Class
|
Outstanding
at November 14, 2006
|
Common
Stock, $.001 par value
|
12,317,992
|
Transitional
Small Business Disclosure Format: YES [ ] NO
[X]
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial Statements
|
|
Condensed
Consolidated Balance Sheets as of September 30, 2006 and December
31,
2005
|
1
|
Condensed
Consolidated Statements of Operations for the Three and Nine Months
Ended
September 30, 2006 and 2005
|
2
|
Condensed
Consolidated Statements of Cash Flows for the Nine Months Ended September
30, 2006 and 2005
|
3
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity for the Nine
Months Ended September 30, 2006
|
4
|
Notes
to the Condensed Consolidated Financial Statements
|
5
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
13
|
Item
3. Controls and Procedures
|
24
|
PART
II. OTHER INFORMATION
|
|
Item
6. Exhibits
|
26
|
Signatures
|
27
|
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash and cash equivalents
|
$
|
923,957
|
$
|
746,581
|
|||
Short-term investments
|
3,800,000
|
4,500,000
|
|||||
Accounts receivable, less allowances: 2006: $37,157; 2005:
$18,697
|
472,944
|
244,100
|
|||||
Inventory
|
463,442
|
814,548
|
|||||
Prepaid expenses and other current assets
|
380,905
|
358,306
|
|||||
Total current assets
|
6,041,248
|
6,663,535
|
|||||
Property
and equipment, net
|
943,061
|
1,143,309
|
|||||
Other
assets
|
17,732
|
17,731
|
|||||
Total assets
|
$
|
7,002,041
|
$
|
7,824,575
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts payable
|
$
|
762,260
|
$
|
766,158
|
|||
Accrued expenses
|
273,020
|
451,109
|
|||||
Accrued severance expense
|
-
|
318,250
|
|||||
Note payable - short-term portion
|
379,751
|
295,838
|
|||||
Total current liabilities
|
1,415,032
|
1,831,355
|
|||||
Convertible notes payable
|
5,210,860
|
-
|
|||||
Accrued interest - convertible notes
|
103,430
|
-
|
|||||
Note payable - long-term portion
|
184,025
|
613,727
|
|||||
Total liabilities
|
6,913,347
|
2,445,082
|
|||||
Stockholders'
equity:
|
|||||||
Common stock
|
12,318
|
12,313
|
|||||
Additional paid-in capital
|
53,114,329
|
54,848,711
|
|||||
Deferred compensation
|
-
|
(2,189,511
|
)
|
||||
Accumulated other comprehensive loss
|
(36,694
|
)
|
(49,137
|
)
|
|||
Accumulated deficit
|
(53,001,259
|
)
|
(47,242,883
|
)
|
|||
Total stockholders' equity
|
88,694
|
5,379,493
|
|||||
Total liabilities and stockholders' equity
|
$
|
7,002,041
|
$
|
7,824,575
|
|||
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
September
30
|
September
30
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Contract
revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
1,750,000
|
|||||
Net
product revenues
|
164,699
|
225,248
|
641,115
|
603,339
|
|||||||||
Net revenues
|
164,699
|
225,248
|
641,115
|
2,353,339
|
|||||||||
Cost
of goods sold
|
202,839
|
151,646
|
810,677
|
400,695
|
|||||||||
Gross
(loss) profit
|
(38,140
|
)
|
73,602
|
(169,562
|
)
|
1,952,644
|
|||||||
Operating
expenses:
|
|||||||||||||
Research and development
|
544,505
|
401,873
|
1,444,281
|
1,415,584
|
|||||||||
