Updated from 8:56 a.m. EDT
plunged 11% Friday after the company late Thursday reported another significant quarterly loss and reiterated that it will need to raise more money to survive its fiscal year, which ends Oct. 31, and even more funds to make it through the calendar year.
The company -- which has had a series of financial, managerial and regulatory setbacks in its efforts to develop a blood substitute -- said it had $11.9 million in cash as of April 30, the end of its second quarter. That's enough to keep operating into September, but the company said it needs another $3.5 million to finance operations through October, plus another $4 million to keep going through December.
Shares lost 9 cents, or 11%, to 73 cents, having broken through a dollar a share on May 3, and a far cry from their 52-week high of $9.03.
"We're not considering Chapter 11
bankruptcy," said Francis H. Murphy, the interim CEO, responding to an investor's question during a telephone conference call. He added that Biopure "is confident" it can raise enough money to meet its immediate goals, which include resolving regulatory issues about the blood substitute and finding a permanent chief executive. Murphy said it will probably take "a few more months" to find a replacement for Thomas A. Moore, who resigned in late February.
Cambridge, Mass.-based Biopure has been cutting costs and cutting staff to be able to conduct more tests and evaluate more data that was required by the Food and Drug Administration in its original review of Hemopure, the experimental blood substitute.
For the three months ended April 30, Biopure lost $12 million, or 25 cents a share, on revenue of $893,000. That compares to a loss of $11.7 million, or 35 cents a share, on sales of $1.96 million for the same period last year. Research and development expenses rose to $3.5 million from $2.5 million, primarily due to Biopure's conducting extra animal tests to meet FDA requirements and to an ongoing human clinical trial in Europe.
The company's cash crunch has forced it to reduce manufacturing and marketing of its only approved product, Oxyglobin, a version of Hemopure sold to treat anemic dogs. The job cuts and expense reductions mean the company cannot produce enough Oxyglobin to meet demand, Biopure said.
The company is limiting sales of the product, which means the fixed costs of production will exceed Oxyglobin's revenue "until the company more fully utilizes its manufacturing capability," Biopure said Thursday.
Biopure's fortunes started sinking after Aug. 1, the day the company announced that the FDA requested some additional data on the Hemopure application. At the time, Biopure said the agency wasn't seeking additional tests, and the stock hit a 52-week high of $9.03. Biopure said it could answer all of the questions in 30 to 60 days, which prompted hopeful investors to believe the FDA might act on the application by late 2003.
But the FDA has continued to ask more questions, request more historical data and require more tests, pushing up Biopure's expenditures and pushing back prospects for a decision on Hemopure. Now Biopure said it expects to address the FDA's questions about Hemopure's safety efficacy by the fall. Results from FDA-ordered animal tests also should be ready this fall, Murphy said.
The company also repeated Thursday that it may be required by the FDA to conduct "one or more" additional human clinical trials before the FDA considers reviewing the product. If that happens, Biopure's expenses will increase and the chance of an FDA decision will move even farther into the future.