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 Company’s behalf in commercialising Axiron. Acrux conducted a careful evaluation of a number of international investment banks before choosing Credit Suisse and subsequent developments have confirmed our belief that this selection will result in the optimal outcome for shareholders. We will advise shareholders of progress when it is appropriate. While we appreciate the level of interest in commercialisation discussions we cannot comment on negotiations at this stage. We know you will recognise the commercial sensitivity involved in the process and the need for Management to retain confidentiality.

While we have made progress with Evamist, with continued growth in the US market and significant progress with licensing agreements for the rest of world markets, the probable value of the product is low relative to Axiron.

The potential value of Acrux’s application for female testosterone (‘Luramist™’) is likely to be significantly higher than Evamist, but we have not achieved a satisfactory commercial outcome from our license to Vivus. As we have advised the market previously, this has been the subject of a lengthy arbitration hearing that resulted in Vivus being set specific milestones, including the commencement of first patient, first dose by April 2010. We continue to engage with Vivus in the hope of having this milestone met and will keep shareholders advised of progress.

I will now pass over to Richard to provide a more complete overview of the Company’s progress since the last AGM.

CEO’s Presentation

(Slide 1) Introduction

Ladies and gentleman, it is my pleasure to review the progress that has been made by Acrux over the last 12 months, as well as set out our objectives for the balance of the current financial year.

In October of this year Acrux was awarded the prestigious Ausbiotech-Roche 2009 Excellence award for outstanding contribution to the biotechnology industry by a company. The award followed the successful Phase 3 development of AXIRON executed and fully funded by Acrux. F

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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 report that that the development of this unique and exciting product has progressed according to plan, in line with our projected timelines and costs, and most importantly, it has exceeded the expected clinical outcomes.

(Slide 2) 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 materially different from the statements in this presentation.

Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of patent protection

(Slide 3) Delivering Value

Despite the challenging financial conditions over the last 24 months we have maintained a disciplined and focused approach towards our business, actively advancing our key projects and continuing to build a range of commercial partnerships around the world. Despite the broader market challenges, Acrux has emerged in a very strong position, and is now well placed to capitalise on the real progress that has been made during this intervening period.

We anticipate that 2009/10 will be an exciting and pivotal year for Acrux, given that a number of our products are now at an advanced commercial stage and we fully expect they will begin to generate meaningful revenue and returns for our shareholders.

I should add as an important footnote, that we continue to maintain our status as a Pooled Development Fund and we do not expect that this will be relinquished or altered in the near-future.

(Slide 4) AXIRON

I wish to start by reviewing the AXIRON development programme, before moving on to discuss the progress that has been made in other areas of the business.

We believe that AXIRON is the world’s first and only therapeutic product applied into the armpit of a patient, and subject to FDA approval; we envisage that it will be made available to patients in the USA during the course of 2011.

In July 2007, following successful results in Phase 2 trials, Acrux raised $23 million in new capital specifically to fund the final stage in AXIRON’s development. We viewed

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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 benefits to patients and offer a clear, unique selling proposition against the existing products in this space. A strong and lengthy patent position, an established source of cost-effective product supply, excellent clinical trial data and a successful pre-NDA meeting with the FDA completes what we believe to be a very compelling commercial opportunity for prospective marketers of AXIRON.

(Slide 5) The Testosterone Therapy Market

AXIRON is targeting an annual market worth more than US$1 billion, growing at 20% per annum. A much greater awareness of men’s health conditions in recent years, has contributed to this strong underlying growth trend.

Testosterone deficiency in men is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. Estimates of men over 50 years of age having testosterone levels below the normal healthy range vary from 10% to 39%. However, in the majority of men this remains undiagnosed, with only around 5% to 10% of those with the condition receiving treatment.

Treatment involves the delivery of appropriate amounts of testosterone into the blood, in order to restore levels into the normal healthy range. With a high incidence rate, rapidly growing treatment rates and a favourable pricing and reimbursement environment, male testosterone replacement therapy is unquestionably a highly attractive commercial opportunity.

AXIRON has been designed to overcome the issues and drawbacks associated with the existing gel treatments. Currently, large volumes of a gel are applied by hand and rubbed on to the abdomen, shoulders or arms. These products are considered to be messy, sticky, and slower-drying and may have an unpleasant odour to some patients. One of the biggest drawbacks however is the risk of transference to other people through contact with the application site or from residue left on the hands following application. In sharp contrast, AXIRON is a faster-drying and pleasant smelling solution that is applied to the armpits once daily, using a convenient “no-touch” applicator.

