Recent Updates
Recently added Catalysts
CATX

Unassociated Document NEWS RELEASE for

Key Takeaway: NEWS RELEASE for September Contact: Dwight Babcock, CEO (520) 240-4840 dbabcock@isoray.com Inc. Announces Fiscal Year 2009 Results Washington (September 24, 2009) IsoRay Inc. (AMEX:ISR), a medical isotope company focused on the treatment of lung cancer, head and neck tumors

Full Press Release Details

NEWS RELEASE for September
Contact: Dwight Babcock, CEO
(520) 240-4840
dbabcock@isoray.com
Inc. Announces Fiscal Year 2009 Results
Washington (September 24, 2009) IsoRay Inc. (AMEX:ISR), a medical isotope
company focused on the treatment of lung cancer, head and neck tumors, prostate
cancer and other malignant disease through use of its proprietary radioisotope
technology, announces today its financial results for the quarter and year ended
FY2009 FY2008 % Chg
Product sales 5,417,815 7,158,690 -24 %
Gross loss (353,332 ) (151,434 ) 133 %
Net loss (6,160,841 ) (8,557,507 ) -28 %
FY2009 gross and net loss included a $425,434 impairment charge relating to a
license. Excluding this one-time write off, IsoRay would have
recognized a gross margin of $72,102 and a net loss of $5,735,407 in
the Company's revenues were generated through sales of Proxcelan Cesium-131
seeds for the treatment of prostate cancer. Since the first patient
implant in October 2004 over 4,000 prostate cancer patients have been treated
with Proxcelan Cesium-131 Brachytherapy seeds.
Company had cash and short-term investments of $4,670,564 as of June 30,
Babcock, IsoRay CEO, stated "This past year has seen the culmination of
numerous changes at IsoRay. Although it has been a challenging year
for prostate brachytherapy in general, and also for IsoRay, we are very
encouraged by where we stand today."
first two months of the first quarter of fiscal year 2010 the company has seen
dramatic improvements in the gross margin, net loss, and cash burn rate over the
comparable periods of fiscal year 2009. From July 1, 2009 through
August 31, 2009, based on our unreviewed preliminary internal results, gross
margin is approximately 288% higher, net loss is approximately 47% lower, and
cash used in operations is approximately 66% lower than the comparable two month
period of fiscal year 2009. These gross margin, net loss and cash used in
operations percentages do not take into account any adjustments that may be
required in connection with the completion of the company's review process and
should be considered preliminary until IsoRay files its Form 10-Q for the fiscal
quarter ended September 30, 2009.
milestones achieved during the past fiscal year in the areas of restructuring,
improvements and new product development that provide the company a solid
platform to move forward include:
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 or prostate cancer(c) and ocular melanoma(d),
among other cancerous conditions.
based in Richland, Washington. More information is available about IsoRay at
Armpilia 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
DeFoe 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
Bice 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
Melhus CS, Rivard MJ. COMS eye plaque brachytherapy dosimetry simulations
for 103Pd, 125I, and 131Cs. Medical Physics
Safe Harbor Statement
Statements 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, IsoRay's manufacturing
needs and capabilities, whether IsoRay will continue to be able to reduce
operating costs and increase revenue, whether expansion into new markets will be
successful or result in improved sales, whether IsoRay will continue to meet
Health Canada's requirements and expectations to sell Proxcelan in Canada,
whether IsoRay will be able to start and complete its proposed clinical trial in
Canada, whether IsoRay will be successful in launching any new products and
whether such new products will result in cost increases, whether the hiring of
the Vice President of Sales and related changes in IsoRay's sales and marketing
strategy will result in improved sales, whether the company's efforts at ASTRO
will result in expansion in the lung market, whether results of future studies
and protocols will support the findings from initial studies, 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, 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 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, and other risks detailed from time to
time in IsoRay's reports filed with the SEC.
IsoRay Inc. and Subsidiaries
Consolidated Statements of
Year Ended Year Ended
June 30, 2009 June 30, 2008
Product sales $ 5,417,815 $ 7,158,690
Cost of product sales 5,771,147 7,310,124
Gross loss (353,332 ) (151,434 )
Operating expenses:
Research and development expenses 958,665 1,358,075
Sales and marketing expenses 2,365,973 3,725,164
General and administrative expenses 2,792,611 3,568,048
Total operating expenses 6,117,249 8,651,287
Operating loss (6,470,581 ) (8,802,721 )
Non-operating income (expense):
Interest income 111,047 612,077
Gain (loss) on fair value of
short-term investments 274,000 (274,000 )
Financing and interest expense (75,307 ) (92,863 )
Non-operating income, net 309,740 245,214
Net loss $ (6,160,841 ) $ (8,557,507 )
Basic and diluted loss per share $ (0.27 ) $ (0.37 )
Weighted average shares used in computing net loss per share:
Basic and diluted 22,942,088 23,063,282
Last updated: Sep 24, 2009