Full Press Release Details
terna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Qu bec (Qu bec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
Zentaris Reports Second Quarter 2012 Financial and Operating Results
All amounts are in U.S. dollars
Quebec City, Canada, August 14, 2012 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company ), today reported
financial and operating results as at and for the second quarter ended June 30, 2012.
Perifosine (Oral Akt Inhibitor)
AEZS-130 (Oral Ghrelin Agonist)
AEZS-108 (LHRH agonist linked to doxorubicin)
AEZS-136 (Oral PI3K/Akt Inhibitor)
Corporate Developments
Share Consolidation (Reverse Stock Split)
At-The-Market Issuance Program (ATM Program)
Appointment to Board of Directors
Cash and cash equivalents totalled $39.8 million as at June 30, 2012, compared
to $46.9 million as at December 31, 2011.
Juergen Engel, PhD, Aeterna Zentaris President and Chief Executive Officer, commented,
Unfortunately, the last quarter was marked by unexpected disappointing results for the perifosine Phase 3 trial in colorectal cancer. Nevertheless, we pushed forward with a strategic plan aimed at refocusing the Company s activities and
implementing cost-cutting measures in order to control our burn-rate.
As for perifosine, we decided to continue the Phase 3 trial in multiple
myeloma as we believe this compound still has the potential to become a novel oral anticancer treatment. Meanwhile, our partner, Yakult, initiated a Phase 1 trial in the same indication in Japan, showing their belief in perifosine s potential.
Our NDA filing proceedings for AEZS-130 as an oral diagnostic test for AGHD continued to make progress with our request to the FDA for Fast Track designation in the hope of accelerating the review process; and just last week, we announced that
AEZS-130 had been granted a patent for the U.S. in this same indication, which will expire in 2027. Still with AEZS-130, the Michael E. DeBakey VA Medical Center initiated a Phase 2 trial with this compound as a treatment for cancer cachexia.
Regarding AEZS-108, we expect to file a SPA in September for our upcoming Phase 3 trial in endometrial cancer.
At the human resources level,
we implemented an attrition policy whereby approximately 16% of the workforce at our facility in Germany were terminated or will terminate over the next year; we gained access to governmental programs which refund salaries for another approximately
6% of our German workforce; and put some of our earlier-stage drug development programs on hold to focus on our late-stage programs.
believe that the strategic plan that we have put in place will enable us to overcome our recent set back as we remain committed to moving our late-stage drugs to market for the benefit of both patients and shareholders.
Dennis Turpin, CPA, CA, Senior Vice President and Chief Financial Officer at Aeterna Zentaris stated, As of June 30, 2012, we had a cash
position of $39.8 million which allows us to be well poised to continue to move our key product candidates through the pipeline.
CONSOLIDATED RESULTS AS AT AND FOR THE SECOND QUARTER ENDED JUNE 30, 2012
Revenues were $7.5 million for the quarter ended June 30, 2012, compared to $6.5 million for the same quarter in
2011. This increase is largely attributable to comparative higher deliveries of Cetrotide to certain customers
and to higher research and development services provided, partly offset by the relative weakening of the euro against the US dollar.
R&D costs, net of refundable tax credits and grants were relatively stable at $5.2 million for the quarter ended June 30, 2012, compared
to $5.6 million for the same quarter in 2011.
Finance income was $12.1 million for the quarter ended June 30, 2012,
compared to finance costs of $2.6 million for the same quarter in 2011. The significant increase in net finance income is mainly due to the change in fair value of our warrant liability, as well as to 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. dollars.
amounted to $4.5 million, or $0.04 per basic and diluted share, for the quarter ended June 30, 2012, compared to a net loss of $10.6 million, or $0.12 per basic and diluted share, for the same quarter in 2011. This significant decrease in
net loss is mainly attributable to higher net finance income.
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday, August 15,
2012, to discuss the 2012 second 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 ( MD&A ) for the second quarter 2012 with the associated Unaudited Interim Consolidated Financial Statements can be found at
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
Director of Communications
(418) 652-8525 ext. 406
Interim Consolidated Statements of Comprehensive Income (Loss) Information
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| (in thousands, except for share and per share data) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | ||||||||||||||||
| Sales and royalties | 7,239 | 6,114 | 15,547 | 13,206 | ||||||||||||
| License fees and other | 232 | 409 | 1,434 | 706 | ||||||||||||
| 7,471 | 6,523 | 16,981 | 13,912 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of sales | 6,262 | 5,497 | 13,775 | 11,520 | ||||||||||||
| Research and development costs, net of tax credits and grants | 5,167 | 5,563 | 10,739 | 11,061 | ||||||||||||
| Selling, general and administrative expenses | 3,642 | 3,434 | 6,855 | 6,593 | ||||||||||||
| 15,071 | 14,494 | 31,369 | 29,174 | |||||||||||||
| Loss from operations | (7,600 | ) | (7,971 | ) | (14,388 | ) | (15,262 | ) | ||||||||
| Finance income | 12,145 | 265 | 7,483 | 1,089 | ||||||||||||
| Finance costs | (5 | ) | (2,863 | ) | (6 | ) | (5,612 | ) | ||||||||
| Net finance income (costs) | 12,140 | (2,598 | ) | 7,477 | (4,523 | ) | ||||||||||
| Income (loss) before income taxes | 4,540 | (10,569 | ) | (6,911 | ) | (19,785 | ) | |||||||||
| Income tax expense | (841 | ) | ||||||||||||||
| Net income (loss) | 4,540 | (10,569 | ) | (6,911 | ) | (20,626 | ) | |||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation adjustments | 52 | (526 | ) | (203 | ) | (1,865 | ) | |||||||||
| Comprehensive income (loss) | 4,592 | (11,095 | ) | (7,114 | ) | (22,491 | ) | |||||||||
| Net income (loss) per share | ||||||||||||||||
| Basic and diluted | 0.04 | (0.12 | ) | (0.06 | ) | (0.23 | ) | |||||||||
| Weighted average number of shares outstanding | ||||||||||||||||
| Basic | 111,058,138 | 90,690,019 | 108,537,490 | 88,721,832 | ||||||||||||
| Diluted | 111,059,815 | 90,690,019 | 108,537,490 | 88,721,832 |
Interim Consolidated Statement of Financial Position Information
| (in thousands) | As at June 30, 2012 | As at December 31, 2011 | ||||||
| $ | $ | |||||||
| Cash and cash equivalents | 39,759 | 46,881 | ||||||
| Trade and other receivables and other current assets | 11,073 | 13,258 | ||||||
| Restricted cash | 792 | 806 | ||||||
| Property, plant and equipment | 2,223 | 2,512 | ||||||
| Other non-current assets | 11,521 | 11,912 | ||||||
| Total assets | 65,368 | 75,369 | ||||||
| Payables and other current liabilities | 15,778 | 17,784 | ||||||
| Long-term payable (current and non-current portions) | 59 | 88 | ||||||
| Warrant liability (current and non-current portions) | 2,086 | 9,204 | ||||||
| Non-financial non-current liabilities* | 49,267 | 52,839 | ||||||
| Total liabilities | 67,190 | 79,915 | ||||||
| Shareholders deficiency | (1,822 | ) | (4,546 | ) | ||||
| Total liabilities and shareholders deficiency | 65,368 | 75,369 |