2014

Aeterna Zentaris Reports Fourth Quarter and Full-Year 2013 Financial and Operating Results

All amounts are in US dollars

QUEBEC CITY, March 20, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology, today reported financial and operating results as at and for the fourth quarter and the year ended December 31, 2013.

Revenues for the year ended December 31, 2013 were $6.2 million compared to $2.1 million for the same period in 2012. This increase is attributable to the accelerated recognition of deferred revenues.

Research and development ("R&D") costs, net of refundable tax credits and grants, for the three-month period ended December 31, 2013 were fairly stable at $5.3 million, compared to $5.5 million for the same period in 2012. R&D costs, net of refundable tax credits and grants, for the year ended December 31, 2013 were $21.3 million, compared to $20.6 million for the same period in 2012.

Net loss for the three-month period ended December 31, 2013 was $8.2 million, or $0.22 per basic and diluted share, compared to $6.9 million, or $0.29 per basic and diluted share, for the same period in 2012. Net income for the year ended December 31, 2013 was $6.8 million, or $0.24 per basic and diluted share, compared to a net loss of $20.4 million, or $1.03 per basic and diluted share, for the same period in 2012. The comparative quarter-over-quarter increase in net loss is mainly due to increased finance costs (primarily related to the change in fair value of warrant liability), partially offset by higher net income from discontinued operations (related to Cetrotide® manufacturing activities and the recognition of related deferred revenues) and lower operating expenses. The comparative year-over-year decrease in net loss is mainly due to higher net income from discontinued operations and higher revenues, partially compensated by higher operating costs and lower finance income.

Cash and cash equivalents totalled $43.2 million as at December 31, 2013, compared to $39.5 million as at December 31, 2012. In January 2014, subsequent to year-end, the Company completed a public offering of 11.0 million units, generating net proceeds of approximately $12.2 million.

Juergen Ernst, Chairman of the Board, commented, "2013 and the first few months of 2014 have been an important period of transition for the Company, as we appointed a new President and Chief Executive Officer and made other significant organizational changes, resulting in a strong team dedicated to the success of this Company."

David Dodd, Aeterna Zentaris President and CEO, commented, "Over the last twelve months, we made great strides in the transition toward becoming an operating biopharmaceutical company, filing the NDA for MACRILEN™ for the evaluation of AGHD and initiating patient recruitment for the pivotal ZoptEC Phase 3 trial in endometrial cancer with zoptarelin doxorubicin. We also significantly improved our financial position in order to secure the necessary funds needed to pursue these two major programs. Over the course of this year, our primary focus will be on finalizing our pre-launch activities for MACRILEN™, and completing initiation of all clinical sites for our ZoptEC Phase 3 trial, while we continue to aggressively pursue opportunities to in-license, acquire and/or promote existing commercial products in order to more quickly transform Aeterna Zentaris into a successful commercial organization. All of us within the Company are highly focused on achieving such a transition."

Pipeline Highlights

MACRILEN (macimorelin)

  • New Drug Application ("NDA") accepted for filing by the U.S. Food and Drug Administration ("FDA") with a Prescription Drug User Fee Act date of November 5, 2014. Currently under review, the NDA seeks approval for the commercialization of MACRILEN™ as the first available oral product indicated for the evaluation of Adult Growth Hormone Deficiency ("AGHD").

Zoptarelin Doxorubicin

  • Agreement reached with the FDA on a Special Protocol Assessment for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with locally advanced, recurrent or metastatic endometrial cancer. The proposed trial protocol design, clinical end-points and planned analysis will therefore be acceptable to support regulatory submission.
  • Signing of a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. ("Ergomed") as the contract clinical development organization for the current Phase 3 ZoptEC trial. Ergomed has agreed to assume 30% (up to $10 million) of the clinical and regulatory costs for this trial. In turn, Ergomed will receive single digit percentage of future net income from the product in the endometrial cancer indication, up to a pre-specified amount.
  • Initiation of patient recruitment for the Phase 3 ZoptEC trial. There are currently over 90 sites actively recruiting patients across 16 countries.


