The net loss for the second quarter was $11.3 million, or $0.71 per share, compared to a net loss of $12.0 million, or $0.80 per share, for the second quarter of 2001. The reduction in the net loss for the quarter was primarily due to a $5 million milestone payment from Baxter Healthcare Corporation earned upon the regulatory approval of the disposable set for the INTERCEPT Blood System for platelets in Europe. Revenue from development agreements and government grants was $5.6 million, compared to $1.6 million for the second quarter of 2001. Operating expenses for the quarter increased as a result of expanded research and development activities in support of the INTERCEPT Blood System. At June 30, 2002, the company had cash, cash equivalents and short-term investments of $93.3 million. The cash balance at June 30, 2002 does not include the $5 million milestone payment that was received from Baxter in July.
“We had a very successful second quarter, attaining our most significant milestone to date with CE Marking of the disposable set for platelets,” said Stephen Isaacs, president and chief executive officer of Cerus. “Following CE Mark for the system illumination device, we are positioned to receive our first INTERCEPT product revenue this year.”
Recent Cerus Corporation highlights include:- INTERCEPT Blood System for platelets: Received CE Mark for the disposable set for the system in Europe;
- INTERCEPT Blood System for plasma: Received concurrence from the FDA that current enrollment in the Phase IIIc clinical trial is sufficient for PMA submission; and
- INTERCEPT Blood System for red blood cells: Continued enrollment and transfusion of patients in two Phase III clinical trials for acute and chronic transfusion support and received U.S. patent number 6410219 which significantly expands coverage of nucleic acid binding compounds to inactivate pathogens in red blood cells.
Cerus and its development and commercialization partner, Baxter Healthcare Corporation, are collaborating on the development of the INTERCEPT Blood System to enhance the safety of blood transfusions. A CE Mark for the INTERCEPT Blood System disposable set for platelets has been received. The next step is completion of the CE mark process for the illumination device prior to commercialization of the system. Regulatory submissions have been completed in Australia and Canada, and the companies have begun the regulatory submission process to obtain approval in the United States. Separately, the companies are preparing the U.S. submission for the INTERCEPT Blood System for plasma, which will be followed by a CE Mark application for this product. In addition, the companies are conducting Phase III clinical trials for INTERCEPT Red Blood Cells.
QUARTERLY CONFERENCE CALL
The company has scheduled its quarterly conference call for 4:30 p.m. EDT today. Interested parties can access a live Internet webcast. For those unable to listen to the live broadcast, the call will be archived for 72 hours.
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 System, based on the company's Helinx technology, is 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 Blood System is a trademark of Baxter International, Inc. (NYSE: BAX)
Forward-looking statements in this news release, including those regarding clinical trials, regulatory filings and approvals, product development, commercial potential and potential revenue, involve risks and uncertainties. Actual results could differ materially from such 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, including the company's annual report on Form 10-K and quarterly reports on Form 10-Q. 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
June 30, | Six Months Ended
June 30, | | | 2002 | 2001 | 2002 | 2001 | | Revenue | $ 5,649 | $1,559 | $6,152 | $3,003 | | Operating expenses: | | | Research and development | 14,484 | 12,086 | 26,405 | 23,404 | | General and administrative | 3,024 | 2,658 | 5,826 | 5,037 | | Total operating expenses | 17,508 | 14,744 | 32,231 | 28,441 | | Loss from operations | (11,859) | (13,185) | (26,079) | (25,438) | | Interest income, net | 575 | 1,210 | 1,248 | 2,398 | | Loss before income taxes | $(11,284) | $ (11,975) | $(24,831) | $(23,040) | | Provision for income taxes | - | - | - | (100) | | Net loss | $(11,284) | $(11,975) | $(24,831) | $(23,140) | | Net loss per share – basic and diluted | $ (0.71) | $ (0.80) | $(1.57) | $ (1.60) | Shares used in computing
net loss per share - basic and diluted | 15,782 | 14,887 | 15,767 | 14,492 |
Condensed Balance Sheets
(in thousands) | | June 30,
2002 | December 31,
2001 | | Cash, cash equivalents and short-term investments | $93,274 | $123,461 | | Accounts receivable from a related party | 5,028 | 26 | | Other current assets | 2,752 | 1,573 | | Furniture and equipment, net | 6,274 | 3,012 | | Other assets | 218 | 188 | | Total assets | $107,546 | $128,260 | | | | Accounts payable to a related party | $8,410 | $5,029 | | Other current liabilities | 10,950 | 11,425 | | Capital lease obligation, less current portion | 34 | 51 | | Redeemable convertible preferred stock | 5,000 | 5,000 | | Stockholders' equity | 83,152 | 106,755 | | Total liabilities and stockholders' equity | $107,546 | $128,260 |
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