Full Press Release Details
Reports Third Quarter 2007 Financial Results
YORK, NY-November 13, 2007 - Nephros, Inc. (AMEX: NEP)
announced today financial results for the three and nine month periods ended
third quarter of 2007 has been an exciting period for Nephros," said Norman J.
Barta, Chairman and CEO of Nephros. "With our recent financing, the
Company is now poised to execute the commercialization of our filtration
anticipate 2008 to be a transforming year for Nephros. Upon
successful completion of the U.S. clinical trial, Nephros plans to seek FDA
approval to market both the OLp r(TM)
H2H(TM) Module and the OLp r(TM)
Hemodiafilter series in the U.S., with a product launch targeted for
2008. We were pleased with the physician interest and enthusiasm
during our product demonstrations at the recent American Society of Nephrology
(ASN) Renal Week in San Francisco, CA. It was clear these physicians
understood the value our technologies can bring to both the patient and the
progress with our leading-edge technologies for ESRD therapy, we are also
placing our water ultrafiltration products on the fast track, moving forward
with our marketing and sales in hospital, assisted living, and related domains
and pursuing our military product development."
October 16, 2007, Nephros announced the initiation of its pivotal U.S. clinical
trial for the OLp r(TM)
H2H(TM) Hemodiafiltration Module and OLp r(TM)
220 Hemodiafilter. Nephros believes that, upon approval, its
mid-dilution HDF technology would be the first approved online HDF therapy
quarter ended September 30, 2007, Nephros reported net product revenues of
$112,000, attributable to sales of its OLp r(TM)
MD190 and MD220 products in Europe, compared with $165,000 in the corresponding
period of 2006, a decrease of 32%. The decrease is largely due to a few
customers in the U.K. drawing down surplus inventory positions.
Company's net loss was $1,462,000 or $(0.12) per basic and diluted common
for the third quarter of 2007 versus a net loss of $1,906,000 or $(0.15)
basic and diluted common share in the third quarter of 2006. The Company's net
loss was decreased in the current quarter primarily due to the gain
recorded on the exchange of notes which includes approximately the gain realized
on debt extinguishment and the impact of refunds received from New York
State for Qualified Emerging Technology Credits.
product revenues for the nine months ended September 30, 2007 were $755,000
compared to $641,000 in the corresponding period of 2006, an increase of almost
18%. The Company's net loss was $4,663,000 or $(0.38) per basic and diluted
common share for the nine months ended September 30, 2007 compared with
$5,758,000 or $(0.47) per basic and diluted common share for the corresponding
September 30, 2007, Nephros had cash, cash equivalents and short-term
investments of $10,513,000.
Inc., headquartered in New York, is a medical device company developing and
marketing products designed to improve the quality of life for the End-Stage
Renal Disease (ESRD) patient, while addressing the critical financial and
clinical needs of the care provider. ESRD is a disease state characterized
the irreversible loss of kidney function. The Nephros HDF system is designed
remove a range of harmful substances more effectively, and more
cost-effectively, than existing ESRD treatment methods; particularly with
respect to substances known collectively as "middle molecules." These molecules
have been found to contribute to such conditions as dialysis-related
amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately,
mortality in the ESRD patient. Nephros products are sold and distributed
throughout Europe and are currently being used in over fifty clinics in
also markets a line of water filtration products, the Dual Stage Ultrafilter
(DSU). The Company's patented dual stage cold sterilization Ultrafilter has
capability to filter out bacteria and, due to its exceptional filtration levels,
filter out many viruses and parasites. The DSU proprietary design provides
dual-stage filtration which reduces the risk of filtration failure. With an
initial focus on health care, the DSU is in a pilot-use program at a major
medical center and has been selected for further development by the U.S. Marine
information on Nephros please visit the Company's website, www.nephros.com.
release contains certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended. Such
statements include statements regarding the efficacy and intended use of the
Company's technologies under development, the timelines for bringing such
products to market and the availability of funding sources for continued
development of such products and other statements that are not historical facts,
including statements which may be preceded by the words "intends," "may,"
"will," "plans," "expects," "anticipates," "projects," "predicts," "estimates,"
"aims," "believes," "hopes," "potential" or similar words. For such statements,
the Company claims the protection of the Private Securities Litigation Reform
statements are not guarantees of future performance, are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control. Actual
results may differ materially from the expectations contained in the
forward-looking statements. Factors that may cause such differences include
risks that: (i) Nephros may not be able to satisfy its obligations when
they become due and payable and meet its anticipated cash needs and may not
able to obtain funding if and when needed or on terms favorable to it in order
to continue operations or fund its clinical trials; (ii) Nephros may not be
to continue as a going concern; (iii) Nephros may be unable to show progress
consistent with its plan of compliance to meet the American Stock Exchange's
continued listing standards or may be otherwise unable to timely regain
compliance with the AMEX listing standards; (iv) products that appeared
promising to Nephros in research or clinical trials may not demonstrate
anticipated efficacy, safety or cost savings in subsequent pre-clinical or
clinical trials; (v) Nephros may not obtain appropriate or necessary
governmental approvals to achieve its business plan or effectively market its
products; (vi) Nephros may encounter unanticipated internal control deficiencies
or weaknesses or ineffective disclosure controls and procedures; (vii) HDF
therapy may not be accepted in the United States and/or Nephros' technology and
products may not be accepted in current or future target markets, which could
lead to failure to achieve market penetration of Nephros' products; (viii)
Nephros may not be able to sell its ESRD therapy or water filtration products
competitive prices or profitably; (ix) Nephros may not be able to secure or
enforce adequate legal protection, including patent protection, for its
products; (x) FDA approval relating to Nephros' OLp r HD190 filter may not
facilitate or have any effect on the regulatory approval process for its other