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DIMERIX LIMITED — AGM Information 2008
May 14, 2008
64804_rns_2008-05-14_d7b3f48c-7f2a-4ca6-9ce0-89cdd6a7ca9e.pdf
AGM Information
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SUN BIOMEDICAL LIMITED
ACN 001 285 230
Chairman’s Address at General Meeting
Ladies and Gentlemen,
I would like to take this opportunity to provide you with a brief update on Sun Biomedical Limited’s financial performance during this year and tell you a bit about the progress we have been making on some of the key business initiatives.
1. Financial Performance
As we noted in our recent investor update, SBL’s sales during the March quarter of $282k was a significant improvement on the prior quarter of $120k. The key contributors to this strong performance were existing US and Australian distributors purchasing larger volumes of Oraline. The sales for the June quarter will be significantly lower due to a general slowdown in purchases by US distributors who have been impacted by the slackening of demand for Oraline as the downturn in the US economy is affecting the construction and staffing industries.
2. Capital Raising
As we foreshadowed in the February and March investor updates, the Board plans to invite shareholders to participate in a capital raising during May/June 2008. We expect to make a formal announcement on this matter in the next two to three weeks once the details have been finalized.
The funds raised would be used to continue to progress the company’s key business initiatives over the next 12 months as well as to make the final repayment on the vendor promissory note which is due in July 2008 .
3. Key Sales Initiatives
I will now turn to the key business initiatives that SBL is currently working on.
a) Visualine
The first one is the Visualine relaunch project which consists of:
(i) BioScreens Agreement
An agreement with BioScreens to create a quality, low cost cup and tailoring Visualine to be an integral part of the new BioScreens cup. The BioScreens cup attacks the most value added part of the urine test cup market, the split specimen cup.
The launch of the finished product is still expected to occur in the quarter ending in September 30, 2008.
(ii) Visualine Re-Launch
In addition to the BioScreens initiative, Visualine production costs are being tackled by utilizing SBL’s core competence, its test strip chemistry, with lower assembly cost from contract manufacturers. The re-launch of the product is progressing in sync with the efforts to support the new BioScreens cup and is expected to occur in the quarter ending September 30, 2008.
b) China
Many of you will be aware that SBL has entered into a joint venture with a company called SiYi in China is to sell and assembly Oraline products for use by the Ministry of Public Security (MPS) in China and future nongovernmental customers in China. MPS has conducted its initial testing of Oraline and requested that SBL further define the detection range of the Oraline product. SBL will deliver the results of that evaluation to MPS by the end of June 2008 for their review and confirmation. Provided MPS are satisfied with the results, the field trials in 15 cities are projected to begin by November 2008 with purchases increasing during CY 2009.
c)
Oraline VIII
In addition, SBL has also been working on the development of a new product, Oraline VIII. Prototypes of the new device have been developed and are currently in SBL’s lab for testing. Oraline VIII will deliver eight drug tests in one device with improved saliva collection. Discussions with existing distributors indicate that the ability to test for 8 drugs rather than 4 will provide SBL with a significant advantage over its competitors. The expected launch date for this new product is September 2008
d)
Mexico
The small test program of 2,000 Oraline units in Mexican schools has begun. SBL anticipates that if the program is approved for expansion new orders would be received at the start of the new school year in September 2008.
4. Legal and Regulatory Matters
a) Avitar
On the legal and regulatory front, I am pleased to advise that a settlement of the claim against Avitar has now been agreed upon and confirmed by the courts. The terms of the settlement are confidential but it is pleasing that the status of our patent has been recognized.
b) FDA update
Third Party Review
During the quarter, a third party review of SBL’s FDA filings was undertaken. This review confirmed that, with the appropriate resources, SBL’s current plan will be able to secure 510k clearance for both Oraline and Visualine in the timeframes and budgets proposed
FDA Inspections
The FDA is currently conducting its bi-annual review of SBL’s operations. The results of this review will be available by late May/early June.
As you can see, SBL has a number of exciting opportunities in the pipeline which we hope will dramatically change the financial performance of the business during 2009.