Acrux Limited · ASX:ACR
Acrux — Investor Presentation (September 2008)
31 slides from Acrux's investor presentation, Sep 5, 2008
Slide 1: More Products, More Partners
MORE PRODUCTS, MORE PARTNERS For personal use only 5 September 2008 MORE PRODUCTS, MORE PARTNERS
Slide 2: Forward-Looking Statements
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 mate
Slide 3: Acrux at a Glance
ACRUX AT A GLANCE For personal use only ASX: ACR; Pooled Development Fund (no CGT); 159m shares, 40% institutions Lead product launched in US pharmaceutical market 6 more products using same proven technology in clinical trials – 3 at Phase 3 Major recent advances in product commercialisation and de
Slide 4: Major Recent Advances
MAJOR RECENT ADVANCES For personal use only Evamist™ launched in USA by KV Pharmaceutical Expansion of KV partnership - access to Evamist™ data secured Commenced Phase 3 trial of Testosterone MD-Lotion® Strategic commercial manufacturing alliance with Orion First animal health product Phase 3 comple
Slide 5: The Acrux Technology
THE ACRUX TECHNOLOGY For personal use only ACROSS® Enhancers MD-Lotion® Application Allow drugs to pass through Patents pending to skin more rapidly 2026 and 2027 Patents granted to 2017, pending to 2023 Patchless PATCH® MDTS® Application Invisible reservoir within the skin Patents granted to 2021 5
Slide 6: Competitive Advantage
COMPETITIVE ADVANTAGE For personal use only Key advantages – Steady, continuous delivery – Sustained efficacy, reduced toxicity – Lower drug load and flexible dosing Overcomes patch disadvantages – Dosage limitations – Skin irritation – Cosmetic unacceptability – Cost of manufacture Patient preferen
Slide 7: Commercial Strategy
COMMERCIAL STRATEGY For personal use only Apply delivery technology to proven drugs – lower cost and less risk Product development to optimise commercial value Commercialise in major markets through licensing Deliver maximum value from proven transdermal platform Access a novel complementary technol
Slide 8: Partnered Products
PARTNERED PRODUCTS For personal use only Therapeutic Area Formulation Phase 1 Phase 2 Phase 3 Registration Marketing KV (USA) Menopausal symptoms Evamist™ (Estradiol MDTS®) Aspen (AUS) Menopausal symptoms Duomist™ KV (USA) Testosterone MDTS® VIVUS (USA) Decreased libido in women CSL (AU/NZ) Companio
Slide 9: Unpartnered Products
UNPARTNERED PRODUCTS For personal use only Therapeutic Area Formulation Phase 1 Phase 2 Phase 3 Registration Marketing Menopausal symptoms Ellavie™ (Estradiol MDTS®) Ex-USA Menopausal symptoms Duomist™ Ex-USA Hypogonadism Testosterone MD-Lotion® Global Contraception Nestorone® MDTS® Global Chronic p
Slide 10: Hormone Therapy for Menopause Symptoms
HORMONE THERAPY FOR MENOPAUSE SYMPTOMS For personal use only Treatment of menopause symptoms Estrogen only therapy - Estrogen + Progestin therapy - menopausal women without uterus menopausal women with intact uterus Estradiol spray Estradiol + Progestin spray Evamist™ – US brand Duomist™ – Global br
Slide 11: KV Partnership Expansion
KV PARTNERSHIP EXPANSION For personal use only Acrux accesses Evamist™ US data for ex-USA regulatory filings – Enables immediate commercialisation of Ellavie™ by Acrux – No sharing of Ellavie™ value and no impact on Evamist™ value KV licences Duomist™ and 2 other pre-clinical products – KV to fund d
Slide 12: Evamist Target Market
EVAMIST™ TARGET MARKET For personal use only US Estrogen Only Market (US$1,400m) Other transdermal 129m Vivelle-Dot patch 151m Vaginal 398m Oral 723m Source: IMS 12
Slide 13: Evamist US Economics
EVAMIST™ US ECONOMICS For personal use only Evamist™ marketed through KV’s established Ther-Rx women’s health sales force of 330 KV official target peak annual sales of US$125m – approaching current sales of leading patch Acrux receives royalties on KV sales - royalty % increases as annual sales inc
Slide 14: Evamist Launch
EVAMIST™ LAUNCH For personal use only Launched April 2008 – after 3 months ranked second transdermal hormone therapy, as measured by “New to Brand Prescriptions” (new patient starts or switches from other brands) KV fiscal 2009 first quarter results to 30 June 2008: “…Trending towards more than 4,00
Slide 15: Ellavie Target Market
ELLAVIE™ TARGET MARKET For personal use only Ex-US Estrogen Only Market (US$361m) Europe sales by dosage form Transdermals Europe 207m 53% Injectables 1% Asia/Africa/Aus 63m Oral Ex-USA America’s 91m 46% Prices significantly lower than US market Fragmented markets – requires multiple partners Source
Slide 16: Ellavie Economics