At this point, I would like to show a 2 minute video that demonstrates just how convenient it is for a patient to apply the AXIRON product as part of their normal daily grooming routine. F

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(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 hypogonadal men used AXIRON placebo for four consecutive days. The research specifically evaluated in-use handling and the application routine compared with existing gel treatments. After trialling AXIRON for 4 days, two thirds of patients responded that they would prefer AXIRON to their existing gel product and 94% believed that AXIRON would reduce the risk of inadvertent transference.

The significance of AXIRON’s potential for reducing the risk of inadvertent transference of testosterone to others (“secondary exposure”) was further reinforced in May 2009 when the FDA announced that the product labels of the leading testosterone gels, AndroGel® and Testim®, would be required to include a so-called boxed-warning about the risk of secondary exposure and the steps that should be taken to reduce this risk. The FDA acted after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these gels.

(Slide 7) Positive acceptance by physicians

A second market research study was conducted on the attitudes of physicians towards AXIRON. The study incorporated the main prescribing groups for testosterone therapy in the USA, with a total of 136 Endocrinologists, Urologists and Primary Care Physicians.

91% of all physicians surveyed rated AXIRON very good or excellent in being able to improve the overall patient experience, compared with existing gel treatments. Furthermore, 92% rated AXIRON as very good or excellent in its ability to reduce the risk of transference to others when compared with the gels. Most importantly, when asked about their intention to prescribe the product, 90% of physicians using gels as first line therapy said they would offer AXIRON to their existing gel patients.

(Slide 8) Phase 3 Clinical Trial

In late September 2009 we announced excellent results from the international Phase 3 trial of AXIRON. 155 hypogonadal men enrolled in the trial at sites in the USA, Australia, France, Germany, Sweden and the UK. 135 men completed the trial and 52 men continued treatment for a further 2 months, specifically to monitor skin safety following 6 months’ continuous use, as required by the FDA. During the trial, blood samples were analysed to determine the level of testosterone in the blood at defined time points.

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(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 subjects, comfortably exceeding the requirement of 75% that was agreed to with the FDA.

Blood levels of testosterone were also measured after 2 weeks and 2 months of treatment. Notably 76% of subjects had average blood levels of testosterone within the normal range after only 2 weeks of treatment with AXIRON.

(Slide 10) - Dose Distribution on Day 120

4 different dose levels were tested and the trial demonstrated that the optimum dose for 75% of subjects was 60mg testosterone per day, which represents the most convenient treatment regimen of one application of AXIRON to each armpit.

Subjects were also permitted to use an underarm deodorant or antiperspirant product during the trial. More than half of the men continued to apply an underarm product as a part of their daily routine and an analysis of these sub-groups showed that this had no impact on the efficacy of AXIRON.

(Slide 11) Psychosexual measures

Comprehensive data collection and subsequent analysis of mood, sexual desire, sexual activity and sexual performance before and after 4 months of treatment showed statistically significant improvement from baseline across all key parameters.

(Slide 12) Safety measures

There were no serious adverse events related to treatment with AXIRON and no adverse trends were identified with the biochemical safety measures. Some form of transient application site reaction was reported by 8 men during the main treatment phase and by 2 men during the two month extension; however these reported events were all mild or moderate and resolved quickly without requiring intervention.

(Slide 13) Commercial Manufacturing

Reliable and cost-effective commercial manufacturing arrangements for AXIRON are a key component of both the FDA marketing application as well as the commercial package for prospective marketing partners. In August 2008, Acrux announced an alliance with the Orion Corporation in Finland, appointing it as the exclusive manufacturer of AXIRON. The alliance has involved an investment by both companies F

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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, owned by Acrux, was installed and commissioned at the Orion factory and Orion has successfully scaled-up the process and manufactured three registration batches as required by the FDA.

(Slide 14) Ellavie (Estradiol ex-USA)

Commercial progress with Ellavie was made possible by an important agreement concluded in August 2008 between Acrux and KV Pharmaceutical. Under this agreement, Acrux obtained full rights to use the FDA-approved US registration package in order to pursue marketing approvals in all ex-USA territories.

In December 2008, Acrux submitted a marketing application for Ellavie to the Swedish regulatory authority. Approval of this application will facilitate the approval process in other European Community countries under a Mutual Recognition procedure.

Since June 2009 Acrux has signed four agreements appointing marketing and distribution partners in key territories around the world including Europe, Africa and Asia. These agreements provide Acrux with aggregate fees on signing, regulatory approvals and market launch, of approximately $4.7 million, as well as ongoing distribution fees based on sales in each country. Each partner was selected for its strength in the particular territory and/or its experience in the sales and marketing of women’s health products.

The estradiol spray is targeting an estrogen therapy market outside the USA of approximately US$360 million per annum. Acrux estimates the aggregate peak annual sales potential for the estradiol spray outside the USA to be at least $30 million. Launch in these markets is expected to commence in the 2010/11 financial year.

