Exhibit 1
Æterna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Québec (Québec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
Press Release
For immediate release
Æterna Zentaris Reports Fourth Quarter and Full-Year 2007 Financial and Operating Results
Year marked by strengthened leadership team and the initiation of Phase 3 program for cetrorelix in BPH
All amounts are in U.S. dollars
Quebec City, Canada, March 5, 2008 – Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results for the fourth quarter and full year ended December 31, 2007.
David J. Mazzo, Ph.D., Æterna Zentaris’ President and Chief Executive Officer commented, “2007 was a challenging year; a year marked by important changes to both our corporate structure and business plan. The result has given our stakeholders a sharper image of our objectives and ongoing priorities. 2007 also involved a great deal of groundbreaking, marking for example, the first time our team launched an international Phase 3 program as is the case for cetrorelix in BPH. Another first was the opening of our offices in New Jersey as part of our strategy to gain more exposure with the pharmaceutical and financial communities in the United States. Furthermore, following the appointment of three new key executives during the year, we now have a team of the highest level in clinical research, regulatory affairs, business development, pharmaceutical discovery, development and commercialization — vital assets for the successful pre-launch activities for cetrorelix, as well as for the thrust of our entire pipeline.
Moving forward, we will continue to strive to expose the depth, breadth and potential of our robust pipeline and will diligently execute our business plan with the primary objective of creating value for our shareholders.”
CONSOLIDATED RESULTS FOR THE FOURTH QUARTER ENDED DECEMBER 31, 2007
Consolidated revenues were $10.2 million for the fourth quarter ended December 31, 2007 compared to $11.9 million for the same quarter in 2006. The decrease in revenues is attributable to lower sales of Impavido®, as well as active pharmaceutical ingredients to the Company’s partners, combined with lower license fees from the Company’s partners.
Selling, General and Administrative (SG&A) expenses were $5.1 million for the fourth quarter ended December 31, 2007 compared to $4.2 million for the same quarter in 2006. The increase in SG&A is mainly related to the support of the continuation of a Phase 3 program with cetrorelix in benign prostatic hyperplasia (BPH) and the opening of a new operational headquarters in New Jersey.
Consolidated Research & Development (R&D) expenses were $13.6 million for the fourth quarter ended December 31, 2007 compared to $7.9 million for the same quarter in 2006. The increase in R&D expenses relates to the continuation of the Company’s Phase 3 program with cetrorelix in BPH.
Consolidated net loss was $13.6 million or $0.26 per basic and diluted share for the fourth quarter ended December 31, 2007 compared to consolidated net earnings of $39.1 million or $0.74 per basic and diluted share for the same quarter in 2006. The increased net loss in the fourth quarter 2007 is related to higher loss from operations of nearly $5.2 million mainly related to increased R&D expenses, as well as to lower income tax recovery of nearly $28.4 million attributable to the recognition of future income tax assets mainly related to the sale of Atrium shares in 2006 and the special distribution of the Company’s remaining interest in January 2007, combined with the decrease in net earnings from Atrium’s discontinued operations of approximately $16.3 million.
The consolidated cash and short-term investments were $41.4 million as of December 31, 2007.
CONSOLIDATED RESULTS FOR THE FULL YEAR ENDED DECEMBER 31, 2007
Consolidated revenues for the year ended December 31, 2007 were $42.1 million compared to $38.8 million for the same period in 2006. The increase in revenues for 2007 is mainly related to increased sales of Cetrotide® and Impavido®, partly compensated by lower license fees revenues from the Company’s partners.
Consolidated R&D costs were $39.2 million for the year ended December 31, 2007 compared to $27.4 million for the same period in 2006. The increase in R&D expenses of $11.8 million in 2007 is mainly related to the advancement of the Company’s lead product cetrorelix in Phase 3 for BPH; as well as to further advancement of targeted, earlier-stage development programs including AEZS-108, a cytotoxic conjugate and AEZS-112, a tubulin inhibitor.
Consolidated loss from operations increased to $34.8 million for the year ended December 31, 2007 compared to $23.8 million for the same period in 2006. The increase in loss from operations in 2007 is attributable to a combination of lower license revenues, increase in non-recurring G&A corporate expenses and additional R&D expenses mainly related to the advancement of the Company’s Phase 3 program with cetrorelix in BPH. This increase in loss from operations in 2007 was partly offset by increased sales and royalties, as well as lower D&A expenses.
Consolidated net loss was $32.3 million or $0.61 per basic and diluted share for the year ended December 31, 2007 compared to consolidated net earnings of $33.4 million or $0.64 per basic share and $0.62 per diluted share for the same period in 2006. The increased net loss in 2007 is related to a higher loss from operations of nearly $10 million, lower income tax recovery of nearly $27 million related to the recognition of future income tax assets, mainly attributable to the sale of Atrium shares in 2006, and the special distribution of Æterna Zentaris’ remaining interest in January 2007, as well as lower net earnings from discontinued operations of Atrium of nearly $26 million.
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CONFERENCE CALL
Management will be hosting a conference call for the investment community beginning at 10:00 a.m. Eastern Time today, Wednesday, March 5, to discuss fourth quarter and full-year 2007 results.
To participate in the live conference call by telephone, please dial 416-644-3425, 514-807-8791 or 800-595-8550. Individuals interested in listening to the conference call on the Internet may do so by visiting www.aezsinc.com. A replay will be available on the Company’s Web site for 30 days.
