NEPHROS INC - Quarter Report: 2009 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON
D.C. 20549
FORM
10-Q
(Mark
One)
x QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
quarterly period ended:
September 30, 2009
OR
¨ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
transition period from: _______ to _______
Commission
File Number: 001-32288
NEPHROS,
INC.
(Exact
name of Registrant as Specified in Its Charter)
DELAWARE
|
13-3971809
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S.
Employer Identification No.)
|
41
Grand Avenue
River
Edge, NJ
|
07661
|
(Address
of Principal Executive Offices)
|
(Zip
code)
|
(201)
343-5202
Registrant’s
Telephone Number, Including Area Code
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days
x YES
¨ NO
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
¨
YES o NO
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
¨
YES x NO
As of
November 11, 2009, 41,604,798 shares of issuer’s common stock, with $0.001 par
value per share, were outstanding.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
¨
|
Accelerated
filer
¨
|
Non-accelerated
filer
¨
|
Smaller
reporting company
x
|
(Do not
check if a smaller reporting company)
Table
of Contents
Page No.
|
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PART I –
FINANCIAL INFORMATION
|
||
Item
1.
|
Financial
Statements
|
3
|
Condensed
Consolidated Balance Sheets – September 30, 2009 (unaudited) and December
31, 2008 (audited)
|
3
|
|
Condensed
Consolidated Statements of Operations – Three and nine months ended
September 30, 2009 and 2008 (unaudited)
|
4
|
|
Condensed
Consolidated Statements of Cash Flows – Nine months ended September 30,
2009 and 2008 (unaudited)
|
5
|
|
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
|
6
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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13
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Item
4T.
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Controls
and Procedures
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20
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PART
II – OTHER INFORMATION
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||
Item
1.
|
Legal
Proceedings
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21
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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21
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Item
6.
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Exhibits
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21
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SIGNATURES
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22
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2
PART I – FINANCIAL
INFORMATION
Item 1. Financial
Statements.
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share amounts)
(Unaudited)
|
(Audited)
|
|||||||
September 30,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 1,795 | $ | 2,306 | ||||
Short-term
investments
|
- | 7 | ||||||
Accounts
receivable, less allowances of $0 and $4, respectively
|
525 | 404 | ||||||
Inventory
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607 | 724 | ||||||
Prepaid
expenses and other current assets
|
113 | 162 | ||||||
Total
current assets
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3,040 | 3,603 | ||||||
Property
and equipment, net
|
218 | 412 | ||||||
Other
assets
|
21 | 21 | ||||||
Total
assets
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$ | 3,279 | $ | 4,036 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 616 | $ | 986 | ||||
Accrued
expenses
|
251 | 411 | ||||||
Accrued
severance expense
|
- | 105 | ||||||
Total
current liabilities
|
867 | 1,502 | ||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at September 30, 2009
and December 31, 2008; no shares issued and outstanding at September 30,
2009 and December 31, 2008
|
- | - | ||||||
Common
stock, $.001 par value; 60,000,000 shares authorized at September 30, 2009
and December 31, 2008; 41,604.798 shares issued and outstanding at
September 30, 2009 and 38,165,380 at December 31, 2008
|
42 | 38 | ||||||
Additional
paid-in capital
|
91,774 | 90,375 | ||||||
Accumulated
other comprehensive income
|
88 | 70 | ||||||
Accumulated
deficit
|
(89,492 | ) | (87,949 | ) | ||||
Total
stockholders’ equity
|
2,412 | 2,534 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 3,279 | $ | 4,036 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
3
NEPHROS,
INC. AND SUBSIDIARY
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share and per share amounts)
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
September
30,
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September
30,
|
|||||||||||||||
2009
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2008
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2009
|
2008
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|||||||||||||
Product
revenues
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$ | 711 | $ | 393 | $ | 1,869 | $ | 1,033 | ||||||||
Cost
of goods sold
|
463 | 254 | 1,251 | 654 | ||||||||||||
Gross
margin
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248 | 139 | 618 | 379 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
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62 | 191 | 212 | 2,072 | ||||||||||||
Depreciation
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53 | 84 | 190 | 255 | ||||||||||||
Selling,
general and administrative
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676 | 1,242 | 2,093 | 3,830 | ||||||||||||
Total
operating expenses
|
791 | 1,517 | 2,495 | 6,157 | ||||||||||||
Loss
from operations
|
(543 | ) | (1,378 | ) | (1,877 | ) | (5,778 | ) | ||||||||
Interest
income
|
2 | 27 | 8 | 185 | ||||||||||||
Interest
expense
|
- | - | (2 | ) | - | |||||||||||
Impairment
of auction rate securities
|
- | - | - | (114 | ) | |||||||||||
Unrealized
holding gain - auction rate securities
|
- | (114 | ) | - | - | |||||||||||
Gain
on sale of investments
|
- | 114 | - | 114 | ||||||||||||
Other
income
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146 | 5 | 328 | 163 | ||||||||||||
Net
loss
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$ | (395 | ) | $ | (1,346 | ) | $ | (1,543 | ) | $ | (5,430 | ) | ||||
Net
loss per common share, basic and diluted
|
$ | (0.01 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.14 | ) | ||||
Weighted
average common shares outstanding, basic
and diluted
|
40,439,506 | 38,165,380 | 38,961,179 | 38,165,380 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
4
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In
thousands)
Nine Months Ended September 30,
|
||||||||
2009
|
2008
|
|||||||
Operating
activities:
|
||||||||
Net
loss
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$ | (1,543 | ) | $ | (5,430 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
190 | 255 | ||||||
Amortization
of research & development assets
|
- | 12 | ||||||
Loss
on disposal of equipment
|
- | 3 | ||||||
Impairment
of auction rate securities
|
- | 114 | ||||||
Gain
on sale of investments
|
- | (114 | ) | |||||
Stock-based
compensation
|
68 | 97 | ||||||
(Increase)
decrease in operating assets:
|
||||||||
Accounts
receivable
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(114 | ) | 93 | |||||
Inventory
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118 | (1 | ) | |||||
Prepaid
expenses and other current assets
|
49 | 48 | ||||||
Increase
(decrease) in operating liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
(638 | ) | 594 | |||||
Net
cash used in operating activities
|
(1,870 | ) | (4,329 | ) | ||||
Investing
activities:
|
||||||||
Purchase
of property and equipment
|
- | (63 | ) | |||||
Proceeds
from sale of short-term investments
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- | 4,100 | ||||||
Maturities
of short-term investments
|
7 | 593 | ||||||
Net
cash provided by investing activities
|
7 | 4,630 | ||||||
Financing
activities:
|
||||||||
Proceeds
from private placement
|
1,251 | - | ||||||
Exercise
of stock options
|
84 | - | ||||||
Net
cash provided by investing activities
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1,335 | - | ||||||
Effect
of exchange rates on cash
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17 | (5 | ) | |||||
Net
increase (decrease) in cash and cash equivalents
|
(511 | ) | 296 | |||||
Cash
and cash equivalents, beginning of period
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$ | 2,306 | $ | 3,449 | ||||
Cash
and cash equivalents, end of period
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1,795 | 3,745 | ||||||
Supplemental
disclosure of cash flow information:
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||||||||
Cash
paid for interest
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2 | - | ||||||
Cash
paid for taxes
|
6 | 8 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
5
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1.
|
Basis
of Presentation and Going Concern
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Interim
Financial Information
The
accompanying unaudited condensed consolidated interim financial statements of
Nephros, Inc. and its wholly owned subsidiary, Nephros International, Limited
(collectively, the “Company”), should be read in conjunction with the audited
consolidated financial statements and notes thereto included in the Company’s
2008 Annual Report on Forms 10-K and 10K/A filed with the Securities and
Exchange Commission (the “SEC”) on March 31, 2009 and April 30, 2009,
respectively. The accompanying consolidated financial statements have
been prepared in accordance with accounting principles generally accepted in the
United States of America (“GAAP”) for interim financial information and in
accordance with the instructions to Form 10-Q and Article 8 and Article 10 of
Regulation S-X. Accordingly, since they are interim statements, the
accompanying consolidated financial statements do not include all of the
information and notes required by GAAP for a complete financial statement
presentation. The condensed consolidated balance sheet as of December
31, 2008 was derived from the Company’s audited consolidated financial
statements but does not include all disclosures required by GAAP. In
the opinion of management, the interim consolidated financial statements reflect
all adjustments consisting of normal, recurring adjustments that are necessary
for a fair presentation of the financial position, results of operations and
cash flows for the condensed consolidated interim periods
presented. Interim results are not necessarily indicative of results
for a full year. All significant intercompany transactions and balances have
been eliminated in consolidation.
