RIVER EDGE, NJ, May 14, 2014 /PR Newswire-FirstCall/ — Nephros, Inc. (OTCQB:NEPH), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration system for the treatment of chronic renal failure patients, announced today financial results for the three months ended March 31, 2014.
- Commenced shipment of our NanoGuard-D and NanoGuard-S ultrafilters
- Extended and expanded Bellco S.r.l. license agreement for the MD220 dialyzer
- Signed distribution agreement with Mar Cor for the DSU and SSU ultrafilters
- Completed $2.1 million Rights Offering
- First commercial placement of the Nephros on-line mid-dilution Hemodiafiltration system and treatment of first patient
“Despite residual activities related to our product recall in the fourth quarter, Nephros continued to make commercial progress with multiple product lines during the first quarter of this year,” said John C. Houghton, President and CEO of Nephros. “We have extended the reach of our dialysis water filters by adding additional distributors, we have extended the reach of our MD220 dialyzer by expanding the geographical territory of the Bellco license agreement and we have provided alternative in-line filters for filtering water for washing and drinking in commercial properties with the launch of our NanoGuard-D and NanoGuard-S.”
“More recently, we announced the first commercial treatment of a patient using our on-line mid-dilution hemodiafiltration system, and we are preparing to file a 510(k) medical device submission with the FDA within the second quarter in order to seek clearance approval for commercialization in the U.S. of the DSU-H and SSU-H in-line ultrafilters for use in hospitals. We have had no further update on the status of the U.S. Army RFP.”
Financial Performance for the First Quarter Ended March 31, 2014
Total net revenues for the three months ended March 31, 2014 were approximately $473,000 compared to approximately $521,000 for the three months ended March 31, 2013. Total net revenues decreased approximately $48,000, or 9%, arising from approximately $127,000 of lower water filter sales on dialysis and commercial water partially offset by a 47% increase, or approximately $79,000, of licensing revenue related to the Bellco license agreement.
Total operating expenses for the quarter ended March 31, 2014 were $929,000 compared with $1,333,000 for the quarter ended March 31, 2013. The decrease was primarily driven by decreases in personnel, legal and professional services fees as well as research and development costs during the quarter ended March 31, 2014 compared to the quarter ended March 31, 2013.
Net loss for the quarter ended March 31, 2014 was $760,000, or $0.04 per share (based on 18.8 million weighted average shares outstanding) compared to $1,242,000, or $0.10 per share (based on 12.0 million shares outstanding) for the quarter ended March 31, 2013. As of March 31, 2014, the Company had approximately 25.2 million shares outstanding.
Nephros ended the first quarter of 2014 with cash and cash equivalents of $473,000.
About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters. Our filters, which we call ultrafilters, are primarily used in dialysis centers for the removal of biological contaminants from water, bicarbonate concentrate and/or blood.
We were founded in 1997 by healthcare professionals affiliated with Columbia University Medical Center/New York-Presbyterian Hospital to develop and commercialize an alternative method to hemodialysis (HD). We have extended our filtration technologies to meet the demand for liquid purification in other areas, in particular water purification.
Presently, we offer ultrafilters for sale to customers in four markets:
- Dialysis Centers – Water/Bicarbonate: Filtration of water or bicarbonate concentrate used in hemodialysis devices
- Dialysis Centers – Blood: Clearance of toxins from blood using an alternative method to HD in patients with chronic renal failure
- Military and Outdoor Recreation: Highly compact, individual water purification devices used by soldiers and backpackers to produce drinking water in the field
- Commercial Facilities including Hospitals: Filtration of water for drinking and washing
For more information about Nephros, please visit the company’s website at www.nephros.com.
Certain statements in this press release constitute “forward-looking statements”. Such statements include statements regarding the efficacy and intended use of our 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. Forward-looking 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 our control. Actual results may differ materially from the expectations contained in the forward looking statements. Factors that may cause such differences include, but are not limited to, the risks that:
- we may not be able to find a strategic partner to successfully market our HDF system;
- our HDF system may not be accepted by patients or health care providers in the U.S. marketplace;
- we may not be able to continue as a going concern;
- the voluntary recalls of point of use and DSU in-line ultrafilters used in hospital water treatment applications announced on October 30, 2013 and the related circumstances could subject us to claims or proceedings by consumers, the FDA or other regulatory authorities which may adversely impact our sales and revenues;
- we face significant challenges in obtaining market acceptance of our products, which could adversely affect our potential sales and revenues;
- there are product-related deaths or serious injuries or product malfunctions, which could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products;
- we face potential liability associated with the production, marketing and sale of our products, and/or the expense of defending against claims of product liability, could materially deplete our assets and generate negative publicity which could impair our reputation;
- to the extent our products or marketing materials are found to violate any provisions of the FDC Act or any other statutes or regulations then we could be subject to enforcement actions by the FDA or other governmental agencies;
- we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations;
- we may not have sufficient capital to successfully implement our business plan;
- we may not be able to effectively market our products;
- we may not be able to sell our water filtration products or chronic renal failure therapy products at competitive prices or profitably;
- we may encounter problems with our suppliers, manufacturers and distributors;
- we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
- we may not obtain appropriate or necessary regulatory approvals to achieve our business plan;
- products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;
- we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and
- we may not be able to achieve sales growth in key geographic markets.
More detailed information about the company and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and our other periodic reports filed with the SEC. We urge you to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.
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