lilly. We were able to utilise most of our accumulated tax losses and this revenue underpinned our maiden profit of $46.6m at June 30th 2010. Acrux’s achievements have also been recognised amongst its peers and in October of last year, Acru
Slide 7: Testosterone Market Outlook
AXIRON will be targeting an annual market worth more than US$1.2 billion per annum, with a CAGR of 18%, measured from 2005-2009. We have every reason to believe that this strong growth trend will continue. Underpinning this growth is an ageing population in most of the major markets, a greater aware
Slide 8: Axiron and the Commercial Impact on Acrux
Axiron and the commercial impact on Acrux It is worth me spending a little time detailing the commercial impact of the Lilly partnership. Firstly I will run through the breakdown of the various milestone payments that total US$335 million. For personal use only In late March Acrux received a US$50 m
Slide 9: Axiron Manufacturing and Launch
Let’s now take a brief look at the actual manufacturing line at Orion in action, as it goes about filling and capping the Axiron bottles. For market introduction, Lilly will retain the registered trademark - Axiron, however For personal use only they have chosen to introduce the product with a stron
Slide 10: Animal Health
Acrux has an exclusive global licence for the application of the Acrux drug delivery technology in animal health pharmaceutical products. Marketing applications for the first Lilly developed product are currently being For personal use only reviewed by the veterinary division of the FDA as well as t
Slide 11: Women's Health: Evamist and Ellavie
In 2009, KV underwent a significant restructuring of its business following a number of product recalls and the suspension of its manufacturing activities by the FDA. This suspension did not impact Evamist directly, although given the nature of KV’s challenges, it is reasonable to assume that the po
Slide 12: Financials
In summary, we will be actively exploring all strategic alternatives for our portfolio of female health products, including the contraceptive sprays, with the clear objective of capturing and returning maximum value to our shareholders. Financials For personal use only I will now detail our company’
Slide 13: Upcoming Milestones and Growth Opportunities
3. Thirdly, with regards to our global veterinary health partnership, Elanco is anticipating a decision from the FDA in Q1 2011 in relation to their first animal health product and if approved this could be available in the US by mid-2011. 4. And fourthly, we are expecting a decision from the Swedis
Slide 14: Acknowledgements and Thanks
My sincere thanks in particular to Ross, our Chairman, who has never tired or wavered in his own belief of what this company could achieve, and to Ken and Barrie for their unqualified support of management’s efforts. Finally, to you our loyal shareholders, many who have stayed the course for a numbe
Slide 15: Acrux Annual General Meeting November 2010 - CEO & Managing Director Presentation
For personal use only Acrux Annual General Meeting 30 November 2010 CEO & MANAGING DIRECTOR PRESENTATION
Slide 16: Media coverage of Axiron FDA approval
PM theage.com.au THE 28. AGE rf on Victoria National World Environment National Times Business : Home 2 Breaking News Business » Article underarm Ed Logue (47456/ Breating News ae Barefoot Investor Your Hip Packet a Last Updated: November 29, 2010 Firming Acrux set to reap bonanza Olga Galacho | Her
Slide 17: Forward-Looking Statements
3 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 18: Achievements in Last Months
4 ACHIEVEMENTS IN LAST 12 MONTHS For personal use only • January 2010 - New Drug Application for Axiron submitted to FDA on time • March 2010 - global deal for Axiron with Eli Lilly – largest Australian biotech licensing deal • March 2010 – joined S&P/ASX 300 index • June 2010 – delivered maiden pro
Slide 19: Axiron
5 AXIRON® For personal use only • Testosterone replacement therapy to treat testosterone deficiency in men • $23 million capital raised in 2007 to fund Phase 3 development • Successful Phase 3 trial results in September 2009 • New Drug Application submitted to FDA in January 2010 • Global deal for A
Slide 20: Testosterone Therapy Market
6 TESTOSTERONE THERAPY MARKET Global market For personal use only US market • US Market: $1.0B • Global Market: $1.2B • US CAGR Growth ‘04 to ‘09: 18% • Global CAGR Growth ‘04 to ‘09: 17% • Androgel still growing significantly in the US • US Market: 83% of global market 6
Slide 21: Lilly Is the Ideal Commercial Partner
LILLY IS THE IDEAL COMMERCIAL 7 PARTNER For personal use only 1. Top 10 global pharma company - 2009 revenue US$22 billion 2. Leadership position in men’s health - erectile dysfunction therapy Cialis® sales grew to US$1.6 billion in 2009 3. Distribution in 143 countries - including high growth emerg
Slide 22: Axiron Partnership with Eli Lilly
8 AXIRON PARTNERSHIP WITH ELI LILLY For personal use only • Lilly receives exclusive worldwide rights to commercialise Axiron • Acrux eligible for US$335 million in milestone payments: – US$50 million up-front (received 2009/10) – US$3 million on transfer of manufacturing assets ($1m received 2009/1
Slide 23: Next Steps for Axiron
NEXT STEPS FOR AXIRON For personal use only • US market launch • Marketing applications in other territories • Working with patent offices to expedite pending patents, including patents that potentially extend protection of AXIRON to 2026 9
Slide 24: Animal Health
ANIMAL HEALTH • Exclusive global licence for For personal use only 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 $8.25m in product app
Slide 25: Women's Health Products
WOMEN’S HEALTH PRODUCTS For personal use only • Estradiol spray USA (Evamist™) for menopause – Marketed by licensee KV Pharmaceutical – KV facing major corporate challenges • Estradiol spray ex-USA (Ellavie™) – In registration for Sweden, Switzerland, South Africa and South Korea • Testosterone spra
Slide 26: Financials
FINANCIALS For personal use only • $46.6m maiden profit after tax in 2009/10 • $145 million cash following US$87 million payment • 186% share price growth since 30 June 2009 • Pooled Development Fund - capital gains and dividends exempt from tax 3.50 3.00 Acrux (ACR) ASX All Ordinaries 2.50 ACR Shar
Slide 27: Outlook
OUTLOOK For personal use only • First dividend in early 2011 • US launch of Axiron by Lilly • Pending patents that potentially extend protection of Axiron to 2026 • Axiron marketing applications in other countries • FDA review of first animal health product with Elanco • Swedish regulatory review of
Slide 28: For personal use only
topical solution @ Lilly Answers That Matter.