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 2014 Financial and Operating Results
All amounts are in US dollars
Quebec City, Canada, November 4, 2014 - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, today reported financial and operating results as at and for the third quarter ended September 30, 2014.
Research and development ("R&D") costs, net of refundable tax credits and grants, for the three-month period ended September 30, 2014, were $6.1 million, as compared to $6.2 million for the same period in 2013. R&D costs for the quarter ended September 30, 2014 include a provision for restructuring costs, amounting to approximately $1.6 million, for severance payments and other directly related costs associated with our R&D restructuring activities.
Selling, general and administrative ("SG&A") expenses were $3.7 million for the three-month period ended September 30, 2014, compared to $2.4 million for the same period in 2013. The increase in SG&A expenses is mainly related to higher comparative foreign exchange losses, the ramping up of our pre-commercialization activities associated with Macrilen and the recording of restructuring costs related to planned administrative staff redundancies.
Net loss for the three-month period ended September 30, 2014 was $11.3 million, or $0.20 per basic and diluted share, compared to a net income of $3.8 million, or $0.13 per basic and diluted share, for the same period in 2013. The decrease in net income is due largely to lower net income from discontinued operations related to our former Cetrotide Business, higher comparative operating expenses and higher comparative net finance costs.
Cash and cash equivalents totaled $42.0 million as at September 30, 2014, as compared to $43.2 million as at December 31, 2013.
David Dodd, Chairman and CEO of Aeterna Zentaris, commented, "During the quarter, we intensified our commercial development efforts which resulted in the signing of a co-promotion agreement with Ascend Therapeutics for the selling of their already marketed leading non patch transdermal hormone replacement therapy product, EstroGel , in specific US territories. This agreement will jump start our commercial activities as we expect to start the field selling of EstroGel in a few weeks through our sales force of about 20 representatives. We intend to pursue additional commercial opportunities, including other co-promotional arrangements, in-licensing transactions or product acquisitions throughout the remainder of the year. For Macrilen , we continued to focus on our pre-commercialization activities while building our core business team. We are awaiting the FDA's imminent decision on its review of our NDA for Macrilen , which has a PDUFA date of November 5, 2014. If approved, Macrilen would be the only FDA indicated oral drug for use in evaluating Adult Growth Hormone Deficiency. As for our ongoing ZoptEC Phase 3 trial in endometrial cancer, we are very pleased to report that we have completed clinical site initiation with 120 sites currently in operation, and to date, over 300 of the expected 500 patients have been entered into the trial. We are on track to reach the number of patients required to secure our first interim analysis in the first half of 2015. Finally, we started implementing our global resources optimization program which is expected to lead to the termination of 31 employees over a 12-month period. This program should enable us to streamline R&D activities, increase commercial operations and flexibility, ultimately reduce our operating cash burn and more appropriately align our financial resources with our strategic goal of transitioning into a commercially operating specialty biopharmaceutical company."
Dennis Turpin, CFO of Aeterna Zentaris commented, "With our cash position, combined with the streamlining of our R&D activities, we are able to continue to advance our strategic programs in pursuit of our near-term milestones."
Macrilen (macimorelin)
Zoptarelin Doxorubicin
Commercial Developments
Resource Optimization and Executive Appointment
Corporate Developments
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday, November 5, 2014, to discuss the 2014 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 of Financial Condition and Results of Operations for the third quarter of 2014, as well as the Company's condensed interim 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 and commercializing novel treatments in oncology and endocrinology. For more information, visit www.aezsinc.com
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor 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 US 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.
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Attachment: Financial summary
Condensed Interim Consolidated Statements of Comprehensive (Loss) Income Information
| Three months ended September 30, | Nine months ended September 30, | |||||||||||
| (in thousands, except share and per share data) | 2014 | 2013 | 2014 | 2013 | ||||||||
| $ | $ | $ | $ | |||||||||
| Revenues | ||||||||||||
| Sales and royalties | - | - | - | 96 | ||||||||
| License fees and other | - | 17 | - | 6,079 | ||||||||
| - | 17 | - | 6,175 | |||||||||
| Operating expenses | ||||||||||||
| Cost of sales | - | - | - | 51 | ||||||||
| Research and development costs, net of refundable tax credits and grants | 6,142 | 6,230 | 17,434 | 15,939 | ||||||||
| Selling, general and administrative expenses | 3,701 | 2,435 | 9,014 | 9,689 | ||||||||
| 9,843 | 8,665 | 26,448 | 25,679 | |||||||||
| Loss from operations | (9,843 | ) | (8,648 | ) | (26,448 | ) | (19,504 | ) | ||||
| Finance income | 1,091 | 1,384 | 5,266 | 3,567 | ||||||||
| Finance costs | (2,877 | ) | (535 | ) | - | (707 | ) | |||||
| Net finance (costs) income | (1,786 | ) | 849 | 5,266 | 2,860 | |||||||
| Net loss from continuing operations | (11,629 | ) | (7,799 | ) | (21,182 | ) | (16,644 | ) | ||||
| Net income from discontinued operations | 292 | 11,641 | 465 | 31,702 | ||||||||
| Net (loss) income | (11,337 | ) | 3,842 | (20,717 | ) | 15,058 | ||||||
| Other comprehensive (loss) income: | ||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||
| Foreign currency translation adjustments | (387 | ) | 550 | (481 | ) | 649 | ||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||
| Actuarial loss on defined benefit plans | (1,099 | ) | - | (3,169 | ) | - | ||||||
| Comprehensive (loss) income | (12,823 | ) | 4,392 | (24,367 | ) | 15,707 | ||||||
| Net loss per share (basic and diluted) from continuing operations | (0.20 | ) | (0.26 | ) | (0.37 | ) | (0.62 | ) | ||||
| Net income per share (basic and diluted) from discontinued operations | - | 0.39 | 0.01 | 1.18 | ||||||||
| Net (loss) income per share (basic and diluted) | (0.20 | ) | 0.13 | (0.36 | ) | 0.56 | ||||||
| Weighted average number of shares outstanding: | ||||||||||||
| Basic and diluted | 59,163,710 | 29,627,222 | 56,881,919 | 26,848,668 |
Condensed Interim Consolidated Statement of Financial Position Information
| As at September 30, | As at December 31, | |||||
| (in thousands) | 2014 | 2013 | ||||
| $ | $ | |||||
| Cash and cash equivalents | 41,952 | 43,202 | ||||
| Trade and other receivables and other current assets | 2,124 | 2,453 | ||||
| Restricted cash equivalents | 794 | 865 | ||||
| Property, plant and equipment | 705 | 1,351 | ||||
| Other non-current assets | 9,942 | 11,325 | ||||
| Total assets | 55,517 | 59,196 | ||||
| Payables and other current liabilities 1 | 7,364 | 7,242 | ||||
| Warrant liability | 22,304 | 18,010 | ||||
| Non-financial non-current liabilities 2 | 18,445 | 16,880 | ||||
| Total liabilities | 48,113 | 42,132 | ||||
| Shareholders' equity | 7,404 | 17,064 | ||||
| Total liabilities and shareholders' equity | 55,517 | 59,196 |
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