Attached files
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| 8-K - Isoray, Inc. | v211536_8k.htm |
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FOR
IMMEDIATE RELEASE
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Contact:
Sharon Schultz
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Tel:
(301) 351-0109
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Email:
schultzpr@mchsi.com
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ISORAY,
INC. ANNOUNCES SECOND QUARTER FISCAL YEAR 2011 RESULTS
Reduced
Cash Burn and Domestic and International Developments Points to
Growth
RICHLAND,
Washington (February 15, 2011) – IsoRay Inc. (AMEX:
ISR), announced its financial results for the quarter ended December 31, 2010
with highlights of important new advances. IsoRay is the exclusive manufacturer
of Cesium-131 used in internal radiation therapy (brachytherapy) for
the treatment of lung, brain, colon, head and neck, ocular melanoma, and
prostate cancer
as well as other cancers throughout the body.
IsoRay
Chairman and CEO Dwight Babcock said, “Along with our initiatives to increase
sales and our ongoing fiscal responsibility, we expect to continue to show
improvement in cash burn even as we invest in key growth
areas."
IsoRay is making significant progress
in bringing the Gliasite radiation therapy system to market. The Company has
initiated ordering of inventory to construct and
manufacture the GliaSite® radiation therapy system
with an expected launch of a
sales initiative in late July or August. GliaSite® therapy system is the world's
only FDA-approved balloon catheter device used in the brachytherapy treatment of
brain cancer.
This landmark technology allows physicians to treat more patients than ever
before with internal radiation and provides important benefits over other
radiation treatment options including enhanced patient
lifestyle.
In
related developments, the
Company is finalizing its worldwide acquisition of Iotrex, a liquid iodine which
has FDA approval, for use in the GliaSite® therapy system. Use of Iotrex opens
an immediate market opportunity to generate revenues from sales of GliaSite® in
the brain cancer market, while IsoRay seeks final approval for liquid Cesium-131
for use in the GliaSite® therapy system. IsoRay is also negotiating a
distribution agreement with the previous European distributor of GliaSite®,
which would open a substantial market opportunity with the potential to generate
immediate sales following the launch.
While
domestic adoption of IsoRay's pioneering internal radiation therapy remains a
primary focus, CEO Babcock said international interest is on the rise. "With our
demonstrated successes in treating a variety of cancers, we are getting more
inquiries from hospitals, medical facilities, and physicians in countries
ranging from Hong Kong and Spain to Israel and Saudi Arabia." U.S. physicians adopting Cesium-131
internal radiation therapy have been reporting positive patient outcomes
involving the use of Cesium-131 radiation therapy. While a detailed
analysis is not yet complete,
informal indications from presiding physicians on the application of Cesium-131
to new cancer sites reveals that patients have shown no local recurrence of
cancer to date and the treatment has been well-tolerated.
IsoRay is continuing expansion of
treatment options with the launch of a new dual therapy prostate study involving
Cesium-131 and external radiation therapy. The new study comes as the Company
reports progress on its multi-institutional lung study with requirements for
that study now finalized. At the same time, IsoRay is anticipating the
publication of another important study in the near future. An independent group
has submitted its 5-year data on Cesium-131 prostate cancer treatment for peer
review. Study findings are anticipated to demonstrate excellent
results.
In other highlights, IsoRay continued
to successfully build on its initiative to expand awareness of its innovative
Cesium-131 treatment. IsoRay's Dwight Babcock was a
featured speaker at OneMed Forum, a medical forum attended by investment
bankers. IsoRay won distinction
by being selected to the Deloitte Fast 500, which recognizes the 500
fastest-growing technology companies in regions around the world and includes
both public and private companies. The Company has also been nominated
for Seattle Business Magazine's Health Awards for Outstanding Achievement in
Medical Devices.
IsoRay,
Inc. and Subsidiaries
Consolidated
Statements of Operations
(Unaudited)
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Three
months ended
December
31, 2010
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Six
months ended
December
31, 2010
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2010
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2009
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2010
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2009
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Product
sales
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$ | 1,244,922 | $ | 1,368,347 | $ | 2,572,049 | $ | 2,747,434 | ||||||||
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Cost
of product sales
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1,117,005 | 1,100,193 | 2,228,532 | 2,260,282 | ||||||||||||
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Gross
income
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127,917 | 268,154 | 343,517 | 487,152 | ||||||||||||
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Operating
expenses:
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||||||||||||||||
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Research
and development expenses
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15,612 | 59,078 | 130,133 | 127,960 | ||||||||||||
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Sales
and marketing expenses
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335,612 | 603,980 | 709,038 | 1,046,879 | ||||||||||||
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General
and administrative expenses
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561,208 | 550,009 | 1,157,341 | 1,152,440 | ||||||||||||
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Total
operating expenses
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912,432 | 1,213,067 | 1,996,512 | 2,327,279 | ||||||||||||
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Operating
loss
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(784,515 | ) | (944,913 | ) | (1,996,995 | ) | (1,840,127 | ) | ||||||||
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Non-operating
income (expense):
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||||||||||||||||
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Interest
income
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979 | 2,944 | 2,040 | 8,811 | ||||||||||||
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Gain
on fair value of warrant liability
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420,000 | - | 420,000 | - | ||||||||||||
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Other
income
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149,879 | 149,879 | ||||||||||||||
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Financing
and interest expense
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(14,412 | ) | (7,898 | ) | (18,875 | ) | (25,259 | ) | ||||||||
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Non-operating
income
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||||||||||||||||
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(expense),
net
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556,446 | (4,954 | ) | 553,044 | (16,448 | ) | ||||||||||
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Net
loss
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(228,069 | ) | (949,867 | ) | (1,099,951 | ) | (1,856,575 | ) | ||||||||
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Preferred
stock dividends
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(2,658 | ) | (36,679 | ) | (5,316 | ) | (36,679 | ) | ||||||||
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Net
loss applicable to common shareholders
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$ | (230,727 | ) | $ | (986,546 | ) | $ | (1,105,267 | ) | $ | (1,893,254 | ) | ||||
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Basic
and diluted loss per share
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$ | (0.01 | ) | $ | (0.04 | ) | $ | (0.05 | ) | $ | (0.08 | ) | ||||
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Weighted
average shares used in
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||||||||||||||||
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computing
net loss per share:
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||||||||||||||||
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Basic
and diluted
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25,070,992 | 22,942,088 | 24,059,873 | 22,942,088 | ||||||||||||
About
IsoRay, Inc.
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 will increase in future periods, whether
IsoRay will be able to expand its base beyond prostate cancer, whether IsoRay's
Cesium-131 seed will be used to treat additional cancers and malignant disease,
the advantages of the Gliasite delivery system, 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 international interest
will result in international sales, 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 net cash used by operating
activities, 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, 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, whether the proposed European GliaSite distribution agreement is
finalized and signed, 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.
###