CONFERENCE CALL

Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Friday, March 21, 2014, to discuss the 2013 fourth quarter and full year 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 of Financial Condition and Results of Operations for the fiscal year 2013, as well as the Company's consolidated financial statements, can be found at www.aezsinc.com in the "Investors" section.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology. The Company's pipeline encompasses compounds at various stages of development. For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the US 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 efficiently commercialize one or more of its products or product candidates, 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.

Attachment: Financial summary

Consolidated Statements of Comprehensive Income (Loss)

    Three-month periods
ended December 31,
  Years ended December 31,
(in thousands, except share and per share data)   2013   2012   2013   2012   2011
    $   $   $   $   $
Revenues                    
Sales       96   834   250
License fees and other     281   6,079   1,219   4,455
      281   6,175   2,053   4,705
Operating expenses                    
Cost of sales       51   591   212
Research and development costs, net of refundable tax credits and grants   5,345   5,523   21,284   20,592   24,245
Selling, general and administrative expenses   2,627   2,877   12,316   10,606   11,955
    7,972   8,400   33,651   31,789   36,412
Loss from operations   (7,972)   (8,119)   (27,476)   (29,736)   (31,707)
Finance income   65   689   1,748   6,974   6,239
Finance costs   (2,689)   (700)   (1,512)   (382)   (8)
Net finance income   (2,624)   (11)   236   6,592   6,231
Loss before income taxes   (10,596)   (8,130)   (27,240)   (23,144)   (25,476)
Income tax expense           (1,104)
Net loss from continuing operations   (10,596)   (8,130)   (27,240)   (23,144)   (26,580)
Net income (loss) from discontinued operations   2,353   1,183   34,055   2,732   (487)
Net income (loss)   (8,243)   (6,947)   6,815   (20,412)   (27,067)
Other comprehensive income (loss):                    
Items that may be reclassified subsequently to profit or loss:                    
  Foreign currency translation adjustments   424   (204)   1,073   (504)   (789)
Items that will not be reclassified to profit or loss:                    
  Actuarial gain (loss) on defined benefit plans   2,346   (3,705)   2,346   (3,705)   (1,335)
Comprehensive income (loss)   (5,473)   (10,856)   10,234   (24,621)   (29,191)
Net loss per share (basic and diluted) from continuing operations   (0.28)   (0.34)   (0.92)   (1.17)   (1.69)
Net income (loss) (basic and diluted) from discontinued operations   0.06   0.05   1.16   0.14   (0.03)
Net income (loss) (basic and diluted) per share   (0.22)   (0.29)   0.24   (1.03)   (1.72)
Weighted average number of shares outstanding:                    
Basic   37,274,129   24,181,462   29,476,455   19,775,073   15,751,331
Diluted   37,274,129   24,181,462   29,476,455   19,806,687   15,751,331



Consolidated Statement of Financial Position Information

    As of December 31,
(in thousands)   2013   2012
    $   $
Cash and cash equivalents   43,202   39,521
Trade and other receivables and other current assets   2,453   13,780
Restricted cash   865   826
Property, plant and equipment   1,351   2,147
Other non-current assets   11,325   11,391
Total assets   59,196   67,665
Payables and other current liabilities   7,242   10,470
Current portion of deferred revenues     5,235
Warrant liability (current and non-current portions)   18,010   6,176
Non-financial non-current liabilities*   16,880   52,479
Total liabilities   42,132   74,360
Shareholders' equity (deficiency)   17,064   (6,695)
Total liabilities and shareholders' equity (deficiency)   59,196   67,665

_________________________
* Comprised mainly of non-current portion of deferred revenues, employee future benefits and provisions.

 

 

SOURCE Aeterna Zentaris Inc.




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