Adoption
of Standards
We follow
accounting standards set by the Financial Accounting Standards Board
(“FASB”). The FASB sets generally accepted accounting principles
(“GAAP”) that we follow to ensure we consistently report our financial
condition, results of operations, and cash flows. References to GAAP
issued by the FASB in these footnotes are to the FASB Accounting Standards
Codification,™ sometimes referred to as the Codification or
“ASC.” In June 2009, the FASB issued ASC Topic 105, Generally
Accepted Accounting Principals, which became the single source of authoritative
nongovernmental U.S. GAAP, superseding existing FASB, American Institute of
Certified Public Accountants (“AICPA”), Emerging Issues Task Force (“EITF”), and
related accounting literature. This pronouncement reorganizes the
thousands of GAAP pronouncements into roughly 90 accounting topics and displays
them using a consistent structure. Also included is relevant
Securities and Exchange Commission guidance organized using the same topical
structure in separate sections and has been adopted by the Company for the
quarter ended September 30, 2009. This has an impact on the Company’s
financial disclosures since all future references to authoritative accounting
literature will be referenced in accordance with ASC Topic 105.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management
to make estimates and assumptions that affect the amounts reported in the
Company’s consolidated financial statements and accompanying
notes. Actual results could differ materially from those
estimates.
Going
Concern and Management’s Response
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. The Company’s recurring losses and
difficulty in generating sufficient cash flow to meet its obligations and
sustain its operations raise substantial doubt about its ability to continue as
a going concern. The consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
On July
24, 2009, the Company raised gross proceeds of $1,251,000 through the private
placement to eight accredited investors of an aggregate of 1,345,161 shares of
its common stock and warrants to purchase an aggregate of 672,581 shares of its
common stock, representing 50% of the shares of common stock purchased by each
investor. The Company sold the shares to investors at a price per
share equal to $0.93. The warrants have an exercise price of
$1.12, are exercisable immediately and will expire on July 24,
2014.
Each
investor agreed that it will not sell, pledge, sell short or otherwise dispose
of any of the purchased shares or warrants during the period commencing on the
date of purchase and ending on January 31, 2010.
The
shares of common stock and the warrants issued to the investors were not
registered under the Securities Act of 1933, as amended, in reliance upon the
exemption from registration provided by Section 4(2) and Regulation D
thereunder.
6
Based on
the Company’s current cash flow projections, it will need to raise additional
funds through either the licensing or sale of its technologies or additional
public or private offerings of its securities before the end of
2010. The Company continues to investigate strategic funding
opportunities as they are identified. However, there is no guarantee
that the Company will be able to obtain further financing. If it is
unable to raise additional funds on a timely basis or at all, the Company would
not be able to continue its operations. The
Company has incurred significant losses in its operations in each quarter since
inception. For the nine months ended September 30, 2009 and 2008, the
Company has incurred net losses of approximately $1,543,000 and $5,430,000,
respectively. In addition, the Company has not generated positive
cash flow from operations for the nine months ended September 30, 2009 and
2008. To become profitable, the Company must increase revenue
substantially and achieve and maintain positive gross and operating
margins. If the Company is not able to increase revenue and gross and
operating margins sufficiently to achieve profitability, the Company’s results
of operations and financial condition will be materially and adversely
affected.
The Company’s current operating plans primarily include the continued development and support of the Company’s business in the European market, organizational changes necessary to begin the commercialization of the Company’s water filtration business and the completion of current year milestones which are included in the Office of Naval Research appropriation. There can be no assurance that the Company’s future cash flow will be sufficient to meet its obligations and commitments. If the Company is unable to generate sufficient cash flow from operations in the future to service its commitments, the Company will be required to adopt alternatives, such as seeking to raise debt or equity capital, curtailing its planned activities or ceasing its operations. There can be no assurance that any such actions could be effected on a timely basis or on satisfactory terms or at all, or that these actions would enable the Company to continue to satisfy its capital requirements.
2.
|
Concentration
of Credit Risk
|
For the
nine months ended September 30, 2009 and 2008, the following customers accounted
for the following percentages of the Company’s sales, respectively.
Customer
|
2009
|
2008
|
||||||
A
|
45 | % | 84 | % | ||||
B
|
42 | % | 10 | % |
As of
September 30, 2009 and December 31, 2008, the following customers accounted for
the following percentages of the Company’s accounts receivable,
respectively.
Customer
|
2009
|
2008
|
||||||
A
|
47 | % | 66 | % | ||||
B
|
32 | % | 23 | % |
3.
|
Revenue
Recognition
|
Revenue
is recognized in accordance with ASC Topic 605. Four basic criteria
must be met before revenue can be recognized: (i) persuasive evidence that an
arrangement exists; (ii) delivery has occurred or services have been rendered;
(iii) the fee is fixed or determinable; and (iv) collectability is reasonably
assured.
The
Company recognizes revenue related to product sales when delivery is confirmed
by its external logistics provider and the other criteria of ASC Topic 605 are
met. Product revenue is recorded net of returns and
allowances. All shipments are currently received directly by the
Company’s customers.
4.
|
Stock-Based
Compensation
|
The
Company accounts for stock-based compensation in accordance with ASC 718 by
recognizing the fair value of stock-based compensation in the statement of
operations. The fair value of the Company’s stock option awards are
estimated using a Black-Scholes option valuation model. This model
requires the input of highly subjective assumptions and elections including
expected stock price volatility and the estimated life of each
award. In addition, the calculation of compensation costs requires
that the Company estimate the number of awards that will be forfeited during the
vesting period. The fair value of stock-based awards is amortized
over the vesting period of the award. For stock-based awards that
vest based on performance conditions (e.g. achievement of certain milestones),
expense is recognized when it is probable that the condition will be
met.
For the
three months ended September 30, 2009 and 2008, stock-based compensation expense
was approximately $33,000 for both periods. For the nine months ended
September 30, 2009 and 2008, stock-based compensation expense was approximately
$68,000 and $97,000, respectively.
7
There was
no tax benefit related to expense recognized in the three and nine months ended
September 30, 2009 and 2008, as the Company is in a net operating loss
position. As of September 30, 2009, there was approximately $256,000
of total unrecognized compensation cost related to unvested share-based
compensation awards granted under the equity compensation
plans. Such amount does not include the effect of future grants of
equity compensation, if any. Of this amount, approximately $256,000
will be amortized over the weighted-average remaining requisite service period
of 2.7 years. Of the total $256,000, the Company expects to recognize
approximately 10% in the remaining interim periods of 2009, approximately 37% in
2010, approximately 35% in 2011 and approximately 18% in 2012.
5.
|
Comprehensive
Income
|
The
Company complies with the provisions of ASC 220-10, which requires companies to
report all changes in equity during a period, except those resulting from
investment by owners and distributions to owners, for the period in which they
are recognized. Comprehensive income is the total of net
income and all other non-owner changes in equity (or other comprehensive
income (loss)) such as unrealized gains or losses on securities classified as
available-for-sale and foreign currency translation adjustments. As
of September 30, 2009 and December 31, 2008, accumulated other comprehensive
income was approximately $88,000 and $70,000, respectively.
