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 1st Quarter 2015 Financial and Operating Results
Company to hold annual and special meeting of shareholders on May 8, 2015
All amounts are in US dollars
Quebec City, Canada, May 7, 2015 - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health, today reported financial and operating results for the first quarter ended March 31, 2015.
Research and development ("R&D") costs, were $4.5 million for the three-month period ended March 31, 2015, compared to $5.8 million for the same period in 2014. This decrease is attributable to lower comparative employee compensation and benefits costs, facilities rent and maintenance as well as other costs. A substantial portion of this decrease is due to the realization of cost savings in connection with the Company's global resource optimization program as well as the lower comparative exchange rate of the EUR against the US dollar. This decrease was partly compensated by higher third-party costs, mostly related to the Company's ZoptEC Phase 3 clinical trial in endometrial cancer.
Selling, general and administrative ("SG&A") expenses were $5.1 million for the three-month period ended March 31, 2015, as compared to $2.4 million for the same period in 2014. This increase is attributable to the Company's increased selling activities, associated with the co-promotion efforts related to EstroGel , with $1.1 million of first quarter 2015 expenses being related to higher costs associated with Aeterna Zentaris' contracted sales force and its own sales and marketing staff. Additionally, approximately $0.8 million of the quarter-over-quarter increase is attributable to transaction costs incurred in connection with the completion of the March 2015 Offering. Other increases are attributable in large part to lower comparative foreign exchange gains.
Net loss for the three-month period ended March 31, 2015 was $9.7 million, or $0.13 per basic and diluted share, compared to $4.4 million, or $0.08 per basic and diluted share, for the same period in 2014. This increase in net loss is due largely to higher comparative SG&A expenses and to higher comparative net finance costs, partially offset by lower comparative R&D costs.
Cash and cash equivalents totaled $53.3 million as at March 31, 2015, as compared to $34.9 million as at December 31, 2014.
David Dodd, Aeterna Zentaris Chairman and CEO, commented, "During the quarter and in recent weeks, both of our late-stage drug development programs reached important milestones. As for zoptarelin doxorubicin, we received the DSMB's recommendation to continue our ZoptEC Phase 3 clinical trial in endometrial cancer as planned, following its first interim analysis. Now, with over 90% of patients enrolled, we are well on our way to completing patient recruitment earlier than expected, and look forward to achieve a second interim analysis by year-end. Regarding Macrilen , after recommendations from the FDA and a panel of endocrinology experts, we announced our decision to proceed with a confirmatory Phase 3 efficacy clinical trial for the evaluation of adult growth hormone deficiency that we expect to initiate by year-end. At the commercial level, we've initiated the field selling, in specific US territories, of EstroGel , Ascend Therapeutics' leading non-patch hormone replacement therapy product. Our selling efforts associated with EstroGel are expected to result in successfully exceeding pre-established unit sales baseline thresholds on a total Aeterna Zentaris national basis. Furthermore, we just added another marketed product, EMD Serono's Saizen , for the treatment of growth hormone deficiency, that we expect to shortly start promoting in specific US markets. As part of our strategy to become a
growth-oriented, commercially operating specialty biopharmaceutical organization, we expect to continue to evaluate potential in-licensing and/or acquisition opportunities, as well as additional promotional or co-promotional arrangements related to targeted commercial products, while continuing to develop our key product candidates in our existing pipeline. Finally, we accentuated the implementation our global resources optimization program which has resulted in significant personnel reduction and increased overall flexibility."
Dennis Turpin, Chief Financial Officer of the Company added, "With our cash and cash equivalents position of $53.3 million as at March 31, 2015, and our controlled burn rate, the Company has a solid financial position upon which it can advance its strategic initiatives."
Product Candidate Developments
Zoptarelin Doxorubicin
Macrilen (macimorelin)
Commercial Developments
Corporate Developments
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Friday, May 8, 2015, to discuss the 2015 first 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 first quarter 2015, as well as the Company's consolidated financial statements, can be found at www.aezsinc.com in the "Investors" section.
Annual and Special Shareholders Meeting
The Company will hold an Annual and Special Shareholders Meeting also on Friday, May 8, 2015, starting at 10:30 a.m., Eastern Time, at the offices of Norton Rose Fulbright Canada, 1 Place Ville-Marie, Suite 2500, in Montreal, Canada.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. 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 and clinical trials, 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, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits 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 place undue reliance 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.
Director of Communications
(418) 652-8525 ext. 406
Attachment: Financial summary
Condensed Interim Consolidated Statements of Comprehensive Loss Information
| Three months ended March 31, | ||||||
| (in thousands) | 2015 | 2014 | ||||
| $ | $ | |||||
| Revenues | ||||||
| License fees | 73 | - | ||||
| Operating expenses | ||||||
| Research and development costs | 4,466 | 5,830 | ||||
| Selling, general and administrative expenses | 5,143 | 2,365 | ||||
| 9,609 | 8,195 | |||||
| Loss from operations | (9,536 | ) | (8,195 | ) | ||
| Finance income | 1,374 | 4,919 | ||||
| Finance costs | (1,474 | ) | (1,028 | ) | ||
| Net finance (costs) income | (100 | ) | 3,891 | |||
| Net loss from continuing operations | (9,636 | ) | (4,304 | ) | ||
| Net loss from discontinued operations | (100 | ) | (52 | ) | ||
| Net loss | (9,736 | ) | (4,356 | ) | ||
| Other comprehensive income (loss): | ||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||
| Foreign currency translation adjustments | 1,775 | 23 | ||||
| Items that will not be reclassified to profit or loss: | ||||||
| Actuarial loss on defined benefit plans | (1,301 | ) | (959 | ) | ||
| Comprehensive loss | (9,262 | ) | (5,292 | ) | ||
| Net loss per share (basic and diluted) from continuing operations | (0.13 | ) | (0.08 | ) | ||
| Net loss per share (basic and diluted) from discontinued operations | - | - | ||||
| Net loss (basic and diluted) per share | (0.13 | ) | (0.08 | ) | ||
| Weighted average number of shares outstanding: | ||||||
| Basic | 71,653,626 | 54,921,459 | ||||
| Diluted | 71,653,626 | 54,921,459 |
Condensed Interim Consolidated Statement of Financial Position Information
| As at March 31, | As at December 31, | |||||
| (in thousands) | 2015 | 2014 | ||||
| $ | $ | |||||
| Cash and cash equivalents 1 | 53,259 | 34,931 | ||||
| Trade and other receivables and other current assets | 2,292 | 1,286 | ||||
| Restricted cash equivalents | 674 | 760 | ||||
| Property, plant and equipment | 529 | 797 | ||||
| Other non-current assets | 8,520 | 9,661 | ||||
| Total assets | 65,274 | 47,435 | ||||
| Payables and other current liabilities 2 | 6,078 | 7,304 | ||||
| Current portion of deferred revenues | 239 | 270 | ||||
| Warrant liability | 22,151 | 8,225 | ||||
| Non-financial non-current liabilities 3 | 16,425 | 17,152 | ||||
| Total liabilities | 44,893 | 32,951 | ||||
| Shareholders' equity | 20,381 | 14,484 | ||||
| Total liabilities and shareholders' equity | 65,274 | 47,435 |
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