RICHLAND, Wash., Feb. 10, 2016 /PRNewswire/ -- IsoRay, Inc.
(NYSE MKT: ISR), a medical technology company and innovator in seed
brachytherapy and medical radioisotope applications for the
treatment of prostate, brain, lung, head and neck and gynecological
cancers, today announced its financial results for the second
quarter and six months of fiscal 2016, which ended December 31, 2015.
Revenue was $1.19 million for the
second quarter of fiscal 2016, which ended December 31, 2015, a 12% increase compared to
$1.07 million for the second quarter
of fiscal 2015, which ended December
31, 2014. Operating expenses were $1.44 million compared to $0.98 million in the second quarter of last
fiscal year. Operating loss was $1.41
million compared to $1.02
million loss in the comparable period of the last fiscal
year. The increased operating loss for the quarter is
attributed to an increase in legal costs of approximately
$0.2 million and accrual of
$0.3 million for CEO severance
costs. The increased legal costs are a result of the
Company's defense of its pending class action lawsuit. By the end
of the second quarter of fiscal 2016, the Company had incurred all
but approximately $40k of its
self-insurance retention to defend this lawsuit, and once these
amounts have been paid, all future costs are expected to be paid
out of the Company's directors and officers insurance
coverage. IsoRay had cash and cash equivalents and
certificates of deposits of $17.76
million as of December 31,
2015 and no debt.
Revenue was $2.45 million for the
six months ended December 31, 2015, a
16% increase compared to $2.11
million for the six months ended December 31, 2014. Operating expenses were
$2.61 million compared to
$2.09 million in the six months ended
December 31, 2015 and 2014,
respectively. Operating loss was $2.50
million compared to $2.18
million loss in the six months ended December 31, 2015 and 2014, respectively.
The increased operating loss for the six month period ended
December 31, 2015 is attributed to an
increase in legal costs of approximately $
.2 million and $.3 million
related to CEO severance costs. These increases in costs are
considered non-recurring expenses.
In January 2016, the Company
announced Thomas LaVoy, Chairman of
the Board, will assume the position of IsoRay's Chief Executive
Officer. Mr. LaVoy will take office effective February 15, 2016. Mr. LaVoy stated, "I am
pleased to have been appointed by the Board of Directors to lead
IsoRay to the next level of growth. We have a strong balance sheet
on which we will build. I have met with the management team,
and beginning February 16, 2016 we
will begin a complete, top to bottom, 90 day strategic review of
the entire Company. During that period, the team will
determine the best allocation of resources to coincide with our
growth strategy. We intend to revise our sales, marketing and
communications platforms while aligning all parts of our
business. In addition, we will determine if we need to create
and fill additional positions to ensure the most effective and
efficient operation of IsoRay."
Mr. LaVoy added, "The use of our Cesium-131 brachytherapy seeds
continues to attract the interest of the medical community.
Three peer reviewed studies that focused on brain surgery, one in
Neurosurgery and two in the Journal of
Neuro-Oncology, have been released since mid-December 2015. These studies, published in
two of the leading scientific journals in this field,
presented discussions on: the excellent response rates with minimal
toxicity, dose homogeneity and minimizing the risk of radiation
induced injury, and the cost effectiveness of Cesium-131 in
intraoperative brachytherapy. We look forward to additional
scientific papers and publications that apprise members of the
medical community on the significance of brachytherapy using
Cesium-131 seeds."
Mr. LaVoy concluded, "The IsoRay team was pleased to staff an
exhibition booth to raise the visibility of our Cesium-131 seeds
during the 52nd Annual Meeting of The Society of Thoracic Surgeons
(STS 52nd Annual Meeting and STS/AATS Tech-Con 2016), which was
held in Phoenix, Arizona,
January 23-27, 2016. Positive
feedback was expressed by many conference attendees and management
continues to follow-up on industry leads generated during the
event. The Company will continue to build our presence at
industry events and build out our relationships with members of the
medical and scientific community. As so many continue to face
the challenges of combatting cancer, the entire team at IsoRay is
committed to work together to help patients and their caregivers
achieve better outcomes."
