Zevalin(R) net sales of $15 million in 2008 on target; Potential label
expansion could further drive sales
SEATTLE, Aug. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported financial results for the quarter ended June 30, 2008. Total revenues for the quarter were $2.9 million compared to $20,000 for the second quarter of 2007 due primarily to sales of Zevalin(R) (Ibritumomab Tiuxetan), a commercial radiopharmaceutical that CTI acquired in December 2007. Net product sales of Zevalin reached $2.9 million in the second quarter of 2008.
"Given recent sales trends and growing physician interest, as well as recent Congressional action to extend reimbursement rates for Zevalin, we believe we are on track to reach $15 million in annual net sales for Zevalin this year," said James A. Bianco, M.D., CEO of CTI. "Furthermore, potential expansion of the label for Zevalin based upon data we recently obtained from Bayer Schering Pharma's First-line Indolent Trial (FIT) could support future sales growth. In addition to our progress with Zevalin, we now have OPAXIO's Marketing Authorization Application under review in Europe and expect results from our phase III pixantrone trial in the fourth quarter."
-- Entered into agreement with Bayer Schering Pharma for access to phase III Zevalin(R) FIT data for potential U.S. supplemental Biologics License Application (sBLA) to seek label expansion.
-- Scheduled meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the possibility of filing a sBLA for use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma based on FIT trial data.
-- Legislation was passed by Congress that would continue the 2007 reimbursement methodology for therapeutic radioimmunotherapies for an additional 18 months with a start date of July 1, 2008. Separately, the Centers for Medicare & Medicaid Services proposed to reimburse Zevalin based on the Average Sales Price methodology, which is currently used for drugs and biologicals, in 2009.
-- Completed enrollment for phase II clinical trial of brostallicin as first-line therapy in patients with newly diagnosed advanced or metastatic soft tissue sarcoma.
-- Announced that Craig Philips, most recently Vice President and General Manager of Bayer Healthcare Oncology, assumed day to day role as President of CTI with direct responsibilities for development and commercial operations.
-- Repaid balance of approximately $10.7 million for 2008 Convertible Notes leaving Company with no debt maturing before Q3 2010 and established equity line of credit for the sale of up to $12 million of common stock over time.
Total operating expenses increased to $28.7 million for the quarter ended June 30, 2008 compared to $24.3 million for the same period in 2007 mainly as a result of increased expenses related to support expansion of Zevalin sales and marketing efforts and legal expenses. Net loss attributable to common shareholders for the quarter ended June 30, 2008, totaled $59.3 million ($0.52 per share), which included $25.6 million in make-whole interest expense due to the conversion of the 9% and 13.5% convertibles notes into common stock that resulted in a decrease of approximately $39.6 million in debt, compared to $27.9 million ($0.65 per share) for the comparable period in 2007. The decrease in net loss per share is due to an increase in the number of shares outstanding.
The Company had approximately $12.4 million in cash and cash equivalents, securities available-for-sale, and interest receivable as of June 30, 2008. This does not include $26.9 million in restricted cash held in escrow for future make-whole and interest payments on our 9%, 13.5% and 15% convertible notes as well as net cash proceeds of approximately $4.5 million, before fees and expenses, from the issuance in July 2008 of convertible notes and warrants with an additional $4.5 million expected to be received prior to August 25 as agreed to in the July 2008 financing. The Company has also entered into an agreement in July 2008 which makes available an equity line of credit enabling the sale of up to $12 million of common stock over time.
Conference Call Information
On Monday, August 18, 2008, at 8:30 a.m. Eastern/2:30 p.m. Central
European/5:30 a.m. Pacific members of Cell Therapeutics, Inc.'s (CTI)
(Nasdaq and MTA: CTIC) management team will host a quarterly conference
call to discuss the company's 2008 second quarter achievements and
Conference Call Numbers
Monday, August 18
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-800-218-8862 (US Participants)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-405-2236 (US Participants)
Live audio webcast at http://www.celltherapeutics.com will be archived for post- 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 http://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. Specifically, the risks and
uncertainties include statements about future sales of Zevalin, including
the risk that the data from the FIT trial may not prove adequate to support
an sBLA for label expansion of that product or that if an sBLA is submitted
to the FDA, it may not be approved, statements about reducing net operating
expenses in 2008, the closing of an additional financing prior to August
25, 2008, the availability of adequate shares for future financings, and
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, determinations by regulatory, patent and
administrative governmental authorities, competitive factors, technological
developments, costs of developing, producing and selling Zevalin, OPAXIO,
pixantrone, and brostallicin, the Company's ability to continue to raise
capital as needed to fund its operations, 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. Except as may be required by
law, CTI does not intend to update or alter its forward-looking statements
whether as a result of new information, future events, or otherwise.
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
Product sales $2,870 $ - $6,244 $ -
License and contract revenue 20 20 40 40
Total revenues 2,890 20 6,284 40
Cost of product sold 767 - 1,657 -
Research and development 15,857 16,516 31,712 31,802
Selling, general and
administrative 11,518 7,590 22,692 15,720
Amortization of purchased
intangibles 537 212 934 419
Acquired in-process research
and development - - 36 -
Total operating expenses 28,679 24,318 57,031 47,941
Loss from operations (25,789) (24,298) (50,747) (47,901)
Other income (expense):
Investment and other income 93 738 353 1,441
Interest expense (2,395) (2,098) (4,380) (4,019)
Amortization of debt discount
and issuance costs (30,202) (1,580) (41,146) (3,575)
Foreign exchange gain (loss) 76 387 (2,161) 834
Make-whole interest expense (25,596) - (33,377) (2,310)
Gain on derivative liabilities 31,433 906 43,177 3,614
Loss on exchange of
convertible notes (3,313) - (5,608) -
Write-off of financing
arrangement costs (2,361) - (2,361) -
Settlement expense - (17) - (160)
Loss before minority interest (58,054) (25,962) (96,250) (52,076)
Minority interest in net loss
of subsidiary 31 - 63 -
Net loss (58,023) (25,962) (96,187) (52,076)
Preferred stock beneficial
conversion feature (1,067) (1,789) (1,067) (4,383)
Preferred stock dividends (226) (150) (468) (181)
Deemed dividends on conversion
of preferred stock - - (16,198) -
Net loss attributable to common
shareholders $(59,316) $(27,901) $(113,920) $(56,640)
Basic and diluted net loss per
common share $(0.52) $(0.65) $(1.23) $(1.41)
Shares used in calculation of
basic and diluted net loss per
common share 114,470 42,713 92,772 40,165
Balance Sheet Data: (amounts in thousands)
June 30, December 31,
Cash and cash equivalents, securities
available-for-sale and interest (unaudited)
receivable $12,419 $18,392
Restricted cash 26,862 -
Working capital (3,023) (30,909)
Total assets 96,818 73,513
Convertible debt 160,997 137,396
Accumulated deficit (1,223,333) (1,109,413)
Shareholders' deficit (134,205) (134,125)
|SOURCE Cell Therapeutics, Inc.|
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