x |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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¨ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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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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|
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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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Financial
Statements
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3
|
|
Unaudited
Condensed Consolidated Interim Financial Statements
|
|
||
Condensed
Consolidated Balance Sheets
|
3
|
||
Unaudited
Condensed Consolidated Statements of Operations
|
4
|
||
Unaudited
Condensed Consolidated Statements of Cash Flows
|
5
|
||
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
|
6
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||
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
11
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|
Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk.
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18
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Item
4T.
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Controls
and Procedures
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18
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PART II – OTHER INFORMATION | |||
Item 4. |
20
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||
Item
6.
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Exhibits
|
20
|
(Unaudited)
|
|||||||
|
June 30,
|
December 31,
|
|||||
2008
|
2007
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,404
|
$
|
3,449
|
|||
Short-term
investments
|
4,100
|
4,700
|
|||||
Accounts
receivable, less allowances of $3 and $7, respectively
|
278
|
419
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|||||
Inventory,
less allowances of $32 and $30, respectively
|
422
|
336
|
|||||
Prepaid
expenses and other current assets
|
490
|
392
|
|||||
Total
current assets
|
6,694
|
9,296
|
|||||
Property
and equipment, net
|
632
|
762
|
|||||
Other
assets
|
27
|
27
|
|||||
Total
assets
|
$
|
7,353
|
$
|
10,085
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,125
|
$
|
488
|
|||
Accrued
expenses
|
1,414
|
841
|
|||||
Total
current liabilities
|
2,539
|
1,329
|
|||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at June 30, 2008
and
December 31, 2007; no shares issued and outstanding at June 30, 2008
and
December 31, 2007.
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|||||||
Common
stock, $.001 par value; 60,000,000 shares authorized at June 30,
2008 and
December 31, 2007; 38,165,380 shares issued and outstanding at June
30,
2008 and December 31, 2007.
|
38
|
38
|
|||||
Additional
paid-in capital
|
90,284
|
90,220
|
|||||
Accumulated
other comprehensive income
|
187
|
110
|
|||||
Accumulated
deficit
|
(85,695
|
)
|
(81,612
|
)
|
|||
Total
stockholders’ equity
|
4,814
|
8,756
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
7,353
|
$
|
10,085
|
Three
Months Ended
|
Six
Months
Ended
|
|||||||||||||||
June
30,
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June
30,
|
|||||||||||||||
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Net
product revenues
|
|
$
|
253
|
|
$
|
348
|
|
$
|
640
|
|
$
|
644
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Cost
of goods sold
|
|
|
162
|
|
|
245
|
|
|
400
|
|
|
450
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Gross
margin
|
|
|
91
|
|
|
103
|
|
|
240
|
|
|
194
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research
and development
|
|
|
1,149
|
|
|
416
|
|
|
1,872
|
|
|
804
|
|
|||
Depreciation
|
|
|
92
|
|
|
84
|
|
|
180
|
|
|
167
|
|
|||
Selling,
general and administrative
|
|
|
1,474
|
|
|
1,152
|
|
|
2,588
|
|
|
2,290
|
|
|||
Total
operating expenses
|
|
|
2,715
|
|
|
1,652
|
|
|
4,640
|
|
|
3,261
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Loss
from operations
|
|
|
(2,624
|
)
|
|
(1,549
|
)
|
|
(4,400
|
)
|
|
(3,067
|
)
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Interest
income
|
|
|
66
|
|
|
8
|
|
|
158
|
|
|
33
|
|
|||
Interest
expense
|
|
|
|
|
|
(81
|
)
|
|
|
|
|
(168
|
)
|
|||
Impairment
of auction rate securities
|
|
|
|
|
|
|
|
|
(114
|
)
|
|
|
|
|||
Unrealized
holding gain - auction rate securities
|
|
|
114
|
|
|
|
|
|
114
|
|
|
|
|
|||
Other
income (expense)
|
|
|
|
|
|
(8
|
)
|
|
158
|
|
|
1
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Net
loss
|
|
$
|
(2,444
|
)
|
$
|
(1,630
|
)
|
$
|
(4,084
|
)
|
$
|
(3,201
|
)
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|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Net
loss per common share, basic and diluted
|
|
$
|
(0.06
|
)
|
$
|
(0.13
|
)
|
$
|
(0.11
|
