IsoRay Inc. (AMEX: ISR), announced its financial results for the quarter ended December 31, 2010 with highlights of important new advances. 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 said, “Along with our initiatives to increase sales and our ongoing fiscal responsibility, we expect to continue to show improvement in cash burn even as we invest in key growth areas."
IsoRay is making significant progress in bringing the Gliasite radiation therapy system to market. The Company has initiated ordering of inventory to construct and manufacture the GliaSite® radiation therapy system with an expected launch of a sales initiative in late July or August. GliaSite® therapy system is the world's only FDA-approved balloon catheter device used in the brachytherapy treatment of brain cancer . This landmark technology allows physicians to treat more patients than ever before with internal radiation and provides important benefits over other radiation treatment options including enhanced patient lifestyle.
In related developments , the Company is finalizing its worldwide acquisition of Iotrex, a liquid iodine which has FDA approval, for use in the GliaSite® therapy system. Use of Iotrex opens an immediate market opportunity to generate revenues from sales of GliaSite® in the brain cancer market, while IsoRay seeks final approval for liquid Cesium-131 for use in the GliaSite® therapy system. IsoRay is also negotiating a distribution agreement with the previous European distributor of GliaSite®, which would open a substantial market opportunity with the potential to generate immediate sales following the launch.While domestic adoption of IsoRay's pioneering internal radiation therapy remains a primary focus, CEO Babcock said international interest is on the rise. "With our demonstrated successes in treating a variety of cancers, we are getting more inquiries from hospitals, medical facilities, and physicians in countries ranging from Hong Kong and Spain to Israel and Saudi Arabia." U.S. physicians adopting Cesium-131 internal radiation therapy have been reporting positive patient outcomes involving the use of Cesium-131 radiation therapy. While a detailed analysis is not yet complete, informal indications from presiding physicians on the application of Cesium-131 to new cancer sites reveals that patients have shown no local recurrence of cancer to date and the treatment has been well-tolerated. IsoRay is continuing expansion of treatment options with the launch of a new dual therapy prostate study involving Cesium-131 and external radiation therapy. The new study comes as the Company reports progress on its multi-institutional lung study with requirements for that study now finalized. At the same time, IsoRay is anticipating the publication of another important study in the near future. An independent group has submitted its 5-year data on Cesium-131 prostate cancer treatment for peer review. Study findings are anticipated to demonstrate excellent results. In other highlights, IsoRay continued to successfully build on its initiative to expand awareness of its innovative Cesium-131 treatment. IsoRay's Dwight Babcock was a featured speaker at OneMed Forum, a medical forum attended by investment bankers. IsoRay won distinction by being selected to the Deloitte Fast 500, which recognizes the 500 fastest-growing technology companies in regions around the world and includes both public and private companies. The Company has also been nominated for Seattle Business Magazine's Health Awards for Outstanding Achievement in Medical Devices.
|IsoRay, Inc. and Subsidiaries|
|Consolidated Statements of Operations|
|Three months ended||Six months ended|
|December 31, 2010||December 31, 2010|
|Cost of product sales||1,117,005||1,100,193||2,228,532||2,260,282|
|Research and development expenses||15,612||59,078||130,133||127,960|
|Sales and marketing expenses||335,612||603,980||709,038||1,046,879|
|General and administrative expenses||561,208||550,009||1,157,341||1,152,440|
|Total operating expenses||912,432||1,213,067||1,996,512||2,327,279|
|Non-operating income (expense):|
|Gain on fair value of warrant liability||420,000||-||420,000||-|
|Financing and interest expense||(14,412||)||(7,898||)||(18,875||)||(25,259||)|
|Preferred stock dividends||(2,658||)||(36,679||)||(5,316||)||(36,679||)|
|Net loss applicable to|
|Basic and diluted loss per share||$||(0.01||)||$||(0.04||)||$||(0.05||)||$||(0.08||)|
|Weighted average shares used in|
|computing net loss per share:|
|Basic and diluted||25,070,992||22,942,088||24,059,873||22,942,088|
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