DELAWARE
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13-3971809
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(State
or Other Jurisdiction of Incorporation or Organization)
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(I.R.S.
Employer Identification No.)
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3960
Broadway
New
York, New York
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10032
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(Address
of Principal Executive Offices)
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(Zip
code)
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Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨
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Smaller
reporting company x
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Page No.
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PART I –
FINANCIAL INFORMATION
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||
Item
1.
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Unaudited
Condensed Consolidated Interim Financial Statements
|
1
|
Unaudited
Condensed Consolidated Balance Sheets
|
1
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
2
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows
|
3
|
|
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
|
4
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
11
|
Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk.
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23
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Item
4T.
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Controls
and Procedures
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23
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Item
6.
|
Exhibits
|
|
March
31,
|
December
31,
|
||||||
|
2008
|
2007
|
|||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,505
|
$
|
3,449
|
|||
Short-term
investments
|
4,700
|
||||||
Accounts
receivable, less allowances of $3 and $7, respectively
|
405
|
419
|
|||||
Inventory,
less allowances of $32 and $30, respectively
|
355
|
336
|
|||||
Prepaid
expenses and other current assets
|
459
|
392
|
|||||
Total
current assets
|
3,724
|
9,296
|
|||||
|
|||||||
Property
and equipment, net
|
724
|
762
|
|||||
Investments
|
4,286
|
||||||
Other
assets
|
27
|
27
|
|||||
Total
assets
|
$
|
8,761
|
$
|
10,085
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
610
|
$
|
488
|
|||
Accrued
expenses
|
922
|
841
|
|||||
Total
current liabilities
|
1,532
|
1,329
|
|||||
|
|||||||
Stockholders’
equity :
|
|||||||
|
|||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at March 31,
2008 and
December 31, 2007; no shares issued and outstanding at March 31,
2008 and
December 31, 2007.
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|||||||
|
|||||||
Common
stock, $.001 par value; 60,000,000 and 60,000,000 shares authorized
at
March 31, 2008 and December 31, 2007, respectively; 38,165,380
and
38,165,380 shares issued and outstanding at March 31, 2008 and
December
31, 2007, respectively.
|
38
|
38
|
|||||
|
|||||||
Additional
paid-in capital
|
90,252
|
90,220
|
|||||
Accumulated
other comprehensive income
|
191
|
110
|
|||||
Accumulated
deficit
|
(83,252
|
)
|
(81,612
|
)
|
|||
Total
stockholders’ equity
|
7,229
|
8,756
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
8,761
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$
|
10,085
|
Three
Months Ended
March
31,
|
|||||||
2008
|
2007
|
||||||
Net
product revenues
|
$
|
387
|
$
|
296
|
|||
Cost
of goods sold
|
238
|
205
|
|||||
Gross
margin
|
149
|
91
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
723
|
388
|
|||||
Depreciation
expense
|
88
|
83
|
|||||
Selling,
general and administrative
|
1,114
|
1,138
|
|||||
Total
operating expenses
|
1,925
|
1,609
|
|||||
Loss
from operations
|
(1,776
|
)
|
(1,518
|
)
|
|||
Interest
income
|
92
|
25
|
|||||
Interest
expense
|
(84
|
)
|
|||||
Impairment
of auction rate securities
|
(114
|
) |
|
||||
Amortization
of debt discount
|
(3
|
)
|
|||||
Other
income
|
158
|
9
|
|||||
Net
loss
|
$
|
(1,640
|
)
|
$
|
(1,571
|
)
|
|
Net
loss per common share, basic and diluted
|
$
|
(0.04
|
)
|
$
|
(0.13
|
)
|
|
Weighted
average common shares outstanding, basic and diluted
|
38,165,380
|
12,317,992
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Three
Months Ended
March
31,
|
|||||||
2008
|
2007
|
||||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(1,640
|
)
|
$
|
(1,571
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
88
|
83
|
|||||
Amortization
of research & development assets
|
4
|
4
|
|||||
Impairment
of auction rate securities
|
114
|
||||||
Amortization
of debt discount
|
3
|
||||||
Change
in valuation of derivative liability
|
(7
|
)
|
|||||
Stock-based
compensation
|
32
|
187
|
|||||
(Increase)
decrease in operating assets:
|
|||||||
Accounts
receivable
|
40
|
(17
|
)
|
||||
Inventory
|
5
|
(138
|
)
|
||||
Prepaid
expenses and other current assets
|
(55
|
)
|
122
|
||||
Increase
(decrease) in operating liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
235
|
(195
|
)
|
||||
Accrued
severance expense
|
(62
|
)
|
(94
|
)
|
|||
Accrued
interest-convertible notes
|
76
|
||||||
Other
liabilities
|
(192
|
)
|
|||||
Net
cash used in operating activities
|
(1,239
|
)
|
(1,739
|
)
|
|||
Investing
activities
|
|||||||
Purchase
of property and equipment
|
(10
|
)
|
(2
|
)
|
|||
Purchase
of short-term investments
|
(100
|
)
|
|||||
Maturities
of short-term investments
|
400
|
1,900
|
|||||
Net
cash provided by investing activities
|
290
|
1,898
|
|||||
Effect
of exchange rates on cash
|
5
|
1
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
(944
|
)
|
160
|
||||
Cash
and cash equivalents, beginning of year
|
3,449
|
253
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,505
|
$
|
413
|
|||
Supplemental
disclosure of cash flow information
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|||||||
Cash
paid for interest
|
$
|
|
$
|
5
|
|||
Cash
paid for taxes
|
$
|
9
|
$
|
32
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1.
