UNITED
STATES
|
SECURITIES
AND EXCHANGE COMMISSION
|
WASHINGTON,
DC 20549
|
Class
|
Outstanding
at August 13, 2007
|
Common
Stock, $.001 par value
|
12,317,992
|
Transitional
Small Business Disclosure Format: YES [ ] NO
[X]
|
|
|
|
PART
I. FINANCIAL INFORMATION
|
Page
|
|
|
Item
1. Financial Statements
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets as of June 30, 2007 and December
31,
2006
|
1
|
|
|
Unaudited
Condensed Consolidated Statements of Operations for the three and
six
months ended June 30, 2007 and 2006
|
2
|
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows for the six months
ended
June 30, 2007 and 2006
|
3
|
|
|
Unaudited
Condensed Consolidated Statement of Changes in Stockholders’ Deficit
and Comprehensive
|
|
Loss
for the six months ended June 30, 2007
|
4
|
Notes
to the Unaudited Condensed Consolidated Interim Financial
Statements
|
5
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
|
11
|
|
|
Item
3. Controls and Procedures
|
22
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PART
II. OTHER INFORMATION
|
|
Item
4. Submission of Matters to a Vote of Security Holders
|
24
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|
|
Item
6. Exhibits
|
26
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|
|
Signatures
|
27
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June
30,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$
|
530
|
$
|
253
|
||||
Short-term
investments
|
-
|
2,800
|
||||||
Accounts
receivable, less allowances of $7 and $48 as of June 30, 2007 and
December
31, 2006, respectively
|
10
|
228
|
||||||
Inventory,
net
|
634
|
512
|
||||||
Prepaid
expenses and other current assets
|
432
|
440
|
||||||
|
|
|
|
|
|
|
|
|
Total
current assets
|
1,606
|
4,233
|
||||||
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
751
|
911
|
||||||
Other
assets
|
23
|
23
|
||||||
Total
assets
|
$
|
2,380
|
$
|
5,167
|
||||
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts payable
|
$
|
770
|
$
|
568
|
||||
Accrued
expenses
|
620
|
649
|
||||||
Accrued
severance expense
|
-
|
94
|
||||||
Note
payable - short-term portion
|
417
|
380
|
||||||
Total
current liabilities
|
1,807
|
1,691
|
||||||
Long-term
liabilities:
|
||||||||
Convertible
notes payable
|
5,210
|
5,205
|
||||||
Accrued
interest-convertible notes
|
337
|
183
|
||||||
Note
payable - long-term portion
|
-
|
184
|
||||||
Total
long-term liabilities
|
5,547
|
5,572
|
||||||
Commitments
and contingencies
|
||||||||
Stockholders'
deficit:
|
||||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized, none
issued
|
-
|
-
|
||||||
Common
stock, $.001 par value; 40,000,000 and 25,000,000 shares authorized
and
12,317,992
shares
issued and outstanding as of June 30, 2007 and December 31, 2006,
respectively
|
12
|
12
|
||||||
Additional
paid-in capital
|
53,430
|
53,135
|
||||||
Accumulated
other comprehensive income
|
40
|
12
|
||||||
Accumulated
deficit
|
(58,456
|
)
|
(55,255
|
)
|
||||
Total
stockholders' deficit
|
(4,974
|
)
|
(2,096
|
)
|
||||
Total
liabilities and stockholders' deficit
|
$
|
2,380
|
$
|
5,167
|
Three
Months Ended
June
30,
|
Six
Months Ended
June
30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Net
product revenues
|
$ |
348
|
$ |
302
|
$ |
644
|
$ |
476
|
||||||||
Cost
of goods sold
|
245
|
462
|
450
|
608
|
||||||||||||
Gross
margin
|
103
|
(160 | ) |
194
|
(132 | ) | ||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
416
|
554
|
804
|
900
|
||||||||||||
Depreciation
|
84
|
84
|
167
|
160
|
||||||||||||
Selling,
general and administrative
|
1,152
|
1,392
|
2,290
|
2,709
|
||||||||||||
Total
operating expenses
|
1,652
|
2,030
|
3,261
|
3,769
