Full Press Release Details
Aeterna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Qu bec (Qu bec) Canada G1P 4P5 T 418-652-8525
Aeterna Zentaris Reports Third Quarter 2012 Financial and Operating Results
All amounts are in U.S. dollars
Quebec City, Canada, November 13, 2012 - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs, today reported financial and operating results for the third quarter ended September 30, 2012.
Perifosine (Oral Akt Inhibitor)
AEZS-108 (Cytotoxic Peptide Conjugate Linked to Doxorubicin)
AEZS-130 (Oral Ghrelin Agonist)
Corporate Developments
Share Consolidation and NASDAQ Minimum Bid Price Compliance
Cash and cash equivalents, excluding the net proceeds raised in the Offering subsequent to quarter-end, totalled $33.2 million as at September 30, 2012, compared to $46.9 million as at December 31, 2011.
Juergen Engel, PhD, Aeterna Zentaris President and Chief Executive Officer, commented, "This has been quite an eventful quarter for our Company. At the drug development level, we focused on opening new sites and increasing patient recruitment for our ongoing Phase 3 trial of perifosine in multiple myeloma. Meanwhile, our partner, Yakult, continued to make progress with a Phase 1 trial of perifosine in the same indication in Japan.
As for AEZS-108, we filed a SPA with the FDA for our upcoming Phase 3 trial in endometrial cancer. Earlier this week, we were pleased to report the initiation of the Phase 2 portion of the investigator driven Phase 1/2 trial of AEZS-108 in prostate cancer.
Regarding AEZS-130 as an oral diagnostic test for AGHD, all efforts are concentrated on filing an NDA in the first quarter of 2013. We also announced that a first patient had been recruited for an investigator driven Phase 2A trial of AEZS-130 in cancer-induced cachexia.
2013 looks promising, and we remain confident that the market will come to recognize the full potential of our innovative pipeline."
Dennis Turpin, CPA, CA, Senior Vice President and Chief Financial Officer at Aeterna Zentaris stated, "As of September 30, 2012, including net proceeds from the Offering, we had a pro forma cash and cash equivalents position of $48.4 million which means that we should be well poised to continue to move our key product candidates through the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE THIRD QUARTER ENDED SEPT. 30, 2012
Revenues were $7.1 million for the quarter ended September 30, 2012, compared to $9.5 million for the same quarter in 2011. The decrease is largely attributable to lower deliveries of Cetrotide to certain customers and to the relative weakening of the euro against the US dollar.
R&D costs, net of refundable tax credits and grants were $4.3 million for the quarter ended September 30, 2012, compared to $5.7 million for the same quarter in 2011. The comparative decrease is attributable to lower third-party costs associated with the development of perifosine and AEZS- 108, combined with the weakening of the euro against the US dollar.
Net finance income (costs) totalled $(0.9) million for the quarter ended September 30, 2012, compared to $9.3 million for the same quarter in 2011. The significant fluctuation in net finance (costs) income is mainly due to the change in fair value of our warrant liability, as well as to (losses) or gains due to changes in foreign currency exchange rates, which are mainly related to the period-over-period continued weakness of the Euro against the U.S. dollar.
Net loss amounted to $6.6 million, or $0.35 per basic and diluted share for the quarter ended September 30, 2012, compared to a net income of $1.1 million, or $0.07 per basic and $0.06 per diluted share, for the same quarter in 2011. The significant increase in net loss for the three-month period ended September 30, 2012, as compared to the same period in 2011, is due largely to lower net finance income, partly compensated by lower R&D and SG&A expenses.
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday, November 14, 2012, to discuss the 2012 third quarter results. Individuals interested in participating in the live conference call by telephone may dial, in Canada, 514-807-9895 or 647-427-7450, outside Canada, 888-231-8191. They may also listen through the Internet at www.aezsinc.com in the "newsroom" section. A replay will be available on the Company's website for 30 days following the live event.
For reference, the Management's Discussion and Analysis for the third quarter 2012 with the associated Unaudited Interim Consolidated Financial Statements can be found at www.aezsinc.com in the "Investors" section.