6.
|
Loss
per Common Share
|
In
accordance with ASC 260-10, net loss per common share amounts (“basic EPS”) are
computed by dividing net loss by the weighted-average number of common shares
outstanding and excluding any potential dilution. Net loss per common
share amounts assuming dilution (“diluted EPS”) are generally computed by
reflecting potential dilution from conversion of convertible securities and the
exercise of stock options and warrants. However, because their effect
is antidilutive, the Company has excluded stock options and warrants aggregating
9,698,539 and 14,339,324 from the computation of diluted EPS for the three and
nine month periods ended September 30, 2009 and 2008, respectively.
7.
|
Recent
Accounting Pronouncements
|
Fair Value
Measurements – In September 2006, the FASB issued guidance regarding fair
value measurements. This guidance defines fair value, establishes a
framework for measuring fair value, and expands disclosures about fair value
measurements. It applies to other accounting pronouncements where the
FASB requires or permits fair value measurements but does not require any new
fair value measurements. In February 2008, FASB issued a
pronouncement, which delayed the effective date of its prior guidance regarding
fair value measurements, specifically for certain non-financial assets and
non-financial liabilities to fiscal years beginning after November 15, 2008, and
interim periods within those fiscal years. The Company adopted the
guidance for financial assets and liabilities on January 1, 2008. It
did not have any impact on the Company’s results of operations or financial
position and did not result in any additional disclosures and the Company
adopted the guidance for non-financial assets and non-financial liabilities on
January 1, 2009, resulting in no impact to the Company’s consolidated financial
position, results of operations or cash flows.
In April
2009, the FASB issued new accounting guidance on determining fair value when the
volume and level of activity for the asset or liability have significantly
decreased and identifying transactions that are not orderly. The
guidance affirms that the objective of fair value when the market for an asset
is not active is the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at
the measurement date under current market conditions. It provides
guidance for estimating fair value when the volume and level of market activity
for an asset or liability have significantly decreased and determining whether a
transaction was orderly. It applies to all fair value measurements
when appropriate. The adoption of this guidance did not have a
significant impact on the Company’s consolidated financial position, results of
operations or cash flows, or related footnotes.
In April
2009, the FASB issued new accounting guidance on interim disclosures about fair
value of financial instruments, which is effective for the Company for the
quarterly period beginning April 1, 2009. The guidance requires an
entity to provide the annual disclosures required by a prior pronouncement
regarding disclosures about fair value of financial instruments, in its interim
financial statements. The application of the guidance did not have a significant
impact on the Company’s consolidated financial position, results of operations
or cash flows, or related footnotes.
In August
2009, the FASB issued an update to provide further guidance on how to measure
the fair value of a liability, an area where practitioners have been seeking
further guidance. It primarily does three things: 1) sets
forth the types of valuation techniques to be used to value a liability when a
quoted price in an active market for the identical liability is not available,
2) clarifies that when estimating the fair value of a liability, a reporting
entity is not required to include a separate input or adjustment to other inputs
relating to the existence of a restriction that prevents the transfer of the
liability and 3) clarifies that both a quoted price in an active market for the
identical liability at the measurement date and the quoted price for the
identical liability when traded as an asset in an active market when no
adjustments to the quoted price of the asset are required are Level 1 fair value
measurements. This standard is effective beginning fourth quarter of
2009 for the Company. The adoption of this standard update is not
expected to impact the Company’s consolidated financial position, results of
operations or cash flows.
8
Business Combinations
– In December 2007, the FASB issued new accounting guidance on business
combinations. The pronouncement establishes principles and
requirements for how the acquirer in a business combination recognizes and
measures in its financial statements the fair value of identifiable assets
acquired, the liabilities assumed and any noncontrolling interest in the
acquiree at the acquisition date. The pronouncement determines what information
to disclose to enable users of the financial statements to evaluate the nature
and financial effects of the business combination. It is effective
for fiscal years beginning after December 15, 2008. The Company
adopted the pronouncement on January 1, 2009 resulting in no impact to the
Company’s consolidated financial position, results of operations or cash
flows.
Subsequent Events –
On May 28, 2009, the FASB issued guidance regarding subsequent events, which the
Company adopted on a prospective basis beginning April 1, 2009. The
guidance is intended to establish general standards of accounting and disclosure
of events that occur after the balance sheet date but before financial
statements are issued or are available to be issued. It requires the
disclosure of the date through which an entity has evaluated subsequent events
and the basis for selecting that date. The application of the
pronouncement did not have an impact on the Company’s consolidated financial
position, results of operations or cash flows.
FASB Accounting Standards
Codification – On June 29, 2009, the FASB issued an accounting
pronouncement establishing the FASB Accounting Standards Codification as the
source of authoritative accounting principles recognized by the FASB to be
applied by nongovernmental entities. This pronouncement was effective
for financial statements issued for interim and annual periods ending after
September 15, 2009, for most entities. On the effective date, all
non-SEC accounting and reporting standards will be superseded. The
Company adopted this new accounting pronouncement for the quarterly period ended
September 30, 2009, as required, and adoption did not have a material impact on
the Company’s consolidated financial position, results of operations or cash
flows.
Recognition and Presentation
of Other-Than-Temporary Impairments – In April 2009, the FASB issued
an accounting pronouncement, which is effective for the Company for interim and
annual reporting periods ending after June 15, 2009, that amends existing
guidance for determining whether an other than temporary impairment of debt
securities has occurred. Among other changes, the FASB replaced the
existing requirement that an entity’s management assert it has both the intent
and ability to hold an impaired security until recovery with a requirement that
management assert (a) it does not have the intent to sell the security, and
(b) it is more likely than not it will not have to sell the security before
recovery of its cost basis. The Company has no debt securities as of June 30,
2009 therefore there is no impact on the Company’s September 30, 2009
consolidated financial position, results of operations or cash
flows.
8.
|
Fair
Value of Financial Instruments
|
The
carrying amounts of cash and cash equivalents, short-term investments, accounts
receivable, accounts payable and accrued expenses approximate fair value due to
the short-term maturity of these instruments.
The
following table details the fair value measurements within the fair value
hierarchy of the Company’s financial assets at December 31,
2008:
Fair Value Measurements at Reporting
Date Using
|
||||||||||||||||
Total Fair Value at
December 31, 2008
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Certificate
of deposit
|
$ | 7,000 | $ | 7,000 | $ | — | $ | — | ||||||||
Total
|
$ | 7,000 | $ | 7,000 | $ | — | $ | — |
The
Company had no financial assets held at fair value at September 30,
2009.
9.
|
Inventory
|
Inventory
is stated at the lower of cost or market using the first-in first-out method.
The Company’s inventory as of September 30, 2009 and December 31, 2008 was
approximately as follows:
Unaudited
|
Audited
|
|||||||
September 30, 2009
|
December 31, 2008
|
|||||||
Raw
Materials
|
$ | 109,000 | $ | 382,000 | ||||
Finished
Goods
|
498,000 | 342,000 | ||||||
Total
Inventory
|
$ | 607,000 | $ | 724,000 |
9
10.
|
Equity
Transactions
|
Warrants
Class D
Warrants — As disclosed in Note 8 to the December 31, 2008
consolidated financial statements, the Company issued Class D warrants to
purchase an aggregate of 9,112,566 shares of the Company’s common stock to the
investors upon conversion of the purchased notes. The Company recorded the
issuance of the Class D warrants at their approximate fair market value of
$3,763,000. The value of the Class D warrants was computed using the
Black-Scholes option pricing model.
Placement
Agent Warrants — As disclosed in Note 8 to the December 31,
2008 consolidated financial statements , the Company issued placement agent
warrants to purchase an aggregate of 1,756,374 shares of the Company’s common
stock to the Company’s placement agents in connection with their roles in the
Company’s fall 2007 financing (“the 2007 Financing”). The Company recorded the
issuance of the placement agent warrants at their approximate fair market value
of $1,047,000. The value of the placement agent warrants was computed using the
Black-Scholes option pricing model.