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 requested by a governmental authority or applicable law.
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Contacts
Jenene Thomas
Senior Director, Investor Relations & Corporate Communications
(908) 626-5509
jthomas@aezsinc.com
Paul Burroughs
Media Relations
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
Attachment: Financial summary
3
(In thousands of US dollars, except share
and per share data)
CONSOLIDATED RESULTS
Unaudited
|
| Three months ended |
| Year ended |
| ||||
|
| 2007 |
| 2006 |
| 2007 |
| 2006 |
|
|
| $ |
| $ |
| $ |
| $ |
|
Revenues |
|
|
|
|
|
|
|
|
|
Sales and royalties |
| 6,435 |
| 6,800 |
| 28,825 |
| 25,123 |
|
License fees |
| 3,705 |
| 5,137 |
| 12,843 |
| 13,652 |
|
Other |
| 100 |
| — |
| 400 |
| 24 |
|
|
| 10,240 |
| 11,937 |
| 42,068 |
| 38,799 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
Cost of sales, excluding depreciation and amortization |
| 3,255 |
| 3,556 |
| 12,930 |
| 11,270 |
|
Selling, general and administrative |
| 5,146 |
| 4,159 |
| 20,403 |
| 16,478 |
|
R&D costs |
| 13,574 |
| 7,926 |
| 39,248 |
| 27,422 |
|
R&D tax credits and grants |
| (1,941 | ) | (1,442 | ) | (2,060 | ) | (1,564 | ) |
Depreciation and amortization |
| 1,135 |
| 4,195 |
| 5,566 |
| 8,964 |
|
Impairment of long-lived asset held for sale |
| 735 |
| — |
| 735 |
| — |
|
|
| 21,904 |
| 18,394 |
| 76,822 |
| 62,570 |
|
Loss from operations |
| (11,664 | ) | (6,457 | ) | (34,754 | ) | (23,771 | ) |
|
|
|
|
|
|
|
|
|
|
Other revenues (expenses) |
|
|
|
|
|
|
|
|
|
Interest income |
| 535 |
| 703 |
| 1,904 |
| 1,441 |
|
Interest expense |
| (23 | ) | 14 |
| (85 | ) | (1,433 | ) |
Foreign exchange gain (loss) |
| (269 | ) | 384 |
| (1,035 | ) | 319 |
|
Loss on disposal of equipment |
| (28 | ) | — |
| (28 | ) | — |
|
Gain on disposal of long-term investment |
| — |
| 409 |
| — |
| 409 |
|
Other |
| — |
| (163 | ) | — |
| — |
|
|
| 215 |
| 1,347 |
| 756 |
| 736 |
|
Share in the results of an affiliated company |
| — |
| 1,575 |
| — |
| 1,575 |
|
Loss before Income taxes |
| (11,449 | ) | (3,535 | ) | (33,998 | ) | (21,460 | ) |
Income tax recovery (expense) |
| (2,405 | ) | 26,061 |
| 1,961 |
| 29,037 |
|
Net earnings (loss) from continuing operations |
| (13,854 | ) | 22,526 |
| (32,037 | ) | 7,577 |
|
Net earnings (loss) from discontinued operations |
| 218 |
| 16,575 |
| (259 | ) | 25,813 |
|
Net earnings (loss) for the year |
| (13,636 | ) | 39,101 |
| (32,296 | ) | 33,390 |
|
Net earnings (loss) per share from continuing operations |
|
|
|
|
|
|
|
|
|
Basic and diluted |
| (0.26 | ) | 0.42 |
| (0.61 | ) | 0.14 |
|
Net earnings (loss) per share |
|
|
|
|
|
|
|
|
|
Basic |
| (0.26 | ) | 0.74 |
| (0.61 | ) | 0.64 |
|
Diluted |
| (0.26 | ) | 0.74 |
| (0.61 | ) | 0.62 |
|
Weighted average number of shares |
|
|
|
|
|
|
|
|
|
Basic |
| 53,182,803 |
| 52,694,868 |
| 53,182,803 |
| 52,099,290 |
|
Diluted |
| 53,182,803 |
| 53,035,786 |
| 53,182,803 |
| 52,549,260 |
|
Issued and outstanding shares |
|
|
|
|
| 53,187,470 |
| 53,169,470 |
|
4
(In thousands of US dollars, except share
and per share data)
CONSOLIDATED BALANCE SHEET
Unaudited
|
| December 31, |
| December 31, |
|
|
| 2007 |
| 2006 |
|
|
| $ |
| $ |
|
Cash and short-term investments |
| 41,387 |
| 60,489 |
|
Other current assets |
| 18,193 |
| 41,234 |
|
|
| 59,580 |
| 101,723 |
|
Long-term assets |
| 63,783 |
| 121,768 |
|
Total assets |
| 123,363 |
| 223,491 |
|
|
|
|
|
|
|
Current liabilities |
| 22,255 |
| 16,310 |
|
Long-term debt |
| — |
| 687 |
|
Other long-term liabilities |
| 12,517 |
| 27,615 |
|
|
| 34,772 |
| 44,612 |
|
Shareholders’ equity |
| 88,591 |
| 178,879 |
|
Total liabilities and shareholders’ equity |
| 123,363 |
| 223,491 |
|
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