Full Press Release Details
| FOR IMMEDIATE RELEASE | Contact: Sharon Schultz |
| Tel: (301) 351-0109 | |
| Email: schultzpr@mchsi.com |
Inc. reports PERFORMANCE FOR SECOND FISCAL QUARTER
Initiatives and Treatment Sites Expected to Stimulate Growth
Washington (February 15, 2012) - IsoRay Inc. (AMEX: ISR), a medical technology
company and innovator in seed brachytherapy and medical radioisotope applications, announced its financial
results for the second fiscal quarter ended December 31, 2011.
IsoRay Chairman and CEO Dwight Babcock
commented, "For some time, prostate brachytherapy has been declining in volume nationally. While we are not exempt from
this reality, we do believe this market will begin expanding as more studies like the recent Cleveland Clinic study demonstrate
that brachytherapy has the highest efficacy and lowest cost for prostate cancer patients." Babcock explained
that while IsoRay remains successful in treating slow growing cancers like prostate cancer, it is the
only brachytherapy company with the advanced isotope, (Cesium-131), which has enough energy
and a short enough half life to combat fast growing, aggressive cancers located anywhere in the body including lung, brain, gynecological,
colon, ocular melanoma, and head and neck cancers. He stated that IsoRay's market position and
the ever-expanding applications for brachytherapy throughout the body will drive the Company's long term growth noting,
"By successfully rotating our revenue stream from prostate to other body sites, we grew our non-prostate revenues by 81% quarter
over quarter." In addition, while revenues remained static this quarter, the Company did achieve a 52% gain in gross profit
primarily through a one time reduction in costs from a savings on our materials.
IsoRay has realized some other notable
advances during the quarter. The Company initiated sales of the GliaSite radiation therapy system, a balloon catheter
device used in the treatment of brain cancer, after receiving final approval from the State of Washington Department
of Health for its manufacture. The Washington State approval was IsoRay's final regulatory hurdle to commence the sale of
its GliaSite brain cancer treatment in the United States. According to Babcock, "Following our
FDA and Washington State approvals, we have had 4 successful GliaSite implants
in just the first 60 days. As with all of our innovative products, we have major institutions modifying their RAM (radio active
materials) licenses to handle our new catheters and isotope. Once an institution receives its license modification, we expect it
will identify 1-3 patients per month that will be candidates for our solutions and sales should grow as additional institutions
have licenses in place to offer GliaSite to their patients."
The Washington State approval followed
shortly after IsoRay's completion of an international distribution agreement with Karlheinz Goehl-Medizintechnik Goehl for distribution
of the GliaSite radiation system in key European markets. IsoRay continues its efforts toward attainment of FDA clearance
of liquid Cesium-131 for use with the GliaSite system and hopes to file with the FDA in the next 45 to 60 days.
In other recent developments, IsoRay previously reported that new
prostate cancer studies were initiated for monotherapy and combined therapy by a major medical center and by private cancer centers.
IsoRay, Inc. and Subsidiaries Consolidated
Statements of Operations
| Three months ended | Six months ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Product sales | $ | 1,228,655 | $ | 1,244,922 | $ | 2,442,072 | $ | 2,572,049 | ||||||||
| Cost of product sales | 1,029,757 | 1,117,005 | 2,176,832 | 2,228,532 | ||||||||||||
| Gross profit | 198,898 | 127,917 | 265,240 | 343,517 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 189,661 | 15,612 | 440,975 | 130,133 | ||||||||||||
| Research and development reimbursement | - | (149,879 | ) | (50,000 | ) | (149,879 | ) | |||||||||
| Sales and marketing expenses | 304,120 | 335,612 | 618,538 | 709,038 | ||||||||||||
| General and administrative expenses | 497,168 | 561,208 | 1,150,095 | 1,157,341 | ||||||||||||
| Total operating expenses | 990,949 | 762,553 | 2,159,608 | 1,846,633 | ||||||||||||
| Operating loss | (792,051 | ) | (634,636 | ) | (1,894,368 | ) | (1,503,116 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest income | 268 | 979 | 455 | 2,040 | ||||||||||||
| Gain on fair value of warrant liability | 166,000 | 420,000 | 166,000 | 420,000 | ||||||||||||
| Financing and interest expense | (2,962 | ) | (14,412 | ) | (3,056 | ) | (18,875 | ) | ||||||||
| Non-operating income, net | 163,306 | 406,567 | 163,399 | 403,165 | ||||||||||||
| Net loss | (628,745 | ) | (228,069 | ) | (1,730,969 | ) | 1,099,951 | |||||||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | (5,316 | ) | (5,316 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (631,403 | ) | $ | (230,727 | ) | $ | (1,736,285 | ) | $ | (1,105,267 | ) | ||||
| Basic and diluted loss per share | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.06 | ) | $ | (0.05 | ) | ||||
| Weighted average shares used in computing net loss per share: | ||||||||||||||||
| Basic and diluted | 28,593,845 | 25,070,992 | 27,540,492 | $ | 24,059,873 |
IsoRay, Inc., through its subsidiary, IsoRay
Medical, Inc., is the exclusive producer of Cesium-131 internal radiation therapy, which is expanding brachytherapy options throughout
the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by
visiting www.isoray.com.
Safe Harbor Statement
Statements in this news
release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, future demand for IsoRay's existing
and planned products, whether revenue, cash flows and other financial metrics will improve in future periods, whether IsoRay will
be able to continue to expand its base beyond prostate cancer to use Cesium-131 to treat additional cancers and malignant disease,
whether IsoRay will be able to generate sales in Europe, the advantages of the GliaSite delivery system, whether institutions will
be successful in modifying their RAM licenses to offer GliaSite and whether sales will increase as additional institutions can
offer GliaSite, whether a liquid form of Cesium-131 will be developed that receives regulatory approval and can be used successfully
with the GliaSite delivery system, whether additional studies will be published with favorable outcomes from treatment with Cesium-131,
and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose
of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual
results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors
as physician acceptance, training and use of IsoRay's products, changing levels of demand for IsoRay's current and proposed future
products, IsoRay's ability to reduce or maintain expenses while increasing sales, whether later studies and protocols support the
findings of the initial studies, success of future research and development activities, IsoRay's ability to successfully manufacture,
market and sell its products, whether resources are available as needed to develop a liquid form of Cesium-131 and whether such
liquid form receives and maintains all required regulatory approvals, whether any liquid form of Cesium-131 is able to be used
successfully with the GliaSite delivery system, patient results achieved when Cesium-131 is used for the treatment of cancers and
malignant diseases beyond prostate cancer whether with the GliaSite delivery system or in another delivery system, patient results
achieved with the GliaSite radiation therapy system, IsoRay's ability to manufacture its products in sufficient quantities to meet
demand within required delivery time periods while meeting its quality control standards, IsoRay's ability to enforce its intellectual
property rights, changes in reimbursement rates, changes in laws and regulations applicable to our product, and other risks detailed
from time to time in IsoRay's reports filed with the SEC.