IsoRay, Inc.
and Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three months
ended December 31,
|
|
Six months
ended December 31,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
Product
sales
|
$ 1,189,008
|
|
$ 1,065,585
|
|
$ 2,450,330
|
|
$ 2,107,686
|
Cost of product
sales
|
1,162,097
|
|
1,103,549
|
|
2,339,960
|
|
2,200,452
|
|
|
|
|
|
|
|
|
Gross profit /
(loss)
|
26,911
|
|
(37,964)
|
|
110,370
|
|
(92,766)
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
58,235
|
|
140,627
|
|
202,138
|
|
317,237
|
Sales and
marketing
|
254,471
|
|
303,783
|
|
532,892
|
|
657,526
|
General and
administrative
|
1,124,683
|
|
537,940
|
|
1,876,395
|
|
1,113,891
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
1,437,389
|
|
982,350
|
|
2,611,425
|
|
2,088,654
|
|
|
|
|
|
|
|
|
Operating
loss
|
(1,410,478)
|
|
(1,020,314)
|
|
(2,501,055)
|
|
(2,181,420)
|
|
|
|
|
|
|
|
|
Non-operating
income (expense):
|
|
|
|
|
|
|
|
Interest
income
|
55,890
|
|
72,360
|
|
113,307
|
|
145,055
|
Change in fair
value of warrant derivative liability
|
43,000
|
|
41,000
|
|
58,000
|
|
347,000
|
Financing and
interest expense
|
-
|
|
-
|
|
(950)
|
|
(3,451)
|
|
|
|
|
|
|
|
|
Non-operating
income / (expense), net
|
98,890
|
|
113,360
|
|
170,357
|
|
488,604
|
|
|
|
|
|
|
|
|
Net
loss
|
(1,311,588)
|
|
(906,954)
|
|
(2,330,698)
|
|
(1,692,816)
|
Preferred stock
dividends
|
(2,658)
|
|
(2,658)
|
|
(5,316)
|
|
(5,316)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common shareholders
|
$ (1,314,246)
|
|
$ (909,612)
|
|
$ (2,336,014)
|
|
$ (1,698,132)
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share
|
$
(0.02)
|
|
$ (0.02)
|
|
$
(0.04)
|
|
$
(0.03)
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
55,013,553
|
|
54,883,445
|
|
55,013,227
|
|
54,875,749
|
|
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these consolidated 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; future demand for IsoRay's products; whether
IsoRay will be able to continue to expand its base beyond prostate
cancer; whether sales and use of our products will continue at
historic levels or increase; whether awareness of our products in
the medical community will continue or increase; whether our sales,
marketing and communications efforts will be successful; whether
additional studies will be published or presented with favorable
outcomes from treatment with our products; whether the Company's
educational efforts will continue or be successful; whether the
planned strategic review of the Company will be completed as
planned or will result in any favorable changes; whether the
increases in legal costs and CEO severance costs will continue to
be non-recurring expenses; whether future costs of the pending
class action lawsuit will be covered by insurance; 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, patient results
achieved using our products in both the short and long term,
success of future research and development activities, patient
results achieved when our products are 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 products, whether
additional studies and protocols are released and support the
conclusions of past studies and protocols, whether ongoing patient
results with our products are favorable and in line with the
conclusions of clinical studies and initial patient results,
whether we, our distributors and our customers will successfully
obtain and maintain all required regulatory approvals and licenses
to market, sell and use our products in their various forms,
continued compliance with ISO standards as audited by BSI, and
other risks detailed from time to time in IsoRay's reports filed
with the SEC. Unless required to do so by law, the Company
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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visit:http://www.prnewswire.com/news-releases/isoray-reports-second-quarter-fiscal-2016-financial-results-300217875.html
SOURCE IsoRay, Inc.