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DIMERIX LIMITED Interim / Quarterly Report 2008

Oct 27, 2008

64804_rns_2008-10-27_7e0eed7b-bf51-4112-9a8e-8130756fc103.pdf

Interim / Quarterly Report

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ASX Company Announcement

28 October 2008

CORRECTION TO INVESTOR UPDATE

The Investor Update previously lodged on 28 October 2008 at section 1 ‘Financial Performance for September Quarter’, incorrectly named the last column as ‘Dec 2008 Quarter’ instead of ‘Dec 2007 Quarter’.

Please find attached an amended Investor Update incorporating this correction.

For further information contact:

Jim Hallam Director Mobile: 0414965442 Email: [email protected]

Sun Biomedical Limited ABN 18 001 285 230

Investor Communications Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | E: [email protected]

ASX:SBN www.sunbiomed.com

28 October 2008

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ASX Company Announcement

Investor Update

The Directors of Sun Biomedical Limited (ASX: SBN or the Company) wish to provide the following update to investors in relation to the operations of Sun Biomedical Laboratories Inc. (SBL).

1. Financial Performance for September Quarter

Sept 2008
Quarter
Jun 2008
Quarter
Mar 2008
Quarter
Dec 2007
Quarter
Sales revenues (AUD$’000)~~(1)~~ 240 140 282 120
Number of OraLine units sold
39,650 23,950 59,111 17,335
~~(1)~~
Unaudited. Represents sales made not cash received as per Appendix 4C. At 30 September 2008, SBL had
trade debtors of A$143k

The increase in September quarter sales from the June quarter is due primarily to increased US distribution of OraLine. While the downturn in the US economy has slowed down sales to existing distributors, the effort launched in January 2008 to broaden the base of distributors has enabled OraLine sales to grow in the US.

The group is now free of interest bearing debt and, as at 30 September 2008, had $1.74m in cash reserves.

Sun Biomedical Investor Communications Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | ABN 18 001 285 230 E: [email protected]

ASX:SBN www.sunbiomed.com

The table below summarises the status of the key initiatives identified in the Prospectus:

Use of Funds Minimum
Subscription
Maximum
Subscription
Status
Payment to Dr Ming and Alice Sun as
final consideration for the acquisition
of SBL
$516,000 $516,000 $0.6m was paid in September
quarter
Commercialisation of China joint
venture, including capital expenditure
required to increase the production
capacity of the current plant
$140,000 $400,000 In progress (refer 4(a) below).
Production capacity will only
need expansion if demand
exceeds one million units per
year.
Development of BioScreens Cup and
VisuaLine 510(k) Clearance
$170,000 $170,000 Cup development is in progress
(refer 4(b) below). The
submission of the 510k is
dependent upon attainment of
adequate cup sales to justify
cost.
Development and marketing of
OraLine VIII
$125,000 $125,000 In progress (refer 4(c) below)
FDA Good Manufacturing Practice
compliance and quality control
measures
$100,000 $100,000 In progress – a new Quality
Assurance manager has been
employed (refer 5 below)
Working capital to support operating
costs of SBL and the Company
$619,000 $1,517,963 Ongoing
Expenses of the Rights Issue $330,000 $350,000 All expenses have now been
paid.
Total funds raised $2,000,000 $3,178,963

2. Capital Raising

The Rights Issue closed on 14 August 2008 and raised the Minimum Subscription Amount of $2,000,000. Since then, the Company has placed an additional amount of $1,178,963 through the Shortfall placement capacity which brings the total amount raised to the Maximum Subscription Amount of $3,178,963.

SBN is very pleased with this outcome, particularly in the light of current economic conditions. These funds will allow the Company to pursue its sales initiatives for at least the next twelve months. In addition, the Company has maintained the support of its key shareholders with Log Creek Pty Ltd now holding 14.1% of the issued ordinary shares and Dr Ming Sun holding 11.3%. Dr Sun increased his shareholding from 10.6% to 11.3% through the subscription of an additional $100,000 in October 2008.

The latest top 20 shareholder and option holder listings are attached to this update.

Sun Biomedical Investor Communications ASX:SBN Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | www.sunbiomed.com ABN 18 001 285 230 E: [email protected]

The Company’ share price since 1 July 2008 is shown in the chart below:

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0.025
0.020
0.015
0.010
0.005
0.000
1/07/2008 31/07/2008 30/08/2008 29/09/2008
Share price (A$)
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3. Repayment of Promissory Note

During the quarter, the final repayment on the Promissory Note of USD 980,000 due to Dr Sun was made with USD 490,000 converting into New Ordinary Shares at the Rights Issue price of A$0.01 and the remaining amount of USD 490,000 being repaid from the proceeds of the Rights Issue on 5 September 2008. The Company is now free of interest bearing debt.

4. Update on SBL’s Sales Initiatives

a) China

Siyi has received the test report from the Ministry of Public Security (MPS) confirming that OraLine is in compliance with its quality standards. The Quality Standard Number Q/SIRL1-2008 has been issued by Shanghai Technology Quality Administration.

The Chinese version of OraLine IV has been specially tailored by SBL for Siyi and is called ‘Ai Rui Te 4-in-1 Saliva Drug Screen Device’. The major customized details are as follows:

  • Modified the Claimed Sensitivity Cutoff Values (CSCV). The new CSCV are based on the MPS lab test report (ng/mL): MET 50, COC 50, OPI 30, THC 8;

  • Modified the saliva collection method in the instructions for use. The new method is cup collection (spitting to the cup) only, instead of direct collection of saliva from the mouth using the device itself; and

  • Added a saliva collection cup to each unit of product.