Depreciation expense
|
64,223
|
75,345
|
224,250
|
230,050
|
|||||||||
Selling, general and administrative
|
1,256,354
|
1,404,660
|
3,965,817
|
4,658,975
|
|||||||||
Total
operating expenses
|
1,865,082
|
1,881,878
|
5,634,348
|
6,304,609
|
|||||||||
Loss
from operations
|
(1,903,222
|
)
|
(1,808,276
|
)
|
(5,803,910
|
)
|
(4,351,965
|
)
|
|||||
Interest
income
|
116,014
|
60,394
|
163,855
|
178,863
|
|||||||||
Interest
expense
|
113,494
|
-
|
113,494
|
-
|
|||||||||
Other
expense
|
4,826
|
-
|
4,826
|
-
|
|||||||||
Net
loss
|
$
|
(1,905,528
|
)
|
$
|
(1,747,882
|
)
|
$
|
(5,758,375
|
)
|
$
|
(4,173,102
|
)
|
|
Basic
and diluted net loss per common shares
|
$
|
(0.15
|
)
|
$
|
(0.14
|
)
|
$
|
(0.47
|
)
|
$
|
(0.34
|
)
|
|
Shares
used in computing basic and
|
|||||||||||||
diluted net loss per common share
|
12,317,992
|
12,307,089
|
12,316,773
|
12,254,753
|
Nine
Months Ended September 30,
|
|||||||
2006
|
2005
|
||||||
Operating
activities:
|
|||||||
Net
loss
|
$ |
(5,758,375
|
)
|
$
|
(4,173,102
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
224,250
|
229,828
|
|||||
Loss
on disposal of equipment
|
24,293
|
-
|
|||||
Amortization
of debt discount
|
3,939
|
-
|
|||||
Noncash
stock-based compensation
|
453,693
|
326,458
|
|||||
(Increase)
decrease in operating assets:
|
|||||||
Accounts
receivable
|
(181,076
|
)
|
(54,813
|
)
|
|||
Inventory
|
387,087
|
184,445
|
|||||
Prepaid
expenses and other current assets
|
(490
|
)
|
(248,800
|
)
|
|||
Increase
(decrease) in operating liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
(614,736
|
)
|
267,987
|
||||
Accrued
severance expense
|
(335,402
|
)
|
-
|
||||
Accrued
interest-convertible notes
|
103,430
|
-
|
|||||
Deferred
revenue
|
-
|
(64,058
|
)
|
||||
Net
cash used in operating activities
|
(5,693,387
|
)
|
(3,532,055
|
)
|
|||
Investing
activities
|
|||||||
Purchase
of property and equipment
|
(32,776
|
)
|
(228,990
|
)
|
|||
Purchase
of short-term investments
|
(3,000,000
|
)
|
-
|
||||
Maturities
of short-term investments
|
3,700,000
|
-
|
|||||
Net
cash provided by (used in) investing activities
|
667,224
|
(228,990
|
)
|
||||
Financing
activities
|
|||||||
Proceeds
from private placement of common stock
|
-
|
955,521
|
|||||
Proceeds
from private placement of convertible notes
|
5,206,921
|
-
|
|||||
Adjustment
to proceeds from IPO of common stock
|
-
|
44,361
|
|||||
Proceeds
from exercise of stock options
|
1,441
|
1,439
|
|||||
Net
cash provided by financing activities
|
5,208,362
|
1,001,321
|
|||||
Effect
of exchange rates on cash
|
(4,824
|
)
|
(130,514
|
)
|
|||
Net
increase (decrease) in cash and cash equivalents
|
177,375
|
(2,890,238
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
746,581
|
3,719,181
|
|||||
Cash
and cash equivalents, end of period
|
$
|
923,957
|
$
|
828,943
|
|||
Supplemental
disclosure of cash flow information
|
|||||||
Cash
paid for taxes
|
$
|
32,283
|
$
|
11,630
|
|||
See
accompanying notes to the condensed consolidated financial
statements
|
Common
Stock
|
Additional
Paid-in
|
Deferred
|
Accumulated
