Full Press Release Details
Third 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
nine months ended March 31, 2008.
revenue for the quarter increased by 8 percent to approximately $1.8 million
over approximately $1.65 million in the year-earlier period. Medical centers
ordering the Company's Proxcelan seeds increased to 57, a 63 percent increase
over the 36 centers that ordered in the third quarter of fiscal 2007.
Company's revenues during the quarter were generated through sales of Proxcelan
Cesium-131 seeds for the treatment of prostate cancer. Since the first patient
implant in October 2004 through April 2008, approximately 2600 prostate cancer
patients have been treated with Cesium-131.
Company's net loss increased from approximately $2.0 million or $0.12 loss per
share in fiscal year 2007's third quarter, to approximately $2.2 million or
$0.09 loss per share in the quarter ended March 31, 2008. The increased loss
mainly due to depreciation costs of the new facility, increases in the cost
isotope, increased occupancy costs of the new facility and a small increase
sales and marketing.
Company had cash of approximately $3.4 million and short-term investments
approximately $6.5 million as of March 31, 2008.
Company had a gross margin of $100,661 for the three month period ended March
is to focus on increasing sales and decreasing operational costs by gaining
efficiencies in our core business, prostate brachytherapy" said IsoRay Chairman
and Interim CEO Dwight Babcock. "We continue to build on the past success of our
Cesium educational workshops, have refocused the sales force through a new
compensation package that increases the emphasis not only on generating new
customers but also supporting the growth of existing customers.
operations we are reviewing our production processes and initiating strategic
automation to reduce our labor costs and gain efficiencies."
added, "We are very pleased with the strong showing of additional clinical data
from the ongoing trials as well as the presentation of recommendations for
implanting brachytherapy with Cesium-131 by the Cesium Advisory Group at
American Brachytherapy Society meeting this past weekend in Boston."
fully subscribed Cesium educational workshop will be held on
29th and 30th, 2008 at the Chicago Prostate Cancer Center. Additional training
is planned to be available online through webcasts for physicians using real
time planning and techniques presented by Steve Kurtzman, M.D., IsoRay's Medical
Director, later this year.
pipeline during Q3-FY2008 included 7 new sites or customers that collectively
placed 11 orders for Proxcelan Cesium-131 brachytherapy seeds during the
sites received amended Radioactive Material (RAM) licenses; 15 sites have
submitted RAM licenses for amendment and 19 potential new sites have begun
process for amending their licenses during the quarter ended March 31, 2008.
previously announced, a conference call is scheduled for 1:30 p.m. Pacific
(4:30 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: 877-407-9210 (from the US and Canada) or +1 201-689-8049
(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
00284225. An online archive will also be available immediately following
call at the sites noted above. Both are available for ten days, through May
financial results reported today do not take into account any adjustments
may be required in connection with the completion of the Company's review
process and should be considered preliminary until IsoRay files its Form
for the fiscal quarter ended March 31, 2008.
Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer
Cesium-131 brachytherapy seed, used to treat prostate and other cancers.
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.
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
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 changes in IsoRay's sales and marketing strategy
will result in improved sales, whether IsoRay will be able to reduce operating
costs and increase revenue, and all other statements in this release, other
historical facts, are "forward-looking statements" within the meaning of
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
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.
| IsoRay, Inc. and Subsidiaries | |||||||||||||
| Consolidated Statements of Operations | |||||||||||||
| (Unaudited) | |||||||||||||
| Three months ended March 31, | Nine months ended March 31, | ||||||||||||
| 2008 | 2007 | 2008 | 2007 | ||||||||||
| Product sales | $ | 1,783,642 | $ | 1,645,694 | $ | 5,397,705 | $ | 4,085,293 | |||||
| Cost of product sales | 1,682,981 | 1,456,978 | 5,930,278 | 4,132,518 | |||||||||
| Gross margin (loss) | 100,661 | 188,716 | (532,573 | ) | (47,225 | ) | |||||||
| Operating expenses: | |||||||||||||
| Research and development | 434,418 | 437,143 | 1,086,333 | 898,995 | |||||||||
| Sales and marketing expenses | 888,448 | 849,744 | 3,091,091 | 2,412,691 | |||||||||
| General and administrative expenses | 869,436 | 937,905 | 2,690,625 | 3,492,565 | |||||||||
| Total operating expenses | 2,192,302 | 2,224,792 | 6,868,049 | 6,804,251 | |||||||||
| Operating loss | (2,091,641 | ) | (2,036,076 | ) | (7,400,622 | ) | (6,851,476 | ) | |||||
| Non-operating income (expense): | |||||||||||||
| Interest income | 131,442 | 68,760 | 549,993 | 158,947 | |||||||||
| Unrealized loss on short-term investments (see Note 4) | (187,300 | ) | - | (187,300 | ) | - | |||||||
| Financing expense | (22,826 | ) | (56,772 | ) | (78,140 | ) | (177,443 | ) | |||||
| Non-operating income (expense), net | (78,684 | ) | 11,988 | 284,553 | (18,496 | ) | |||||||
| Net loss | $ | (2,170,325 | ) | $ | (2,024,088 | ) | $ | (7,116,069 | ) | $ | (6,869,972 | ) | |
| Basic and diluted loss per share | $ | (0.09 | ) | $ | (0.12 | ) | $ | (0.31 | ) | $ | (0.42 | ) | |
| Weighted average shares used in computing net loss per share: | |||||||||||||
| Basic and diluted | 23,090,200 | 17,400,355 | 23,054,375 | 16,198,067 |