IsoRay Inc. (AMEX: ISR), announced financial results for the third fiscal quarter ended March 31, 2011 underscoring significant improvements in quarterly sales revenue growth both sequentially and in the prior year quarter. Sales increased 17% in the period with the Company posting a 581% gain in gross profit compared to the prior year third quarter.
The growth in revenue was attributed to a 21% increase in patient cases over Q3 FY2010. Significantly, IsoRay's non-prostate cases represented 10% of overall sales. This rise reflects increasing adoption of the Company's breakthrough internal radiation therapy by medical practitioners and facilities across the country. IsoRay is the exclusive manufacturer of Cesium-131 used in internal radiation therapy ( brachytherapy) for the treatment of lung, brain, colon, head and neck, ocular melanoma, and prostate cancer as well as other cancers throughout the body.
IsoRay Chairman and CEO Dwight Babcock, commenting on the quarter's improved performance said, "We are very pleased to have achieved these milestones including the second best quarterly revenues in the Company's history and the highest gross profit. The numbers reflect important gains for the Company and serve to endorse our ongoing strategy for expanding treatment applications beyond the prostate. We are particularly excited about the growth in sales of non-prostate treatment products. It is indicative of the Company's transformation from an exclusive prostate focus to a total body internal radiation therapy company. We are effectively opening new horizons for brachytherapy by making Cesium-131 available to address cancers in locations throughout the body in contrast to other internal radiation therapy alternatives."
In other developments , IsoRay received its CE mark certification giving European approval to IsoRay's stranded and mesh seed (Cesium-131 seeds) configuration for cancer applications throughout the body including head and neck, lung, brain, colon, and prostate cancers. With this approval, IsoRay will now be seeking distributors throughout Europe.Looking forward, IsoRay's GliaSite® radiation therapy system remains on target for the launch of its sales initiative in August 2011. GliaSite® therapy system is the world's only FDA-approved balloon catheter device used in the brachytherapy treatment of brain cancer. This innovative technology allows physicians to treat more brain cancer patients than ever before with internal radiation therapy (brachytherapy) with benefits over alternative radiation options while enhancing patient lifestyle. Of the anticipated launch, CEO Babcock added, "We expect GliaSite sales to be an important factor in driving our cash flow." Along with building inventory for the product, he reported that the Company has completed the final testing and manufacture of Iotrex, a liquid iodine, which will initially be used in the GliaSite radiation therapy system. IsoRay is in the final stage of testing its GliaSite catheter system with Iotrex for submission of its 510K for GliaSite to the FDA. Use of Iotrex allows IsoRay to address imminent market opportunities both in the U.S. and Europe, while the Company seeks final approval for liquid Cesium-131 and its use in the GliaSite® therapy system. In another important development, IsoRay has just launched its real-time, E-clinical data collection system. IsoRay will be using the E-clinical data system to provide patient data for various new studies providing an independent source for clinical analysis and publication. The ease and accuracy of data submission offers physicians important benefits and features, while lowering the cost of acquiring empirical data. The online web data collection registry will immediately be used by physicians in the multi-institutional lung study examining the efficacy of brachytherapy over other techniques and treatments. Led by New York physician Dr. Bhupesh Parashar, the lung study has expanded with a growing number of institutions signing on to participate.
|IsoRay, Inc. and Subsidiaries|
|Consolidated Statements of Operations|
Three months ended March 31,
Nine months ended March 31,
|Cost of product sales||1,053,268||1,150,730||3,281,800||3,411,012|
|Research and development expenses||244,184||98,964||374,317||226,924|
|Research and development reimbursement||(56,118||)||-||(205,947||)|
|Sales and marketing expenses||235,206||447,693||944,244||1,494,572|
|General and administrative expenses||627,592||596,224||1,784,933||1,748,664|
|Total operating expenses||1,050,864||1,142,881||2,897,547||3,470,160|
|Non-operating income (expense):|
|Gain / (loss) on fair value of warrant liability||(163,000||)||-||257,000||-|
|Financing and interest expense||(174,675||)||(6,445||)||(193,500||)||(31,704||)|
|Non-operating income (expense), net||(336,827||)||(4,898||)||66,388||(21,346||)|
|Preferred stock dividends||(2,658||)||-||(7,974||)||(36,679||)|
|Net loss applicable to common shareholders||$||(1,032,923||)||$||(1,095,293||)||$||(2,138,190||)||$||(2,988,547||)|
|Basic and diluted loss per share||$||(0.04||)||$||(0.05||)||$||(0.09||)||$||(0.13||)|
|Weighted average shares used in computing net loss per share:|
|Basic and diluted||26,008,878||22,942,458||24,709,541||22,942,458|
|The accompanying notes are an integral part of these consolidated financial statements.|