IsoRay Inc. (AMEX:ISR), Richland, Washington, a medical isotope
company focusing on the treatment of prostate and other malignant
disease through use of its proprietary radioisotope technology,
announces its financial results for the quarter and year ended June 30,
2007. All of 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 through September 2007, over
1,600 prostate cancer patients have been treated with Cesium-131.
For the fiscal year, product sales increased by 188% to $5,738,033
over fiscal year 2006, highlighted by same-quarter product sales
increase of 102% to $1,652,740 for Q4-FY2007 over Q4-FY2006. Centers
ordering in fiscal year 2007 have increased to 59, or a 127% increase
from 26 in fiscal year 2006. The increase in Proxcelan sales during the
fiscal year can be attributed to several factors, including an increase
in the company's direct sales team (from three to ten sales
associates), and the increased number of medical centers ordering
Proxcelan seeds. Sales were further influenced by the availability of
peer-reviewed clinical data, including the completion of a 100 patient,
multi-institutional trial showing homogeneous gland coverage, quicker
resolution of side effects, and rapidly declining PSAs for Proxcelan
patients.
The increase in product sales in Q4-FY2007 over the Q3-FY2007 sales
was nominal, and the company has observed that seasonality plays a role
in ordering as implantation procedures are often deferred due to
physician vacations (particularly in the summer months), holidays,
medical conventions, and sabbaticals. In addition, the company has also
observed that physicians, once they have implanted a few patients, may
wait to observe their own patients' outcomes before choosing to
regularly use Cesium-131 over their existing preferred isotope.
Gross loss for Q4-FY2007 was $7,372, an improvement of 99% over the
gross loss of $569,306 for Q4-FY2006. Gross loss for the fiscal year
ended June 30, 2007 was $54,597, which represents an improvement of 97%
over the fiscal year 2006 gross loss of $1,820,816. The improvement in
each period is due to increased sales volume offsetting fixed production
costs and increased production efficiency.
Gross loss in Q4-FY2007 decreased by 104% over the Q3-FY2007 gross
margin of $188,716. The decrease in gross margin is due to rental
payments for the new production, facility that was being constructed,
and were not capitalized and depreciation on additional equipment placed
in service. The company had cash of $9,355,730 and short-term
investments of $9,942,840 as of June 30, 2007.
As of September 28, 2007, management believes that top line
revenues in Q1-FY2008 will be up about 12% from Q4-FY2007. This revenue
number does 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-QSB
for the fiscal quarter ended September 30, 2007.
"This was a year of milestones for the company, with a robust
increase in Proxcelan sales, a stream of new clinical data and the
opening of a new production facility," said IsoRay Chairman and CEO
Roger Girard. "Furthermore, we have laid the groundwork for
additional technology opportunities."
Another major milestone achieved this fiscal year is the removal of
the going concern paragraph from the audit report issued by our
independent registered public accounting firm. Due to the capital raised
in various financing rounds throughout the fiscal year, management
believes our current cash and short-term investment positions are
sufficient to meet our cash requirements for operations, debt service,
and capital expenditures during fiscal year 2008. This will allow
management to focus on executing our business strategy without the need
to raise additional capital over the coming fiscal year. Several
clinical trials and studies supported the growing adoption of Proxcelan
during the past fiscal year:
A multi-institutional Cesium-131 monotherapy protocol was fully
enrolled as of February 2007. Conducted by Dr. Bradley Prestidge and Dr.
Bill Bice, the 100 patient trial demonstrated that Cesium-131 provided
patients relatively rapid resolution of side effects compared to similar
studies with Iodine-125, and low levels of PSA with no biochemical
failures.
A second ongoing study compared the dosimetry of Cesium-131 and
Palladium-103 directly. The study showed a 17.5% reduction in number of
seeds, 6% reduction in planned needles, 35.5% reduction in V150 (percent
of gland that receives more than 150% of the prescription dose), and
44.2% reduction in R100 (percent of rectal tissue that receives the full
prescription dose). (Musmacher, J., "Dosimetric comparison of
Cesium-131 and Palladium-103 for permanent prostate brachytherapy,"
poster presented at 49th AAPM Annual Conference, Minneapolis, MN, July
22-26, 2007.)
A continuing prospective randomized monotherapy trial headed by Dr.
Brian Moran compares Cesium-131 and Iodine-125 treatment related
morbidities such as sexual dysfunction and incontinence in low to
intermediate risk patients. Initial data was released at the American
Brachytherapy Association annual meeting in April, concluding that
Cesium-131 "is effective and well-tolerated in its use to kill
cancer cells in low dose (LDR) brachytherapy therapy for the treatment
of prostate cancer," stated Moran.
The company has also commissioned a dual therapy protocol. This
multi-institutional trial observes the dosimetric characteristics of
Cesium-131 and health related quality of life (HRQOL) results following
combined Cesium-131 transperineal permanent prostate brachytherapy and
external beam radiation therapy in patients with intermediate to high
risk prostate cancer. This protocol is being conducted to confirm
clinically what radiobiological data suggests regarding this treatment
modality. The quantified dosimetric variables collected will be
correlated to the reported HRQOL data and ultimately compared to
existing data in the literature for similar investigations using
Iodine-125 and Palladium-103. Patient enrollment for this study began in
April 2007.
At ASTRO 2008, to be held in Los Angeles this November, abstracts
will be presented from each of the protocols (with the exception of the
dual therapy, which is in the process of enrolling patients) and other
institutions will also be presenting on Cesium-131. The sales
opportunity pipeline during Q4-2007 included 22 new sites or customers
that placed 18 orders for Proxcelan Cesium-131 brachytherapy seeds.
Nineteen sites received amended Radioactive Active Material (RAM)
licenses; 14 sites have submitted RAM licenses for amendment and 29
potential new sites have started the process for amending their license.
In September 2007, three months ahead of schedule and under budget, the
company opened a new manufacturing and production facility at the
Applied Process Engineering Laboratory in Richland, WA, to support the
increasing production requirements. The 19,000 square-foot facility--
four times the size of the original facilitywill initially increase
IsoRay's capacity to 100,000 seeds per month.
Several continuing initiatives by the company include: The company
has used Pacific Northwest National Laboratory (PNNL) to provide
third-party assay of its products. Management is currently setting up
facilities to move the independent assay of its products to its new
production facility and will utilize in-house resources which will
reduce isotope depletion and also minimize assay expenditures. The
company is currently developing an enrichment device to produce
"enriched barium" having a higher concentration of the
Barium-130 isotope than is found in naturally occurring barium.
Irradiating enriched barium will result in higher yields of Cesium-131.
The company anticipates the use of enriched barium will also streamline
the manufacturing process and significantly reduce Cesium-131 production
costs.
The company anticipates signing a contract with the ATR Nuclear
facility in Idaho in fiscal year 2008 to irradiate enriched barium
targets. This will serve not only as an additional supply source in the
United States, but through the enrichment initiative, gives IsoRay
flexibility in meeting the world demand for Cesium-131 either from the
United States or Russia, or both.
IsoRay intends to expand the benefits of Cesium-131 to other
organs. Currently the company is drafting a protocol for using
Cesium-131 to support the treatment of lung cancer. The protocol once
completed will require IRB approval from the institutions participating,
which can take several months to complete. In addition to the protocol,
a 510(k) or premarket notification with the FDA will be required for the
device the company intends to use for this application. Finalizing the
protocols and receiving approval on the 510(k) should take approximately
four months. The company has no control over the length of each
institution's IRB approval process.
About IsoRay
IsoRay, 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. IsoRay
is based in Richland, Washington.
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