(Slide 15) Evamist (Estradiol USA)

The graph shows the steadily growing number of weekly prescriptions written by doctors for Evamist in the USA since market launch in 2008. Evamist is marketed and distributed under license by a KV Pharmaceutical. During the year, KV has undergone a significant restructuring of its business following a number of product recalls and the temporary suspension of its manufacturing operations by the FDA. The supply of Evamist, which is manufactured by an independent third party, was not adversely affected by these events. KV has since provided reassurances that despite their organisational challenges they remain fully committed to focusing their sales force on the promotion of Evamist. KV has furthermore confirmed that the marketing and F

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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.

(Slide 16) Other products

Animal health

The transdermal administration of drugs in companion animals has always represented a compelling application of the Acrux drug delivery technology. Over the last year, Acrux’s partner Eli Lilly and Company has made excellent progress with its plans to make a range of transdermal animal health products available globally.

In December 2008, Elanco submitted an application to the FDA for marketing approval of the first product in this range. On approval of this application, Acrux will receive a milestone payment, followed by royalties on sales, which are expected to commence in 2010.

A number of additional products are already in clinical development and these will likewise attract product approval milestone payments and royalties. This veterinary product range has the potential to make a significant contribution to Acrux’s future revenue and profitability.

Testosterone spray to treat HSDD in women

During the year, Acrux was vindicated in its actions in seeking to enforce the performance obligations of US licensee Vivus Inc. through a formal arbitration process in the United States. An independent arbitration panel convened by the Judicial Arbitration and Mediation Service in California conducted a hearing and made two interim rulings.

In the second interim ruling released in June 2009, the panel set a new “Outside Date” of 1 April 2010, by which Vivus must dose the first patient in a Phase 3 trial for Acrux’s testosterone spray for women (trademarked Luramist™ by Vivus). This was the date sought by Acrux in arbitration. Importantly, the panel will keep jurisdiction over the matter until at least 1 April 2010.

In the first interim ruling released in April 2009, the panel had found that whilst Vivus was not in breach of the licence agreement and to date had used diligent, commercially reasonable efforts to develop Luramist, the prior regulatory environment that made it commercially reasonable for Vivus to proceed as it did with respect to the development of Luramist, no longer existed and there was no reason for further delay by Vivus. F

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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

I will now turn to the FY09 financial performance and current cash position of the company.

In the 2008/09 financial year, we recorded revenue of $3.5 million and a net loss of $7.7 million. Our operating costs are now reducing as the Phase 3 activity winds down and in the 2009/10 financial year we are targeting our first profit which we expect to be underpinned by product revenue, mainly from the AXIRON marketing deal(s), and supported by revenues from our Eli Lilly animal health partnership, our estradiol spray and our testosterone spray for women.

At 30 September 2009 we had cash reserves of $11 million and we continue to manage our ongoing cash burn carefully, ensuring that we remain in a strong financial position as we seek to conclude the AXIRON partnering deal(s).

(Slide 18) Objectives

Finally, I wish to outline for you the specific objectives that we have set ourselves for the current financial year, ending June 2010.

1. Firstly, we are well advanced in the compilation of the AXIRON New Drug Application (NDA). The file will be completed in December and we anticipate submission of the application to the FDA in January of next year.

2. Secondly, we have now commenced a formal process of selecting one or more partners, for the sales, marketing and distribution of AXIRON. We have already received strong and genuine interest from a wide range of pharmaceutical companies and we recently appointed Credit Suisse as our corporate advisors to assist us with the process. We expect to conclude our partner selection during the first half of 2010.

3. Thirdly, and with regards to our global veterinary partnership, Eli Lilly is anticipating FDA approval of its first animal health product utilising the Acrux drug-delivery technology, during the first quarter of 2010.

4. Fourth, we expect to receive approval of our Ellavie product from the Swedish regulatory authority by mid 2010, and in parallel to this, we will seek to conclude further distribution partnerships in additional territories around the world. F

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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.

In concluding, I would like to thank the entire Acrux staff for their tremendous work over the last 12 months and for their tangible level of commitment and belief in what we can achieve as a team

My sincere thanks to Ross our Chairman and the Acrux Directors for their unqualified support and guidance which makes our tasks and responsibilities as a management team that much easier.

Finally, to our shareholders, many of who have supported us now for a number of years, we are grateful for your trust and support and for sharing our vision of what this business is capable of delivering.

Thank you for your attention.

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Acrux Annual General Meeting, 24 November 2009For

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FORWARD-LOOKING STATEMENTSThis 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 materially different from the statements in this presentation.

Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of patent protection.

