Full Press Release Details
ISORAY, INC. REPORTS FIRST QUARTER RESULTS
7% Revenue Growth In Prostate Cancer
Cases Quarter Over Quarter
RICHLAND, Washington (November 17, 2014) - 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 prostate, brain, lung, head and neck and gynecological, announced its financial results for the quarter
ended September 30, 2014.
Management is encouraged by the increase in prostate revenues
from this quarter compared to the quarter ended September 30, 2013 as well as our October 2014 prostate revenues. Although is it
difficult to establish any trend from these results, management hopes the new healthcare reforms coupled with the number of aging
baby boomers that will seek prostate treatment could result in more consistent prostate revenue increases for the Company. Management
believes that brachytherapy treatments offer some of the best results for the patient, with fewer side effects and faster recovery
back to base line, at the lowest industry cost.
While IsoRay remains committed to the prostate market, management
believes its strategic focus continues to remain on expanding 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.
Recent medical journals have reported significant success using
Cesium-131 in treating metastatic brain cancer and gynecological cancer. These published peer reviewed studies have created increased
interest in leading medical institutions preparing to duplicate these studies independently or join an existing multi-institutional
study. During the last quarter, IsoRay added a number of outstanding new medical centers which have either filed for Cesium-131
to be added to their license or have performed cases based on the reported experience of Weill Cornell and University of Kentucky.
Some notable names now utilizing Cesium-131 in treating tumors in various body sites include Massachusetts General Hospital, Johns
Hopkins, Harvard affiliate Brigham and Women's, Rutgers Medical School and MD Anderson.
With the anticipated addition of new studies being launched
and the expectation of other study results being released, IsoRay continues to recruit for its sales and marketing staff. As of
December 1, 2014 we have planned new hires which will result in a total of nine (9) sales representatives strategically located
IsoRay continues to invest in R&D data protocols geared
to showing improved efficacy over current cancer treatments while providing the patient with an improved quality of life experience.
Several new studies are expected to launch in the foreseeable future in various body sites. IsoRay Chairman and CEO Dwight Babcock
commented, "Clinical evidence provided through protocols performed by major medical centers that prove utilizing Cesium-131
is either equal to or better than the current standard of care alternatives, together with patients enjoying an improved quality
of life, remains the key to IsoRay's success. These studies also aid in generating awareness and ultimately general adoption
by community hospitals/physicians which will drive consumers to our product offerings. To this end and given this growing acceptance
and interest in our now published results, 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 quarter ended | ||||||||
| September 30, | ||||||||
| 2014 | 2013 | |||||||
| Product sales, net | $ | 1,042,101 | $ | 1,049,915 | ||||
| Cost of product sales | 1,096,903 | 1,127,223 | ||||||
| Gross loss | (54,802 | ) | (77,308 | ) | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 176,610 | 146,990 | ||||||
| Sales and marketing expenses | 353,743 | 359,185 | ||||||
| General and administrative expenses | 575,951 | 651,036 | ||||||
| Total operating expenses | 1,106,304 | 1,157,211 | ||||||
| Operating loss | (1,161,106 | ) | (1,234,519 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 72,695 | 354 | ||||||
| Change in fair value of warrant derivative liability | 306,000 | (36,000 | ) | |||||
| Financing and interest expense | (3,451 | ) | (741 | ) | ||||
| Non-operating income (expense), net | 375,244 | (36,387 | ) | |||||
| Net loss | (785,862 | ) | (1,270,906 | ) | ||||
| Preferred stock deemed dividends (Note 10) | - | (726,378 | ) | |||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | ||||
| Net loss applicable to common shareholders | $ | (788,520 | ) | $ | (1,999,942 | ) | ||
| Basic and diluted loss per share | $ | (0.01 | ) | $ | (0.06 | ) | ||
| Weighted average shares used in computing net | ||||||||
| loss per share: | ||||||||
| Basic and diluted | 54,868,053 | 35,921,712 |
The accompanying notes are an integral part
of these financial statements
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
Safe Harbor Statement
Statements in this news release about IsoRay's future
expectations, including: the advantages of our products and their delivery systems, whether sales of our products will continue
at historic levels, decrease or increase, whether the use of our products will increase or continue, whether future studies of
treatment of various cancers using our products will have favorable results, whether awareness of our products in the medical community
will continue or increase, 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 and physicians will begin using Cesium-131, whether new
studies will be launched, whether additional studies will be published or presented with favorable outcomes from treatment with
our products, 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, successful completion of future research and development activities,
our ability and the ability of our distributors and customers to receive and maintain all required regulatory approvals in the
U.S. and internationally, continued compliance with ISO standards as audited by BSI, whether timely licensing of facilities for
new treatments can be achieved, 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.