Full Press Release Details
Reports 2010 First Quarter Financial Results
EDGE, NJ--(PRNewswire)-May 13, 2010 -- Nephros, Inc. (OTC:NEPH.OB - News)
announced today financial results for the three months ended March 31,
remainder of 2010, the company's primary focus is to obtain a formal response to
our pending 510(k) submission and complete the approval process," said Paul A.
Mieyal, acting CEO of Nephros. "At the same time, we are aggresively
evaluating ways to reduce our cost of goods and increase sales of MD filters in
Europe. Nephros has an installed base of DSU filters for infection
control in several major hospitals. Nephros is seeking additional
distributors and plans to hire additional salespeople to expand this
market. Our relationship with the U.S. military remains
solid. Our goal is to leverage research funding to obtain contracts
to supply filtration products to the military. We continue to seek additional
funding opportunities to support our business plan."
Performance for the First Quarter Ended March 31, 2010 (Unaudited)
quarter ended March 31, 2010, Nephros recognized net product revenues of
approximately $989,000 compared with $631,000 in the corresponding period of
2009, an increase of $358,000 or 57%. The increase is primarily attributable to
an approximately $120,000 or 36% increase in revenue related to the contract
with the Office of Naval Research recognized in the first quarter of 2010
compared to the same period in 2009. Sales of the OLpurTM MD 190
and MD 220 products in Europe increased by approximately $140,000 or 51% in the
first quarter of 2010 compared to the same period in 2009. Sales of
Dual Stage Ultrafilters (DSUs) in the United States increased by approximately
$98,000 or 408% in the first quarter of 2010 compared to the same period in
expenses for the three months ended March 31, 2010 were approximately $916,000
compared with $919,000 in the corresponding period of 2009. The decrease of
approximately $3,000 is primarily related to the reduction in depreciation
expense of $36,000 or 50% in the first quarter of 2010 compared to the same
period in 2009. Selling,
general and administrative expenses were approximately $18,000 or 2% more in the
first quarter of 2010 compared to the same period in 2009. Increased
spending in severance pay, legal and accounting expenses was partially offset by
reduced spending in personnel related and marketing
expenses. Research and development expenses increased by
approximately $15,000 in the first quarter of 2010 compared to the same period
in 2009. Increases were primarily related to personnel
net loss was approximately $528,000 or $0.01 per basic and diluted common share
for the first quarter of 2010 versus a net loss of approximately $735,000 or
$0.02 per basic and diluted common share in the fourth quarter of 2009. Nephros'
net loss decreased $207,000 or 28% in the current quarter primarily due to the
approximately $213,000 or 29% reduction in loss from operations in the first
quarter of 2010 compared to the same period in 2009.
Renal Disease (ESRD) Products
completed the patient treatment phase of the U.S. clinical trial evaluation of
the OLpurTM H2HTM module
filter during the second quarter of 2008. The Company submitted the clinical
data to the FDA with the 510(k) application for U.S. marketing approval of these
products in November 2008. Following its review of the application,
the FDA requested additional information from us. We replied to the
FDA inquiries on March 13, 2009. The FDA has not provided us with any
additional requests for information or rendered a decision on our
application. We have made inquiries to the FDA about the status of
our application and have most recently been informed that as of March 10, 2010
our application is still under their review process. Nephros believes
that, if approved, its technology would be the first FDA-approved on-line HDF
therapy available in the U.S.
Ultrafiltration Products
1, 2009, we received FDA approval to market the DSU to be used to filter
biological contaminants from water and bicarbonate concentrate used in
hemodialysis procedures. Nephros is investigating a range of
commercial, industrial and retail opportunities for its DSU
technology. On March 23, 2010, Nephros announced a product
development agreement with STERIS Corporation (NYSE: STE).
has contracted with the Office of Naval Research to develop an advanced water
purification system for military field use. Nephros' proprietary dual stage cold
sterilization ultrafilter will form the basis of the portable system. Nephros is
continuing the development of its dual stage ultra reliable personal water
filtration system under support from its U.S. Department of Defense
appropriation and has completed initial concept development. Once work on this
initial project was completed in August 2009, we were awarded a new $1.8 million
research contract from the Office of Naval Research for continued development of
a potable dual-stage military water purifying filter. We have
also introduced the DSU to various government agencies as a solution to
providing potable water in certain emergency response situations.
Inc., headquartered in River Edge, New Jersey, is a medical device company
developing and marketing filtration products for therapeutic applications,
infection control, and water purification.
Nephros hemodiafiltration ("HDF") system is 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 by the irreversible loss of kidney function. The Nephros HDF
system removes a range of harmful substances more effectively, and with greater
capacity, 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 ESRD products are sold and distributed throughout Europe
and are currently being used in over fifty clinics in Europe.
Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water
filtration products. The patented dual stage cold sterilization ultrafilter has
the capability to filter out bacteria and, due to its exceptional filtration
levels, filter out many viruses, parasites and biotoxins. Nephros's DSUs are
being evaluated at several major U.S. medical centers for infection control. The
DSU has also been selected for further development by the U.S. Marine Corps for
purification of drinking water by soldiers in the field.
information about Nephros, please visit our website at
in this news release that are not historical facts constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act