Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009
SEATTLE, Feb. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2009.
Review of 2009 Key Accomplishments and Targeted 2010 Milestones
- Pixantrone New Drug Application ("NDA") for relapsed/refractory aggressive non-Hodgkin's lymphoma filed with the U.S. Food and Drug Administration (the "FDA") and accepted for review in 2009. The FDA established Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
- Initiated a Marketing Authorization Application ("MAA") for pixantrone in Europe in 2009 and received Orphan Drug Designation by the European Medicines Agency. CTI expects to file a Marketing Authorization Application in mid-2010.
- Phase II clinical data on OPAXIO demonstrated high rates of pathologic complete remissions for treatment of patients with advanced esophageal cancer paving way for potential registration trial as radiation sensitizer. CTI expects to meet with the FDA in the first half of 2010 to discuss a potential registration trial for OPAXIO as a radiation sensitizer.
- Decreased debt in 2009 by $57.4 million through exchanges and eliminated all of outstanding preferred stock.
- Added in 2009 to the Russell 2000, 3000 and Global Indices as well as the Nasdaq Global Biotechnology Index.
- Adopted Shareholder Rights Plan designed to deter coercive takeover tactics, and to prevent an acquirer from gaining control of CTI without offering a fair price to all of CTI's shareholders.
- Received net proceeds of $136 million in 2009 through sale of Zevalin and investments by institutions to fund operations and decrease debt.
"In 2009 we focused on streamlining our operations, improving our balance sheet and supporting our late stage product to position us for the potential commercialization of a CTI product," stated James A. Bianco, M.D., CEO of CTI. "We look forward to presenting the benefit-risk pixantrone data to the Oncologic Drugs Advisory Committee at the meeting which is being rescheduled especially in light of the completion of the updated study overall survival results."
Financial Results
For the quarter ended December 31, 2009, total net operating expenses were approximately $26.2 million, compared to $11.2 million for the same period in 2008. The increase in total net operating expenses was mainly a result of a non-cash equity based compensation expense of $11.7 million for the quarter ended December 31, 2009 and a $9.4 million gain on the sale of Zevalin to a 50/50 owned joint venture with Spectrum that was recognized in the quarter ended December 31, 2008. Research and development expenses decreased by 15% to $7.3 million compared to $8.6 million for the same period in 2008. Net loss attributable to common shareholders decreased by 34% to $27.4 million ($0.05 per share), compared to a net loss attributable to common shareholders of $41.3 million ($0.52 per share) for the same period in 2008. The decrease in net loss for the quarter ended December 31, 2009 is mainly a result of the decrease in expenses associated with financings for the quarter ended December 31, 2009 compared to the expenses associated with financings incurred in the same period in 2008.
For the year ended December 31, 2009, total net operating expenses decreased to $81.6 million, compared to $88.7 million for the same period in 2008. Research and development expenses decreased by 42% to $30.2 million compared to $51.6 million for the same period in 2008. Net loss attributable to common shareholders decreased 42% to $116.8 million ($0.25 per share), compared to a net loss attributable to shareholders of $202.9 million ($7.00 per share) for the same period in 2008. The decrease in net loss for the year ended December, 31, 2009 compared to the same period in 2008 is mainly the result of a decrease in research and development expenses and expenses associated with financings.
CTI had approximately $37.8 million in cash, cash equivalents and securities available-for-sale as of December 31, 2009. This does not include approximately $28.2 million in net proceeds, the Company received in January 2010 in connection with a registered offering of preferred stock and warrants.
Conference Call Information
On Thursday, February 11, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of CTI's management team will host a conference call to discuss CTI's 2009 fourth quarter and year end achievements and financial results.
Conference Call Numbers |
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Thursday, February 11, 2010 |
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8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time |
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1-877-941-6009 (US Participants) |
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1-480-629-9770 (International) |
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Call-back numbers for post-listening available at 11:30 a.m. Eastern: |
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1-800-406-7325 (US Participants) |
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1-303-590-3030 (International) |
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Passcode: 4199432 |
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Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.
