The net loss for the first quarter was $13.5 million, or $0.86 per share, compared to a net loss of $11.2 million, or $0.79 per share, for the first quarter of 2001. The increased net loss for the quarter was primarily due to expanded research and development activities in support of the INTERCEPT Blood Systems. Revenue from development agreements and government grants was $0.5 million, compared to $1.4 million for the first quarter of 2001. At March 31, 2002, the company had cash, cash equivalents and short-term investments of $107.5 million.
“Cerus is off to a great start in 2002 and entering a very exciting stage for the company,” said Stephen Isaacs, president and chief executive officer of Cerus. “We are expecting to hear from the European regulatory authorities soon on the CE Mark application seeking approval of the INTERCEPT Platelet System and we are poised to receive our first product revenue this year.”
First quarter Cerus Corporation highlights included:- INTERCEPT Platelet System: Continued submission of regulatory modules to the U.S. Food and Drug Administration;
- INTERCEPT Plasma System: Continued enrollment in the Phase IIIc clinical trial;
- INTERCEPT Red Blood Cell System: Initiated two Phase III clinical trials for acute and chronic transfusion support.
Cerus and its development and commercialization partner, Baxter Healthcare Corporation, are collaborating on the development of the INTERCEPT Blood Systems to enhance the safety of blood transfusions. A CE Mark application seeking European approval of the INTERCEPT Platelet System has been submitted, regulatory submissions have been completed in Australia and Canada and the companies have begun the regulatory submission process in the United States. Separately, the companies are preparing the U.S. submission for the INTERCEPT Plasma System, which will be followed by a CE Mark application for this product. Cerus and Baxter are conducting pivotal Phase III clinical trials of the INTERCEPT Red Blood Cell System.
ABOUT CERUS
Cerus Corporation is developing medical systems and therapeutics based on its proprietary Helinx, technology for controlling biological replication. Cerus' most advanced programs are focused on systems to enhance the safety of blood products used for transfusion. The INTERCEPT Blood Systems, based on the company's Helinx technology, are designed to inactivate viruses, bacteria, other pathogens and white blood cells. The Concord, California-based company also is pursuing therapeutic applications of Helinx technology to treat and prevent serious diseases.
Helinx is a U.S. registered trademark of Cerus Corporation.
INTERCEPT is a trademark of Baxter International, Inc. (NYSE: BAX).
Statements in this news release regarding clinical trials, regulatory filings and approvals, product development, commercial potential and potential revenue are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risks and uncertainty of the timing and results of clinical trials and other development and commercialization activities, actions by regulatory authorities at any stage of the development process, additional financing activities, manufacturing, market acceptance of any products, competitive conditions and other factors discussed in the company's most recent filings with the Securities and Exchange Commission. Cerus does not undertake any obligation to update forward-looking statements.
Cerus Corporation
Selected Unaudited Financial Information Condensed Statements of Operations
(in thousands, except per share information) | | Three Months Ended
March 31, | | | 2002 | 2001 | | Revenue | $ 503 | $1,444 | | Operating expenses: | | | Research and development | 11,921 | 11,318 | | General and administrative | 2,802 | 2,379 | | Total operating expenses | 14,723 | 13,697 | | Loss from operations | (14,220) | (12,253) | | Interest income, net | 673 | 1,188 | | Loss before income taxes | $ (13,547) | $ (11,065) | | Provision for income taxes | - | (100) | | Net loss | $ (13,547) | $ (11,165) | | Net loss per share – basic and diluted | $ (0.86) | $ (0.79) | Shares used in computing
net loss per share - basic and diluted | 15,751 | 14,097 |
Condensed Balance Sheets
(in thousands) | | March 31,
2002 | December 31,
2001 | | Cash, cash equivalents and short-term investments | $107,496 | $123,461 | | Accounts receivable from a related party | 28 | 26 | | Other current assets | 2,951 | 1,573 | | Furniture and equipment, net | 5,385 | 3,012 | | Other assets | 214 | 188 | | Total assets | $116,074 | $128,260 | | | | Accounts payable to a related party | $5,121 | $5,029 | | Other current liabilities | 11,759 | 11,425 | | Capital lease obligation, less current portion | 45 | 51 | | Redeemable convertible preferred stock | 5,000 | 5,000 | | Stockholders' equity | 94,149 | 106,755 | | Total liabilities and stockholders' equity | $116,074 | $128,260 |
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