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Thu, May 13, 2010

Aeterna Zentaris Reports First Quarter 2010 Financial and Operating Results


Published on 2010-05-13 04:00:29 - Market Wire
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 - January 25, 2010: Updated results of a Phase 2 study related to the use of perifosine in the treatment of advanced metastatic colon cancer showing a statistically significant benefit in survival, including 5 FU-refractory patients. - January 29, 2010: Publication in the February 2010 issue of the Journal of Clinical Cancer Research of positive Phase 2 results for perifosine as a single agent for the treatment of advanced Waldenstrom's macroglobulinemia. - February 3, 2010: Special Protocol Assessment ("SPA") granted by the United States Food and Drug Administration ("FDA") for the Phase 3 trial of perifosine in combination with capecitabine (Xeloda(R)) in refractory advanced colorectal cancer. The trial is to be conducted by Keryx Biopharmaceuticals, Inc. ("Keryx") (NASDAQ: KERX), Aeterna Zentaris' partner and licensee for perifosine in North America. - March 1, 2010: Disclosure that the Committee for Orphan Medicinal Products of the European Medicines Agency ("EMA") had issued a positive opinion for orphan medicinal product designation for perifosine for the treatment of multiple myeloma. 
 - April 5, 2010: Perifosine receives FDA Fast Track Designation for the Phase 3 X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) registration trial. - April 8, 2010: Initiation of a Phase 3 registration trial with perifosine in refractory advanced colorectal cancer by Keryx. - April 15, 2010: Positive Scientific Advice from the EMA for the Phase 3 program with perifosine in multiple myeloma. Data from ongoing Phase 3 study, sponsored by Keryx, can be used to register perifosine in multiple myeloma in Europe. - April 20, 2010: Presentations of preclinical data on Erk inhibitor, AEZS-131, and Erk/PI3K dual inhibitor, AEZS-132, as well as preclinical data from a study sponsored by the National Institutes of Health with perifosine in oncology at the American Association for Cancer Research Annual Meeting in Washington, D.C. - April 20, 2010: Completion of a $15.0 million registered direct offering with certain institutional investors. - April, 23, 2010: Company regained compliance with Nasdaq's minimum bid price listing requirement. - May 6, 2010: Company receives orphan-drug designation from the FDA for AEZS-108 in ovarian cancer. - May 12, 2010: FDA approves the Company's Investigational New Drug (IND) application for AEZS-108 in LHRH-receptor positive urothelial (bladder) cancer. 
 Interim Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) ------------------------------------------------------------------------- Three months ended March 31, 2010 2009 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ Revenues Sales and royalties 5,716 4,971 License fees and other 706 1,140 ------------------------------------------------------------------------- 6,422 6,111 ------------------------------------------------------------------------- Operating expenses Cost of sales, excluding depreciation and amortization 4,617 3,694 Research and development costs, net of tax credits and grants 5,701 11,437 Selling, general and administrative expenses 2,792 3,554 Depreciation and amortization Property, plant and equipment 263 311 Intangible assets 389 557 ------------------------------------------------------------------------- 13,762 19,553 ------------------------------------------------------------------------- Loss from operations (7,340) (13,442) ------------------------------------------------------------------------- Other income Interest income 58 154 Foreign exchange gain 1,402 900 ------------------------------------------------------------------------- 1,460 1,054 ------------------------------------------------------------------------- Net loss for the period (5,880) (12,388) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Net loss per share Basic and diluted (0.09) (0.23) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares Basic and diluted 63,089,954 53,187,470 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Interim Consolidated Balance Sheet Information (in thousands) (unaudited) ------------------------------------------------------------------------- As at As at March 31, December 31, 2010 2009 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ Cash and cash equivalents 26,947 38,100 Accounts receivable and other current assets 10,383 10,913 Restricted cash 833 878 Property, plant and equipment 3,885 4,358 Other long-term assets 29,924 32,013 ------------------------------------------------------------------------- Total assets 71,972 86,262 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Accounts payable and other current liabilities 14,777 19,211 Current portion of long-term payable 59 57 Long-term payable 118 143 Non-financial long-term liabilities* 53,848 57,625 ------------------------------------------------------------------------- Total liabilities 68,802 77,036 Shareholders' equity 3,170 9,226 ------------------------------------------------------------------------- Total liabilities and shareholders' equity 71,972 86,262 ------------------------------------------------------------------------- ------------------------------------------------------------------------- * Comprised mainly of deferred revenues and employee future benefits. 
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