The
following table summarizes certain terms of all of the Company’s outstanding
warrants at December 31, 2008.
Total
Outstanding Warrants as of December 31, 2008
Title of Warrant
|
Date Issued
|
Expiry Date
|
Exercise Price
|
Total Common
Shares Issuable
|
||||||||
IPO
Underwriter Warrants
|
3/24/2005
|
9/20/2009
|
$ | 7.50 | 200,000 | |||||||
Lancer
Warrants
|
1/18/2006
|
1/18/2009
|
$ | 1.50 | 21,308 | |||||||
Class
D Warrants
|
11/14/2007
|
11/14/2012
|
$ | 0.706 | 9,112,566 | |||||||
Placement
Agent Warrants
|
11/14/2007
|
11/14/2012
|
$ | 0.90 | 1,756,374 | |||||||
Total
all Outstanding Warrants
|
$ | 1.02 |
(1)
|
11,090,248 |
(1)
Weighted average.
The IPO
Underwriter Warrants expired on September 20, 2009.
The
Lancer Warrants expired on January 18, 2009.
Issuance
of Common Stock due to Class D Warrants’ Cashless Exercise
Provision
The
Series D warrants have a cashless exercise provision which
states, “ If, and only if, at the time of exercise pursuant to this
Section 1 there is no effective registration statement registering, or no
current prospectus available for, the sale of the Warrant Shares to the Holder
or the resale of the Warrant Shares by the Holder and the VWAP (as defined
below) is greater than the Per Share Exercise Price at the time of exercise,
then this Warrant may also be exercised at such time and with respect to such
exercise by means of a “cashless exercise” in which the Holder shall be entitled
to receive a certificate for the number of Warrant Shares equal to the quotient
obtained by dividing (i) the result of (x) the difference of (A) minus (B),
multiplied by (y) (C), by (ii) (A), where:
(A)
=
|
the
VWAP (as defined below) on the Trading Day (as defined below) immediately
preceding the date of such election;
|
(B)
=
|
the
Per Share Exercise Price of this Warrant, as adjusted;
and
|
(C)
=
|
the
number of Warrant Shares issuable upon exercise of this Warrant in
accordance with the terms of this Warrant by means of a cash exercise
rather than a cashless
exercise.
|
10
“VWAP”
means, for any date, the price determined by the first of the following clauses
that applies: (a) if the Common Stock is then listed or quoted for trading
on the New York Stock Exchange, American Stock Exchange, NASDAQ Capital Market,
NASDAQ Global Market, NASDAQ Global Select Market or the OTC Bulletin Board, or
any successor to any of the foregoing (a “ Trading Market ”), the daily volume
weighted average price of the Common Stock on the Trading Market on which the
Common Stock is then listed or quoted for trading as reported by Bloomberg L.P.
for such date if such date is a date on which the Trading Market on which the
Common Stock is then listed or quoted for trading (a “ Trading Day ”) or the
nearest preceding Trading Date (based on a Trading Day from 9:30 a.m. (New York
City time) to 4:02 p.m. (New York City time); (b) if the Common Stock is
not then listed or quoted for trading on a Trading Market and if prices for the
Common Stock are then reported in the “Pink Sheets” published by Pink Sheets,
LLC (or a similar organization or agency succeeding to its functions of
reporting prices), the most recent bid price per share of the Common Stock so
reported; or (c) in all other cases, the fair market value of a share of
Common Stock as determined by an independent appraiser selected in good faith by
the Holder and reasonably acceptable to the Company.”
The
Company did not have an effective registration statement or a current prospectus
available for the sale of the warrant shares to the holder or the resale of the
warrant shares by the holder and the VWAP (as defined above) was greater than
the per share exercise price during the months of June through September
2009.
A Class D
warrant holder elected to exercise 1,723,001 of the 9,112,566 Class D Warrants
outstanding as of June 2009 pursuant to the cashless exercise provision of the
warrant. As a result, 1,091,222 shares of common stock were issued to
this Class D warrant holder in August 2009. The number of shares
outstanding in the September 30, 2009 balance sheet and the number of shares
outstanding used in the earnings per share calculation for the three and nine
months ended September 30, 2009 include these shares.
Issuance
of Common Stock due to Placement Agent Warrants’ Cashless Exercise
Provision
National
Securities Corporation (“NSC”) and Dinosaur Securities, LLC (“Dinosaur” and
together with NSC, the “Placement Agents”) acted as co-placement agents in
connection with the 2007 Financing pursuant to an Engagement Letter, dated June
6, 2007 and a Placement Agent Agreement dated September 18, 2007. The
Placement Agents received (i) an aggregate cash fee equal to 8% of the face
amount of the notes purchased in the 2007 Financing (“the Purchased Notes”) and
paid 6.25% to NSC and 1.75% to Dinosaur, and (ii) warrants (“Placement Agent
Warrant”) with a term of five years from the date of issuance to purchase 10% of
the aggregate number of shares of the Company’s common stock issued upon
conversion of the Purchased Notes with an exercise price per share of the
Company’s common stock equal to $0.706. The Company issued Placement
Agents Warrants to purchase an aggregate of 1,756,374 shares of the Company’s
common stock to the Placement Agent in November 2007 in connection with their
roles in the 2007 Financing.
The
Placement Agent Warrants have a cashless exercise provision identical to that in
the Series D Warrants.
The
Company did not have an effective registration statement or a current prospectus
available for the sale of the warrant shares to the holders or the resale of the
warrant shares by the holders and the VWAP (as defined above) was greater than
the per share exercise price during the months of June through September
2009. Several Placement Agents elected to exercise the cashless
exercise provision of their warrants.
Placement
Agents elected to exercise 1.348,690 of the 1,756,374 Placement Agent Warrants
outstanding in June 2009. All elected the Cashless Exercise provision
of their warrants. As a result, 594,492 shares of common stock were
issued to the Placement Agents in June 2009. The number of shares
outstanding in the June 30, 2009 balance sheet and the number of shares
outstanding used in the earnings per share calculation for the three and six
months ended June 30, 2009 include these shares.
As of
June 30, 2009 there were 407,684 Placement Agent Warrants
outstanding.
Placement
Agents elected to exercise 278,003 of the 407,684 Placement Agent Warrants
outstanding in June 2009. All elected the cashless exercise provision
of their warrants. As a result, 143,762 shares of common stock were
issued to the Placement Agents in the three months ended September 30,
2009. The number of shares outstanding in the September 30, 2009
balance sheet and the number of shares outstanding used in the earnings per
share calculation for the three and six months ended September 30, 2009 include
these shares.
As of
September 30, 2009 there were 129,681 Placement Agent Warrants
outstanding.
11
July
2009 Private Placement
On July
24, 2009, the Company raised gross proceeds of $1,251,000 through the private
placement to eight accredited investors of an aggregate of 1,345,161 shares of
its common stock and warrants to purchase an aggregate of 672,581 shares of its
common stock, representing 50% of the shares of common stock purchased by each
investor. The Company sold the shares to investors at a price per
share equal to $0.93. The warrants have an exercise price of
$1.12, are exercisable immediately and will terminate on July 24,
2014.
Total
Outstanding Warrants as of September 30, 2009
Title of Warrant
|
Date Issued
|
Expiry Date
|
Exercise Price
|
Total Common
Shares Issuable
|
||||||||
Class
D Warrants
|
11/14/2007
|
11/14/2012
|
$ | 0.90 | 7,389,565 | |||||||
Placement
Agent Warrants
|
11/14/2007
|
11/14/2012
|
$ | 0.706 | 129,681 | |||||||
July
2009 Warrants
|
7/24/2009
|
7/24/2014
|
$ | 1.12 | 672,581 | |||||||
Total
all Outstanding Warrants
|
$ | .92 |
(1)
|
8,191,827 |
(1)
Weighted average.
