Acrux Limited · ASX:ACR
Acrux — Investor Presentation (October 2005)
23 slides from Acrux's investor presentation, Oct 19, 2005
Slide 1: HEGRE
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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
Fewer, faster and lower cost trials because we use proven drugs Strong competitive advantage - “patient-preferred, patent-protected” Lead product in phase 3 (under SPA) in the USA 7 products in human clinical trials Track record of commercial deals - Eli Lilly, Vivus, CSL A$26m cash reserves
Slide 4: Combining proven drugs with novel patented delivery technology
* Combining proven drugs with our novel patented delivery technology, to create new drug products * Developing multiple products simultaneously at relatively low cost — “pre-clinical” means formulation development — no animal safety testing — “Phase 1” and typically “Phase 2” are small blood level (
Slide 5: Acrux's first product - Evamist
Drug 7 Years US$15-50 million 10% Delivery Drug 15 Years Up to US$800 0.01% Discovery million Acrux’s first product - Evamist™ ¢ Expected to launch in 2007 after 7 years of development * Acrux total cost approx. US$9 million; VIVUS funding the simple Phase 3 trials
Slide 6: Patchless Patch technology platform
of . Patchless Patch® Reservoir Forms an invisible reservoir within the skin US Pat. no. 6,818,226 (expires 2017) aC RU TECHNOLOGY PLATFORM pr " across enhancers. Wo ACROSS® Enhancers more rapidly ® . weet ° oper & . US Pat. no. 6,299,900 Used for simple, accurate flexible dosing (expires 2017) US P
Slide 7: Key advantages over traditional patches
as . ae Ss ae Dy _ ULLAL | - - - / . a S * Key advantages — Gastro-intestinal system avoidance BLOOD ~ Steady, continuous delivery LEVEL OF DRUG ~ Reduced dose frequency and increased patient compliance — Dose flexibility ¢ Traditional patch disadvantages —Dosage limitations of existing drugs —Skin
Slide 8: Advantages of the delivery system
- . 7 7 S a : _ | : | LLL ’ . - A MMe! a Q mez Tae No or low risk of skin irritation Cosmetic acceptability Dosage flexibility Ease of manufacture Cost effective Range of applications Preference by patients AINININI NNN
Slide 9: Market research with post-menopausal women
Market research with 200 women of post-menopause age ~— Patch or implant hormone therapy users — 100% would switch to MDTS® — Tablet hormone therapy users — 88% would switch to MDTS® Backed up in studies conducted by others
Slide 10: Therapeutic areas and formulations
SL Therapeutic Area Menopausal symptoms Market Size (US$bn) Formulation Evamist'™ (Estradiol MDTS™ Decreased libido in women Contraception Chronic pain Male testosterone deficiency Companion animal health Anxiety-related disorders Nausea Smoking cessation Various CNS diseases
Slide 11: Commercial partners: VIVUS and Eli Lilly (Elanco)
« VIVUS: NASDAQ listed company focused on sexual function disorders — USS. licence for Evamist™ and Testosterone MDTS® — Targeting billion dollar markets — US$13.3 million in milestones (US$3.8 million received) + sales royalties — VIVUS funds R&D, manufacturing, sales and marketing — Acrux retains
Slide 12: Evamist: global market dominated by Premarin
Global market US$1.2 billion dominated by Premarin® Evamist™ - convenient product preferred by many women VIVUS funding US Phase 3 under SPA from the FDA Phase 3 patient enrolment completed - on track for NDA mid-2006 US$4m milestones remaining (filing and approval of NDA), then royalties
Slide 13: Testosterone for women
No product approved - analysts predict global market US$1-4 billion; testosterone patch and gel in development Convenient, low-dose skin spray preferred to patches and gels FDA Advisory Panel recommended against approval of Intrinsa® testosterone patch - more safety data required VIVUS submitting pr
Slide 14: Fentanyl patches
Fentanyl patches sell US$1.6 billion Targeting flexible dosing, better pain control, minimal skin irritation FDA confirmed development path is “505-b2” (same as Evamist™) Positive results in 3 phase | trials Acrux funding small trials in 2006 to finalise product design Seeking commercial partner for
Slide 15: Testosterone for men
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 3 single dose trials ~— Complete remaining trials under US IND in 2006 & 2007 File NDA in m
Slide 16: Management experience
+ Considerable international experience + Proven commercialisation expertise + Extensive experience at large pharma companies
Slide 17: Financial summary
Product revenues 2.7 3.3 Grant income Interest and other income 13 0.5 Total expenditure Net loss Net cash outflow before new capital * Goal is profit in FY 2007/2008, then rapid growth from multiple product royalties * Current cash A$26m sufficient for goal and maintain a prudent buffer ¢ Testoster
Slide 18: Highlights of the past year
Evamist™ -~- into Phase 3 and on track for NDA in mid-2006 Testosterone for women - large Phase 2b trial met primary endpoint Fentanyl - successful Phase | trial and pre-IND meeting with FDA Testosterone for men - 3 successful Phase | trials and pre-IND meeting with FDA Contraceptive - successful Ph
Slide 19: Fewer, faster and lower cost trials because we use proven drugs
Fewer, faster and lower cost trials because we use proven drugs Strong competitive advantage - “patient-preferred, patent-protected” Lead product in phase 3 (under SPA) in the USA 7 products in human clinical trials Track record of commercial deals - Eli Lilly, Vivus, CSL A$26m cash reserves
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Slide 21: Share ownership
eer rrr ee SHARE OWNERSHIP (TOTAL 133.6m) institutions 37% directors & managers 16% founders 4% other / retail 43% MN ng *Pooled Development Fund — no tax on capital gain *Orbis global funds acquired 12% in Oct 2005 *Directors in escrow until Sep 2006 Ambition to list on NASDAQ
Slide 22: Board skills and backgrounds
¢ Balance of skills and backgrounds covering: - Science - Finance - Business
Slide 23: Board and advisors
Professor Barrie Finnin (Chairman) Professor Tsuneji Naga ZAMMIT Professor Howard Mail: (UC San Francisco) Professor Richard Gu (Univers. 23