Acrux Limited · ASX:ACR
Acrux — Shareholder Meeting (October 2006)
29 slides from Acrux's shareholder meeting presentation, Oct 31, 2006
Slide 1: 2006 AGM - Chairman's Address
ACRUX (ACR) - ASX ANNOUNCEMENT 31 OCTOBER 2006 2006 ANNUAL GENERAL MEETING - CHAIRMAN’S ADDRESS Since last year’s AGM, we have made significant changes to the management and Board to enable us to accelerate commercialisation of Acrux’s technology. We are entering a new phase in the Company’s growth
Slide 2: Chairman's Address (continued)
This morning we are pleased to announce an expansion of our commercial agreement with Elanco Animal Health, the veterinary division of Eli Lilly and Company. In his presentation, Richard will expand on this development and other commercialisation activity. Our share price currently stands at 70 cent
Slide 3: Simin
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Slide 4: Forward-looking statements
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 pres
Slide 5: Proven technology
Proven technology —» First product successfully through Phase 3 in USA and in registration ~» Other products use same delivery technology Access to major markets — Broad core patents to 2017 & 2022 granted in USA and Europe, pending elsewhere — New patents pending out to 2026 Expert management —> Ne
Slide 6: Key achievements Feb-Aug 2006
0 Feb 2006 - New generation contraceptive Nestorone® licensed from Population Council Mar 2006 - US patent granted covering MDTS® applicator to 2022 April 2006 - Core technology patent granted in Europe, earning $0.5m May 2006 - Positive results in EvaMist™ US Phase 3 trial May 2006 - Leadership cha
Slide 7: Key achievements Sep-Oct 2006
0 Sep 2006 - Filed an Investigational New Drug Application with the FDA for Testosterone MD-Lotion Sep 2006 - EvaMist™ marketing application submitted to FDA, earning US$Im Oct 2006 — Placement of escrowed share, institutional shareholding rises to 40% Oct 2006 - Commenced US Phase 2 trial of unique
Slide 8: EvaMist Phase 3 results
* Statistical significance over placebo for all three dose levels - 1, 2 and 3 sprays per day, giving dosing flexibility * Most effective dose 78% reduction in hot flashes (oral HT average 75%) Frequency of Moderate to Severe Hot Hashes 18 3 onion 3 Spray Flashes per Day Moderate to Severe Hot Basel
Slide 9: Contraceptive sprays
ills Hormonal contraceptive market US$6.7 billion per annum Rapid uptake of transdermal patch in USA — now sells $0.5 billion Market characterised by numerous combination products — opportunity to license a range of contraceptive sprays to a range of partners Several combinations in development, inc
Slide 10: Testosterone MD-Lotion
IN * Global market US$0.6 billion, dominated by Androgel® « US market research confirms strong patient preference for Acrux’s convenient and discreet lotion over current therapies ¢ Patent pending protects unique application to the armpit until 2026 ¢ October 2006 - Phase 2 trial started in USA unde
Slide 11: Veterinary health - Elanco
i so ¢ Global licence for multiple products in multiple animal species with . Eli Lilly (Elanco) - top 10 vet company by sales April 2006 - $500k received on grant of Acrux’s core patent in Europe October 2006 - new therapy area added to licence; $150k additional fee First product final trials start
Slide 12: Financial results
WO Product revenues 13 0.5 2.7 Grant income 1.0 0.8 Interest and other income 0.3 14 1.3 Total expenditure 5 (10.8) _Net loss + (7.3) N et cash outflow before new capital . ; (6.4) » Net cash outflow expected to reduce in 2006/07 financial year » Priority to grow revenue from new & existing licences
Slide 13: Management team responsibilities
oe on Dr Adam Watkinson Tim Saunders Dr Richard Treagus a —New compounds —Testosterone MD-Lotion® —Partner Performance —Technology improvements —Fentanyl UDTS™ —New Licence Agreements — Synergistic technologies —Contraceptive sprays —Collaborative Agreements
Slide 14: Emphasis on commercialisation and initiating new products
phasis on commercialisation and initiating new products
Slide 15: Performance culture - outcomes focused
Slide 16: Maximise value of the current transdermal technology
HE Maximise value of the current transdermal technology Exploit the core competency of transdermal drug delivery New products added to the pipeline New license partnerships in all major markets Synergistic transdermal technologies
Slide 17: Share ownership
