Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its Fiscal 2010 first quarter, ended September 30, 2009.
"We ended the first quarter of Fiscal 2010 in a strong position, with current assets of $25.3 million, 53% of which is cash," stated Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc. "The signing of a licensing agreement with Endo Pharmaceuticals Inc. ("Endo") for exclusive rights to develop and market Urocidin(TM) in North America and receipt of a related up-front payment of US$20 million, has transformed our balance sheet from that of our Fiscal 2009 year-end."
Under the licensing agreement, the Company has the potential to receive a further US$110 million in additional payments associated with the achievement of certain clinical, regulatory and commercial milestones.
The Company is pleased to announce that it has now met the obligations associated with the first milestone, triggering a US$6 million payment from Endo. Future milestones will be announced as they are achieved.
Urocidin(TM) is a patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing.
It should be noted that, until further notice, future disclosures regarding progress made on development and commercialization activities supporting the advancement of Urocidin(TM), with the exception of milestone achievements by the Company, will be made by Endo.
Fiscal 2010 Q1 Financial Results Highlights
Consolidated revenues for the quarter totaled $7.1 million, a decrease of 11.6% from the same period in Fiscal 2009. Sales promotions in the last quarter of Fiscal 2009 as well as recessionary conditions in all markets, slightly offset by an amortized portion of the license revenues from Endo ($0.3M of the US$20M up-front payment in the quarter) and the sale of U.S. rights to an animal health product in July, 2009 for proceeds of $0.9 million, contributed to this result.
Gross profit totalled $4.4 million in the quarter, as compared to $4.3 million in the same quarter last year. Gross profit as a percentage of product sales totaled 53.1% this quarter, compared to 53.4% in Fiscal 2009.
For the quarter ended September 30, 2009, expenses before research and development totaled $6.8 million, as compared to $8.0 million in the same quarter last year. This decrease can be attributed to a reduction in administration, sales and marketing expenses. These areas have been affected by personnel changes and temporary cutbacks which continued to the end of July, 2009. Management expects administration and marketing costs to increase over the remainder of Fiscal 2010 to sustain and grow the business.
Gross research and development (R&D) expenses in this quarter totaled $3.5 million, a decrease of $300,000 as compared to the same period in Fiscal 2009. The majority of these costs continue to be attributed to the ongoing Phase III clinical program for the Company's Urocidin(TM) bladder cancer therapy and the E. coli O157 cattle vaccine development program. This expense line will increase going forward with the start of the second Phase III clinical trial with Urocidin(TM) in non-muscle-invasive bladder cancer.
The basic and fully-diluted net loss per share for the first quarter of Fiscal 2010 was ($0.09), compared to a loss per share of ($0.05) for the corresponding period in Fiscal 2009. Total common shares outstanding at September 30, 2009 were 71,959,642 as compared to 70,803,850 for the corresponding period in Fiscal 2009.
Earnings before interest, taxes, depreciation, amortization and foreign exchange during the first quarter of Fiscal 2010 were $1.1 million, no change from the same period last year.
At September 30, 2009, the Company's net working capital totaled $18.1M, excluding the current portion of deferred licensing revenue, a substantial improvement over the prior quarter.