Full Press Release Details
2005 Annual Stockholders Meeting
Forward Looking Statements
This presentation contains certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended.
Such statements may include statements regarding the efficacy and intended use
of Nephros'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,
we claim the protection of the Private Securities Litigation Reform Act of 1995.
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 the control of Nephros. Actual results
may differ materially from the expectations contained in the forward-looking
statements. Factors that may cause such differences include the risks that: (i)
potential products that appeared promising in early research or clinical trials
to Nephros may not demonstrate efficacy or safety in subsequent pre-clinical or
clinical trials; (ii) Nephros may not obtain appropriate or necessary
governmental approvals; (iii) product orders may be cancelled, patients
currently using Nephros's products may cease to do so and patients expected to
begin using Nephros's products may not; (iv) Nephros may not be able to obtain
funding if and when needed; (v) Nephros may encounter unanticipated internal
control deficiencies or weaknesses or ineffective disclosure controls and
procedures; (vi) HDF therapy may not be accepted in the United States and/or
Nephros's technology and products may not be accepted in target markets; (vii)
Nephros may not be able to sell its products at competitive prices or
profitably; and (viii) Nephros may not be able to secure or enforce adequate
legal protection, including patent protection, for its products. More detailed
information about Nephros and the risk factors that may affect the realization
of forward-looking statements is set forth in Nephros's filings with the
Securities and Exchange Commission, including Nephros's Annual Report on Form
10-KSB filed with the SEC for the fiscal year ended December 31, 2004 and its
Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter ended
March 31, 2005. Investors and security holders are urged to read those documents
free of charge on the SEC's web site at www.sec.gov. Nephros does not undertake
to publicly update or revise its forward-looking statements as a result of new
information, future events or otherwise.
Nephros has transitioned from a Development Stage Company
Successfully completed our Initial Public Offering
2.1 million shares issued
$10.8 million in net proceeds
Company can operate through 2nd quarter 2006 without revenues
Nephros has transitioned from a Development Stage Company (cont'd)
o Strengthened our Management Team
+ Marc Panoff: Chief Financial Officer
+ Jan Rehnberg: Senior Vice President, European Sales (organizing
distribution channels)
+ Nick Staub: Director, Sales & Marketing (direct sales development)
Nephros has transitioned from a
Development Stage Company (cont'd)
o Established our European Sales & Marketing Program
In-house sales team operating in UK, Ireland and France
Added renal and medical product distributors in Europe [map highlighting
Germany, Italy, Greece, Belgium and the Netherlands]
In-house: distributor supervision and support: sales training, nursing and
Nephros has transitioned from a
Development Stage Company (cont'd)
o Initiated Sales of OLpur MD190 in Europe while reducing product
manufacturing and materials costs
Sales increasing quarter over quarter
New and improved fiber in the MD190 since April:
>> Improved clinical performance
>> Fiber cost per unit now reduced by 25%
Research and Development Progress
>> OLpur H2H moving forward towards US clinical trials, targeted for early
>> Working with an established dialysis machine manufacturer to develop and
manufacture a stand-alone HDF machine based on our H2H architecture
Combined with our Olpur mid-dilution technology, we believe this machine
will be both the most cost-effective and the most therapeutically
effective stand-alone system in the ESRD therapy marketplace
What has happened since year-end?
Adding distributors and patients, and continuing to increase market share [map
showing distribution of distributors: (i) at year-end 2004 - Ireland, UK,
France, Italy, Germany and Greece; (ii) engaged in 2005 - Spain, Norway, Denmark
and Sweden; and (iii) in discussions to engage - Switzerland, Finland and
Favorable articles regarding our Olpur MD190 in Kidney International:
"...promises to be a true technological step ahead"
...and Nephrology, Dialysis and Transplantation:
"...may become the new standard for renal replacement therapy"
What has happened since year-end? (Cont'd)
Initiated three marketing trials across five countries to reaffirm and validate
OLpur MD190's patient benefits and cost savings [map highlighting Great Britain,
France, Italy, Germany and Sweden]
In June, Fresenius Medical Care AG announced study results (>2,500 patients, 56
clinics) showing HDF therapy provides a 35% lower mortality rate than
Received 510(k) approval from the FDA for our OLpur HD190 filter
What has happened since year-end? (Cont'd)
Continuing to add patients and grow sales as our marketing trials progress:
>> Continuing our education program for physicians, nurses and other
industry professionals: Europe and US
>> Continuing to engage key physicians in our target markets: France,
UK, Italy, Germany, Spain, Denmark, US
>> We believe the marketing trials are a key part of our strategy to
gain market share for Nephros mid-dilution therapy
A New Strategic Alliance
o Asahi Kasei Medical
Received $2.7 million in investment and license fees; Asahi will develop
and market our technology in Japan