Acrux Limited · ASX:ACR
Acrux — Investor Presentation (April 2009)
20 slides from Acrux's investor presentation, Apr 21, 2009
Slide 1: Acrux Investor Update
ACRUX INVESTOR UPDATE For personal use only 21 APRIL 2009
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 AXIRON™ nearing end of Phase 3 trial – high value, wholly owned asset First human product launched in USA and filed in Europe; first animal product filed in USA 6 more products in develo
Slide 4: Major Recent Advances
MAJOR RECENT ADVANCES For personal use only AXIRON™ - enrolment in Phase 3 trial and transfer of commercial manufacturing to Orion completed ELLAVIE™ - marketing application submitted in Europe Animal health - first product marketing application submitted to FDA by Eli Lilly Testosterone MDTS® - int
Slide 5: AXIRON
AXIRON™ For personal use only “One of the five most promising drugs entering Phase 3 trials” 1 1 Thomson Reuters, Pharma Matters Report “The Ones to Watch”; April – June 2008 5
Slide 6: 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 7: AXIRON Advantage
AXIRON™ ADVANTAGE For personal use only “After trialling AXIRON™ for 4 days, two thirds of patients indicated that they would prefer it to their existing gel treatment” 1 “91% of physicians rated AXIRON™ very good or excellent in being able to improve patient experience, compared with existing gels;
Slide 8: 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 9: Phase 3 Trial
PHASE 3 TRIAL For personal use only Open-label trial with 150 hypogonadal men in USA, Europe and Australia Primary endpoint is restoration of average testosterone levels in the blood into the normal range after 4 months’ treatment – subjects titrated up onto optimum dose 72 men already completed tre
Slide 10: Commercialisation
COMMERCIALISATION For personal use only Long patent life – granted to 2017, pending to 2026 Commercial product supply by Acrux, through Orion Corporation alliance Pre-registration distribution and product supply deals targeted for H1 2010 Acrux expects to receive value equivalent to 40% - 50% of pro
Slide 11: Other Products
For personal use only OTHER PRODUCTS 11
Slide 12: Evamist
EVAMIST™ For personal use only Marketed through KV’s women’s health sales force – reaches 90% of HRT market Acrux royalty % increases as annual sales increase - expect modest royalties in 2009, growing to $15m per annum at peak sales Slow, but steady prescription growth since launch in 2008 3,000 2,
Slide 13: Ellavie
ELLAVIE™ For personal use only Targets ex-USA estrogen only therapy market of US$360m – transdermals have larger share than in US market Acrux has full access to Evamist™ US data for ex-USA regulatory filings – first European filing in Sweden completed December 2008 – first round of Mutual Recogniti
Slide 14: Other Partnered Products
OTHER PARTNERED PRODUCTS For personal use only Animal health – First product marketing application submitted to FDA by Eli Lilly in December 2008 – Further products in clinical development – Acrux receives royalties plus up to $8.25m in product approval milestones – Milestone payment due on FDA appr
Slide 15: Partnering Opportunities
PARTNERING OPPORTUNITIES For personal use only Nestorone® MDTS® contraceptive spray – Clinical trials demonstrated required delivery of both Nestorone® and ethinyl estradiol – 2 out of 3 contraceptive pills contain a progestin and ethinyl estradiol – Partnering process underway NSAIDs MDTS® for pain
Slide 16: 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) Companion animal health Undisclosed Eli Lilly Companion animal health Undisclosed Eli Lilly VIVUS (USA) Decreased l
Slide 17: Unpartnered Products
UNPARTNERED PRODUCTS For personal use only Therapeutic Area Formulation Phase 1 Phase 2 Phase 3 Registration Marketing Hypogonadism AXIRON™ Global Menopausal symptoms Ellavie™ (Estradiol MDTS®) Ex-USA Menopausal symptoms Duomist™ Global Contraception Nestorone® MDTS® Global Smoking cessation Nicotin
Slide 18: Finance
FINANCE For personal use only $ million HY Dec 08 FY June 08 Outlook: Licensing 0.7 3.8 Cash at 31 March 2009 $19.6m Grants/interest 1.7 3.2 $9m further AXIRON™ costs during 09/10 Revenue 2.4 7.0 and 10/11– fully funded Total costs (12.6) (16.0) Revenue growth to achieve profit in 09/10 Less capital
Slide 19: Major Value Drivers
MAJOR VALUE DRIVERS For personal use only 2009 2010 BEYOND 19
Slide 20: 2008/09 Objectives
2008/09 OBJECTIVES 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