IsoRay, Inc. Reports Fiscal Year 2014 Results
September 30 2014 - 8:30AM
eTeligis
RICHLAND, WA(Eteligis Inc.)
RICHLAND, WA, United States, via ETELIGIS INC., 09/30/2014 - -
IsoRay Inc. (NYSE MKT: ISR), a medical technology company and
innovator in seed brachytherapy and medical radioisotope
applications, announced its financial results for the quarter and
year ended June 30, 2014.
In fiscal year 2014, IsoRay made significant progress in its
efforts to focus on non-prostate cancer treatments and expand
brachytherapy use in aggressive cancers found throughout the body.
Overall, sales declined slightly, primarily due to a continuing
weak prostate treatment market with less PSA screening being
performed. However, recently released peer reviewed publications
reporting positively on Cesium-131 in the treatment of cancer have
continued to provide proof and evidence of our product's
effectiveness as reported by industry leaders within the medical
field. Sales to the major medical centers that originally performed
many of the efficacy studies on Cesium-131 remain strong and
continue to order beyond the initial studies. Orders exceeding the
established study minimums required for statistical significance
imply that the product must be working well for these institutions.
These early adopters are seeing firsthand the results being
achieved even though time must elapse, allowing their data to
mature, prior to any publication of the results. Management
believes market interest is growing in the following areas: the
treatment of brain cancers (meningiomas, brain metastases and
glioblastomas); lung cancer (NSCLC); gynecological cancer; prostate
cancer; head and neck cancer; and liquid Cesium-131 in the
GliaSite(R) Radiation Therapy System, used to treat brain
cancers.
IsoRay Chairman and CEO Dwight Babcock commented, "2014 was a
monumental year in the number of achievements IsoRay completed,
particularly for a company our size. We are committed to
positioning IsoRay as the premier brachytherapy company offering
cancer solutions throughout the body. We are now actively
soliciting new institutions based on our published results, in an
effort to have them join existing studies or start their own. In
the future we expect to have additional reports reflecting similar
successes as the early adopters have achieved. Currently, we are
attracting new centers based on published results and new major
medical centers are applying for licenses and joining multi
institutional studies or initiating their own. IsoRay's products
for both prostate and other cancers continue to receive great
reviews with numerous papers being submitted for publication and
early stage posters/abstracts being presented at various medical
society conventions. Cesium-131, I can confidently say, is the
isotope of the future and will prove to be the premier isotope
providing safe and effective cancer treatment throughout the body
with a strong emphasis on quality of life."
Major milestones achieved during the 2014 fiscal year
include:
-IsoRay's Cesium-131 was used for the first time in treating
colon cancer.
-FDA cleared the use of liquid Cesium-131 (Cesitrex(R)) in the
GliaSite(R) Radiation Therapy Balloon Catheter System.
-Gynecologic Oncologic published the first peer reviewed report
showing the efficacy of Cesium-131 for gynecological cancer -
"Implementation and early clinical results utilizing Cs-131
permanent interstitial implants for gynecologic malignancies."
-IsoRay's liquid Cesium-131 (Cesitrex(R)) was used with
GliaSite(R) in treating metastatic brain cancer.
-IsoRay added two new international distributors operating in
Russia and Peru.
-Cesium-131 was used for the first time to treat a recurrent
metastatic Wilms Tumor.
-IsoRay's Cesium-131 seeded mesh was used for the first time for
advanced rectal cancer.
-IsoRay completed a major capital raise providing substantial
capitalization.
-A substantial percentage of IsoRay's outstanding warrants were
exercised.
-Cesium-131 seeds were selected to be stranded for use with C-4
Imaging's new positive MRI markers.
-IsoRay was added to the Russell Microcap Index.
-IsoRay's subsidiary in May completed an annual audit
ISO13485:2330 from BSI (British Standards Institution) with no
nonconformities, confirming IsoRay's manufacturing and quality
assurance systems.
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IsoRay, Inc. and Subsidiaries
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Consolidated Statements of Operations
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Year ended
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June 30,
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2014
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2013
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Product sales
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$
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4,219,158
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$
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4,525,233
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Cost of product sales
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4,415,629
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4,375,057
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Gross profit / (loss)
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(196,471
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)
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150,176
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Operating expenses:
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Research and development expenses
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668,803
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627,107
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Sales and marketing expenses
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1,234,725
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1,296,149
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General and administrative expenses
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2,488,219
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2,294,173
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Total operating expenses
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4,391,747
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4,217,429
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Operating loss
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(4,588,218
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(4,067,253
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Non-operating income (expense):
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Interest income
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12,113
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664
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Change in fair value of warrant liability
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(1,382,134
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)
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210,000
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Financing and interest expense
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(883
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)
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(7
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)
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Non-operating income (expense), net
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(1,370,904
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)
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210,657
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Net loss
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(5,959,122
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(3,856,596
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Preferred stock deemed dividends (Note 11)
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(726,378
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-
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Preferred stock dividends
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(10,632
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)
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(10,632
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Net loss applicable to
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common shareholders
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$
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(6,696,132
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$
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(3,867,228
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)
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Basic and diluted loss per share
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$
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(0.16
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$
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(0.11
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Weighted average shares used in computing net loss per
share:
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Basic and diluted
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42,675,158
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34,423,420
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The accompanying notes are an integral part of these financial
statements.
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 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, whether we will maintain required
manufacturing standards and quality assurance processes, 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 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 future proposed products, IsoRay's ability to
reduce or maintain expenses while increasing sales, whether
additional studies are released and support the conclusions of past
studies, patient results achieved with our products, 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, the success of our sales and marketing efforts,
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 products, whether timely licensing of facilities for new
treatments can be achieved, and other risks detailed from time to
time in IsoRay's reports filed with the SEC.
Contact:
Investor Relations
(509) 375-1202
Or
Worldwide Financial
Info@wwfinancial.com
(954) 360-9998
SOURCE: IsoRay ,
Inc.
Associated Documentation:
http://www.eteligis.com/ViewSubmission.aspx?submissionRequest=27954
- Link to submission on http://www.eteligis.com
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