Acrux Limited · ASX:ACR
Acrux — Investor Presentation (July 2007)
30 slides from Acrux's investor presentation, Jul 16, 2007
Slide 1: Going to the next level
Going to the next level 1 For personal use only 16 July 2007
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: Agenda
Agenda 3 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 4: Introduction
Introduction 4 For personal use only • Acrux is developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin • Testosterone MD-Lotion® Phase 2 trial has been successful and plans
Slide 5: Agenda
Agenda 5 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 6: The Acrux technology
The Acrux technology 6 For personal use only Patchless Patch® Reservoir Forms an invisible reservoir within the skin US Pat. no. 6,818,226 (expires 2017) ACROSS® Enhancers Allow drugs to pass through skin more rapidly GRAS status MDTS® Applicator US Pat. no. 6,299,900 Used for simple, accurate & EU
Slide 7: Beyond the patch
Beyond the patch 7 For personal use only • Key advantages – Steady, continuous delivery – Sustained efficacy, reduced toxicity – Lower dose frequency leads to increased patient compliance – Works for many injectable drugs • Acrux overcomes traditional patch disadvantages –Dosage limitations –Skin ir
Slide 8: Commercial strategy
8 Commercial strategy For personal use only • Apply delivery technology to proven drugs – abbreviated development with lower cost and less risk • Progress products through clinical and regulatory milestones to optimise commercial value • Commercialise in major pharmaceutical markets through licensin
Slide 9: Product pipeline
9 Product pipeline For personal use only Therapeutic Area Target market Formulation Phase 1 PK Phase 2 PK Phase 2 Phase 3 Registration Current Partner (US$bn) efficacy Menopausal symptoms 1.3 KV (USA) EvaMist™ (Estradiol MDTS®) Aspen (AU/NZ) 1-4 Testosterone MDTS® VIVUS (USA) Decreased libido in wom
Slide 10: Material progress with more to come
10 Material progress with more to come Progress since Sep 2006… More to come in 2007… For personal use only 9 Two licensing deals with Organon ¾ More licensing deal opportunities 9 EvaMist™ US NDA submitted ¾ EvaMist™ approval 9 Testosterone for men Phase 2 completed ¾ Testosterone for men Phase 2 r
Slide 11: Agenda
Agenda 11 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 12: Clear product benefits
Clear product benefits 12 For personal use only • Product attributes deliver significant benefits for patients • Clear and unique selling proposition against existing products – Unique ‘no-touch’ application • No sticky or messy hands • Fast drying – No lingering odour or tackiness – Total applicati
Slide 13: Market dynamics
Market dynamics 13 For personal use only • Testosterone replacement market US$0.6b growing at 14% • 20% to 39% of men over the age of 50 are hypogonadal • Only 5% to 10% are currently diagnosed and treated • Increasing awareness leading to increasing treatment rates • As awareness and treatment rate
Slide 14: Product mix
Product mix 14 For personal use only US Testosterone Market: Gels versus Inj/Patches/Oral $600 $49 $72 $500 $31 $7 $400 USD Sales $300 $377 $309 $334 $288 $200 $198 $117 $100 $35 $104 $104 $120 $117 $119 $77 $83 $93 $49 $59 $- 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Patches/Inj/Oral Androg
Slide 15: Phase 2 trial
Phase 2 trial 15 For personal use only • Conducted in 9 centres in the USA – 41 hypogonadal men recruited (testosterone levels below 300ng/dL) – Principal Investigator Dr Christina Wang - LA Biomedical Research Institute – All subjects completed treatment with 33 evaluable • Once daily application –
Slide 16: Phase 2 results
Phase 2 results 16 For personal use only Primary Endpoint • 60mg elevated average Testosterone level into the normal range in 29 of 33 patients (88%) • 30mg elevated the average Testosterone level into the normal range in 25 of 33 patients (76%) • 6 of the 8 patients below normal range on 30mg were
Slide 17: Phase 2 results
Phase 2 results 17 For personal use only Average total testosterone at steady state in patients receiving 30mg or 60mg Testosterone MD-Lotion® 700 600 Total testosterone [ng/dL] 500 400 300 Treatment A [3 mL] 30 mg (average 419 ng/dL) 200 Lower limit of Treatment B [6 mL] normal range 60 mg (average
Slide 18: Phase 2 results
Phase 2 results 18 For personal use only Secondary Endpoints • only one patient with maximum testosterone level >1500ng/dL; no subjects had maximum level >2500 ng/dL • No serious adverse events • Only three reports of mild, temporary skin irritation • Levels of DHT and SHBG within normal range • Pat
Slide 19: Investment decision
Investment decision 19 For personal use only Preclinical Development Phase Phase I Phase II Phase III Preregistration Registered 0 10 20 30 40 50 60 70 80 % Value Retained by the licensor • Acrux may secure double the value by licensing at pre- registration versus licensing at end of Phase 2 • Low r
Slide 20: Key activity and timelines
Key activity and timelines 20 For personal use only Activity Date Washing, transfer & deodorant study results Q3’07 Applicator validation Additional market research & reimbursement strategy Strengthen skills in manufacturing area Identification of commercial contract manufacturer Engage CRO for Phas
Slide 21: Agenda
Agenda 21 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 22: Pending EvaMist approval
Pending EvaMist™ approval 22 For personal use only • US marketing application submitted to FDA by licensee VIVUS - approval anticipated Q3 2007 • VIVUS sub-licensed rights to KV Pharmaceutical for US$150m plus US$30m sales milestones plus Acrux royalties – Acrux rights unchanged • KV is a capable pa
Slide 23: Organon Partnership
Organon Partnership 23 For personal use only • Healthcare business of Akzo Nobel; a leader in women’s health - number 3 in US$6.7 billion global contraception market • Organon funds all clinical, regulatory and commercialisation in two worldwide licence deals: Deal 1: Deal 2: 9 Organon selects contr
Slide 24: Testosterone Spray for Women
Testosterone Spray for Women 24 For personal use only • VIVUS negotiating with FDA on Phase 3 design – resolution expected H2 2007 • Remains a huge market opportunity – certainty on regulatory requirements likely to trigger commercial interest • Acrux enforcing VIVUS performance obligations • Testos
Slide 25: Agenda
Agenda 25 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 26: Finance
Finance 26 For personal use only • Cash reserves $17m - cash outflow FY 2006/07 $8m before options proceeds • Cash reserves will fund existing business to profitability • New capital will fund Testosterone MD-Lotion® opportunity • Existing licensing revenue sources: – Licences to Organon (up to US$1
Slide 27: Share register
Share register 27 For personal use only SHARE OWNERSHIP (Total 142.8m) Controlled improvement in register quality: institutions 40% 9 Nov 2006 to Feb 2007; former other / CEO options expiry – 4m options retail expired, 8m shares placed/sold 48% 9 Oct 2006; 2 year escrow expiry – 3m shares acquired b
Slide 28: Agenda
Agenda 28 For personal use only • Introduction • Company overview • Testosterone MD-Lotion® for men • Summary of progress on other products • Corporate information • Key near term events
Slide 29: Key near term events
Key near term events 29 For personal use only 9 Licensing - further deal opportunities 9 Evamist™ - FDA approval of NDA and US$3m milestone (Q307) 9 Testosterone MD-Lotion® - Start Phase 3 trial (Q208) 9 Testosterone MDTS® - confirm US Phase 3 requirements and progress commercialisation options for
Slide 30: For personal use only
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