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IsoRay Announces Third Quarter Fiscal 2016 Financial Results and Early Conclusions from Ongoing Strategic Review Process

Key Takeaway: IsoRay Announces Third Quarter Fiscal 2016 Financial Results and Early Conclusions from Ongoing Strategic Review Process RICHLAND, Wash., May 10, 2016 IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applic

Full Press Release Details

IsoRay Announces Third Quarter Fiscal
2016 Financial Results and Early Conclusions from Ongoing Strategic Review Process
RICHLAND, Wash., May 10, 2016 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
"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
IsoRay, Inc. and Subsidiaries
Consolidated Statements of Operations
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
notes are an integral part of these consolidated financial statements.
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
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.
Stephanie Prince, Managing Director
Sean Leous, Managing Director
Last updated: May 10, 2016