|
||||||||||||
Loss
from operations
|
(1,549 | ) | (2,190 | ) | (3,067 | ) | (3,901 | ) | ||||||||
Other
income (expenses):
|
||||||||||||||||
Interest
income
|
8
|
9
|
33
|
48
|
||||||||||||
Interest
expense
|
(81 | ) |
-
|
(168 | ) |
-
|
||||||||||
Other
|
(8 | ) |
-
|
1
|
-
|
|||||||||||
Net
loss
|
$ | (1,630 | ) | $ | (2,181 | ) | $ | (3,201 | ) | $ | (3,853 | ) | ||||
Basic
and diluted net loss per common share
|
$ | (0.13 | ) | $ | (0.18 | ) | $ | (0.26 | ) | $ | (0.31 | ) | ||||
Shares
used in computing basic and diluted net loss
|
||||||||||||||||
per
common share
|
12,317,992
|
12,317,992
|
12,317,992
|
12,316,153
|
Six
Months ended June 30,
|
||||||||
2007
|
2006
|
|||||||
Cash
flows from operating activities:
|
||||||||
|
|
|
|
|
|
|
||
Net
loss
|
$
|
(3,201
|
)
|
$
|
(3,853
|
)
|
||
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
|
|
|
|
|
|
|
|
|
Depreciation
|
167
|
157
|
||||||
Amortization
of research and development assets
|
7
|
-
|
||||||
Amortization
of debt discount
|
6
|
-
|
||||||
Change
in valuation of derivative liability
|
(1
|
)
|
-
|
|||||
Stock-based
compensation
|
295
|
373
|
||||||
|
|
|
|
|
|
|
|
|
(Increase)
decrease in operating assets:
|
||||||||
Accounts
receivable, net
|
220
|
(88
|
)
|
|||||
Inventory,
net
|
(111
|
)
|
367
|
|||||
Prepaid
expenses and other current assets
|
10
|
63
|
||||||
|
|
|
|
|
|
|
|
|
Increase
(decrease) in operating liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
165
|
(731
|
)
|
|||||
Accrued
severance expense
|
(95
|
)
|
76
|
|||||
Accrued
interest-convertible notes
|
154
|
-
|
||||||
Other
liabilities
|
(147
|
)
|
(100
|
)
|
||||
Net
cash used in operating activities
|
(2,531
|
)
|
(3,736
|
)
|
||||
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
||||||||
Purchase
of property and equipment
|
(2
|
)
|
(18
|
)
|
||||
Purchase
of short-term investments
|
-
|
(3,000
|
)
|
|||||
Proceeds
received from maturities of short-term investments
|
2,800
|
2,500
|
||||||
Net
cash provided by (used in) investing activities
|
2,798
|
(518
|
)
|
|||||
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
||||||||
Proceeds
from exercise of stock options
|
-
|
1
|
||||||
Proceeds
from private placement of convertible securities
|
-
|
5,200
|
||||||
Net
cash provided by financing activities
|
-
|
5,201
|
||||||
|
|
|
|
|
|
|
|
|
Effect
of exchange rates on cash
|
10
|
(3
|
)
|
|||||
|
|
|
|
|
|
|
|
|
Net
increase in cash and cash equivalents
|
277
|
944
|
||||||
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, beginning of period
|
253
|
747
|
||||||
Cash
and cash equivalents, end of period
|
$
|
530
|
$
|
1,691
|
||||
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information
|
||||||||
Cash
paid during the period for income taxes
|
$
|
1
|
$
|
-
|
Common
Stock
|
Additional
Paid-in
|
Accumulated
Other Comprehensive
|
Accumulated
|
Total
Stockholders’
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income
|
Deficit
|
Deficit
|
|||||||||||||||||||
Balances,
December 31, 2006
|
12,317,992
|
$ |
12
|
$ |
53,135
|
$ |
12
|
$ | (55,255 | ) | $ | (2,096 | ) | |||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,201 | ) | (3,201 | ) | ||||||||||||||||
Net
unrealized gains on foreign currency translation, net of
taxes
|
-
|
-
|
-
|
28
|
-
|
28
|
||||||||||||||||||
Comprehensive
loss
|
-
|
-
|
-
|
-
|
-
|
(3,173 | ) | |||||||||||||||||
Stock-based
compensation
|
-
|
-
|
295
|
-
|
-
|
295
|
||||||||||||||||||
Balances,
June 30, 2007
|
12,317,992
|
$ |
12
|
$ |
53,430
|
$ |
40
|
$ | (58,456 | ) | $ | (4,974 | ) |
See
accompanying notes to the unaudited condensed consolidated interim
financial statements
|
1.