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Basis
of Presentation and
Liquidity
|
2.
|
Concentration
of Credit Risk
|
Customer
|
2008
|
2007
|
|||||
A
|
90%
|
|
90%
|
|
|||
B
|
6%
|
|
0%
|
|
|||
Customer
|
2008
|
2007
|
|||||
A
|
94%
|
|
91%
|
|
|||
B
|
6%
|
|
0%
|
|
|||
3.
|
Revenue
Recognition
|
4.
|
Stock-Based
Compensation
|
5.
|
Comprehensive
Income
|
6.
|
Loss
per Common Share
|
7.
|
Recently
Adopted Accounting
Pronouncements
|
8.
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New
Accounting Pronouncements
|
9.
|
Fair
Value of Financial
Instruments
|
10.
|
Inventory,
net
|
Unaudited
March 31, 2008
|
Unaudited
December 31, 2007
|
||||||
Raw
Materials
|
$
|
161,000
|
$
|
62,000
|
|||
Finished
Goods
|
226,000
|
304,000
|
|||||
Total
Gross Inventory
|
$
|
387,000
|
$
|
366,000
|
|||
Less:
Inventory reserve
|
32,000
|
30,000
|
|||||
Total
Inventory
|
$
|
355,000
|
$
|
336,000
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11.
|
Subsequent
Events
|
(1) |
the
completion and success of additional clinical trials and of our regulatory
approval processes for each of our ESRD therapy products in our target
territories;
|
(2) |
the
market acceptance of HDF therapy in the United States and of our
technologies and products in each of our target
markets;
|
(3) |
our
ability to effectively and efficiently manufacture, market and distribute
our products;
|
(4) |
our
ability to sell our products at competitive prices which exceed our
per
unit costs; and
|
(5) |
the
consolidation of dialysis clinics into larger clinical
groups.
|
·
|
During
the 2008 period, our net loss increased by approximately
$69,000;
|
·
|
During
the 2008 period, our stock-based compensation expense decreased by
approximately $155,000;
|
·
|
During
the 2008 period, we recognized an expense of approximately $114,000
due to
an impairment of ARS, given current market
conditions;
|
·
|
Our
accounts receivable decreased by approximately $40,000 during the
2008
period compared to an increase of approximately $17,000 during the
2007
period;
|
·
|
Our
inventory increased by approximately $5,000 during the 2008 period
compared to an increase of approximately $138,000 during the 2007
period;
|
·
|
Our
prepaid expenses and other assets increased by approximately $55,000
in
the 2008 period compared to a decrease of approximately $122,000
in the
2007 period;
|
·
|
Our
accounts payable and accrued expenses increased by approximately
$235,000
in the aggregate in the 2008 period compared to a decrease of
approximately $195,000 in the 2007
period;
|
·
|
Our
accrued severance expenses decreased by approximately $62,000 in
the
aggregate in the 2008 period compared to a decrease of approximately
$94,000 in the 2007 period;
|
·
|
Our
other liabilities did not change during the 2008 period compared
to a
decrease of approximately $192,000 during the 2007 period (consisting
of
amounts due under settlement
agreements);
|
·
|
We
did not incur any interest expense during the 2008 period compared
to
approximately $76,000 incurred in the 2007 period (consisting of
accrued
interest related to the convertible notes that were issued in June
2006).
|
·
|
future
auctions for our ARS are successful;
|
·
|
another
secondary market evolves for our ARS;
|
·
|
our
ARS are redeemed by their issuer;
or
|
·
|
our
ARS mature.
|
·
|
we
may not be able to obtain funding if and when needed or on terms
favorable
to us in order to continue operations or fund our clinical trials;
|
·
|
we
may not be able to continue as a going concern;
|
·
|
we
may not be able to liquidate our ARS investments when needed to fund
our
operations;
|
·
|
we
may be unable to maintain compliance with the American Stock Exchange's
continued listing standards;
|
·
|
products
that appeared promising to us in research or clinical trials may
not
demonstrate anticipated efficacy, safety or cost savings in subsequent
pre-clinical or clinical trials;
|
·
|
we
may not obtain appropriate or necessary governmental approvals to
achieve
our business plan or effectively market our products;
|
·
|
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 its 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; and
|
·
|
we
may not be able to achieve sales growth in Europe or expand into
other key
geographic markets.
|
• |
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-Q and
10-K;
|
• |
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-Q
and 10-K.
|
10.1
|
Executive
Employment Agreement, dated as of April 1, 2008, between Nephros,
Inc. and
Gerald J. Kochanski
|
10.2
|
Separation
Agreement, dated as of April 28, 2008, between Nephros, Inc. and
Mark W.
Lerner
|
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.
|
32.1
|
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.
|
NEPHROS,
INC.
|
||
Date:
May 15, 2008
|
By:
|
/s/
Norman J. Barta
|
Name:
|
Norman
J. Barta
|
|
Title:
|
President
and Chief Executive Officer (Principal
Executive Officer)
|
|
Date:
May 15, 2008
|
By:
|
/s/
Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
|
Chief
Financial Officer (Principal Financial and Accounting
Officer)
|
10.1
|
Executive
Employment Agreement, dated as of April 1, 2008, between Nephros,
Inc. and
Gerald J. Kochanski
|
10.2
|
Separation
Agreement, dated as of April 28, 2008, between Nephros, Inc. and
Mark W.
Lerner
|
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.
|
32.1
|
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.
|