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 Second Quarter 2013 Financial and Operating Results
All amounts are in U.S. dollars (unless otherwise noted)
Quebec City, Canada, August 8, 2013 - 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 second quarter ended June 30, 2013.
Appointment of New President and CEO
Zoptarelin Doxorubicin (AEZS-108)
Macimorelin Acetate (AEZS-130)
Cetrotide Manufacturing Rights
"At-the-Market" Issuance Program
Class Action Lawsuit
Registered Direct Offering
Cash and cash equivalents totalled $25.3 million as at June 30, 2013, compared to $39.5 million as at December 31, 2012.
David Dodd, Aeterna Zentaris President and Chief Executive Officer, commented, "Over the past few months, we have successfully met four out of the five critical objectives that were previously outlined: (1) transfer of Cetrotide manufacturing rights to Merck Serono; (2) initiation of patient recruitment and dosing of the first patient, as well the signed agreement with Ergomed as CRO for our very important Phase 3 ZoptEC trial in endometrial cancer; (3) successful raising of important financing in support of our ongoing operations and development programs; and (4) significant efforts related to obtaining on-the-market products that will accelerate our strategy aimed at transitioning to a revenue and cash generating company. As for the fifth objective, we are finalizing our preparation for submitting the NDA for macimorelin acetate (AEZS 130) as the only approved oral diagnostic test for adult hormone growth deficiency. Having now completed my initial three months with the Company, I am even more confident in our ability to successfully develop Aeterna Zentaris to a position of commercial and competitive presence within our target markets."
Dennis Turpin, CPA, CA, Senior Vice President and Chief Financial Officer at Aeterna Zentaris stated, "As of June 30, 2013, including net proceeds from the recent Offering, we had a pro forma cash and cash equivalents position of $32.3 million which enables us to continue to move our key product candidates through the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE SECOND QUARTER ENDED JUNE 30, 2013
Revenues were $30.1 million for the three-month period ended June 30, 2013, compared to $7.5 million for the same period in 2012. The increase is largely attributable to the acceleration of the recognition of previously deferred revenues received in connection with the 2008 sale of the Cetrotide royalty stream to HealthCare Royalty Partners L.P.
R&D costs, net of refundable tax credits and grants were $5.3 million for the three-month period ended June 30, 2013, compared to $5.2 million for the same period in 2012.
Selling, general and administrative ("SG&A") expenses were $5.8 million for the three-month period ended June 30, 2013, compared to $3.6 million for the same period in 2012. The increase is mainly related to the termination benefits granted to the Company's former CEO and to the related non-cash share-based compensation costs.
Net income for the three-month period ended June 30, 2013 was $9.3 million or $0.37 per basic and diluted share, compared to $4.5 million or $0.25 per basic and diluted share for the same period in 2012. The significant increase is due largely to the significant increase in royalties revenues (non-cash), partly offset by lower net finance income (non-cash), as well as by higher SG&A.
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Friday, August 9, 2013, to discuss the 2013 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 2013 with the associated Unaudited Interim Condensed Consolidated Financial Statements can be found at www.aezsinc.com in the Investors section.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology. The Company's pipeline encompasses compounds from drug discovery to regulatory approval. 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 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 Income Information
| Three months ended June 30, | Six months ended June 30, | |||||||||||
| (in thousands, except share and per share data) | 2013 | 2012 | 2013 | 2012 | ||||||||
| $ | $ | $ | $ | |||||||||
| Revenues | ||||||||||||
| Sales and royalties | 29,751 | 7,239 | 39,960 | 15,547 | ||||||||
| License fees and other | 336 | 232 | 6,726 | 1,434 | ||||||||
| 30,087 | 7,471 | 46,686 | 16,981 | |||||||||
| Operating expenses | ||||||||||||
| Cost of sales | 9,438 | 6,262 | 18,122 | 13,775 | ||||||||
| Research and development costs, net of refundable tax credits and grants | 5,316 | 5,167 | 9,717 | 10,739 | ||||||||
| Selling, general and administrative expenses | 5,848 | 3,642 | 9,642 | 6,855 | ||||||||
| 20,602 | 15,071 | 37,481 | 31,369 | |||||||||
| Income (loss) from operations | 9,485 | (7,600 | ) | 9,205 | (14,388 | ) | ||||||
| Finance income | 379 | 12,140 | 2,183 | 7,477 | ||||||||
| Finance costs | (534 | ) | - | (172 | ) | - | ||||||
| Net finance (costs) income | (155 | ) | 12,140 | 2,011 | 7,477 | |||||||
| Net income (loss) | 9,330 | 4,540 | 11,216 | (6,911 | ) | |||||||
| Other comprehensive income (loss): | ||||||||||||
| Items that may be reclassified subsequently to profit or loss | ||||||||||||
| Foreign currency translation adjustments | (141 | ) | 52 | 99 | (203 | ) | ||||||
| Comprehensive income (loss) | 9,189 | 4,592 | 11,315 | (7,114 | ) | |||||||
| Net income (loss) per share | ||||||||||||
| Basic | 0.37 | 0.25 | 0.44 | (0.38 | ) | |||||||
| Diluted | 0.37 | 0.25 | 0.44 | (0.38 | ) | |||||||
| Weighted average number of shares outstanding | ||||||||||||
| Basic | 25,542,263 | 18,509,690 | 25,436,364 | 18,089,582 | ||||||||
| Diluted | 25,542,263 | 18,509,969 | 25,436,385 | 18,089,582 |
Interim Consolidated Statement of Financial Position Information
| As at June 30, | As at December 31, | |||||
| (in thousands) | 2013 | 2012 | ||||
| $ | $ | |||||
| Cash and cash equivalents | 25,339 | 39,521 | ||||
| Trade and other receivables and other current assets | 14,111 | 13,780 | ||||
| Restricted cash | 816 | 826 | ||||
| Property, plant and equipment | 1,611 | 2,147 | ||||
| Other non-current assets | 11,034 | 11,391 | ||||
| Total assets | 52,911 | 67,665 | ||||
| Payables and accrued liabilities | 11,532 | 10,440 | ||||
| Current portion of deferred revenues | 11,842 | 5,235 | ||||
| Current portion of long-term payable | - | 30 | ||||
| Warrant liability | 4,078 | 6,176 | ||||
| Non-financial non-current liabilities* | 17,669 | 52,479 | ||||
| Total liabilities | 45,121 | 74,360 | ||||
| Shareholders' equity (deficiency) | 7,790 | (6,695 | ) | |||
| Total liabilities and shareholders' equity (deficiency) | 52,911 | 67,665 |
_________________________
* Comprised mainly of non-current portion of deferred revenues, employee future benefits and provision.