Aeterna Zentaris Inc. ( AEZS, TSX: AEZ) ("the Company"), a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results as at and for the three months ended March 31, 2010.
First Quarter 2010 Highlights
- January 25, 2010: Updated results of a Phase 2 study related to the use of perifosine in the treatment of advanced metastatic colon cancer showing a statistically significant benefit in survival, including 5 FU-refractory patients. - January 29, 2010: Publication in the February 2010 issue of the Journal of Clinical Cancer Research of positive Phase 2 results for perifosine as a single agent for the treatment of advanced Waldenstrom's macroglobulinemia. - February 3, 2010: Special Protocol Assessment ("SPA") granted by the United States Food and Drug Administration ("FDA") for the Phase 3 trial of perifosine in combination with capecitabine (Xeloda(R)) in refractory advanced colorectal cancer. The trial is to be conducted by Keryx Biopharmaceuticals, Inc. ("Keryx") ( KERX), Aeterna Zentaris' partner and licensee for perifosine in North America. - March 1, 2010: Disclosure that the Committee for Orphan Medicinal Products of the European Medicines Agency ("EMA") had issued a positive opinion for orphan medicinal product designation for perifosine for the treatment of multiple myeloma.
Subsequent to Quarter-End
- April 5, 2010: Perifosine receives FDA Fast Track Designation for the Phase 3 X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) registration trial. - April 8, 2010: Initiation of a Phase 3 registration trial with perifosine in refractory advanced colorectal cancer by Keryx. - April 15, 2010: Positive Scientific Advice from the EMA for the Phase 3 program with perifosine in multiple myeloma. Data from ongoing Phase 3 study, sponsored by Keryx, can be used to register perifosine in multiple myeloma in Europe. - April 20, 2010: Presentations of preclinical data on Erk inhibitor, AEZS-131, and Erk/PI3K dual inhibitor, AEZS-132, as well as preclinical data from a study sponsored by the National Institutes of Health with perifosine in oncology at the American Association for Cancer Research Annual Meeting in Washington, D.C. - April 20, 2010: Completion of a $15.0 million registered direct offering with certain institutional investors. - April, 23, 2010: Company regained compliance with Nasdaq's minimum bid price listing requirement. - May 6, 2010: Company receives orphan-drug designation from the FDA for AEZS-108 in ovarian cancer. - May 12, 2010: FDA approves the Company's Investigational New Drug (IND) application for AEZS-108 in LHRH-receptor positive urothelial (bladder) cancer.
Juergen Engel, Ph.D., Aeterna Zentaris' President and Chief Executive Officer commented, "This has been a very exciting quarter as we made great strides in the development of our lead oncology compound, perifosine, now in Phase 3 registration trials for multiple myeloma and refractory advanced colorectal cancer. Furthermore, the different designations recently granted by the FDA in both indications and the EMA's positive Scientific Advice for multiple myeloma, will accelerate as well as facilitate the future review and marketing authorization processes in North America and Europe."
Dennis Turpin, Senior Vice President and Chief Financial Officer of Aeterna Zentaris added, "With more than $40 million in cash, including proceeds from our recent $15 million registered direct offering and no debt, combined with our expected significantly reduced burn rate, we are in a solid financial position to execute our focused drug development and business strategy."
CONSOLIDATED RESULTS FOR THE THREE MONTHS ENDED MARCH 31, 2010
Revenues were $6.4 million for the three-month period ended March 31, 2010, compared to $6.1 million for the same period in 2009. The increase is mainly due to a comparative increase in sales of Cetrotide(R) to certain customers in the first quarter of 2010. This increase was partly offset by lower amortization of upfront license fee payments in 2010 related to our agreement with sanofi-aventis U.S. LLC ("sanofi-aventis"), which was entered into in March 2009, in connection with our now discontinued development program involving cetrorelix for the treatment of Benign Prostatic Hyperplasia ("BPH"), and subsequently terminated.
Research and development ("R&D") costs, net of tax credits and grants, were $5.7 million for the three-month period ended March 31, 2010, compared to $11.4 million for the same period in 2009. The comparative decrease in net R&D costs is almost entirely attributable to the winding down and termination of development activities related to cetrorelix in BPH, despite the presence in the first quarter of 2010 of residual expenditures associated with certain remaining contractual obligations.
Selling, general and administrative ("SG&A") expenses were $2.8 million for the three-month period ended March 31, 2010, compared to $3.6 million for the same period in 2009. This decrease is primarily related to lower comparative salary and benefit costs, lower legal expenses and other cost-saving measures.
Net loss was $5.9 million, or $0.09 per basic and diluted share, for the three-month period ended March 31, 2010, compared to $12.4 million, or $0.23 per basic and diluted share, for the same period in 2009. This decrease is mainly related to lower comparative net R&D costs, lower SG&A expenses and higher foreign exchange gains, partly offset by lower comparative license fee revenues and lower sales and royalty margins.
Cash and cash equivalents were $26.9 million as at March 31, 2010. This amount excludes an estimated $13.7 million of net proceeds received in connection with the registered direct offering completed on April 20, 2010.