Financial Statement 08/09
Fourth Quarter Report, Stockholm, October 23, 2009 Fourth Quarter Report for Diamyd Medical AB (publ.), Fiscal Year 2008/2009 (www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY) Fourth quarter, June 1, 2009 – August 31, 2009
• The US FDA approves the inclusion of children aged 10 and above in American Phase III study with the Diamyd® diabetes vaccine • The first children are vaccinated in a prevention study with Diamyd® with the aim of preventing type 1 diabetes • The Company begins to include children and accelerate patient recruitment for its American Phase III study with the Diamyd® diabetes vaccine • Group net sales for the quarter amounted to KSEK 29 (133) • Loss before tax for the quarter was KSEK -29 772 (-20 327) • Earnings per share for the quarter were SEK -2,7 (-1,9) Significant events after reporting period • A four-year follow-up of type 1 diabetes patients who were part of the Company's Phase II study shows a clear positive trend • The Company signs an agreement with Inclinix Inc. to accelerate recruitment of patients for the American Phase III study of the Diamyd® diabetes vaccine • 90 percent of the patients in the Company’s European Phase III study with the Diamyd® diabetes vaccine are included • An extra shareholders’ meeting resolves, in accordance with the proposal put forward by the Board of Directors, to implement a new share issue of just under MSEK 220 with preferential rights for existing shareholders • The Company executes a settlement agreement with Apoteket AB regarding a clinical study in LADA patients, which was invalidated in 2007. Diamyd has claimed damages from Apoteket AB for unnecessary costs related to the invalidated study. The settlement agreement includes a payment of SEK 11 million to Diamyd as compensation for the insufficiencies in Apoteket's routines and documentation causing Diamyd to invalidate the study. Full year, September 1, 2008 – August 31, 2009 • Group net sales for the year were KSEK 1 105 (1 092) • Loss before tax for the year was KSEK -81 803 (-63 945) • Group liquid assets amounted to KSEK 37 287 (81 890) • Earnings per share for the year were SEK -7,4 (-6,3) CEO COMMENTS Diamyd is in a great position In the past year Diamyd Medical came ever closer to realizing its vision of being able to prevent and cure the autoimmune form of diabetes in the future. Continued success in the clinical trials of the Company's three candidate drugs is positioning Diamyd as a diabetes company with an exciting future. Interest in Diamyd’s business has increased markedly as the positive results of our clinical trials have been published in respected scientific journals and several prominent research groups has chosen to work with the Diamyd® vaccine. Several large international pharmaceutical companies are following our progress closely, and their interest in the structured licensing process for Diamyd® that we are managing in cooperation with an American consulting firm is confirmation of our belief that the diabetes vaccine is an extremely valuable asset for the Company. We are conducting clinical trials of the Diamyd® vaccine for treatment of newly diagnosed type 1 diabetes in nine European countries and the US. The pace of recruitment indicates that we can begin to report Phase III data in the spring of 2011, and that a market approval application can be submitted in the same year. Market approval is now within Diamyd’s reach! For business reasons Diamyd has chosen to secure the financing of the operations through a preferential rights issue until we have study results. New shares may be subscribed for through October 30, 2009, and the issue is fully underwritten. In my judgment, as well as the Board's, the issue will provide Diamyd with the necessary resources by some margin until our Phase III results are available. This strengthens our bargaining position in current partnership negotiations, while enabling us to choose the optimal structure and time for a licensing agreement. We could recently report that we executed a settlement agreement with Apoteket AB regarding the LADA study of 160 patients, which was invalidated in 2007. The settlement agreement includes a payment of SEK 11 million to Diamyd as compensation for the insufficiencies in Apoteket’s routines and documentation causing Diamyd to invalidate the study. It is extremely gratifying to put this behind us, and we are looking forward to new LADA studies where we will try to confirm the positive results that we previously received with this patient group after treatment with the Diamyd® diabetes vaccine. Development of new pharmaceuticals entails risks as well as opportunities. My strong belief is that in Diamyd´s case the opportunities outweigh the risks and our latest successes have further strengthened me in this belief. Elisabeth Lindner President and CEO, Diamyd Medical AB -- To read the complete report, please see attached PDF, or read the report at www.diamyd.com --
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