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Northfield Laboratories Inc. Reports Fiscal 2009 Second Quarter Financial Results
EVANSTON, Ill.--([ BUSINESS WIRE ])--Northfield Laboratories Inc. (Nasdaq: NFLD) announced today financial results for the second fiscal quarter ended November 30, 2008.
For the second fiscal quarter, Northfield reported a net loss of $5.6 million, or $0.21 per share, compared with a net loss of $5.0 million, or $0.19 per share, for the corresponding period last year. At the close of the quarter, Northfield reported shareholders' equity of $16.5 million, with $10.1 million in cash and marketable securities. As a development stage company, Northfield does not generate revenues.
Recent and Upcoming Events
- Northfield announced that its BLA for PolyHeme was accepted for filing and that FDA has designated the submission for Priority Review, with a review goal date of April 30, 2009.
- Northfield announced the manuscript entitled Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial was published in the January 2009 print edition of the Journal of the American College of Surgeons. The paper appeared in the on-line version in November 2008.
- Northfield's Chairman and CEO Steven A. Gould, M.D., presented at the Rodman and Renshaw 10th Annual Healthcare Conference in New York in November.
- Dr. Gould has also accepted the invitation of BIO to present at the upcoming BIO CEO & Investor conference in New York.
Conference Call
Northfield will host its second quarter 2009 earnings conference call with the financial community on Monday, January 12, 2009 at 11:00 a.m. Eastern Time (10 a.m. Central Time).
This call is being webcast by Thomson Reuters and can be accessed at Northfield's Web site at [ http://www.northfieldlabs.com ]. A replay will be available in the same location for two weeks following the call.
The webcast is also being distributed through the Thomson StreetEvents Network to both institutional and individual investors. Individual investors may listen to the call at [ http://www.fulldisclosure.com ], the Thomson Reuters individual investor portal powered by StreetEvents. Institutional investors may access the call via Thomson's password-protected event management site, StreetEvents ([ http://www.streetevents.com ]).
Investors may also dial 866.783.2139 and enter the passcode 97752406. A replay of the call will be available for two weeks by dialing 888.286.8010 and entering the passcode 34016526.
About Northfield Laboratories
Northfield Laboratories is a leader in developing a hemoglobin-based oxygen-carrying red blood cell substitute. The initial indication we are seeking for our investigational product PolyHeme is the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme is a solution of chemically modified human hemoglobin that requires no cross-matching and is therefore compatible with all blood types. It has an extended shelf life in excess of 12 months. For further information, visit [ http://www.northfieldlabs.com ].
Forward Looking Statement
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 FDA may not meet the required time periods for the review of our BLA under applicable laws, regulations and guidances, our potential inability to obtain FDA approval to market PolyHeme commercially based on our BLA, our potential inability to regain compliance with applicable Nasdaq listing standards, our need to obtain additional capital to finance our ongoing business operations and the construction of an expanded commercial-scale manufacturing facility, our potential inability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our potential inability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our potential inability to protect our intellectual property rights, the outcome of a purported class action lawsuit as described in our most recently filed quarterly report on Form 10-Q, 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 and quarterly report on Form 10-Q. 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.
NORTHFIELD LABORATORIES INC. | ||||||||
(a company in the development stage) | ||||||||
Balance Sheets | ||||||||
November 30, 2008 and May 31, 2008 | ||||||||
(In thousands) | ||||||||
Nov 31, | May 31, | |||||||
2008 | 2008 | |||||||
Assets | (unaudited) | |||||||
Current assets: | ||||||||
Cash | $5,030 | $12,747 | ||||||
Restricted cash | 77 | 301 | ||||||
Short-term marketable securities | 4,998 | 7,980 | ||||||
Prepaid expenses | 466 | 696 | ||||||
Other current assets | 306 | - | ||||||
Total current assets | 10,877 | 21,724 | ||||||
Plant and equipment, net | 8,436 | 8,241 | ||||||
Other assets | 20 | 20 | ||||||
Total assets | $19,333 | $29,985 | ||||||
Liabilities and Shareholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $1,655 | $1,917 | ||||||
Accrued expenses | 72 | 112 | ||||||
Government grant liability | 77 | 301 | ||||||
Accrued compensation and benefits | 710 | 658 | ||||||
Other current liabilities | 306 | - | ||||||
Total current liabilities | 2,820 | 2,988 | ||||||
Other liabilities | 15 | 14 | ||||||
Total liabilities | 2,835 | 3,002 | ||||||
Shareholders' equity: | ||||||||
Capital stock | 270 | 270 | ||||||
Additional paid-in capital | 247,960 | 246,929 | ||||||
Deficit accumulated during the development stage | -231,732 | -220,216 | ||||||
Total shareholders' equity | 16,498 | 26,983 | ||||||
Total liabilities and shareholders' equity | $19,333 | $29,985 | ||||||
NORTHFIELD LABORATORIES INC. | ||||||||
(a company in the development stage) | ||||||||
Statements of Operations | ||||||||
Three months ended November 30, 2008 and November 30, 2007 | ||||||||
(In thousands except per share data) | ||||||||
Three Months Ended | ||||||||
Nov 30, | Nov 30, | |||||||
2008 | 2007 | |||||||
(unaudited) | (unaudited) | |||||||
Revenues - license income | $ | - | $ | - | ||||
Costs and expenses: | ||||||||
Research and development | 4,271 | 3,940 | ||||||
General and administrative | 1,377 | 1,482 | ||||||
5,648 | 5,422 | |||||||
Other income and expense: | ||||||||
Interest income | 54 | 401 | ||||||
Interest expense | - | - | ||||||
Cumulative effect of change in accounting principle | - | - | ||||||
Net loss | $ | -5,594 | $ | -5,021 | ||||
Net loss per basic share | $ | -0.21 | $ | -0.19 | ||||
Shares used in calculation of per share data | 26,959 | 26,938 |