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Unassociated Document Contact: Dwight Babcock, CEO 520 240 4840 dbabcock@isoray.com ISORAY, INC. ANNOUNCES FISCAL YEAR 2010 RESULTS Expanding Applications and Diversification Expected to Fuel Growth and Sales RICHLAND, W

Key Takeaway: Contact: Dwight Babcock, CEO 520 240 4840 dbabcock@isoray.com ISORAY, INC. ANNOUNCES FISCAL YEAR 2010 Expanding Applications and Diversification Expected to Fuel Growth and Sales RICHLAND, Washington (September 28, 2010) - IsoRay Inc. (AMEX: ISR,) a medical isotope comp

Full Press Release Details

Contact: Dwight Babcock, CEO
520 240 4840
dbabcock@isoray.com
ISORAY, INC. ANNOUNCES FISCAL YEAR 2010
Expanding Applications and
Diversification Expected to Fuel Growth and Sales
RICHLAND, Washington (September 28,
2010) - IsoRay Inc. (AMEX: ISR,) a medical isotope company and the exclusive
manufacturer of Cesium-131 used in internal radiation therapy for the treatment
of lung, colon, head and neck, and prostate cancers, ocular melanoma, and other
malignant disease through the use of its proprietary radioisotope technology,
announced its financial results for the year ended June 30,
FY 2010 FY 2009 % Change
Product sales 5,286,084 5,417,815 -2 %
Gross Income / (loss) 725,797 (353,332 ) 305 %
Net loss (4,070,535 ) (6,160,841 ) -34 %
In fiscal year 2010, 97% of revenue was
generated from the sales of ProxcelanTM Cesium-131 brachytherapy seeds for the
treatment of prostate cancer while the other 3% of revenue was generated by
sales of Proxcelan seeds for the treatments of lung, head and neck, ocular and
colon cancer. Since the first implant in October 2004, over 5,000
patients have been treated with ProxcelanTM Cesium-131 brachytherapy seeds for
prostate alone with extraordinary results.
The Company had cash and cash
equivalents of $1,678,869 as of June 30, 2010.
Babcock, IsoRay Chairman and CEO, commented, "We have completed our first phase
of right-sizing the Company as we prepare for our future growth with sales
increasing in the application of Cesium-131 for the treatment of various new
cancer body sites. Our competitors in low dose rate brachytherapy
treating prostate cancer only, experienced another year of declining annual
sales of between 15%-25%. While the Company has yet to achieve its sales goals,
IsoRay remains uniquely positioned as the brachytherapy isotope provider of
choice due to the unique characteristics of Isoray's Cesium-131. Its high energy
and short half-life remain important distinctions."
says the future holds great promise. "With our existing FDA approvals
and established CMS codes, I believe we will see revenue growth from
non-prostate applications and growing numbers of cases as we continue to execute
our business plan and promote Cesium-131 brachytherapy for treatment of cancers
throughout the body. Increasingly, we are hearing from leading physicians,
worldwide, who are requesting Cesium-131 for patients who have an immediate need
for treatment. These physicians are seeking out Cesium-131 as a
solution to the management of challenging oncologic cases, which haven't had the
benefit of an alternative like our isotope available to them in the past," he
year ended June 30, 2010, the Company has seen dramatic improvements in the cost
of product sales, gross margin, operating expenses, net loss and cash burn rate
when compared to fiscal year 2009. We continue to evaluate several FDA-cleared
devices that would expand the use of our proprietary isotope in both seed and
liquid form to expand our reach. In addition, we are investigating other
non-medical uses of our isotope. These non-medical uses will further help to
ensure an expanding revenue base for IsoRay.
milestones achieved during the past fiscal year include several new product
innovations and the continuation of manufacturing process
IsoRay, Inc., through its subsidiary,
IsoRay Medical, Inc., is the sole producer of the Cesium-131 brachytherapy seed,
used to treat prostate and other cancers. The Cesium-131 seed offers a
significantly shorter half-life than the two other isotopes commonly used for
brachytherapy, which results in a substantially faster delivery of therapeutic
radiation, lower probability of cancer cell survival and reduction of the
longevity of common brachytherapy side effects (a)(b). IsoRay is based in
Richland, Washington. More information is available about
IsoRay at 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 the increase
in gross margin and decreases in cost of product sales, operating expenses, net
loss and cash burn rate seen in fiscal 2010 as compared to fiscal 2009 will
continue in the future, whether revenue will increase in future periods, whether
IsoRay will be able to continue to expand its base beyond prostate cancer,
whether IsoRay's Cesium-131 seed will be used to treat additional cancers and
malignant disease, whether Cesium-131 will be successfully used in other
delivery devices to treat malignant disease or in non-medical applications,
whether changes in IsoRay's sales and marketing strategy will result in improved
sales, IsoRay's manufacturing needs and capabilities, whether expansion into new
markets (including non-medical markets) will be successful or result in improved
sales, whether IsoRay will continue to meet Health Canada's requirements and
expectations to sell Proxcelan in Canada, whether IsoRay will be successful in
launching any new products and whether such products will result in cost
increases, whether results of future studies and protocols will support the
findings from initial studies, 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 net cash used by operating activities, whether the brachytherapy
industry as a whole continues to experience declining sales, whether later
studies and protocols support the findings of the initial studies, success of
future research and development activities, whether initial implants of
Cesium-131 to treat non-prostate cancers result in favorable patient outcomes in
both the short- and long-term, 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, IsoRay's ability to enforce its intellectual property rights, changes
in reimbursement rates, changes in laws and regulations applicable to our
product both in the United States and internationally, and other risks detailed
from time to time in IsoRay's reports filed with the
Inc and Subsidiaries
Statements of Operations
June 30, June 30,
2010 2009
Product sales 5,286,084 5,417,815
Cost of product sales 4,560,287 5,771,147
Gross income / (loss) 725,797 (353,332 )
Operating expenses:
Research and development 340,959 958,665
Sales and marketing 1,953,598 2,365,973
General and administrative 2,440,140 2,792,611
Total operating expenses 4,734,697 6,117,249
Operating loss (4,008,900 ) (6,470,581 )
Non-operating income (expense):
Interest income 11,433 111,047
Gain on fair value of short-term investments - 274,000
Financing and interest expense (36,389 ) (75,307 )
Non-operating income / (expense), net (24,956 ) 309,740
Net loss (4,033,856 ) (6,160,841 )
Preferred stock dividends (10,632 ) (10,632 )
Net loss applicable to common shareholders (4,044,488 ) (6,171,473 )
Basic and diluted loss per share (0.18 ) (0.27 )
Weighted average shares used in computing net loss per share:
Basic and diluted 22,960,421 22,942,088
Last updated: Sep 28, 2010