Full Press Release Details
Inc. reports Third QUARTER RESULTS
Increase in Third Quarter Revenues Over Second Quarter
Washington (May 15, 2013) - IsoRay, Inc. (AMEX: ISR), a medical technology
company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer,
lung cancer, head and neck cancer, prostate cancer and gynecologic ("gyn") cancer, announced its financial results
for the quarter and nine months ended March 31, 2013.
In the current quarter ended March 31, 2013, IsoRay's
prostate treatment revenues increased approximately 20% over prostate revenues in the quarter ended December 31, 2012, with several
new facilities choosing IsoRay's Cesium-131 (Cs-131) brachytherapy despite the continued national market weakness for all prostate
treatment modalities caused by a report published by the U.S. Preventive Services Task Force recommending against routine PSA screening,
which has resulted in men avoiding the test or electing the option of "watchful waiting" if cancer is found. Both approaches
leave men at risk of having more advanced disease at the time of diagnosis and perhaps not fully utilizing proven cost effective
treatments such as brachytherapy utilizing Cesium 131, which has 98% effectiveness at the five year mark.
IsoRay's strategic focus is on using its unique isotope
Cs-131 to attack cancers in the prostate and other body sites, such as brain cancer, head and neck cancer, lung cancer and gyn
cancers, while providing patients with a better quality of life than many competing treatments. Isoray and Cesium-131 were with
the subject of multiple favorable presentations and posters by leading institutions during the Annual Meeting of the American Brachytherapy
Society (ABS) held last month. University of Pittsburgh Medical Center (UPMC) showed its 5 year data with a high range of 97% freedom
from biochemical failure. In addition, York Cancer Center showed its prostate patients returned to base line within 90 days, far
faster than any other isotope. MD Anderson presented what IsoRay management believes is the first of several papers showing a comparison
of Cesium to Iodine and Palladium, showing Cesium as a favorable isotope for intermediate prostate cancer.
IsoRay also attended the American Association for Thoracic Surgery
(AATS) convention for the first time, making contact with a number of national and international surgeons. This group will be instrumental
for the market acceptance of IsoRay's lung mesh product. The lung mesh product is being studied by Dr. Parashar at Cornell Medical
Center, who will be giving an oral presentation on the study results to the American Society for Radiation Oncology (ASTRO) in
IsoRay is pleased to report a 28% increase
in quarterly revenues overall from the quarter ended December 31, 2012 to the quarter ended March 31, 2013. Prostate revenues increased
by 20% and non prostate revenues increased 83% from the quarter ended December 31, 2012 to the quarter ended March 31, 2013.
Several multi-institutional studies
are being finalized and expected to be launched following institutional review board (IRB) approval. If these studies are completed
with successful results as with IsoRay's prior studies, then management expects Cesium (Cs-131) will rise to a status of standard
of care for primary as well as recurrent cancers.
IsoRay Chairman and CEO Dwight Babcock
commented, "Only now are the studies we initiated 2-3 years ago being published in abstract form and in journals showing
the success of Cs-131 in fighting deadly brain, head and neck, lung and gyn cancers. We are very optimistic about the growth in
adoption of our growing array of new products and look to the international market to contribute in the coming quarter as some
foreign institutions have now received their amended licenses. Physicians and institutions throughout the US are reporting outstanding
results in the use of our Cs-131 seeds for brain cancer, head and neck cancer, prostate cancer and lung cancers. Given this growing
acceptance and interest, we remain committed to our strategic sales and market objectives, which we believe will contribute to
The Company's continued investment
in research and development focusing on Cs-131 efficacy for various cancers located throughout the body is expected to have a direct
impact on its overall revenue growth with an expanding array of non-prostate cancer treatments. The increase in the size, quality
and reorganization of the sales organization has created the means to contact more facilities than ever before with the Company's
new and novel treatment alternatives.
IsoRay, Inc. and Subsidiaries
Consolidated Statements of Operations
| Three months ended | Nine months ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Product sales | $ | 1,251,478 | $ | 1,317,371 | $ | 3,283,167 | $ | 3,759,443 | ||||||||
| Cost of product sales | 1,065,574 | 1,113,151 | 3,276,314 | 3,289,982 | ||||||||||||
| Gross profit | 185,904 | 204,220 | 6,853 | 469,461 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 155,137 | 132,237 | 445,785 | 573,212 | ||||||||||||
| Research and development reimbursement | - | - | - | (50,000 | ) | |||||||||||
| Sales and marketing expenses | 290,812 | 259,010 | 928,962 | 877,549 | ||||||||||||
| General and administrative expenses | 564,075 | 575,832 | 1,678,487 | 1,726,017 | ||||||||||||
| Total operating expenses | 1,010,024 | 967,079 | 3,053,234 | 3,126,778 | ||||||||||||
| Operating loss | (824,120 | ) | (762,859 | ) | (3,046,381 | ) | (2,657,317 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest income | 83 | 144 | 355 | 599 | ||||||||||||
| Change in fair value of warrant derivative liability | 109,000 | 213,095 | 183,000 | 379,095 | ||||||||||||
| Financing and interest expense | - | (3,266 | ) | (6 | ) | (6,323 | ) | |||||||||
| Non-operating income / (expense), net | 109,083 | 209,973 | 183,349 | 373,371 | ||||||||||||
| Net loss | (715,037 | ) | (552,886 | ) | (2,863,032 | ) | (2,283,946 | ) | ||||||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | (7,974 | ) | (7,974 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (717,695 | ) | $ | (555,544 | ) | $ | (2,871,006 | ) | $ | (2,291,920 | ) | ||||
| Basic and diluted loss per share | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.08 | ) | $ | (0.08 | ) | ||||
| Weighted average shares used in computing net loss per share: | ||||||||||||||||
| Basic and diluted | 34,611,517 | 29,316,306 | 34,359,567 | 28,128,125 |
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is
the sole producer of Cesium-131 brachytherapy seeds, which
is expanding brachytherapy options throughout the body. Learn
more about this innovative Richland, Washington
company and explore the many benefits and uses of GliaSite
and Cesium-131 by visiting www.isoray.com. Join
Info2wwfinancial.com
Safe Harbor Statement
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 and other financial metrics will improve in future periods, whether IsoRay will be able to
continue to expand its base beyond prostate cancer, whether IsoRay will be able to generate sales in the U.S. and internationally,
whether additional studies will be published with favorable outcomes from treatment with Cesium-131, whether IsoRay's sales and
marketing and research and development efforts will contribute to growth, 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, patient results achieved when Cesium-131 is used for the treatment of cancers and
malignant diseases beyond prostate cancer, IsoRay's ability to successfully manufacture, market and sell its products, whether
institutions will receive all required state, federal and foreign regulatory approvals and licenses to use IsoRay's products,
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 products, and other risks detailed from time to time in IsoRay's reports filed