Sun Biomedical Investor Communications ASX:SBN Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | www.sunbiomed.com ABN 18 001 285 230 E: [email protected]

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Following the issuance of the MPS report, Siyi obtained approval for starting the MPS field trials of OraLine in 15 cities. The table below summarises the required steps until receipt of the final product approval, SBN’s current expected timing and anticipated sales arising from each stage:

Step Anticipated orders Expected timing
1. Commencement of MPS field trials 20,000 unit order has been received
by SBL
December 2008
2. Completion of MPS field trials and
receipt of trial reports from cities
Further 40,000 to 60,000 units for
completion of trials
End of March 2009
3. Application for final product
approval
None though some trial sales may
continue during the approval period
Second half of CY
2009

Under the agreement with Siyi, SBL supplies the OraLine detection strips to Siyi, and, in the early stages, also provides assistance to Siyi regarding the manufacture of the finished products through OEM contracts. SBL earns its revenue and profits from the sale of the strips as the product housings are sourced separately by Siyi.

b) BioScreens

BioScreens is progressing with the manufacture of its new urine test cup. The first delivery of new cups is now anticipated to occur in early 2009 with SBL’s strips to be incorporated into those cups.

c) OraLine VIII

SBL has assigned the initial production of prototype units for delivery in early November and the product will be launched at the Medica show which is being held in Germany on 19 to 22 November 2008.

Sun Biomedical Investor Communications ASX:SBN Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | www.sunbiomed.com ABN 18 001 285 230 E: [email protected]

The permanent mould will be produced during December 2008 with a volume production run planned for delivery in late January 2009.

d) Russia

Sub-distribution agreements are currently being developed in Russia and sales are expected early 2009.

e) United States

SBL has added new US distributors in the current quarter. Sales from new OraLine distributors continue to grow and expand the coverage of the US market place for workplace testing.

SBL, in conjunction with its US marketing partner, has conducted market testing of a new consumer based drug residue kit, Probeline. Initial market tests run exclusively in the US have been positive. The next phase of testing will be conducted to determine optimal price points and offer content by selling 2,000 units through existing sales channels. If preliminary test results support the sales potential of this new product, then SBL anticipates a commercial launch of this product in early 2009.

f) Mexico

Mexican officials are reviewing OraLine’s application for import approval. SBL has continued to provide information as requested by Mexican officials and it is anticipated that a decision will be reached in the near future.

g) Latvia

SBL sold 3,000 units of OraLine to the Latvian Police Department during the quarter for roadside testing. SBL expects that further orders will be placed in the future.

Roadside testing programs continue to be an area of interest to the Company. However, given the demanding needs of most law enforcement organizations for a comprehensive system of testing, record keeping, chain of custody control, training and the varying requirements of the judicial systems in each country, SBN will not invest heavily in developing roadside testing applications until a established marketing and support partner with extensive law enforcement experience is ready to enter the field with us. In the interim, SBN will continue to provide testing devices to discrete opportunities, such as Latvia, and will engage with research projects such as the European Union’s Druid project on roadside testing.

OraLine IV was evaluated as part of the European Union’s DRUID roadside testing project by the European police requirements (“ESTHER”) project in 2006 to 2007. Although the review panel concluded that the product in its current form was not suitable for roadside testing, the recommendations made in relation to improvements to the operational design of the product gave rise to the development of OraLine VIII.

Sun Biomedical Investor Communications ASX:SBN Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | www.sunbiomed.com ABN 18 001 285 230 E: [email protected]

h) Australia

Clinical Medical Marketing has continued to purchase OraLine from SBL during the quarter. They have identified the Australian cutoff standards they wish SBL to develop and work will begin on this in early 2009 once the work on the BioScreens cup and OraLine VIII is complete. The Australian cutoff standards are higher than the sensitivity obtained by OraLine IV, in particular THC which obtains a cutoff of 4ng. The Australian standard is at 25ng

5. Management/Staff Changes

There have been no changes to the senior management team during the September 2008 quarter. SBL has employed a Sales Manager to lead the expansion of US OraLine sales. A new Quality Assurance (QA) Manager has been engaged to enable the current QA manager to assume an Operations role upon her return from maternity leave. The R&D department has been expanded with a new research scientist added during the quarter to concentrate on the launch of Oraline VIII and the development of new products in 2009 and beyond.

6. Foreign Exchange

The AUD/USD exchange rate has fallen dramatically during the quarter. SBN has not hedged its currency exposure because of the uncertainty associated with the timing of the funds transfers to SBL. Further, it is expected that as SBL’s sales increase, the frequency and volume of these transfers will reduce. Conversely, the value of SBN’s investment in SBL will benefit from the depreciation of the AUD against the USD.

7. Regulatory

No further issues have arisen with the Food and Drug Administration (FDA). During the December 2008 quarter, SBL will work with the FDA to resolve the remaining issue raised in the May 2008 audit in relation to the calibration of the centrifuge.

For further information in relation to this announcement or any aspects of SBN’s operations please visit SBN website at www.sunbiomed.com or contact:

Jim Hallam Director Mobile: 0414965442 Email: [email protected]

Sun Biomedical Investor Communications Limited Computershare T: +61 1300 850 505 | F: +61 3 9473 2500 | ABN 18 001 285 230 E: [email protected]

ASX:SBN www.sunbiomed.com