Æterna Zentaris Reports Third Quarter 2009 Financial and Operating Results
All amounts are in U.S. dollars
Third Quarter 2009 Highlights - July 7, 2009. Publication in Proceedings of the National Academy of Sciences, of new data supporting the use of AEZS-123 for the treatment of alcohol dependence that involves ghrelin. - August 3, 2009. The Company's licensee partner for perifosine in North America, Keryx Biopharmaceuticals ("Keryx"), disclosed that it had reached an agreement with the FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for multiple myeloma. - August 17, 2009. Disclosure of results for two Phase 3 studies with cetrorelix in benign prostatic hyperplasia ("BPH"). The efficacy study Z-033 did not achieve its primary endpoint. Results from the safety study Z-041 were positive and exhibited a similar level of efficacy as the previously disclosed Phase 2 study results. - September 16, 2009. Disclosure that Keryx received Orphan Drug designation from the FDA for perifosine for multiple myeloma. - September 21, 2009. Disclosure of Phase 1 study results with AEZS-112 in advanced solid tumors or lymphoma showed prolonged courses of stable disease, excellent tolerability and potential for long-term use as a combination treatment for cancer. - September 30, 2009. Disclosure of results for the Thorough QT Z-043 ("TQT") study, which is part of the cetrorelix pamoate clinical development in BPH. The study met its primary endpoint. Subsequent to Quarter-End - October 19, 2009. Disclosure of the initiation of activities to complete a Phase 3 trial with macimorelin (AEZS-130) as a first approved oral diagnostic test for Growth Hormone Deficiency. - October 23, 2009. Completion of a $5.5 million registered direct offering. - November 2, 2009. Disclosure of positive preliminary results for the Phase 2 study with AEZS-108 in ovarian cancer.
Juergen Engel, Ph.D., Æterna Zentaris President and Chief Executive Officer, commented, "During this quarter, we disclosed results for the first of two efficacy trials of our Phase 3 program in BPH with cetrorelix. The first efficacy trial did not reach its primary endpoint, while results for the safety and TQT trials were positive. We remain committed to this program and are working towards receiving the results of the second efficacy study next month. Furthermore, we made significant progress with other innovative late-stage compounds such as perifosine and AEZS-108 in oncology, as well as AEZS-130 in endocrinology, which are further proof of the breadth of our pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2009
Consolidated revenues were
Consolidated research and development ("R&D") costs, net of tax credits and grants, were
Consolidated net loss for the three-month period ended
Consolidated cash, cash equivalents and short-term investments were
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About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.
Attachment: Financial summary
Interim Consolidated Statements of Loss (Unaudited) (in thousands, except share and per share data) Three months ended Nine months ended September 30, September 30, 2009 2008 2009 2008 --------------------------------------------------- --------------------------------------------------- $ $ $ $ Revenues Sales and royalties 5,539 8,630 15,937 24,822 License fees and other 3,026 2,399 7,118 6,412 --------------------------------------------------- 8,565 11,029 23,055 31,234 --------------------------------------------------- Operating expenses Cost of sales 4,488 4,986 12,727 14,348 Research and development costs, net of tax credits and grants 9,738 13,880 33,251 44,914 Selling, general and administrative expenses 3,193 3,277 9,849 14,287 Depreciation and amortization Property, plant and equipment 341 433 983 1,199 Intangible assets 594 839 1,714 2,555 --------------------------------------------------- 18,354 23,415 58,524 77,303 --------------------------------------------------- Loss from operations (9,789) (12,386) (35,469) (46,069) --------------------------------------------------- Other income (expenses) Interest income 41 149 315 737 Interest expense (2) - (4) (68) Foreign exchange (loss) gain (1,538) (1,324) (1,598) 429 Loss on disposal of long-lived assets held for sale - (90) - (125) --------------------------------------------------- (1,499) (1,265) (1,287) 973 --------------------------------------------------- Loss before income taxes (11,288) (13,651) (36,756) (45,096) Income tax expense - (228) - (228) --------------------------------------------------- Net loss for the period (11,288) (13,879) (36,756) (45,324) --------------------------------------------------- --------------------------------------------------- Net loss per share Basic and diluted (0.19) (0.26) (0.67) (0.85) --------------------------------------------------- --------------------------------------------------- Weighted average number of shares Basic and diluted 58,506,619 53,187,470 55,135,876 53,187,470 --------------------------------------------------- --------------------------------------------------- Interim Consolidated Balance Sheet Information (Unaudited) ------------------------------------------------------------------------- ------------------------------------------------------------------------- As at As at September 30, December 31, (in thousands) 2009 2008 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ Cash and cash equivalents 43,051 49,226 Short-term investments 562 493 Accounts receivable and other current assets 11,127 12,005 Restricted cash 901 - Property, plant and equipment 6,738 6,682 Other long-term assets 41,237 39,936 ------------------------------------------------------------------------- Total assets 103,616 108,342 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Accounts payable and other current liabilities 23,015 22,121 Current portion of long-term payable 56 49 Long-term payable 140 172 Non-financial long-term liabilities 88,390 64,525 ------------------------------------------------------------------------- Total liabilities 111,601 86,867 Shareholders' equity (deficiency) (7,985) 21,475 ------------------------------------------------------------------------- Total liabilities and shareholders' equity (deficiency) 103,616 108,342 ------------------------------------------------------------------------- -------------------------------------------------------------------------
For further information: Investor Relations: Ginette Vallières, Investor Relations Coordinator, (418) 652-8525 ext. 265, [email protected]; Media Relations: Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406, [email protected]
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