RICHLAND, Wash., May 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 third
quarter and nine months of fiscal 2016, ended March 31, 2016.
Revenue was $1.2 million for the
third quarter of fiscal 2016, ended March
31, 2016, a 3.5% increase compared to $1.16 million for the third quarter of fiscal
2015, ended March 31, 2015. Prostate
brachytherapy represented 87% and 86% of total revenue for the
third quarter of fiscal 2016 and 2015, respectively. Operating
expenses were $1.39 million compared
to $1.11 million in the third quarter
of the last fiscal year. The increase is due to greater general and
administrative expenses of $0.3
million primarily due to expenses related to the transition
to a new CEO. Operating loss was $1.33
million compared to $1.05
million loss in the comparable period of the last fiscal
year. IsoRay had cash and cash equivalents and certificates of
deposit of $16.80 million as of
March 31, 2016, and no debt.
For the nine months ended March 31,
2016, revenue was $3.65
million, an 11.6% increase compared to $3.27 million for the nine months ended
March 31, 2015. Prostate
brachytherapy represented 88% and 87% of total revenue for the nine
months ended March 31 of fiscal 2016
and 2015, respectively. Operating expenses were $4.0 million compared to $3.19 million in the nine months ended
March 31, 2015. Operating loss was
$3.83 million in the nine months
ended March 31, 2016, compared to
$3.23 million loss in the comparable
period of the last fiscal year. The increased operating loss for
the nine month period ended March 31,
2016, is attributed to increased costs associated with the
transition to a new CEO as well as an increase in legal costs of
approximately $0.2 million related to
the outstanding class action shareholder lawsuit.
In February 2016, Thomas LaVoy, IsoRay's recently appointed
Chairman and Chief Executive Officer, announced he would lead
IsoRay's management team through a 90-day comprehensive business
review, which is drawing to a close. Mr. LaVoy stated, "We have
reviewed every component of our business and our team is analyzing
the information as it becomes available. We believe that
there are significant opportunities in the brachytherapy market for
IsoRay's Cesium-131, especially in the prostate area given the
consolidation that has occurred among industry providers."
"Early on in the review process, it became clear to us that we
needed to further invest in our business to generate future revenue
growth. One of our first moves was to invest in our sales and
marketing organization. As an immediate result, we hired a
Vice President of Sales and Marketing with extensive experience in
brachytherapy and retained our former COO as a part-time marketing
consultant. The sales force has now been fully staffed and
reorganized and is energized to address the significant market
opportunities we've identified for Cesium-131. We have also engaged
an external consultant to review and provide direction for
reimbursement strategies and the payment process for all payors,
including Medicare, Medicaid, and private insurers, for both
prostate and surgically placed brachytherapy. It is the
Company's hope that we can work with all payors in order to
simplify the process and ensure coverage for all eligible
procedures and patients. We also intend to overhaul the external
communications of the Company, including branding, messaging and
our website, with the goal of producing new marketing collateral
with a unified message targeted to the specific audience, including
clinicians, patients, and their families and support systems,"
continued Mr. LaVoy.
"Finally, we remain a science-driven company. We have
found the best acceptance of Cesium-131 results from educating
leading physicians about its benefits. As such, we will continue to
invest in protocols that will lead to scientifically-based,
peer-reviewed articles that evaluate the effectiveness of the
application of Cesium-131 in multiple ways, including treatment
outcome, quality of life and total treatment costs. These protocols
have previously generated peer-reviewed publications including the
clinical study discussing the cost effectiveness of surgical
resection and IsoRay's Cesium-131 intraoperative brachytherapy,
which was discussed in a press release issued on January 13, 2016. We've also continued attending
professional meetings to engage leading physicians including the
52nd Society of Thoracic Surgeons (STS) Annual Meeting and STS/AATS
Tech-Con 2016 in Phoenix, AZ in
late January 2016 as well as the
Multidisciplinary Head and Neck Symposium in Scottsdale, AZ in mid-February. As we move our
business forward, we are committed to investing in protocols that
will provide scientifically–based peer-reviewed research that will
bring our life-changing technology to a wider audience."
