Full Press Release Details
Immediate Release: November
Inc. First Quarter Fiscal Year 2008 Results
Washington - IsoRay Inc. (AMEX: ISR) a medical isotope company focusing on
treatment of prostate and other malignant disease through use of its proprietary
radioisotope technology, announced its financial results for the quarter ended
revenue in Q1-FY2008 increased by 81% to $1,855,719 over Q1-FY2007. Medical
centers ordering in Q1-FY2008 increased to 49, or a 113% increase from the
centers that ordered in Q1-FY2007. The increase in Proxcelan sales during the
quarter can be attributed to several factors, including an increase in the
Company's direct sales team (from three to eleven sales associates from
Q1-FY2007 to Q1-FY2008), and the increased number of medical centers ordering
the Company's revenues were generated through sales of Proxcelan Cesium-131
seeds for the treatment of prostate cancer. Since the first patient implant
October 2004 through October 2007, approximately 1900 prostate cancer patients
had been treated with Cesium-131 (123 patients having been treated in October
Company's net loss decreased from $2,927,435 in Q1-FY2007 to $2,159,401 in
Q1-FY2008, an improvement of 26% quarter over quarter.
Company had cash of $6,448,058 and short-term investments of $8,972,430 as
have in place a robust production platform--which was developed well ahead
schedule," said IsoRay Chairman and CEO Roger Girard. "Our ongoing goal is to
drive sales growth by continuing to expand our sales pipeline and supporting
physician customers through the licensing process."
pipeline during Q1-FY2008 included 10 new sites or customers that collectively
placed 35 orders for Proxcelan Cesium-131 brachytherapy seeds during the
quarter. Thirteen sites received amended Radioactive Material (RAM) licenses;
sites have submitted RAM licenses for amendment and 18 potential new sites
begun the process for amending their license. Currently, the sales team is
up of 11 sales personnel covering most of the United States.
Centers for Medicare and Medicaid Services (CMS) on November 1, 2007 released
its final payment rates for brachytherapy seeds. The final non-stranded rate
seed for Cesium ($64.08) was an improvement of $12.73 over the proposed rate
($51.35). The final rate per seed for stranded was unchanged ($97.72) from
proposed rate. The increase for non-stranded Cesium-131 seeds marked the largest
increase in any low dose rate (LDR) seed pricing category, including Iodine-125
and Palladium-103 radioisotope seeds. The CMS non-stranded and stranded seed
payment rates for brachytherapy sources are scheduled to take effect January
addition, IsoRay is applying for Canadian and EU certifications to sell the
Proxcelan seed in those countries.
previously announced, a conference call is scheduled for 2:00 p.m. Pacific
(5:00 p.m. Eastern Time) today to discuss this earnings release. To participate
in the call, dial 1-800-944-8766 and provide conference ID # 39141. This call
will also be webcast and can be accessed from the Company's website. Simply log
on to www.isoray.com
select Investor Information, then Webcasts, and First Quarter Fiscal 2008
Earnings. The webcast will be available for replay on www.isoray.com
financial results reported today 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, 2007.
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of
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
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, whether we will be
successful in obtaining licensure and meeting other regulatory requirements
sell our product outside of the United States, and all other statements in
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.
the protections of the safe harbor provisions of the PSLRA. It is important
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
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
| IsoRay, Inc. and Subsidiary | |||||||
| Consolidated Statements of Operations | |||||||
| (Unaudited) | |||||||
| Three months ended September 30, | |||||||
| 2007 | 2006 | ||||||
| Product sales | $ | 1,855,719 | $ | 1,025,444 | |||
| Cost of product sales | 2,005,502 | 1,288,145 | |||||
| Gross loss | (149,783 | ) | (262,701 | ) | |||
| Operating expenses: | |||||||
| Research and development | 256,370 | 245,598 | |||||
| Sales and marketing expenses | 1,059,816 | 672,930 | |||||
| General and administrative expenses | 902,025 | 1,733,132 | |||||
| Total operating expenses | 2,218,211 | 2,651,660 | |||||
| Operating loss | (2,367,994 | ) | (2,914,361 | ) | |||
| Non-operating income (expense): | |||||||
| Interest income | 238,696 | 40,183 | |||||
| Financing expense | (30,103 | ) | (53,257 | ) | |||
| Non-operating income (expense), net | 208,593 | (13,074 | ) | ||||
| Net loss | $ | (2,159,401 | ) | $ | (2,927,435 | ) | |
| Basic and diluted loss per share | $ | (0.09 | ) | $ | (0.19 | ) | |
| Weighted average shares used in computing net loss per share: | |||||||
| Basic and diluted | 23,001,041 | 15,300,747 |
Hunt, Chief Financial Officer