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DELIVERING VALUE

3

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0.50

1.00

1.50

2.00

2.50

Jul-2008 Sep-2008 Nov-2008 Jan-2009 Mar-2009 May-2009 Jul-2009 Sep-2009 Nov-2009

ACR

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Acrux (ACR)

ASX All Ordinaries

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AXIRONAXIRON™™

• 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

• Comprehensive patent protection granted to 2017 and pending to 2026

• Integrated and cost-effective product supply established

• Excellent Phase 3 trial results

• Successful pre-NDA meeting August 2009

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The Testosterone MarketThe Testosterone Market

NORTH AMERICA,   $850,662 , 82%EUROPE ,

$108,635 , 10%

ASIA/AFRICA/AUS,  $53,118 , 5%

LATIN AMERICA,  $32,468 , 3%

$373,644$446,754

$554,660

$73,819

$104,792

$141,389

$55,310

$55,601

$60,571

$56,575

$59,333

$62,671

$0

$100,000

$200,000

$300,000

$400,000

$500,000

$600,000

$700,000

$800,000

$900,000

MAT MAR07 USD MNF MAT MAR08 USD MNF MAT MAR09 USD MNF

Sales USD

 000

's

INJ/OTHER ANDRODERM TESTIM ANDROGEL

Source: IMS

Global Testosterone Market: US$1.04B

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Positive Acceptance by PatientsPositive Acceptance by Patients

‐40% ‐20% 0% 20% 40% 60% 80% 100%

Time it takes to Apply 

Time  it takes to Dry 

Ease of Application

Risk of Transference

Accommodate  into Daily Routine 

Time to Clean Up 

26%

26%

24%

21%

15%

15%

18%

18%

32%

38%

38%

21%

29%

29%

21%

38%

29%

29%

‐24%

‐24%

‐18%

‐6%

‐15%

‐26%

‐3%

‐3%

‐6%

‐3%

‐9%

Somewhat Better/Better/Much BetterMuch Worse/Worse

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Positive acceptance by PhysiciansPositive acceptance by Physicians

134 Physicians surveyed in the US•30 primary care physicians•51 endocrinologists•53 urologists

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Phase 3 Trial Design and DemographicsPhase 3 Trial Design and Demographics

• 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• Titration to 30mg, 90mg or 120mg if required• Intensive sampling and profiling of testosterone levels on day

15, day 60 and day 120• Primary endpoint: to restore normal levels of testosterone

(300 – 1,050ng/dl) in >75% of patients

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Efficacy ResultsEfficacy Results

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65

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75

80

85

90

95

100

Res

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(%

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Time (days)

15

75% primary endpoint target at Day 120

66.8% lower bound of 95% CI required to meet primary endpoint

76%

84%85%

60 120

Primary endpoint – proportion in normal range ±95% CI

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Dose Distribution on Day 120Dose Distribution on Day 120

60 mg75%

90 mg17%

120 mg6%

30 mg2%

Single application to each armpit – most convenient dosing regimen

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Psychosexual MeasuresPsychosexual Measures

1 p-value <0.0001

13%

-26%

79%

104%

35%

-40%

-20%

0%

20%

40%

60%

80%

100%

120%

Positive Mood Negative Mood Sexual Desire Sexual Activity Sexual Performance

% Change from Baseline1

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Safety MeasuresSafety Measures

• 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 transient application site reaction reported

by 8 subjects during main treatment phase and 2 subjects

during two month extension phase

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Commercial manufacturing

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

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ELLAVIE™ (Estradiol ex-USA)

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• 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 European marketing application filed in Sweden Dec 2008

– First round of Mutual Recognition Procedure planned for 2010

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EVAMIST™ (Estradiol USA)

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Source: IMS

©2008 Ther-Rx Corporation 0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

Apr-08 Jul-08 Oct-08 Jan-09 Apr-09 Jul-09 Oct-09

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• 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 target

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OTHER PRODUCTS

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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® for women• Arbitration panel set outside date of 1 April 2010 by which Vivus must start

Phase 3 trial – panel jurisdiction until at least the outside date

• Potential to be the preferred product in billion dollar market

• Acrux receives US$5.5m in regulatory milestones plus royalty on salesFor

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FINANCE

Outlook

• Cash at 30 September 2009 $11m

• Costs reducing post-Phase 3

• Profitable in 09/10, driven by H1 2010

revenue:

- AXIRON partnering deal

- Eli Lilly animal health milestone

- Ellavie™/Evamist™ fees & royalties

- Vivus female testosterone milestone

$ million FY June 2009

Products 0.6

Grants/interest 2.9

Revenue 3.5

Total costs (23.9)

Less capitalised 12.7

Loss before tax (7.7)

Net cash outflow before new share capital

(19.7)

New share capital 0.1

Cash 14.7

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OUTLOOK FOR 2009/10OUTLOOK FOR 2009/10AXIRON• 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 deals and marketing

approval in Sweden• Testosterone for women - start of Phase 3 trial• Financials – first profit driven by AXIRON marketing deals

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