BERLIN, Nov. 14, 2006 (PRIMEZONE) -- Jerini AG (FSE:JI4) reported financial results according to International Financial Reporting Standards (IFRS) for the first nine months ended September 30, 2006.
Total revenues for the nine-month period ended September 30, 2006, increased by 35.7 percent to EUR 9.5 million (compared to EUR 7.0 million in the prior year period). Revenues from collaboration agreements increased by 55.5 percent to EUR 7.0 million (prior year period: EUR 4.5 million), which was primarily attributable to revenues from the partnership agreement with Kos Life Sciences, Inc. Cash and cash equivalents as of September 30, 2006 amounted to EUR 74.5 million. "Our strong financial position will allow us to achieve our goal of bringing Icatibant, for the subcutaneous treatment of hereditary angioedema, to the European market ourselves," said Jens Schneider-Mergener, CEO of Jerini.
Research and development expenses increased in this nine-month period to EUR 17.4 million (EUR 10.8 million in the prior year period), the result of higher spending for the Phase III HAE studies and the advancement of other projects. General and administrative expenses stayed approximately at the level of the prior year period at EUR 5.7 million (EUR 5.5 million in the prior year period). Selling and distribution costs increased in this nine-month period to EUR 3.4 million (prior year period: EUR 0.7 million), mainly due to increased preparation costs for the market launch of Icatibant. Therefore, loss from operations before tax and finance cost (EBIT) increased, as anticipated, to EUR 18.4 million (EUR 11.9 million in the prior year period). Net loss for the nine-month period ended September 30, 2006, amounted to EUR 16.7 million (EUR 8.0 million in 2005); loss per share for this period amounted to EUR 0.32 (prior year period: EUR 0.91).
Net cash burn for the first nine months of 2006 amounted to EUR 21.4 million. Net cash burn is calculated by the sum of cash used in operating activities (EUR 20.2 million) and cash used in investing activities (EUR 1.2 million), as disclosed in the unaudited consolidated cash-flow statements for the nine-month period ended September 30, 2006.
Outlook
Since completion of the Phase III studies, Jerini's clinical team has been concentrating on the analyses of the FAST-1 and FAST-2 data and completing the documentation required for submission to the FDA and the EMEA. The company is in close communication with both regulatory authorities, and Jerini is preparing for the pre-NDA meeting with the FDA, which is planned for January 2007. Submissions to the FDA and EMEA are expected to be completed in the first quarter of 2007 or early second quarter.
In order to expand the number of indications treatable with Icatibant, Jerini is planning additional clinical testing for other forms of angioedema. In the first half of 2007, Jerini plans to start a Phase II proof-of-concept clinical trial for the treatment of drug-induced angioedema. This trial will be conducted in the United States and Europe. In addition, initiation of a Phase I clinical trial of JSM 6427 for the treatment of age-related macular degeneration (AMD), the leading cause of vision loss and blindness in people over the age of 55 in developed countries, is also expected to begin in the first half of 2007.
On November 6, 2006, Abbott and Kos Pharmaceuticals announced a definite agreement for Abbott to acquire Kos Pharmaceuticals. On November 2005, Jerini and Kos Pharmaceuticals signed an exclusive collaboration and license agreement for the development, marketing, and distribution of Jerini's compound Icatibant in the United States and Canada. If the takeover of Kos is completed, the license will be assigned to Abbott or one of its affiliates.
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 which have limited or no treatment options and has built a drug pipeline composed of its own programs, as well as others in collaboration with partners. Jerini recently reported positive Phase III clinical results of Icatibant in the subcutaneous treatment of hereditary angioedema and plans to begin filing for marketing approval in the first quarter of 2007, with product launch in 2007. Based on its technology platform, Jerini has also established several in-house development programs, which address indications within ophthalmology, oncology, and inflammatory therapeutic areas.
ISIN: DE0006787476
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