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"While we have started to prepare for the launch of pixantrone in 2010 with the recruitment of key commercial personnel and conducting important market research, we remained focused on tight fiscal controls while continuing to clean-up our balance sheet," said James A. Bianco, M.D., CEO of the Company. "We are pleased with our continued financial progress demonstrating a decrease in net loss of 45% for the nine months in 2009 compared to the same period for 2008," noted Dr. Bianco. "With the recent developments and progress we are making in advancing pixantrone through its New Drug Application (NDA) review process we expect the next 3 to 6 months to be an exciting and transformative period for the Company."
Recent Highlights
-- FDA accepted and filed for review the Company's NDA for pixantrone as
treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma
(NHL).
-- The Company initiated the process of obtaining marketing approval in
Europe in July 2009, for the treatment of relapsed or refractory
aggressive NHL.
-- Further reduced debt through the exchange of $4.5 million principal in
debt for common stock resulting in a total of $57.4 million principal
reduction in debt through exchanges so far in 2009.
-- Added to the NASDAQ OMX Global Biotechnology Index (Nasdaq: QGBI).
For the quarter ended September 30, 2009, total net operating expenses were approximately $27.1 million, compared to $20.5 million for the same period in 2008. Research and development expenses decreased by 33% to $7.6 million compared to $11.3 million for the same period in 2008. Net loss attributable to common shareholders was $48.8 million ($0.09 per share), compared to a net loss attributable to common shareholders of $47.6 million ($2.83 per share) for the same period in 2008. The net loss for the quarter ended September 30, 2009 included the following non-cash expenses: $11.4 million in equity-based compensation expense, $6.0 million in milestone payment modification expense and $13.8 million preferred stock deemed dividend expenses. Combined, these non-cash expenses totaled $31.2 million. The modification to the milestone expense relates to the agreement to issue $6.0 million of shares of the Company's common stock to Systems Medicine, Inc. shareholders, which replaced potential milestone payments of up to $15.0 million based certain FDA milestones for the Company's product candidate brostallicin.
For the nine months ended September 30, 2009, total net operating expenses decreased approximately 29% to $55.4 million, compared to $77.5 million for the same periods in 2008. The decrease is mainly a result of a 47% decrease in research and development expenses and a $10.2 million gain on the sale of the Company's remaining interest in a 50/50-owned joint venture with Spectrum Pharmaceuticals, Inc. in 2009. Net loss attributable to shareholders decreased 45% to $89.4 million ($0.21 per share), compared to a net loss attributable to shareholders of $161.6 million ($13.68 per share) for the same period in 2008.
Conference Call Information
On Thursday, November 5, 2009, 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 quarterly conference call to discuss CTI's 2009 third quarter achievements and financial results.
Conference Call Numbers
Thursday, November 5, 2009
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-6010 (US Participants)
1-480-629-9772 (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: 4168724#
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 market price of our securities. Specifically, the risks and uncertainties include statements about our ability to continue to reduce our operating expenses, our ability to continue to raise capital as needed to fund our operations, the development of OPAXIO, pixantrone, and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with OPAXIO, pixantrone, and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian 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, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling OPAXIO, pixantrone, and brostallicin, and the risk factors listed or described from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, we do not intend to update or alter our 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
F: 206.272.4434
E: deramian@ctiseattle.com
www.celltherapeutics.com/media.htm
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.celltherapeutics.com/investors.htm
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Product sales $- $2,580 $- $8,824
License and contract revenue 20 20 60 60
--- --- --- ---
Total revenues 20 2,600 60 8,884
--- ----- --- -----
Operating expenses, net:
Cost of product sold - 692 - 2,349
Research and
development 7,602 11,326 22,878 43,038
Selling, general
and administrative 19,667 7,834 38,997 30,562
Amortization of
purchased intangibles - 606 - 1,540
Restructuring charges and
related gain on sale of
assets, net (178) - 3,766 -
Gain on sale of investment
in joint venture - - (10,244) -
--- --- ------- ---
Total operating
expenses, net 27,091 20,458 55,397 77,489
------ ------ ------ ------
Loss from operations (27,071) (17,858) (55,337) (68,605)
Other income (expense):
Investment and
other income, net 26 146 97 499
Interest expense (826) (2,575) (4,026) (6,955)
Amortization of
debt discount and
issuance costs (227) (11,113) (5,575) (52,259)
Foreign exchange
gain 183 3,070 278 909
Make-whole
interest expense - (19,135) (6,345) (52,512)
Gain on
derivative
liabilities, net - 12,915 7,218 56,092
Gain (loss) on
exchange of
convertible notes 180 (10,272) 7,381 (15,880)
Equity loss from
investment in
joint venture - - (1,204) -
Milestone
modification
expense (6,000) - (6,000) -
Settlement
expense, net (1,342) (799) (4,710) (799)
Write-off of
financing
arrangement costs - - - (2,361)
--- --- --- ------
Net loss before
noncontrolling
interest (35,077) (45,621) (68,223) (141,871)
Noncontrolling
interest 53 32 205 95
--- --- --- ---
Net loss
attributable to CTI (35,024) (45,589) (68,018) (141,776)
Gain on
restructuring of
preferred stock - - 2,116 -
Preferred stock
dividends - (106) (24) (574)
Deemed dividends
on preferred
stock (13,812) (1,951) (23,460) (19,216)
------- ------ ------- -------
Net loss
attributable to CTI
common shareholders $(48,836) $(47,646) $(89,386) $(161,566)
======== ======== ======== =========
Basic and diluted
net loss per common
share $(0.09) $(2.83) $(0.21) $(13.68)
====== ====== ====== =======
Shares used in calculation
of basic and diluted
net loss per
common share 527,204 16,812 420,520 11,807
======= ====== ======= ======
Balance Sheet Data: (amounts in thousands)
September 30, December 31,
2009 2008
---- ----
(unaudited)
Cash and cash
equivalents and
securities
available-for-sale $54,992 $10,671
Restricted cash - 6,640
Working capital (13,385) (14,141)
Total assets 87,299 64,243
Convertible debt 62,015 142,373
Accumulated deficit (1,401,706) (1,312,320)
Total deficit (11,633) (132,061)
SOURCE Cell Therapeutics, Inc.
http://www.celltherapeutics.com
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