Acrux Limited · ASX:ACR
Acrux — Investor Presentation (October 2009)
16 slides from Acrux's investor presentation, Oct 6, 2009
Slide 1: Acrux investor presentation, October 2009
For personal use only Acrux investor presentation, October 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™ excellent Phase 3 trial results – 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 deve
Slide 4: AXIRON
AXIRON™ For personal use only • Phase 3 investment identified as outstanding opportunity for shareholders • AXIRON provides best-in-class benefits to patients and clear, unique advantages relative to existing treatments • Thoroughly tested in US market research – Two thirds of gel users would switch
Slide 5: The Testosterone Market
The Testosterone Market For personal use only INJ/OTHER ANDRODERM TESTIM ANDROGEL $900,000 $800,000 $62,671 LATIN AMERICA, $32,468 , 3% $60,571 $700,000 ASIA/AFRICA/AUS, $59,333 $141,389 $600,000 Sales USD 000's $53,118 , 5% $55,601 $56,575 $500,000 $104,792 NORTH AMERICA, $55,310 EUROPE , $850,662
Slide 6: Phase 3 Trial Design and Demographics
Phase 3 Trial Design and Demographics For personal use only • 26 sites in USA, UK, Europe and Australia • 155 hypogonadal men – mean age 52 years (19 – 78) – mean baseline testosterone level 190ng/dl • Daily application of AXIRON into the armpit • 4-months treatment, commenced on 60mg dose • Titrati
Slide 7: Efficacy Results
Efficacy Results For personal use only 100 95 85% 84% 90 Response rate (%) 85 76% 80 75 75% primary endpoint target at Day 120 70 66.8% lower bound of 95% CI required to meet 65 primary endpoint 60 15 60 120 Time (days) Primary endpoint – proportion in normal range ±95% CI 7
Slide 8: Dose Distribution on Day 120
Dose Distribution on Day 120 For personal use only 120 mg 30 mg 6% 2% Single application to each armpit – most convenient dosing regimen 90 mg 17% 60 mg 75% 8
Slide 9: Testosterone Profile on Day 120
Testosterone Profile on Day 120 For personal use only 1100 1050 1000 900 Normal range Total testosterone [ng/dL] 800 700 600 500 400 300 300 200 100 0 0 6 12 18 24 Time (hours) Cavg of all responders on Day 120 = 504 ng/dL 9
Slide 10: Psychosexual Measures
Psychosexual Measures For personal use only % Change from Baseline1 120% 104% 100% 79% 80% 60% 40% 35% 20% 13% 0% -20% -26% -40% Positive Mood Negative Mood Sexual Desire Sexual Activity Sexual Performance 1 p-value <0.0001 10
Slide 11: Safety Measures
Safety Measures For personal use only • No serious adverse events related to AXIRON • No negative safety trends observed • 8 subjects reported transient application site reaction – All were mild or moderate and all resolved without intervention – No patient withdrew due to a skin reaction • Biochemi
Slide 12: Conclusion and next steps
Conclusion and next steps For personal use only • Exceptionally strong trial result • Successful pre-NDA meeting August 2009 • New Drug Application filed by end 2009 • Product supply from Orion – Registration batches successfully manufactured – Commercial validation batches in 2010 • Progress partne
Slide 13: ELLAVIE (Estradiol ex-USA)
ELLAVIE™ (Estradiol ex-USA) For personal use only • Ex-USA peak sales estimate $30m - $50m ($25m in “EU 5”) • Distributors appointed for 9 European countries, Southern Africa, South Korea and Australia • HRA-Pharma to distribute in key European countries Appointment, product approval and launch fees
Slide 14: EVAMIST (Estradiol USA)
EVAMIST™ (Estradiol USA) • Marketed through KV’s women’s health sales force – reaches 90% of HRT For personal use only market • Slow, but steady prescription growth continuing • Acrux royalty % increases as annual sales increase - currently modest royalties, growing to $15m per annum at KV’s peak sa
Slide 15: Other Partnered Products
OTHER PARTNERED PRODUCTS For personal use only Animal health – First marketing application submitted to FDA by Eli Lilly Dec 2008 – Milestone payment due on FDA approval – Further products in clinical development – Acrux receives royalties plus up to $8.25m in product approval milestones Testosteron
Slide 16: Finance
FINANCE For personal use only FY June $ million 2009 Products 0.6 Outlook: Grants/interest 2.9 • Cash at 30 June 2009 $14.7m Revenue 3.5 • Costs reducing post-Phase 3 Total costs (23.9) • Profitable in 09/10, driven by Less capitalised 12.7 AXIRON™ partnering Loss before tax (7.7) Net cash outflow (