News for 'CTIC' - (Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009)
CTIC News -- Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009.
Thursday, February 11, 2010 1:33 AM
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News for 'CTIC' - (Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009)
SEATTLE, Feb 11, 2010 /PRNewswire via COMTEX/ -- 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
Thursday, February 11, 2010
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-6009 (US Participants)
1-480-629-9770 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4199432
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:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: deramian@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors
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.
www.prnewswire.com
Copyright (C) 2010 PR Newswire. All rights reserved
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KEYWORD: Washington
INDUSTRY KEYWORD: HEA
MTC
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PHA
SUBJECT CODE: ERN
CCA
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