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Capital
|
Compensation
|
Loss
|
Deficit
|
Total
|
||||||||||||||||
Balance,
December 31, 2005
|
12,313,494
|
$
|
12,313
|
$
|
54,848,711
|
$
|
(2,189,511
|
)
|
$
|
(49,137
|
)
|
$
|
(47,242,883
|
)
|
$
|
5,379,493
|
||||||
Comprehensive
loss:
|
||||||||||||||||||||||
Net loss
|
(5,758,375
|
)
|
(5,758,375
|
)
|
||||||||||||||||||
Net unrealized losses on foreign currency translation
|
12,443
|
12,443
|
||||||||||||||||||||
Comprehensive loss
|
(5,745,932
|
)
|
||||||||||||||||||||
Reclassification
of deferred compensation
|
(2,189,511
|
)
|
2,189,511
|
-
|
||||||||||||||||||
Noncash
stock-based compensation
|
453,693
|
453,693
|
||||||||||||||||||||
Exercise
of stock options
|
4,498
|
5
|
1,436
|
1,441
|
||||||||||||||||||
Balance,
September 30, 2006
|
12,317,992
|
$
|
12,318
|
$
|
53,114,329
|
$
|
-
|
$
|
(36,694
|
)
|
$
|
(53,001,259
|
)
|
$
|
88,694
|
See
accompanying notes to the condensed consolidated financial
statements
|
1. |
Basis
of Presentation and Going
Concern
|
Customer
|
2006
|
2005
|
||
A
|
|
63%
|
|
41%
|
B
|
|
20%
|
|
3%
|
Customer
|
2006
|
2005
|
||
A
|
|
71%
|
|
65%
|
C
|
|
12%
|
|
11%
|
2. |
Stock
Based Compensation
|
Nine
Months Ended
September
30,
|
||
2006
|
2005
|
|
Expected
volatility
|
65%
to 92%
|
80%
|
Risk-free
interest rate
|
4.3%
to 5.0%
|
4.0%
|
Expected
life of options (in years)
|
5.8
to 6.0
|
7.0
|
Three
Months
Ended
September
30,
|
NineMonths
Ended
September30,
|
||||||
2005
|
2005
|
||||||
Net
loss as reported
|
$
|
(1,747,882
|
)
|
$
|
(4,173,102
|
)
|
|
Add back: compensation expense recorded under the intrinsic method | 35,566 | 326,458 | |||||
Deduct:
compensation expense under the fair value method
|
(161,862 | ) | (675,728 | ) | |||
Pro
forma net loss using the fair value method
|
$
|
(1,874,178
|
)
|
$
|
(4,522,372
|
)
|
|
Net
loss per share:
|
|||||||
As
reported
|
$
|
(0.14
|
)
|
$
|
(0.34
|
)
|
|
Pro
forma
|
$ |
(0.15
|
)
|
$ |
(0.37
|
)
|
Number
of options
|
Weighted
Average
Exercise
Price
|
||||||
At
January 1, 2006
|
|
1,884,537
|
|
$
|
1.91
|
|
|
Granted | 650,500 | 1.14 | |||||
Exercised
|
(4,498 | ) | 0.32 | ||||
Canceled or expired
|
|
(202,573
|
)
|
|
2.65
|
|
|
Outstanding
at September 30, 2006
|
2,327,966
|
$ |
1.75
|
||||
Exercisable
at September 30, 2006
|
|
1,387,611
|
|
$
|
1.54
|
|
3. |
Loss
per Common Share
|
4. |
Inventory
|
September
30, 2006
|
December
31, 2005
|
||||||
Raw
Materials
|
$
|
187,006
|
$
|
153,299
|
|||
Finished Goods | 276,436 | 661,249 | |||||
Total
Inventory
|
$ | 463,442 | $ | 814,548 | |||
5. |
Convertible
Notes due 2012
|
6. |
Commitments
and Contingencies
|
· |
OLpūr
MDHDF filter series (currently consisting of our MD 190 and MD220
diafilters) designed expressly for HDF therapy and employing our
proprietary Mid-Dilution Diafiltration
technology;
|
· |
OLpūr
H2H,
our add-on module designed to allow the most common types of hemodialysis
machines to be used for HDF therapy;
and
|
· |
OLpūr
NS2000 system, our stand-alone HDF machine and associated filter
technology.