|
Basis
of Presentation and Going
Concern
|
2.
|
Concentration
of Credit Risk
|
Customer
|
|
2007
|
|
2006
|
A
|
|
94%
|
|
72%
|
B
|
|
0%
|
|
17%
|
Customer
|
|
2007
|
|
2006
|
A
|
|
0%
|
|
71%
|
C
|
|
0%
|
|
14%
|
3.
|
Stock-Based
Compensation
|
4.
|
Comprehensive
Income
|
5.
|
Loss
per Common Share
|
6.
|
Recent
Accounting Pronouncements
|
7.
|
Inventory,
net
|
June
30, 2007
|
December
31,
2006
|
|||||||
|
|
|
|
|
|
|
||
Raw
Materials
|
$
|
83,000
|
$
|
54,000
|
||||
Finished
Goods
|
551,000
|
458,000
|
||||||
Total
Inventory, net
|
$
|
634,000
|
$
|
512,000
|
8.
|
Convertible
Notes due 2012
|
9.
|
Commitments
and Contingencies
|
|
||
•
|
the
market acceptance of our products, and our ability to effectively
and
efficiently produce and market our products;
|
|
•
|
the
availability of additional financing, through the sale of equity
securities or otherwise, on commercially reasonable terms or at
all;
|
|
•
|
the
timing and costs associated with obtaining the Conformité Européene, or
CE, mark, which demonstrates compliance with the relevant European
Union
requirements and is a regulatory prerequisite for selling our ESRD
therapy
products in the European Union and certain other countries that recognize
CE marking (for products other than our OLpūr
MDHDF Filter Series, for which the CE mark was obtained in July 2003),
or
United States regulatory approval;
|
|
|
||
•
|
the
ability to maintain the listing of our common stock on the
AMEX;
|
|
•
|
the
continued progress in and the costs of clinical studies and other
research
and development programs;
|
|
|
||
•
|
the
costs involved in filing and enforcing patent claims and the status
of
competitive products; and
|
|
|
||
•
|
the
cost of litigation, including potential patent litigation and any
other
actual or threatened litigation.
|
•
|
for
outstanding accounts payable and accrued expenses;
|
•
|
for
the marketing and sales of our products;
|
•
|
to
complete certain clinical studies, obtain appropriate regulatory
approvals
and expand our research and development with respect to our ESRD
therapy
products;
|
•
|
to
continue our ESRD therapy product engineering;
|
|
|
•
|
to
pursue business opportunities with respect to our DSU water-filtration
product;
|
|
|
•
|
to
pay the Receiver of Lancer Offshore, Inc. amounts due under the settlement
with respect to the Ancillary Proceeding between us and the Receiver
(See
“Note 9—Commitments and Contingencies—Settlement Agreements” to the
Unaudited Condensed Consolidated Financial Statements for a description
of
the settlement);
|
|
|
•
|
to
pay a former supplier, Plexus Services Corp., amounts due under our
settlement agreement; and
|
|
|
•
|
for
working capital purposes, additional professional fees and expenses,
additional financial resources in the finance department and for
other
operating costs.
|
·
|
During 2007,
our net loss decreased approximately $652,000 and our stock-based
compensation expense decreased approximately $78,000 compared to
2006.
|
·
|
Our
accounts receivable decreased by approximately $220,000 during 2007
compared to an increase of approximately $88,000 during 2006. In
order to
accelerate collections of accounts receivable we offered a discount
to our
largest customer. Our customer accepted this offer and paid the net
balances due prior to June 30, 2007.
|
·
|
Our
inventory increased by approximately $111,000 during 2007 compared
to a
decrease of approximately $367,000 during 2006.
|
·
|
Our
accounts payable and accrued expenses increased in total by approximately
$165,000 in 2007 compared to a decrease of approximately $731,000
in
2006.
|
·
|
Our
prepaid expenses and other assets increased by approximately $10,000
in
2007 compared to a increase of approximately $63,000 in
2006.
