BERLIN, May 15, 2008 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) reported financial results for the first quarter ended March 31, 2008. Under International Financial Reporting Standards (IFRS), revenues for the three-month period decreased by 31.5 percent to EUR 2.5 million from EUR 3.6 million for the same period in 2007, primarily attributable to the termination of a partnership agreement with Abbott. As of March 31, 2008, cash and cash equivalents amounted to EUR 28.0 million, compared to EUR 38.2 million as of year-end 2007.
"The recent positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and expected upcoming European approval for Icatibant in the treatment of hereditary angioedema (HAE) bring Jerini to a new level and open significant opportunities for our future growth," said Jens Schneider-Mergener, CEO of Jerini. "Our sales and marketing teams are in place and ready to begin Icatibant's product launch in the third quarter of this year."
First quarter research and development expenses increased to EUR 6.0 million (prior year period: EUR 5.3 million), mainly due to higher subcontracting costs for Jerini's US subsidiary, Jerini Ophthalmic, Inc. (JOI). An increase in general and administrative expenses to EUR 2.9 million (prior year period: EUR 2.1 million) is mainly attributable to increased headcount and stock-based compensation. Marketing and sales expenses increased to EUR 2.0 million (prior year period: EUR 1.1million), as a result of expenses related to product launch preparation. Consequently, loss from operations before tax and finance cost (EBIT) increased to EUR 9.1 million (prior year period: EUR 5.4 million). For the three-month period ended March 31, 2008, net loss amounted to EUR 8.8 million (prior year period: EUR 4.8 million), and loss per share amounted to EUR 0.17 (prior year period: EUR 0.09).
Cash used in operating activities as of March 31, 2008 totaled EUR 9.5 million (prior year period: EUR 4.3 million). Net cash burn for the first three months of 2008 amounted to EUR 10.0 million (prior year period: EUR 4.5 million). Net cash burn is calculated by the addition of cash used in operating activities (EUR 9.5 million) and cash used in investing activities (EUR 0.5 million), as disclosed in the unaudited consolidated cash flow statements for the three-month period ended March 31, 2008.
Outlook
Given the positive CHMP opinion and expected European Commission approval in June, Jerini expects European product launch for Icatibant in the treatment of HAE in the third quarter of 2008. Jerini's sales and marketing teams are completing their pre-marketing activities and, led by Jerini's commercial directors and key account managers, the company continues to work closely with HAE treating physicians, key opinion leaders, and patient organizations. In addition, country-specific reimbursement documentation is being prepared along with the logistical processes needed for successful product distribution. The optimal launch sequence has been determined and will begin in Germany and the UK in August 2008. In the remaining European countries, reimbursement is managed on a country-by-country basis and is expected to be completed within three to twelve months, depending on the country.
Jerini Ophthalmic, Inc. is currently conducting a Phase I clinical trial for JSM 6427 in the treatment of AMD, and trial results are expected in the second half of 2008.
Additional financing will be needed to support Icatibant's European product launch, Jerini's ophthalmology programs, and the company's preclinical product pipeline. Several financing options are currently being evaluated, including strategic partnerships and capital market transactions. Given the company's current cash position, management anticipates that funding will be secured before the end of the third quarter of this year.
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's lead compound, Icatibant, is a first-in-class compound developed for the treatment of hereditary angioedema (HAE) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), and European product launch is expected in the third quarter of 2008. Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease. For more information, please visit www.jerini.com.
ISIN: DE0006787476