Full Press Release Details
RELEASE for February 16, 2010 at 4:30PM EST
Inc. Reports Second Quarter Results
Washington - IsoRay Inc. (AMEX: ISR) a medical isotope company focusing on the
treatment of prostate, lung, head and neck and other malignant disease through
the use of its proprietary radioisotope technology, announced its financial
results for the second quarter of fiscal year 2010, ended December 31,
revenue for the quarter increased by 3% to approximately $1,368,347 as compared
to approximately $1,326,703 in the second quarter of fiscal 2009. The
revenue increase is primarily related to orders for the new treatment modalities
such as head and neck, lung and colorectal cancers.
Company's revenues during the quarter were primarily generated through the sales
of Proxcelan Cesium-131 seeds for the treatment of prostate
cancer. The Company has now sold Proxcelan Cesium-131 seeds
that have treated in excess of 5,100 patients throughout the US.
Company recognized a gross income of $268,154 for the three month period ended
December 31, 2009, compared to a gross loss of $397,522 which included a
one-time impairment of $425,434 for the corresponding period ended December 31,
2008. If the one-time impairment had not been present in the second quarter
of fiscal 2009, the Company would have had gross income of
$27,912. Using this gross income amount for the second quarter of
fiscal 2009, gross income for the second quarter of fiscal 2010 grew by
Company's net loss decreased 42% from approximately $1.6 million for the three
months ended December 31, 2008 to $950,000 in quarter ended December 31,
Company's cash burn this quarter decreased by 32% to approximately $859,000 as
compared to approximately $1,256,000 in the second quarter of fiscal
Company had cash and short-term investments of approximately $3,106,000 as of
Babcock, IsoRay Chairman and CEO, commented "We are pleased with our 3% gain in
revenue while some of our competitors have recorded drops of 10-20% in
brachytherapy seed sales. Certainly with prostate cancer being highly
curable by most modalities, physician choices are being driven by financial
drivers. Most importantly in an effort to accelerate our revenue growth,
IsoRay is focused on the opportunity to expand our markets beyond prostate
cancer. While we will continue to grow the prostate brachytherapy
business, we have embarked on promoting our brand as the LDR isotope of choice
throughout the body. This quarter we are receiving an increasing
number of patient and physician inquiries regarding the applicability of Cesium
for other body locations. We are continuing to explore other delivery
systems that in combination with Cesium can aid in our fight against
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the
Cesium-131 brachytherapy seed, used to treat prostate and other cancers. The
Cesium-131 seed offers a significantly shorter half-life than the two other
isotopes commonly used for brachytherapy, which results in a substantially
faster delivery of therapeutic radiation, lower probability of cancer cell
survival and reduction of the longevity of common brachytherapy side
effects(a)(b). IsoRay is based in Richland, Washington. More information is
available about IsoRay at www.isoray.com.
Armpilia CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically
Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants.
Int. J. Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385.
Prestidge B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate
Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005;
Safe Harbor Statement
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 nominal increase in revenue, increase in gross
income, and decrease in the cash burn rate seen in the second quarter of fiscal
2010 as compared to the second quarter of fiscal 2009 will continue in the
future, 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 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 physician acceptance, training and use of IsoRay's products, changing
levels of demand for IsoRay's current and proposed future products; whether
later studies and protocols support the findings of the initial studies, success
of future research and development activities, whether initial implants of
Cesium-131 to treat non-prostate cancers result in favorable patient outcomes in
both the short- and long-term, patient results achieved when Cesium-131 is 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, IsoRay's ability to enforce its intellectual property rights, changes
in reimbursement rates, changes in laws and regulations applicable to our
product, and other risks detailed from time to time in IsoRay's reports filed
Inc. and Subsidiaries
Statements of Operations
| Six months ended December 31, | ||||||||
| 2009 | 2008 | |||||||
| Product sales | $ | 1,368,347 | $ | 1,326,703 | ||||
| Cost of product sales | 1,100,193 | 1,724,229 | ||||||
| Gross margin (loss) | 268,158 | (397,522 | ) | |||||
| Operating expenses: | ||||||||
| Research and development expenses | 59,078 | 306,056 | ||||||
| Sales and marketing expenses | 603,980 | 620,700 | ||||||
| General and administrative expenses | 550,009 | 758,822 | ||||||
| Total operating expenses | 1,213,067 | 1,685,578 | ||||||
| Operating loss | (944,913 | ) | (2,083,100 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 2,944 | 37,562 | ||||||
| Gain (loss) on fair value of short-term investments | - | 433,200 | ||||||
| Financing and interest expense | (7,898 | ) | (20,769 | ) | ||||
| Non-operating income (expense), net | (4,954 | ) | 449,993 | |||||
| Net loss | (949,867 | ) | (1,633,107 | ) | ||||
| Preferred stock dividends | (36,679 | ) | - | |||||
| Net loss applicable to common shareholders | $ | (986,546 | ) | $ | (1,633,107 | ) | ||
| Basic and diluted loss per share | $ | (0.04 | ) | $ | (0.07 | ) | ||
| Weighted average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 22,942,088 | 22,942,088 |