Full Press Release Details
| For Release: | November 16, 2009 at 7:30AM EST |
| Contact: | Dwight Babcock, CEO |
| 520 240 4840 | |
| dbabcock@isoray.com |
Inc. Reports First 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 first quarter of fiscal year 2010, ended September 30,
revenue for the quarter decreased by 9% to approximately $1,379,087 as compared
to approximately $1,519,582 in the first quarter of fiscal
2009. However, 50 medical centers ordered the Company's Proxcelan
seeds in the first quarter of fiscal 2010 compared to the 47 centers that
ordered in the first quarter of fiscal 2009. Management believes that
the decline in sales revenue is primarily attributable to a lower average
invoice price due to the change in the seed loading configurations being ordered
by our current customers in comparison to the first quarter of FY2009. In
addition, as physicians have become more comfortable with the increased energy
of Cs-131 seeds, fewer seeds are being used.
margin for the quarter increased by 208% to approximately $218,998 as compared
to approximately $ 71,146 in the first quarter of fiscal 2009.
diluted loss per share for the quarter decreased by 50% to approximately
per share as compared to approximately $ (.08) per share in the first quarter of
Company's net loss decreased 49% from approximately $1,793,596 in the quarter
ended September 30, 2008 to $906,708 in the quarter ended September 30,
Company reduced its cash burn this quarter by 48% to approximately $515,597 as
compared to approximately $989,015 in the first quarter of fiscal 2009. The
Company had cash and short-term investments of approximately $4,029,087 as of
September 30, 2009. Management believes that this cash position
combined with our reduced monthly cash requirements can be used to support all
of the current initiatives.
the first quarter of FY2010, IsoRay commenced shipping seeds for use in other
disease sites including lung, head and neck, and ocular melanomas, supporting
the expansion of our total body brachytherapy isotope.
Babcock, IsoRay Chairman and CEO, commented "There is a unique opportunity for
Cesium-131 with its short half life and energy level to become the isotope of
choice for brachytherapy applications throughout the entire body. We
are aggressively expanding the use of Cesium-131 throughout the body with our
physician partners and demonstrating that Cs-131 can be effectively used as
primary and adjunct treatment for many cancers. It is our expectation to
continue to gain market share in the prostate market as well as expand into all
other areas of the body with a total isotope solution. We already see our
strategic plan gaining momentum and expect more facilities to adopt Cs-131 for
other tumor locations."
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the
Cesium-131 brachytherapy seed.
Cesium-131 seed offers a significantly shorter radiation half-life than the two
other isotopes commonly used for brachytherapy, which results in a substantially
faster delivery of therapeutic radiation, a theoretically improved radiation
delivery against aggressively replicating cancer(a), and
the potential for a reduced longevity of common brachytherapy side effects(b).
is currently used in the treatment of prostate cancer(c) and
ocular melanoma(d), among
other cancerous conditions.
is based in Richland, Washington. More information is available about IsoRay at
CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized
Half-lives for Radionuclides Used in Permanent Brachytherapy Implants.
International Journal of Radiation Oncology, Biology, and Physics
SG, Beriwal S, Smith R, Benoit R. Is there decreased duration of acute urinary
and bowel symptoms after prostate brachytherapy with cesium 131 isotope?
International Journal of Radiation Oncology, Biology, and Physics
WS, Prestidge BR, Kurtzman SM, Beriwal S, Moran BJ, Patel RR, Rivard,
MJ. Recommendations for permanent prostate brachytherapy with
(131)Cs: a consensus report from the cesium advisory
group. Brachytherapy 2008;7(4):290-6.
CS, Rivard MJ. COMS eye plaque brachytherapy dosimetry simulations
for 103Pd, 125I, and 131Cs. Medical Physics
in this news release about IsoRay's future expectations, including: the
advantages of our Cesium-131 seed, whether cash on hand will be sufficient to
fund planned operations throughout FY2010, whether reductions in the Company's
burn rate will continue, whether physicians and facilities will adopt Cs-131 for
use for non-prostate cancers, future demand for IsoRay's
existing and planned products, IsoRay's manufacturing needs and capabilities,
whether IsoRay will continue to be able to reduce operating costs and increase
revenue, 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, 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, success of future research and
development activities, 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 both in the United States and internationally, whether
later studies and protocols are completed and support the conclusions of the
initial studies, patient results achieved when Cesium-131 is used for the
treatment of cancers and malignant diseases beyond prostate cancer, successful
completion of future research and development activities, increases in expenses
or other items affecting the Company's burn rate, and other risks detailed from
time to time in IsoRay's reports filed with the SEC.
Inc. and Subsidiaries
Statements of Operations
| Three months ended | ||||||||
| September 30, | ||||||||
| 2009 | 2008 | |||||||
| Product sales | $ | 1,379,087 | $ | 1,519,582 | ||||
| Cost of product sales | 1,160,089 | 1,448,436 | ||||||
| Gross margin (loss) | 218,998 | 71,146 | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | 68,882 | 218,550 | ||||||
| Sales and marketing expenses | 442,899 | 730,774 | ||||||
| General and administrative expenses | 602,431 | 780,157 | ||||||
| Total operating expenses | 1,114,212 | 1,729,481 | ||||||
| Operating loss | (895,214 | ) | (1,658,335 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 5,867 | 44,786 | ||||||
| Gain (loss) on fair value of short-term investments | - | (159,200 | ) | |||||
| Financing and interest expense | (17,361 | ) | (20,847 | ) | ||||
| Non-operating income (expense), net | (11,494 | ) | (135,261 | ) | ||||
| Net loss | $ | (906,708 | ) | $ | (1,793,596 | ) | ||
| Basic and diluted loss per share | $ | (0.04 | ) | $ | (0.08 | ) | ||
| Weighted average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 22,942,088 | 22,942,088 |