Northfield Laboratories Inc. Reports Fiscal 2007 Fourth Quarter and Year-End Financial Results
EVANSTON, Ill., Aug 14. -- Northfield Laboratories Inc. announced today financial results for the fourth fiscal quarter and year-ended May 31, 2007.
For the fiscal year, Northfield reported a net loss of $27.7 million, or $1.03 per share, compared with a net loss of $26.8 million, or $1.00 per share, for the prior fiscal year. The Company reported shareholders' equity of $45.3 million, with $40.7 million in cash and marketable securities.
Northfield reported a loss of $6.4 million, or $0.24 cents per share, for the fiscal fourth quarter, compared with a loss of $8.3 million, or $0.31 cents per share, for the corresponding period last year.
"Our singular focus in FY08 is the successful submission of a Biologics License Application for PolyHeme(R) with a request for priority review," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We have already submitted a detailed summary of the pivotal Phase III trial data to FDA, which was followed by a pre-BLA meeting. Given our strong belief in PolyHeme's ability to address a critical unmet medical need and its potential to save lives, we are committed to making our product available for patients with urgent, life-threatening blood loss when blood is not available."
Highlights of the Year and Upcoming Events
-- Northfield supported the clinical trial sites through completion of the planned enrollment of 720 patients in its pivotal Phase III study.
-- Northfield and its contract research organization completed the initial analysis of the data from the study.
-- Northfield prepared and submitted a detailed summary of the study data to FDA.
-- Northfield participated in a pre-BLA meeting with FDA in anticipation of its planned submission of a BLA.
-- Northfield formed a publications committee of principal investigators from the trial to prepare an abstract for presentation at a scientific meeting and a manuscript for publication in a peer-reviewed scientific journal.
-- Northfield purchased the building it previously occupied as lessee for future expansion activities.
-- Northfield initiated pharmacoeconomic research designed to better understand and develop policy and reimbursement strategies for the commercialization of PolyHeme.
-- Northfield was awarded an appropriation of $3.5 million in the 2006 Defense Appropriations budget. This brings the total amount of the Congressional appropriations awarded to the Company to $4.9 million.
-- A preclinical study describing the use of a novel formulation of the Company's human hemoglobin-based oxygen carrier in pancreatic islet cell isolation and transplantation was presented at the World Transplantation Congress by researchers from the Department of Surgery/Division of Transplantation, University of Illinois at Chicago.
-- Dr. Ernest E. Moore, lead Phase III study investigator, will present a paper entitled "Postinjury Resuscitation with Human Polymerized Hemoglobin: The USA Multicenter Trial" at the 93rd Annual Clinical Congress of the American College of Surgeons in October in New Orleans.
-- Dr. Steven A. Gould was invited to serve as a key speaker and present the study results at the XI International Symposium on Blood Substitutes in Beijing in October.
-- Northfield presented at seven institutional investor conferences during FY 2007.
-- Northfield is scheduled to present at the Thomas Weisel Partners Healthcare Conference and the UBS Global Life Sciences Conference in September and at the BIO Investor Conference in October.
Annual Meeting of Stockholders
Northfield will hold its 2007 annual meeting of stockholders on Tuesday, September 25, 2007, at 10:00 a.m., local time, at the Deer Path Inn, Lake Forest, Illinois. The entire meeting, including the official proceedings, the annual business update, and the question and answer session will be broadcast live on the Internet. Details will be provided approximately two weeks before the meeting date.
For additional information about Northfield Laboratories Inc. please refer to the Company's 2007 annual report on Form 10-K filed with the SEC. The Company's Annual Report and Proxy Statement will be mailed to shareholders and be available electronically at www.northfieldlabs.com.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme(R) is a solution of chemically modified human hemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life in excess of 12 months. For further information, visit www.northfieldlabs.com.
This press release may contain forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme red blood cell substitute product. These forward-looking statements are identified by the use of such terms as "intends," "expects," "plans," "estimates," "anticipates," "should," "believes" and similar terms. These forward-looking statements involve inherent risks and uncertainties. Our actual results may therefore differ materially from those predicted by the forward-looking statements because of various factors and possible events, including the possibility that since the full data from our Phase III clinical trial have not been submitted to, or reviewed by, FDA, they may not be sufficient to demonstrate the safety or effectiveness of PolyHeme, our ability to successfully file a Biologics License Application, our ability to be granted priority review of our Biologics License Application, our ability to obtain FDA approval to market PolyHeme commercially, the availability of capital to finance our ongoing business operations and the construction of an expanded commercial-scale manufacturing facility, our ability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our ability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our ability to protect our intellectual property rights, the outcome of certain governmental inquiries and purported class action lawsuit as described in our most recently filed annual report on Form 10-K, the possibility that we may be subject to product liability claims and other legal actions, our dependency on a limited number of key personnel, the uncertainty of third party reimbursement for our product and other risks and uncertainties described from time to time in our periodic reports filed with the Securities and Exchange Commission, including our most recently filed annual report on Form 10-K. These forward-looking statements speak only as of the date of this press release. We do not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the time such statement is made. All subsequent written and oral forward-looking statements attributable to Northfield or any person acting on our behalf are qualified by this cautionary statement.