ELLAVIE™ ECONOMICS For personal use only Targets ex-USA estrogen only therapy market of US$360m – transdermals have larger share than in US market Acrux now has access to Evamist™ US data for ex-USA regulatory filings – targeting European filing in H2 2008 Strong commercial interest from potential m
Slide 17: Duomist Target Market
DUOMIST™ TARGET MARKET For personal use only Global Estrogen + Progestin Therapy Market (US$705m) Europe 217m Asia/Africa/Aus 51m Latin America 60m US 377m Source: IMS 17
Slide 18: Duomist Economics
DUOMIST™ ECONOMICS For personal use only Targets global combination hormone therapy market of US$700m KV funds all development costs, Acrux accesses US data package KV commercialises in USA, Acrux commercialises in rest of world KV and Acrux apportion value in all territories on pre-agreed terms 18
Slide 19: Testosterone MD-Lotion
TESTOSTERONE MD-LOTION ® For personal use only 19
Slide 20: Testosterone Market
TESTOSTERONE MARKET For personal use only Global market US$0.9b growing at 20% Only 5% to 10% are currently diagnosed and treated 20% to 39% of men over the age of 50 are As awareness and treatment rates rise, sales growth hypogonadal will continue ANDRODERM INJECTION/OTHER ANDROGEL TESTIM 700 LATIN
Slide 21: Testosterone MD-Lotion
TESTOSTERONE MD-LOTION® For personal use only “After trialling the Acrux product for 4 days, two thirds of patients indicated that they would prefer it to their existing gel treatment” 1 “91% of physicians rated Testosterone MD-Lotion® very good or excellent in being able to improve patient experien
Slide 22: Phase 2 Results
PHASE 2 RESULTS For personal use only Results strongly indicative of meeting Phase 3 endpoints Armpit application convenient and easy for patients No interaction with deodorants/antiperspirants, applied before or after lotion 700 Average total testosterone at steady state in patients receiving 30mg
Slide 23: Phase 3 Trial
PHASE 3 TRIAL For personal use only Recruiting 150 hypogonadal men in USA, Europe and Australia Commenced June 2008, results expected Q3 2009 – targeting marketing applications in USA and Europe Q4 2009 Primary endpoint is restoration of average testosterone levels in the blood into the normal range
Slide 24: Commercialisation
COMMERCIALISATION For personal use only Long patent life – granted to 2017, pending to 2026 Commercial product supply by Acrux, through alliance with Orion Corporation Pre-registration licensing and product supply deals targeted for H1 2010 Acrux expects to retain 40% to 50% of product value Develop
Slide 25: Orion Strategic Alliance
ORION STRATEGIC ALLIANCE For personal use only Orion Corporation (Finland, market cap EUR 1.8 billion) develops, manufactures and markets products in global pharmaceutical markets – core therapeutic focus of female health, male health and CNS FDA approved manufacturing facility in Finland Alliance s
Slide 26: Other Products Update
OTHER PRODUCTS UPDATE For personal use only Animal health – First product Phase 3 completed by Eli Lilly, marketing application anticipated in H2 2008 Testosterone MDTS® – Phase 3 design agreed by FDA in “Special Protocol Assessment”; VIVUS arbitration hearing scheduled January 2009 Nestorone® MDTS®
Slide 27: Product to Market
PRODUCT TO MARKET For personal use only KV (LAUNCHED) ELI LILLY (PHASE 3) ASPEN (FILED) CSL (PHASE 2) VIVUS (PHASE 2) Commercial manufacturing Product development & Commercialisation supply 27
Slide 28: Finance
FINANCE For personal use only $ million 30 June 08 30 June 07 Outlook: Licensing 3.8 2.9 Current cash $33m Grants/interest 3.2 2.2 $15m further Phase 3 costs to Dec 2009 Revenue 7.0 5.1 Revenue growth to achieve profit in 09/10 Total costs (16.0) (13.0) Key projected revenue sources: Less capitalise
Slide 29: Meeting Milestones
MEETING MILESTONES For personal use only Achievement of 2007/08 Goals: Licensing – two new deals Evamist™ - US launch by KV Pharmaceutical Testosterone MD-Lotion® - Start Phase 3 trial Animal Health – Eli Lilly starts Phase 3 trial X Organon – Start Phase 1 trial H2 08 Contraceptives – Complete mult
Slide 30: Major Value Drivers
MAJOR VALUE DRIVERS For personal use only Multiple Product Revenues Testosterone MD- Lotion® partnering Complementary Evamist™ US Launch Evamist™ royalties technology Testosterone MD- Lotion® Phase 3 Ellavie™ commercialisation 2008 2009 2010 BEYOND 30
Slide 31: 2008/09 Milestones
2008/09 MILESTONES For personal use only Licensing – Ellavie™ ex-USA partnering plus one other product deal Ellavie™ - Submit marketing application to European regulatory authority Testosterone MD-Lotion® - Complete Phase 3 trial subject recruitment Animal Health – Eli Lilly submits marketing applic