Cell Therapeutics, Inc.'s Second Quarter 2008 Financial Results
"Given recent sales trends and growing physician interest, as well asrecent Congressional action to extend reimbursement rates for Zevalin, webelieve we are on track to reach $15 million in annual net sales for Zevalinthis year," said James A. Bianco, M.D., CEO of CTI. "Furthermore, potentialexpansion of the label for Zevalin based upon data we recently obtained fromBayer Schering Pharma's First-line Indolent Trial (FIT) could support futuresales growth. In addition to our progress with Zevalin, we now have OPAXIO'sMarketing Authorization Application under review in Europe and expect resultsfrom our phase III pixantrone trial in the fourth quarter."
-- Entered into agreement with Bayer Schering Pharma for access to phaseIII Zevalin(R) FIT data for potential U.S. supplemental Biologics LicenseApplication (sBLA) to seek label expansion.
-- Scheduled meeting with the U.S. Food and Drug Administration (FDA) inSeptember to discuss the possibility of filing a sBLA for use of Zevalin asconsolidation therapy after remission induction in previously untreatedpatients with follicular non-Hodgkin's lymphoma based on FIT trial data.
-- Legislation was passed by Congress that would continue the 2007reimbursement methodology for therapeutic radioimmunotherapies for anadditional 18 months with a start date of July 1, 2008. Separately, theCenters for Medicare & Medicaid Services proposed to reimburse Zevalin basedon the Average Sales Price methodology, which is currently used for drugs andbiologicals, in 2009.
-- Completed enrollment for phase II clinical trial of brostallicin asfirst-line therapy in patients with newly diagnosed advanced or metastaticsoft tissue sarcoma.
-- Announced that Craig Philips, most recently Vice President and GeneralManager of Bayer Healthcare Oncology, assumed day to day role as President ofCTI with direct responsibilities for development and commercial operations.
-- Repaid balance of approximately $10.7 million for 2008 ConvertibleNotes leaving Company with no debt maturing before Q3 2010 and establishedequity line of credit for the sale of up to $12 million of common stock overtime.
Total operating expenses increased to $28.7 million for the quarter endedJune 30, 2008 compared to $24.3 million for the same period in 2007 mainly asa result of increased expenses related to support expansion of Zevalin salesand marketing efforts and legal expenses. Net loss attributable to commonshareholders for the quarter ended June 30, 2008, totaled $59.3 million ($0.52per share), which included $25.6 million in make-whole interest expense due tothe conversion of the 9% and 13.5% convertibles notes into common stock thatresulted 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. Thedecrease in net loss per share is due to an increase in the number of sharesoutstanding.
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 forfuture make-whole and interest payments on our 9%, 13.5% and 15% convertiblenotes as well as net cash proceeds of approximately $4.5 million, before feesand expenses, from the issuance in July 2008 of convertible notes and warrantswith an additional $4.5 million expected t
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