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Bioniche Pharma Ltd. Reports Fiscal 2010 First Quarter Results And Achievement of First Milestone Under Licensing Agreement


11/6/2009 10:15:05 AM

BELLEVILLE, ON, Nov. 6 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , 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.

Long-term debt at September 30, 2009 totaled $11.0M, excluding deferred licensing revenue of $20.5M, which compares to $8.2M reported at June 30, 2009. The increase reflects the trigger of the required long-term repayment of government assistance to the ITO of $3.0M, less repayments of capital leases and long-term debt. The up-front payment related to the licensing agreement with Endo is reflected as deferred licensing revenue, the current portion being $1.5M and long-term portion $20.5M. The total revenue received was $22.3M which will be brought into income over the next 15 years.

Outcome of 2009 Annual & Special Meeting of Shareholders

The Annual & Special Meeting of Shareholders was held yesterday afternoon in Belleville, Ontario. Shareholders voted to elect the following individuals as members of the Board of Directors:

Dr. Armen Aprikian remains an Observer on the Board. Also at yesterday's meeting, the shareholders voted to appoint Ernst & Young, LLP, Chartered Accountants, as auditors of the Corporation.

The shareholders also voted to approve a resolution approving an increase in the number of Common Shares available to be issued from Treasury in payment of the Corporation's contributions to the Group Registered Retirement Savings and Employee Savings Plans by 3,000,000.

The shareholders also voted to approve a resolution regarding the increase in the number of common shares available to be issued from treasury for payment of employee bonuses under the Corporation's Deferred Compensation Plan by 3,000,000.

Further, the shareholders voted to approve a resolution approving amendments to the Stock Option Plan of the Corporation to a "rolling" 10% Plan.

Lastly, the shareholders voted to approve a resolution repealing By-Law 1A and enacting By-Law 1B, a more streamlined by-law that does not repeat statutory requirements set out in the Canada Business Corporations Act. The new by-law also changes notice of directors' meetings from 48 hours in advance to 24 hours in advance.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 190 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. For more information, please visit www.Bioniche.com.

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

CONTACT: Jennifer Shea, Vice-President, Communications, Investor &
Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com; or Brian Ford,
Chief Financial Officer, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 242-2298, Brian.Ford@Bioniche.com



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