|
·
|
During
2007, our accrued severance expenses decreased by approximately $95,000,
which was substantially offset by an increase of approximately $154,000
in
accrued interest relating to the convertible notes that were issued
in
June 2006.
|
·
|
During 2007,
we paid amounts due under settlement agreements totaling approximately
$225,000 (included within “other liabilities” on the statement of cash
flow).
|
·
|
we
may not be able to satisfy our obligations when they become due and
payable;
|
·
|
products
that appeared promising in research or clinical trials to us may
not
demonstrate anticipated efficacy, safety or cost savings in subsequent
pre-clinical or clinical trials;
|
·
|
we
may not obtain appropriate or necessary governmental or regulatory
approvals to achieve our business
plan;
|
·
|
product
orders may be cancelled, patients currently using our products may
cease
to do so, patients expected to begin using our products may not and
we may
not be able to bring on new patients at the rate originally
anticipated;
|
·
|
we
may not be able to obtain funding if and when needed or on terms
favorable
to us;
|
·
|
we
may encounter unanticipated internal control deficiencies or weaknesses
or
ineffective disclosure controls and
procedures;
|
·
|
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;
|
·
|
we
may not be able to sell our ESRD therapy or water filtration products
at
competitive prices or profitably;
|
·
|
we
may not be able to secure or enforce adequate legal protection, including
patent protection, for our
products;
|
·
|
FDA
approval relating to our OLpūr HD190 filter may not facilitate or
have any effect on the regulatory approval process for our other
products;
|
·
|
we
may not be able to achieve sales growth in Europe or expand into
other key
geographic markets;
|
·
|
we
may not be able to meet the AMEX’s continued listing standards and as a
result, we may be delisted from the AMEX;
and
|
·
|
we
may not be able to continue as a going
concern.
|
·
|
Develop
procedures to implement a formal monthly closing process and hold
monthly
meetings to address the monthly closing process;
|
·
|
Establish
a detailed timeline for review and completion of financial reports
to be
included in our Forms 10-QSB and 10-KSB;
|
·
|
Enhance
the level of service provided by outside accounting service providers
to
further support and supplement our internal staff in accounting and
related areas;
|
·
|
Seek
additional staffing to provide additional resources for internal
preparation and review of financial reports; and
|
·
|
Employ
the use of appropriate supplemental SEC and U.S. GAAP checklists
in
connection with our closing process and the preparation of our Forms
10-QSB and 10-KSB.
|
|
Votes
For
|
Votes
Withheld
|
|
|
|
|
|
Norman
J. Barta
|
9,047,427
|
23,785
|
|
|
|
|
|
Lawrence
J. Centella
|
9,047,427
|
23,785
|
|
Dr.
Eric A. Rose
|
9,047,427
|
23,785
|
Votes
For
|
Votes Against
|
Votes Abstained
|
||
9,069,812
|
700
|
700
|
Votes
For
|
Votes Against
|
Votes Abstained
|
||
9,047,427
|
28,785
|
0
|
Votes
For
|
Votes Against
|
Votes Abstained
|
||
9,046,427
|
24,085
|
700
|
Votes
For
|
Votes Against
|
Votes Abstained
|
||
8,986,002
|
84,510
|
700
|
Votes
For
|
Votes Against
|
Votes Abstained
|
||
9,911,948
|
52,249
|
1,550
|
3.1
|
Fourth
Amended and Restated Certificate of Incorporation of the Registrant
(Incorporated by reference to Nephros, Inc.’s Registration Statement on
Form S-8 (No. 333-127264), as filed with the Securities and Exchange
Commission on August 5, 2005).
|
3.2
|
Certificate
of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Registrant, effective as of June 4,
2007.
|
3.3
|
Certificate
of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Registrant, effective as of June 29,
2007.
|
31.1
|
Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
Certification
by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
3.1
|
Fourth
Amended and Restated Certificate of Incorporation of the Registrant
(Incorporated by reference to Nephros, Inc.’s Registration Statement on
Form S-8 (No. 333-127264), as filed with the Securities and Exchange
Commission on August 5, 2005).
|
3.2
|
Certificate
of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Registrant, effective as of June 4,
2007.
|
3.3
|
Certificate
of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Registrant, effective as of June 29,
2007.
|
31.1
|
Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
Certification
by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|