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Jerini AG (OJ:JI4) Berlin, November 14, 2008 - Jerini AG (FSE:JI4) reported financial results according to International Financial Reporting Standards (IFRS) for the first nine months ended September 30, 2008.
Total revenues for the nine-month period ended September 30, 2008, decreased by 51.6 percent to € 7.8 million (prior year period: € 16.2 million). Revenues from collaboration agreements decreased to € 3.3 million (prior year period: € 13.0 million). Revenues from product sales amounted to € 4.5 million (prior year period: € 3.2 million) and were mainly generated by Jerini's wholly-owned subsidiary JPT Peptide Technologies GmbH, whose revenues increased to € 4.3 million (prior year period: € 3.2 million). In the third quarter 2008, for the first time Jerini AG generated revenues from product sales in Germany and France amounting to € 0.2 million (prior year period: € 0.0 million) following granting of a marketing authorization for Firazyr® by the European Commission. Cash and cash equivalents as of September 30, 2008, amounted to € 19.4 million.
Research and development expenses decreased in the first nine months of 2008 to € 18.5 million (prior year period: € 20.3 million). General and administrative expenses increased to € 15.1 million (prior year period: € 7.0 million). Marketing and sales expenses increased to € 7.9 million (prior year period: € 4.8 million). Loss from operations before tax and finance cost (EBIT) increased to € 35.4 million (prior year period: € 17.2 million). Net loss for the nine-month period ended September 30, 2008 amounted to € 34.2 million (€ 15.5 million for the first nine months of 2007). Loss per share for this period amounted to € 0.63 (prior year period: € 0.29).
Net cash burn for the first nine months of 2008 amounted to € 41.3 million (prior year period: € 15.3 million). Net cash burn is calculated by the addition of cash used in operating activities (€ 36.4 million) and cash used in investing activities (€ 4.9 million), as disclosed in the unaudited consolidated cash-flow statements for the nine-month period ended September 30, 2008.
Outlook In April 2008, Jerini received a Not Approvable Letter from the US Food and Drug Administration (FDA) in response to the company's request for marketing authorization of Icatibant for the treatment of hereditary angioedema (HAE) in the US. Jerini plans to file a complete response to the FDA's letter by the end of the year in which it will address the issues raised by the FDA and specifically outline how the Phase III data demonstrate the safety and efficacy of Icatibant for the treatment of HAE.
Jerini's roll-out activities for Firazyr® in Europe are ongoing, and commercial and preapproval sales have begun in France, Germany, Belgium, and the UK. Product launch is expected in Austria and Luxemburg by the end of the year. In addition, Jerini expects that Firazyr® will be available in the next two months in Italy, Spain, Norway, Sweden, Denmark, Finland, and Portugal via paid named patient programs, while pricing and reimbursement procedures continue.
About Jerini AG Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own programs, as well as others in collaboration with established partners. Jerini has been granted marketing authorization by the European Commission for Firazyr® in the treatment of acute attacks of hereditary angioedema. Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease. On July 3, 2008, Jerini and Shire Limited's German wholly-owned indirect subsidiary Shire Deutschland Investments GmbH ("Shire") entered into a business combination agreement regarding a strategic partnership. Jerini is now a subsidiary of Shire plc and a member of the Shire group of companies. Shire currently holds more than 93 percent of Jerini's shares. www.jerini.com. ISIN: DE0006787476 For questions, please contact: Stacy Wiedenmann Director Investor Relations & Corporate Communications Jerini AG Invalidenstr. 130 10115 Berlin T + 49 - 30 - 97893 - 285 X + 49 - 30 - 97893 - 105 wiedenmann@jerini.com
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