Acrux Limited · ASX:ACR
Acrux — Shareholder Meeting (November 2009)
27 slides from Acrux's shareholder meeting presentation, Nov 24, 2009
Slide 1: 2009 AGM Chairman's Address and CEO's Presentation
ACRUX LIMITED (ACR) - ASX ANNOUNCEMENT 24 NOVEMBER 2009 2009 AGM CHAIRMAN’S ADDRESS AND CEO’S PRESENTATION Chairman’s Address As some of you may be aware, Acrux has appointed Credit Suisse to act on the For personal use only Company’s behalf in commercialising Axiron. Acrux conducted a careful evalu
Slide 2: CEO's presentation: introduction and forward-looking statements
AXIRON has been central to the company’s investment proposition and indeed it has been our primary focus within the organisation for the last 24 months. In that respect the Acrux team has been meticulous in the execution of our clinical, regulatory and commercial plans and I am very pleased to repor
Slide 3: The Testosterone Therapy Market
this as a compelling investment opportunity for our shareholders. We set out a detailed plan for the time and costs to execute the Phase 3 trial, to establish commercial manufacturing and submit a marketing application to the FDA. We believe that AXIRON’s attributes will deliver best-in-class benefi
Slide 4: Positive Acceptance by Patients
(Slide 6) Positive Acceptance by Patients Acrux has undertaken detailed market research with both users and prescribers of the current market-leading products. Firstly, a patient focused market research study was conducted in the USA in which 63 For personal use only hypogonadal men used AXIRON plac
Slide 5: AXIRON Efficacy Results
(Slide 9) AXIRON Efficacy Results In terms of the primary objective of the trial, 4 months of treatment with AXIRON achieved average blood levels of testosterone within the normal range in 84% of For personal use only subjects, comfortably exceeding the requirement of 75% that was agreed to with the
Slide 6: Commercial manufacturing and Ellavie
in additional infrastructure at Orion’s FDA-approved facility in Turku. The investment by Acrux formed part of the original budget for the AXIRON Phase 3 programme. The transfer and scale-up of the manufacturing process at Orion has proceeded according to plan. The dedicated product filling machine,
Slide 7: Evamist and other products
promotional support for Evamist™ remains unchanged by the restructuring elsewhere in the company and that it expects the weekly growth in sales for Evamist to continue. Acrux earns a royalty on sales of Evamist, which is not yet a significant contributor to Acrux’s revenues. For personal use only (S
Slide 8: Luramist and Finance
We continue to believe that Luramist is capable of generating strong commercial returns for Acrux, representing a best-in-class product in a market that may be worth more than US$1 billion annually. (Slide 17) Finance For personal use only I will now turn to the FY09 financial performance and curren
Slide 9: Objectives and closing remarks
5. Finally, we intend at all times to maintain a strong cash position, while targeting our first profit in the 09/10 financial year, underpinned primarily by a successful AXIRON partnering deal. For personal use only In concluding, I would like to thank the entire Acrux staff for their tremendous wo
Slide 10: Acrux Annual General Meeting, November 2009
For personal use only Acrux Annual General Meeting, 24 November 2009
Slide 11: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS For personal use only This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Acrux to be mate
Slide 12: Delivering Value
DELIVERING VALUE For personal use only 2.50 Acrux (ACR) 2.00 ASX All Ordinaries ACR Share Price ($) 1.50 1.00 0.50 0.00 Jul-2008 Sep-2008 Nov-2008 Jan-2009 Mar-2009 May-2009 Jul-2009 Sep-2009 Nov-2009 3
Slide 13: AXIRON
AXIRON™ For personal use only • Phase 3 investment identified as outstanding opportunity for shareholders • Billion dollar high growth market • AXIRON provides best-in-class benefits to patients and clear, unique advantages relative to existing treatments • Thoroughly tested in US market research •
Slide 14: 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 15: Positive Acceptance by Patients
Positive Acceptance by Patients For personal use only Much Worse/Worse Somewhat Better/Better/Much Better Time to Clean Up ‐9% ‐26% 15% 21% 29% Accommodate into Daily Routine ‐3% ‐15% 15% 38% 29% Risk of Transference ‐6% 21% 38% 38% Ease of Application ‐6% ‐18% 24% 32% 21% Time it takes to Dry ‐3% ‐
Slide 16: Positive acceptance by Physicians
Positive acceptance by Physicians For personal use only 134 Physicians surveyed in the US •30 primary care physicians •51 endocrinologists •53 urologists
Slide 17: 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 18: 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 9
Slide 19: 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% 10
Slide 20: 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 11
Slide 21: Safety Measures
Safety Measures For personal use only • No serious adverse events related to AXIRON • No negative safety trends observed • Biochemical safety parameters all within normal limits – Prostate Specific Antigen (PSA) – Haematocrit – Dihydrotestosterone (DHT): Testosterone ratio • Mild or moderate transie
Slide 22: Commercial manufacturing
Commercial manufacturing For personal use only Alliance with Orion • Process transferred to FDA approve facility in Finland • Dedicated filling machine installed • Process scaled-up and 3 registration batches manufactured for FDA marketing application 13
Slide 23: 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 • Appointment, regulatory approval and launch fees $4.7m plus ongoing fees based on sales • First
Slide 24: EVAMIST (Estradiol USA)
EVAMIST™ (Estradiol USA) For personal use only • Marketed by KV’s women’s health sales force – reaches 90% of HRT 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 sales t
Slide 25: Other Products
OTHER 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 Testosterone MDTS® fo
Slide 26: Finance
FINANCE For personal use only FY June $ million 2009 Products 0.6 Outlook Grants/interest 2.9 • Cash at 30 September 2009 $11m Revenue 3.5 • Costs reducing post-Phase 3 Total costs (23.9) • Profitable in 09/10, driven by H1 2010 Less capitalised 12.7 revenue: Loss before tax (7.7) - AXIRON partnerin
Slide 27: Outlook for 2009/10
OUTLOOK FOR 2009/10 AXIRON For personal use only • New Drug Application to FDA filed by end 2009 • Marketing deals H1 2010 – Significant international interest – Credit Suisse appointed corporate advisor Other • Animal health - 1st product marketing approval in US • Ellavie - further distribution de