11.
|
Contingencies
|
A former
employee in the United States filed a claim in March 2009 against the Company
and our CEO alleging breach of the individual’s employment agreement and
fraud. The individual was employed with us from April 2008 through
January 8, 2009. The claim was settled as of September 30, 2009 for
approximately $11,000. An accrual of $6,000 has been recorded as of
September 30, 2009.
A third
party has brought a claim against the Company alleging they incurred damages as
a result of its cancellation of a transaction in 2008 involving the sale of
Auction Rate Securities. The claim has been referred to a Financial
Industry Regulatory Authority (FINRA) binding arbitration panel and is scheduled
to be heard in March 2010. There is no specific amount of damages
identified in the claim. The Company denies that a transaction
agreement had been reached and denies any liability involving this
claim. No contingent loss accrual has been recorded by the Company as
of September 30, 2009.
12.
|
Subsequent
Events
|
A former
employee in France filed a claim in October 2008 stating that the
individual is due 30,000 Euro or approximately $42,000 in back
wages. The individual left our employment four years ago and signed a
Separation Agreement which stated we had no further liability to the
individual. Our attorney has advised us that the Separation Agreement
is valid and should preclude us from having any liability. A judgment
dated October 15, 2009 was issued by a French court whereby the claimant was
awarded 11,707 Euro. The judgment is final. An accrual of
$18,000 has been recorded as of September 30, 2009 to cover this
liability.
On
October 26, 2009, the Company amended the certificate of incorporation to
increase the authorized capital stock from 65,000,000 shares to 95,000,000
shares and the authorized common stock from 60,000,000 shares to 90,000,000
shares. This increase was approved by the Company’s stockholders on
October 22, 2009. The amount of authorized preferred stock, which is
5,000,000 shares, was not increased.
The
Company has evaluated subsequent events through November 12, 2009, the date of
issuance of these financial statements.
12
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
This discussion should be read in
conjunction with our consolidated financial statements included in this
Quarterly Report on Form 10-Q and the notes thereto, as well as the other
sections of this Quarterly Report on Form 10-Q, including the “Risk Factors”
section hereof, and our Annual Report for the year ended December 31, 2008 on
Form 10-K, including the “Certain Risks and Uncertainties” and “Description of
Business” sections thereof. This discussion contains a number of forward-looking
statements, all of which are based on our current expectations and could be
affected by the uncertainties and risk factors described in this Quarterly
Report and our Annual Report for the year ended December 31, 2008 on Form
10-K. Our actual results may differ materially.
Financial
Operations Overview
Revenue
Recognition: Revenue is recognized in accordance with ASC
605. Four basic criteria must be met before revenue can be
recognized: (i) persuasive evidence that an arrangement exists; (ii) delivery
has occurred or services have been rendered; (iii) the fee is fixed and
determinable; and (iv) collectability is reasonably assured.
Cost of Goods
Sold: Cost of goods sold represents the acquisition cost for
the products we purchase from our third party manufacturers as well as damaged
and obsolete inventory written off.
Research and
Development: Research and development expenses consist of
costs incurred in identifying, developing and testing product
candidates. These expenses consist primarily of salaries and related
expenses for personnel, fees of our scientific and engineering consultants and
subcontractors and related costs, clinical studies, machine and product parts
and software and product testing. We expense research and development
costs as incurred.
Selling, General and
Administrative: Selling, general and administrative
expenses consist primarily of sales and marketing expenses as well as personnel
and related costs for general corporate functions, including finance,
accounting, legal, human resources, facilities and information systems
expense.
Business
Overview
Founded
in 1997, we are a Delaware corporation that has been engaged primarily in the
development of hemodiafiltration, or HDF, products and technologies for treating
patients with End Stage Renal Disease, or ESRD. In January 2006, we
introduced our new Dual Stage Ultrafilter (the “DSU”) water filtration system,
which represents a new and complementary product line to our existing ESRD
therapy business.
We
currently have three products in various stages of development in the HDF
modality to deliver improved therapy to ESRD patients:
|
·
|
OLpur
MDHDF filter series (which we sell in various countries in Europe and
currently consists of our MD190 and MD220 diafilters), which is to our
knowledge, the only filter designed expressly for HDF therapy and
employing our proprietary Mid-Dilution Diafiltration
technology;
|
|
·
|
OLpur
H2H, our add-on module designed to allow the most common types of
hemodialysis machines to be used for HDF therapy;
and
|
|
·
|
OLpur
NS2000 system, our stand-alone HDF machine and associated filter
technology.
|
We have
also developed our OLpur HD 190 high-flux dialyzer cartridge, which incorporates
the same materials as our OLpur MD series but does not employ our proprietary
Mid-Dilution Diafiltration technology. Our OLpur HD190 was designed for use with
either hemodialysis or hemodiafiltration machines, and received its approval
from the U.S. Food and Drug Administration, or FDA, under Section 510(k) of the
Food, Drug and Cosmetic Act, or the FDC Act, in June 2005.
OLpur
and H2H are among our trademarks for which U.S. registrations are pending. H2H
is a registered European Union trademark. We have assumed that the reader
understands that these terms are source-indicating. Accordingly, such terms
appear throughout the remainder of this Quarterly Report without trademark
notices for convenience only and should not be construed as being used in a
descriptive or generic sense.
13
We
believe that products in our OLpur MDHDF filter series are more effective than
any products currently available for ESRD therapy because they are better at
removing certain larger toxins (known in the industry as “middle molecules”
because of their heavier molecular weight) from blood. The accumulation of
middle molecules in the blood has been related to such conditions as
malnutrition, impaired cardiac function, carpal tunnel syndrome, and
degenerative bone disease in the ESRD patient. We also believe that OLpur H2H
will, upon introduction, expand the use of HDF as a cost-effective and
attractive alternative for ESRD therapy, and that, if approved by the FDA in
2009, our OLpur H2H and MDHDF filters will be the first, and only, HDF therapy,
approved by the FDA, available in the United States at that time.
We
believe that our products will reduce hospitalization, medication and care costs
as well as improve patient health (including reduced drug requirements and
improved blood pressure profiles), and therefore, quality of life, by removing a
broad range of toxins through a more patient-friendly, better-tolerated process.
In addition, independent studies in Europe have indicated that, when compared
with dialysis as it is currently offered in the United States, HDF can reduce
the patient’s mortality risk by up to 35%. We believe that the OLpur MDHDF
filter series and the OLpur H2H will provide these benefits to ESRD patients at
competitive costs and without the need for ESRD treatment providers to make
significant capital expenditures in order to use our products. We also believe
that the OLpur NS2000 system, if successfully developed, will be the most
cost-effective stand-alone hemodiafiltration system available.
In the first quarter of
2007, we received approval from the FDA for our Investigational Device Exemption
(“IDE”) application for the clinical evaluation of our OLpūr H2H module and
OLpūr MD 220 filter. We completed the patient treatment phase of our
clinical trial during the second quarter of 2008. We have submitted our data to
the FDA with our 510(k) application on 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 been
informed that our application is still under their review process.
In
January 2006, we introduced our new Dual Stage Ultrafilter (the “DSU”) water
filtration system. Our DSU represents a new and complementary product line to
our existing ESRD therapy business. The DSU incorporates our unique and
proprietary dual stage filter architecture and is, to our knowledge, the only
water filter that allows the user to sight-verify that the filter is properly
performing its cleansing function. Our research and development work on the
OLpur H2H and MD Mid-Dilution filter technologies for ESRD therapy provided the
foundations for a proprietary multi-stage water filter that we believe is cost
effective, extremely reliable, and long-lasting. We believe our DSU can offer a
robust solution to a broad range of contaminated water and disease prevention
issues. Hospitals are particularly stringent in their water quality
requirements. Transplant patients and other individuals whose immune systems are
compromised can face a substantial infection risk in drinking or bathing with
standard tap water that would generally not present a danger to individuals with
normal immune function. The DSU is designed to remove a broad range of bacteria,
viral agents and toxic substances, including salmonella, hepatitis, cholera,
HIV, Ebola virus, ricin toxin, legionella, fungi and e-coli. With over 5,000
registered hospitals in the United States (as reported by the
American Hospital Association in Fast Facts of October 20, 2006), we believe the
hospital shower and faucet market can offer us a valuable opportunity as a first
step in water filtration.
