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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aeterna Zentaris Inc | NASDAQ:AEZS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.14 | 7.18% | 2.09 | 1.92 | 2.17 | 2.15 | 1.95 | 1.95 | 81,047 | 00:47:45 |
All amounts are in US dollars
QUEBEC CITY, March 17, 2015 /CNW Telbec/ - 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 as at and for the fourth quarter and the year ended December 31, 2014.
Research and development ("R&D") costs, net of refundable tax credits and grants, were $6.3 million and $23.7 million for the three-month period and the year ended December 31, 2014, respectively, as compared to $5.3 million and $21.3 million for the same periods in 2013. The increase for the year ended December 31, 2014, as compared to the same period in 2013, is attributable to higher comparative employee compensation and benefits costs, which in turn are mainly due to the recording of R&D restructuring costs of approximately $2.5 million related to R&D staff redundancies resulting from the Company's global resource optimization program (the "Resource Optimization Program"), partly offset by lower comparative salaries, short-term employee benefits and share-based compensation costs.
Selling, general and administrative ("SG&A") expenses were $4.7 million and $13.7 million for the three-month period and the year ended December 31, 2014, respectively, compared to $2.6 million and $12.3 million for the same periods in 2013. For the three-month period ended December 31, 2014, the increase in SG&A expenses, as compared to the same period in 2013, is mainly related to the deployment of the Company's contracted sales force, which is currently detailing EstroGel®, and higher comparative operating foreign exchange losses. For the year ended December 31, 2014, the increase in SG&A expenses, as compared to the same period in 2013, is mainly related to higher comparative operating foreign exchange losses, the ramping up of the Company's pre-commercialization activities, the deployment of its contracted sales force related to its co-promotion activities and to the recording of restructuring costs related to administrative staff redundancies resulting from the Resource Optimization Program.
Net income (loss) for the three-month period and the year ended December 31, 2014 was $4.2 million and $(16.6) million, or $0.06 and $(0.28) per basic and diluted share, respectively, as compared to $(8.2) million and $6.8 million, or $(0.22) and $0.24 per basic and diluted share, for the same periods in 2013. The increase in net income for the three-month period ended December 31, 2014, as compared to the same period in 2013, is due largely to higher comparative net finance income, offset partially by higher comparative operating expenses and by lower net income from discontinued operations. The decrease in net income for the year ended December 31, 2014, as compared to the same period in 2013, is due largely to the higher loss from operations and to lower net income from discontinued operations, partially offset by higher comparative net finance income.
Cash and cash equivalents totaled $34.9 million as at December 31, 2014, as compared to $43.2 million as at December 31, 2013.
David Dodd, Aeterna Zentaris Chairman and CEO, commented, "During 2014, we achieved significant progress in the implementation of our strategy of transitioning into a commercially operating specialty biopharmaceutical company, as we put our commercial structure in place, built a full-time contract sales force of 19 representatives, signed a co-promotion agreement with ASCEND and started selling its product EstroGel® in our specific territories in the US. We are continuing to evaluate potential in-licensing and/or acquisition opportunities, as well as additional co-promotional arrangements related to marketed products, in order to grow our commercial activities. We are also proud of our collaboration agreement for our lead oncology compound, zoptarelin doxorubicin, with Sinopharm A-Think for China, one of the largest markets in the world. With regards to our ZoptEC Phase 3 study in endometrial cancer with zoptarelin doxorubicin, we are very pleased with the progress of patient recruitment as we now have over 400 patients enrolled in the trial out of an expected total of 500, which is in line with our projections. Therefore, we expect that at this rate, a first interim analysis of the trial should be secured in the first half of the current year, and patient recruitment should be completed by year-end. As for Macrilen™, following the FDA's Complete Response Letter, we intend to make a decision in the near term on our different options for this product in the evaluation of AGHD. For 2015, we remain fully focused on becoming a growth-oriented, commercially operating specialty biopharmaceutical organization, while continuing to develop key late-stage product candidates in our existing pipeline, such as our novel targeted anti‑cancer agent, zoptarelin doxorubicin."
Dennis Turpin, Chief Financial Officer of the Company added, "With our cash and cash equivalents position of $34.9 million as at December 31, 2014, our controlled burn rate and the completion of our recent public offering, which resulted in net proceeds of approximately $34.5 million, the Company has a solid financial position upon which it can advance its strategic initiatives."
2014 Highlights
Commercial Developments
Product Candidate Developments
Zoptarelin Doxorubicin
Macrilen™
Corporate Developments
Establishment of Global Commercial Operations and Resource Optimization
Public Offerings
"At-the-Market" Issuance Program
NASDAQ Minimum Bid Price Compliance
CONFERENCE CALL
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday, March 18, 2015, to discuss the 2014 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 2014, 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 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, 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.
