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Release issued 9th November 2007
Amsterdam – November 9, 2007 – Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, today announced key achievements and financial results for the three months ended September 30, 2007.
The Company disclosed recent business and clinical developments related to its preparations for the commercial launch of its lead proprietary product candidate, Zentase™ (EUR-1008), currently being developed for the treatment of exocrine pancreatic insufficiency (EPI), as well as an update on the Company’s most advanced product candidates, both partnered and proprietary.
Gearóid Faherty, Chief Executive Officer of Eurand, commented, “The third quarter was a very successful time for Eurand and we achieved a number of significant milestones. Two important highlights included the acquisition by Cephalon of Amrix® (cyclobenzaprine HCl), a product we co-developed, from ECR Pharmaceuticals and the successful completion of a pivotal clinical study of EUR-1048, our undisclosed co-development product with GSK. Cephalon expects to launch Amrix this month. In addition, the Company expects GSK to file a New Drug Application (NDA) for EUR-1048 in the near future. On the business development front, we continue to make progress expanding the geographical and therapeutic reach of our established base business. We signed four co-development deals in the last quarter, taking our deal total year-to-date in 2007 to six. These deals are with some of the world’s leading pharmaceutical and biotechnology companies and we continue to look to for new collaborations.”
PRODUCT DEVELOPMENT PIPELINE UPDATES:
ZENTASE™ (EUR-1008)
EUR-1002 – Amrix® (cyclobenzaprine HCl)
EUR-1048 - Co-Development Product with GSK
Eurand has more than 10 other product candidates in various earlier stages of development, both on a proprietary basis and for co-development partners.
Eurand signed six co-development agreements to date in 2007 and is in discussions on a number of other potential agreements with multinational pharmaceutical companies for the development of products using Eurand’s drug formulation technologies.
RECENT CORPORATE DEVELOPMENTS:
On September 27, 2007, Eurand announced the expansion of its research and development facilities in Dayton, OH. The purpose of the extension is to cope with the increased number of collaborative and internal projects entering development. The $5.5 million construction project includes the renovation of approximately 13,000-square-feet of the existing building and a 13,000-square-foot addition. The project is expected to be completed in 2009.
On September 13, 2007, Eurand announced the appointment of Angelo C. Malahias and Rolf A. Classon to the Eurand Board of Directors. Mr. Malahias and Mr. Classon joined the Board as independent, non-executive directors.
YEAR-TO-DATE AND THIRD QUARTER 2007 FINANCIAL RESULTS:Total revenues were Eur63.7 ($90.5 million) for the nine months ended September 30, 2007, representing an increase of approximately 5 percent at constant currency rates compared to the same period in 2006. Product sales were Eur53.4 million ($75.9 million), representing an increase of 4 percent at constant currency compared to the same period in 2006. Royalties were Eur2.9 million ($4.1 million), representing an increase of 5 percent at constant currency compared to the same period in 2006. Development fees were Eur7.4 million ($10.5 million), representing an increase of 9 percent at constant currency compared to the same period in 2006. The increase in development fees was primarily due to milestones earned during the nine-month period.
Research and development expenses were Eur12.0 million ($17.1 million) for the nine months ended September 30, 2007, representing an increase of 1 percent at constant currency rates compared to the same period in 2006. Selling, general and administrative (SG&A) expenses were Eur14.7 million ($20.9 million), representing an increase of 44 percent at constant currency compared to the same period in 2006. This increase was primarily due to increased head count and other costs associated with the build-out of the sales and marketing infrastructure for Zentase, the costs of public company compliance, and legal costs related to the ongoing litigation between Eurand and UCB.
Operating profit was Eur0.8 million ($1.2 million) for the nine months ended September 30, 2007 compared to Eur4.0 million ($5.7 million) for the same period in 2006. The lower operating profit was primarily due to increased SG&A spending.
Financial expenses were Eur1.5 million ($2.1 million) for the nine months ended September 30, 2007, compared to Eur5.8 million ($8.2 million) for the same period of 2006. The reduction in financial costs was mainly due to the repayment of debt with proceeds from the Company’s May 2007 IPO.
Net loss was Eur1.6 million (Eur0.04 per share on a pro forma basis) for the nine months ended September 30, 2007, compared to Eur3.0 million (Eur0.09 per share on a pro forma basis) for the same period in 2006.
For the three months ended September 30, 2007, total revenues were Eur20.0 million ($28.4 million), representing an increase of approximately 1 percent at constant currency rates compared to the same period in 2006. For the same period, the Company reported net loss of Eur1.1 million (Eur0.03 per share) compared to Eur1.7 million (Eur0.05 per share) for the same period in 2006.
The Company’s financial position improved as proceeds from the IPO were used to reduce gross debt from Eur63.1million to Eur1.6 million (from $89.8 million to $2.2 million) and increase cash from Eur5.8 million to Eur19.4million (from $8.3 million to $27.6 million).
If you want to find out more about the company visit Eurand Spa profile.
(15th April 2008) Eurand in Licenses Corticosteroid GI Product From Chiesi Farmaceutici SpA
(3rd December 2007) Eurand Acquires Specialty Cystic Fibrosis Company
(27th November 2007) Eurand Completes Bioavailability Study of Zentase
(20th November 2007) Eurand to Present at Lazard Capital Markets 4th Annual Healthcare Conference
(12th November 2007) Eurand Added to NASDAQ Biotechnology Index