Due to
the ongoing concerns of maintaining water quality, on October 7, 2008, we filed
a 510(k) application for approval to market our DSU to dialysis clinics for
in-line purification of dialysate water. Following its review of the
application, the FDA requested additional information from us. On
February 24, 2009, we provided a formal response to the FDA. On July 1,
2009, we received FDA approval of the DSU to be used to filter biological
contaminants from water and bicarbonate concentrate used in hemodialysis
procedures.
During
the nine months ended September 30, 2009, we were granted four new
patents. In the U.S., the Company was issued patent #7,534,349 for a
Dual Stage Ultrafilter with pump mechanism and/or shower feature. In Canada, the
Company was issued patent #2,430,575 for a valve mechanism used in Infusion
Fluid systems which is a feature used on our H 2 H TM module and patent
#2,396,852 for an Ionic Enhanced
Dialysis/Diafiltration system which is related to mid-dilution HDF. In China,
the Company was issued patent #200510092067.3 for a Dual Stage Hemodiafiltration
cartridge used in its OLpūr TM MD HDF
Filter.
In 2006,
the U.S. Defense Department budget included an appropriation for the U.S. Marine
Corps for development of a dual stage water ultra filter. In
connection with this Federal appropriation of approximately $1 million, we are
developing a personal potable water purification system for use by warfighters.
Work on this project was completed in August 2009 and we have billed
approximately $900,000 during the twenty months ended August 2009. In
August 2009, we were awarded a new $1.8 million research contract from the
Office of Naval Research (ONR) for development of a potable dual-stage military
water purifying filter. The research contract is an expansion of our current ONR
contract which is being performed as part of the Marine Corps Advanced
Technology Demonstration (ATD) project. The primary objective of this
expanded research program is to select concepts and functional prototype
filter/pump units which were developed during the first phase of the project,
and further develop them into smaller field-testable devices that can be used
for military evaluation purposes. An advantage of our ultrafilter is
the removal of viruses which are not removed with commercially available
off-the-shelf microfilter devices. Such devices generally rely on a secondary
chemical disinfection step to make the water safe to drink. The expanded
contract also includes research geared toward improving membrane performance,
improving device durability, developing larger squad-level water purifier
devices, and investigating desalination filter/pump devices for emergency-use
purposes.
14
We have
also introduced the DSU to various government agencies as a solution to
providing potable water in certain emergency response situations. We have also
begun investigating a range of commercial, industrial and retail opportunities
for our DSU technology.
NYSE
Alternext US LLC (formerly, the American Stock Exchange or “AMEX”)
Issues
On
January 8, 2009, we received a letter from the AMEX notifying us that it
was rejecting our plan of compliance regarding the following listing standards
to which we were in noncompliance of:
|
·
|
Section
1003(a)(iii), which states AMEX will normally consider suspending dealings
in, or removing from the list, securities of an issuer which has
stockholders’ equity of less than $6,000,000 if such issuer has sustained
net losses in its five most recent fiscal
years;
|
|
·
|
Section
1003(a)(ii), which states AMEX will normally consider suspending dealings
in, or removing from the list, securities of an issuer which has
stockholders’ equity of less than $4,000,000 if such issuer has sustained
net losses in its three of its four most recent fiscal years;
and
|
|
·
|
Section
1003(f)(v), which states AMEX will normally consider suspending dealings
in, or removing from the list, common stock that sells for a substantial
period of time at a low price per
share.
|
The AMEX
further stated that the AMEX intended to strike our common stock from the AMEX
by filing a delisting application with the SEC pursuant to Rule 1009(d) of the
AMEX Company Guide. Given the turmoil in the capital markets,
we decided not to seek an appeal of the AMEX’s intention to delist our
common stock.
On
January 22, 2009, we were informed by the AMEX that the AMEX had suspended
trading in our common stock effective immediately. Immediately
following the notification, our common stock was no longer traded on the
AMEX.
Effective
February 4, 2009, our common stock was quoted on the Over the Counter Bulletin
Board under the symbol “NEPH.OB”.
In a
letter dated April 13, 2009, we received a copy of the AMEX’s application to
strike our common stock from the AMEX.
Critical
Accounting Policies
The
discussion and analysis of our consolidated financial condition and results of
operations are based upon our condensed financial statements. These condensed
financial statements have been prepared following the requirements of accounting
principles generally accepted in the United States (“GAAP”) and Rule 8-03
of Regulation S-X for interim periods and require us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, we evaluate our estimates,
including those related to potential impairment of investments and share-based
compensation expense. As these are condensed consolidated financial
statements, you should also read expanded information about our critical
accounting policies and estimates provided in “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” included in our Form
10-K for the year ended December 31, 2008. There have been no
material changes to our critical accounting policies and estimates from the
information provided in our Form 10-K for the year ended December 31,
2008.
New
Accounting Pronouncements
See Note
7 to our condensed consolidated financial statements set forth in Item 1 of this
quarterly report for information regarding new accounting
pronouncements.
Results of
Operations
Fluctuations
in Operating Results
Our
results of operations have fluctuated significantly from period to period in the
past and are likely to continue to do so in the future. We anticipate that our
quarterly results of operations will be impacted for the foreseeable future by
several factors including the progress and timing of expenditures related to our
research and development efforts, as well as marketing expenses related to
product launches. Due to these fluctuations, we believe that the
period to period comparisons of our operating results are not a good indication
of our future performance.
15
Three
Months Ended September 30, 2009 Compared to the Three Months Ended September 30,
2008
Product
Revenues
Net
product revenues were approximately $711,000 for the three months ended
September 30, 2009 compared to approximately $393,000 for the three months ended
September 30, 2008, an increase of 81%. The $318,000 increase in net
product revenues is due to: increased water filter sales of $98,000; increased
military project revenue of $172,000 and increased blood filter sales in Europe
of $48,000.
Cost
of Goods Sold
Cost of
goods sold (“COGS”) was approximately $463,000 for the three months ended
September 30, 2009 compared to approximately $254,000 for the three months ended
September 30, 2008. The increase of approximately $209,000, or
82%, in cost of goods sold is primarily due to: increased water filter COGS of
$32,000; increased military project COGS of $129,000 and increased blood filter
COGS of $48,000. All increases were due to the increased sales or
activities in these areas.
Research
and Development
Research
and development expenses were approximately $62,000 for the three months ended
September 30, 2009 compared to approximately $191,000 for the three months ended
September 30, 2008, a decrease of 68% due primarily to our planned reduction of
activities to conserve our resources. This decrease of $129,000 is
primarily due to: decreased salaries of $25,000; decreased supplies
of $59,000; decreased machine development expense of $34,000; and decreased
testing expenses of $11,000.
Depreciation
Expense
Depreciation
expense was approximately $53,000 for the three months ended September 30, 2009
compared to approximately $84,000 for the three months ended September 30, 2008,
a decrease of 37%. The decrease of approximately $31,000 is primarily due to
several assets having been fully depreciated as of year end 2008 resulting in no
depreciation expense for those assets during the three months ended September
30, 2009. There was not a significant disposition of assets during
the three months ended September 30, 2009 compared to the same period in
2008.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $676,000 for the three
months ended September 30, 2009 compared to approximately $1,242,000 for the
three months ended September 30, 2008, a decrease of $566,000 or
46%. The decrease reflects a reduction in: compensation and benefits
of $389,000; recruiting fees of $55,000; marketing expenses of $50,000;
insurance expense of $52,000 and legal expenses of $20,000 for the three months
ended September 30, 2009 compared to the same period in 2008. The
decreases were primarily due to our reduced headcount and operations
to conserve our resources.
