Highlights:
* EUR 38.2 million in cash and cash equivalents as of
December 31, 2007
* Revenues in 2007 increased by 42 percent to EUR 18.6 million
* Marketing applications for Icatibant in the treatment of HAE
submitted to the FDA and EMEA; regulatory decisions expected the
end of April 2008
* Jerini is prepared to launch Icatibant in both the EU and US,
once approved
BERLIN, March 27, 2008 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) announced today its financial results for the fiscal year ended December 31, 2007. "We have made significant progress in moving both the European and US regulatory processes forward and are expecting the EMEA and FDA decisions for Icatibant in the treatment of hereditary angiodema (HAE) at the end of next month," said Jens Schneider-Mergener, CEO of Jerini. "Given the positive feedback from physicians who have treated patients with Icatibant, I look forward to the day when we can bring this novel medication to HAE patients."
Financial Review for Fiscal Year 2007
Under International Financial Reporting Standards (IFRS), revenues in 2007 increased by 42 percent to EUR 18.6 million from EUR 13.1 million in 2006, due to revenues generated from collaboration agreements with US-based pharmaceutical companies Alcon Research Ltd., Baxter AG, and Abbott, along with higher revenues in its peptide services unit (JPT Peptide Technologies). Research and development expenses increased as expected to EUR 29.3 million (EUR 23.2 million in 2006), largely attributable to expenses associated with the regulatory submissions of Icatibant in the treatment of HAE and the establishment of sales and marketing structures in Europe and the US. The loss from operations (EBIT) of EUR 31.2 million (compared to EUR 25.1 million in 2006) was in line with the company's forecast. The increase in net loss (EUR 29.1 million, compared to EUR 22.9 million in 2006) was also anticipated. Net cash burn (calculated as cash used in operating activities plus cash for investment in property and equipment) amounted to EUR 27.5 million in 2007, compared to EUR 30.4 million in 2006.
As of December 31, 2007, cash and cash equivalents amounted to EUR 38.2 million (December 31, 2006: EUR 66.9 million). "Product approval and market launch would bring Jerini to the next level in its development as a company. Product sales will enable us to increase our revenues, thereby supporting our future growth and expansion," said Berndt Modig, CFO of Jerini. "We are now evaluating several financial options, including commercial partnerships, which can provide us with the additional funding needed to support a successful product launch."
Outlook
The upcoming FDA and EMEA regulatory decisions for Icatibant in the treatment of HAE will significantly affect company developments and strategic decisions in 2008. Jerini currently plans to market Icatibant on its own in the major European markets as well as the United States and has established core sales and marketing structures in preparation for product launch. Additional financing would be needed to support product launch, and several options are being explored to secure the necessary funding, including strategic partnerships and capital market transactions.
Jerini Ophthalmic, Inc. (JOI), Jerini's U.S. subsidiary, is currently conducting a Phase I clinical trial for JSM 6427 in the treatment of age-related macular degeneration (AMD), and trial results are expected in the second half of 2008. Given that further development of JOI's ophthalmology compounds will require additional funding in 2008, both internal and external financing options are being evaluated.
Jerini anticipates a higher net loss in the coming year as compared to 2007 due to expected expenses in connection with planned product launch. Although short-term losses are likely to increase, Jerini sees these investments as the foundation for its marketing infrastructure, which has the potential, in the long term, to generate substantially increased revenues for the company.
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 for the treatment of hereditary angioedema (HAE), is under regulatory review with the EMEA and FDA, and decisions from the agencies are expected in the first half of 2008. Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease.
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 - 599 wiedenmann@jerini.com