"We believe that the actions we have taken thus far – to fully
staff and increase support of our sales team and invest in the
payment process and scientific protocols – will enable IsoRay to
more fully benefit from the opportunities we've identified in the
marketplace. Going forward we intend to continually evaluate the
market to ensure we are ahead of any changing market conditions so
that we can proactively adjust IsoRay's response. We will announce
further details of our strategic plan as they are developed,"
concluded Mr. LaVoy.
IsoRay, Inc.
and Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three months
ended March 31,
|
|
Nine months
ended March 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Product
sales
|
$ 1,198,701
|
|
$ 1,158,109
|
|
$ 3,649,031
|
|
$ 3,265,795
|
Cost of product
sales
|
1,132,397
|
|
1,102,912
|
|
3,472,357
|
|
3,303,364
|
|
|
|
|
|
|
|
|
Gross profit
(loss)
|
66,304
|
|
55,197
|
|
176,674
|
|
(37,569)
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
183,187
|
|
141,399
|
|
385,325
|
|
458,636
|
Sales and
marketing
|
300,995
|
|
374,876
|
|
833,887
|
|
1,032,402
|
General and
administrative
|
909,144
|
|
589,934
|
|
2,785,539
|
|
1,703,825
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
1,393,326
|
|
1,106,209
|
|
4,004,751
|
|
3,194,863
|
|
|
|
|
|
|
|
|
Operating
loss
|
(1,327,022)
|
|
(1,051,012)
|
|
(3,828,077)
|
|
(3,232,432)
|
|
|
|
|
|
|
|
|
Non-operating
income (expense):
|
|
|
|
|
|
|
|
Interest
income
|
53,725
|
|
68,954
|
|
167,032
|
|
214,009
|
Change in fair
value of warrant derivative liability
|
78,000
|
|
28,605
|
|
136,000
|
|
375,605
|
Financing and
interest expense
|
-
|
|
(100)
|
|
(950)
|
|
(3,551)
|
|
|
|
|
|
|
|
|
Non-operating
income (expense), net
|
131,725
|
|
97,459
|
|
302,082
|
|
586,063
|
|
|
|
|
|
|
|
|
Net
loss
|
(1,195,297)
|
|
(953,553)
|
|
(3,525,995)
|
|
(2,646,369)
|
Preferred stock
dividends
|
(2,658)
|
|
(2,658)
|
|
(7,974)
|
|
(7,974)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common shareholders
|
$ (1,197,955)
|
|
$ (956,211)
|
|
$ (3,533,969)
|
|
$ (2,654,343)
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share
|
$
(0.02)
|
|
$ ( 0.02)
|
|
$
(0.06)
|
|
$
(0.05)
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
55,022,668
|
|
54,883,551
|
|
55,010,619
|
|
54,878,297
|
|
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these consolidated financial
statements.
|
About IsoRay
IsoRay, Inc., through its subsidiary,
IsoRay Medical, Inc. is the sole producer of Cesium-131
brachytherapy seeds, which are 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.
Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release
about IsoRay's future expectations, including: the advantages of
our products and their delivery systems, whether interest in and
use of our products will increase or continue, whether awareness
and adoption of our products in the medical community will continue
or increase, whether opportunities will be available to expand the
market for Cesium-131 brachytherapy, whether changes to IsoRay's
sales and marketing team and strategy will result in growth,
whether IsoRay will be successful in simplifying the payment
process for its products, whether IsoRay's protocols will produce
favorable results or lead to publications, whether peer-reviewed
publications of treatment results using our products will report
favorable results, 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 our products, our ability
to successfully manufacture, market and sell our products, our
ability to manufacture our products in sufficient quantities to
meet demand within required delivery time periods while meeting our
quality control standards, our ability to enforce our intellectual
property rights, whether additional studies are released and
support the conclusions of past studies, whether ongoing patient
results with our products are favorable and in line with the
conclusions of clinical studies and initial patient results,
patient results achieved when our products are used for the
treatment of cancers and malignant diseases beyond prostate,
successful completion of future research and development
activities, 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 its various
forms, continued compliance with ISO standards as audited by BSI,
the success of our sales and marketing efforts, changes in
reimbursement rates, changes in laws and regulations applicable to
our products, 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.
Logo -
http://photos.prnewswire.com/prnh/20160301/339505LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/isoray-announces-third-quarter-fiscal-2016-financial-results-and-early-conclusions-from-ongoing-strategic-review-process-300266209.html
SOURCE IsoRay, Inc.