Interest
Income
Interest
income was approximately $2,000 for the three months ended September 30, 2009
compared to approximately $27,000 for the three months ended September 30,
2008. The decrease of approximately $25,000 is due to the
decreased investments held during the three months ended September 30, 2009
compared to the three months ended September 30, 2008.
Interest
Expense
There was
no interest expense for the three months ended September 30, 2009 or September
30, 2008.
Other
income and expenses
Other
income in the amount of approximately $146,000 for the three months ended
September 30, 2009 resulted primarily from receipt of 2007 New York State
Qualified Emerging Technology Company (“QETC”) tax refunds. Other
income for the three months ended September 30, 2008 was approximately
$5,000.
16
Nine
Months Ended September 30, 2009 Compared to the Nine Months Ended September 30,
2008
Revenues
Total
revenues for the nine months ended September 30, 2009 were approximately
$1,869,000 compared to approximately $1,033,000 for the nine months ended
September 30, 2008. Total revenues increased approximately $836,000
or 81%. The increase in net product revenues is due to increased
water filter sales of $190,000; increased military project revenue of $684,000
and decreased blood filter sales in Europe of $38,000.
Cost
of Goods Sold
Cost of
goods sold was approximately $1,251,000 for the nine months ended September 30,
2009 compared to approximately $654,000 for the nine months ended September 30,
2008. The increase of approximately $597,000, or 91%, in cost of
goods sold is primarily due to: increased water filter COGS of
$43,000; increased military project COGS of $521,000 and increased blood filter
COGS of $33,000. All increases were due to the increased sales and
activities in these areas.
Research
and Development
Research
and development expenses were approximately $212,000 for the nine months ended
September 30, 2009 compared to approximately $2,072,000 for the nine months
ended September 30, 2008, a decrease of 90%, due primarily to our planned
reduction of activities to conserve our resources. This decrease of
$1,860,000 is primarily due to the fact that there was no clinical trial being
conducted in the nine months ended September 30, 2009 compared to the same
period in 2008. The decreased spending related to: decreased clinical
trial expense of $1,060.000; decreased salaries of $567,000; decreased supplies
of $102,000 decreased machine development expense of $92,000; decreased testing
expenses of $26,000 and decreased computer software development expenses of
$13,000.
Depreciation
Expense
Depreciation
expense was approximately $190,000 for the nine months ended September 30, 2009
compared to approximately $255,000 for the nine months ended September 30, 2008,
a decrease of 25%. The decrease of approximately $65,000 is primarily due to
several assets having been fully depreciated as of year end 2008 resulting in no
depreciation expense for those assets during the nine months ended September 30,
2009.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $2,093,000 for the nine
months ended September 30, 2009 compared to approximately $3,830,000 for the
nine months ended September 30, 2008, a decrease of $1,737,000 or
45%. The decrease reflects a reduction in: compensation and benefits
of $990,000; recruiting fees of $186,000; professional fees of $54,000; legal
fees of $289,000; insurance expense of $110,000, and facilities expense of
$108,000 for the nine months ended September 30, 2009 compared to the same
period in 2008. The decreases were due primarily to our planned
reduction in headcount and operations to conserve our resources.
Interest
Income
Interest
income was approximately $8,000 for the nine months ended September 30, 2009
compared to approximately $185,000 for the nine months ended September 30,
2008. The decrease of approximately $177,000 or 96% is due to the
decrease in investments held during the nine months ended September 30, 2009
compared to the nine months ended September 30, 2008. We had in excess of $4
million of investments generating interest income during the nine months ended
September 30, 2008 compared to none in the comparable period of
2009.
Interest
Expense
We
incurred approximately $2,000 of interest expense for the nine months ended
September 30, 2009. This interest relates primarily to financing of
premiums for product liability insurance. There was no interest
expense for the nine months ended September 30, 2008.
Impairment
Loss of Auction Rate Securities
Effective
January 1, 2008, we adopted fair value measurements under ASC Topic
820, which applied to our financial assets such as available-for-sale
marketable securities (included as part of investments in the Unaudited
Condensed Consolidated Balance Sheet). These items were to be
marked-to-market at each reporting period; however, the definition of fair value
used for these mark-to-markets is now applied using ASC Topic
820. Our available-for-sale marketable securities consisted of
auction rate securities (ARS) at September 30, 2008.
17
During
the first three months of 2008, our ARS failed at auction due to sell orders
exceeding buy orders in the entire ARS market. Based upon an analysis
of other-than-temporary impairment factors, ARS with an original par value of
approximately $4.4 million were written-down to an estimated fair value of $4.3
million as of March 31, 2008. We reviewed impairments associated
with the above in accordance with ASC Topic 320 to determine the classification
of the impairment as “temporary” or “other-than-temporary.”
An
impairment loss of approximately $114,000 on ARS was charged to our results of
operations for the nine months ended September 30,
2008. Approximately $300,000 of ARS were redeemed at par during the
three months ended June 30, 2008 thereby reducing the total par value from $4.4
million to $4.1 million as of June 30, 2008.
We sold,
at par value, our remaining ARS to a third party on July 22, 2008 for $4.1
million. We recorded an Unrealized Holding Gain in the second quarter
of 2008 of approximately $114,000 when we adjusted such investment to fair
value, as a result of our reclassification of such investment from
Available-for-Sale to Trading Securities. We subsequently reversed
the Unrealized Holding Gain and recorded a Realized Gain on Sale of Investments
of approximately $114,000 in the third quarter of 2008 when the sale transaction
was executed.
There was
no impact on our operations for the nine month period ended September 30, 2009
because the ARS investment was sold in 2008.
Other income and
expenses
Other
income in the amount of approximately $328,000 and $163,000 for the nine months
ended September 30, 2009 and September 30, 2008, respectively, resulted
primarily from receipt of New York State Qualified Emerging Technology Company
(“QETC”) tax refunds in each of these periods. Tax credits for the
years 2006 and 2007 were received during the nine months ended September 30,
2009. The tax credit for the year 2005 was received during the nine
months ended September 30, 2008.
Liquidity
and Capital Resources
Net cash
used in operating activities was approximately $1,870,000 for the nine months
ended September 30, 2009 compared to approximately $4,329,000 for the nine
months ended September 30, 2008. The $2,459,000 decrease in cash used
in operating activities was primarily due to:
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·
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During
the 2009 period, our net loss decreased by approximately
$3,887,000;
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·
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During
the 2009 period, our stock-based compensation expense decreased by
approximately $29,000;
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·
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Our
accounts receivable increased by approximately $114,000 during the 2009
period compared to a decrease of approximately $93,000 during the 2008
period;
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·
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Our
inventory decreased by approximately $118,000 during the 2009 period
compared to an increase of approximately $1,000 during the 2008
period;
|
|
·
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Our
prepaid expenses and other assets decreased by approximately $49,000 in
the 2009 period compared to a decrease of approximately $48,000 in the
2008 period; and
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|
·
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Our
accounts payable and accrued expenses decreased by approximately $638,000
in the aggregate in the 2009 period compared to an increase of
approximately $594,000 in the 2008
period.
|
Net cash
provided by investing activities was approximately $7,000 for the nine months
ended September 30, 2009, compared to net cash provided by investing activities
of approximately $4,630,000 for the nine months ended September 30,
2008. Our net cash provided by investing activities for the nine
months ended September 30, 2008 reflects the proceeds from the sales of auction
rate securities of approximately $4,100,000 plus maturities of short-term
investments net of purchases in the amount of approximately $593,000 partially
offset by approximately $63,000 for purchases of computer
equipment.
