Full Press Release Details
FIRST QUARTER FISCAL 2016 FINANCIAL RESULTS
Growth In The 1st Quarter 2016 Over 1st Quarter 2015
RICHLAND, Washington (November 10, 2015)
- 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 first quarter of fiscal 2016, which ended September 30, 2015.
Revenue was $1.26 million for the first
quarter, a 21% increase compared to $1.04 million for the first quarter of fiscal 2015, which ended September 30, 2014. Operating
expenses were $1.17 million compared to $1.11 million in the first quarter of the last fiscal year. Operating loss was $1.09 million
compared to a $1.16 million operating loss in the comparable period of the last fiscal year. IsoRay had cash, cash equivalents
and certificates of deposit of $18.6 million as of September 30, 2015 and no debt.
Management continues to promote Cesium-131's
success with major U.S. universities, teaching hospitals and cancer specialist groups. "The recent peer reviewed publications
demonstrating the efficacy of IsoRay's brachytherapy, combined with our increased marketing efforts, have begun to impact
the number of procedures done with our Cesium-131 seed therapy in other parts of the body," said Dwight Babcock, Chairman
and CEO of IsoRay. "While prostate treatment still represents the main use of our seed therapy, usage has begun to expand
in head and neck, lung, brain and gynecological cancers. There are a number of additional independent studies currently underway,
and we expect usage to continue slowly expanding as additional published studies re-confirm the initial positive results. As more
key opinion leaders in the field learn of other institutions' success with Cesium-131 and begin administering treatments
and experiencing first-hand the lower recurrence of cancer and improved quality of life that the published studies have shown Cesium-131
can deliver to their cancer patients, we anticipate additional growth."
IsoRay's management continues to
work on educating new institutions and physician groups on the benefits of its Cesium-131 brachytherapy product line. Management
spends considerable time at national conventions and regional conferences exhibiting the Company's products as well as hosting
formal dinners which promote peer-to-peer conversations among cancer surgeons and other medical practitioners. Most recently, IsoRay
exhibited at the American Association of Physicists in Medicine Conference (AAPM) and the American Society for Radiation Oncology
Conference (ASTRO). IsoRay also participated in a conference at the MD Anderson Center titled "The Utilization of MRI in
LDR and HDR Prostate Brachytherapy: From Diagnostics to Response Assessment". Mr. Babcock concluded, "We are establishing
a better paradigm in cancer treatment. We look forward to bringing new treatment options to an expanding group of patients and
their medical professionals."
| IsoRay, Inc. and Subsidiaries Consolidated Statements of Operations | ||||||||
| (Unaudited) | ||||||||
| Three months ended September 30, | ||||||||
| 2015 | 2014 | |||||||
| Product sales, net | $ | 1,261,322 | $ | 1,042,101 | ||||
| Cost of product sales | 1,177,863 | 1,096,903 | ||||||
| Gross profit / (loss) | 83,459 | (54,802 | ) | |||||
| Operating expenses: | ||||||||
| Research and development | 143,903 | 176,610 | ||||||
| Sales and marketing | 278,421 | 353,743 | ||||||
| General and administrative | 751,712 | 575,951 | ||||||
| Total operating expenses | 1,174,036 | 1,106,304 | ||||||
| Operating loss | (1,090,577 | ) | (1,161,106 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 57,417 | 72,695 | ||||||
| Change in fair value of warrant derivative liability | 15,000 | 306,000 | ||||||
| Financing and interest expense | (950 | ) | (3,451 | ) | ||||
| Non-operating income (expense), net | 71,467 | 375,244 | ||||||
| Net loss | (1,019,110 | ) | (785,862 | ) | ||||
| Preferred stock deemed dividends | - | - | ||||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | ||||
| Net loss applicable to common shareholders | (1,021,768 | ) | (788,520 | ) | ||||
| Basic and diluted loss per share | $ | (0.02 | ) | $ | (0.01 | ) | ||
| Weighted average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 55,012,901 | 54,868,053 |
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.
Investors: Stephanie Prince
Safe Harbor Statement
this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems; 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 sales and use of our products will continue
at historic levels or increase; whether additional physicians and medical centers will begin using our products; whether awareness
of our products in the medical community will continue or increase; whether our sales and marketing 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; 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.