In looking to the future, Babcock said, "I believe that current sales figures, while stable, should be enhanced as we advance our new marketing efforts focusing on Cesium-131's application to other cancer sites. I look with great anticipation toward expected future growth in revenue as a result of new product introductions as well." Babcock noted that IsoRay has strengthened its position as the brachytherapy isotope provider of choice because, unlike many of its competitors who are generally limited to prostate cancer, IsoRay continues to pursue the non-prostate market.Major milestones achieved during the past fiscal year include:
- The Company completed a license agreement with Dr. Reddy’s Laboratories (NYSE: RDY) for exclusive worldwide licensing rights to Iotrex ®, a liquid iodine radiation, for use in brain cancer treatment . Iotrex ® is a critical component in the GliaSite ® radiation therapy system. The Iotrex ® licensing agreement was a crucial step in the process needed to allow IsoRay to achieve FDA clearance and address an immediate market opportunity and patient needs, while the Company proceeds toward FDA clearance of its proprietary liquid Cesium-131 for use in the GliaSite ® therapy system.
- The FDA cleared the Company's GliaSite® radiation therapy system, a balloon catheter device used in the treatment of brain cancer. The clearance was the major step required to return the GliaSite® radiation therapy system to the marketplace. The system’s balloon catheter is a landmark technology that allows physicians to treat more brain cancer patients than ever before with internal radiation or brachytherapy.
- The Company announced that a growing number of hospitals and medical treatment centers are adopting the Company's proprietary mesh Cesium-131 (Cs-131) brachytherapy seeds for use in conjunction with the da Vinci® Surgical System to treat early stage lung cancer patients.
- The Company announced a new dual therapy study using Cesium-131 brachytherapy and external beam radiation. Multiple sites have received Institutional Review Board (IRB) approval for the study, which is examining the efficacy of combining intensity modulated radiation (IMRT) with Cesium-131 to treat intermediate and high risk, early stage prostate cancer.
- The Company has launched its E-clinical data collection system for ease of data management. The online, real-time system provides an inexpensive vehicle to gather data from physicians allowing lead investigators to easily publish data on their successes.
- University of Kentucky Radiation Oncologist Dr. Marcus E. Randall performed the world's first Cesium-131 brachytherapy seed implant for gynecological cancer on a female patient whose cancer had reoccurred following previous radiation treatment.
- A multi-institutional lung study has launched examining the efficacy of brachytherapy over other techniques and treatments. New York Physician Dr. Bhupesh Parashar is leading the study which has expanded to include a growing number of institutions.
- 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.
- The Company won Seattle Business Magazine's Health Award for Outstanding Achievement in Medical Devices.
- IsoRay was selected, again, to the Washington State Deloitte Fast 500, which recognizes leading technology companies in regions around the world and includes both public and private companies.
|IsoRay, Inc. and Subsidiaries Consolidated Statements of Operations|
|Year ended June 30,|
|Cost of product sales||4,081,556||4,560,287|
|Research and development expenses||981,186||340,959|
|Research and development reimbursement||(515,853||)||-|
|Sales and marketing expenses||1,232,188||1,953,598|
|General and administrative expenses||2,422,884||2,440,140|
|Total operating expenses||4,120,405||4,734,697|
|Non-operating income (expense):|
|Gain on fair value of warrant liability||334,000||-|
|Financing and interest expense||(216,606||)||(36,389||)|
|Non-operating income (loss), net||120,775||(24,596||)|
|Preferred stock dividends||(10,632||)||(10,632||)|
|Net loss applicable to common shareholders||$||(2,852,845||)||$||(4,044,488||)|
|Basic and diluted loss per share||$||(0.11||)||$||(0.18||)|
|Weighted average shares used in computing net loss per share:|
|Basic and diluted||25,131,563||22,960,421|