IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced its financial results for the third fiscal quarter ended March 31, 2012.
IsoRay Chairman and CEO Dwight Babcock commented, "Our quarterly financial performance, while flat, reflects the building of inventory and marketing efforts aimed at growing product awareness in anticipation of the launch of our GliaSite® radiation therapy system and lung cancer mesh sales internationally. Our revenues from sales for the treatment of other body sites beyond the prostate grew 27% comparing the nine months ended March 31, 2012 to the nine months ended March 31, 2011. We also saw growth in the number of physicians and facilities ordering cases for non-prostate body sites. The number of physicians ordering grew 57% and the number of facilities ordering grew 60% year to date respectively."
The GliaSite® radiation therapy system is the world's only balloon catheter device used in the treatment of brain cancer, and is being reintroduced to the market by IsoRay, which has exclusive worldwide rights to the system. IsoRay is also the exclusive manufacturer of Cesium-131, which represents one of the most important advancements in internal radiation therapy in 20 years. Cesium-131 allows for the internal radiation treatment of many different cancers because of its peerless combination of high energy and its matchless speed in giving off therapeutic radiation (9.7 day half-life).
IsoRay has taken some significant steps forward during the quarter. A growing number of institutions, including John Hopkins Hospital, Columbia University Medical Center, Baylor and others, are seeking amendments to their state radiation licenses. Typically, a license amendment is a 2 to 4 month process which allows institutions, upon approval, to make IsoRay's products available for patient treatment.In recent weeks, the Company participated in the 80th Annual Meeting of the American Association of Neurological Surgeons (AANS) marking the Company's formal introduction to the neuroscience community. During the meeting, a number of thought leaders in the medical community spoke about their experiences with the GliaSite® radiation therapy system. At the meeting, one physician reported historical results with GliaSite® in treating his last surviving patient with metastasized brain cancer. This metastasized brain cancer patient experienced an extraordinary 6 year extension of life with improved quality of life. IsoRay also participated in the World Congress of Brachytherapy in Barcelona, Spain where the Company reintroduced the GliaSite® brain cancer treatment and introduced its Cesium-131 lung cancer mesh to the international community. At the meeting, the Company met with 10 international distributors from a variety of countries who are seeking international distribution agreements for IsoRay's products. IsoRay CEO Babcock says the Company is currently engaged in due diligence to evaluate whether to proceed with negotiations with those companies. Also at that meeting, a number of studies, as published in the Brachytherapy Journal of the ABS, were presented spotlighting crucial findings regarding Cesium-131 brachytherapy. New York Presbyterian Radiation Oncologist Dr. A. Gabriella Wernicke, M.D., M.Sc., presented a paper reporting on the successful results New York-Presbyterian/Weill Cornell Medical Center doctors have achieved using sutured Cesium-131 seeds to treat metastasized brain cancer. Dr. Bhupesh Parashar, Radiation Oncologist at New York-Presbyterian/Weill Cornell Medical Center, presented an initial report of outcomes relative to toxicity and radiation exposure in the use of Cesium-131 brachytherapy for head and neck cancers. The report concludes that Cesium-131 brachytherapy is a safe and effective option for high risk head and neck cancers, producing high control rates, limited toxicity and is safe for health personnel in terms of radiation exposure. In addition, UPMC radiation oncologist and associate professor of radiation oncology Dr. Sushil Beriwal reported on long term toxicity following Cs-131 prostate brachytherapy. Dr. Beriwal and his colleagues found most patients undergoing prostate brachytherapy with Cs-131 have no urinary or bowel toxicity at the three year post-brachytherapy mark. Dr. Beriwal also presented a paper which investigated whether there is a difference in PSA spikes using Cesium-131 brachytherapy as opposed to other radioisotopes. While Cesium-131 treats cancer more aggressively, the report states that it has no different long term PSA spike effect than other radioisotopes. In addition, Dr. Deepak Khuntia, Director of Research and Education for Western Radiology Oncology in California, was a speaker on Robot Assisted Mesh Brachytherapy after Sublobar Resection for Early Stage Lung Cancer. In comments following his presentation, Dr. Khuntia cited several advantages in the use of Cesium-131 in robot assisted mesh brachytherapy treatment over radioisotope I-125.
|IsoRay, Inc. and Subsidiaries|
|Consolidated Statements of Operations|
|Three months ended||Nine months ended|
|March 31,||March 31,|
|Cost of product sales||1,113,151||1,053,268||3,289,982||3,281,800|
|Research and development expenses||132,237||244,184||573,212||374,317|
|Research and development reimbursement||-||(56,118||)||(50,000||)||(205,947||)|
|Sales and marketing expenses||259,010||235,206||877,549||944,244|
|General and administrative expenses||575,832||627,592||1,726,017||1,784,933|
|Total operating expenses||967,079||1,050,864||3,126,778||2,897,547|
|Non-operating income (expense):|
|Gain (loss) on fair value of warrant liability||213,095||(163,000||)||379,095||257,000|
|Financing and interest expense||(3,266||)||(174,675||)||(6,323||)||(193,500||)|
|Non-operating income (expense), net||209,973||(336,827||)||373,371||66,388|
|Preferred stock dividends||(2,658||)||(2,658||)||(7,974||)||(7,974||)|
Net loss applicable to common shareholders
|Basic and diluted loss per share||$||(0.02||)||$||(0.04||)||$||(0.08||)||$||(0.09||)|
Weighted average shares used in computing net loss per share:
|Basic and diluted||29,316,306||26,008,878||28,128,125||24,709,541|