TORONTO, Feb. 13 /PRNewswire-FirstCall/ - Microbix Biosystems Inc. said today that despite a challenging year for the biopharmaceutical industry, it has maintained its focus and continued its advance toward the ultimate goal of sustained profitability. The Company was announcing results for the first quarter ended December 31, 2008.
In a news release today, William J. Gastle, CEO of Microbix said “the Company has improved the fundamentals of its core business and we are approaching major milestones in our product pipeline. We are waiting for the FDA to authorize release of Kinlytic inventory, our Urokinase product, we are in discussions with potential pharma partners for our Hunan (China) influenza vaccine business and we expect to provide guidance on the SST program as we near the end of the expanded sex specific protein investigation described in 2008.”
Growth was robust in the first quarter with sales improving over 50 per cent compared to the same quarter last year. “We exceeded our sales target in the first quarter,” Mr. Gastle continued “and we are on a path to meet or exceed projections for this fiscal year. The Company will open its new facility in Mississauga, Ontario in March 2009 with significantly improved capacity.
VIRUSMAX(TM)
The Company is collaborating with a major firm to evaluate VIRUSMAX in their influenza vaccine manufacturing process in the second quarter. Preliminary results were promising and the evaluation has moved to the next phase at the partner’s manufacturing facility.
We are pleased with the arrangement to form a manufacturing joint venture agreement to build and operate an influenza vaccine plant in China based on VIRUSMAX. We are making solid progress towards completing the pre-conditions that have been set for financing of the Hunan project to occur. The Company is working with the Hunan Provincial Government and now also Chinese Central Government organizations to complete the financing.
Semen Sexing Technology (SST)
The SST program has focused on executing the program’s strategy to hold a comprehensive intellectual property position for sex-specific proteins on sperm cells. “We are approaching an important juncture in the completion of this phase of the work”, said Mr. Gastle. “Once reached, we will be able to provide specific guidance on the timelines through field trials and to market”.
Urokinase
The Company acquired all Urokinase assets from ImaRx Therapeutics, Inc. of Tucson, Arizona, in September 2008. These assets included ImaRx’ remaining Urokinase inventory as well as the regulatory file for the product (formerly known as Abbokinase(R), now rebranded as Kinlytic(R)), key raw materials for Urokinase manufacture, and the corresponding sales and marketing infrastructure.
The acquired inventory is awaiting US FDA release in the coming weeks, allowing Microbix to begin sales and marketing activities in the second quarter fiscal 2009.
Other Highlights
“We are in the final steps towards completing expansion of our new manufacturing facility to accommodate increased demand for virology products,” said Mr. Gastle. “The additional capacity will begin to further expand sales in 2010.”
Financial Results
For the quarter ended December 31, 2008, the Company recorded a net loss of $583,668 or 1 cent a share compared to a loss of $944,987 or 2 cents a share in the same period in fiscal 2008. Cash flow was negative for the first quarter 2009 compared to cash flow positive in fiscal 2008.
The loss for the quarter was due to ongoing investment in SST development and commercializing the new Urokinase product, Kinlytic. Microbix continues its corporate restructuring to conserve cash and lower its burn rate in order to ensure its pipeline products reach their full potential.
“Given the unusually difficult market conditions, Microbix is controlling its cash flow prudently”, said Mr. James A. Long, CFO. “We remain confident in our ability to operate the business using existing cash flow from our core business.” The planned launch of Urokinase in 2009 would be accretive to the Company’s projected positive cash flows.
Cash flow was negative at $2,362,069, due mostly to expenditures related to the expansion of the core business manufacturing facilities and continued effort on the Kinlytic commercial development. The Company was cash flow positive $5,603,173, in the same period in 2008 due to an equity financing.
Microbix specializes in the development of biological technologies and commercializing them through global partners. The Company has intellectual property in large market biotherapeutic drugs, vaccine technologies and animal reproduction technologies. Established in 1988, Microbix is headquartered in Toronto.
This press release contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements including the risks associated with failure to get authorization to release Kinlytic for distribution in the US from the FDA, inability to complete financing for the Hunan China project currently the subject of financing; risks associated with commercializing the technologies; risks associated with the ability to license VIRUSMAX to industry; risks associated with failure to develop and commercialize SST; non-adoption of SST. These forward-looking statements represent the Company’s judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
CONTACT: visit www.microbix.com or contact: William J. Gastle, CEO,
Microbix Biosystems Inc., (416) 234-1624 x 230; James Long, CFO, Microbix
Biosystems Inc., (416) 234-1624 x 265