On
July 24, 2009, the Company raised gross proceeds of $1,251,000 through the
private placement to eight accredited investors of an aggregate of 1,345,161
shares of its common stock and warrants to purchase an aggregate of 672,581
shares of its common stock, representing 50% of the shares of common stock
purchased by each investor. The Company sold the shares to investors
at a price per share equal to $0.93. The warrants have an exercise
price of $1.12, are exercisable immediately and will terminate on July 24,
2014.
18
Off-Balance
Sheet Arrangements
We did
not engage in any off-balance sheet arrangements during the nine month periods
ended September 30, 2009 and 2008.
Certain
Risks and Uncertainties
Our
Annual Report on Form 10-K for the year ended December 31, 2008 includes a
detailed discussion of risk factors associated with our business under the
heading “Certain Risks and Uncertainties.” The information presented below
should be read in conjunction with the risk factors and information disclosed in
such Form 10-K.
Safe
Harbor for Forward-Looking Statements
This
report 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 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. 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 our control.
Actual results may differ materially from the expectations contained in the
forward-looking statements. Factors that may cause such differences
include the risks that:
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·
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we
may not be able to obtain funding if and when needed or on terms favorable
to us in order to continue
operations;
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·
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we
may not be able to continue as a going
concern;
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·
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we
may not obtain appropriate or necessary regulatory approvals to achieve
our business plan or efeeffectivelyemarket our
products;
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effectively
market our products;
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·
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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;
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·
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we
may encounter unanticipated internal control deficiencies or weaknesses or
ineffective disclosure controls and
procedures;
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|
·
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HDF
therapy may not be accepted in the United States and/or our technology and
products may not be accepted in current or future target markets, which
could lead to failure to achieve market penetration of our
products;
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·
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we
may not be able to sell our ESRD therapy or water filtration products at
competitive prices or profitably;
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·
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we
may not be able to secure or enforce adequate legal protection, including
patent protection, for our products;
and
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·
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We
may not be able to achieve sales growth in Europe or expand into other key
geographic markets.
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More
detailed information about us and the risk factors that may affect the
realization of forward-looking statements, including the forward-looking
statements in this Quarterly Report, is set forth in our filings with the SEC,
including our Annual Report on Form 10-K for the fiscal year ended December 31,
2008 and in this Quarterly Report on Form 10-Q. We urge investors and
security holders 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, unless required by law.
19
Item
4T. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
maintain a system of disclosure controls and procedures, as defined in
Securities and Exchange Act Rule 13a-15(e),which is designed to provide
reasonable assurance that information, which is required to be disclosed in our
reports filed pursuant to the Securities and Exchange Act of 1934, as amended ,
is accumulated and communicated to management in a timely manner. At
the end of the period covered by this Quarterly Report on Form 10-Q, we carried
out an evaluation, under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer,
of the effectiveness of the design and operation of our disclosure controls and
procedures pursuant to Securities and Exchange Act Rule
13a-15(b). Based upon that evaluation, our Chief Executive Officer
and Chief Financial Officer concluded that our disclosure controls and
procedures as of the end of the period covered by this report were
effective.
Changes
in Internal Control over Financial Reporting
In
connection with the preparation of our Annual Report of Form 10-KSB for the year
ended December 31, 2007, management identified a material weakness, due to an
insufficient number of resources in the accounting and finance department,
resulting in (i) an ineffective review, monitoring and analysis of schedules,
reconciliations and financial statement disclosures and (ii) the misapplication
of U.S. GAAP and SEC reporting requirements. Throughout fiscal year
2008 and as reported in our Form 10-Qs filed during the year, we initiated and
implemented the following measures:
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·
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Developed
procedures to implement a formal quarterly closing calendar and process
and held quarterly meetings to address the quarterly closing
process;
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·
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Established
a detailed timeline for review and completion of financial reports to be
included in our Forms 10-Q and
10-K;
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·
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Enhanced
the level of service provided by outside accounting service providers to
further support and provide additional resources for internal preparation
and review of financial reports and supplemented our internal staff in
accounting and related areas; and
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·
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Employed
the use of appropriate supplemental SEC and U.S. GAAP checklists in
connection with our closing process and the preparation of our Forms 10-Q
and 10-K.
|
As a
result of the implementation of the above items, the material weakness was
remediated in the fourth quarter of 2008.
In the
quarter ended September 30, 2009, there were no significant changes in our
internal control over financial reporting or in other factors that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting. Through the evaluation of the Sarbanes-Oxley
internal control assessment, a more structured approach, including checklists,
reconciliations and analytical reviews, has been implemented to reduce risk in
the financial reporting process.
20
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
A former
employee in France filed a claim in October 2008 stating that the
individual is due 30,000 Euro or approximately $42,000 in back
wages. The individual left our employment four years ago and signed a
Separation Agreement which stated we had no further liability to the
individual. Our attorney has advised us that the Separation Agreement
is valid and should preclude us from having any
liability. A judgment dated October 15, 2009 was issued by
a French court whereby the claimant was awarded 11,707 Euro. The
judgment is final. An accrual of $18,000 has been recorded as of
September 30, 2009 to cover this liability.
A former
employee in the United States filed a claim in March 2009 against us and
our CEO alleging breach of the individual’s employment agreement and
fraud. The individual was employed with us from April 2008 through
January 8, 2009. The claim was settled as of September 30, 2009 for
approximately $11,000. An accrual of $6,000 has been
recorded as of September 30, 2009.
A third party has brought
a claim against us alleging they incurred damages as a result of our
cancellation of a transaction in 2008 involving the sale of Auction Rate
Securities. The claim has been referred to a Financial Industry
Regulatory Authority (FINRA) binding arbitration panel and is scheduled to be
heard in March 2010. There is no specific amount of damages
identified in the claim. We deny that a transaction agreement had
been reached and deny any liability involving this claim. No
contingent loss accrual has been recorded by the Company as of September 30,
2009.
There are
no other currently pending legal proceedings and, as far as we are aware, no
governmental authority is contemplating any proceeding to which we are a party
or to which any of our properties is subject.
Item
4. Submission of Matters to a Vote of Security Holders
On
October 22, 2009 we held our annual meeting of our shareholders at
which our shareholders of record as of September 18, 2009 were asked to vote on
three proposals.
Of the
41,604,798 shares of common stock eligible to vote at this meeting, a total of
approximately 32,373,586 shares of common stock were actually present or
represented by proxy. This represents a vote by approximately 77.8%
of the total shares eligible to vote.
The first
proposal was to elect one director to serve on our Board of Directors for a
three-year term. Paul A. Mieyal was re-elected.
The
second proposal was to approve the amendment of our Fourth Amended and Restated
Certificate of Incorporation to increase the authorized shares of our capital
stock from 65,000,000 shares to 95,000,000 shares and increase the authorized
shares of our common stock from 60,000,000 shares to 90,000,000
shares. An aggregate of approximately 64% of the total shares
outstanding was voted in favor of this proposal.
The third
proposal was to ratify the selection of Rothstein Kass & Company, P.C. as
our independent auditors for the year ending December 31, 2009. An
aggregate of approximately 75.9% of the total shares represented and voting at
the meeting was voted in favor of this proposal.
Item 6. Exhibits
EXHIBIT
INDEX
31.1
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Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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31.2
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Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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|
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32.1
|
Certifications
by the Chief Executive Officer and Chief Financial Officer Pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
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21
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
NEPHROS,
INC.
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||
Date:
November 12, 2009
|
By:
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/s/
Ernest A. Elgin III
|
Name:
|
Ernest
A. Elgin III
|
|
Title:
|
President
and Chief Executive Officer
(Principal
Executive Officer)
|
|
Date:
November 12, 2009
|
By:
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/s/
Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
|
Chief
Financial Officer (Principal Financial
and
Accounting Officer)
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22
Exhibit
Index
31.1
|
Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
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31.2
|
Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
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32.1
|
Certifications
by the Chief Executive Officer and Chief Financial Officer Pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
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23