Full Press Release Details
| FOR IMMEDIATE RELEASE | Contact: | Dwight Babcock | |
| Tel: | (520) 240-4840 | ||
| Email: | dbabcock@isoray.com |
INC. ANNOUNCES FIRST QUARTER FISCAL YEAR 2011 RESULTS
Adoption and New Developments Expected to Stimulate Sales and Spur
Washington (November 16, 2010) - IsoRay Inc. (AMEX:
ISR) the exclusive manufacturer of Cesium-131 used in internal radiation therapy
for the treatment of lung, brain, colon, head and neck, ocular melanoma, and
as well as cancers throughout the body due to its proprietary radioisotope
technology, announced its financial results for the quarter ended September 30,
quarter of fiscal year 2011, 93% of revenue was generated from the sales of
(Cs-131) brachytherapy seeds for the treatment of prostate cancer. The
additional 7% of revenue was generated by sales for the treatment of lung, head
and neck, ocular and colon cancer. This is an increase of 193% in non-prostate cancer treatment
revenue over the first quarter of fiscal year 2010. The Company had cash
and cash equivalents of $1,024,569 as of September 30, 2010.
Chairman and CEO Dwight Babcock commented, "Our first fiscal quarter has seen
significant developments that point to our gaining traction in the medical
community's adoption of Cesium-131 for the treatment of cancers throughout the
body. Our recently announced lung cancer study and the breast cancer feasibility
study are milestone achievements and we expect these advancements to set the
tone for the year ahead. In addition, we have high
expectations for the progress we are seeing in our research and
development work building on IsoRay's acquisition of the GliaSite radiation
therapy system, the world's only FDA-cleared balloon catheter device used in the
treatment of brain cancer."
Babcock's comments highlight two key announcements made
during the first quarter of fiscal year 2011. The company announced the initiation
of a multi-institutional study of Cesium-131 internal radiation therapy for use
in Non Small Cell Lung Cancers (NSCLC). A number of institutions and
physicians will be working to collect scientific data to further the use of
IsoRay's patented Cesium-131 in conjunction with surgery for NSCLC. The study expands participation in
the application of IsoRay's breakthrough internal radiation treatment. It
allows doctors to aggressively treat lung cancer using a
single procedure upon tumor removal and is already demonstrating its impact as a
new vital weapon in the war on cancer. The implications of this announcement
are significant because lung cancer continues to be the leading cause of
cancer deaths worldwide. This year alone, an estimated 225,000 cases of lung
cancer will be diagnosed of which some 80% will be Non Small Cell Lung
The Company also announced it has
completed an initial feasibility study which demonstrates the ability
to use its patented Cesium-131 internal radiation therapy in accelerated partial
breast irradiation (APBI) for breast cancer treatment. APBI
is one of the most exciting, emerging treatments available today for early
stage, localized breast cancer. This new application of Cesium-131
will have a significant impact on breast cancer and improve the quality of life
for many women who are battling the devastating
Babcock reiterated that IsoRay remains uniquely positioned as the brachytherapy
isotope provider of choice due to the unique characteristics of Cesium-131. Its
high energy and short half-life remain important distinctions compared to
IsoRay's competitors in low dose rate brachytherapy who are treating
prostate cancer only.
developments in the first fiscal quarter of 2011, IsoRay has successfully moved
forward with its initiative to expand awareness of its landmark Cesium-131
treatment. In the first phase of this effort, IsoRay CEO Dwight Babcock was
interviewed by three prestigious media outlets including Washington, D.C.'s
highly regarded news and information station, WTOP, the Georgia News Network and
the nationally acclaimed American Urban Radio Network with its more than 26
annual meeting of the American Society for Therapeutic Radiation and Oncology
(ASTRO), the premier medical society for radiation oncologists and other members
of the radiation therapy treatment team, Cesium-131 was featured in 4
presentations at the annual meeting in October of this year.
| Q1 FY 2011 | Q1 FY 2010 | % Change | ||||||||||
| Product sales | $ | 1,327,127 | $ | 1,379,087 | -4 | % | ||||||
| Gross income / (loss) | $ | 215,600 | $ | 218,998 | -2 | % | ||||||
| Net loss | $ | (868,480 | ) | $ | (895,214 | ) | -3 | % |
Inc. and Subsidiaries
Statements of Operations
| Three months ended | ||||||||
| September 30 | ||||||||
| 2010 | 2009 | |||||||
| Product sales | $ | 1,327,127 | $ | 1,379,087 | ||||
| Cost of product sales | 1,111,527 | 1,160,089 | ||||||
| Gross income | 215,600 | 218,998 | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | 114,522 | 68,882 | ||||||
| Sales and marketing expenses | 373,425 | 442,899 | ||||||
| General and administrative expenses | 596,133 | 602,431 | ||||||
| Total operating expenses | 1,084,080 | 1,114,212 | ||||||
| Operating loss | (868,480 | ) | (895,214 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 1,061 | 5,867 | ||||||
| Financing and interest expense | (4,463 | ) | (17,361 | ) | ||||
| Non-operating income (expense), net | (3,402 | ) | (11,494 | ) | ||||
| Net loss | (871,882 | ) | (906,708 | ) | ||||
| Preferred stock dividends | (2,658 | ) | (2,658 | ) | ||||
| Net loss applicable to common shareholders | $ | (874,540 | ) | $ | (909,366 | ) | ||
| Basic and diluted loss per share | $ | (0.04 | ) | $ | (0.04 | ) | ||
| Weighted average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 23,048,754 | 22,942,088 |
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.
in this news release about IsoRay's future expectations, including: the
advantages of our Cesium-131 seed, future demand for IsoRay's existing and
planned products, whether the increase in non-prostate cancer treatment revenue
seen in the first quarter of fiscal 2011 as compared to the first quarter of
fiscal 2010 will continue in the future, whether revenue will increase in future
periods, whether IsoRay will be able to expand its base beyond prostate cancer,
whether IsoRay's Cesium-131 seed will be used to treat additional cancers and
malignant disease, whether Cesium-131 will be able to be used for APBI in human
patients, whether the use of Cesium-131 to treat breast or other cancers using
APBI or other methods will be successful in the initial and any future implants,
whether a clinical trial for APBI will be completed, the advantages of the
Gliasite delivery system, whether Cesium-131 will be successfully used in other
delivery devices to treat malignant disease, whether IsoRay will be successful
in launching any new products and whether such products will result in cost
increases, whether changes in IsoRay's sales and marketing strategy will result
in improved sales, 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 sufficient capital
to fund protocols and enhance delivery systems for other applications, physician
acceptance, training and use of IsoRay's products, changing levels of demand for
IsoRay's current and proposed future products, whether the brachytherapy
industry as a whole continues to experience declining sales, whether later
studies and protocols support the findings of the initial studies, success of
future research and development activities, patient results achieved when
Cesium-131 is used for the treatment of cancers and malignant diseases beyond
prostate cancer, the ability for users of the Cesium-131 implants to comply with
regulations related to ongoing radiation emitting from the breast, whether