)
|
$
|
(0.26
|
)
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|||
|
|
|
|
|
|
|
|
|
|
|
|
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|
|||
Weighted
average common shares outstanding,
basic
and diluted
|
|
|
38,165,380
|
|
|
12,317,992
|
|
|
38,165,380
|
|
|
12,317,992
|
|
Six Months Ended June 30,
|
|||||||
2008
|
2007
|
||||||
Operating
activities:
|
|||||||
Net
loss
|
$ |
(4,084
|
)
|
$ |
(3,201
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
172
|
167
|
|||||
Amortization
of research & development assets
|
8 |
7
|
|||||
Impairment
of auction rate securities
|
114
|
|
|||||
Unrealized
holding gain – auction rate securities
|
(114
|
)
|
|
||||
Amortization
of debt discount
|
6
|
||||||
Change
in valuation of derivative liability
|
(1
|
)
|
|||||
Stock-based
compensation
|
64
|
295
|
|||||
(Increase)
decrease in operating assets:
|
|||||||
Accounts
receivable
|
164
|
220
|
|||||
Inventory
|
(59
|
)
|
(111
|
)
|
|||
Prepaid
expenses and other current assets
|
(86
|
)
|
10
|
||||
Increase
(decrease) in operating liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
1,181
|
70
|
|||||
Accrued
interest-convertible notes
|
154
|
||||||
Other
liabilities
|
(147
|
)
|
|||||
Net
cash used in operating activities
|
(2,640
|
)
|
(2,531
|
)
|
|||
Investing
activities:
|
|||||||
Purchase
of property and equipment
|
(8
|
)
|
(2
|
)
|
|||
Purchase
of short-term investments
|
(100
|
)
|
|||||
Maturities
of short-term investments
|
700
|
2,800
|
|||||
Net
cash provided by investing activities
|
592
|
2,798
|
|||||
Effect
of exchange rates on cash
|
3
|
10
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
(2,045
|
)
|
277
|
||||
Cash
and cash equivalents, beginning of period
|
3,449
|
253
|
|||||
Cash
and cash equivalents, end of period
|
|
1,404
|
|
530
|
|||
Supplemental
disclosure of cash flow information:
|
|||||||
Cash
paid for taxes
|
9
|
1
|
1. |
Basis
of Presentation and
Liquidity
|
2. |
Concentration
of Credit Risk
|
Customer
|
2008
|
2007
|
|||||
A
|
84%
|
|
94%
|
|
|||
B
|
8%
|
|
0%
|
|
Customer
|
2008
|
2007
|
|||||
A
|
72%
|
|
0%
|
|
|||
B
|
19%
|
|
0%
|
|
3. |
Revenue
Recognition
|
4. |
Stock-Based
Compensation
|
5. |
Comprehensive
Income
|
6. |
Loss
Per Common
Share
|
7. |
Recently
Adopted Accounting
Pronouncements
|
9. |
Fair
Value of Financial
Instruments
|
10. |
Inventory,
net
|
Unaudited
|
|
||||||
June 30, 2008
|
December 31, 2007
|
||||||
Raw
Materials
|
$
|
144,000
|
$
|
62,000
|
|||
Finished
Goods
|
310,000
|
304,000
|
|||||
Total
Gross Inventory
|
|
454,000
|
|
366,000
|
|||
Less:
Inventory reserve
|
32,000
|
30,000
|
|||||
Total
Inventory
|
$
|
422,000
|
$
|
336,000
|
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
$883,000;
|
|
·
|
During
the 2008 period, adjustments to net loss were approximately
$230,000
lower than during the 2007 period;
|
|
·
|
During
the 2008 period, our decrease in current assets was approximately
$100,000
lower than during the 2007 period;
and
|
|
·
|
During
the 2008 period, our increase in current liabilities was approximately
$1,104,000 higher than during the 2007 period due to higher operating
expenses in the 2008 period as compared to the 2007
period.
|
|
·
|
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 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 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;
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.
|
1.
|
Our
stockholders elected the following persons to serve as directors
for terms
of three years, or until their successors are duly elected and qualified.
Votes were cast as follows:
|
Votes
For
|
Votes
Withheld
|
||||||
Arthur
H. Amron
|
28,987,841
|
34,388
|
|||||
James
S. Scibetta
|
28,988,541
|
33,688
|
2.
|
Our
stockholders approved the appointment of Rothstein Kass & Company,
P.C. as our independent registered public accounting firm for the
fiscal
year ending December 31, 2008. Votes were cast as
follows:
|
Votes
For
|
Votes
Against
|
Votes
Abstained
|
|||||
28,997,680
|
22,303
|
2,246
|
3.
|
Our
stockholders approved the amendment to our 2004 Stock Incentive Plan
that
increases the total number of shares of common stock that may be
granted
pursuant to awards under the Plan from 1,300,000 to 2,696,976. Votes
were
cast as follows:
|
Votes
For
|
Votes
Against
|
Votes
Abstained
|
|||||
25,470,508
|
448,658
|
4,600
|
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:
August 14, 2008
|
By:
|
/s/
Norman J. Barta
|
|
Name:
|
Norman
J. Barta
|
|
Title:
|
President
and Chief Executive Officer (Principal
Executive
Officer) |
|
|
|
Date:
August 14, 2008
|
By:
|
/s/
Gerald J. Kochanski
|
|
Name:
|
Gerald
J. Kochanski
|
|
|
Chief
Financial Officer (Principal Financial and
Accounting
Officer) |
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.
|