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.celltherapeutics.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 and the trading price of CTI's securities. Specifically, the risks and uncertainties include statements about CTI's ability to continue to reduce CTI's operating expenses, CTI's ability to continue to raise capital as needed to fund CTI's operations, the development of pixantrone, OPAXIO and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with pixantrone, OPAXIO and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for the treatment of ovarian cancer, esophageal cancer, non-Hodgkin's lymphoma and sarcoma or to achieve market acceptance for such treatments, the possibility that FDA approval is not granted for pixantrone at all, the possibility that CTI does not file an MAA, that the potential registration trial for OPAXIO does not occur, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, OPAXIO and brostallicin, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission, including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter CTI's forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact: |
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Dan Eramian |
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T: 206.272.4343 |
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C: 206.854.1200 |
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Investors Contact: |
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Ed Bell |
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T: 206.272.4345 |
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Lindsey Jesch Logan |
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T: 206.272.4347 |
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F: 206.272.4434 |
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www.CellTherapeutics.com/investors |
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Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
------------ ------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Product sales $- $2,528 $- $11,352
License and contract
revenue 20 20 80 80
--- --- --- ---
Total revenues 20 2,548 80 11,432
--- ----- --- ------
Operating expenses, net:
Cost of product sold - 895 - 3,244
Research and
development 7,301 8,576 30,179 51,614
Selling, general
and administrative 18,728 11,081 57,725 41,643
Amortization of
purchased intangibles - 118 - 1,658
Restructuring charges
and related gain on
sale of assets, net 213 - 3,979 -
Gain on sale of Zevalin - (9,444) - (9,444)
Gain on sale of investment
in joint venture - - (10,244) -
--- --- ------- ---
Total operating
expenses, net 26,242 11,226 81,639 88,715
------ ------ ------ ------
Loss from operations (26,222) (8,678) (81,559) (77,283)
Other income (expense):
Investment and
other income, net 36 50 133 549
Interest expense (780) (1,604) (4,806) (8,559)
Amortization of
debt discount and
issuance costs (213) (14,271) (5,788) (66,530)
Foreign exchange
gain (loss) (245) 2,728 33 3,637
Make-whole interest
expense - (17,731) (6,345) (70,243)
Gain on derivative
liabilities, net - 13,647 7,218 69,739
Gain (loss) on exchange
of convertible notes - (9,223) 7,381 (25,103)
Equity loss from investment
in joint venture - (123) (1,204) (123)
Milestone modification
expense - - (6,000) -
Settlement expense, net - (2,594) (4,710) (3,393)
Write-off of financing
arrangement costs - (485) - (2,846)
--- ---- --- ------
Net loss before
noncontrolling
interest (27,424) (38,284) (95,647) (180,155)
Noncontrolling interest 47 31 252 126
--- --- --- ---
Net loss attributable
to CTI (27,377) (38,253) (95,395) (180,029)
Gain on restructuring
of preferred stock - - 2,116 -
Preferred stock
dividends - (88) (24) (662)
Deemed dividends
on preferred stock - (3,000) (23,460) (22,216)
--- ------ ------- -------
Net loss
attributable to
common shareholders $(27,377) $(41,341) $(116,763) $(202,907)
======== ======== ========= =========
Basic and diluted net
loss per common share $(0.05) $(0.52) $(0.25) $(7.00)
====== ====== ====== ======
Shares used in
calculation of basic
and diluted net loss
per common share 570,630 80,074 458,356 28,967
======= ====== ======= ======
Balance Sheet Data: (amounts in thousands)
December 31,
2009 2008
---- ----
Cash and cash equivalents (unaudited)
and securities
available-for- sale $37,811 $10,671
Restricted cash - 6,640
Working capital (21,694) (14,141)
Total assets 69,595 64,243
Convertible debt 62,142 142,373
Accumulated deficit (1,429,083) (1,312,320)
Shareholders' deficit (18,769) (132,061)
SOURCE Cell Therapeutics, Inc.
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