All amounts are in U.S. dollars (unless otherwise noted)
QUEBEC CITY, Nov. 5, 2013 /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 three months ended September 30, 2013.
Zoptarelin Doxorubicin (AEZS-108)
- Initiation of patient dosing in the Phase 3 "ZoptEC" (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.
Macimorelin Acetate (AEZS-130)
- Subsequent to quarter-end, submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for macimorelin acetate for the evaluation of Adult Growth Hormone Deficiency ("AGHD").
- Subsequent to quarter-end, successful completion of the transfer of Cetrotide® manufacturing rights in all territories to Merck Serono, in exchange for an upfront payment of €2.5 million (approximately $3.3 million).
"At-the-Market" Issuance Program
- Between May 21, 2013 and November 5, 2013, the Company sold a total of approximately 1.5 million common shares under its At-the-Market ("ATM") sales program at an average price of $1.80 per share, for aggregate gross proceeds of approximately $2.7 million. This includes approximately 0.8 million common shares at an average price of $1.50 per share, for aggregate gross proceeds of approximately $1.2 million, between July 1 and November 5, 2013. This ATM allows the Company to sell up to a maximum of 2.5 million common shares through ATM issuances on the NASDAQ Capital Market® for aggregate gross proceeds not to exceed $4.6 million.
Registered Direct Offering
- Completion of a registered direct offering of 5.2 million units at a purchase price of $1.50 per unit, generating net proceeds of approximately $7 million.
Appointment to Management Team
- Subsequent to quarter-end, appointment of Jude Dinges as Senior Vice President, Chief Commercial Officer.
Cash and cash equivalents totalled $24.8 million as at September 30, 2013, compared to $39.5 million as at December 31, 2012.
David Dodd, Aeterna Zentaris President and Chief Executive Officer, commented, "We have spent the last few months conducting an in-depth review of all our R&D and corporate activities leading to our new strategic vision for the Company: transform Aeterna Zentaris into a biopharmaceutical operating company through the commercialization of our pipeline, as well as by pursuing in‑licensing and acquisition opportunities. To that effect, we have submitted a NDA for macimorelin acetate as potentially the first approved oral product for the evaluation of AGHD, we have appointed a Chief Commercial Officer responsible for all macimorelin acetate branding, marketing and sales activities, as well as for overseeing future commercial opportunities. We have also prioritized projects such as the ZoptEC Phase 3 trial in endometrial cancer and the Phase 2 investigator-driven trials in prostate and breast cancer with zoptarelin doxorubicin, while deciding to stop the Phase 2 trial in bladder cancer with this product, and transferring the manufacturing rights related to Cetrotide® to Merck Serono for $3.3 million. Also, we continue to review opportunities to better align our resources with our business priorities to ensure that our investments reflect our focus on achieving success as a biopharmaceutical operating company. In that regard, we have taken concrete actions, and in the months ahead, we will continue focusing all our efforts towards achieving our new strategic vision for the Company."
Dennis Turpin, CPA, CA, Senior Vice President and Chief Financial Officer at Aeterna Zentaris stated, "As of September 30, 2013, we had a cash and cash equivalents position of $24.8 million which enables us to continue to move our key product candidates through the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2013
Revenues were $21.1 million for the three-month period ended September 30, 2013, compared to $7.1 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 $6.2 million for the three-month period ended September 30, 2013, compared to $4.3 million for the same period in 2012. The increase is attributable to higher third-party costs associated with the development of the Company's products.
Selling, general and administrative ("SG&A") expenses were $3.0 million for the three-month period ended September 30, 2013, compared to $2.9 million for the same period in 2012.
Net income (loss) for the three-month period ended September 30, 2013 was $3.8 million or $0.13 per basic and diluted share, compared to $(6.6) million or $(0.35) per basic and diluted share for the same period in 2012. The significant increase is due largely to the significant increases in royalties revenues (non-cash), as mentioned above, and in net financed income (non-cash), partly offset by higher net R&D costs.
Management will be hosting a conference call for the investment community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday, November 6, 2013, to discuss the 2013 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 ("MD&A") for the third 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.
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.
Attachment: Financial summary
Interim Consolidated Statements of Comprehensive Income (Loss) Information
|Three months ended September 30,||Nine months ended September 30,|
|(in thousands, except share and per share data)||2013||2012||2013||2012|
|Sales and royalties||20,834||6,826||60,794||22,373|
|License fees and other||225||313||6,951||1,747|
|Cost of sales||8,860||5,556||26,982||19,331|
|Research and development costs, net of refundable tax credits and grants||6,230||4,342||15,947||15,081|
|Selling, general and administrative expenses||2,976||2,921||12,618||9,776|
|Income (loss) from operations||2,993||(5,680)||12,198||(20,068)|
|Net finance income (costs)||849||(874)||2,860||6,603|
|Net income (loss)||3,842||(6,554)||15,058||(13,465)|
|Other comprehensive income (loss):|
|Items that may be reclassified subsequently to profit or loss|
|Foreign currency translation adjustments||550||(97)||649||(300)|
|Comprehensive income (loss)||4,392||(6,651)||15,707||(13,765)|
|Net income (loss) per share|
|Weighted average number of shares outstanding|
Interim Consolidated Statement of Financial Position Information
|As at September 30,||As at December 31,|
|Cash and cash equivalents||24,829||39,521|
|Trade and other receivables and other current assets||11,435||13,780|
|Property, plant and equipment||1,537||2,147|
|Other non-current assets||11,322||11,391|
|Payables and accrued liabilities||8,599||10,470|
|Current portion of deferred revenues||—||5,235|
|Non-financial non-current liabilities*||18,375||52,479|
|Shareholders' equity (deficiency)||17,598||(6,695)|
|Total liabilities and shareholders' equity (deficiency)||49,971||67,665|
* Comprised mainly of non-current portion of deferred revenues, employee future benefits and provision.
SOURCE Aeterna Zentaris Inc.