Full Press Release Details
Inc. reports FIRST QUARTER RESULTS
Revenue Growth In Brain, Lung and Other Non-Prostate Cancer Cases Quarter Over Quarter
Washington (November 15, 2013) - IsoRay,
Inc. (NYSE MKT: ISR), a
medical technology company and innovator in seed brachytherapy and medical radioisotope applications
for the treatment of cancers of the brain, lung, head and neck, prostate and gynecological, announced its financial results for
the quarter ended September 30, 2013.
Management has continued to promote and diversify IsoRay's
treatment revenues by offering Cesium-131 as the alternative for treating recurrent and difficult cancers located throughout the
body. IsoRay, like other medical device companies, is feeling the effects of the new medical device
tax created by the Affordable Care Act. Despite what has been a weak prostate market for the industry as a whole, management
is seeing indications that new adopters are considering Cesium-131 in the coming year. While IsoRay remains committed to the prostate
market, IsoRay's primary strategic focus is to expand the use of Cesium 131 to combat cancers in numerous other body sites.
We are extremely pleased with the effectiveness of Cesium-131 as a treatment solution for brain cancer, head and neck cancer, lung
cancer, prostate cancer and gynecological cancers while providing far better quality of life
for the patient than other alternatives.
During the last quarter IsoRay added a number of outstanding
new medical centers, including Johns Hopkins, Harvard Affiliate Brigham and Women's, University
Medical Center of Princeton and Rutgers Medical School, that performed their first cases utilizing Cesium-131 and more are
expected in the near future. .
continued to invest in R&D data protocols to support our future sales efforts for each new body site. In addition we have participated
in more national conferences than ever before as our product portfolio expands. IsoRay Chairman and CEO Dwight Babcock commented,
"Clinical evidence provided through protocols performed by major medical centers that prove successful with a significant
improvement is the key to getting general adoption by community hospitals/physicians which will drive consumers to our product
offerings. To this end IsoRay is totally committed. Physicians and institutions through oral presentations, posters and abstracts
are reporting outstanding results in the use of Cesium-131 seeds for the treatment of cancers of the brain, head and neck, prostate,
gynecological, colon and lung. Given this growing acceptance and interest, we remain committed
to our strategic sales and marketing objectives, which we believe will contribute to long term growth and achieving profitability."
IsoRay, Inc. and Subsidiaries
Consolidated Statements of Operations
| For the three months ended | ||||||||
| September 30, | ||||||||
| 2013 | 2012 | |||||||
| Product sales | $ | 1,049,915 | $ | 1,056,232 | ||||
| Cost of product sales | 1,127,223 | 1,076,657 | ||||||
| Gross loss | (77,308 | ) | (20,425 | ) | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 146,990 | 141,472 | ||||||
| Sales and marketing expenses | 359,185 | 316,056 | ||||||
| General and administrative expenses | 651,036 | 644,853 | ||||||
| Total operating expenses | 1,157,211 | 1,102,381 | ||||||
| Operating loss | (1,234,519 | ) | (1,122,806 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 354 | 144 | ||||||
| Change in fair value of warrant derivative liability | (36,000 | ) | 129,000 | |||||
| Financing and interest expense | (741 | ) | (6 | ) | ||||
| Non-operating income/( expense), net | (36,387 | ) | 129,138 | |||||
| Net loss | (1,270,906 | ) | (993,668 | ) | ||||
| Preferred stock deemed dividends (Note 9) | (726,378 | ) | - | |||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | ||||
| Net loss applicable to common shareholders | $ | (1,999,942 | ) | $ | (996,326 | ) | ||
| Basic and diluted loss per share | $ | (0.06 | ) | $ | (0.03 | ) | ||
| Weighted average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 35,921,712 | 33,866,563 |
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
Safe Harbor Statement
news release about IsoRay's future expectations, including: the advantages of our Cesium-131 products, 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, whether additional
medical centers will begin using Cesium-131, whether additional studies will be published or presented 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, patient results achieved using our products in both the
short and long term, 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, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery
time periods while meeting its quality control standards, the success of our sales and marketing efforts, 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.