REPORT FOR FIRST HALF AND SECOND QUARTER 2009
A quarter reaching our milestones; obtaining CE marked products, first distributor contracts and biomarker agreement. The first half and second quarter report for 2009 was approved by the Board of Directors on 20 August. Please find the report and an investor presentation attached. Highlights from the report: • CE marking of ADtect® • CE marking of BCtect® • Agreement with Merz Pharmaceuticals • Distributor contracts covering 8 countries signed During second quarter 2009 DiaGenic CE-marked ADtect® for clinical diagnostic use of Alzheimer’s disease and BCtect® for clinical diagnosis of breast cancer. Both tests are released under the European CE IVD directive for "In Vitro Diagnostic Medical Devices 98/79/EC". This CE marking is a major milestone in the development and validation of the tests, as the tests now complies with the requirements in the IVD directive.Consequently, DiaGenic can start marketing the tests in EU and EFTA countries. In second quarter 2009 DiaGenic has entered into an option agreement with Merz Pharmaceuticals GmbH to develop a biomarker for patient stratification in clinical trials, and an option for Merz to use the biomarker in future drug development. Based upon the commercial strategy of a central testing facility in Belgium and sale of tests directly to clinicians in Europe, a targeted approach towards distributors with competence and sales force within the neurology and cancer field is being executed. Distribution agreements covering 8 countries were entered into during second quarter 2009. These distributors are preparing for their local launches. DiaGenic representatives will provide additional scientific support in these markets. Negotiations with distributors in other important European markets are ongoing. Net Income totalled NOK -7.5 million for the second quarter in 2009 compared with NOK -7.9 million in the corresponding period in 2008. Total operating costs for the second quarter 2009 amounted to NOK 7.5 million compared with NOK 8.3 million in the second quarter 2008. The company’s liquid assets totalled NOK 8.1 million at 30 June 2009. Post quarter end a bridge financing of NOK 9.35 million has been secured. The share issue was subscribed at market price by leading shareholders, directors and one new institutional investor. The Board and its advisors are working to secure further financing. Attachments: The First Half and Second Quarter report and presentation Contact: MD PhD Erik Christensen, Managing Director Telephone: +47 95939918 e-mail: erik.christensen@diagenic.com