|
· |
advancing
our OLpūr
H2H
product development in order to apply for regulatory approval for
the
OLpūr
H2H
and OLpūr
MDHDF filter series products in the United States which we have targeted
for the fourth quarter of 2007;
|
· |
advancing
our OLpūr
H2H
product development in order to apply for regulatory approval for
the
OLpūr
H2H
product in the European Community which we have targeted for the
first
half of 2007;
|
· |
developing
alternative configurations using our proprietary water filtration
technology to address a growing range of market opportunities;
and
|
· |
advancing
our OLpūr
NS2000 product development in conjunction with a European dialysis
machine
manufacturer in order to eventually obtain regulatory approval in
the
European Community and in the United States in
2007.
|
· |
our
OLpūr
MD
190 and MD220 products principally in France, Germany, Ireland, Italy,
and
the United Kingdom as well as Cyprus, Denmark, Greece, the Netherlands,
Norway, Portugal, Spain, Sweden and Switzerland (collectively, our
“Target
European Market”).
|
· |
our
ultrapure water filtration systems in the U.S. in the health care
and
other commercial markets, primarily our MediWash shower in the U.S.
medical community.
|
(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 that exceed our
per
unit costs; and
|
(5)
|
the
consolidation of dialysis clinics into larger clinical
groups.
|
· |
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 CE mark for products
other
than our OLpūr
MDHDF filter series, for which the CE mark was obtained in July 2003,
or
United States regulatory approval;
|
· |
our
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
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 6 to our Condensed Consolidated Financial Statements for additional
information regarding such
payment);
|
· |
to
pay a former supplier, Plexus Services Corp., amounts due under our
settlement agreement; and
|
· |
for
working capital purposes and for additional professional fees and
expenses
and other operating costs.
|
· |
make
it more difficult for us to satisfy our other
obligations;
|
· |
require
us to dedicate a substantial portion of any cash flow we may generate
to
payments on our debt obligations, which would reduce the availability
of
our cash flow to fund working capital, capital expenditures and other
corporate requirements;
|
· |
impede
us from obtaining additional financing in the future for working
capital,
capital expenditures and general corporate purposes;
and
|
· |
make
us more vulnerable in the event of a downturn in our business prospects
and limit our flexibility to plan for, or react to, changes in our
industry.
|
· |
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 the Company;
|
· |
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 satisfy our debt obligations when they become
due and
payable;
|
· |
we
may not be able to continue as a going concern;
and
|
· |
we
may not be able to meet the AMEX’s continued listing standards and as a
result, we may be delisted from the
AMEX.
|
· |
Monthly
meetings to address all expense and accrual activity focusing on
analysis
of budget variances. Meetings are led by the Chief Financial Officer
and
attended by the Chief Executive Officer and other functional departmental
executives; and
|
· |
Engaging
outside accounting services to support and supplement our internal
staff
and enhance our internal controls over accounting and related
areas.
|
10.1
|
Employment
Agreement between Nephros, Inc. and William J. Fox, entered into
on August
2, 2006 (incorporated by reference to Exhibit 10.1 to Nephros, Inc.’s
Current Report on Form 8-K
filed with the Securities and Exchange Commission on August 4,
2006)
|
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
|
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
|
NEPHROS,
INC.
|
|
Date:
November 14, 2006
|
By: By: /s/
Mark W. Lerner
By:
/s/ Mark W.
Lerner
Mark
W. Lerner
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
10.1
|
Employment
Agreement between Nephros, Inc. and William J. Fox, entered into
on August
2, 2006 (incorporated by reference to Exhibit 10.1 to Nephros,
Inc.’s
Current Report on Form 8-K
filed with the Securities and Exchange Commission on August 4,
2006)
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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
|
32.1
|
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
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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
|