Acrux Limited · ASX:ACR
Acrux — Shareholder Meeting (November 2005)
16 slides from Acrux's shareholder meeting presentation, Nov 8, 2005
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Slide 2: Forward-looking statements
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 materially different from the statements in this pres
Slide 3: Fewer, faster and lower cost trials because we use proven drugs
J) Fewer, faster and lower cost trials because we use proven drugs Strong competitive advantage - “patient-preferred, patent-protected” Lead product in phase 3 under Special Protocol Assessment Agreement with FDA in the USA Products in seven therapeutic areas in clinical development Track record of
Slide 4: Market Size and Product Pipeline
1 We : IME Market Size Therapeutic Area ‘US$bn} Menopausal symptoms Decreased libido in women Contraception Chronic pain Male testosterone deficiency Companion animal health Anxiety-related disorders Formulation Phase 1 Phase 2 Phase 3 Registration Partners Testosterone MD-Loation’ Buspirone MDTS®
Slide 5: Key developments over the past year
1 Evamist™ - into Phase 3 and on track for submission for registration in USA in mid-2006 Testosterone for women - large Phase 2b trial met primary endpoint Fentanyl - successful Phase | trial, meeting with FDA to agree on approval path Testosterone for men - three successful Phase | trials and meet
Slide 6: Evamist: Global market US$1.2 billion
Lo Global market US$1.2 billion VIVUS funding US Phase 3 study with design agreed by FDA Phase 3 patient enrolment completed — VIVUS on track for application in mid-2006 for approval in USA Market research in USA by VIVUS confirming previous Australian research results - Evamist™ preferred by many w
Slide 7: Testosterone for women: no product approved
° No product approved - analysts predict global market US$1-4 billion; only three competing products (testosterone patch and gels) in development Our convenient, low-dose skin spray preferred to patches and gels US partner VIVUS will seek a legally binding agreement with FDA on the US Phase 3 studie
Slide 8: Fentanyl patch sales reached US$1.6 billion in 2004
Fentanyl patch sales reached US$1.6 billion in 2004 Fentanyl UDTS™ targeting flexible dosing, better pain control, minimal skin irritation Confirmed development path for approval in USA with FDA (same as Evamist™) Positive results in three phase | trials Funding additional small trials in 2006 to in
Slide 9: Testosterone for men: global market US$0.4 billion
Lo * Global market US$0.4 billion, dominated by Androgel® * Targeting faster drying, better dose control, smaller application area * No efficacy trials required by FDA, all pharmacokinetic trials -~ Positive results in three single dose trials ~ Complete remaining trials under US IND in 2006 & 2007
Slide 10: Cosmeceutics, Buspirone, Dermatology and Granisetron updates
Cosmeceutics: Direct TV sales in USA difficult to arrange - exploring other channels to provide value for shareholders Buspirone: The treatment of target disease fibromyalgia is not well understood - partnering slower than expected Dermatology portfolio: Agreement with Napa Biosciences terminated as
Slide 11: Financial results
susie Product revenues 33 Grant income 0.0 Interest and other income 13 0.5 Net loss , ~ (6.0) (4.2) al (6.4) (4.3) Net cash outflow before new capi * Testosterone for men, fentanyl and contraceptive main 2005/2006 funding commitments
Slide 12: Appointment of Professor Adam Watkinson as Chief Scientific Officer
Appointment of Professor Adam Watkinson as the Chief Scientific Officer with responsibilities for new product development Enhanced process for development of additional “patient-preferred, patent-protected” products using our technologies with more proven drugs Expansion of Scientific Advisory Board
Slide 13: Annual General Meeting, November 2005 - Dear Shareholders
Annual General Meeting, 8 November 2005 Dear Shareholders, Thank you very much for your personal attendance at our 2005 Annual General Meeting. It is my pleasure to review the key developments at Acrux since the last AGM. (Slide 1) Acrux is a specialty pharmaceutical company with products in late st
Slide 14: Robust pipeline overview (speech notes)
(Slide 4) We have a robust pipeline: our products span all the way from late stage development (Phase 3 human clinical trials) back through multiple Phase 1 and Phase 2 programs to preclinical development. We also cover a number of valuable therapeutic areas. VIVUS and CSL are amongst the partners f
Slide 15: Testosterone for women trial and FDA path (speech notes)
we expect a very high preference by women for our mode of delivery over patches and gels. We reported earlier this year that, using a clinical trial design agreed upon with FDA, we have successfully proved the primary endpoint, which was a statistically significant increase in the number of satisfac
Slide 16: Cosmeceutics, Buspirone and dermatology (speech notes)
succeeded in commercialization of our first cosmeceutic product in USA through direct TV sales. Although the investment in our Cosmeceutics Solutions subsidiary was modest, we are continuing to seek other means to return value on that investment to our shareholders. We have been looking for a partne