Attachment: Financial summary
Consolidated Statements of Comprehensive Income (Loss) Information | ||||||||||||
Three-month periods |
Years ended December 31, | |||||||||||
(in thousands, except share and per share data) |
2014 |
2013 |
2014 |
2013 |
2012 | |||||||
$ |
$ |
$ |
$ |
$ | ||||||||
Revenues |
||||||||||||
Sales |
— |
— |
— |
96 |
834 | |||||||
License fees |
11 |
— |
11 |
6,079 |
1,219 | |||||||
11 |
— |
11 |
6,175 |
2,053 | ||||||||
Operating expenses |
||||||||||||
Cost of sales |
— |
— |
— |
51 |
591 | |||||||
Research and development costs, net of refundable tax credits and grants |
6,282 |
5,345 |
23,716 |
21,284 |
20,592 | |||||||
Selling, general and administrative expenses |
4,676 |
2,627 |
13,690 |
12,316 |
10,606 | |||||||
10,958 |
7,972 |
37,406 |
33,651 |
31,789 | ||||||||
Loss from operations |
(10,947) |
(7,972) |
(37,395) |
(27,476) |
(29,736) | |||||||
Finance income |
15,053 |
65 |
20,319 |
1,748 |
6,974 | |||||||
Finance costs |
— |
(2,689) |
— |
(1,512) |
(382) | |||||||
Net finance income (costs) |
15,053 |
(2,624) |
20,319 |
236 |
6,592 | |||||||
Income (loss) before income taxes |
4,106 |
(10,596) |
(17,076) |
(27,240) |
(23,144) | |||||||
Income tax expense |
(111) |
— |
(111) |
— |
— | |||||||
Net income (loss) from continuing operations |
3,995 |
(10,596) |
(17,187) |
(27,240) |
(23,144) | |||||||
Net income from discontinued operations |
158 |
2,353 |
623 |
34,055 |
2,732 | |||||||
Net income (loss) |
4,153 |
(8,243) |
(16,564) |
6,815 |
(20,412) | |||||||
Other comprehensive income (loss): |
||||||||||||
Items that may be reclassified subsequently to profit or loss: |
||||||||||||
Foreign currency translation adjustments |
(677) |
424 |
(1,158) |
1,073 |
(504) | |||||||
Items that will not be reclassified to profit or loss: |
||||||||||||
Actuarial gain (loss) on defined benefit plans |
1,336 |
2,346 |
(1,833) |
2,346 |
(3,705) | |||||||
Comprehensive income (loss) |
4,812 |
(5,473) |
(19,555) |
10,234 |
(24,621) | |||||||
Net income (loss) per share (basic and diluted) from continuing operations |
0.06 |
(0.28) |
(0.29) |
(0.92) |
(1.17) | |||||||
Net income (basic and diluted) from discontinued operations |
— |
0.06 |
0.01 |
1.16 |
0.14 | |||||||
Net income (loss) (basic and diluted) per share |
0.06 |
(0.22) |
(0.28) |
0.24 |
(1.03) | |||||||
Weighted average number of shares outstanding: |
||||||||||||
Basic |
65,383,290 |
37,274,129 |
59,024,730 |
29,476,455 |
19,775,073 | |||||||
Diluted |
65,383,290 |
37,274,129 |
59,024,730 |
29,476,455 |
19,806,687 |
Consolidated Statement of Financial Position Information | ||||||
As at December 31, | ||||||
(in thousands) |
2014 |
2013 | ||||
$ |
$ | |||||
Cash and cash equivalents1 |
34,931 |
43,202 | ||||
Trade and other receivables and other current assets |
1,286 |
2,453 | ||||
Restricted cash equivalents |
760 |
865 | ||||
Property, plant and equipment |
797 |
1,351 | ||||
Other non-current assets |
9,661 |
11,325 | ||||
Total assets |
47,435 |
59,196 | ||||
Payables and other current liabilities2 |
7,304 |
7,242 | ||||
Current portion of deferred revenues |
270 |
— | ||||
Warrant liability |
8,225 |
18,010 | ||||
Non-financial non-current liabilities3 |
17,152 |
16,880 | ||||
Total liabilities |
32,951 |
42,132 | ||||
Shareholders' equity |
14,484 |
17,064 | ||||
Total liabilities and shareholders' equity |
47,435 |
59,196 |
_________________________ | |
1 |
Of which approximately $3.6 million was denominated in EUR as at December 31, 2014. |
2 |
Of which approximately $1.5 million is related to a provision for restructuring costs. |
3 |
Comprised mainly of employee future benefits, provisions for onerous contracts and non-current portion of deferred revenues. |
SOURCE Aeterna Zentaris Inc.
Copyright 2015 Canada NewsWire
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