About Aeterna Zentaris Inc.
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that 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 risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, 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 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, unless required to do so by a governmental authority or by applicable law.
Ginette Beaudet Valli res
Investor Relations Coordinator
(418) 652-8525 ext. 265
Director of Communications
(418) 652-8525 ext. 406
Attachment: Financial summary
Interim Consolidated Statements of Comprehensive (Loss) Income Information
| Three months ended September 30, | Nine months ended September 30, | ||||||||||
| (in thousands, except for share and per share data) | 2012 | 2011 | 2012 | 2011 | |||||||
| $ | $ | $ | $ | ||||||||
| Revenues | |||||||||||
| Sales and royalties | 6,826 | 8,783 | 22,373 | 21,989 | |||||||
| License fees and other | 313 | 731 | 1,747 | 1,437 | |||||||
| 7,139 | 9,514 | 24,120 | 23,426 | ||||||||
| Operating expenses | |||||||||||
| Cost of sales | 5,556 | 7,926 | 19,331 | 19,446 | |||||||
| Research and development costs, net of refundable tax credits and grants | 4,342 | 5,663 | 15,081 | 16,724 | |||||||
| Selling, general and administrative expenses | 2,921 | 4,169 | 9,776 | 10,762 | |||||||
| 12,819 | 17,758 | 44,188 | 46,932 | ||||||||
| Loss from operations | (5,680 | ) | (8,244 | ) | (20,068 | ) | (23,506 | ) | |||
| Finance income | 35 | 9,324 | 6,610 | 4,805 | |||||||
| Finance costs | (909 | ) | (2 | ) | (7 | ) | (6 | ) | |||
| Net finance (costs) income | (874 | ) | 9,322 | 6,603 | 4,799 | ||||||
| (Loss) income before income taxes | (6,554 | ) | 1,078 | (13,465 | ) | (18,707 | ) | ||||
| Income tax expense | - | - | - | (841 | ) | ||||||
| Net (loss) income | (6,554 | ) | 1,078 | (13,465 | ) | (19,548 | ) | ||||
| Other comprehensive (loss) income: | |||||||||||
| Foreign currency translation adjustments | (97 | ) | 907 | (300 | ) | (958 | ) | ||||
| Comprehensive (loss) income | (6,651 | ) | 1,985 | (13,765 | ) | (20,506 | ) | ||||
| Net (loss) income per share | |||||||||||
| Basic | (0.35 | ) | 0.07 | (0.74 | ) | (1.28 | ) | ||||
| Diluted | (0.35 | ) | 0.06 | (0.74 | ) | (1.28 | ) | ||||
| Weighted average number of shares outstanding | |||||||||||
| Basic | 18,703,023 | 16,214,779 | 18,295,555 | 15,268,138 | |||||||
| Diluted | 18,703,023 | 16,810,666 | 18,295,555 | 15,268,138 |
Interim Consolidated Statement of Financial Position Information
| As at September 30, | As at December 31, | ||||
| (in thousands) | 2012 | 2011 | |||
| $ | $ | ||||
| Cash and cash equivalents | 33,202 | 46,881 | |||
| Trade and other receivables and other current assets | 10,596 | 13,258 | |||
| Restricted cash | 806 | 806 | |||
| Property, plant and equipment | 2,146 | 2,512 | |||
| Other non-current assets | 11,518 | 11,912 | |||
| Total assets | 58,268 | 75,369 | |||
| Payables and other current liabilities | 14,328 | 17,784 | |||
| Long-term payable (current and non-current portions) | 31 | 88 | |||
| Warrant liability (current and non-current portions) | 2,710 | 9,204 | |||
| Non-financial non-current liabilities* | 48,719 | 52,839 | |||
| Total liabilities | 65,788 | 79,915 | |||
| Shareholders' deficiency | (7,520 | ) | (4,546 | ) | |
| Total liabilities and shareholders' deficiency | 58,268 | 75,369 |
_________________________
* Comprised mainly of non-current portion of deferred revenues, employee future benefits and provision.