SHARE OWNERSHIP (TOTAL 134.6m) Acrux (ACR) share price July 2005 - August 2006 institutions Cents per Share 40% directors & iad managers 13% 85 B&eSasge Jd Aug Sep- Oct Now Dec: Jan Feb- Mar Apr May Jun uk Auge 05 408 405 05 05 05 06 05 OS 06 06 08 06 06
Slide 18: Objectives for the year
Licensing - secure significant new deal Evamist™ - VIVUS files Evamist marketing application with FDA (achieved September 2006) Testosterone MDTS® - VIVUS starts Phase 3 trials (H1 2007) Contraceptive sprays - start proof of concept trials of combinations Testosterone MD-Lotion® - complete Phase 2 t
Slide 19: CEO's Address - AGM 31 October 2006
ACRUX LIMITED CEO’s ADDRESS AGM, 31°" OCTOBER 2006 Thank you Mr Chairman. It is my pleasure to report on the major developments at Acrux since the last AGM, as well as talk about the outlook for the business and the specific objectives that we have set ourselves for the year ahead. (Slide 1} Acrux i
Slide 20: CEO's Address: disclaimer and key areas
regulatory actions, the strength of competition and the effectiveness of patent protection (Slide 3) The value in Acrux is a function of our technology, our product pipeline, the skilled people we employ and the business partnerships that we create and exploit. | am pleased to report on the progress
Slide 21: CEO's Address: recent developments
« And later the same month, the EvaMist marketing application was submitted to the FDA, earning Acrux a milestone payment from Vivus of US$1m. | can confirm that this payment has now been received. « In the first week of October, we facilitated the placement of 3m escrowed shares, from company found
Slide 22: CEO's Address: EvaMist filing and contraception
The marketing application for EvaMist was submitted to the FDA on September 28" and we expect the approval process to be approximately 12 months. Subject only to the FDA approval, we can reasonably anticipate that EvaMist will be launched in the USA market in late 2007 or early 2008. This milestone
Slide 23: CEO's Address: Testosterone MD-Lotion
made to date in terms of the initial formulation work in this area and initial discussions with large pharma have proven encouraging. (Slide 8) Testosterone MD-Lotion. The market for testosterone supplementation in hypogonadal males is US$0.6 billion and growing at approximately 9% per annum. The ma
Slide 24: CEO's Address: veterinary health
efficacy endpoints, the development pathway for MD-Lotion is considered to be relatively low-risk and we anticipate being able to file a marketing application in the second half of 2008. (Slide 9) Veterinary Health. We have an important and potentially very valuable partnership with Elanco Animal He
Slide 25: CEO's Address: financial update
In terms of the partnership, Acrux may receive further milestone payments of up to $8.25 million and receive royalties on global sales of the products if regulatory authorities approve a number of products for marketing. (Slide 10) The US$1 million milestone from VIVUS boosted our revenue for the fi
Slide 26: CEO's Address: management and business development
Since my appointment in May this year we have placed a far greater emphasis on two of these three functional areas, namely new product research and commercialisation. It is worth noting that revenue from additional licensing activity can be grown and similarly new products can be added to the pipeli
Slide 27: CEO's Address: new products and partnerships
We will continue to actively develop new combinations of pharmaceutical compounds with our technology. Simultaneously, we will aggressively seek out appropriate commercial partnerships in all major markets. These partnerships not only provide the primary source of revenue for our business, but impor
Slide 28: CEO's Address: shareholders and objectives
At the end of September, a final tranche of shares was released from ASX escrow. This enabled a further transition of shares from founders to institutions. Our largest shareholder Orbis has increased their holding to 14% over the course of the year, and two new institutions have more recently taken
Slide 29: CEO's Address: remaining objectives and close
5. To complete the Phase 2 clinical trial on Testosterone MD- Lotion®. We expect to report the resuits of this study in H1 2007. 6. To announce one successful proof_of concept trial for a new pharmaceutical compound. 7. To open an IND with FDA for the Phase 2 study on Fentanyl UDTS™, 8. And finally,