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Brachytherapy: An Initial Report.

Key Takeaway: RELEASE for August 20, 2008 Contact: Allen & Caron Jonathan Hunt, CFO Michael Mason (investors) 509-375-1202 Brian Kennedy (media) jhunt@isoray.com 212 691 8087 michaelm@allencaron.com brian@allencaron.com Fourth Quarter & Fiscal Year 2008 Results Washington (August 20

Full Press Release Details

RELEASE for August 20, 2008
Contact: Allen & Caron Jonathan Hunt, CFO
Michael Mason (investors) 509-375-1202
Brian Kennedy (media) jhunt@isoray.com
212 691 8087
michaelm@allencaron.com
brian@allencaron.com
Fourth Quarter & Fiscal Year 2008 Results
Washington (August 20, 2008) IsoRay Inc. (AMEX:ISR), a medical isotope company
focused on the treatment of prostate cancer and other malignant disease through
use of its proprietary radioisotope technology, announces today its financial
results for the quarter and year ended June 30, 2008.
year has seen many changes at IsoRay," said IsoRay Chairman and CEO Dwight
Babcock. "We have made significant steps in focusing on the core business,
gaining efficiencies, lowering the cost structure, and reducing cash
expenditures. With the majority of the operational changes in place we are
actively hiring and building up our sales force in an effort to substantially
improve our top line growth."
the Company's revenues were generated through sales of Proxcelan Cesium-131
seeds for the treatment of prostate cancer. Since
first patient implant in October 2004 over 2,800 prostate cancer patients have
been treated with Cesium-131.
Key Financial Metrics
FY2008 FY2007 % Chg
Product sales 7,158,690 5,738,033 25%
Gross loss (151,434) (54,597) 177%
Net loss (8,557,507) (9,605,155) -11%
Q4-FY2008 Q4-FY2007 % Chg
Product sales 1,760,985 1,652,740 7%
Gross margin (loss) 381,139 (7,372) 5,270%
Net loss (1,441,439) (2,735,183) -47%
Q4-FY2008 Q3-FY2008 % Chg
Product sales 1,760,985 1,783,642 -1%
Gross margin 381,139 100,661 279%
Net loss (1,441,439) (2,170,324) -34%
fiscal year 2008, sales revenue increased by 25% to $7,158,690 over fiscal
ordering in fiscal year 2008 have increased 25% to 99, an increase from 79
centers in fiscal year 2007. The increase in Proxcelan sales during the fiscal
year can be attributed mainly to the increased number of centers ordering,
the accruing data from the monotherapy multi-institutional trial that continues
to show homogeneous gland coverage, quicker resolution of side effects, and
rapidly declining PSAs for Proxcelan patients.
for fiscal year 2008 decreased 11% to $8,557,507. Over the past six months,
Company has improved its overall cost structure by refocusing on its core
business and working to further streamline its business processes. This effort
has resulted in improved margins and lower expenses.
revenue increased 7%
$1,760,985 for the fourth quarter ending June 30, 2008 compared to the prior
quarter ended June 30, 2007. Gross
margin for the fourth quarter was $381,139, an improvement of 5,270% over the
gross loss of $7,372 for the prior year fourth quarter and increased 279% from
the gross margin of $100,661 for the previous quarter. Over the past six months,
the Company has focused on improving its production cost structure by improving
isotope forecasting and ordering, labor efficiency, and production procedures.
This focus on the production cost structure has led to improved gross margins
and the Company is continually reviewing its processes to discover additional
for the quarter ended June 30, 2008 was $1,441,439 which represents an
improvement of 47% and 34% over the net loss for the quarters ended June 30,
2007 and March 31, 2008, respectively. The reduced net loss again demonstrates
the Company's improvements in production efficiencies and overall cost structure
during the past six months as discussed above.
Company had cash and short-term investments of $8,546,033 as of June 30,
financial results reported today do not take into account any adjustments that
may be required in connection with the completion of the Company's audit and
review process and should be considered preliminary until IsoRay files its
10-K for the fiscal year ended June 30, 2008.
Company said additional major milestones achieved during the past fiscal year
Company also said that continuing initiatives include:
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole manufacturer
marketer of the Cesium-131 brachytherapy seed, used to treat prostate and other
cancers. The Cesium-131 seed offers a significantly shorter half-life than
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 common brachytherapy side
is based in Richland, Washington. More information is available about IsoRay
CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized
Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. Int.
Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385.
B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate
Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005;
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 new
sites will achieve licensure and result in future sales both in the U.S. and
abroad, whether enrichment technology will develop a viable method for producing
enriched barium and create manufacturing efficiencies, and whether IsoRay will
be able to reduce operating costs and increase revenue, 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.
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
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 with the SEC.
Inc. and Subsidiaries
Statements of Operations
Year Ended Year Ended
June 30, 2008 June 30, 2007
(unaudited)
Product sales $ 7,158,690 $ 5,738,033
Cost of product sales 7,310,124 5,792,630
Gross loss (151,434 ) (54,597 )
Operating expenses:
Research and development expenses 1,358,075 1,345,163
Sales and marketing expenses 3,725,164 3,384,472
General and administrative expenses 3,568,048 4,915,598
Total operating expenses 8,651,287 9,645,233
Operating loss (8,802,721 ) (9,699,830 )
Non-operating income (expense):
Interest income 612,077 406,921
Unrealized loss on short-term investments (274,000 ) -
Financing expense (92,863 ) (312,246 )
Non-operating income, net 245,214 94,675
Net loss $ (8,557,507 ) $ (9,605,155 )
Basic and diluted loss per share $ (0.37 ) $ (0.54 )
Weighted average shares used in computing net loss per share:
Basic and diluted 23,063,282 17,827,522
Last updated: Aug 20, 2008