Full Press Release Details
11, 2008 at 7:30AM EST
| Contact: | Michael Mason (investors) | Jonathan Hunt, CFO | |
| Brian Kennedy (media) | 509 375 1202 | ||
| Allen & Caron Inc | jhunt@isoray.com | ||
| 212 691 8087 | |||
| michaelm@allencaron.com | |||
| brian@allencaron.com |
Inc. Reports Second Quarter 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 and
months ended December 31, 2007.
revenue for the quarter increased by 24 percent to approximately $1.8 million
over approximately $1.4 million in the year-earlier period. Medical centers
ordering the Company's Proxcelan seeds increased to 53, a 61 percent increase
over the 33 centers that ordered in the second quarter of fiscal 2007.
Company's revenues during the quarter were generated through sales of Proxcelan
Cesium-131 seeds for the treatment of prostate and ocular cancers. Since the
first patient implant in October 2004 through January 2008, approximately 2300
prostate cancer patients have been treated with Cesium-131.
Company's net loss increased from $1.9 million or $0.12 loss per share in fiscal
year 2007's second quarter, to $2.8 million or $0.12 loss per share in the
quarter ended December 31, 2007. The larger loss was mainly due to costs of
new facility, the cost of decommissioning the old facility, higher production
costs, increased protocol expenses, and higher sales and marketing personnel
expenses due to higher
commissions paid based on higher revenues and an increase in the sales
Company had cash of $3.5 million and short-term investments of $8.7 million
of December 31, 2007.
sales for the second fiscal quarter of fiscal 2008 showed a significant increase
from the second fiscal quarter of 2007," said IsoRay Chairman and CEO Roger
Girard. "Our ongoing goal is to drive sales growth and to that end we have
initiated educational workshops in 2008 to help provide physicians with the
tools to understand the unique characteristics of Cesium-131, and how these
differences translate into modified implant planning techniques."
added, "Our focus in the rest of fiscal 2008 is on increasing revenue while at
the same time increasing the efficiency of the manufacturing process and thereby
reducing costs. Key initiatives in 2008 include taking directly to the consumer
the favorable initial 2 year clinical results from our monotherapy protocols
report the latest data from our other ongoing trials".
pipeline during Q2-FY2008 included 9 new sites or customers that collectively
placed 16 orders for Proxcelan Cesium-131 brachytherapy seeds during the
sites received amended Radioactive Material (RAM) licenses; 27 sites have
submitted RAM licenses for amendment and 50 potential new sites have begun
process for amending their licenses during the quarter ended December 31, 2007.
previously announced, a conference call is scheduled for 1:30 Pacific Time
p.m. Eastern Time) today to discuss this earnings release. Participants should
dial into the call 10-15 minutes before the scheduled time using the following
numbers: 877-407-8031 (from the US and Canada) or +1 201 689-8031 (from outside
the US and Canada). A live webcast of the conference call will also be
accessible via the Internet at www.isoray.com,
going to www.investorcalendar.com.
telephonic replay of the conference call will be available by dialing
877-660-6853 (from the US and Canada) or +1 201 612-7415 (from outside the
and Canada) and by entering account number 286 and conference ID number 273560.
An online archive will also be available immediately following the call at
sites noted above. Both are available for ten days, through February 21,
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 December 31, 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
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 planned
physician education activities will be held or will result in favorable
physician responses, whether IsoRay will be able to reduce production costs
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
included for the express purpose of availing IsoRay, Inc. of the protections
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
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, and other risks detailed from time to time in
IsoRay's reports filed with the SEC.
Statements of Operations
| Three months ended December 31, | Six months ended December 31, | ||||||||||||
| 2007 | 2006 | 2007 | 2006 | ||||||||||
| Product sales | $ | 1,758,344 | $ | 1,414,155 | $ | 3,614,063 | $ | 2,439,599 | |||||
| Cost of product sales | 2,241,795 | 1,387,394 | 4,247,297 | 2,675,539 | |||||||||
| Gross loss | (483,451 | ) | 26,761 | (633,234 | ) | (235,940 | ) | ||||||
| Operating expenses: | |||||||||||||
| Research and development | 395,545 | 216,254 | 651,915 | 461,852 | |||||||||
| Sales and marketing expenses | 1,142,827 | 890,018 | 2,202,643 | 1,562,948 | |||||||||
| General and administrative expenses | 919,164 | 821,529 | 1,821,189 | 2,554,661 | |||||||||
| Total operating expenses | 2,457,536 | 1,927,801 | 4,675,747 | 4,579,461 | |||||||||
| Operating loss | (2,940,987 | ) | (1,901,040 | ) | (5,308,981 | ) | (4,815,401 | ) | |||||
| Non-operating income (expense): | |||||||||||||
| Interest income | 179,855 | 50,004 | 418,551 | 90,187 | |||||||||
| Financing expense | (25,211 | ) | (67,413 | ) | (55,314 | ) | (120,670 | ) | |||||
| Non-operating income (expense), net | 154,644 | (17,409 | ) | 363,237 | (30,483 | ) | |||||||
| Net loss | $ | (2,786,343 | ) | $ | (1,918,449 | ) | $ | (4,945,744 | ) | $ | (4,845,884 | ) | |
| Basic and diluted loss per share | $ | (0.12 | ) | $ | (0.12 | ) | $ | (0.21 | ) | $ | (0.31 | ) | |
| Weighted average shares used in computing net loss per share: | |||||||||||||
| Basic and diluted | 23,072,272 | 15,919,236 | 23,036,657 | 15,609,992 | |||||||||
| The accompanying notes are an integral part of these financial statements. |