AEZS Aeterna Zentaris Inc

All amounts are in U.S. dollars QUEBEC CITY, Aug. 12 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (NASDAQ:AEZSNASDAQ:TSX:NASDAQ:AEZ), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results for the second quarter ended June 30, 2008. Second Quarter 2008 Highlights - Advancement of cetrorelix Phase 3 program in BPH; - First efficacy trial: patient enrollment completed; - Second efficacy trial: patient enrollment ongoing / completion planned for third quarter of 2008 remains on target; - Safety trial: first patient dosing initiated. - Completion of sale of Quebec City building for $7.1 million. Juergen Ernst, Chairman, Interim President and CEO at AEterna Zentaris commented, "During the quarter, we achieved our key objectives as our Phase 3 program in BPH with our lead compound cetrorelix met all recruitment goals and remains on track, with first results expected in the third quarter of 2009. Furthermore, we monetized our Quebec City building which provided additional non-dilutive funding. Over the next few months, we will focus on advancing our Phase 3 program in BPH with cetrorelix, while we endeavour to conclude additional non-dilutive transactions and strategic partnerships." CONSOLIDATED RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2008 Consolidated sales and royalties increased to $8.2 million for the three-month period ended June 30, 2008, compared to $7.7 million for the same period in 2007. The increase in sales and royalties for the three-month period ended June 30, 2008 is related primarily to additional sales of Cetrotide(R), partly offset by the exclusion of sales from Impavido(R) in the second quarter of 2008. License fees revenues decreased to $2.2 million for the three-month period ended June 30, 2008, compared to $3.9 million for the same period in 2007. The decrease for the three-month period ended June 30, 2008, is mainly attributable to the termination of the Company's licensing agreement with Solvay in 2007, which triggered additional amortization of upfront payments in the second quarter of 2007. Consolidated R&D costs, net of tax credits and grants were $17.3 million for the three-month period ended June 30, 2008 compared to $7.8 million for the same period in 2007. Additional R&D expenses for the three-month period ended June 30, 2008, are mainly related to the advancement of our Phase 3 program in BPH with our lead product, cetrorelix. Consolidated selling, general and administrative (SG&A) expenses were $6.6 million for the three-month period ended June 30, 2008 compared to $4.5 million for the same period in 2007. The increase in SG&A expenses for the three-month period ended June 30, 2008 is primarily due to non-recurring corporate expenses related to organizational changes, including severance paid to the former President and CEO as well as to the Senior Vice President and CBO that were implemented in the second quarter of 2008. Consolidated net loss for the three-month period ended June 30, 2008 was $20.6 million or $0.39 per basic and diluted share, compared to $4.8 million or $0.09 per basic and diluted share for the same period in 2007. The increase in net loss for the three-month period ended June 30, 2008, compared to the same period in 2007, is primarily attributable to the increased R&D costs related to the advancement of cetrorelix into our Phase 3 program for the treatment of BPH and non-recurring SG&A corporate costs. The consolidated cash and short-term investments were $24.8 million as at June 30, 2008. CONFERENCE CALL Management will be hosting a conference call for the investment community beginning at 4:30 p.m. Eastern Time today, Tuesday, August 12, to discuss second quarter 2008 results. To participate in the live conference call by telephone, please dial 416-644-3430, 514-807-8791 or 800-814-4862. Individuals interested in listening to the conference call on the Internet may do so by visiting http://www.aezsinc.com/. A replay will be available on the Company's Web site for 30 days. About AEterna Zentaris Inc. AEterna 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 http://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 requested by a governmental authority or applicable law. Attachment: Financial summary (In thousands of US dollars, except share and per share data) Three months ended Six months ended CONSOLIDATED RESULTS June 30, June 30, Unaudited 2008 2007 2008 2007 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ $ $ Revenues Sales and royalties 8,250 7,698 16,192 15,020 License fees 2,207 3,853 4,013 5,765 ------------------------------------------------------------------------- 10,457 11,551 20,205 20,785 ------------------------------------------------------------------------- Operating expenses Cost of sales 4,758 3,075 9,362 6,385 R&D costs, net of tax credits and grants 17,345 7,815 31,034 15,722 Selling, general and administrative 6,606 4,517 11,010 9,410 Depreciation and amortization Property, plant and equipment 397 392 766 757 Intangible assets 876 928 1,716 1,990 ------------------------------------------------------------------------- 29,982 16,727 53,888 34,264 ------------------------------------------------------------------------- Loss from operations (19,525) (5,176) (33,683) (13,479) Other revenues (expenses) Interest income 311 300 588 875 Interest expense (53) (53) (68) (53) Foreign exchange (loss) gain (502) (637) 1,753 (596) Loss on disposal of long-lived assets held for sale (810) - (35) - ------------------------------------------------------------------------- (1,054) (390) 2,238 226 ------------------------------------------------------------------------- Loss before income taxes (20,579) (5,566) (31,445) (13,253) Income tax recovery - 731 - 3,275 ------------------------------------------------------------------------- Net loss from continuing operations (20,579) (4,835) (31,445) (9,978) Net (loss) earnings from discontinued operations - (11) - 22 ------------------------------------------------------------------------- Net loss for the period (20,579) (4,846) (31,445) (9,956) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Net loss per share from continuing operations Basic and diluted (0.39) (0.09) (0.59) (0.19) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Net loss per share Basic and diluted (0.39) (0.09) (0.59) (0.19) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of shares Basic and diluted 53,187,470 53,179,470 53,187,470 53,179,470 (In thousands of US dollars) CONSOLIDATED BALANCE SHEETS June 30, December 31, Unaudited 2008 2007 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ $ Cash and short-term investments 24,827 41,387 Other current assets 18,018 18,193 ---------------------- 42,845 59,580 Long-term assets 52,704 63,783 ---------------------- Total assets 95,549 123,363 ---------------------- ---------------------- Current liabilities 24,046 22,255 Deferred revenues 3,112 3,333 Long-term payable 235 - Employee future benefits 10,337 9,184 ---------------------- 37,730 34,772 Shareholders' equity 57,819 88,591 ---------------------- Total liabilities and shareholders' equity 95,549 123,363 ---------------------- ---------------------- DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Investor Relations: Dennis Turpin, CA, Senior Vice President and Chief Financial Officer, (908) 626-5503, ; Media Relations: Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406,

Copyright