>>SEATTLE, July 27 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) reported financial results for the second quarter ended June 30, 2004. Total revenues for the quarter were $8.3 million compared to $6.1 million in the second quarter of 2003. Net product sales for TRISENOX® (arsenic trioxide) were $7.9 million compared to $5.3 million for the same period in 2003.
CTI reported a net loss for the quarter of $37.5 million ($0.75 per share) compared to a net loss of $30.8 million ($0.93 per share) for the same period in 2003. The Company ended the quarter with approximately $90 million in cash, cash equivalents, securities available-for-sale, and interest receivable.
"We're encouraged by the rebound in TRISENOX® sales, making this the best quarter since launch," stated James A. Bianco, M.D., President and CEO of CTI. "We are also very excited about the completion of enrollment in our XYOTAX(TM) STELLAR lung cancer trials. Our STELLAR 3 data release has been pushed out to early 2005 due to longer patient survival estimates. As such our efforts are now focused on pre-launch activities and being in position to submit a new drug application as soon as possible following positive trial results."
Second Quarter Highlights
Initiated a phase I/II clinical trial of CT-2106 in combination with 5- FU/leucovorin in patients with metastatic colorectal cancer.
Issued patent by U.S. Patent and Trademark office for TRISENOX® extending marketing exclusivity from 2007 to 2018; launched TRISENOX® in Italy.
Completed enrollment in XYOTAX(TM) STELLAR 4 phase III clinical trial.
Held investor meeting at American Society of Clinical Oncology (ASCO); announced extension of NDA timeline for XYOTAX(TM) STELLAR 3 as a result of an encouraging higher than historically predicted survival rate.
Presented results of TRISENOX®, XYOTAX(TM), pixantrone, and CT-2106 at the ASCO and European Hematology Association.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.cticseattle.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the forward-looking statements contained in this press release include statements about future financial and operating results and risks and uncertainties that could affect CTI's products and products under development, including TRISENOX®, XYOTAX(TM), and pixantrone. These risks include, but are not limited to, preclinical, clinical, and sales and marketing developments in the biopharmaceutical industry in general and in particular including, without limitation, the potential failure to meet TRISENOX® revenue goals, the potential failure of TRISENOX® to continue to be safe and effective for cancer patients, the potential failure of XYOTAX(TM) to prove safe and effective for non-small cell lung and ovarian cancers, the potential failure of pixantrone to prove safe and effective for non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling TRISENOX® and CTI's products under development; and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Cell Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2004 2003 2004 2003
Revenues:
Product sales $7,942 $5,281 $11,800 $9,591
License, contract
and other revenue 358 848 995 1,419
Total revenues 8,300 6,129 12,795 11,010
Operating expenses:
Cost of product sold 276 252 428 398
Research and development 23,773 22,024 52,680 42,652
Selling, general
and administrative 19,802 12,809 39,868 25,817
Acquired in-process
research and development (404) -- 88,120 --
Amortization of
purchased intangibles 569 333 1,147 667
Total operating expenses 44,016 35,418 182,243 69,534
Loss from operations (35,716) (29,289) (169,448) (58,524)
Other income (expense):
Investment and other income 364 451 880 1,105
Interest and other expense (2,704) (1,938) (5,428) (3,826)
Exchange gain 599 -- 144 --
Net loss (37,457) (30,776) (173,852) (61,245)
Basic and diluted
net loss per common share $(0.75) $(0.93) $(3.50) $(1.85)
Shares used in calculation
of basic and diluted
net loss per common share 49,651 33,168 49,604 33,141
Balance Sheet Data: (amounts in thousands)
June 30, December 31,
2004 2003
Cash, cash equivalents, securities
available-for-sale and interest receivable $89,744 $92,838
Working capital 71,518 71,898
Total assets 161,945 146,090
Convertible debt 190,099 190,099
Accumulated deficit (644,338) (470,486)
Shareholders' deficit (65,314) (82,542)<<
Desite the trumpeting about the record Trisenox revenues, analysts estimates called for better earnings and revenue. This is a miss, and I gather there was nothing new in the CC.
Cheers, Tuck |
